Rule: Acquisition Regulations: Administrative and Editorial Changes

Wednesday,
December 20, 2006
Part III
Department of
Health and Human
Services
48 CFR Parts 301, 302 et al.
Acquisition Regulations; Final Rule
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76488 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations
DEPARTMENT OF HEALTH AND • Updating the text of clauses Health and Human Services is making
HUMAN SERVICES required to be inserted in solicitations the rule effective upon publication in
and contracts. the Federal Register.
Office of the Secretary
B. Comments on the Notice of Proposed List of Subjects in 48 CFR Chapter 3
48 CFR Parts 301, 302, 303, 304, 305, Rulemaking Government procurement.
306, 307, 309, 311, 312, 314, 315, 316, The Department published a Notice of Dated: September 21, 2006.
319, 323, 324, 325, 330, 332, 333, 334, Proposed Rulemaking (NPRM) on May Joe W. Ellis,
335, 339, 342, 352, and 370 26, 2006 (70 FR 30520). The comment
Assistant Secretary for Administration and
period closed on July 25, 2006. The Management.
Acquisition Regulations Department received one comment from
AGENCY: Department of Health and the public regarding section 352.270–8. Editorial Note: This document was
The commenter stated that the Office for received in the Office of the Federal Register
Human Services (HHS). on December 13, 2006.
Human Research Protections (OHRP),
ACTION: Final rule. ■ Under the authority of 5 U.S.C. 301;
which was cited as an office within the
SUMMARY: The Department of Health and National Institutes of Health (NIH), is 40 U.S.C. 486(c), the Department of
Human Services is amending its now an office in the Office of Public Health and Human Services amends 48
acquisition regulations (HHSAR) to Health and Science (OPHS). Section CFR Chapter 3 as set forth below.
make administrative and editorial 352.270–8 has been corrected in this CHAPTER 3—HEALTH AND HUMAN
changes to reflect organizational title final rule to refer to the new office SERVICES
changes resulting from Office of the location. ■ 1. The authority citation for 48 CFR
Secretary (OS) and Operating Division In addition, the Department’s internal chapter 3, parts 301 through 370
(OPDIV) reorganizations and to update review of the NPRM has resulted in a continues to read as follows:
or remove outdated text and references. number of editorial changes and
corrections, none of which are Authority: 5 U.S.C. 301; 40 U.S.C. 486(c).
The intent of the final rule is to bring
the HHSAR up to date and to make the substantive.
HHSAR consistent with the latest PART 301—HHS ACQUISITION
C. Regulatory Flexibility Act REGULATION SYSTEM
amendments to the Federal Acquisition
The Department of Health and Human
Regulations (FAR). ■ 2. Revise paragraph (b) of section
Service certifies this rulemaking will
DATES: Effective Date: December 20, 301.101 to read as follows:
not have a significant economic effect
2006. on a substantial number of small entities
301.101 Purpose.
FOR FURTHER INFORMATION CONTACT: under the Regulatory Flexibility Act (5
Katherine Hughes, Office of Acquisition U.S.C. 601 et seq.) because it does not * * * * *
Management and Policy, telephone impose any new requirements. (b) The HHSAR implements FAR
(202) 690–7079, e-mail: Therefore, no regulatory flexibility policies and procedures and provides
Katherine.Hughes@hhs.gov. statement has been prepared. Since this additional policies and procedures that
rule conveys existing acquisition supplement the FAR to satisfy the needs
SUPPLEMENTARY INFORMATION:
policies or procedures and does not of HHS.
A. Background promulgate any new policies or * * * * *
The Department is not making procedures that would impact the ■ 3. Revise section 301.270 to read as
significant amendments to the existing public, it has been determined that this follows:
HHSAR. The amendments to the rule will not have a significant
economic effect on a substantial number 301.270 Executive Committee for
HHSAR concern internal procedural Acquisition.
matters which are administrative in of small entities, and, thus, a regulatory
nature, and will not have a major effect flexibility analysis was not performed. (a) The Deputy Assistant Secretary for
on the general public or on contractors Acquisition Management and Policy has
D. Paperwork Reduction Act established the Executive Committee for
or offerors supporting the Department.
The majority of the amendments The Paperwork Reduction Act does Acquisition (ECA) to assist and facilitate
address the following: not apply because the changes to the the planning and development of
• HHS organizational title changes HHSAR do not impose any record departmental acquisition policies and
resulting from agency reorganizations. keeping or information collection procedures and to assist in responding
• Eliminating procedural guidance no requirements that require approval by to other agencies and organizations
longer deemed necessary. the Office of Management and Budget concerning policies and procedures
• Changing contracting review and under 44 U.S.C. 3501, et seq. Existing impacting the Federal acquisition
approval authorities to situate them at approvals cited in 48 CFR 301.106 process.
levels more appropriate to remain in effect. The provisions of this (b) The ECA consists of members and
simplification, streamlining, and regulation are issued under 5 U.S.C. alternates from the Division of
empowerment. 301; 40 U.S.C. 486(c). Acquisition Policy (DAP), Agency for
• Updating the HHSAR to bring it in Healthcare Research and Quality,
E. Administrative Procedure Act Centers for Medicare & Medicaid
line with the latest amendments made
Exception Services, Program Support Center,
to the Federal Acquisition Regulation
(FAR). This final rule imposes no new Centers for Disease Control and
• Clarifying authorities for selecting burdens on the public and merely Prevention, Food and Drug
and terminating Contracting Officers. updates, corrects, or clarifies existing Administration, Health Resources and
• Establishing minimum training regulations. Therefore, good cause exists Services Administration, Indian Health
requirements for certain positions. under 5 U.S.C. 553(d) to dispense with Service, National Institutes of Health,
• Specifically referencing regulations the 30-day delay in the effective date and Substance Abuse and Mental Health
of other Federal agencies. requirement, and the Department of Services Administration. The ECA is
Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations 76489
chaired by the Director, Division of (e) Procedures. (1) The individual Contracting Officer warrants will be
Acquisition Policy (DAP). All meetings who made the unauthorized contractual issued to civil service personnel only. A
will be held at the call of the Chair, and commitment shall furnish the reviewing delegation of procurement authority
all activities will be carried out under Contracting Officer all records and shall be set forth in a memorandum that
the direction of the Chair. documents concerning the commitment describes the spending limits and
(c) The purposes of the ECA are to: and a complete written statement of authority. Changes to appointments
(1) Advise and assist the Chair on facts, including, a description of the shall be made by issuing a new
major acquisition policy matters; requirement, the estimated or agreed appointment document. Each
(2) Review and evaluate the overall upon price, the funds citation, an appointment document shall be
effectiveness of existing policies and explanation of why the contracting prepared and maintained in accordance
procedures and the impact of new office was not used and why the with FAR 1.603–1 and shall state the
acquisition policies, procedures, and proposed contractor was selected, a list limits of the individual’s authority.
regulations on current acquisition of other sources considered, and a (c) An individual must be certified at
policies and procedures. statement as to whether the contractor the appropriate level as a prerequisite to
(d) The Chair will periodically issue has commenced work. being appointed as a Contracting Officer
a list of current members and alternates, (2) The Contracting Officer will with authority to obligate funds in
including each person’s name, title, review the submitted material and excess of the micro-purchase threshold
organization, address, telephone prepare it for ratification if it is (see 301.603–72). The HCA will
number, and e-mail address. ECA determined that the commitment is determine and require training for
members are responsible for apprising ratifiable. The Contracting Officer shall individuals appointed as Contracting
the Chair of any changes to the list. forward the ratification document and Officers/Contract Specialists at dollar
■ 4. Revise section 301.403 to read as the submitted material to the HCA or levels below the micropurchase
follows: CCO with any comments or information threshold. Individuals selected for
which should be considered in Contracting Officer warrant authority
301.403 Individual deviations. must meet the education, training, and
evaluation of the request for ratification.
Requests for individual deviations to If legal review is desirable, the HCA or experience requirements that are
either the FAR or HHSAR shall be CCO will coordinate the request for established for the warrant level. An
prepared in accordance with 301.470 ratification with the Office of General individual shall be appointed as a
and forwarded to the Deputy Assistant Counsel, Business and Administrative Contracting Officer only in instances
Secretary for Acquisition Management Law Division. where a valid organizational need is
and Policy (DASAMP). demonstrated. Factors to be considered
* * * * *
■ 5. Revise section 301.404 to read as in assessing the need for an
■ 8. Revise section 301.603 and
follows: appointment of a Contracting Officer
301.603–1 to read as follows: include volume of actions, complexity
301.404 Class deviations. of work, and structure of the
301.603 Selection, appointment, and
Requests for class deviations to either termination of appointment of Contracting organization.
the FAR or HHSAR shall be prepared in Officers/Contract Specialists. (d) Contracting Officers (GS–1102’s)
accordance with 301.470 and forwarded shall not sign contracts or modifications
to the Deputy Assistant Secretary for 301.603–1 General. to contracts which will result in the
Acquisition Management and Policy (a) The appointment, selection, and total amount of the contract exceeding
(DASAMP). termination of appointment of their delegated warrant authority (as
■ 6. Amend section 301.470 by revising Contracting Officers/Contract specified on the SF–1402). This
paragraph (a) to read as follows: Specialists shall be made by the HCA. includes Indefinite Delivery Indefinite
This authority is not delegable. The Quantity (IDIQ) contracts. However,
301.470 Procedure. procedures for the selection and orders placed against an IDIQ may be
(a) Deviation requests shall be appointment of Contracting Officers/ issued by Contracting Officers up to
prepared in memorandum form and Contract Specialists shall apply to their delegated authority provided that
forwarded through the Head of the anyone seeking a Contracting Officer each order is separate and distinct.
Contracting Activity (HCA) to the warrant. OPDIV procedures shall be (e) Employees delegated warrant
Director, Division of Acquisition Policy. followed in the appointment and authority are the only individuals
A deviation may be requested verbally termination of Contracting Officers/ legally authorized to bind the
in an exigency situation; however, the Contract Specialists in offices that have Government by executing contracts or
request must be confirmed in writing as Contracting Officers/Contract signing determinations and findings
soon as possible. Specialists with dual signature required by the FAR. The amount
* * * * * warrants. specified on the warrant shall cover the
■ 7. Amend section 301.602–3 by (b) Standard Form (SF) 1402, estimated maximum contract amount,
revising paragraphs (b)(3), (e)(1), and ‘‘Certificate of Appointment,’’ shall be including all option periods. For
(e)(2) to read as follows: used to appoint personnel in the 1102 example, an employee with a $500,000
series as Contracting Officers. It shall Contracting Officer Certificate of
301.602–3 Ratification of unauthorized also be used for personnel in any other Appointment may not award a contract
commitments. series who will obligate the Government for a base year of $300,000 if the
* * * * * to the expenditure of funds in excess of contract includes a one-year option for
(b) * * * the micro-purchase threshold. The SF an additional $300,000. In this case, the
(3) Ratification authority for actions 1402 shall indicate the Contracting total contract amount, including
up to $100,000 may be redelegated by Officer’s warrant level and threshold options, exceeds the amount stipulated
the HCA to the chief of the contracting and any other limitations. The HCA may in the warrant. If a warrant is limited to
office (CCO). No other redelegations are determine an alternate appointment $500,000 (for example), the holder may
authorized. document for appointments at or below not sign a contract for more than that
* * * * * the micropurchase threshold level. amount, even if the additional amount
is subject to the availability of funds. ■ 12. Revise section 301.603–70 to read 301.603–72 Training and certification
Contracting Officers with higher warrant as follows: requirements for Contracting Officers/
levels may sign the action when Contract Specialists.
modifications to orders and contracts 301.603–70 Delegation of Contracting (a) Federal Acquisition Certification
Officer responsibilities. in Contracting (FAC–C) certification is
make the total amount of the contract
exceed the Contracting Officer’s warrant (a) Contracting Officer responsibilities not mandatory for all GS–1102s;
limitation. which do not involve the obligation or however, members of the workforce
deobligation of funds or result in issued new Contracting Officer (CO)
■ 9. Revise section 301.603–2 to read as
establishing or modifying contractual warrants on or after January 1, 2007,
follows:
provisions may be delegated by the regardless of GS series, must be certified
301.603–2 Selection of Contracting Contracting Officer by means of a at an appropriate level to support their
Officers. written memorandum that clearly warrant obligations, pursuant to agency
When it has been determined that the delineates the delegation and its limits. policy. New CO warrants are defined in
appointment is in the best interest of the (b) Contracting Officers may designate OFPP Policy Letter 05–01 as warrants
OPDIV and/or Department and there is individuals as ordering officials to make issued to employees for the first time at
a demonstrated need for the purchases or place orders under blanket a department or agency. FAC–C
procurement authority requested, purchase agreements, indefinite certification does not apply to:
nominations for appointment of (1) Senior level officials responsible
delivery contracts, or other
Contracting Officers shall be submitted for delegating procurement authority;
preestablished mechanisms. Ordering (2) Non-1102s whose warrants are
to the HCA through appropriate officials, including those under the
organizational channels for review. The generally used to procure emergency
National Institutes of Health’s (NIH) goods and services; or
HCA is responsible for appointing Delegated Acquisition Program
Contracting Officers in accordance with (3) Non-1102s whose warrants are so
(DELPRO), are not Contracting Officers. limited as to be outside the scope of this
FAR 1.603. This authority is not
delegable. The HCA will determine the ■ 13. Add sections 301.603–71 through program, as determined by the Chief
documentation required, consistent 301.603–76 to subpart 301.6 to read as Acquisition Officer (CAO).
follows: (b) HHS requires a senior level FAC–
with FAR 1.603–2, when the resulting
C certification for any employee issued
appointment and authority will not Subpart 301.6—Career Development,
an unlimited Contracting Officer’s
exceed the micropurchase threshold. Contracting Authority, and Responsibilities
warrant on or after January 1, 2007.
■ 10. Revise section 301.603–3 to read * * * * * (c) Achievement of the FAC–C is
as follows: 301.603–71 Waivers to warrant standards. based on three requirements: education,
301.603–72 Training and certification
training, and experience, and the
301.603–3 Appointment of Contracting requirements for Contracting Officers/
Officers. Contract Specialists. requirements are cumulative, (i.e., a
301.603–73 Earned value training person must meet the requirements of
(a) Appointing officials must ensure each previous certification level).
requirement for Contracting Officers/
that a warrant candidate meets the Contract Specialists who administer an (d) FAC–C training requirements are
experience and education/training IT contract. as follows:
requirements listed in 301.603–72. 301.603–74 Training policy exception. (1) FAC–C Level I:
(b) If it is essential to appoint an 301.603–75 Training requirement for (i) CON 100 Shaping Smart Business
individual who does not fully meet the purchase cardholders, Approving Arrangements.
certification requirements for the Officials (AOs), and Agency/ (ii) CON 110 Mission Support
Contracting Officer authority sought, an Organization Program Coordinators (A/ Planning.
interim appointment may be granted by OPCs). (iii) CON 111 Mission Strategy
301.603–76 Requirement for certification Execution.
the HCA. HCAs are responsible for
retention and maintaining currency of
ensuring that training requirements are (iv) CON 112 Mission Performance
acquisition knowledge and skills for
met within the specified time frame. Contracting Officers/Contract Specialists Assessment.
Interim appointments may not exceed and purchasing agents. (v) CON 120 Mission Focused
one year in total, and shall not be Contracting.
granted unless the individual can meet Subpart 301.6—Career Development, (vi) 1 Elective.
the certification requirements within Contracting Authority, and (2) FAC–C Level II:
one year from the date of appointment. Responsibilities (i) CON 202 Intermediate Contracting.
(ii) CON 204 Intermediate Contract
The HCA may extend an interim
301.603–71 Waivers to warrant standards. Pricing.
appointment by granting additional time
(iii) CON 210 Government Contract
to complete the requirements of a There may be an unusual Law.
permanent appointment. If the circumstance that requires delegation of (iv) 2 Electives.
certification requirements are not a warrant to an employee who does not (3) FAC–C Level III:
completed by the extended date, the meet the warrant standards in of the (i) CON 353 Advanced Business
appointment will automatically HHS Contracting Officer Warrant Solutions for Mission Support.
terminate. Program. Any requests for waivers (ii) 2 Electives.
■ 11. Revise section 301.603–4 to read requesting deviations from the (e) Those conducting simplified
as follows: requirements and policies of the HHS acquisitions from $2,500 to $100,000
Contracting Officer Warrant Program will need to be issued an HHS
301.603–4 Termination or revocation of a shall be sent in writing to the SPE for Simplified Acquisition Certificate.
Contracting Officer’s appointment. approval. The SPE will either approve Required training is as follows:
Termination or revocation of or disapprove in writing the request for (1) HHS Simplified Acquisition
Contracting Officer appointments shall a waiver to the warrant standards. The Certificate A:
be accomplished in accordance with SPE may grant waivers on a case-by-case (ii) Basic Simplified Acquisition
FAR 1.603–4. basis in unique situations only. Procedures/DAU’s CON 237.
(iii) Advanced Simplified Acquisition 301.603–73 Earned value training Contract Specialist to award or
Procedures or Appropriations Law. requirement for Contracting Officers/ administer an IT contract, and the
Contract Specialists who administer an IT
(2) HHS Simplified Acquisition Earned Value training requirement has
contract.
Certificate B: not been met, the HCA (not delegable)
All GS–1102s who administer an IT
may waive the training requirement and
(i) Basic Simplified Acquisition contract, regardless of dollar threshold,
authorize the individual to perform the
Procedures/DAU’s CON 237. are required to successfully complete
the Department’s (offered through HHS job duties, provided that the individual
(ii) Advanced Simplified Acquisition attends the next scheduled ‘‘Early
University) one-day course entitled
Procedures or Appropriations Law. Warning Project Management System
‘‘Early Warning Project Management
(iii) CON 100 (Shaping Smart Systems Workshop,’’ or an equivalent Workshop’’ course, or an equivalent
Business Arrangements). Earned Value training course. Earned Value course.
(iv) CON 110 (Mission Support Determination of course equivalency
301.603–75 Training requirement for
Planning). shall be made jointly by the Office of purchase cardholders, Approving Officials
Acquisition Management and Policy/ (AOs), and Agency/Organization Program
(f) For additional information, see
ASAM and the HHS Office of the Chief Coordinators (A/OPCs).
http://www.knownet.hhs.gov/ Information Officer.
acquisition/careerhandbookver.1.0.doc. Training requirements for purchase
301.603–74 Training policy exception. cardholders, AOs, and A/OPCs are
In the event there is an urgent listed in the following table:
requirement for a Contracting Officer/
Authority a Program participant Required training b
Up to $2,500 .............. Prospective/newly appointed purchase Basic purchase card course (HHS University 1-day course) or an equivalent
cardholders and Approving Officials. course that has been approved by the HHS Acquisition Training Coordinator
prior to appointment. Training will include green-purchasing and Section 508
requirements.
Purchase card holders and Approving Refresher purchase card training, including green-purchasing training and
Officials. Section 508 training, every 2 years.
$2,501 to $25,000 ..... Prospective/newly appointed purchase • Basic Purchase Card course.
cardholders and Approving Officials. • Basic Simplified Acquisition Procedures/DAU’s CON 237.
• Advanced Simplified Acquisition Procedures or Appropriations Law.
Purchase card holders and Approving Refresher purchase card training, including green-purchasing training and
$25,001 to $100,000 Prospective/newly appointed purchase • Basic Purchase Card course.
cardholders and Approving Officials. • Basic Simplified Acquisition Procedures/DAU’s CON 237.
• Advanced Simplified Acquisition Procedures or Appropriations Law.
• CON 100 (Shaping Smart Business Arrangements).
• CON 110 (Mission Support Planning).
Purchase cardholders and Approving Refresher purchase card training, including green-purchasing training and
Not applicable ............ Prospective/newly appointed Agency/ Basic Purchase Card course, Basic Simplified Acquisition Procedures or
Organization Program Coordinators. DAU’s CON 237, Advanced Simplified Acquisition Procedures or Appropria-
tions Law, CON 100 (Shaping Smart Business Arrangements), and CON
110 (Mission Support Planning).
Agency/Organization Program Coordi- Refresher purchase card training, including green-purchasing training and
nators. Section 508 training, every 2 years (attendance at GSA’s annual training
conference satisfies refresher training).
a Cardholders and Approving Officials with authorized increases in DPA have up to 6 months to complete the training requirements for the new
DPA.
b CON 237, CON 100, and CON 110 are available at the DAU Web site at http://www.dau.mil/registrar/enroll.asp. CON 100 is also offered
through HHS University (see Web site at: http://learning.hhs.gov).
301.603–76 Requirement for certification not earned every two years, and may (CMS), Food and Drug Administration
retention and maintaining currency of result in a loss of warrant authority. (FDA), Health Resources and Services
acquisition knowledge and skills for Administration (HRSA), Indian Health
Contracting Officers/Contract Specialists PART 302—DEFINITIONS OF WORDS Service (IHS), National Institutes of
and purchasing agents. AND TERMS Health (NIH), Substance Abuse and
To maintain a FAC–C, GS–1102s, Mental Health Services (SAMHSA), and
including all warranted Contracting ■ 14. Revise section 302.101 to read as the Deputy Secretary for the Office of
Officers regardless of series, shall earn follows: the Secretary (OS).
80 continuous learning points (CLPs) 302.101 Definitions. Chief of the Contracting Office (CCO)
every two years beginning January 1, is typically a mid-level management
2008. For GS–1105s and GS–1106s, a Agency head or head of the Agency,
unless otherwise specified, means the official, usually an office director,

minimum of forty (40) hours (or division director, or branch chief, who
continuous learning points) is required head of the Operating Division (OPDIV)
for Agency for Healthcare Research and manages and monitors the daily contract
every two years after all mandatory operations of an OPDIV or major
Quality (AHRQ), Centers for Disease
training requirements have been met. component of an OPDIV. The CCO is
Control and Prevention (CDC), Centers
Certification will expire if the CLPs are for Medicare & Medicaid Services subordinate to the Head of Contracting
Activity (HCA), except where the HCA Project Officer is a Federal employee consult with the Office of General
and CCO are the same individual. who monitors contractor performance Counsel (OGC) and the Office of
Head of the contracting activity and provides technical guidance to the Inspector General (OIG), as appropriate;
(HCA)— Contract Specialist/Contracting Officer. and
(1) Occupies designated organization The Project Officer serves as the * * * * *
positions as follows: Contract Specialist/Contracting Officer’s ■ 18. Revise section 303.303 to read as
ASAM–OS—Deputy Assistant Secretary authorized representative to monitor follows:
for Acquisition Management and specific aspects of the contract, thereby
Policy ensuring that the contractor’s 303.303 Reporting suspected antitrust
AHRQ—Director, Division of Contracts performance meets the standards set violations.
Management forth in the contract, the technical (h) A copy of the agency report of
CMS—Director, Office of Acquisition requirements under the contract are met suspected antitrust violations submitted
and Grants Management by the delivery date(s) and/or within the to the Attorney General by the HCA
PSC—Director, Division of Acquisition period of performance, and performance shall also be submitted to the Director,
Management is accomplished within the price or Office of Acquisition Management and
CDC—Director, Procurement and Grants estimated cost stated in the contract. A Policy.
Office Project Officer is required to comply ■ 19. Revise section 303.405 to read as
FDA—Director, Office of Acquisitions & with HHS Project Management follows:
Grant Services Certification Program training
HRSA—Director, Division of requirements. The term ‘‘Project 303.405 Misrepresentations or violations
Procurement Management Officer’’ is synonymous with of the Covenant Against Contingent Fees.
IHS—Director, Division of Acquisition Contracting Officer’s Representative (a) Reports shall be made promptly to
Policy (COR) and Contracting Officer’s the Contracting Officer.
NIH—Director, Office of Acquisition Technical Representative (COTR). (b)(4) Suspected fraudulent or
Management and Policy ■ 15. Revise section 302.201 to read as criminal matters to be reported to the
SAMHSA—Director, Division of follows: Department of Justice shall be prepared
Contracts Management in letter format and forwarded through
302.201 Contract clause. acquisition channels to the head of the
(2) Each HCA is responsible for
conducting an effective and efficient The FAR clause, Definitions, at contracting activity for signature. The
acquisition program. Adequate controls 52.202–1 shall be used as prescribed in letter must contain all pertinent facts
shall be established to assure FAR 2.201, except as follows: and background information considered
compliance with applicable laws, (a) In accordance with 52.202–1(a)(1), by the Contracting Officer and chief of
regulations, procedures, and the dictates paragraph (a) at 352.202–1 shall be used the contracting office that led to the
of good management practices. Periodic in place of paragraph (a) of the FAR decision that fraudulent or criminal
reviews shall be conducted and clause. matters may be present. A copy of the
evaluated by qualified personnel, (b) In accordance with 52.202–1(a)(1), signed letter shall be sent to the
preferably assigned to positions other paragraph (h), or its alternate, at Director, Office of Acquisition
than in the contracting office being 352.202–1 shall be added to the end of Management and Policy.
reviewed, to determine the extent of the FAR clause. Use paragraph (h) when ■ 20. Revise section 303.704 to read as
adherence to prescribed policies and a fixed-priced contract is anticipated; follows:
regulations, and to detect a need for use the alternate to paragraph (h) when
a cost-reimbursement contract is 303.704 Policy.
guidance and/or training.
(3) The heads of contracting activities anticipated. This is an authorized (a) For purposes of implementing FAR
may redelegate their HCA authorities to deviation. subpart 3.7, the authorities granted to
the extent that redelegation is not the ‘‘agency head or designee’’ shall be
prohibited by the terms of their PART 303—IMPROPER BUSINESS exercised by the HCA (not delegable).
respective delegations of authority, by PRACTICES AND PERSONAL
CONFLICTS OF INTEREST PART 304—ADMINISTRATIVE
law, by the Federal Acquisition
MATTERS
Regulation, by the HHS Acquisition ■ 16. Revise section 303.101–3 to read
Regulation, or by other regulations. as follows: ■ 21. Revise section 304.602 to read as
However, HCA and other contracting follows:
approvals and authorities shall not be 303.101–3 Agency regulations.
redelegated below the levels specified in (a)(3) The Department of Health and 304.602 Federal Procurement Data
the HHS Acquisition Regulation or, in Human Services’ Standards of Conduct System—Next Generation (FPDS–NG).
the absence of coverage in the HHS are prescribed in 45 CFR part 73. The Departmental Contracts
Acquisition Regulation, the Federal ■ 17. Revise paragraph (a)(2)(i) of Information System (DCIS) represents
Acquisition Regulation. To ensure section 303.104–7 to read as follows: the Department’s implementation of the
proper control of redelegated FPDS-NG. All departmental contracting
acquisition authorities, HCAs shall 303.104–7 Violations or possible activities are required to use the DCIS
maintain a file containing successive violations of the Procurement Integrity Act. and follow the procedures stated in the
delegations of HCA authority through (a) * * * Enhanced Departmental Contracts
and including the Contracting Officer (2) * * * Information System Manual, available at
level. Personnel delegated responsibility (i) Refer the matter immediately to the http://dcis.hhs.gov, and amendments to
for acquisition functions must possess a Deputy Assistant Secretary for the manual. The HCA (not delegable)
level of experience, training, and ability Acquisition Management and Policy shall ensure that all required contract
commensurate with the complexity and (DASAMP), Assistant Secretary for information is collected, submitted, and
magnitude of the acquisition actions Administration and Management, Office received into the DCIS on or before the
involved. of the Secretary, for review, which may 15th of each month for all contracts and
contract modifications awarded in the Handicapped (NISH), and the Federal award document face page to the
previous month. Prison Industries (UNICOR) referenced office prior to the day of
■ 22. Amend 304.804–70 by revising L Lease Agreement award, or in sufficient time to allow for
paragraphs (a) and (b)(1) to read as W Government-wide Acquisition an announcement to be made by 5 p.m.
follows: Contract (GWAC) Washington, DC time on the day of
E Letter Contract award. Notification may also be
304.804–70 Contract closeout audits. G Federal Supply Schedule accomplished by e-mailing a copy of the
(a) Contracting Officers shall rely, to M Micropurchase contract or award document face page to
the maximum extent possible, on single For example, the first contract for grantfax@hhs.gov, or faxing to (202)
audits to close physically completed NIH, National Cancer Institute, for fiscal 205–2420.
cost-reimbursement contracts with year 2005 may be numbered ■ 26. Revise section 305.502 to read as
colleges and universities, hospitals, HHSN261200500001C. follows:
non-profit firms, and State and local * * * * *
governments. In addition, where 305.502 Authority.
(e) Assignment of identification codes.
appropriate, a sample of these Each contracting office of the The Contracting Officer may advertise
contractors may be selected for audit, in Department shall be assigned a three or place notices in newspapers and
accordance with paragraph (b) of this digit identification code by the ASAM/ periodicals to announce that proposals
section. OAMP. Requests for the assignment of are being sought.
(b) * * * codes for newly established contracting
(1) The Office of the Inspector General PART 306—COMPETITION
offices shall be submitted by a
(OIG) and ASAM’s Deputy Assistant REQUIREMENTS
headquarters official from the new
Secretary for Acquisition Management contracting office to the OAMP. A ■ 27. Revise section 306.302–1 to read
and Policy in conjunction with the listing of the contracting office as follows:
OPDIV’s cost advisory/audit focal point, identification codes currently in use is
determine which contracts or contained in the Enhanced 306.302–1 Only one responsible source
contractors will be audited, which audit Departmental Contracts Information and no other supplies or services will
agency will perform the audit, and the satisfy agency requirements.
System Manual, available at http://
type and scope of closeout audit to be dcis.hhs.gov. (a)(2)(iv) Follow-on contracts for the
performed. These decisions shall be continuation of major research and
based upon the needs of the customer, PART 305—PUBLICIZING CONTRACT development studies on long-term social
risk analysis, return on investment, and ACTIONS and health programs, major research
the availability of audit resources. When studies, or clinical trials may be deemed
an audit is warranted prior to closing a ■ 24. Revise section 305.202 to read as to be available only from the original
contract, the Contracting Officer shall follows: source when it is likely that award to
submit the audit request to the OIG’s any other source would result in
305.202 Exceptions.
Office of Audit, via the OPDIV’s cost unacceptable delays in fulfilling the
(b) When a contracting office believes Department’s or OPDIV’s requirements.
advisory/audit focal point.
that it has a situation where advance (b) Application. (5) When the head of
* * * * * notice is not appropriate or reasonable, the program office has determined that
■ 23. Revise paragraphs (b)(3), (b)(6), it shall prepare a memorandum citing only specified makes and models of
and (e) of section 304.7001 to read as all pertinent facts and details and send technical equipment or parts must be
follows: it, through normal acquisition channels, obtained to meet the activity’s program
to the Deputy Assistant Secretary for responsibility to test and evaluate
304.7001 Numbering acquisitions.
Acquisition Management and Policy certain kinds and types of products, and
* * * * * (DASAMP) requesting relief from
(b) * * * only one source is available. (This
synopsizing. The DASAMP shall review criterion is limited to testing and
(3) The three digit numeric the request and decide whether an
identification code assigned by the evaluation purposes only and may not
exception to synopsizing is appropriate be used for initial outfitting or repetitive
Deputy Assistant Secretary for or reasonable. If it is, the DASAMP shall
Acquisition Management and Policy acquisitions. Project officers should
take the necessary coordinating actions support the use of this criterion with
(DASAMP) to the contracting office required by FAR 5.202(b). Whatever the
within the servicing agency; citations from their agency’s legislation
decision is on the request, the DSAMP and the technical rationale for the item
* * * * * shall promptly notify the contracting of equipment required.)
(6) A one digit code describing the office when a determination has been ■ 28. Revise section 306.303–1 to read
type of contract action: made. as follows:
A Commercial Item Acquisition ■ 25. Revise section 305.303 to read as
C New Definitive Contract follows: 306.303–1 Requirements.
P Purchase Using Simplified (a)(1) The Program Office must
Acquisition 305.303 Announcement of contract provide a written justification whenever
I Indefinite Delivery Contract (IDIQ) awards. it requests that certain goods or services
O Basic Ordering Agreement (BOA) (a) Public announcement. Awards be obtained without full and open
B Blanket Purchase Agreement (BPA) over $3.5 million, not otherwise exempt competition. The justification must
F Facilities Contract under FAR 5.303, shall be reported by explain why full and open competition
U Contracts placed with or through the Contracting Officer to the Office of is not feasible and must be submitted
other Government departments, GSA the Assistant Secretary for Legislation with the requisition or request for
contracts, or against mandatory source (Congressional Liaison), Room 406G, contract.
contracts such as the National Hubert H. Humphrey Building. (i) Justifications in excess of the
Industries for the Blind (NIB), the Notification shall be accomplished by simplified acquisition threshold shall be
National Industries for the Severely providing a copy of the contract or in the form of a separate, self-contained
document, prepared in accordance with requirements of FAR 6.304 (a)(3)(ii). (2) Estimated award amount;
FAR 6.303 and 306.303, and called a This authority is not delegable. (3) Requested award date;
‘‘JOFOC’’ (Justification for Other Than (4) The senior procurement executive (4) Name and phone number of
Full and Open Competition). of the Department is the Deputy contact person (usually the Project
Justifications at or below the simplified Assistant Secretary for Acquisition Officer);
acquisition threshold may be in the Management and Policy. This (5) Other information required for
form of a paragraph or paragraphs designation has been made pursuant to OPDIV needs.
contained in the requisition or request the OFPP Act (41 U.S.C. 414(c)(2)(B). (b) Once the AAP is obtained from the
for contract. (c) A class justification shall be program planning/budget office, the
(ii) Justifications, whether over or processed the same as an individual Contracting Officer/Contract Specialist
under the simplified acquisition justification. shall initiate discussions with the
threshold, shall fully describe what is to ■ 31. Revise section 306.501 to read as assigned Project Officer for each
be acquired, offer reasons which go follows: planned negotiated acquisition over
beyond inconvenience, and explain why $100,000 except for:
306.501 Requirement. (1) Acquisitions made under
it is not feasible to obtain competition.
The Department’s competition interagency agreements, and
The justifications shall be supported by (2) Contract modifications which
verifiable facts rather than mere advocate is the Director, Strategic
Acquisition Service, Program Support exercise options, make changes
opinions. Documentation in the authorized by the Changes clause, or
justification should be sufficient to Center (PSC). The competition
advocates for each of the Department’s add funds to an incrementally funded
permit an individual with technical contract. (The HCA may prescribe
competence in the area to follow the contracting activities are as follows:
AHRQ—Director, Office of Performance procedures for contract actions not
rationale. covered by this subpart.)
(iii) Sole source justifications using Accountability, Resources and
Technology (c) The purpose of the discussions
the Federal Supply Schedule shall between the Contracting and Project
include the content listed in FAR 6.303– CDC—Chief Information Officer
CMS—Chief Operating Officer Officers is to develop an individual
2. FDA—Chief, Office of Shared Services acquisition planning schedule and to
(b) Preliminary arrangements or HRSA—Associate Administrator, Office address areas that will need to be
agreements with the proposed of Administration and Financial covered in the request for contract
contractor shall have no effect on the Management (RFC), including clearances, acquisition
rationale used to support an acquisition IHS—Director, Office of Management strategy, sources, etc. The Project Officer
for other than full and open Services must either have a statement of work
competition. NIH—Senior Scientific Advisor for (SOW) ready at this time or must
■ 29. Revise section 306.303–2 to read Extramural Research, Office of discuss in more detail the nature of the
as follows: Extramural Research (R&D) and services/supplies that will be required.
Senior Advisor to the Director (Other (d) Standard lead-times for processing
306.303–2 Content. than R&D) various types of acquisitions and
(a)(1) Each justification shall include PSC—Director, Strategic Acquisition deadlines for submission of acceptable
the name of the program office; the Service RFCs (that is, RFCs which include all
name, address, and phone number of SAMHSA—Executive Officer required elements such as clearances,
the Project Officer; and project funding documents, and an acceptable
identification, such as the authorizing PART 307—ACQUISITION PLANNING SOW) for award in a given fiscal year
program legislation, to include citations shall be established by the HCA or
■ 32. Revise section 307.104 to read as
or other internal program identification designee not lower than the CCO.
follows:
data such as title, contract number, etc. (e) The outcome of the discussions
(2) The description may be in the 307.104 General procedures. referenced in paragraph (c) of this
form of a statement of work, purchase (a) Each contracting activity shall section between the Project Officer and
description, or specification. A prepare an Annual Acquisition Plan the Contracting Officer/Contract
statement is to be included to explain (AAP). The AAP is a macro plan, Specialist will be an agreement
whether the acquisition is an entity in containing a list of anticipated contract concerning the dates of significant
itself, whether it is one in a series, or actions over the simplified acquisition transaction-specific acquisition
part of a related group of acquisitions. threshold and their associated funding, milestones, including the date of
(c) JOFOCs shall be signed by the as well as the aggregate planned dollars submission of the RFC to the
Project Officer, the Project Officer’s for simplified acquisitions by quarter, Contracting Officer. This milestone
immediate supervisor, the Contracting developed for each fiscal year. The AAP schedule document will be prepared
Officer, and the approving official (if the shall conform to reasonable budget with those dates and will be signed by
approving official is not the Contracting expectations and shall be reviewed at the Project Officer and the Contracting
Officer). least quarterly and modified as Officer. The milestones cannot be
■ 30. Revise section 306.304 to read as appropriate. The HCA or the CCO shall revised except by mutual agreement of
follows: obtain this information from the these same individuals. If the planning
program planning/budget office of the schedule indicates the need to obtain
306.304 Approval of the justification. contracting activity and use the AAP to approval of a Justification for Other than
(a)(2) The competition advocates are provide necessary reports and monitor Full and Open Competition, the HCA or
listed in 306.501. This authority is not the workload of the contracting office. CCO must sign the milestone agreement.
delegable. For contract actions, the plan shall This document shall be retained in the
(3) The competition advocate shall contain, at a minimum: contract file. All other considerations
exercise this approval authority, except (1) A brief description (descriptive that will affect the acquisition
where the individual designated as the title, perhaps one or two sentences if (technical, business, management) shall
competition advocate does not meet the necessary); be addressed in the RFC (see 307.71).
■ 33. Revise section 307.170 to read as training course(s), the HCA (not 307.170–4 Reqired training in HHS’
follows: delegable) may waive the training portfolio management tool.
requirement and authorize the All current and proposed IT program/
307.170 Program training requirements. project managers, as well as alternate IT
individual to perform the project duties,
(a) HHS will maintain a program for provided that: program/project managers and IT CORs/
certifying employees before they may be (a) The individual first meets with the COTRs (as well as alternate IT CORs/
considered eligible for appointment as a cognizant Contracting Officer to review COTRs), regardless of dollar threshold,
program/project manager or COR/COTR. the HHS ‘‘Project Officer’s Contracting must successfully complete training in
(b) All HHS program/project HHS’ portfolio management tool
Handbook’’ to discuss the important
managers, alternate program/project (contact the HHS Office of the Chief
aspects of the contracting-program office
managers, CORs/COTRs, alternate Information Officer for additional
relationship as appropriate to the
CORs/COTRs, and at least fifty percent information).
circumstances; and
of the HHS program personnel
performing the function of technical (b) The individual attends the next 307.170–5 Maintenance/refresher training
proposal evaluator on a technical scheduled ‘‘Basic Project Officer’’ requirement for program/project managers
evaluation team or panel for a course, or an equivalent course, and, for and CORs/COTRs.
competitively solicited HHS contract, those current and proposed IT program/ Program/Project Managers and CORs/
shall have successfully completed the project managers, as well as alternate IT COTRs who monitor one or more
Department’s ‘‘Basic Project Officer’’ program/project managers and IT CORs/ contracts are required to take 40 CLPs
course, or an equivalent course, before COTRs (as well as alternate CORs/ each year.
assuming the duties of their designated COTRs) assigned to HHS IT projects
(including those designated as major or 307.170–6 Warranting of Other
role, or take the next available class. Transaction Officers for Other
This requirement applies to the initial tactical by HHS), the next ‘‘Early
Transactions.
technical proposal evaluation and any Warning Project Management System
Workshop.’’ (a) Other Transaction (OT) Officers
subsequent technical evaluations that shall possess the qualifications
may be required. (*Peer and objective ■ 35. Add sections 307.170–3 through
necessary to ensure that OTs are in
reviewers are excluded from these 307.170–9 to subpart 307.1 to read as
compliance with applicable laws and
requirements). Course equivalency for follows:
regulations. The ASAM/OAMP will
the ‘‘Basic Project Officer’’ course will Subpart 307.1—Acquisition Planning have the sole authority to warrant OT
be determined by the ASAM/OAMP. Officers at HHS. To receive a warrant as
307.170–3 Earned value training
The Contracting Officer is responsible requirement for IT program/project an HHS OT Officer, the individual must
for ensuring that the program/project managers and IT CORs/COTRs. be a Contracting Officer, preferably with
manager, COR/COTR, and proposal 307.170–4 Required training in HHS’ an unlimited warrant, with a Federal
evaluators have successfully completed portfolio management tool. Acquisition Certification in Contracting
the required training. Non-information 307.170–5 Maintenance/refresher training
(FAC–C) Level III, or a Level III or IV
technology (IT) program/project requirement for program/project
managers and CORs/COTRs. certified Grants Officer within HHS.
managers and non-IT CORs/COTRs who Nominations for appointment of OT
have successfully completed the 307.170–6 Warranting of Other Transaction
Officers for Other Transactions. Officers shall be submitted to the Head
appropriate ‘‘Basic Project Officer’’ of Contracting Activity in writing
307.170–7 Training Requirements for Other
course, or an equivalent course, are Transaction Officers. through appropriate organizational
highly encouraged to take the 307.170–8 Appointment of an Other channels for review. The nomination
Department’s one-day course entitled Transaction Officer Technical package shall include the following:
‘‘Early Warning Project Management Representative for an Other Transaction. (1) A completed Appendix A (‘‘OT
System Workshop,’’ or an equivalent 307.170–9 Training requirement for an Officer’s Warrant Application Form’’) of
Earned Value course. Program/Project Other Transaction Officer Technical
HHS Other Transaction Authority
managers and CORs/COTRs are highly Representative.
Guidebook;
encouraged to take the Department’s (2) A recommendation from the
‘‘Writing Statements of Work’’ course, or Subpart 307.1—Acquisition Planning
employee’s immediate supervisor
an equivalent course. Peer and objective * * * * * providing justification for the
reviewers are excluded from these appointment of an HHS OT Officer;
requirements. (*The peer review process 307.170–3 Earned value training (3) Current resume/OF 612/SF 171
pertains specifically to NIH in the peer requirement for IT program/project
managers and IT CORs/COTRs.
and/or other documentation describing
review of applications for grants and the employee’s experience, education,
contracts. Applications are evaluated by All current and proposed IT program/ and training relevant to the position for
a peer review group composed of project managers, alternate IT program/ which warrant authority is being sought;
scientists from the extramural research project managers, IT CORs/COTRs, and (4) A copy of the employee’s most
community.) All courses are offered alternate CORs/COTRs assigned to HHS recent performance appraisal;
through HHS University. IT projects (including those IT projects (5) Type of work to be performed
■ 34. Revise section 307.170–1 to read designated as major or tactical), under the warrant, i.e., executing OTs;
as follows: regardless of dollar threshold, must (6) A copy of the certificate issued
successfully complete the Department’s under the HHS Acquisition Certification
307.170–1 Training policy exceptions. (offered through HHS University) one- Program indicating the employee’s
In the event there is an urgent day course entitled ‘‘Early Warning current certification level and a copy of
requirement for a specific individual to Project Management System previous warrant certificate, if
serve as a program/project manager and Workshop,’’ or an equivalent Earned applicable; or a copy of the certificate
COR/COTR (or alternate program/ Value training course. Course issued under the HHS Grants
project manager and alternate COR/ equivalency will be determined jointly Certification Program, if applicable; and
COTR) and that individual has not by the ASAM/OAMP and the HHS (7) Proof of successful completion of
successfully completed the prerequisite Office of the Chief Information Officer. the ‘‘Cooperative Agreements, CRADAs
& Other Transactions’’ course taught by appointed and prior to assuming job should be addressed during the
Federal Publications Seminars, or an duties associated with the OT. planning discussions between the
equivalent course. (c) Refresher training in the policies Project Officer and Contracting Officer/
(b) For additional information, see and procedures of awarding cooperative Contract Specialist (see 307.104(c)) and
http://www.knownet.hhs.gov/ agreements, CRADAs and OTs is immediate action should be initiated by
acquisition/hhs_epp_postings/ required every three years. the Project Officer to obtain the
HHSGuidebook1-OTAMarch2005.doc. necessary clearances or approvals. The
307.302, 307.303, 307.304, and 307.307 Contracting Officer/Contract Specialist
307.170–7 Training Requirements for [Removed]
shall provide a comprehensive checklist
Other Transaction Officers. ■ 36. Remove subpart 307.3 (sections of these and any OPDIV special
OT Officers must successfully 307.302, 307.303, 307.304, and approvals, clearances, and requirements
complete the ‘‘Cooperative Agreements, 307.307). to the program office. If the approval or
CRADAs & Other Transactions’’ course, ■ 37. Revise paragraph (b)(2) of section clearance has been requested and is
or an equivalent course, prior to 307.7001 to read as follows: being processed at the time of RFC
appointment as an OT Officer. Grants submission, a footnote to this effect,
Officers who serve as OT Officers are 307.7001 Distinction between acquisition including all pertinent details, must be
required to have successfully completed and assistance. included in this section.
the following courses: CON 110 * * * * * (i) Commercial activities. (OMB
(‘‘Mission Support Planning’’); CON 111 (b) * * * Circular No. A–76). An RFC must
(‘‘Mission Strategy Execution,’’); CON (2) The Department determines in a contain a statement as to whether the
112 (‘‘Mission Performance,’’) or CON specific instance that the use of a type proposed solicitation is or is not to be
120 (‘‘Mission Focused Contracting.’’), of contract is appropriate. That is, it is used as part of an OMB Circular No. A–
or equivalent courses prior to being determined in a certain situation that 76 public-private cost comparison. (See
appointed as an OT Officer. The HHS specific needs can be satisfied best by OMB Circular No. A–76, Performance of
OTA Board will determine course using the acquisition process. However, Commercial Activities.)
equivalency. this authority does not permit * * * * *
circumventing the criteria for use of (7) Special terms and conditions. Any
307.170–8 Appointment of an Other acquisition or assistance instruments.
Transaction Officer Technical suggested special terms and conditions
Representative for an Other Transaction.
Use of this authority is restricted to not already covered in the statement of
extraordinary circumstances and only work.
The program office nominates the with the prior approval of the Deputy
Other Transaction Officer Technical * * * * *
Assistant Secretary for Acquisition
Representative (OTR). The OT Officer Management and Policy (DASAMP). ■ 40. Amend section 307.7106 by
prepares an OTR delegation revising paragraphs (a) and (d) to read
* * * * *
memorandum that describes the OTR’s as follows:
authority and assigns the OTR specific ■ 38. Revise section 307.7104 to read as
follows: 307.7106 Statement of work.
responsibilities, with limitations of
authority, in writing. The OTR (a) General. A statement of work
307.7104 Transmittal. (SOW) describes the work or services to
represents the OT Officer only to the
The RFC must be conveyed to the be performed in reaching an end result
extent delegated in the written
contracting office by use of a cover without describing the method that will
appointment and does not have the
memorandum. The cover memorandum be used unless the method of
authority to change the terms and
must be signed by the head of the performance is critical or required in
conditions of the OT.
sponsoring program office and include order to obtain successful performance.
307.170–9 Training requirement for an both a statement attesting to the The SOW should be clear and concise
Other Transaction Officer Technical conclusiveness of the review described and must completely define the
Representative. in 307.7103(b) and a list identifying all responsibilities of both the contractor
(a) Program personnel selected to attachments to the RFC. and the Government. The SOW should
serve as an OTR or an alternate OTR ■ 39. Amend section 307.7105 by be worded to make more than one
assigned to an OT, and at least fifty revising the introductory text for the interpretation virtually impossible.
percent of the technical evaluators that section, the introductory text for * * * * *
review the initial and any subsequent paragraph (b)(4), and paragraphs (b)(4)(i) (d) Elements of the SOW. The
proposals or revisions thereof, shall and (b)(7) to read as follows: elements of the SOW will vary with the
successfully complete the Department’s objective, complexity, size, and nature
‘‘Basic Project Officer’’ course, or an 307.7105 Format and content.
of the acquisition. In general, it should
equivalent course prior to being The Department is in the process of include the following:
appointed. Determination of course standardizing a format for the RFC. In (1) Purpose of the project. This
equivalency shall be made by the HHS the interim, the information in includes a general description of the
OTA Board. paragraph (a) of this section must be objectives of the project and the desired
(b) In addition to the Department’s included. Paragraph (b) contains results.
required ‘‘Basic Project Officer’’ course, information that must also be included (2) Background information. This
the OTR or alternate OTR assigned to an if applicable. includes a brief history of the project
OT, and at least fifty percent of the * * * * * and the importance of the project to the
technical evaluators that review the (b) * * * overall program objectives.

initial and any subsequent proposals or (4) Special program clearances or (3) A detailed description of the
revisions thereof, shall successfully approvals. The following special technical requirements. The statement
complete the ‘‘Cooperative Agreements, program clearances or approvals should of work should provide sufficient detail
CRADAs & Other Transactions’’ course, be reviewed for applicability to each to accurately reflect the Government’s
or an equivalent course, prior to being acquisition. Those which are applicable requirement. It should state what is to
be done without prescribing the method 309.404 List of parties excluded from initiating official and the Contracting
to be used and should include Federal procurement and nonprocurement Officer. If it is determined that
performance standards. The statement programs. debarment procedures shall commence,
of work may be broken down into tasks (c) The Office of Acquisition the debarring official shall consult with
and subtasks. The degree of breakout Management and Policy (OAMP) shall the Office of General Counsel and then
depends on the size and complexity of perform the actions required by FAR notify the contractor in accordance with
the project. The statement of work 9.404(c). FAR 9.406–3(c). If the proposed action
should indicate whether the tasks are (4) OAMP shall maintain all is not based on a conviction or judgment
sequential or concurrent. documentation submitted by the and the contractor’s submission in
(4) Reference material. All reference initiating official recommending the response to the notice raises a genuine
material to be used in the conduct of the debarment or suspension action and all dispute over facts material to the
project that indicates how the work is to correspondence and other pertinent proposed debarment, the debarring
be carried out must be identified. documentation generated during the official shall arrange for fact-finding
Applicability should be explained, and OAMP review. hearings and take the necessary action
a statement made as to where the ■ 43. Amend section 309.405 by specified in FAR 9.406–3(b)(2). The
material can be obtained. revising paragraph (a)(1) to read as debarring official shall also ensure that
(5) Level of effort. When a level of follows: written findings of facts are prepared,
effort is required, the number and type and shall base the debarment decisions
309.405 Effect of listing.
of personnel required should be stated. on the facts as found, after considering
(a) * * * information and argument submitted by
If known, the type and degree of (1) If a Contracting Officer considers
expertise should be specified. the contractor and any other
it necessary to award a contract, or information in the administrative
(6) Special requirements. (as consent to a subcontract with a debarred
applicable). An unusual or special record. The Office of the General
or suspended contractor, the Counsel shall represent the Department
contractual requirement, which would Contracting Officer shall prepare a
impact on contract performance, should at any fact-finding hearing and may
determination, including all pertinent present witnesses for HHS and question
be included as a separate section. documentation, and submit it through any witnesses presented by the
(7) Deliverables reporting acquisition channels to the head of the contractor.
requirements. All deliverables and/or contracting activity. The documentation ■ 45. Revise section 309.407–3 to read
reports must be clearly and completely must include the date by which
described. Include the timeframe for as follows:
approval is required and a compelling
completion, the format, and the number reason for the proposed action. 309.407–3 Procedures.
of copies. Compelling reasons for award of a (a) Investigation and referral. When
contract or consent to a subcontract an apparent cause for suspension
PART 309—CONTRACTOR with a debarred or suspended contractor becomes known, the initiating official
QUALIFICATIONS include: shall prepare a report containing the
(i) The property or services to be information required by 309.470–2
acquired are available only from the along with a written recommendation
follows:
listed contractor; or and forward it through appropriate
309.403 Definitions. (ii) The urgency of the requirement channels to the suspending official.
dictates that the Department conduct Reports shall be forwarded in
Acquiring agency’s head or designee,
business with the listed contractor. accordance with 309.470–1. The
as used in the FAR, shall mean, unless
otherwise stated in this subpart, the * * * * * suspending official shall initiate an
head of the contracting activity. Acting ■ 44. Revise section 309.406–3 to read investigation.
in the capacity of the acquiring agency’s as follows: (b) Decision making process. The
head, the head of the contracting suspending official shall review the
309.406–3 Procedures. results of the investigation, if any, and
activity may make the required
(a) Investigation and referral. When make a written determination whether
justifications or determinations, and
an apparent cause for debarment or not suspension should be imposed. A
take the necessary actions, specified in
becomes known, the initiating official copy of this determination shall be
FAR 9.405, 9.406, and 9.407 for his or
shall prepare a report containing the promptly sent through appropriate
her respective activity, but only after
information required by 309.470–2, channels to the initiating official and
obtaining the written approval of the
along with a written recommendation, the Contracting Officer. If it is
debarring or suspending official, as the
and forward it through appropriate determined that suspension shall be
case may be.
channels to the debarring official. imposed, the suspending official shall
Debarring official means the Assistant consult with the Office of General
Reports shall be forwarded in
Secretary for Administration and Counsel and then notify the contractor
accordance with 309.470–1. The
Management, or his/her designee. in accordance with FAR 9.407–3(c). If
debarring official, the Deputy Assistant
Initiating official means either the Secretary for Acquisition Management the action is not based on an
contracting officer, the head of the and Policy, shall initiate an indictment, and, subject to the
contracting activity, the Deputy investigation. provisions of FAR 9.407–3(b)(2), the
Assistant Secretary for Acquisition (b) Decision making process. The contractor’s submission in response to
Management and Policy, or the debarring official shall review the the notice raises a genuine dispute over
Inspector General. results of the investigation, if any, and facts material to the suspension, the
Suspending official means the make a written determination whether suspending official shall, after
Assistant Secretary for Administration or not debarment procedures are to be suspension has been imposed, arrange
and Management, or his/her designee. commenced. A copy of the for fact-finding hearings and take the
■ 42. Revise section 309.404 to read as determination shall be promptly sent necessary actions specified in FAR
follows: through appropriate channels to the 9.407–3(b)(2).
■ 46. Amend section 309.470–1 by (c) The instructions, including (d) Each proposed determination shall
revising the introductory text to read as approval requirements, and waiver have the concurrence of the Chief,
follows: form, are available at http:// General Law Division, Office of General
dbh.ogam2000.com/ Counsel.
309.470–1 Situations where reports are
HHS_Strategic_Sourcing/
required. PART 315—CONTRACTING BY
Data_Collection/waiver.asp.
A report incorporating the The following links provide more NEGOTIATION
information required by 309.470–2 shall
detailed information regarding the
be forwarded, in duplicate, by the ■ 54. Add section 315.204–1 to read as
supplies, equipment, and services in
Contracting Officer through acquisition follows:
each of the HWACs: the HHS
channels to OAMP when:
Acquisition Integration and 315.204–1 Uniform contract format.
* * * * * Modernization Web site: http://
■ 47. Add part 311 to read as follows:
(a) When preparing solicitations and
intranet.hhs.gov/hwac/index.html and resulting contracts, Contracting Officers/
the HHS Strategic Sourcing Web site: Contract Specialists are strongly
PART 311—DESCRIBING AGENCY http://intranet.hhs.gov/ssc/.
NEEDS encouraged to use as a guide the HHS
PART 314—SEALED BIDDING Solicitation/Contract Structure
Authority: 5 U.S.C. 301; 40 U.S.C. 486(c). Document found at http://
■ 49. Revise section 314.202–7 to read www.knownet.hhs.gov/acquisition/
311.003 Defining Electronic Information policy.htm.
Technology (EIT) requirements.
as follows:
HHS officials who are defining agency 314.202–7 Facsimile bids. 315.204–5 [Removed]
needs for EIT products and services and (c) If the HCA (not delegable) has ■ 55. Remove section 315.204–5.
performing market research to meet determined that the contracting activity
those needs can use the Buy Accessible 315.209 [Amended]
will allow use of facsimile bids and
Wizard (http://www.buyaccessible.gov) proposals, the HCA shall prescribe ■ 56. Amend section 315.209 by
managed by the General Services internal procedures, in accordance with removing paragraph (g).
Administration to document EIT the FAR, to ensure uniform processing ■ 57. Amend section 315.305 by
requirements, identify the applicable and control. revising paragraphs (a)(1), (a)(3)(i)(D),
Section 508 standards, and document (a)(3)(ii)(B), the introductory text of
the market research. 314.213 [Removed] (a)(3)(ii)(E)(1), (a)(3)(ii)(E)(4),
■ 48. Add part 312 to read as follows: ■ 50. Remove section 314.213. (a)(3)(ii)(F)(2), and (a)(3)(ii)(F)(3) to read
■ 51. Revise section 314.404–1 to read as follows:
PART 312—ACQUISITION OF
COMMERCIAL ITEMS as follows: 315.305 Proposal evaluation.
314.404–1 Cancellation of invitations after (a)(1) Cost or price evaluation. (i) The
Authority: 5 U.S.C. 301; 40 U.S.C. 486(c). opening. Contracting Officer shall evaluate
(c) The HCA or CCO (not delegable) business proposals in accordance with
Subpart 312.1—Acquisition of
shall make the determinations required the requirements set forth in FAR
Commercial Items—General
to be made by the agency head in FAR 15.404. The extent of cost or price
312.101 Policy. 14.404–1. analysis in each case depends on the
(a) It is HHS policy to maximize its ■ 52. Revise section 314.407–3 to read
contract type, the amount of the
buying power, reduce acquisition as follows: proposal, the technical complexity, and
administrative costs, and develop long- related cost or price. The Project Officer
term, mutually beneficial, open 314.407–3 Other mistakes disclosed shall be requested to analyze the
partnerships with best-in-class before award. following elements, if applicable, to
providers of products and services. (e) Authority has been delegated to determine if they are necessary and
Accordingly, HHS has implemented a the Departmental Protest Control reasonable for efficient contract
Strategic Sourcing Program under which Officer, Office of Acquisition performance:
Indefinite-Delivery/Indefinite-Quantity Management and Policy, to make (A) The number of labor hours
contracts (IDIQs) and Blanket Purchase administrative determinations in proposed for the various labor categories
Agreements (BPAs), known as HHS- connection with mistakes in bid alleged and the mix in relation to the technical
wide Acquisition Contracts (HWACs), after opening and before award. This requirements;
are awarded to allow for savings for authority may not be redelegated. (B) Types, numbers and hours/days of
commercial items and services across (f) Each proposed determination shall proposed consultants;
HHS and make the acquisition process have the concurrence of the Chief, (C) The kinds and quantities of
more efficient. General Law Division, Office of General material, equipment, supplies, and
(b) If consideration is being given to Counsel. services;
soliciting or acquiring a product or (i) Doubtful cases shall not be (D) Kinds and quantities of
service from a source, other than HHS submitted by the Contracting Officer information technology;
Contract Closeout IDIQs or Strategic directly to the Comptroller General, but, (E) Logic of proposed subcontracting;
Sourcing BPAs, when the category of instead, shall be submitted to the and
the current requirement (e.g. Lab Departmental Protest Control Officer. (F) Travel proposed, including
Supplies, Events Management) is ■ 53. Amend section 314.407–4 by number of trips, locations, purpose, and
encompassed in the portfolio of existing revising paragraph (d) to read as travelers.
IDIQ or BPA categories a waiver request follows: (ii) The Project Officer shall provide
must be prepared and approved in written comments, including the
advance of a purchase or processing of 314.407–4 Mistakes after award. rationale for any exceptions to the
a requirement. * * * * * elements. The Project Officer’s
comments shall be used for negotiations final proposal revisions. To the extent ■ 58. Amend section 315.371 by
or to support award without possible, the same evaluators should be revising the introductory text of
discussions. The Contracting Officer available throughout the entire paragraph (a) to read as follows:
should also request assistance of a cost/ evaluation and selection process to
315.371 Contract preparation and award.
price analyst, when necessary. The ensure continuity and consistency in
Contracting Officer’s negotiation the treatment of proposals. The (a) After details have been finalized
memorandum must include the following are examples of circumstances with the selected offeror, the
rationale used in determining that the when it would not be necessary for the Contracting Officer shall:
price or cost is fair and reasonable. technical evaluation panel to evaluate * * * * *
* * * * * revised proposals submitted during the ■ 59. Amend section 315.372 by
(3) Technical evaluation. acquisition: revising the introductory text and
(i) * * * * * * * * paragraph (a) to read as follows:
(D) The technical evaluation plan (4) When continuity of the evaluation 315.372 Preparation of negotiation
shall be submitted to the Contracting process is not possible, and either new memorandum.
Officer for review and approval before evaluators are selected or the size of the The negotiation memorandum or
the solicitation is issued. The evaluation panel is reduced, all summary of negotiations is a complete
Contracting Officer shall make sure that proposals shall be reviewed by each record of all actions leading to award of
the significant factors and subfactors panel member at the current stage of the a contract and is prepared by the
relating to the evaluation are reflected in acquisition (i.e., initial proposal, final Contracting Officer/Contract Specialist
the evaluation criteria when conducting proposal revisions, etc.). Also, guidance to support the source selection decision
the review of the plan. should be provided concerning what to discussed in FAR 15.308. It should be
(ii) * * * do if an unusually large number of in sufficient detail to explain and
(B) Role of the Project Officer. (1) The proposals are received, including how support the rationale, judgments, and
Project Officer is the Contracting to determine what constitutes an authorities upon which all actions were
Officer’s technical representative for the unusually large number of proposals. predicated. The memorandum will
acquisition action. The Project Officer (F) * * * document the negotiation process and
may be a voting member of the technical reflect the negotiator’s actions, skills,
(2) Decisions to disclose proposals to
evaluation panel, and may also serve as and judgments in concluding a
evaluators outside of the Government
the chairperson of the panel, unless satisfactory agreement for the
shall be made by the official responsible
prohibited by law or contracting activity Government. The negotiation
for appointing panel members in
procedures. memorandum shall address each item
(2) The Project Officer is responsible accordance with operating division
procedures. The avoidance of listed below. If an item is not
for recommending panel members who applicable, it shall be so stated in the
are knowledgeable in the technical organization conflict of interest and
competitive relationships must be taken memorandum. Information already
aspects of the acquisition and capable of contained in the contract file may be
identifying strengths and weaknesses in into consideration when making the
decision to use outside evaluators. referenced rather than reiterated.
the proposals received. Government (a) Description of articles and services
employees serving as panel members (3) When it is determined to disclose and period of performance. A
must be selected in accordance with the a solicited proposal outside the description of articles and services,
requirements set forth in 307.170. Government for evaluation purposes, quantity, unit price, total contract
(3) The Project Officer shall ensure the following or similar conditions shall amount, and period of contract
that persons possessing expertise and be included in the written agreement performance should be set forth.
experience in addressing issues relative with evaluator(s) prior to disclosure:
* * * * *
to sex, race, national origin, and Conditions for Evaluating Proposals ■ 60. Amend section 315.404–4 by
handicapped discrimination are The evaluator agrees to use the data (trade revising paragraphs (b)(1), the
included as panel members for secrets, business data, and technical data) introductory text of (b)(1)(ii), (c),
acquisitions in which such issues are contained in the proposal for evaluation (d)(1)(i), (d)(1)(ii), the introductory text
applicable. purposes only. of (d)(1)(iv), and (d)(3)(iv) to read as
(4) The Project Officer shall submit The foregoing requirement does not apply
to data obtained from another source without
follows:
the list of recommended panel members
to an official within the project office in restriction. 315.404–4 Profit.
a position at least one level higher. This Any notice or legend placed on the
proposal by either the Department or the (b) Policy. (1) The structured
official will review the list and select approach for determining profit or fee
submitter of the proposal shall be applied to
the chairperson. any reproduction or abstract provided to the (hereafter called profit) provides a
(5) The Project Officer shall arrange evaluator or made by the evaluator. Upon technique for establishing a profit
for adequate and secure working space completion of the evaluation, the evaluator objective for negotiation. A profit
for the panel. shall return to the Government the furnished objective is that part of the estimated
* * * * * copy of the proposal or abstract, and all contract price objective or value which,
(E) Continuity of evaluation process. copies thereof, to the Departmental office in the judgment of the Contracting
(1) The technical evaluation panel shall which initially furnished the proposal for Officer, constitutes an appropriate
evaluation.
evaluate all original proposals, make Unless authorized by the Department’s
amount of profit for the acquisition
recommendations to the chairperson initiating office, the evaluator shall not being considered. This technique allows
regarding strengths and weaknesses of contact the submitter of the proposal for consideration of the profit factors
proposals, and, if required by the concerning any aspects of its contents. described in paragraph (d) of this
Contracting Officer, assist the The evaluator’s employees and section. The Contracting Officer’s
Contracting Officer during subcontractors shall abide by these analysis of these factors is based on
communications and discussions, and conditions. available information such as proposals,
review supplemental, revised and/or * * * * * audit data, assessment reports, preaward
surveys, etc. The structured approach capital cost of money is not included. provided to all prospective offerors of
provides a basis for documenting the Form HHS–674, Structured Approach unsolicited proposals:
profit objective. Any significant Profit/Fee Objective, should be used. * * * * *
departure from this objective shall be Form HHS–674 is illustrated in
explained. The amount of 353.370–674. PART 316—TYPES OF CONTRACTS
documentation depends on the dollar * * * * *
value and complexity of the proposed ■ 63. Add section 316.505 to read as
(iv) The structured approach was follows:
acquisition. The profit objective is a part designed for arriving at profit objectives
of the overall negotiation objective and for other than nonprofit organizations. 316.505 Ordering.
is directly related to the cost objective However, the structured approach can (b)(5) The Department’s task-order
and any proposed sharing arrangement. be used for nonprofit organizations if and delivery-order ombudsman is the
The profit objective should be appropriate adjustments are made. The Director, Strategic Acquisition Service,
negotiated at the same time as the other Contracting Officer shall use the Program Support Center (PSC). The
cost items. The profit objective should modified structured approach in task-order and delivery-order
be negotiated as a whole and not as paragraph (d)(1)(iv)(B) of this section to ombudsmen for each of the
individual profit factors. establish profit objectives for nonprofit Department’s contracting activities are
(ii) The profit analysis factors in FAR organizations. as follows:
15.404–4(d) shall be used in lieu of the
structured approach in the following * * * * * AHRQ—Director, Office of Performance
circumstances. Factors considered (3) * * * Accountability, Resources and
inapplicable to the acquisition shall be (iv) Federal socioeconomic programs. Technology
excluded from the profit objective. CDC—Chief Information Officer
This factor, which may apply to special
Documentation shall be provided which CMS—Chief Operating Officer
circumstances or particular acquisitions, FDA—Director, Office of Acquisitions
includes the profit factor breakdown. relates to the extent of a contractor’s and Grants Services
* * * * * successful participation in Government HRSA—Associate Administrator, Office
(c) Contracting Officer sponsored programs such as small of Administration and Financial
responsibilities. The Contracting Officer business, small disadvantaged business, Management
shall develop the profit objective. This women-owned small business, service- Indian Health Service—Director, Office
objective shall realistically reflect the disabled veterans, handicapped of Management Services
total overall task to be performed and sheltered workshops, and energy NIH—Senior Scientific Advisor for
the requirements placed on the conservation efforts. The contractor’s Extramural Research, Office of
contractor. The Contracting Officer shall policies and procedures which Extramural Research (R&D) and
not begin to develop the profit objective energetically support Government Senior Advisor to the Director (Other
until a thorough review of proposed socioeconomic programs and achieve than R&D)
contract work has been made; a review successful results should be given PSC—Director, Strategic Acquisition
of all available knowledge regarding the positive considerations. Conversely, Service
contractor pursuant to FAR subpart 9.1, failure or unwillingness on the part of SAMHSA—Executive Officer
including audit data, preaward survey the contractor to support Government ■ 64. Revise section 316.603–3 to read
reports and financial statements, as socioeconomic programs should be as follows:
appropriate, has been conducted; and an viewed as evidence of poor performance
analysis of the contractor’s cost estimate for the purpose of establishing a profit 316.603–3 Limitations.
and comparison with the Government’s objective. An official one level above the
estimate or projection of cost has been * * * * * Contracting Officer shall make the
made. written determination.
■ 61. Amend section 315.606 by
(d) * * *
revising paragraph (b) to read as follows: 316.770–1 [Removed]
(1) * * *
(i) The Contracting Officer shall 315.606 Agency procedures. ■ 65. Remove section 316.770–1.
measure ‘‘Contractor Effort’’ by * * * * * PART 319—SMALL BUSINESS
assigning a profit percentage within the
(b) The HCA or the HCA’s designee PROGRAMS
designated weight range to each element
of contract cost. The categories listed are shall be the point of contact for
coordinating the receipt and handling of ■ 66. Amend section 319.201 by
for reference purposes only, but are revising paragraph (e) to read as follows:
broad and basic enough to provide unsolicited proposals.
guidance to other elements of cost. ■ 62. Amend section 315.609 by 319.201 General policy.
Facilities capital cost of money is not to revising the introductory text to read as * * * * *
be included. A total dollar profit shall follows: (e)(1) The Department’s Small
be computed for ‘‘Contractor Effort.’’ Business Program shall be carried out by
315.609 Limited use of data.
(ii) The Contracting Officer shall use appointed small business specialists
the total dollar profit for the ‘‘Contractor The legend, Use and Disclosure of (SBS) co-located within the OPDIVs.
Effort’’ to calculate specific profit Data, prescribed in FAR 15.609(a) is to Appointments, and termination of
dollars for ‘‘Other Factors’’—cost risk, be used by the offeror to restrict the use appointments, shall be made in writing
investment, performance, of data for evaluation purposes only. by the Director, Office of Small and
socioeconomic programs, and special However, data contained within the Disadvantaged Business Utilization
situations. The Contracting Officer shall unsolicited proposal may have to be (OSDBU). The Director, OSDBU, will
multiply the total dollar profit for the disclosed as a result of a request exercise full management authority over
‘‘Contractor Effort’’ by the weight submitted pursuant to the Freedom of small business specialists.
assigned to each of the elements in the Information Act. Because of this (2) One or more qualified SBS shall be
‘‘Other Factors’’ category. Facilities possibility, the following notice shall be appointed in the following activities:
Agency for Healthcare Research and solicitation, and the contract clause in the Office of General Counsel. The
Quality (AHRQ), Centers for Medicare & the resultant contract. In addition, the Contracting Officer must remember that
Medicaid Services (CMS), Substance contracting officer shall ensure that the only the FOI Officer has the authority to
Abuse and Mental Health Services solicitation notification, contract clause, release or deny release of records. While
Administration (SAMHSA), Food and and other pertinent information the Contracting Officer should be
Drug Administration (FDA), Health specified in this subpart are included in familiar with the entire FOIA regulation
Resources and Services Administration any contract modification which results in 45 CFR part 5, particular attention
(HRSA), Indian Health Service (IHS), in the Privacy Act requirements should be focused on §§ 5.65 and 5.66;
National Institutes of Health (NIH), becoming applicable to a contract. also of interest are §§ 5.32, 5.33, and
Centers for Disease Control (CDC), (b)(1) The Contracting Officer shall 5.35.
Program Support Center (PSC), and the identify in the contract work statement
Office of the Secretary (OS). the system(s) of records to which the PART 325—[REMOVED]
■ 67. Revise section 319.501 to read as Privacy Act and the implementing
regulations are applicable. ■ 71. Remove part 325.
follows:
(2) The Contracting Officer shall
PART 330—COST ACCOUNTING
319.501 General. include the clause specified in 352.270–
STANDARDS
(e) Subsequent to the Contracting 11 in Section H of any RFP or resulting
Officer’s recommendation on Form contract to notify the contractor that it ■ 72. Revise section 330.201–5 to read
HHS–653, Small Business Set-Aside and its employees are subject to as follows:
Review Form, the SBS shall review each criminal penalties for violations of the
proposed acquisition strategy and either Act (5 U.S.C. 552a(i)) to the same extent 330.201–5 Waiver.
concur or non-concur with the as HHS employees. The clause also (c) The requirements of FAR 30.201–
Contracting Officer’s recommendation. requires that the contractor ensure that 5 shall be exercised by the Director,
The Small Business Administration’s each of its employees knows the Division of Acquisition Policy (DAP).
Procurement Center Representative prescribed rules of conduct and each Requests shall be forwarded through
(SBA/PCR) shall also review the contractor employee is aware that he/ normal acquisition channels to the DAP.
acquisition strategy and either concur or she is subject to criminal penalties for
violations of the Act. These provisions PART 332—CONTRACT FINANCING
non-concur with the Contracting
Officer’s recommendation. If the also apply to all subcontracts awarded
Contracting Officer disapproves the under the contract which require the follows:
SBS’s and/or the SBA PCR’s set-aside design, development or operation of a
recommendation, the reasons must be system of records. The Contracting 332.402 General.
documented on the Form HHS–653, and Officer shall send the contractor a copy (e) The HCA shall determine whether
the form placed in the contract file. The of 45 CFR part 5b, which includes the an advance payment is in the public
Contracting Officer will make the final rules of conduct and other Privacy Act interest in accordance with FAR
determination as to whether the requirements. 32.402(c)(1)(iii)(A). This authority is
proposed acquisition will be set-aside or (c) The Contracting Officer shall non delegable.
not. specify in the contract work statement ■ 74. Amend section 332.407 by
■ 68. Revise the heading of part 323 to
and award the disposition to be made of revising the introductory text of
read as follows: the system(s) of records upon paragraph (d) to read as follows:
completion of contract performance.
PART 323—ENVIRONMENT, ENERGY The contract work statement may 332.407 Interest.
AND WATER EFFICIENCY, require the contractor to destroy the (d) The HCA (not delegable) is
RENEWABLE ENERGY records, remove personal identifiers, or authorized to make the determinations
TECHNOLOGIES, OCCUPATIONAL turn the records over to the Contracting in FAR 32.407(d) and as follows.
SAFETY, AND DRUG-FREE Officer. If there is a legitimate need for Interest-free advance payments may also
WORKPLACE a contractor to keep copies of the be approved for educational institutions
records after completion of a contract, and other nonprofit organizations,
PART 324—PROTECTION OF PRIVACY the contractor must take measures, as whether public or private, performing
AND FREEDOM OF INFORMATION approved by the Contracting Officer, to work under nonprofit contracts (without
keep the records confidential and fee) involving health services,
■ 69. Amend section 324.103 by protect the individuals’ privacy. educational programs, or social service
revising paragraphs (a), (b), and (c) to * * * * * programs, such as:
read as follows: * * * * *
324.202 [Redesignated as 324.203]
■ 75. Revise section 332.501–2 to read
324.103 Procedures.
■ 70–A. Redesignate section 324.202 as as follows:
(a) All requests for contract shall be section 324.203.
reviewed by the contracting officer to ■ 70–B. Amend section 324.203 by 332.501–2 Unusual progress payments.
determine whether the Privacy Act revising paragraph (b) to read as follows: (a)(3) The approval of an unusual
requirements are applicable. The progress payment shall be made by the
Privacy Act requirements are applicable 324.203 Policy. HCA (not delegable).
when the contract will require the * * * * * ■ 76. Revise section 332.702 to read as
contractor to design, develop, or operate (b) The Contracting Officer, upon follows:
any Privacy Act system of records on receiving a Freedom of Information Act

individuals to accomplish an agency (FOIA) request, shall follow Department 332.702 Policy.
function. When applicable, the and OPDIV procedures. As necessary, An incrementally funded contract is a
contracting officer shall include the actions should be coordinated with the multiple year contract in which funds
solicitation notification and contract cognizant Freedom of Information (FOI) are allocated to cover specific phases or
clause required by FAR 24.104 in the Officer and the General Law Division of increments of performance.
(a) Incremental funding may be used than the first year of performance, whether performance has commenced,
in cost-reimbursement type contracts for unless the Contracting Officer shipment or delivery has been made, or
the acquisition of severable services. It determines it is advantageous to the a stop work order has been issued.
shall not be used in contracts for Government to fund the contract for a (I) A copy of any mutual agreement to
construction or architect-engineer lesser period. In that event, the suspend work on a no-cost basis, when
services. Incremental funding allows Contracting Officer shall ensure that the appropriate (see FAR 33.104(c)(4)).
severable cost-reimbursement type obligated funds are sufficient to cover a (J) Copies of the notice of protest
contracts awarded for more than one complete phase or increment of given offerors and other parties when
year to be funded from succeeding fiscal performance representing a material and the notice is appropriate (see FAR
years. measurable part of the total project and 33.104(a)(2)).
(b) It is Departmental policy that the period of time that the funds cover (K) A copy of the negotiation
multiple year contracts be fully funded shall be stated in the contract. memorandum, when applicable.
whenever possible. However, (6) An incrementally funded contract (L) The name and telephone number
incrementally funded contracts may be must contain precise requirements for of the person in the contracting office
used when: progress reports to be sent to the Project who may be contacted for information
(1) A project, which is part of an and Contracting Officers. These reports relevant to the protest.
approved program, is anticipated to be will enable the contract to be effectively (M) A copy of the competitive range
of multiple year duration, but funds are monitored. The Project Officer shall memorandum.
not currently available to cover the prepare periodic performance (N) The contracting officer’s statement
entire project; evaluation reports and provide them to of facts and circumstances, including a
(2) The project represents a valid need the Contracting Officer. discussion of the merits of the protest,
for the fiscal year in which the contract and conclusions and recommendations,
is awarded and for the succeeding fiscal including documentary evidence on
follows: which they are based. The files shall be
years of the project’s duration;
(3) The project is so significant to the 332.704 Limitation of cost or funds. assembled in an orderly manner and
approved program that there is See subpart 342.71, ‘‘Administrative shall have an index of enclosures and
reasonable assurance that it will Actions for Cost Overruns,’’ for any document referred to therein.
command a high priority for proposed procedures for handling anticipated cost (4) The DPCO is responsible for
appropriations to cover the entire overruns. making the necessary distributions
multiple year duration; and referenced in FAR 33.104(a)(4).
(4) The statement of work is specific 332.705 [Removed] (5) The Contracting Officer shall
and is defined by separate phases or ■ 79. Remove section 332.705. furnish the protest file containing the
increments so that, at the completion of documentation specified in paragraph
each, progress can be effectively 332.902 [Removed] (a)(3)(ii) of this section (with the
measured. ■ 80. Remove section 332.902. exception of the contracting officer
■ 77. Revise section 332.703–1 to read
statement of facts and circumstances)
as follows: PART 333—PROTESTS, DISPUTES, and FAR 33.104(a)(3)(ii)(A) through (G)
AND APPEALS to the DPCO within fourteen (14)
332.703–1 General. calendar days from receipt of the
(b) The following general guidelines 333.102 [Amended] protest. The contracting officer shall
are applicable to incrementally funded ■ 81. Amend section 333.102 by submit the contracting officer’s
contracts: removing paragraph (a). statement of facts and circumstances
(1) The estimated total cost of the ■ 82. Amend section 333.103 by within twenty-one (21) calendar days
project (all planned phases or revising paragraph (f)(3) to read as from receipt of the protest. Since the
increments) is to be taken into follows: statute allows only a short time period
consideration when determining the in which to respond to protests lodged
requirements which must be met before 333.103 Protests to the agency. with GAO, the Contracting Officer shall
entering into the contract; i.e., (f) * * * handle each protest on a priority basis.
justification for noncompetitive (3) Protests received after award shall The DPCO shall submit copies of the
acquisition, approval of award, etc. be treated as indicated in FAR protest file to GAO, the protestor, and
(2) The RFP and resultant contract are 33.103(f)(3). any intervenors in accordance with FAR
to include a statement of work which ■ 83. Revise section 333.104 to read as 33.104(a)(4)(i).
describes the total project covering the follows: (6) Since the DPCO will furnish the
proposed multiple year period of protest file to GAO, the protestor, and
performance and indicating timetables 333.104 Protests to GAO. any intervenors, comments on the file
consistent with planned phases or (a) General procedures. (3)(ii) The from the protestor and any intervenors
increments and corresponding DPCO shall process protests filed with will be sent to the DPCO.
allotments of funds. GAO, whether pre- or post award. (7) The DPCO, Division of Acquisition
(3) Offerors’ technical and cost Protest files shall be prepared by the Policy (DAP), shall serve as the GAO
proposals must include the entire contracting office and distributed as point of contact for protests lodged with
project and shall show distinct phases follows: Two copies to the DPCO, one GAO.
or increments and the multiple year copy to the contracting activity’s protest (b) Protests before award. (1) To make
period of performance. control officer, and one copy to OGC– an award notwithstanding a protest, the
(4) Negotiations will be conducted GLD. In addition to the items listed in Contracting Officer shall prepare a
based upon the total project, including 33.104(a)(3)(ii)(A) through (G), the finding using the criteria in FAR
all planned phases or increments, and protest file shall include the following 33.104(b)(1), have it executed by the
the multiple year period of performance. documents: HCA (not delegable), and forward it,
(5) Sufficient funds must be obligated (H) The current status of award. When along with a written request for
under the basic contract to cover no less award has been made, this shall include approval to make the award, to the
Deputy Assistant Secretary for Services’’ before each mention of the by the Government Trial Attorney.
Acquisition Management and Policy term ‘‘Board of Contract Appeals’’. When an appeal is set for hearing, the
(DASAMP). (h) At any time within the period of concerned contracting officer shall be
(2) If the request to make an award appeal, the contracting officer may responsible for providing Government
notwithstanding the protest is approved modify or withdraw his/her final witnesses and specified physical and
by the Deputy Assistant Secretary for decision. If an appeal from the final documentary evidence to the Trial
Acquisition Management and Policy decision has been taken to the ASBCA, Attorney. The Trial Attorney shall
(DASAMP), the DPCO shall notify GAO. the contracting officer will forward his/ ensure the presence of all witnesses and
Whether the request is approved or not, her recommended action to OGC–GLD documentary evidence at both the pre-
the DPCO shall telephonically notify the with the supplement to the contract file hearing conference and hearing.
contracting activity’s protest control which supports the recommended (e) If a contractor which has filed an
officer of the decision of the Deputy correction or amendment. appeal with the ASBCA elects to accept
Assistant Secretary for Acquisition ■ 86. Revise section 333.212 to read as fully the decision from which the
Management and Policy (DASAMP), follows: appeal was taken, or any modification to
and the contracting activity’s protest it, and gives written notification of
control officer shall immediately notify 333.212 Contracting officer’s duties upon
appeal. acceptance to the Government Trial
the Contracting Officer. The DPCO shall Attorney or the concerned contracting
confirm the decision by memorandum (a) Appeals shall be governed by the
rules set forth in the ‘‘Rules of the officer, the Government Trial Attorney
to the contracting activity’s protest will notify the ASBCA of the disposition
control officer. Armed Services Board of Contract
Appeals,’’ or by the rules established by of the dispute in accordance with Rule
(c) Protests after award. (2) If the
the U.S. Court of Federal Claims, as 27 of the ASBCA.
Contracting Officer believes
performance should be allowed to appropriate. (f) If the contractor has elected to
continue notwithstanding the protest, a (b) The Office of General Counsel- appeal to the U.S. Court of Federal
finding shall be prepared by the General Law Division (OGC-GLD) is Claims, the U.S. Department of Justice
Contracting Officer using the criteria in designated as the Government Trial will represent the Department.
FAR 33.104(c)(2), executed by the HCA Attorney to represent the Government in However, the contracting officer shall
(not delegable), and forwarded, along the defense of appeals before the still coordinate all actions through
with a written request for approval, to ASBCA. A decision by the ASBCA will OGC–GLD.
the Deputy Assistant Secretary for be transmitted by the Government Trial
■ 87. Amend section 333.212–70 by
Acquisition Management and Policy Attorney to the appropriate contracting
revising paragraph (a) to read as follows:
(DASAMP). The same procedures for officer for compliance in accordance
notification stated in paragraph (b)(2) of with the ASBCA’s decision. 333.212–70 Formats.
this section shall be followed. (c) If an appeal is filed with the
(d) Findings and notice. The written ASBCA, the contracting officer shall (a) The following format is suggested
notice required by FAR 33.104(d) shall assemble a file within 30 days of receipt for use in transmitting appeal files to the
be provided to the protestor and any of an appeal, or advice that an appeal ASBCA:
intervenors by the DPCO. has been filed, that consists of all Your reference:
(g) Notice to GAO. The Deputy documents pertinent to the appeal, (Docket No.)
Assistant Secretary for Acquisition including: (Name)
Management and Policy (DASAMP) (1) The decision and findings of fact Recorder, Armed Services Board of Contract
shall be the official to comply with the from which the appeal is taken; Appeals
requirements of FAR 33.104(g). (2) The contract, including Skyline Six 5109 Leesburg Pike
■ 84. Revise section 333.203 to read as specifications and pertinent Falls Church, Virginia 22041
follows: modifications, plans and drawings; Dear (Name):
(3) All correspondence between the Transmitted herewith are documents relative
333.203 Applicability. parties pertinent to the appeal, to the appeal under Contract No. ll with
(c) The Secretary has designated the including the letter or letters of claim in the llllll
Armed Services Board of Contract response to which the decision was (Name of contractor)
Appeals (ASBCA) as the authorized issued; in accordance with the procedures under
‘‘Board’’ to hear and determine disputes (4) Transcripts of any testimony taken Rule 4. The Government Trial Attorney for
for the Department. during the course of proceedings, and this case is
affidavits or statements of any witness (Insert General Law Division, Office of
on the matter in dispute made prior to General Counsel, Department of Health
follows: and Human Services, 330 Independence
the filing of the notice of appeal with
333.211 Contracting officer’s decision. the Board; and Avenue, SW., Washington, DC 20201).
(a)(2) The contracting officer shall (5) Any additional information The request for payment of charges resulting
considered pertinent. The contracting from the processing of this appeal should
refer a proposed final decision to the
be addressed to:
Office of General Counsel-General Law officer shall furnish the appeal file to
(Insert name and address of cognizant
Division (OGC–GLD), for advice as to the Government Trial Attorney for
finance office.)
the legal sufficiency and format before review and approval. After approval, the
sending the final decision to the contracting officer shall prepare four Sincerely yours,
contractor. The contracting officer shall copies of the file, one for the ASBCA, Contracting Officer
provide OGC–GLD with the pertinent one for the appellant, one for the Enclosures
documents with the submission of each Government Trial Attorney, and one for * * * * *
proposed final decision. the contracting office.
(a)(4)(v) When using the paragraph in (d) At all times after the filing of an PART 334—[REMOVED]
FAR 33.211 (a)(4)(v), the contracting appeal, the contracting officer shall
officer shall insert the words ‘‘Armed render whatever assistance is requested ■ 88. Remove part 334.
PART 335—RESEARCH AND 339.201–70 Required provision and Government personnel involved with
DEVELOPMENT CONTRACTING contract clause. the contract.
When acquiring EIT, the Contracting (c) The Contracting Officer must
■ 89. Amend section 335.070–2 by Officer shall insert the provision at depend on program, technical, and
revising the introductory text and 352.270–19(a) in solicitations and the other personnel for assistance and
clause in 352.270–19(b) in contracts and advice in monitoring the contractor’s
paragraph (a) to read as follows:
orders for projects that will develop, performance, and in other areas of
335.070–2 Amount of cost-sharing. purchase, maintain, or use electronic postaward administration. The
and information technology (EIT), Contracting Officer must assure that
When cost-sharing is appropriate, use unless these EIT products and/or these individuals understand and carry
the following guidelines to determine services are incidental to the project. out their assigned responsibilities. The
the amount of cost participation by the (Note: Other exceptions to this individual roles and corresponding
contractor: requirement can be found at FAR responsibilities typically involve, but
(a) The amount of cost participation 39.204.) are not limited to, the following:
should depend on the extent to which (1) The role of program and technical
the research effort or results are likely PART 342—CONTRACT personnel in monitoring the contract is
to enhance the performing ADMINISTRATION to assist and/or advise the Contracting
organization’s capability, expertise, or ■ 91. Revise section 342.705 to read as Officer or act as his/her representative
competitive position, and the value of follows: when so designated by the Contracting
this enhancement to the performing Officer. Activities may include:
organization. It should be recognized 342.705 Final indirect cost rates. (i) Providing technical monitoring
that those organizations which are (a) The Director, Division of Cost during contract performance, and
predominantly engaged in research and Allocation of the Program Support issuing letters to the contractor and
development have little or no Center, within each servicing HHS Contracting Officer relating to delivery,
production or other service activities regional office, has been delegated the acceptance, or rejection in accordance
and may not be in a favorable position authority to establish indirect cost rates, with the terms of the contract;
to derive a monetary benefit from their research patient care rates, and, as (ii) Assessing contractor performance,
research under Federal agreements. necessary, fringe benefit, computer, and including inspection and testing of
Therefore, contractor cost participation other special costing rates for use in products and evaluation of reports and
could reasonably range from as little as contracts and grants awarded to State data;
1 percent or less of the total project cost, and local governments, colleges and (iii) Recommending necessary
universities, hospitals, and other changes to the schedule of work and
to more than 50 percent of the total
nonprofit organizations. period of performance in order to
project cost. Ultimately, the Contracting (b) The Division of Financial
Officer should bear in mind that cost- accomplish the objectives of the
Advisory Services of the National contract. Program officials must provide
sharing is a negotiable item. As such, Institutes of Health has the authority to the Contracting Officer a written request
the amount of cost-sharing should be establish indirect cost rates, fringe along with an appropriate justification
proportional to the anticipated value of benefit rates, etc., for use in contracts and a funding document if additional
the contractor’s gain. and grants awarded to commercial funds are needed;
* * * * * organizations. (iv) Reviewing invoices/vouchers and
■ 92. Revise section 342.7001 to read as recommending approval/disapproval
■ 90. Add part 339 to read as follows: follows: action by the Contracting Officer, to
PART 339—ACQUISITION OF 342.7001 Purpose. include comments regarding anything
INFORMATION TECHNOLOGY Contract monitoring is an essential unusual discovered in the review;
element of contract administration and (v) Reviewing and recommending
Authority: 5 U.S.C. 301; 40 U.S.C. 486(c). is performed jointly by the Project approval or disapproval of
Officer and the Contracting Officer. This subcontractors, overtime, travel, and key
339.201–10 Clarification.
subpart describes the Department’s personnel changes; and
operating concepts. (vi) Participating, as necessary, in
FAR Subpart 39.2, Electronic and
various phases of the contract closeout
Information Technology, requires ■ 93. Revise section 342.7002 to read as
process.
Federal agencies to ensure that, when follows:
(2) The role of the Project Officer in
acquiring EIT, Federal employees with monitoring the contract includes the
342.7002 Contract monitoring
disabilities and members of the public responsibilities. applicable activities set forth in
with disabilities have access to and use paragraph (c)(1) of this section. The
(a) The contract establishes the
of information and data that is obligations of both the Government and Project Officer also shall do the
comparable to individuals without the contractor. The Contracting Officer following:
disabilities. This EIT access requirement is the only person authorized to make (i) Submit periodic reports to the
does not apply to a contractor’s internal changes to the contract. The Contracting Contracting Officer that concisely
workplaces. EIT that is not used nor Officer must confirm all changes in explain the status of the contract, and
accessed by Federal employees or writing. include recommended actions for any
members of the public is not subject to (b) The Contracting Officer is problems reported. Provide the
the Architectural and Transportation responsible for assuring compliance Contracting Officer with written
Barriers Compliance Board (Access with all the terms and conditions of the notification of evaluation and approval/
Board) standards. Contractors in their contract. The Contracting Officer shall disapproval of contract deliverables and
professional capacity are not members inform the contractor by letter (if not of completion of tasks or phases. The
of the public for purposes of Section already stipulated in the contract) of the Contracting Officer or designee will
508. authorities and responsibilities of the provide the contractor with written
notification of approval or disapproval her immediate supervisor of problems payments and shall determine whether
and include a copy in the contract file; that cannot be resolved within contract termination for default or other action
(ii) Monitor the technical aspects of limitations and whenever contract or would be in the best interest of the
the contract, identify existing and program objectives are not met. The Government.
potential problems that threaten notification shall include a statement of (c) When the contract does not
performance, and immediately inform action being taken by the Contracting contain a termination for default clause,
the Contracting Officer of deviations Officer. the contractor’s failure to submit any
from contract objectives or from any ■ 94. Revise section 342.7003–1 to read required report, perform services, or
technical or delivery requirements; as follows: deliver work when required by the
(iii) Immediately notify the head of contract shall be considered a failure to
the program office whenever it is § 342.7003–1 Policy. perform. The Contracting Officer shall
determined that objectives are not being (a) All solicitations and resultant immediately issue a written notice to
met and provide specific contracts (other than awards made using the contractor specifying the failure and
recommendations of actions to be taken. simplified acquisition procedures) shall providing a ten-day period (or longer
The Contracting Officer shall receive a contain the withholding of contract period if the Contracting Officer deems
copy of the Project Officer’s report and payments clause at 352.232–9, and an it necessary) in which the contractor
recommendations; excusable delays clause, or a clause shall cure the failure or provide reasons
(iv) Within 120 days after contract which incorporates the definition of for an excusable delay. The notice shall
completion, submit a final written excusable delays. Use the excusable include a statement to the effect that
assessment report to the Contracting delays clause at 352.249–14 when the payments will be withheld if the default
Officer. The report should include solicitation and resultant contract (other is not cured within the time specified in
analysis of the contractor’s performance, than purchase orders) does not contain the notice or if the default is not
including the contract and program a default or other excusable delays determined to be excusable.
objectives achieved and missed. A copy clause. (1) If the failure is cured or is
of the final assessment report shall be (b) When appropriate, the Contracting determined to be excusable, the
forwarded to the head of the program Officer may withhold any contract Contracting Officer shall not initiate the
office responsible for the program for payment when a required report is withholding action.
management review and follow-up, as overdue, or the contractor fails to (2) If the failure is not determined to
necessary; and perform or deliver required work or be excusable or a response is not
(v) Accompany and/or provide, when services. received within the allotted time, the
requested, technical support to the HHS ■ 95. Revise section 342.7003–2 to read Contracting Officer shall initiate
auditor in the conduct of visual as follows: withholding action on all contract
inspections. payments and shall determine whether
(3) The roles of the contract § 342.7003–2 Procedures. termination for convenience or other
administrator, auditor, cost analyst, and (a) The Contracting Officer is action would be in the best interest of
property administrator are to assist and/ responsible for initiating immediate the Government.
or advise the Contracting Officer in action to protect the Government’s (d) The Contracting Officer should
postaward administration activities rights whenever the contractor fails to consult FAR subpart 49.4 for further
such as: comply with either the delivery or guidance before taking any of the
(i) Evaluation of contractor systems reporting terms of the contract. actions described in this section.
and procedures, to include accounting Compliance with the reporting terms ■ 96. Revise section 342.7003–3 to read
policies and procedures, purchasing includes those reports to be submitted as follows:
policies and practices, property directly to the payment office. The
accounting and control, wage and salary payment office shall notify the § 342.7003–3 Withholding payments.
plans and rate structures, personnel Contracting Officer promptly when such (a) When making the determination
policies and practices, etc.; a report is not submitted on time. that contract payments should be
(ii) Processing of disputes under the (b) When the contract contains a withheld in accordance with the
Disputes clause and any resultant termination for default clause, the Withholding of Contract Payments
appeals; contractor’s failure to submit any report, clause, the Contracting Officer shall
(iii) Modification or termination of the perform services, or deliver work when immediately notify the servicing finance
contract; and required by the contract is considered a office in writing of the determination to
(iv) Determination of the allowability default in performance. The Contracting withhold payments. The notice of
of cost charges to incentive or cost- Officer shall immediately issue a formal suspension shall contain all information
reimbursement type contracts and ten-day cure notice pursuant to FAR necessary for the finance office to
progress payments under fixed-price 49.607. The notice shall include a identify the contract, i.e., contract
contracts. This is especially important statement to the effect that payments number, task/delivery order number,
when award is made to new will be withheld if the default is not contractor name and address, etc.
organizations or those with financial cured within the time frame specified in (b) The Contracting Officer shall
weaknesses. the notice or if the default is not immediately notify the contractor in
(d) The Contracting Officer is determined to be excusable. writing that payments have been
responsible for assuring that contractor (1) If the default is cured or is suspended until the default or failure is
performance and contract monitoring determined to be excusable, the cured.
conform with contract terms. If Contracting Officer shall not initiate the (c) When the contractor cures the
performance is not satisfactory or if withholding action. default or failure, the Contracting

problems are anticipated, it is essential (2) If the default is not determined to Officer shall immediately notify, in
that the Contracting Officer take be excusable or a response is not writing, all recipients of the notice of
immediate action to protect the received within the allotted time, the suspension that the suspension is to be
Government’s rights under the contract. Contracting Officer shall initiate lifted and contract payments are to be
The Contracting Officer shall notify his/ withholding action on all contract resumed.
(d) When exercising actions regarding PART 352—SOLICITATION specifically identified by page number,
the withholding of payment procedures, PROVISIONS AND CONTRACT paragraph, etc. by the offeror as containing
the Contracting Officer must be careful restricted information shall not be used or
CLAUSES disclosed except for evaluation purposes.
not to waive any of the Government’s The offeror acknowledges that the
rights when corresponding with the ■ 99. Revise section 352.202–1 to read Department may not be able to withhold a
contractor or when taking any other as follows: record (data, document, etc.) nor deny access
actions. § 352.202–1 Definitions. to a record requested pursuant to the Act and
that the Department’s FOI officials must
■ 97. Revise section 342.7100 to read as As prescribed in 302.201, use the FAR make that determination. The offeror hereby
follows: Definitions clause at 52.202–1 as agrees that the Government is not liable for
modified: disclosure if the Department has determined
§ 342.7100 Scope of subpart. that disclosure is required by the Act.
Definitions (January 2006) If a contract is awarded to the offeror as a
This subpart sets forth the procedures (a) In accordance with 52.202–1(a)(1), result of, or in connection with, the
to follow when a cost overrun is substitute the following as paragraph (a): submission of this proposal, the Government
anticipated. A cost overrun occurs when ‘‘(a) The term ‘‘Secretary’’ or ‘‘Head of the shall have the right to use or disclose the data
the allowable actual cost of performing Agency’’ (also called ‘‘Agency Head’’) means to the extent provided in the contract.
a cost-reimbursement type contract the Secretary, Deputy Secretary, or any Proposals not resulting in a contract remain
exceeds the total estimated cost Assistant Secretary, Administrator or subject to the Act.
Commissioner of the Department of Health The offeror also agrees that the
specified in the contract. Government is not liable for disclosure or use
and Human Services; and the term ‘‘his/her
■ 98. Amend section 342.7101–2 by duly authorized representative’’ means any of unmarked data and may use or disclose
revising the introductory text of person, persons, or board authorized to act the data for any purpose, including the
for the Secretary.’’ release of the information pursuant to
paragraph (a) and paragraph (b)(3) to requests under the Act. The data subject to
(b) In accordance with 52.202–1(a)(1), add
read as follows: this restriction are contained in pages (insert
the following paragraph (h):
‘‘(h) The term ‘‘Project Officer’’ means the page numbers, paragraph designations, etc. or
§ 342.7101–2 Procedures. other identification).’’
person who monitors the technical aspects of
(a) Upon notification that a cost contract performance. The Project Officer is (2) In addition, the offeror must mark each
not authorized to issue any instructions or page of data it wishes to restrict with the
overrun is anticipated, the Contracting
directions which cause any increase or following statement:
Officer shall inform the contractor to ‘‘Use or disclosure of data contained on
submit a request for additional funds decrease in the scope of work which would
result in the increase or decrease in the price this page is subject to the restriction on the
which shall include: of this contract, or changes in the delivery cover sheet of this proposal or quotation.’’
* * * * * (3) Offerors are cautioned that proposals
schedule or period of performance of this
submitted with restrictive statements or
(b) * * * contract. If applicable, the Project Officer is
statements differing in substance from those
not authorized to receive or act upon any
(3) Maintain continuous follow-up cited above may not be considered for award.
notification or revised cost estimate provided
The Government reserves the right to reject
with the program office to obtain a by the Contractor in accordance with the any proposal submitted with nonconforming
timely decision as to whether the work Limitation of Cost or Limitation of Funds statement(s).
under the contract should continue and clauses of this contract.’’
■ 101. Revise section 352.215–70 to
additional funds be provided, or the ■ 100. Revise section 352.215–1 to read read as follows:
contract terminated. An appropriate as follows:
written statement and funding § 352.215–70 Late proposals and
§ 352.215–1 Instructions to offerors— revisions.
authority, or a formal request for Competitive acquisition.
termination, must support the decision As prescribed in 315.208, the
Insert the following paragraph (e) in following provision may be included in
of the program office. After receiving the
place of paragraph (e) of the provision the solicitation:
decision by the program office, the
at FAR 52.215–1:
Contracting Officer shall promptly Late Proposals and Revisions (January 2006)
notify the contractor in writing of the (e) Restriction on disclosure and use of
data. (1) The proposal submitted in response Notwithstanding the procedures contained
following: in FAR 52.215–1(c)(3) of the provision of this
to this request may contain data (trade
(i) The specified amount of additional secrets; business data, e.g., commercial solicitation entitled Instructions to Offerors—
funds allotted to the contract; or information, financial information, and cost Competitive Acquisition, a proposal received
and pricing data; and technical data) which after the date specified for receipt may be
(ii) Work will be discontinued when considered if it appears to offer the best value
the offeror, including its prospective
the allotted funds are exhausted, and subcontractor(s), does not want used or to the Government and it was received before
any work performed after that date is at disclosed for any purpose other than for proposals were distributed for evaluation, or
the contractor’s risk; or evaluation of the proposal. The use and within five calendar days after the exact time
disclosure of any data may be so restricted; specified for receipt, whichever is earlier.
(iii) The Government is considering
provided, that the Government determines (End of provision)
whether to allot additional funds to the
that the data is not required to be disclosed
contract and will notify the contractor ■ 102. Amend section 352.216–72 by
under the Freedom of Information Act,
as soon as possible, but that any work 5 U.S.C. 552, as amended, and the offeror revising the title and paragraph (a)(4) of
performed after the currently allotted marks the cover sheet of the proposal with the ‘‘Additional Cost Principles’’ clause
funds are exhausted is at the the following statements, specifying the to read as follows:
contractor’s risk. Timely, formal particular portions of the proposal which are
notification of the Government’s to be restricted: ‘‘Unless disclosure is § 352.216–72 Additional cost principles.
intention is essential in order to required by the Freedom of Information Act, * * * * *
preclude loss of contractual rights in the 5 U.S.C. 552, as amended, (the Act) as
determined by Freedom of Information (FOI) Additional Cost Principles (January 2006)
event of dispute, termination, or
officials of the Department of Health and (a) * * *
litigation. Human Services, data contained in the (4) Bid and proposal costs do not include
* * * * * portions of this proposal which have been independent research and development costs
covered by the following paragraph, or (c) The Contractor shall maintain an this contract, or a portion thereof, is subject
preaward costs covered by paragraph 36 of accurate record of, and promptly report to the to the Privacy Act, the Contractor will follow
Attachment B to OMB Circular A–122. Contracting Officer, all accidents or incidents the rules and procedures of disclosure set
* * * * * resulting in the exposure of persons to toxic forth in the Privacy Act of 1974, 5 U.S.C.
substances, hazardous materials or hazardous 552a, and implementing regulations and
■ 103. Revise section 352.223–70 to operations; the injury or death of any person; policies, with respect to systems of records
read as follows: and/or damage to property incidental to work determined to be subject to the Privacy Act.
performed under the contract and all (d) Confidential information, as defined in
352.223–70 Safety and health.
violations for which the Contractor has been paragraph (a) of this clause, shall not be
The following clause shall be used as cited by any Federal, State or local disclosed without the prior written consent
prescribed in 323.7002: regulatory/enforcement agency. The report of the individual, institution, or organization.
Safety and Health (January 2006) shall include a copy of the notice of violation (e) Whenever the Contractor is uncertain
and the findings of any inquiry or inspection, with regard to the proper handling of
(a) To help ensure the protection of the life and an analysis addressing the impact these material under the contract, or if the material
and health of all persons, and to help prevent violations may have on the work remaining in question is subject to the Privacy Act or
damage to property, the Contractor shall to be performed. The report shall also state is confidential information subject to the
comply with all Federal, State and local laws the required action(s), if any, to be taken to provisions of this clause, the Contractor
and regulations applicable to the work being correct any violation(s) noted by the Federal, should obtain a written determination from
performed under this contract. These laws State or local regulatory/enforcement agency the Contracting Officer prior to any release,
are implemented and/or enforced by the and the time frame allowed by the agency to
Environmental Protection Agency, disclosure, dissemination, or publication.
accomplish the necessary corrective action. (f) Contracting Officer determinations will
Occupational Safety and Health (d) If the Contractor fails or refuses to
Administration and other agencies at the reflect the result of internal coordination
comply with the Federal, State or local with appropriate program and legal officials.
Federal, State and local levels (Federal, State regulatory/enforcement agency’s directive(s)
and local regulatory/enforcement agencies). (g) The provisions of paragraph (d) of this
regarding any violation(s) and prescribed clause shall not apply to conflicting or
(1) In addition, the following regulations corrective action(s), the Contracting Officer
must be followed when developing and overlapping provisions in other Federal,
may issue an order stopping all or part of the State, or local laws.
implementing health and safety operating work until satisfactory corrective action (as
procedures and practices for both personnel (End of clause)
approved by the Federal, State or local
and facilities involving the use or handling regulatory/enforcement agencies) has been
of hazardous materials and the conduct of taken and documented to the Contracting ■ 105. Amend section 352.228–7 by
research, development, or test projects: Officer. No part of the time lost due to any revising paragraph (d) of the
(i) 29 CFR 1910.1030, Bloodborne stop work order shall be subject to a claim ‘‘Insurance—Liability to Third Persons’’
pathogens; 29 CFR 1910.1450, Occupational for extension of time or costs or damages by clause to read as follows:
exposure to hazardous chemicals in the Contractor.
laboratories; and other applicable (e) The Contractor shall insert the 352.228–7 Insurance—Liability to third
occupational health and safety standards substance of this clause in each subcontract persons.
issued by the Occupational Health and Safety involving toxic substances, hazardous * * * * *
Administration (OSHA) and included in 29 materials, or hazardous operations. (d) The Government’s liability under
CFR Part 1910. These regulations are Compliance with the provisions of this paragraph (c) of this clause is limited to the
available at http://www.osha.gov/comp- clause by subcontractors will be the amounts reflected in final judgments, or
links.html. responsibility of the Contractor. settlements approved in writing by the
(ii) Nuclear Regulatory Commission
(End of clause) Government, but in no event to exceed the
Standards and Regulations, pursuant to the
funds available under the Limitation of Cost
Energy Reorganization Act of 1974 (42 U.S.C.
5801 et seq.). Copies may be obtained from
■ 104. Revise section 352.224–70 to or Limitation of Funds clause of this contract.
the U.S. Nuclear Regulatory Commission, read as follows: Nothing in this contract shall be construed as
Washington, DC 20555–0001. implying that, at a later date, the Government
352.224–70 Confidentiality of information. will request, or the Congress will
(2) The following guidelines are
recommended for use in developing and The following clause covers the appropriate, funds sufficient to meet any
implementing health and safety operating policy set forth in subpart 324.70 and is deficiencies.
procedures and practices for both personnel used in accordance with the * * * * *
and facilities: instructions set forth in 324.7004. ■ 106. Revise section 352.232–9 to read
(i) Biosafety in Microbiological and as follows:
Biomedical Laboratories, CDC and NIH, HHS. Confidentiality of Information (January
This publication is available at http:// 2006)
352.232–9 Withholding of contract
bmbl.od.nih.gov/index.htm. (a) Confidential information, as used in payments.
(ii) Prudent Practices for Safety in this clause, means information or data of a
Laboratories (1995), National Research personal nature about an individual, or Insert the following clause in all
Council, National Academy Press, 500 Fifth proprietary information or data submitted by solicitations and contracts other than
Street, NW., Lockbox 285, Washington, DC or pertaining to an institution or awards made using simplified
20055 (ISBN 0–309–05229–7). This organization. acquisition procedures:
publication can be obtained by telephoning (b) The Contracting Officer and the
Withholding of Contract Payments (January
800–624–8373. It also is available at http:// Contractor may, by mutual consent, identify
2006)
www.nap.edu/catalog/4911.html. elsewhere in this contract specific
(b) Further, the Contractor shall take or information and/or categories of information Notwithstanding any other payment
cause to be taken additional safety measures which the Government will furnish to the provisions of this contract, failure of the
as the Contracting Officer, in conjunction Contractor or that the Contractor is expected Contractor to submit required reports when
with the project or other appropriate officers, to generate which is confidential. Similarly, due or failure to perform or deliver required
determines to be reasonably necessary. If the Contracting Officer and the Contractor work, supplies, or services, may result in the
compliance with these additional safety may, by mutual consent, identify such withholding of payments under this contract
measures results in an increase or decrease confidential information from time to time unless such failure arises out of causes
in the cost or time required for performance during the performance of the contract. beyond the control, and without the fault or
of any part of work under this contract, an Failure to agree will be settled pursuant to negligence of the Contractor as defined by the
equitable adjustment will be made in the ‘‘Disputes’’ clause. clause entitled ‘‘Excusable Delays’’ or
accordance with the applicable ‘‘Changes’’ (c) If it is established elsewhere in this ‘‘Default’’, as applicable. The Government
clause set forth in this contract. contract that information to be utilized under shall immediately notify the Contractor of its
intention to withhold payment of any invoice Government) arising out of any such action facts and extent of such failure and if the
or voucher submitted. or claim against the Contractor; and authorize Contracting Officer determines that any
(End of clause) representatives of the Government to settle or failure to perform was caused by
defend any such action or claim and to circumstances beyond the control and
represent the Contractor in, or to take charge without the fault or negligence of the
352.232–74 [Removed] of, any action. If the settlement or defense of Contractor, the delivery schedule shall be
■ 107. Remove section 352.232–74. an action or claim is undertaken by the revised accordingly, subject to the rights of
Government, the Contractor shall furnish all the Government under the termination clause
■ 108. Revise section 352.232–75 to contained in this contract. (As used in this
reasonable assistance in effecting a
read as follows: settlement or asserting a defense. Where an clause, the terms ‘‘subcontractor’’ and
action against the Contractor is not covered ‘‘subcontractors’’ mean subcontractor(s) at
352.232–75 Incremental funding.
by a policy of insurance, the Contractor shall, any tier.)
The following provision shall be with the approval of the Contracting Officer, (End of clause)
included in all requests for proposals proceed with the defense of the action in
whenever the use of incremental good faith. The Government shall not be ■ 111. Amend section 352.270–1 by
funding is contemplated: liable for the expense of defending any action revising the introductory text of the
or for any costs resulting from the loss section and paragraph (c)(3) of the
Incremental Funding (January 2006)
thereof to the extent that the Contractor Accessibility clause to read as follows:
(a) It is the Government’s intention to would have been compensated by insurance
negotiate and award a contract using the which was required by law or regulation or 352.270–1 Accessibility of meetings,
incremental funding concepts described in by written direction of the Contracting conferences, and seminars to persons with
the clause entitled Limitation of Funds, as Officer, but which the Contractor failed to disabilities.
specified in FAR 52.232–22. Under the secure through its own fault or negligence. In
clause, which will be included in the Use the following clause in
any event, unless otherwise expressly
resultant contract, initial funds will be provided in this contract, the Contractor shall accordance with 370.102:
obligated under the contract to cover the first not be reimbursed or indemnified by the Accessibility of Meetings, Conferences, and
year of performance. The Government Government for any liability loss, cost or Seminars to Persons With Disabilities (Jan
intends to allot additional funds up to and expense, which the Contractor may incur or 2001)
including the full estimated cost of the be subject to by reason of any loss, injury or
contract for the remaining years of * * * * *
damage, to the person or to real or personal
performance by contract modification. (c) * * *
property of any third parties as may accrue (3) At a minimum, when requested in
However, the Government is not obligated to during, or arise from, the performance of this
reimburse the Contractor for costs incurred in advance, the Contractor shall provide the
contract. following services:
excess of the periodic allotments nor is the (End of clause) (i) For persons with hearing impairments,
Contractor obligated to perform in excess of
qualified interpreters. Also, the meeting
the amount allotted. ■ 110. Revise section 352.249–14 to rooms will be adequately illuminated so
(b) The Limitation of Funds clause to be read as follows: signing by interpreters can be easily seen.
included in the resultant contract, as
(ii) For persons with vision impairments,
specified in FAR 52.232–22, shall supersede 352.249–14 Excusable delays. readers and/or cassette materials, as
the Limitation of Cost clause found in the
Insert the following clause in all necessary, to enable full participation. Also,
Section I, Contract Clauses.
solicitations and resultant contracts, meeting rooms will be adequately
(End of provision) illuminated.
other than awards made using
simplified acquisition procedures: (iii) Agenda and other conference
■ 109. Revise section 352.233–70 to material(s) shall be translated into a usable
read as follows: Excusable Delays (January 2006) form for persons with sensory impairments.
(a) Except with respect to failures of Readers, Braille translations, large print text,
352.233–70 Litigation and claims. and/or tape recordings are all acceptable.
subcontractors, the Contractor shall not be
Insert the following clause in all considered to have failed in performance of These materials shall be available to
solicitations and resultant cost- this contract if such failure arises out of individuals with sensory impairments upon
reimbursement contracts: causes beyond the control and without the their arrival.
Litigation and Claims (January 2006) fault or negligence of the Contractor. (End of clause)
(b) Such causes may include, but are not * * * * *
The Contractor shall provide written restricted to, acts of God or of the public
notification immediately to the Contracting enemy, acts of the Government in either its ■ 112. Amend section 352.270–2 by
Officer of any action, including any sovereign or contractual capacity, fires, revising the introductory text to read as
proceeding before an administrative agency, floods, epidemics, quarantine restrictions, follows:
filed against the Contractor arising out of the strikes, freight embargoes, and unusually
performance of this contract, including, but severe weather, but in every case the failure 352.270–2 Indian preference.
not limited to the performance of any to perform must be beyond the control and Use the following clause as prescribed
subcontract hereunder; and any claim against without the fault or negligence of the in 370.202(a):
the Contractor the cost and expense of which Contractor. If the failure to perform is caused
is allowable under the clause entitled by the failure of a subcontractor to perform, * * * * *
‘‘Allowable Cost and Payment.’’ Except as and if such failure arises out of causes ■ 113. Revise section 352.270–3 to read
otherwise directed by the Contracting Officer, beyond the control of both the Contractor and as follows:
the Contractor shall furnish immediately to subcontractor, and without the fault or
the Contracting Officer copies of all pertinent negligence of either of them, the Contractor 352.270–3 Indian preference program.
papers received by the Contractor with shall not be deemed to have failed in Use the following clause as prescribed
respect to such action or claim. To the extent performance of the contract, unless: (1) The in 370.202(b):
not in conflict with any applicable policy of supplies or services to be furnished by the
Indian Preference Program (January 2006)
insurance, the Contractor may, with the subcontractor were obtainable from other
Contracting Officer’s approval, settle any sources, (2) the Contracting Officer ordered (a) In addition to the requirements of the
such action or claim. If required by the the Contractor in writing to procure such clause of this contract entitled ‘‘Indian
Contracting Officer, the Contractor shall supplies or services from such other sources, Preference,’’ the Contractor agrees to
effect an assignment and subrogation in favor and (3) the Contractor failed to comply with establish and conduct an Indian preference
of the Government of all the Contractor’s such order. Upon request of the Contractor, program which will expand opportunities for
rights and claims (except those against the the Contracting Officer shall ascertain the Indians to receive preference for employment
and training in connection with the work to 2205; 25 U.S.C. 450e(b)); (iii) Definitions for economic enterprise’’ are defined in the
be performed under this contract, and which the terms ‘‘Indian organization’’ and ‘‘Indian- clause of this contract entitled ‘‘Indian
will expand the opportunities for Indian owned economic enterprise’’ as prescribed Preference.’’
organizations and Indian-owned economic under the ‘‘Indian Preference’’ clause of this (2) ‘‘Indian reservation’’ includes Indian
enterprises to receive a preference in the contract; (iv) A statement to be completed by reservations, public domain Indian
awarding of subcontracts. In this connection, the bidder or offeror that it is an Indian Allotments, former Indian reservations in
the Contractor shall: organization or Indian-owned economic Oklahoma, and land held by incorporated
(1) Designate a liaison officer who will enterprise; and (v) A closing date for receipt Native groups, regional corporations, and
maintain liaison with the Government and of bids or proposals which provides village corporations under the provisions of
the Tribe(s) on Indian preference matters; sufficient time for preparation and the Alaska Native Claims Settlement Act (85
supervise compliance with the provisions of submission of a bid or proposal. If after Stat. 688; 43 U.S.C. 1601 et seq.)
this clause; and administer the Contractor’s soliciting bids or proposals from Indian (3) ‘‘On or near an Indian Reservation’’
Indian preference program. organizations and Indian-owned economic means on a reservation or reservations or
(2) Advise its recruitment sources in enterprises, no responsive bid or acceptable within that area surrounding an Indian
writing and include a statement in all proposal is received, the Contractor shall reservation(s) where a person seeking
advertisements for employment that Indian comply with the requirements of paragraph employment could reasonably be expected to
applicants will be given preference in (d) of the ‘‘Indian Preference’’ clause of this commute to and from in the course of a work
employment and training incident to such contract. If one or more responsible bids or day.
employment. acceptable proposals are received, award (c) Nothing in the requirements of this
(3) Not more than twenty (20) calendar shall be made to the low responsible bidder clause shall be interpreted to preclude Indian
days after award of the contract, post a or acceptable offeror if the price is Tribes from independently developing and
written notice in the Tribal office of any determined to be reasonable. If the low enforcing their own Indian preference
reservations on which or near where the responsive bid or acceptable proposal is requirements. Such requirements must not
work under this contract is to be performed determined to be unreasonable as to price, conflict with any Federal statutory or
that sets forth the Contractor’s employment the Contractor shall attempt to negotiate a regulatory requirement dealing with the
needs and related training opportunities. The reasonable price and award a subcontract. If award and administration of contracts.
notice shall include the approximate a reasonable price cannot be agreed upon, the (d) The Contractor agrees to include the
numbers and types of employees needed; the Contractor shall comply with the provisions of this clause, including this
approximate dates of employment; the requirements of paragraph (d) of the ‘‘Indian paragraph (d), in each subcontract awarded at
experience or special skills required for Preference’’ clause of this contract. any tier under this contract and to notify the
employment, if any; training opportunities (5) Maintain written records under this Contracting Officer of such subcontracts.
available; and other pertinent information contract which indicate: (i) The numbers of (e) In the event of noncompliance with this
necessary to advise prospective employees of Indians seeking employment for each clause, the Contracting Officer may terminate
any other employment requirements. The employment position available under this the contract in whole or in part or may
Contractor shall also request the Tribe(s) on contract; (ii) The number and types of impose any other sanctions authorized by
or near whose reservation(s) the work is to positions filled by Indians and non-Indians; law or by other provisions of the contract.
be performed to provide assistance to the (iii) The total number of Indians employed (End of clause)
Contractor in filling its employment needs under this contract; (iv) For those positions
and training opportunities. The Contracting where there are both Indian and non-Indian ■ 114. Amend section 352.270–4 by
Officer will advise the Contractor of the applicants, and a non-Indian is selected for revising the introductory text to read as
name, location, and phone number of the employment, the reason(s) why the Indian
follows and by replacing the word
Tribal officials to contact in regard to the applicant was not selected; (v) Actions taken
posting of notices and requests for Tribal to give preference to Indian organizations ‘‘permforming’’ in the table with
assistance. and Indian-owned economic enterprises for ‘‘performing:’’
(4) Establish and conduct a subcontracting subcontracting opportunities which exist
352.270–4 Pricing of adjustments.
program which gives preference to Indian under this contract; (vi) Reasons why
organizations and Indian-owned economic preference was not given to Indian firms as Insert the following clause in all
enterprises as subcontractors and suppliers subcontractors or suppliers for each solicitations and resultant fixed-priced
under this contract. The Contractor shall give requirement where it was determined by the contracts other than awards made using
public notice of existing subcontracting Contractor that such preference would not be simplified acquisition procedures.
opportunities and, to the extent feasible and consistent with the efficient performance of * * * * *
consistent with the efficient performance of the contract; and (vii) The number of Indian
this contract, shall solicit bids or proposals organizations and Indian-owned economic ■ 115. Revise section 352.270–5 to read
only from Indian organizations or Indian- enterprises contacted, and the number as follows:
owned economic enterprises. The Contractor receiving subcontract awards under this
352.270–5 Key personnel.
shall request assistance and information on contract.
Indian firms qualified as suppliers or (6) Submit to the Contracting Officer for Insert the following clause in all
subcontractors from the Tribe(s) on or near approval a quarterly report which solicitations and resultant contracts
whose reservation(s) the work under the summarizes the Contractor’s Indian which require Key Personnel, regardless
contract is to be performed. The Contracting preference program and indicates the number of the type of contract.
Officer will advise the Contractor of the and types of available positions filled by
name, location, and phone number of the Indians and non-Indians, and the dollar Key Personnel (January 2006)
Tribal officials to be contacted in regard to amounts of all subcontracts awarded to The key personnel specified in this
the request for assistance and information. Indian organizations and Indian-owned contract are considered to be essential to
Public notices and solicitations for existing economic enterprises, and to all other firms. work performance. At least 30 days prior to
subcontracting opportunities shall provide an (7) Maintain records pursuant to this diverting any of the specified individuals to
equitable opportunity for Indian firms to clause and keep them available for review by other programs or contracts (or as soon as
submit bids or proposals by including: (i) A the Government for one year after final possible, if an individual must be replaced,
clear description of the supplies or services payment under this contract, or for such for example, as a result of leaving the employ
required, including quantities, specifications, longer period as may be required by any of the Contractor), the Contractor shall notify
and delivery schedules which facilitate the other clause of this contract or by applicable the Contracting Officer and shall submit
participation of Indian firms; (ii) A statement law or regulation. comprehensive justification for the diversion
indicating that preference will be given to (b) For purposes of this clause, the or replacement request (including proposed
Indian organizations and Indian-owned following definitions of terms shall apply: substitutions for key personnel) to permit
economic enterprises in accordance with (1) The terms ‘‘Indian,’’ ‘‘Indian Tribe,’’ evaluation by the Government of the impact
section 7(b) of Public Law 93–638 (88 Stat. ‘‘Indian Organization,’’ and ‘‘Indian-owned on performance under this contract. The
Contractor shall not divert or otherwise of 5 CFR part 1320, Controlling Paperwork (e) In accordance with 45 CFR part 46,
replace any key personnel without the Burdens on the Public, and seek the advice prospective Contractors being considered for
written consent of the Contracting Officer. of the HHS operating division or Office of the award shall be required to file with OHRP an
The Government may modify the contract to Secretary Reports Clearance Officer to acceptable Assurance of Compliance with the
add or delete key personnel at the request of determine the procedures for acquiring OMB regulations, specifying review procedures
the contractor or Government. clearance. and assigning responsibilities for the
(End of clause) (b) The Contractor shall not expend any protection of human subjects. The initial and
funds or begin any data collection until OMB continuing review of a research project by an
■ 116. Revise section 352.270–6 to read Clearance is received. Once OMB Clearance institutional review board shall assure that
as follows: is received from the Project Officer, the the rights and welfare of the human subjects
Contracting Officer shall provide the involved are adequately protected, that the
352.270–6 Publications and publicity. Contractor with written notification risks to the subjects are reasonable in relation
authorizing the expenditure of funds and the to the potential benefits, if any, to the
Insert the following clause in all
collection of data. The Contractor must allow subjects and the importance of the
solicitations and resultant contracts. knowledge to be gained, and that informed
at least 120 days for OMB clearance.
Publications and Publicity (January 2006) Excessive delays caused by the Government consent will be obtained by methods that are
which arise out of causes beyond the control adequate and appropriate. HHS regulations
(a) Unless otherwise specified in this
and without the fault or negligence of the for the protection of human subjects (45 CFR
contract and the Confidentiality of part 46), information regarding OHRP
Information clause is included, the Contractor will be considered in accordance
with the Excusable Delays or Default clause registration and assurance requirements/
Contractor is encouraged to publish the processes, and OHRP contact information can
results of its work under this contract. A of this contract.
be accessed at the OHRP Web site: http://
copy of each article submitted by the (End of clause)
www.hhs.gov/ohrp/.
Contractor for publication shall be promptly (f) It is recommended that OHRP be
sent to the Project Officer. The Contractor ■ 118. Revise section 352.270–8 to read
consulted for advice or guidance concerning
shall also inform the Project Officer when the as follows: either regulatory requirements or ethical
article or other publication is published, and issues pertaining to research involving
furnish a copy of it as finally published. 352.270–8 Protection of human subjects.
human subjects.
(b) The Contractor shall include in any (a) Include the following provision in
(End of provision)
publication resulting from work performed solicitations expected to involve human
under this contract a disclaimer reading as subjects: (b) Include the following clause in
follows: solicitations and resultant contracts
‘‘The views expressed in written Notice to Offerors of Requirements of 45 CFR
Part 46, Protection of Human Subjects involving human subjects:
conference materials or publications and by
speakers and moderators at HHS-sponsored (January 2006) Protection of Human Subjects (January 2006)
conferences, do not necessarily reflect the (a) Copies of the Department of Health and (a) The Contractor agrees that the rights
official policies of the Department of Health Human Services (HHS) regulations for the and welfare of human subjects involved in
and Human Services; nor does mention of protection of human subjects, 45 CFR part 46, research under this contract shall be
trade names, commercial practices, or are available from the Office for Human protected in accordance with 45 CFR part 46
organizations imply endorsement by the U.S. Research Protections (OHRP), Bethesda, and with the Contractor’s current Assurance
Government.’’ Maryland 20892. The regulations provide a of Compliance on file with the Office for
(c) Unless authorized by the Project systematic means, based on established Human Research Protections (OHRP), Office
Officer, the contractor shall not display the ethical principles, to safeguard the rights and of Public Health and Science (OPHS). The
HHS logo on any conference materials or welfare of individuals who participate as Contractor further agrees to provide
publications. subjects in research activities supported or certification at least annually that the
(End of clause) conducted by HHS. Institutional Review Board has reviewed and
(b) The regulations define a human subject approved the procedures, which involve
■ 117. Revise section 352.270–7 to read as a living individual about whom an human subjects in accordance with 45 CFR
as follows: investigator (whether professional or student) part 46 and the Assurance of Compliance.
conducting research obtains data through (b) The Contractor shall bear full
352.270–7 Paperwork Reduction Act. intervention or interaction with the responsibility for the performance of all work
Insert the following clause in all individual, or identifiable private and services involving the use of human
information. The regulations extend to the subjects under this contract and shall ensure
solicitations and contracts subject to the use of human organs, tissue, and body fluids that work is conducted in a proper manner
Paperwork Reduction Act requirements from individually identifiable human and as safely as is feasible. The parties hereto
regarding the collection and recording subjects as well as to graphic, written, or agree that the Contractor retains the right to
of information from 10 or more persons recorded information derived from control and direct the performance of all
other than Federal employees. individually identifiable human subjects. work under this contract. Nothing in this
The use of autopsy materials is governed by contract shall be deemed to constitute the
Paperwork Reduction Act (January 2006) applicable State and local law and is not Contractor or any subcontractor, agent or
(a) This contract involves a requirement to directly regulated by 45 CFR part 46. employee of the Contractor, or any other
collect or record information calling either (c) Activities in which the only person, organization, institution, or group of
for answers to identical questions from 10 or involvement of human subjects will be in one any kind whatsoever, as the agent or
more persons other than Federal employees, or more of the categories set forth in 45 CFR employee of the Government. The Contractor
or information from Federal employees 46.101(b)(1–6) are exempt from coverage. agrees that it has entered into this contract
which is outside the scope of their (d) Inappropriate designations of the and will discharge its obligations, duties, and
employment, for use by the Federal noninvolvement of human subjects or of undertakings and the work pursuant thereto,
government or disclosure to third parties; exempt categories of research in a project whether requiring professional judgment or
therefore, the Paperwork Reduction Act of may result in delays in the review of a otherwise, as an independent contractor
1995 (Pub. L. 104–13) shall apply to this proposal. The OPDIV will make a final without imputing liability on the part of the
contract. No plan, questionnaire, interview determination of whether the proposed Government for the acts of the Contractor or
guide or other similar device for collecting activities are covered by the regulations or its employees.
information (whether repetitive or single- are in an exempt category, based on the (c) If at any time during the performance
time) may be used without first obtaining information provided in the proposal. In of this contract, the Contracting Officer
clearance from the Office of Management and doubtful cases, prior consultation with determines, in consultation with the OHRP,
Budget (OMB). Contractors and Project OHRP, (telephone: 301–496–7014), is OPHS, ASH, that the Contractor is not in
Officers should be guided by the provisions recommended. compliance with any of the requirements
and/or standards stated in paragraphs (a) and the Contractor shall register with the 352.270–15 Salary rate limitation.
(b) above, the Contracting Officer may Secretary of Agriculture of the United States 352.270–16 Native American Graves
immediately suspend, in whole or in part, in accordance with 7 U.S.C. 2136 and 9 CFR Protection and Repatriation Act.
work and further payments under this 2.25 through 2.28. The Contractor shall 352.270–17 Crime Control Act—Reporting
contract until the Contractor corrects the furnish evidence of the registration to the of child abuse.
noncompliance. Notice of the suspension Contracting Officer. 352.270–18 Crime Control Act—
may be communicated by telephone and (b) The Contractor shall acquire vertebrate
Requirement for background checks.
confirmed in writing. If the Contractor fails animals used in research from a dealer
to complete corrective action within the licensed by the Secretary of Agriculture 352.270–19 Electronic information and
period of time designated in the Contracting under 7 U.S.C. 2133 and 9 CFR 2.1 through technology accessibility.
Officer’s written notice of suspension, the 2.11, or from a source that is exempt from
Contracting Officer may, in consultation with licensing under those sections. Subpart 352.2—Texts of Provisions
OHRP, OPHS, ASH, terminate this contract (c) The Contractor agrees that the care and and Clauses
in a whole or in part, and the Contractor’s use of any live vertebrate animals used or
name may be removed form the list of those intended for use in the performance of this * * * * *
contractors with approved Health and contract will conform with the PHS Policy on
Human Services Human Subject Assurances. Humane Care of Use of Laboratory Animals, 352.270–10 Anti-lobbying.
(End of clause) the current Animal Welfare Assurance, the Insert the following clause in all
Guide for the Care and Use of Laboratory
solicitations and resultant contracts
■ 119. Revise section 352.270–9 to read Animals prepared by the Institute of
Laboratory Animal Resources and the expected to exceed $100,000:
as follows:
pertinent laws and regulations of the United Anti-Lobbying (January 2006)
352.270–9 Care of laboratory animals. States Department of Agriculture (see 7
U.S.C. 2131 et seq. and 9 CFR Subchapter A, Pursuant to the current HHS annual
(a) Include the following provision in appropriations act, except for normal and
Parts 1–4). In case of conflict between
solicitations expected to involve standards, the more stringent standard shall recognized executive-legislative
vertebrate animals: be used. relationships, the Contractor shall not use
Notice to Offerors of Requirement for (d) If at any time during performance of any HHS contract funds for (i) publicity or
Compliance With the Public Health Service this contract, the Contracting Officer propaganda purposes; (ii) the preparation,
Policy on Humane Care and Use of determines, in consultation with the Office of distribution, or use of any kit, pamphlet,
Laboratory Animals (January 2006) Laboratory Animal Welfare (OLAW), booklet, publication, radio, television or
National Institutes of Health (NIH), that the video presentation designed to support or
The PHS Policy on Humane Care and Use Contractor is not in compliance with any of
of Laboratory Animals by Awardee defeat legislation pending before the
the requirements and/or standards stated in
Institutions establishes a number of Congress or any State legislature, except in
paragraphs (a) through (c) above, the
requirements for research activities involving Contracting Officer may immediately presentation to the Congress or any State
animals. Before award may be made to an suspend, in whole or in part, work and legislature itself; or (iii) payment of salary or
applicant organization, the organization shall further payments under this contract until expenses of the Contractor, or any agent
file, with the Office of Laboratory Animal the Contractor corrects the noncompliance. acting for the Contractor, related to any
Welfare (OLAW), National Institutes of Notice of the suspension may be activity designed to influence legislation or
Health (NIH), a written Animal Welfare communicated by telephone and confirmed appropriations pending before the Congress
Assurance which commits the organization in writing. If the Contractor fails to complete or any State legislature.
to comply with the provisions of the PHS corrective action within the period of time
Policy on Humane Care and Use of (End of Clause)
designated in the Contracting Officer’s
Laboratory Animals by Awardee Institutions, written notice of suspension, the Contracting
the Animal Welfare Act, and the Guide for Officer may, in consultation with OLAW, 352.270–11 Privacy Act.
the Care and Use of Laboratory Animals NIH, terminate this contract in whole or in
prepared by the Institute of Laboratory The following clause shall be used as
part, and the Contractor’s name may be
Animal Resources. In accordance with the removed from the list of those contractors
prescribed in 324.103(a):
PHS Policy on Humane Care and Use of with approved PHS Animal Welfare
Laboratory Animals by Awardee Institutions, Privacy Act (January 2006)
Assurances.
applicant organizations must establish a This contract requires the Contractor to
committee, qualified through the experience Note: The Contractor may request
perform one or more of the following: (a)
and expertise of its members, to oversee the registration of its facility and a current listing
Design; (b) develop; or (c) operate a Federal
institution’s animal program, facilities and of licensed dealers from the Regional Office
of the Animal and Plant Health Inspection agency system of records to accomplish an
procedures. No award involving the use of agency function in accordance with the
animals shall be made unless OLAW Service (APHIS), USDA, for the region in
which its research facility is located. The Privacy Act of 1974 (Act) (5 U.S.C.
approves the Animal Welfare Assurance. 552a(m)(1)) and applicable agency
Prior to award, the Contracting Officer will location of the appropriate APHIS Regional
Office, as well as information concerning this regulations. The term ‘‘system of records’’
notify Contractor(s) selected for projects that
involve live vertebrate animals that an program may be obtained by contacting the means a group of any records under the
Animal Welfare Assurance is required. The Animal Care Staff, USDA/APHIS, 4700 River control of any agency from which
Contracting Officer will request that OLAW Road, Riverdale, Maryland 20737. information is retrieved by the name of the
negotiate an acceptable Animal Welfare (End of clause) individual or by some identifying number,
Assurance with those Contractor(s). For symbol, or other identifying particular
further information, contact OLAW at NIH,
■ 120. Add sections 352.270–10 through assigned to the individual.
Bethesda, Maryland 20892 (301–496–7163). 352.270–19 to subpart 352.2 to read as Violations of the Act by the Contractor
(End of provision) follows: and/or its employees may result in the
(b) Include the following clause in all Subpart 352.2—Texts of Provisions and imposition of criminal penalties (5 U.S.C.
solicitations and resultant contracts Clauses 552a(i)). The Contractor shall ensure that
each of its employees knows the prescribed
involving research on vertebrate * * * * *

animals: 352.270–10 Anti-lobbying. rules of conduct and that each employee is
352.270–11 Privacy Act. aware that he/she is subject to criminal
Care of Live Vertebrate Animals (January 352.270–12 Pro-Children Act. penalties for violation of the Act to the same
2006) 352.270–13 Tobacco-free facilities. extent as HHS employees. These provisions
(a) Before undertaking performance of any 352.270–14 Restriction on use of human also apply to all subcontracts awarded under
contract involving animal related activities, subjects. this contract which require the design,
development or operation of the designated case, Contractor employees are certification that the research has been
system(s) of records (5 U.S.C. 552a(m)(1)). considered ‘‘visitors.’’ Further, for any reviewed and approved by the Institutional
The contract work statement: (a) identifies proposed or existing construction Review Board (IRB) designated under the
the system(s) of records and the design, Contractor’s Federal-wide assurance of
contract or order, the Contracting compliance. This restriction applies to all
development, or operation work to be
performed by the Contractor; and (b)
Officer should coordinate any collaborating sites, whether domestic or
specifies the disposition to be made of such exceptions to the policy raised by an foreign, and subcontractors. The Contractor
records upon completion of contract incumbent or potential Contractor based must ensure compliance by collaborators and
performance. on union or collective bargaining subcontractors.
(End of clause) agreements with the designated OPDIV (End of clause)
tobacco-free policy contact point for
352.270–12 Pro-Children Act. final disposition. 352.270–15 Salary rate limitation.
Insert the following clause in all Tobacco-Free Facilities (January 2006) Insert the following clause in all new
solicitations and resultant contracts and NIH, SAMHSA, and AHRQ solicitations
In accordance with Department of Health
orders, regardless of dollar amount, for and Human Services (HHS) policy, the and resultant contracts and orders
(i) kindergarten, elementary, or Contractor and its staff are prohibited from (except fixed-price completion
secondary education or library services using tobacco products of any kind (e.g., contracts) and modifications of existing
or (ii) health or day care services that cigarettes, cigars, pipes, and smokeless contracts for projects that support
are provided to children under the age tobacco) while on any HHS property, extramural activities. Projects that
of 18 on a routine or regular basis including use in personal or company support extramural activities include
vehicles operated by Contractor employees extramural R&D, SAMHSA’s mission-
pursuant to the Pro-Children Act of while on an HHS property. This policy also
1994: related requirements, and those
applies to all subcontracts awarded under the
activities commonly referred to as
Pro-Children Act of 1994 (January 2006) contract or order.
The term ‘‘HHS properties’’ includes all ‘‘extramural R&D support.’’
Public Law 103–227, Title X, Part C, also properties owned, controlled and/or leased OR
known as the Pro-Children Act of 1994 (Act),
20 U.S.C. 7183, imposes restrictions on
by HHS when totally occupied by HHS, Insert the following clause in all new
including all indoor and outdoor areas of NIH, SAMHSA, and AHRQ solicitations
smoking in facilities where certain federally such properties. Where HHS only partially
funded children’s services are provided. The and resultant contracts (except fixed-
occupies such properties, it includes all price completion contracts) and
Act prohibits smoking within any indoor HHS-occupied interior space. Where HHS
facility (or portion thereof), whether owned, leases space in a multi-occupant building or
modifications of existing contracts for
leased, or contracted for, that is used for the complex, the tobacco-free HHS policy will extramural R&D and SAMHSA’s
routine or regular provision of (i) apply to the maximum area permitted by law mission-related requirements. Projects
kindergarten, elementary, or secondary and compliance with the provisions of any that are not considered R&D but that
education or library services or (ii) health or current lease agreements. support extramural R&D activities
day care services that are provided to
children under the age of 18. The statutory
The Contractor shall ensure that each of its (commonly referred to as ‘‘extramural
employees, and any subcontractor staff, is R&D support’’) are OR are not included.
prohibition also applies to indoor facilities made aware of, understand, and comply with
that are constructed, operated, or maintained this policy. Salary Rate Limitation (January 2006)
with Federal funds.
(End of clause) Pursuant to the applicable HHS
By acceptance of this contract or order, the
appropriations acts cited in the table below,
Contractor agrees to comply with the
352.270–14 Restriction on use of human the Contractor shall not use contract funds to
requirements of the Act. The Act also applies
subjects. pay the direct salary of an individual at a rate
to all subcontracts awarded under this in excess of the salary level in effect on the
contract for the specified children’s services. If the Contractor has an approved date the expense is incurred as shown in the
Accordingly, the Contractor shall ensure that Federal-wide assurance of compliance table below.
each of its employees, and any subcontractor in place, but the certification that the For purposes of the salary limitation, the
staff, is made aware of, understand, and terms ‘‘direct salary,’’ ‘‘salary,’’ and
comply with the provisions of the Act.
Institutional Review Board (IRB)
designated under the assurance has ‘‘institutional base salary’’ have the same
Failure to comply with the Act may result meaning and are collectively referred to as
in the imposition of a civil monetary penalty reviewed and approved the research
‘‘direct salary’’ in this clause. An individual’s
in an amount not to exceed $1,000 for each cannot be completed prior to contract direct salary is the annual compensation that
violation and/or the imposition of an award because definite plans for the Contractor pays for an individual’s
administrative compliance order on the involvement of human subjects are not appointment whether that individual’s time
responsible entity. Each day a violation set forth in the proposal (e.g., projects in is spent on research, teaching, patient care,
continues constitutes a separate violation. which human subjects’ involvement or other activities. Direct salary excludes any
(End of clause) will depend upon completion of income that an individual may be permitted
instruments, prior animal studies, or to earn outside of duties to the Contractor.
352.270–13 Tobacco-free facilities. purification of compounds), the award Direct salary also excludes fringe benefits,
overhead, and general and administrative
Insert the following clause in all new may be made without the requisite expenses (also referred to as indirect costs or
solicitations and resultant contracts and certification as long as the contract is facilities and administrative [F&A] costs).
orders (including construction) and all appropriately conditioned. Under these The salary rate limitation also applies to
modifications resulting from the conditions, insert the following clause individuals performing under subcontracts.
exercise of an option under a contract or in applicable contracts: However, it does not apply to fees paid to
order, regardless of dollar value, where consultants. If this is a multiple-year
Restriction on Use of Human Subjects contract, it may be subject to unilateral
some or all of the Contractor’s (January 2006)
performance, will take place on HHS modification by the Contracting Officer to

Pursuant to 45 CFR part 46, Protection of ensure that an individual is not paid at a rate
properties. This clause is not required to Human Research Subjects, the Contractor that exceeds the salary rate limitation
be included if contract or order shall not expend funds under this award for provision established in the HHS
performance requires only that research involving human subjects or engage appropriations act in effect when the expense
Contractor staff attend occasional in any human subjects research activity prior is incurred regardless of the rate initially
meetings on HHS properties. In this to the receipt by the Contracting Officer of a used to establish contract funding.
Salary
limitation
Public law Period covered (based on
Executive
Level I)
108–447, Div F, Title II, General Provisions, Section 204 ............................................. 10/01/05—12/31/05 .................................... $180,100
109–149, General Provisions, Section 204 .................................................................... 01/01/06—until revised .............................. $183,500
Executive Level salaries for the current and (or contracted) facility and that involve understand, and comply with the provisions
prior periods can be found at the following the professions/activities performed by of the Act.
Web site: http://www.opm.gov/oca/05tables/ persons specified in the Crime Control (End of clause)
html/ex.asp. Click on ‘‘Salaries and Wages’’ Act of 1990, including, but not limited
and then scroll to the bottom of the page to
select the desired period.
to, physicians, nurses, dentists, health 352.270–18 Crime Control Act—
care practitioners, optometrists, Requirement for background checks.
(End of Clause)
psychologists, emergency medical Insert the following clause in all
technicians, alcohol or drug treatment solicitations and resultant contracts and
352.270–16 Native American Graves
Protection and Repatriation Act.
personnel, child care workers and orders, regardless of dollar amount, for
administrators, emergency medical all child care services to children under
Insert the following clause in any
technicians and ambulance drivers: the age of 18, including social services,
solicitation and resultant contract or
order that requires performance on Crime Control Act of 1990—Reporting of health and mental health care, child
tribal lands and all solicitations and Child Abuse (January 2006) (day) care, education (whether or not
resultant contracts or orders for Public Law 101–647, also known as the directly involved in teaching), and
construction on Federal or tribal lands, Crime Control Act of 1990 (Act), imposes rehabilitative programs covered under
regardless of dollar amount: responsibilities on certain individuals who, the Crime Control Act of 1990 (Act):
while engaged in a professional capacity or
Native American Graves Protection and activity, as defined in the Act, on Federal Crime Control Act of 1990—Requirement for
Repatriation Act (January 2006) land or in a federally-operated (or contracted) Background Checks (January 2006)
Public Law 101–601, dated November 16, facility, learn of facts that give the individual Public Law 101–647, also known as the
1990, also known as the Native American reason to suspect that a child has suffered an Crime Control Act of 1990 (Act), requires that
Graves Protection and Repatriation Act (Act), incident of child abuse. all individuals involved with the provision of
imposes certain responsibilities on The Act designates ‘‘covered child care services to children under the age
individuals and organizations when they professionals’’ as those persons engaged in
of 18 undergo a criminal background check.
discover Native American cultural items professions and activities in eight different
‘‘Child care services’’ include, but are not
(including human remains) on Federal or categories including, but not limited to,
limited to, social services, health and mental
tribal lands. physicians, dentists, medical residents or
interns, hospital personnel and health care, child (day) care, education
In the event the Contractor discovers (whether or not directly involved in
administrators, nurses, health care
Native American cultural items (including teaching), and rehabilitative programs. Any
practitioners, chiropractors, osteopaths,
human remains, associated funerary objects, conviction for a sex crime, an offense
pharmacists, optometrists, podiatrists,
unassociated funerary objects, sacred objects involving a child victim, or a drug felony,
emergency medical technicians, ambulance
and cultural patrimony), as defined in the may be grounds for denying employment or
drivers, alcohol or drug treatment personnel,
Act during contract performance, the for dismissal of an employee providing any
psychologists, psychiatrists, mental health
Contractor shall: (i) Immediately cease of the services listed above.
professionals, child care workers and
activity in the area of the discovery; (ii) The Contracting Officer will provide the
administrators, and commercial film and
notify the Contracting Officer of the necessary information to the Contractor
photo processors. The Act defines the term
discovery; and (iii) make a reasonable effort regarding the process for obtaining the
‘‘child abuse’’ as the physical or mental
to protect the items discovered before injury, sexual abuse or exploitation, or background check. The Contractor may hire
resuming such activity. Upon receipt of the negligent treatment of a child. a staff person provisionally prior to the
Contractor’s discovery notice, the Contracting Accordingly, any person engaged in a completion of a background check, if at all
Officer will notify the appropriate authorities covered profession or activity under an HHS times prior to the receipt of the background
as required by the Act. contract or subcontract, regardless of the check during which children are in the care
Unless otherwise specified by the purpose of the contract or subcontract, shall of the newly-hired person, the person is
Contracting Officer, the Contractor may immediately report a suspected child abuse within the sight and under the supervision of
resume activity in the area on the 31st incident in accordance with the provisions of a previously investigated staff person.
calendar day following the date that the the Act. If a child is suspected of being
appropriate authorities certify receipt of the By acceptance of this contract or order, the
harmed, the appropriate State Child Abuse Contractor agrees to comply with the
discovery notice. The date that the Hotline, local child protective services (CPS),
appropriate authorities certify receipt of the requirements of the Act. The Act also applies
or law enforcement agency should be to all applicable subcontracts awarded under
discovery notice and the date on which the contacted. For more information about where
Contractor may resume activities shall be this contract. Accordingly, the Contractor
and how to file a report, the Childhelp USA, shall ensure that each of its employees, and
provided to the Contractor by the Contracting National Child Abuse Hotline (1–800–4–A–
Officer. any subcontractor staff, is made aware of,
CHILD) should be called. Any covered
understand, and comply with the provisions
(End of clause) professional failing to make a timely report
of the Act.
of such incident shall be guilty of a Class B
misdemeanor. (End of clause)
352.270–17 Crime Control Act—Reporting
of child abuse. By acceptance of this contract or order, the

Contractor agrees to comply with the 352.270–19 Electronic information and
Insert the following clause in all requirements of the Act. The Act also applies technology accessibility.
solicitations and resultant contracts and to all applicable subcontracts awarded under
orders, regardless of dollar amount, this contract. Accordingly, the Contractor (a) The following clause shall be used
where performance will take place on shall ensure that each of its employees, and in solicitations as provided in 339.201–
Federal land or in a federally-operated any subcontractor staff, is made aware of, 70:
Electronic and Information Technology (End of clause) of the additional requirements by all
Accessibility (January 2006) prospective bidders or offerors.
Section 508 of the Rehabilitation Act of PART 370—SPECIAL PROGRAMS * * * * *
1973 (29 U.S.C. 794d), as amended by Public AFFECTING ACQUISITION
Law 105–220 under Title IV (Rehabilitation ■ 123. Revise section 370.301 to read as
Act Amendments of 1998) and the ■ 121. Revise section 370.102 to read as follows:
Architectural and Transportation Barriers
Compliance Board Electronic and
follows: 370.301 Policy.
Information (EIT) Accessibility Standards (36 370.102 Responsibilities. It is the policy of the Department of
CFR part 1194), require that all EIT acquired Health and Human Services (HHS) that
must ensure that: (a) The Contracting Officer shall
(1) Federal employees with disabilities include the clause in 352.270–1 in every no contract involving human subjects
have access to and use of information and solicitation and resulting contract when shall be awarded until acceptable
data that is comparable to the access and use the statement of work requires the assurance has been given that the
by Federal employees who are not contractor to conduct meetings, activity will be subject to initial and
individuals with disabilities; and conferences, or seminars in accordance continuing review by an appropriate
(2) Members of the public with disabilities Institutional Review Board (IRB) as
seeking information or services from an
with 370.101(b).
(b) The Project Officer shall be described in HHS regulations at 45 CFR
agency have access to and use of information 46.103. An applicable Federalwide
and data that is comparable to the access to responsible for obtaining, reviewing,
and use of information and data by members and approving the contractor’s plan, Assurance (FWA), approved by the HHS
of the public who are not individuals with which is to be submitted in response to Office of Human Research Protections
disabilities. paragraph (a) of the contract clause in (OHRP), shall be required of each
This requirement includes the 352.270–1. A consolidated or master contractor, subcontractor, or cooperating
development, procurement, maintenance, plan for contracts requiring numerous institution having responsibility for
and/or use of EIT products/services; human subjects involved in
therefore, any proposal submitted in meetings, conferences, or seminars will
be acceptable. The Project Officer, prior performance of the contract. The HHS
response to this solicitation must OHRP is responsible for negotiating
demonstrate compliance with the established to approving the plan, should consult
EIT Accessibility Standards. Information with the OPDIV or other designated assurances covering all HHS-supported
about Section 508 is available at http:// organization responsible for ensuring or HHS-conducted activities involving
www.section508.gov/. compliance with the Architectural human subjects. OHRP shall guide
(End of provision) Barriers Act of 1968 and the Americans Contracting Officers regarding
with Disabilities Act of 1990 to ensure nonaward or termination of a contract
(b) The following clause shall be used
that the contractor’s plan meets the due to inadequate assurance or breach
in contracts and orders as provided in
accessibility requirements of the of assurance for protection of human
339.201–70:
contract clause. The Project Officer shall subjects.
Electronic and Information Technology
ask the responsible organization to ■ 124. Revise section 370.302 to read as
Accessibility (January 2006)
review, and determine the adequacy of, follows:
Pursuant to Section 508 of the the contractor’s plan, and respond to the
Rehabilitation Act of 1973 (29 U.S.C. 794d) 370.302 Types of assurances.
as amended by Public Law 105–220 under
Project Officer, in writing, within ten
Title IV (Rehabilitation Act Amendments of (10) working days of receiving the (a) In January 2005, OHRP announced
1998), all Electronic and Information request from the Project Officer. that the FWA would be the only new
Technology (EIT) developed, procured, ■ 122. Amend section 370.205 by type of assurance accepted for review
maintained, and/or used under this contract revising paragraph (a) to read as follows: and approval by OHRP. Institutions
shall be in compliance with the ‘‘Electronic holding an OHRP-approved Multiple
and Information Technology Accessibility 370.205 Tribal preference requirements. Project Assurance (MPA) or Cooperative
Standards’’ set forth by the Architectural and Project Assurance (CPA) were required
(a) Where the work under a contract
Transportation Barriers Compliance Board to submit an FWA to OHRP for approval
(also referred to as the ‘‘Access Board’’) in 36 is to be performed on an Indian
CFR part 1194. The complete text of Section reservation, the contracting activity may by December 31, 2005, if the institution
508 Final Standards can be accessed at supplement the clause set forth in is required to have an OHRP-approved
http://www.access-board.gov/sec508/ 352.270–3 by adding specific Indian assurance of compliance. Any Inter-
standards.htm. preference requirements of the Tribe on Institutional Amendment between an
The standards applicable to this whose reservation the work is to be OHRP-approved MPA and an affiliate
requirement are [identified in the Statement performed. The supplemental institution will be deactivated on
of Work/listed below]: January 1, 2006 if the affiliate institution
requirements shall be jointly developed
(Select the appropriate phrase within the for the contract by the contracting has not obtained its own FWA. Single
brackets [ ] and complete if necessary and Project Assurances (SPAs) currently
activity and the Tribe. Supplemental
identify location of/provide complete list of approved by OHRP will remain in effect
applicable provisions. Use the Buy accessible preference requirements must represent
wizard at http://www.buyaccessible.gov if a further implementation of the for the duration of the project and
necessary or contact your Section 508 requirements of section 7(b) of Public through all non-competitive award
Coordinator) Law 93–638 and must be approved by renewals. An FWA listed in OHRP’s
Vendors may document conformance using the affected program director and current ‘‘List of Registered Institutional
[attached documentation/industry-standard approved for legal sufficiency by the Review Boards (IRBs)/Independent
Voluntary Product Accessibility Template at General Law Division, OGC, or a Ethics Committees (IECs) and Approved
http://www.itic.org/archives/articles/ regional attorney before being added to Assurances’’ is acceptable for the
20040506/faq_voluntary_product a solicitation and resultant contract. purposes of this policy. The list may be
_accessibility_template_vpat.php] (select the found at http://ohrp.cit.nih.gov/search/
appropriate phrase within the brackets [ ]).
Any supplemental preference
requirements to be added to the clause asearch.asp.
Vendors should provide detailed information
necessary for determining compliance, in 352.270–3 shall be included in the (b) The OHRP Web site includes links
including defined contractor-incidental solicitation and clearly identified in to instructions and the forms for
exceptions. order to insure uniform understanding submitting both a domestic and
international FWA at http:// vertebrate animals shall be awarded Government-owned, contractor-operated

www.hhs.gov/ohrp/assurances/ until acceptable assurance has been (GOCO) site, does not need a separate
assurances_index.html. To expedite the given that the activity will be subject to assurance because the GOCO site
approval of a FWA, as well as any initial and continuing review by an normally covers the contractor services
update/renewal, the institution shall use appropriate Institutional Animal Care in the GOCO site assurance.
the OHRP Electronic Submission and Use Committee (IACUC) as
System. Once an electronic file is described in the PHS Policy at IV.B.6.
follows:
‘‘submitted’’ to OHRP, the institution and 7. An applicable Full Animal
must fax or mail (do not do both) a copy Welfare Assurance or Interinstitutional 370.403 Notice to offerors.
of the signature page to initiate the Agreement/Assurance, approved by the
review process. FWAs shall be mailed to Office of Laboratory Animal Welfare Solicitations shall contain the notice
the OHRP, U.S. Department of Health (OLAW), National Institutes of Health to offerors in 352.270–9(a) whenever
and Human Services, 1101 Wootton (NIH), shall be required of each contract performance is expected to
Parkway, Suite 200, Rockville, contractor, subcontractor, or cooperating involve the use of live vertebrate
Maryland 20852, or faxed to OHRP at institution having responsibility for animals.
240–453–8202 (do not do both). animal care and use involved in (a) For offerors having a full AWA on
■ 125. Revise section 370.303 to read as performance of the contract (see PHS file with OLAW, IACUC approval of the
follows: Policy II., IV.A., and V.B.). use of animals shall be submitted in the
(b) The OLAW, NIH, is responsible for manner required by instructions for
370.303 Notice to offerors. negotiating assurances covering all completion of the contract proposal, but
(a) Solicitations shall contain the HHS/PHS-supported or HHS/PHS- prior to the technical review of the
notice to offerors in 352.270–8(a) conducted activities involving the care proposal. The date of IACUC review and
whenever contract performance is and use of live vertebrate animals. approval must not be more than 36
expected to involve human subjects. OLAW shall guide Contracting Officers months prior to the deadline for
(b) IRB approval of proposals regarding adequate animal care, and proposal submission.
submitted by institutions having an use, approval, disapproval, restriction, (b) Non-assured offerors are not
OHRP-approved FWA should be or withdrawal of approval of assurances required to submit assurances or IACUC
certified in the manner required by (see PHS Policy V.A.). approval with proposals. OLAW will
instructions for completion of the ■ 127. Revise section 370.402 to read as contact contractors, subcontractors and
contract proposal; or by completion of follows: cooperating institutions to negotiate
an OMB Form No. 0990–0263,
‘‘Protection of Human Subjects 370.402 Assurances. necessary assurances and verify IACUC
Assurance Identification/IRB (a) Assurances may be one of two approvals when requested by
Certification/Declaration of Exemption types: appropriate HHS/PHS staff.
(Common Rule); or by letter indicating (1) Full Animal Welfare Assurance ■ 129. Revise section 370.504 to read as
the institution’s OHRP-assigned FWA (AWA). An AWA describes the follows:
number, the date of IRB review and institution’s complete program for the
370.504 Competition.
approval, and the type of review care and use of animals, including but
(convened or expedited). The date of not limited to the facilities, (a) Contracts awarded under the Buy
IRB approval must not be more than 12 occupational health, training, veterinary Indian Act are subject to competition
months prior to the deadline for care, IACUC procedures and lines of among Indians or Indian concerns to the
proposal submission. authority and responsibility. An AWA maximum extent that the Contracting
(c) FWAs for contractors, listed in OLAW’s list of institutions Officer determines is practicable. When
subcontractors, or cooperating which have an approved full AWA will competition is determined not to be
institutions generally will not be be considered acceptable for purposes of practicable, a Justification for Other
requested prior to determination that a this policy. than Full and Open Competition shall
contract proposal has been selected for (2) Interinstitutional Agreement/ be prepared in accordance with 306.303
negotiation. When an FWA is Assurance (IAA). An IAA describes the and subsequently retained in the
submitted, it provides certification for arrangements between an offeror and contract file.
the initial contract period. No additional usually a subcontractor where animal (b) Solicitations must be synopsized
documentation is required. If the activities will occur. An IAA is limited and publicized in FedBizOpps at http://
contract provides for additional years to to the specific award or single project. www.fedbizopps.gov and copies of the
complete the project, the (b) The Contracting Officer shall synopses sent to the tribal office of the
noncompetitive renewal proposal shall forward copies of proposals selected for Indian tribal government directly
be certified in the manner described in negotiation and requiring an assurance concerned with the proposed
the preceding paragraph. to the Assurance Branch, Office of acquisition as well as to Indian concerns
■ 126. Revise section 370.401 to read as Laboratory Animal Welfare (OLAW), and others having a legitimate interest.
follows: NIH MSC 7507, 6100 Executive Blvd., The synopsis must state that the
Room 3B01, Rockville, Maryland 20892, acquisition is restricted to Indian firms
370.401 Policy. as early as possible to secure the under the Buy Indian Act.
(a) It is the policy of the Department necessary assurances.
of Health and Human Services (HHS) (c) A contractor providing animal care [FR Doc. E6–21505 Filed 12–19–06; 8:45 am]
that no contract involving live services at an assured entity, such as a BILLING CODE 4150–28–P

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Wednesday,

December 20, 2006

Authority a Program participant Required training b

unless otherwise specified, means the official, usually an office director,

technical evaluators that review the (b) * * * overall program objectives.

any Privacy Act system of records on receiving a Freedom of Information Act

performance is not satisfactory or if withholding action. default or failure, the Contracting

involving research on vertebrate * * * * *

performance, will take place on HHS modification by the Contracting Officer to

of child abuse. By acceptance of this contract or order, the

international FWA at http:// vertebrate animals shall be awarded Government-owned, contractor-operated

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