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Federal Register / Vol. 73, No.

58 / Tuesday, March 25, 2008 / Notices 15757

bank holding companies. Unless ACTION:Availability of ICCVAM Test NIEHS, P.O. Box 12233, MD EC–17,
otherwise noted, these activities will be Method Evaluation Report and Final Research Triangle Park, NC 27709,
conducted throughout the United States. Background Review Document. (phone) 919–541–2384, (fax) 919–541–
Each notice is available for inspection 0947, (e-mail) niceatm@niehs.nih.gov.
SUMMARY: NICEATM announces Courier address: NICEATM, NIEHS, 79
at the Federal Reserve Bank indicated.
availability of the ICCVAM Test Method T.W. Alexander Drive, Building 4401,
The notice also will be available for
Evaluation Report: In Vitro Cytotoxicity Room 3128, Research Triangle Park, NC
inspection at the offices of the Board of
Test Methods for Estimating Starting 27709.
Governors. Interested persons may
Doses for Acute Oral Systemic Toxicity
express their views in writing on the SUPPLEMENTARY INFORMATION:
Tests (NIH Publication 07–4519). The
question whether the proposal complies
report describes two in vitro basal Background
with the standards of section 4 of the
cytotoxicity neutral red uptake (NRU) In 2002, NICEATM and ECVAM
BHC Act. Additional information on all
test methods that can be used for initiated a collaborative, international,
bank holding companies may be
estimating starting doses for acute oral multi-laboratory validation study to
obtained from the National Information toxicity tests. The report includes
Center website at www.ffiec.gov/nic/. independently evaluate the usefulness
ICCVAM’s (a) final test method of the 3T3 and NHK NRU basal
Unless otherwise noted, comments recommendations on the use of these
regarding the applications must be cytotoxicity test methods for estimating
two test methods, (b) recommended test acute oral rodent toxicity and for
received at the Reserve Bank indicated method protocols for future use, (c)
or the offices of the Board of Governors estimating starting doses for in vivo
recommendations for future studies to rodent acute oral toxicity tests. The 3T3
not later than April 9, 2008. further characterize the usefulness and
A. Federal Reserve Bank of Chicago and NHK NRU test methods were
limitations of in vitro methods for evaluated with 72 reference substances.
(Burl Thornton, Assistant Vice assessing acute systemic toxicity, and
President) 230 South LaSalle Street, Once the study was completed in
(d) recommended performance January 2005, NICEATM prepared a
Chicago, Illinois 60690-1414: standards for tests with similar draft BRD that contained comprehensive
1. First Fontanelle Employee Stock scientific principles and that measure or summaries of the data generated in the
Ownership Plan and Trust, Fontanelle, predict acute oral systemic toxicity. The validation study, analyses of the
Iowa; to indirectly engage in insurance report recommends the use of these relevance and reliability of the two test
agency activities through Corn Belt methods in a weight-of-evidence methods, and simulation analyses of the
Insurance Agency, Massena, Iowa, and approach to determine starting doses for refinement (i.e., to lessen or avoid pain
thereby indirectly acquire First acute oral systemic toxicity tests with and distress) and reduction in animal
Fontanelle Bancorporation, Fontanelle, rodents. The report also recommends use that might occur if these tests were
Iowa pursuant to section that these in vitro test methods be used as adjuncts to two acute oral
225.28(b)(11)(iii)(A) of Regulation Y. considered before using animals for toxicity test methods (i.e., the Up-and-
Board of Governors of the Federal Reserve acute oral systemic toxicity testing and Down Procedure and the Acute Toxic
System, March 20, 2008. used when determined appropriate. Class method). The draft BRD was
Robert deV. Frierson, NICEATM also announces the released for public comment on March
Deputy Secretary of the Board.
availability of the final Background 21, 2006 (Federal Register, Vol. 71, No.
Review Document: In Vitro Cytotoxicity 54, pp. 14229–14231).
[FR Doc.E8–5970 Filed 3–24–08; 8:45 am]
Test Methods for Estimating Acute Oral On May 23, 2006, NICEATM, on
Systemic Toxicity (BRD) (NIH behalf of ICCVAM, convened an
Publication 07–4518). The BRD independent, scientific peer review
provides data and analyses from a panel meeting to review the draft BRD
collaborative international validation and evaluate the validation status of the
DEPARTMENT OF HEALTH AND study organized by NICEATM and the
HUMAN SERVICES 3T3 and NHK NRU test methods for
European Centre for the Validation of determining starting doses for in vivo
National Toxicology Program (NTP); Alternative Methods (ECVAM) to acute oral systemic toxicity tests. The
NTP Interagency Center for the evaluate the usefulness and limitations peer review panel’s report was released
Evaluation of Alternative Toxicological of two in vitro basal cytotoxicity NRU in July 2006 (Federal Register, Vol. 71,
Methods (NICEATM); Availability of the test methods using either BALB/c 3T3 No. 132, pp. 39122–39123). At a public
Interagency Coordinating Committee mouse fibroblasts (3T3) or primary teleconference meeting on August 3,
on the Validation of Alternative human epidermal keratinocytes (NHK) 2006 (Federal Register, Vol. 71, No. 132,
Methods (ICCVAM) Test Method for estimating acute oral rodent toxicity. pp. 39121–39122), the Scientific
Electronic copies of the ICCVAM Test Advisory Committee on Alternative
Evaluation Report: In Vitro Cytotoxicity
Method Evaluation Report and the BRD Toxicological Methods (SACATM)
Test Methods for Estimating Starting
are available from the ICCVAM/ reviewed and endorsed the conclusions
Doses for Acute Oral Systemic Toxicity
NICEATM Web site at http:// of the peer review panel (minutes from
Tests and the Final Background
iccvam.niehs.nih.gov or by contacting the teleconference are available at
Review Document for In Vitro
NICEATM (see FOR FURTHER http://ntp.niehs.nih.gov/files/
Cytotoxicity Test Methods for
Estimating Acute Oral Systemic
Test Method Evaluation Report and the ICCVAM considered the peer panel
Toxicity; Notice of Transmittal of
final BRD have been forwarded to U.S. report, public comments, SACATM
ICCVAM Test Method
Federal agencies for regulatory and comments, and the draft BRD in
Recommendations to Federal
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other acceptance considerations where finalizing its recommendations on the

applicable. Responses will be posted on use of these two in vitro basal
AGENCY: National Institute of the ICCVAM/NICEATM Web site as cytotoxicity test methods for estimating
Environmental Health Sciences they are received. starting doses for acute oral systemic
(NIEHS), National Institutes of Health FOR FURTHER INFORMATION CONTACT: Dr. toxicity tests. The ICCVAM Test Method
(NIH). William S. Stokes, Director, NICEATM, Evaluation Report includes the ICCVAM

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15758 Federal Register / Vol. 73, No. 58 / Tuesday, March 25, 2008 / Notices

recommendations on the use of the two information about ICCVAM and FOR FURTHER INFORMATION CONTACT:
in vitro NRU test methods, as well as NICEATM can be found on their Web http://www.hhs.gov/healthit/ahic/
recommended test method protocols, site (http://iccvam.niehs.nih.gov). confidentiality/.
recommendations for future studies to SACATM was established January 9, SUPPLEMENTARY INFORMATION: The
further characterize the usefulness and 2002, and is composed of scientists from Workgroup Members will continue
limitations of in vitro methods for the public and private sectors (Federal discussing and evaluating the
assessing acute systemic toxicity, Register, Vol. 67, No. 49, page 11358). confidentiality, privacy, and security
recommended performance standards SACATM provides advice to the protections and requirements for
for tests with similar scientific Director of the NIEHS, to ICCVAM, and participants in electronic health
principles and that measure or predict to NICEATM regarding the statutorily information exchange environments.
acute oral systemic toxicity, the peer mandated duties of ICCVAM and The meeting will be available via Web
panel report and Federal Register activities of NICEATM. Additional cast. For additional information, go to:
notices. The final BRD, which provides information about SACATM, including http://www.hhs.gov/healthit/ahic/
the supporting documentation for this the charter, roster, and records of past cps_instruct.html.
report, is available as a separate meetings, can be found at http://
Dated: March 13, 2008.
document. The ICCVAM Test Method ntp.niehs.nih.gov/ see ‘‘Advisory Board
Evaluation Report and the supporting & Committees’’ (or directly at http:// Judith Sparrow,
final BRD were forwarded to U.S. ntp.niehs.nih.gov/go/167). Director, American Health Information
Federal agencies for their consideration Community, Office of Programs and
Dated: March 14, 2008. Coordination, Office of the National
for regulatory acceptance as required by Samuel H. Wilson, Coordinator for Health Information
the ICCVAM Authorization Act of 2000 Technology.
Acting Director, National Institute of
(42 U.S.C. 285l–3). Agencies’ responses Environmental Health Sciences and National [FR Doc. E8–5853 Filed 3–24–08; 8:45 am]
to the test method recommendations Toxicology Program. BILLING CODE 4150–45–M
will be posted on the ICCVAM/ [FR Doc. E8–5936 Filed 3–24–08; 8:45 am]
NICEATM Web site as they are received.
Background Information on ICCVAM, DEPARTMENT OF HEALTH AND
ICCVAM is an interagency committee HUMAN SERVICES Administration for Children and
composed of representatives from 15 Families
Federal regulatory and research agencies Office of the National Coordinator for
that use, generate, or disseminate Health Information Technology; Proposed Information Collection
toxicological information. ICCVAM American Health Information Activity; Comment Request
conducts technical evaluations of new, Community Confidentiality, Privacy, &
revised, and alternative methods with Proposed Projects
Security Workgroup Meeting
regulatory applicability and promotes Title: Grants to States for Access and
the scientific validation and regulatory ACTION: Announcement of meeting. Visitation: State Child Access Program
acceptance of toxicological test methods Survey.
SUMMARY: This notice announces the
that more accurately assess the safety OMB No.: 0970–0204.
and hazards of chemicals and products 18th meeting of the American Health Description: On an annual basis,
and that refine, reduce, and replace Information Community Confidentiality, States must provide OCSE with data on
animal use. The ICCVAM Authorization Privacy, & Security Workgroup in programs that the Grants to States for
Act of 2000 established ICCVAM as a accordance with the Federal Advisory Access and Visitation Program has
permanent interagency committee of the Committee Act (Pub. L. No. 92–463, 5 funded. These program reporting
NIEHS under NICEATM. NICEATM U.S.C., App.) requirements include, but are not
administers ICCVAM and provides DATES: April 17, 2008, from 1 p.m. to 5 limited to, the collection of data on the
scientific and operational support for p.m. (Eastern Time). number of parents served, types of
ICCVAM-related activities. NICEATM ADDRESSES: Mary C. Switzer Building services delivered, program outcomes,
and ICCVAM work collaboratively to (330 C Street, SW., Washington, DC client socio-economic data, referral
evaluate new and improved test 20201), Conference Room 4090 (please sources, and other relevant data. OCSE
methods applicable to the needs of U.S. bring photo ID for entry to a Federal is proposing revisions to the current
Federal agencies. Additional building). survey.


No. of re- Average bur-
No. of re- Total burden
Instrument sponses per den hours per
spondents hours
respondent response

State Child Access Program Survey ................................................................ 314 1 15 4,710

Estimated Total Annual Burden Families is soliciting public comment to the Administration for Children and
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Hours: 4,710. on the specific aspects of the Families, Office of Administration,

In compliance with the requirements information collection described above. Office of Information Services, 370
of Section 506(c)(2)(A) of the Paperwork Copies of the proposed collection of L’Enfant Promenade, SW., Washington,
Reduction Act of 1995, the information can be obtained and DC 20447, Attn: Office of
Administration for Children and comments may be forwarded by writing Administration, Office of Information

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