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Federal Register / Vol. 72, No.

121 / Monday, June 25, 2007 / Proposed Rules 34655

for information on where and how to available on the Board’s Web site telephone 301–496–4607 (not a toll-free
submit applications. (http://www.access-board.gov). number).
To be effective, the size of the Tricia Mason, SUPPLEMENTARY INFORMATION: On
committee will be limited. Each Chair, Architectural and Transportation
September 30, 2003, NIH Director Elias
organization affected by emergency Barriers Compliance Board. A. Zerhouni announced a series of far-
alarm systems on passenger vessels [FR Doc. E7–12196 Filed 6–22–07; 8:45 am]
reaching strategic initiatives known
need not have its own representative on collectively as the NIH Roadmap for
BILLING CODE 8150–01–P
the committee. Rather, each interest Medical Research (NIH Roadmap). The
must be adequately represented and the NIH Roadmap is an innovative approach
membership must be fairly balanced. designed to transform the nation’s
DEPARTMENT OF HEALTH AND medical research capabilities and
After reviewing the comments HUMAN SERVICES accelerate fundamental research
received in response to this notice and discovery and translation of that
any applications for membership, the National Institutes of Health
knowledge into effective prevention
Board will issue a notice in the Federal strategies and new treatments. One of
42 CFR Part 52
Register announcing the establishment the NIH Roadmap initiatives encourages
of the committee and the committee RIN 0925–AA42 interdisciplinary research and team
membership, unless it is determined science and includes a recommendation
based on comments that the Grants for Research Projects to modify grant and research contract
establishment of the committee would AGENCY: National Institutes of Health, applications to allow proposing of more
be inappropriate. The first committee Department of Health and Human than one Principal Investigator when
meeting is tentatively scheduled for Services. appropriate. This is congruent with the
August 15 and 16, 2007 at the Access January 4, 2005, directive issued by the
ACTION: Notice of proposed rulemaking.
Board offices in Washington, DC. President’s Office of Science and
SUMMARY: The National Institutes of Technology Policy (OSTP) to all Federal
The Board expects the committee to research agency heads instructing the
hold no more than three meetings and Health (NIH) proposes to amend the
existing regulations governing grants for heads to accommodate the recognition
all meetings will be in the Washington, of two or more Principal Investigators
research projects by revising the
DC area. The meetings will be open to on research projects (grants and
definition of Principal Investigator to
the public. Future committee meetings contacts). While this new OSTP policy
mean one or more individuals
will be announced in the Federal designated by the grantee in the grant does not prohibit the use of a single
Register. application and approved by the Principal Investigator when that is most
The Board will provide staff support Secretary, who is or are responsible for appropriate for a particular research
to the committee. Members of the the scientific and technical direction of project, it simply permits the
committee will not be compensated for the project, rather than limiting the role designation of more than one Principal
their service. The Board may pay travel of principal investigator to one single Investigator when that more accurately
expenses for a limited number of individual, and the conditions for reflects the management needs of a
persons who would otherwise be unable multiple or concurrent awards research project.
to serve on the committee. Members permitting the Secretary to evaluate, For the purpose of implementing the
will not be considered special approve and make one or more awards NIH Roadmap initiatives, the NIH plans
government employees since they will pursuant to one or more applications. to modify research grant and contract
DATES: Comments must be received on
applications to request information on
serve as representatives of their
or before August 24, 2007 in order to more than one Principal Investigator,
organizations and will not be required
assure that NIH will be able to consider consistent with the new OSTP policy
to file confidential financial disclosure establishing the appropriateness of
reports. the comments in preparing the final
rule. multiple Principal Investigators.
Availability of Copies and Electronic Accordingly, we propose to revise the
Access ADDRESSES: Persons and organizations definition of the term Principal
interested in submitting comments, Investigator set forth in § 52.2 of the
Single copies of this publication may identified by RIN 0925–AA42, may do Grants for Research Projects regulations
be obtained at no cost by calling the so by any of the following methods: codified at 42 CFR Part 52, and the
Access Board’s automated publications • Federal eRulemaking Portal: http:// conditions for multiple or concurrent
order line (202) 272–0080, by pressing www.regulations.gov. Follow the awards permitting the Secretary to
2 on the telephone keypad and then instructions for submitting comments. evaluate, approve and make one or more
please record your name, address, city, • E-mail: jm40z@nih.gov. Include RIN awards pursuant to one or more
State, zip code, telephone number and number 0925–AA42 in the subject line applications.
request the emergency alarms advisory of the message. Specifically, in this Notice of
• Fax: 301–402–0169. Proposed Rulemaking (NPRM) we
committee notice. Persons using a TTY
• Mail: Jerry Moore, NIH Regulations propose to amend the existing
should call (202) 272–0082. This
Officer, Office of Management regulations governing grants for research
document is available in alternate
Assessment, National Institutes of projects by revising the definition of
formats upon request. Persons who want Health, 6011 Executive Boulevard, Suite Principal Investigator so that it does not
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this publication in an alternate format 601, MSC 7669, Rockville, MD 20892. limit the role of Principal Investigator to
should specify the type of format • Hand Delivery/Courier: 6011 one single individual.
(cassette tape, Braille, large print, or Executive Boulevard, Suite 601, As announced in NIH notice number
ASCII disk). This document is also Rockville, MD 20892. NOT–OD–07–017 (http://grants.nih.gov/
FOR FURTHER INFORMATION CONTACT: Jerry grants/guide/notice-files/NOT-OD-07-
Moore at the address above, or 017.html), these individual(s) must be

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34656 Federal Register / Vol. 72, No. 121 / Monday, June 25, 2007 / Proposed Rules

judged by the applicant organization to flexibility even when components of under the Executive Order and
have the appropriate level of authority such collaborative research programs determined that it does not have any
and responsibility to direct the project are administered by different NIH federalism implications. The Director,
or program supported by the grant in awarding components. NIH, certifies that the proposed rule will
order to be considered Principal The purpose of this NPRM is to invite not have an effect on the States, or on
Investigator(s). While this rule would public comment on the proposed the distribution of power and
permit the applicant organization to regulation. The following is provided as responsibilities among the various
designate multiple individuals as public information. levels of government.
Principal Investigators who share the
Executive Order 12866 Paperwork Reduction Act
authority and responsibility for leading
and directing the project, intellectually Executive Order 12866 requires that This proposed rule does not contain
and logistically, each Principal all regulatory actions reflect any information collection requirements
Investigator is responsible and consideration of the costs and benefits which are subject to Office of
accountable to the applicant they generate, and that they meet certain Management and Budget (OMB)
organization (or, as appropriate, to a standards, such as avoiding the approval under the Paperwork
collaborating organization), for the imposition of unnecessary burdens on Reduction Act of 1995 (44 U.S.C.
proper conduct of the project or the affected public. If a regulatory action chapter 35).
program, including the submission of all is deemed to fall within the scope of the
definition of the term ‘‘significant Catalog of Federal Domestic Assistance
required reports. In other words, the
presence of more than one identified regulatory action’’ contained in § 3(f) of The Catalog of Federal Domestic
Principal Investigator on an application the Order, prepublication review by the Assistance numbered programs affected
or award diminishes neither the Office of Management and Budget’s by the proposed regulations are:
responsibility nor the accountability of Office of Information and Regulatory 93.113—Biological Response to
any individual Principal Investigator. Affairs (OIRA) is necessary. This Environmental Health Hazards
Additionally, we propose to amend proposed rule was reviewed under 93.114—Applied Toxicological
§ 52.6 by revising paragraph (d) Executive Order 12866 by OIRA and Research and Testing
permitting the Secretary to evaluate, was deemed significant. 93.115—Biometry and Risk Estimation-
approve and make one or more awards Executive Order 12866 also requires Health Risks from Environmental
pursuant to one or more applications. each agency to write all rules in plain Exposures
Under current regulations, the language. In addition to your 93.118—Acquired Immunodeficiency
Secretary is permitted to evaluate, substantive comments on this proposed Syndrome (AIDS) Activity
approve and make more than one award rule, we invite comments on how to 93.121—Oral Diseases and Disorders
pursuant to two or more applications. In make this proposed rule easier to Research
some cases, however, it may be understand. For example: 93.135—Centers for Research and
desirable to disaggregate a single • Have we organized the material to Demonstration for Health Promotion
application to make more than one suit your needs? and Disease Prevention
award. For example, in the case of an • Are the requirements in the rule 93.136—Injury Prevention and Control
application for support of a project that clearly stated? Research and State and Community
involves more than one Principal • Does the rule contain technical Based Programs
Investigator affiliated with more than language or jargon that is not clear? 93.172—Human Genome Research
one institution, it may be desirable to • Would a different format (grouping 93.173—Research Related to Deafness
administer the project with more than and order of sections, use of headings, and Communication Disorders
one award. In addition, applications paragraphing) make the rule easier to 93.184—Disabilities Prevention
that involve subprojects may be understand? 93.213—Research and Training in
disaggregated into separate awards to • Could we improve clarity by adding Complementary and Alternative
improve scientific management. The illustrative examples, tables, lists, or Medicine
revised regulatory language clarifies diagrams? 93.242—Mental Health Research Grants
options and provides an opportunity to • What else could we do to make the 93.262—Occupational Safety and Health
contemplate more than one award that rule easier to understand.? Program
may involve more than one institution 93.271—Alcohol Research Career
in response to a single application. In Regulatory Flexibility Act
Development Awards for Scientists
some of these cases separate records The Regulatory Flexibility Act of 1980 and Clinicians
will be associated in the NIH data (5 U.S.C. chapter 6) requires that 93.273—Alcohol Research Programs
system so that the components can be regulatory proposals be analyzed to 93.279—Drug Abuse and Addiction
managed as a single project to promote determine whether they create a Research Programs
close collaboration with their significant impact on a substantial 93.281—Mental Health Research Career/
counterparts. Actual awards also will be number of small entities. The Director, Scientist Development Awards
associated through special terms of NIH, certifies that any final rule 93.283—Centers for Disease Control and
award to clearly note collaborations and resulting from this proposed rule will Prevention-Investigations and
any special requirements resulting from not have any such impact. Technical Assistance
such collaborations, In other cases, it 93.361—Nursing Research
may be appropriate to consider multiple Executive Order 13132
93.389—National Center for Research
applications from more than one Executive Order 13132, Federalism, Sources
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institutions that are managed as a single requires that federal agencies consult 93.390—Academic Research
unit with multiple awards to the with State and local government Enhancement Award
different institutions to facilitate officials in the development of 93.393—Cancer Cause and Prevention
collaboration. This change will foster regulatory policies with federalism Research
interdisciplinary and collaborative implications. The Director, NIH, 93.394—Cancer Detection and Diagnosis
research and will improve management reviewed the proposed rule as required Research

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Federal Register / Vol. 72, No. 121 / Monday, June 25, 2007 / Proposed Rules 34657

93.395—Cancer Treatment Research 52 of title 42 of the Code of Federal to list the Sierra Nevada distinct
93.396—Cancer Biology Research Regulations as set forth below. population segment (DPS) of the
93.821—Biophysics and Physiological mountain yellow-legged frog (Rana
Sciences Research PART 52—GRANTS FOR RESEARCH muscosa) under the Endangered Species
93.837—Heart and Vascular Diseases PROJECTS Act of 1973, as amended (Act). We are
Research 1. The authority citation for part 52 amending our previous 12-month
93.838—Lung Diseases Research continues to read as follows: petition finding, which found that
93.839—Blood Diseases and Resources listing is warranted but precluded, by
Research Authority: 42 U.S.C. 216. revising the preclusion and expeditious
93.846—Arthritis, Musculoskeletal and 1A. We propose to amend § 52.2 by progress section of that finding.
Skin Diseases Research revising the definition of the term DATES: The finding announced in this
93.847—Diabetes, Endocrinology and ‘‘Principal investigator’’ to read as document was made on June 25, 2007.
Metabolism Research follows: ADDRESSES: Supporting documentation
93.848—Digestive Diseases and used in the development of this
Nutrition Research § 52.2 Definitions.
amended 12-month finding will be
93.849—Kidney Diseases, Urology and * * * * * available for inspection, by
Hematology Research Principal investigator means the appointment, during normal business
93.853—Clinical Research Related to individual(s) judged by the applicant hours at the Endangered Species
Neurological Disorders organization to have the appropriate Program, Division of Conservation and
93.855—Allergy, Immunology and level of authority and responsibility to Classification, U.S. Fish and Wildlife
Transplantation Research direct the project or program supported Service, 4401 N. Fairfax Drive, Room
93.856—Microbiology and Infectious by the grant and who is or are 420, Arlington, VA 22203. Comments
Diseases Research responsible for the scientific and and materials received, as well as
93.859—Biomedical Research and technical direction of the project. supporting documentation used in the
Research Training * * * * * development of the initial 12-month
93.865—Research for Mothers and 2. We propose to amend § 52.6 by finding published on January 16, 2003
Children revising paragraph (d) to read as (68 FR 2283), are available for
93.866—Aging Research follows: inspection, by appointment, during
93.867—Vision Research normal business hours at the
§ 52.6 Grant awards.
93.879—Medical Library Assistance Sacramento Fish and Wildlife Office,
93.929—Center for Medical * * * * * U.S. Fish and Wildlife Service, 2800
Rehabilitation Research (d) Multiple or concurrent awards.
Cottage Way, Room W–2605,
93.934—Fogarty International Center Whenever a research project involves a
Sacramento, CA 95825.
Research Collaboration Award number of different but related
FOR FURTHER INFORMATION CONTACT:
93.939—Blood Diseases and Resources problems, activities or disciplines
which require evaluation by different Chris Nolin, Chief, Division of
Research Conservation and Classification,
93.941—HIV Demonstration, Research, groups, or whenever support for a
project could be more effectively Endangered Species Program (see
Public and Professional Education ADDRESSES section) (telephone 703–
Projects administered by separate handling of
separate aspects of the project, the 358–2171). Persons who use a
93.942—Research, Treatment and telecommunications device for the deaf
Education Programs on Lyme Disease Secretary may evaluate, approve and
make one or more awards pursuant to (TDD) may call the Federal Information
in the United States Relay Service (FIRS) at 1–800–877–
93.943—Epidemiologic Research one or more applications.
8339, 24 hours a day, 7 days a week.
Studies of Acquired * * * * *
SUPPLEMENTARY INFORMATION:
Immunodeficiency Syndrome (AIDS) [FR Doc. E7–12223 Filed 6–22–07; 8:45 am]
and Human Immunodeficiency Virus BILLING CODE 4140–01–P Background
(HIV) Infection in Selected Population Section 4(b)(3)(B) of the Endangered
Groups Species Act of 1973, as amended (Act)
93.947—Tuberculosis Demonstration, DEPARTMENT OF THE INTERIOR (16 U.S.C. 1531 et seq.), requires that,
Research, Public and Professional for any petition to revise the Lists of
Education Fish and Wildlife Service Endangered and Threatened Wildlife
List of Subjects in 42 CFR Part 52 and Plants that contains substantial
50 CFR Part 17 scientific or commercial information
Grant programs—Health; Medical that the petitioned action may be
research; Occupational safety and Endangered and Threatened Wildlife warranted, we make a finding within 12
health. and Plants; 12-Month Finding on a months of the date of the receipt of the
Dated: May 11, 2006.
Petition To List the Sierra Nevada petition on whether the petitioned
Distinct Population Segment of the action is: (a) Not warranted, (b)
Elias A. Zerhouni,
Mountain Yellow-Legged Frog (Rana warranted, or (c) warranted, but that the
Director, National Institutes of Health. muscosa)
Approved: October 12, 2006. immediate proposal of a regulation
Michael O. Leavitt, AGENCY: Fish and Wildlife Service, implementing the petitioned action is
Interior. precluded by other pending proposals to
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Secretary.
ACTION: Notice of an amended 12-month determine whether any species is
Editorial Note: This document was petition finding. threatened or endangered, and
received by the Office of the Federal Register expeditious progress is being made to
on June 20, 2007. SUMMARY: We, the U.S. Fish and add or remove qualified species from
For reasons presented in the Wildlife Service (Service), announce an the Lists of Endangered and Threatened
preamble, it is proposed to amend part amended 12-month finding on a petition Wildlife and Plants (Lists). Such 12-

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