[Federal Register Volume 65, Number 184 (Thursday, September 21, 2000)]
[Proposed Rules]
[Pages 57132-57136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24242]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 52h

RIN 0925-AA20


Scientific Peer Review of Research Grant Applications and 
Research and Development Contract Projects

AGENCY: National Institutes of Health, Health and Human Services.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) is proposing to revise 
the regulations governing scientific peer review of research grant 
applications and research and development contract projects and 
contract proposals to clarify the review criteria, revise the conflict 
of interest requirements to reflect the fact that members of Scientific 
Review Groups do not become Federal employees by reason of that 
membership, and make other changes required to update the regulations.

DATES: The NIH invites written comments on the proposed regulations and 
requests that comments identify the regulatory provision to which they 
relate. Comments must be received on or before November 20, 2000.

ADDRESSES: Comments should be sent to Jerry Moore, NIH Regulations 
Officer, National Institutes of Health, 6011 Executive Boulevard, Room 
601, MSC 7669, Rockville, MD 20852. Comments also may be sent 
electronically by facsimile (301-402-0169) or e-mail ([email protected]).

FOR FURTHER INFORMATION CONTACT: Jerry Moore at the address above, or 
telephone (301) 496-4607 (not a toll-free number).

SUPPLEMENTARY INFORMATION: Applications to NIH for grants for 
biomedical and behavioral research and NIH research and development 
contract project concepts and contract proposals are reviewed under a 
two-level scientific peer review system, often referred to as the dual 
review system. This dual review system separates the scientific 
assessment of proposed projects from policy decisions about scientific 
areas to be supported and the level of resources to be allocated, which 
permits a more objective and complete evaluation than would result from 
a single level of review. The review system is designed to provide NIH 
officials with the best available advice about scientific and technical 
merit as well as program priorities and policy considerations.
    The review system consists of two sequential levels of review for 
each application that will be considered for funding. For most grant 
and cooperative agreement (hereafter referred to as grant) 
applications, the initial or first level review involves panels of 
experts established according to scientific disciplines or medical 
specialty areas, whose primary function is to evaluate the scientific 
merit of grant applications. These panels are referred to as Scientific 
Review Groups (SRGs), a generic term that includes both regular study 
sections and special emphasis panels (SEPs). In some cases, SRGs in 
scientifically related areas are organizationally combined into Initial 
Review Groups (IRGs).
    The second level of review of grant applications is performed by 
National Advisory Boards or Councils composed of both scientific and 
lay representatives. The recommendations made by these Boards or 
Councils are based not only on considerations of scientific merit as 
judged by the SRG, but also on the relevance of a proposed project to 
the programs and priorities of NIH. In most cases Councils concur with 
the SRG recommendation. If a Board or Council does not concur with the 
SRG's assessment of scientific merit, the Board or Council can defer 
the application for re-review. Subject to limited exceptions as 
described in Council operating procedures, unless an application is 
recommended by both the SRG and the Board or Council, no award can be 
made.
    The first level of review of grant applications, and both levels of 
review of contract project concepts and contract proposals, are 
governed by the regulations codified at 42 CFR Part 52h, Scientific 
Peer Review of Research Grant Applications and Research and Development 
Contract Projects.
    The regulations at 42 CFR Part 52h were last amended in November 
1982. We are proposing to revise the regulations to incorporate changes 
that are required to update Part 52h.
    The regulations would be revised to: (1) change the section 
pertaining to conflict of interest to reflect that non-Federal members 
of SRGs are not appointed as Special Government Employees and therefore 
are not subject to the conflict of interest statutes and regulations 
applicable to Federal employees, and to provide a more practical view 
of the very complex relationships that occur in the scientific 
community; (2) clarify the applicability of the peer review rules to 
the review of grant applications and contract proposals; (3) clarify 
the review criteria applicable to grant applications; and (4) update 
references, add or amend definitions as necessary, and make appropriate 
editorial changes.
    The conflict of interest provisions in Sec. 52h.5 define real and 
apparent conflicts of interest, prohibit or restrict participation in 
peer review by those who have a conflict of interest, and permit 
waivers of those restrictions under prescribed conditions that are 
intended to protect the integrity of the review process. It is expected 
that the flexibility afforded by the proposed regulations will enhance 
the recruitment of qualified reviewers without compromising the 
integrity of the review process.
    The proposed changes to Sec. 52h.8 ``Grants review criteria'' were 
developed after extensive input from and discussion with the scientific 
community during 1996-1997 in response to a report entitled ``Rating of 
Grant Applications'' that was shared with the scientific community. The 
report and rating criteria were discussed at four open meetings of the 
Peer Review Oversight Group, whose members include representatives from 
the peer review community. That group made recommendations to NIH on 
review criteria (minutes of these meetings are posted on the NIH 
homepage, www.nih.gov). There was extensive discussion of how to 
include the concepts of ``innovativeness'' and ``impact'' of the 
research. After due consideration, the Director, NIH,

[[Page 57133]]

decided on the revised review criteria for rating unsolicited research 
grant applications that were published in the NIH Guide for Grants and 
Contracts, June 27, 1997. These review criteria have been well received 
by the research community and by those involved in the review process, 
who view them as beneficial to the review process.
    The proposed Sec. 52h.8 clarifies and rearranges the previous 
review criteria consistent with the criteria published in the NIH 
Guide. The term ``originality'' would be moved from (a) to the new (c) 
where it becomes ``the innovativeness and originality of the proposed 
research.'' Criterion (b) would be clarified from ``methodology'' to 
``approach and methodology.'' Criterion (e) would be clarified as ``the 
scientific environment and reasonable availability of resources'' 
instead of only ``reasonable availability of resources.'' The 
scientific peer review group would assess the overall impact that the 
project could have on the field in light of the assessment of 
individual review criteria. In addition, review criterion (f), 
concerning plans to include both genders, minorities, children and 
special populations, would be added to reflect current statutes and NIH 
policies.
    Additionally, the authority citation would be amended to reflect 
the current authorities and Secs. 52h.1, 52h.2, 52h.3, 52h.5, and 
52h.10 would be amended to reflect the applicability of the regulations 
to NIH alone. In accordance with the changes in applicability, 
references to the Alcohol, Drug Abuse, and Mental Health Administration 
(ADAMHA) and the Health Resources and Services Administration (HRSA) 
would be deleted. Section 52h.2 would be amended to include definitions 
for several additional terms, and minor editorial changes are proposed 
for several definitions and Sec. 52h.6.
    The following statements are provided for public information.

Executive Order 12866

    Executive Order 12866 requires that all regulatory actions reflect 
consideration of the costs and benefits they generate and that they 
meet certain standards, such as avoiding the imposition of unnecessary 
burdens on the affected public. If a regulatory action is deemed to 
fall within the scope of the definition of the term ``significant 
regulatory action'' contained in Section 3(f) of the Order, pre-
publication review by the Office of Management and Budget's Office of 
Information and Regulatory Affairs (OIRA) is necessary. This action was 
reviewed under Executive Order 12866 by OIRA and was deemed not 
significant.

Regulatory Flexibility Act

    The Department prepares a regulatory flexibility analysis, in 
accordance with the Regulatory Flexibility Act of 1980 (5 U.S.C. 
chapter 6), if a rule is expected to have a significant impact on a 
substantial number of small entities. The Principal Deputy Director, 
NIH, certifies that this proposed rule will not have a significant 
impact on a substantial number of small entities and that a regulatory 
flexibility analysis, as defined under the Regulatory Flexibility Act 
of 1980, is not necessary.

Executive Order 13132

    Executive Order 13132, Federalism, requires that federal agencies 
consult with State and local government officials in the development of 
regulatory policies with federalism implications. The Principal Deputy 
Director, NIH, reviewed the rule as required under the Order and 
determined that it does not have any federalism implications. The 
Principal Deputy Director, NIH, certifies that the changes in the 
scientific peer review regulations will not have an effect on the 
States, or on the distribution of power and responsibilities among the 
various levels of government.

Paperwork Reduction Act

    This proposed rule does not contain any information collection 
requirements that are subject to review by OMB under the Paperwork 
Reduction Act of 1995 (44 U.S.C. Chapter 35).

List of Subjects in 42 CFR Part 52h

    Government contracts, Grant programs--health, Medical research.

    Dated: August 7, 2000.
Ruth L. Kirschstein,
Principal Deputy Director, National Institutes of Health.

    For the reasons stated in the preamble, part 52h of title 42 of the 
Code of Federal Regulations is proposed to be revised to read as set 
forth below.

PART 52h--SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND 
RESEARCH AND DEVELOPMENT CONTRACT PROJECTS

Sec.
52h.1   Applicability.
52h.2   Definitions.
52h.3   Establishment and operation of peer review groups.
52h.4   Composition of peer review groups.
52h.5   Conflict of interest.
52h.6   Availability of information.
52h.7   Grants; matters to be reviewed.
52h.8   Grants; review criteria.
52h.9   Unsolicited contract proposals; matters to be reviewed.
52h.10   Contract projects involving solicited contract proposals; 
matters to be reviewed.
52h.11   Contract projects and proposals; review criteria.
52h.12   Applicability of other regulations.

    Authority: 42 U.S.C. 216; 42 U.S.C. 282(b) 42 U.S.C. 284 (c)(3); 
42 U.S.C. 289a.


Sec. 52h.1  Applicability.

    (a) This part applies to:
    (1) Applications to the National Institutes of Health for grants or 
cooperative agreements (a reference in this part to grants includes 
cooperative agreements) for biomedical and behavioral research; and
    (2) Biomedical and behavioral research and development contract 
project concepts and proposals for contract projects administered by 
the National Institutes of Health.
    (b) This part does not apply to applications for:
    (1) Continuation funding for budget periods within an approved 
project period;
    (2) Supplemental funding to meet increased administrative costs 
within a project period; or
    (3) Construction grants.


Sec. 52h.2  Definitions.

    As used in this part:
    (a) Act means the Public Health Service Act, as amended (42 U.S.C. 
201 et seq.).
    (b) Awarding official means the Secretary of Health and Human 
Services and any other officer or employee of the Department of Health 
and Human Services to whom the authority involved has been delegated; 
Except that, where the Act specifically authorizes another official to 
make awards in connection with a particular program, the ``awarding 
official'' shall mean that official and any other officer or employee 
of the Department of Health and Human Services to whom the authority 
involved has been delegated.
    (c) Budget period means the interval of time (usually 12 months) 
into which the project period is divided for budgetary and reporting 
purposes.
    (d) Close relative means a parent, spouse/domestic partner or son 
or daughter.
    (e) Contract proposal means a written offer to enter into a 
contract that is submitted to the appropriate agency official by an 
individual or non-federal organization which includes, as a minimum, a 
description of the nature, purpose, duration, and cost of the project, 
and the methods, personnel, and facilities to be utilized in carrying 
it out. A contract proposal may be

[[Page 57134]]

unsolicited by the federal government or submitted in response to a 
request for proposals.
    (f) Development means the systematic use of knowledge gained from 
research to create useful materials, devices, systems, or methods.
    (g) Director means the Director of the National Institutes of 
Health and any other official or employee of the National Institutes of 
Health to whom the authority involved has been delegated.
    (h) Grant as used in this part, includes cooperative agreements.
    (i) Peer review group means a group of primarily non-government 
experts qualified by training and experience in particular scientific 
or technical fields, or as authorities knowledgeable in the various 
disciplines and fields related to the scientific areas under review, to 
give expert advice on the scientific and technical merit of grant 
applications or contract proposals, or the concept of contract 
projects, in accordance with this part.
    (j) Principal Investigator has the same meaning as in 42 CFR part 
52.
    (k) Professional associate means any colleague, scientific mentor, 
or student with whom the peer reviewer is currently conducting research 
or other professional activities or with whom the member has conducted 
such activities within three years of the date of the review.
    (l) Project approach means the methodology to be followed and the 
resources needed in carrying out the project.
    (m) Project concept means the basic purpose, scope, and objectives 
of the project.
    (n) Project period has the same meaning as in 42 CFR part 52.
    (o) Request for proposals means a Government solicitation to 
prospective offerors, under procedures for negotiated contracts, to 
submit a proposal to fulfill specific agency requirements based on 
terms and conditions defined in the request for proposals. The request 
for proposals contains information sufficient to enable all offerors to 
prepare proposals, and is as complete as possible with respect to: 
nature of work to be performed; descriptions and specifications of 
items to be delivered; performance schedule; special requirements 
clauses, or other circumstances affecting the contract; format for cost 
proposals; and evaluation criteria by which the proposals will be 
evaluated.
    (p) Research has the same meaning as in 42 CFR part 52.
    (q) Research and development contract project means an identified, 
circumscribed activity, involving a single contract or two or more 
similar, related, or interdependent contracts, intended and designed to 
acquire new or fuller knowledge and understanding in the areas of 
biomedical or behavioral research and/or to use such knowledge and 
understanding to develop useful materials, devices, systems, or 
methods.
    (r) Scientific Review Group has the same meaning as ``peer review 
group'', which is defined in paragraph (i) of this section.
    (s) Solicited contract proposal has the same meaning as the 
definition of ``offer'' in 48 CFR 2.101.
    (t) Unsolicited contract proposal has the same meaning as 
``unsolicited proposal'' in 48 CFR 15.601.


Sec. 52h.3  Establishment and operation of peer review groups.

    (a) To the extent applicable, the Federal Advisory Committee Act (5 
U.S.C. App. 2) and Chapter 9 of the Department of Health and Human 
Services General Administration Manual \1\ will govern the 
establishment and operation of peer review groups.
---------------------------------------------------------------------------

    \1\ The Department of Health and Human Services General 
Administration Manual is available for public inspection and copying 
at the Department's information centers listed in 45 CFR 5.31 and 
may be purchased from the Superintendent of Documents, U.S. Printing 
Office, Washington, DC 20402.
---------------------------------------------------------------------------

    (b) Subject to section 52h.5 and paragraph (a) of this section, the 
Director will adopt procedures for the conduct of reviews and the 
formulation of recommendations under sections 52h.7, 52h.9 and 52h.10.


Sec. 52h.4  Composition of peer review groups.

    (a) To the extent applicable, the selection and appointment of 
members of peer review groups and their terms of service will be 
governed by Chapter 9 of the Department of Health and Human Services 
General Administration Manual.
    (b) Subject to paragraph (a) of this section, members will be 
selected based upon their training and experience in relevant 
scientific or technical fields, taking into account, among other 
factors:
    (1) The level of formal scientific or technical education completed 
or experience acquired by the individual;
    (2) The extent to which the individual has engaged in relevant 
research, the capacities (e.g., principal investigator, assistant) in 
which the individual has done so, and the quality of such research;
    (3) Recognition as reflected by awards and other honors received 
from scientific and professional organizations; and
    (4) The need for the group to have included within its membership 
experts from various areas of specialization within relevant scientific 
or technical fields.
    (c) Except as otherwise provided by law, not more than one-fourth 
of the members of any peer review group to which this part applies may 
be officers or employees of the United States. Being a member of a 
scientific peer review group does not make an individual an officer or 
employee of the United States.


Sec. 52h.5  Conflict of interest.

    (a) This section applies only to conflicts of interest involving 
members of peer review groups who are not federal employees. This 
section does not cover individuals serving on National Advisory 
Councils or Boards, Boards of Scientific Counselors, or Program 
Advisory Committees who, if not already officers or employees of the 
United States, are special Government employees and covered by title 18 
of the United States Code, the Office of Government Ethics Standards of 
Ethical Conduct for Employees of the Executive Branch (5 CFR part 
2635), and Executive Order 11222, as amended. For those federal 
employees serving on peer review groups, in accordance with 52h.4, the 
requirements of title 18 of the United States Code, 5 CFR part 2635 and 
Executive Order 12674, as modified by Executive Order 12731, apply.
    (b)(1) A reviewer has a real conflict of interest when that 
reviewer, or a close relative or professional associate of that 
reviewer, has an interest in an application or proposal that is likely 
to bias the reviewer's evaluation of that application or proposal. If 
such a conflict of interest is acknowledged by a reviewer or determined 
to exist by review staff, the reviewer must recuse him/herself from the 
review of the application or proposal, except as otherwise provided in 
this section.
    (i) A reviewer who is a salaried employee, whether full- or part-
time, of the applicant institution, offeror, or principal investigator, 
or is negotiating for such employment, shall generally be considered to 
have a real conflict of interest with regard to applications/proposals 
from that organization. However, in large organizations or multi-
component organizations there may be circumstances where the components 
are sufficiently independent that an employee of one component can 
review an application/proposal from another component without a real or 
apparent conflict of interest, as determined by the Director.

[[Page 57135]]

    (ii) A reviewer will be considered to have a real conflict of 
interest if he/she:
    (A) Has received or could receive a direct financial benefit of any 
amount deriving from an application or proposal under review; or
    (B) Apart from any direct financial benefit deriving from an 
application or proposal under review, has received, is under contract 
to receive, or is negotiating to receive from the applicant 
institution, offeror or principal investigator, an honorarium, fee, or 
other financial benefit not constituting salary that is valued at $5000 
or more per year. Regardless of the level of financial involvement, if 
the reviewer feels unable to provide objective advice, he/she must 
recuse him/herself from the review of the application or proposal at 
issue.
    (iii) Any financial interest of a close relative or professional 
associate of the reviewer shall be treated as the reviewer's financial 
interest and be subject to paragraph (b)(1) of this section. Depending 
on the nature of the relationship and other pertinent factors, as 
determined by the review staff, the reviewer must either recuse him/
herself from the review of an application or proposal in which a close 
relative or professional associate of the reviewer has a financial 
interest, or that application or proposal shall be reviewed by another 
review group in accordance with paragraph (b)(3) of this section.
    (iv) For contract proposal reviews, an individual with a real 
conflict of interest in a particular proposal(s) is generally not 
permitted to participate in the review of any proposals responding to 
the same request for proposals. However, if there is no other qualified 
reviewer available having that individual's expertise and that 
expertise is essential to ensure a competent and fair review, a waiver 
may be granted by the Director to permit that individual to serve as a 
reviewer of those proposals with which he/she has no conflict, while 
recusing him/herself from the review of the particular proposal(s) with 
which he/she does have a conflict of interest.
    (2) An appearance of a conflict of interest exists where the 
government official managing the review (i.e., the Scientific Review 
Administrator or equivalent) determines, in accordance with this 
subpart, that the circumstances would cause a reasonable person to 
question the reviewer's impartiality if he or she were to participate 
in the review. Any appearance of a conflict of interest should be 
avoided whenever possible through recusal of the reviewer who has an 
appearance of a conflict, but is not sufficient grounds for recusal 
when, in the interest of a competent and fair review, it is documented 
that there is no real conflict of interest, and the Director determines 
that: It would be difficult or impractical to carry out the review 
otherwise; and the integrity of the review process would not be 
impaired.
    (3) When a peer review group meets regularly it is assumed that a 
relationship among individual reviewers in the group exists and that 
the group as a whole may not be objective about evaluating the work of 
one of its members. In such a case, a member's application or proposal 
shall be reviewed by another qualified review group to ensure that a 
competent and objective review is obtained.
    (4) When a member of a peer review group participates in or is 
present during the concept review of a contract project that occurs 
after release of the solicitation, as described under Sec. 52h.10(b), 
but before receipt of proposals, the member is not considered to have a 
real conflict of interest as described in paragraph (b)(1) of this 
section, but is subject to paragraph (b)(2) concerning appearance of 
conflict of interest if the member is planning to respond to the 
solicitation. When concept review occurs after receipt of proposals, 
paragraph (b)(1) applies.
    (5) No member of a peer review group may participate in any review 
of a specific grant application or contract project for which the 
member has had or is expected to have any other responsibility or 
involvement (whether preaward or postaward) as an officer or employee 
of the United States.
    (6) In addition to the preceding requirements in this paragraph 
(b), the Director may determine if other particular situations that 
arise constitute a conflict of interest and require recusal or other 
appropriate action.
    (c) The Director may waive any of the requirements in paragraph (b) 
of this section relating to a real conflict of interest if he or she 
determines that there are no other practical means for securing 
appropriate expert advice on a particular grant or cooperative 
agreement application, contract project, or contract proposal, and that 
the real conflict of interest is not so substantial as to be likely to 
affect the integrity of the advice to be provided by the reviewer.


Sec. 52h.6  Availability of information.

    (a) Transcripts, minutes, and other documents made available to or 
prepared for or by a peer review group will be available for public 
inspection and copying to the extent provided in the Freedom of 
Information Act (5 U.S.C. 552), the Federal Advisory Committee Act (5 
U.S.C. Appendix 2), the Privacy Act (5 U.S.C. 552a), and implementing 
Department of Health and Human Services regulations (45 CFR parts 5 and 
5b).
    (b) Meetings of peer review groups reviewing grant applications or 
contract proposals are closed to the public in accordance with the 
Government in the Sunshine Act (5 U.S.C. 552b(c)(4), and 552b(c)(6)) 
and Section 10(d) of the Federal Advisory Committee Act, as amended (5 
U.S.C. Appendix 2). Documents made available to, or prepared for or by 
such groups that contain trade secrets or commercial or financial 
information obtained from a person that is privileged or confidential, 
and personal information concerning individuals associated with 
applications or proposals, the disclosure of which would constitute a 
clearly unwarranted invasion of personal privacy, are exempt from 
disclosure in accordance with the Freedom of Information Act (5 U.S.C. 
552(b)(4), and 552(b)(6)).
    (c) Meetings of peer review groups reviewing contract project 
concepts are open to the public in accordance with the provisions of 
the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2) 
and the Government in the Sunshine Act (5 U.S.C. 552b).


Sec. 52h.7  Grants; matters to be reviewed.

    (a) Except as otherwise provided by law, no awarding official will 
make a grant based upon an application covered by this part unless the 
application has been reviewed by a peer review group in accordance with 
the provisions of this part and said group has made recommendations 
concerning the scientific merit of that application. In addition, where 
under applicable law an awarding official is required to secure the 
approval or advice of a national advisory council or board concerning 
an application, said application will not be considered by the council 
or board unless it has been reviewed by a peer review group in 
accordance with the provisions of this part and said group has made 
recommendations concerning the scientific merit of the application, 
except where the council or board is the peer review group.
    (b) Except to the extent otherwise provided by law, recommendations 
by peer review groups are advisory only and not binding on the awarding 
official or the national advisory council or board.


Sec. 52h.8  Grants: review criteria.

    In carrying out its review under Sec. 52h.7, the scientific peer 
review group

[[Page 57136]]

shall assess the overall impact that the project could have on the 
field, taking into account, among other factors:
    (a) The significance of the goals of the proposed research, from a 
scientific or technical standpoint;
    (b) The adequacy of the approach and methodology proposed to carry 
out the research;
    (c) The innovativeness and originality of the proposed research;
    (d) The qualifications and experience of the principal investigator 
and proposed staff;
    (e) The scientific environment and reasonable availability of 
resources necessary to the research;
    (f) The adequacy of plans to include both genders, minorities, 
children and special populations as appropriate for the scientific 
goals of the research;
    (g) The reasonableness of the proposed budget and duration in 
relation to the proposed research; and
    (h) The adequacy of the proposed protection for humans, animals, 
and the environment, to the extent they may be adversely affected by 
the project proposed in the application.


Sec. 52h.9  Unsolicited contract proposals; matters to be reviewed.

    (a) Except as otherwise provided by law, no awarding official will 
award a contract based upon an unsolicited contract proposal covered by 
this part unless the proposal has been reviewed by a peer review group 
in accordance with the provisions of this part and said group has made 
recommendations concerning the scientific merit of that proposal.
    (b) Except to the extent otherwise provided by law, such 
recommendations are advisory only and not binding on the awarding 
official.


Sec. 52h.10  Contract projects involving solicited contract proposals; 
matters to be reviewed.

    (a) Subject to paragraphs (b) and (c) of this section, no awarding 
official will issue a request for contract proposals with respect to a 
contract project involving solicited contract proposals, unless the 
project concept has been reviewed by a peer review group or advisory 
council in accordance with this part and said group has made 
recommendations concerning the scientific merit of said concept.
    (b) The awarding official may delay carrying out the requirements 
for peer review of paragraph (a) of this section until after issuing a 
request for proposals if he/she determines that the accomplishment of 
essential program objectives would otherwise be placed in jeopardy and 
any further delay would clearly not be in the best interest of the 
Government. The awarding official shall specify in writing the grounds 
on which this determination is based. Under such circumstances, the 
awarding official will not award a contract until peer review of the 
project concept and the proposals have been completed. The request for 
proposals will indicate that the project concept will be reviewed by a 
peer review group and that no award will be made until the review is 
conducted and recommendations made based on that review.
    (c) The awarding official may determine that peer review of the 
project concept for behavioral or biomedical research and development 
contracts is not needed if one of the following circumstances applies: 
the solicitation is to recompete or extend a project that is within the 
scope of a current project that has been peer reviewed, or there is a 
Congressional authorization or mandate to conduct specific contract 
projects. If a substantial amount of time has passed since the concept 
review, the awarding official shall determine whether peer review is 
required to ensure the continued scientific merit of the concept.
    (d) Except to the extent otherwise provided by law, the 
recommendations referred to in this section are advisory only and not 
binding on the awarding official.


Sec. 52h.11   Contract projects and proposals; review criteria.

    (a) In carrying out its review of a project concept under 
Sec. 52h.10(a) or Sec. 52h.10(b), the peer review group will take into 
account, among other factors:
    (1) The significance from a scientific or technical standpoint of 
the goals of the proposed research or development activity;
    (2) The availability of the technology and other resources 
necessary to achieve those goals;
    (3) The extent to which there are identified, practical uses for 
the anticipated results of the activity; and
    (4) Where the review includes the project approach, the adequacy of 
the methodology to be utilized in carrying out the activity.
    (b) In carrying out its review of unsolicited contract proposals 
under Sec. 52h.9, the peer review group will take into account, among 
other factors, those criteria in Sec. 52h.8 which are relevant to the 
particular proposals.
    (c) In carrying out its review of solicited contract proposals 
under Sec. 52h.10 (a) or (b) the peer review group will evaluate each 
proposal in accordance with the criteria set forth in the request for 
proposals.


Sec. 52h.12  Applicability of other regulations.

    The regulations in this part are in addition to, and do not 
supersede other regulations concerning grant applications, contract 
projects, or contract proposals appearing elsewhere in this title, 
title 48, or title 45 of the Code of Federal Regulations.

[FR Doc. 00-24242 Filed 9-20-00; 8:45 am]
BILLING CODE 4140-01-P