[Federal Register Volume 62, Number 52 (Tuesday, March 18, 1997)]
[Rules and Regulations]
[Pages 12906-12914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6758]
[[Page 12905]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Public Health Service
_______________________________________________________________________
42 CFR Part 67
Health Services Research, Evaluation, Demonstration, and Dissemination
Projects; Peer Review of Grants and Contracts; Final Rule
Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules
and Regulations
[[Page 12906]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 67
RIN 0919-AAOO
Health Services Research, Evaluation, Demonstration, and
Dissemination Projects; Peer Review of Grants and Contracts
AGENCY: Agency for Health Care Policy and Research, HHS.
ACTION: Final regulations.
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SUMMARY: This final rule establishes regulations for grants for health
services research, evaluation, demonstration, and dissemination
projects administered by the Agency for Health Care Policy and Research
(AHCPR). It revises existing regulations governing health services
research grants as administered by the former National Center for
Health Services Research (NCHSR). The regulations set out program and
administrative requirements for grantees and potential grant
applicants, and describe the technical and scientific peer review by
which applications for grants are to be evaluated. The regulations also
establish procedures for the conduct of peer review of AHCPR contracts
for health services research, evaluation, demonstration, and
dissemination projects.
EFFECTIVE DATE: The final regulations are effective March 18, 1997.
FOR FURTHER INFORMATION CONTACT:
Phyllis M. Zucker, Director, Office of Planning and Evaluation, Agency
for Health Care Policy and Research, Executive Office Center, Suite
603, 2101 East Jefferson Street, Rockville, MD 20852. Phone: (301) 594-
2453.
SUPPLEMENTARY INFORMATION: The final regulations revise the existing
regulations at 42 CFR part 67, subpart A, and substitute a new subpart
B, to reflect the establishment of the Agency for Health Care Policy
and Research (AHCPR) and its legislative mandates as set forth in Pub.
L. 101-239, the Omnibus Budget Reconciliation Act of 1989 (OBRA of
1989), enacted on December 19, 1989. Section 6103 of Pub. L. 101-239
added a new Title IX to the Public Health Service (PHS) Act (42 U.S.C.
299-299c-6), which established AHCPR and provided that the Secretary of
Health and Human Services (HHS) shall act through the Administrator of
AHCPR in carrying out the authorities under Title IX. Pub. L. 102-410,
the Agency for Health Care Policy and Research Reauthorization Act
(October 13, 1992), further amended Title IX, and these amendments are
reflected in the final regulations, as well. Technical amendments to
Title IX subsequently included in section 2013 of Pub. L. 103-43, the
National Institutes of Health Revitalization Act of 1993, did not
affect this rule.
A Notice of Proposed Rulemaking (NPRM) was published in the Federal
Register on November 16, 1993 (58 FR 60510), with a 60-day comment
period. No public comments were received.
Background
The AHCPR is charged with enhancing the quality, appropriateness,
and effectiveness of health care services, and access to such services.
The AHCPR achieves these goals through the establishment of a broad
base of scientific research, and through the promotion of improvements
in clinical practice (including the prevention of diseases and other
health conditions) and in the organization, financing, and delivery of
health services. In carrying out these functions, AHCPR has built on
and expanded the work supported over twenty years by its predecessor,
the National Center for Health Services Research and Health Care
Technology Assessment (NCHSR).
Title IX, in particular sections 902 and 925(c), authorizes the
Administrator to award grants to, and enter into cooperative agreements
with, public and private nonprofit entities and individuals to support
research, demonstration projects, evaluations, and dissemination of
information, on health care services and systems for the delivery of
these services. When appropriate, the Administrator also may enter into
contracts with individuals, as well as public and private entities.
Section 902(d) of the PHS Act, as amended by Pub L. 102-410,
specifies that the Administrator may provide financial assistance for
the costs of developing and operating centers for multidisciplinary
health services research, demonstration projects, evaluations,
training, and policy analysis for carrying out the purposes of Title
IX.
Under section 902(e), as amended by Pub. L. 102-410, AHCPR may use
its Title IX authorities to carry out, and coordinate appropriately
with, activities authorized by the Social Security Act, including
experiments, demonstration projects, and other related activities.
Further, section 902(e) requires that research and other activities
conducted under Title IX on the outcomes of health care services and
procedures which affect the Medicare and Medicaid programs be
consistent with the provisions of section 1142 of the Social Security
Act, which, like Title IX, was enacted by section 6103 of Pub. L. 101-
239 (OBRA of 1989). The authorities in section 1142 (42 U.S.C. 1320-
12b) enhance and elaborate on AHCPR's mandate to conduct and support
outcomes and effectiveness research under Title IX.
Section 1142(a)(1) directs the Secretary, acting through the
Administrator of AHCPR, to support research with respect to the
outcomes, effectiveness, and appropriateness of health care services
and procedures, in order to identify the manner in which diseases,
disorders, and other health conditions can be prevented, diagnosed,
treated, and managed most effectively. Section 1142(a)(2) authorizes
evaluations of the comparative effects on health and functional
capacity and of alternative services and procedures for preventing,
diagnosing, treating, and managing health conditions.
Also provided for in section 1142(c), for the purpose of
facilitating outcomes and effectiveness research, are various
authorities to conduct and support activities such as the improvement
of methodologies, criteria, and data bases used in outcomes and
effectiveness research; and research and demonstrations on the use of
claims data and data on the clinical and functional status of patients.
Section 1142(e) requires the Secretary (through AHCPR) to provide
for dissemination of the findings of outcomes and effectiveness
research conducted or supported under section 1142 and clinical
practice guidelines under sections 911-914 of the PHS Act. Section
1142(e)(2) provides that the Secretary (through AHCPR) will work with
professional associations, medical organizations, and other relevant
groups to identify and implement effective means to educate health care
providers, practitioners, educators, consumers, and policymakers in
using research findings and guidelines. Authority to support
evaluations of the impact of such dissemination activities, and
authority to support research with respect to improving methods of
disseminating information on the effectiveness and appropriateness of
health care services and procedures, are provided under sections 1142
(f) and (g).
Pub. L. 102-410 amended section 924(a) of the PHS Act to require
that the Administrator define by regulation what constitutes financial
interests that could reasonably be expected to create a bias in the
results of AHCPR-supported grants, cooperative agreements, or contract
projects; and the actions that
[[Page 12907]]
will be taken in response to any such interests. Pub. L. 103-43
included similar requirements for the National Institutes of Health
(NIH) regarding protection against financial conflicts of interest in
certain projects of research. A final regulation on Objectivity in
Research was published by the Department in the Federal Register on
July 11, 1995 (60 FR 35810). This final rule implements both AHCPR and
NIH statutory requirements for regulations on conflicts of interest in
research projects, and also applies broadly to all research funded by
the Public Health service agencies of the Department, except Phase I
projects under the Small Business Innovation Research (SBIR) program.
The Final Regulations
The provisions in AHCPR final regulations are essentially the same
as those in the NPRM. Modifications incorporated for improved clarity
and increased flexibility are discussed below. Other technical and
editorial changes have also been incorporated.
Subpart A
The regulations at subpart A establish program and administrative
requirements governing grants and cooperative agreements to carry out
the purposes of Title IX of the PHS Act and section 1142 of the Social
Security Act. The regulations set out the technical and scientific peer
review procedures and criteria by which applications for grants and
cooperative agreements are to be reviewed, in accordance with section
922(e) of the PHS Act (42 U.S.C. 229c-1(e)).
Section 67.13 Eligible Projects
The listing of eligible projects dealing with ``health care
technology'' (paragraph (d)) has been reworded from the NPRM to read:
``Health care technologies, facilities, and equipment, including
assessments of health care technologies and innovative approaches to
such assessments, and technology diffusion.'' This new language
reflects the emphasis of Pub. L. 102-410 on innovation in approaches to
technology assessments. The category dealing with special populations
now explicitly lists women and children, and dissemination has been
expanded to include examples of the range of audiences to whom AHCPR
efforts are directed.
Section 67.15 Peer Review of Applications
Proposed Sec. 67.15(a), by exempting ``small grants'' from review
by established peer review groups and procedures, would have
inadvertently restricted the flexibility for review of small grants
provided by section 922(d)(2) of the PHS Act. Section 922(d)(2) permits
the Administrator to make adjustments in the standard review procedures
for ``small grant'' applications, which have direct costs that will not
exceed the amount specified in 922(d)(2) (currently $50,000). These
adjustments may be made for the purpose of encouraging the entry of
individuals into the field of research and promoting clinical practice-
oriented research, as well as for other purposes which the
Administrator may determine.
Accordingly, paragraphs (a) and (b) have been modified and retitled
to allow for ``small grants'' to be reviewed by established peer review
groups, as well as to permit adjustments in the procedures, such as
review by field readers and ad hoc groups. Paragraph (b) describes the
procedures for adjusting the peer review process for ``small grants.''
The new titles are, respectively, ``General procedures for peer
review'' and ``Procedural adjustments for small grants.'' These
modifications will ensure maximum flexibility for the Administrator,
which is consistent with section 922(d)(2).
Section 67.15(c)(1) General Review Criteria
The NPRM included as a proposed review criterion, ``The degree to
which the proposed project addresses the purposes of Title IX of the
PHS Act and section 1142 of the Social Security Act * * *'' This has
been moved to Sec. 67.16, ``Evaluation and disposition of
applications.'' Assuring that broad legislative mandates are being met
is part of AHCPR's overall program and funding decision processes,
rather than the scientific and technical review of individual
applications. The second half of the proposed criterion, the degree to
which the proposed project addresses ``any special AHCPR priorities
that have been announced by the Administrator,'' has been retained for
reviewers' consideration, as applicable.
Also, the review criteria under Sec. 67.15(c)(1) have been expanded
to include, ``The extent to which women and minorities are adequately
represented in study populations.'' This is consistent with AHCPR's
commitment and current requirements, as provided in application
materials, to ensure wide and appropriate representation in study
populations.
Section 67.15(c)(2) Review Criteria for Conference Grants
This section has been streamlined so that the final regulation
includes only the broad general review criteria for conference grants,
comparable to the criteria for non-conference grants. Additional
detailed criteria may be included in published program announcements,
which permit more flexibility for AHCPR in assuring that the criteria
are responsive to the changing needs of the health care community.
Also, included in the final review criteria is: ``The extent to
which the health concerns of women and minorities will be addressed in
conference topic(s), as appropriate.'' This addition makes the
conference grants criteria parallel to the criteria under
Sec. 67.15(c)(1) and reflects AHCPR's commitment to encourage wide and
appropriate representation of the health concerns of women and
minorities in all of its activities.
Consistent with Sec. 67.15(c)(1), ``The degree to which the
proposed project addresses the purposes of Title IX of the PHS Act and
section 1142 of the Social Security Act * * *'' has been moved to
Sec. 67.16. The degree to which a proposed project addresses ``any
special AHCPR priorities that have been announced by the
Administrator'' has been retained for reviewers' consideration, as
applicable.
Section 67.16 Evaluation and Disposition of Applications
``The degree to which the proposed project addresses the purposes
of Title IX of the PHS Act and section 1142 of the Social Security
Act'' included in the NPRM as a peer review criterion is contained in
the final regulations under paragraph Sec. 67.16(a). As discussed
above, the degree to which the overall legislative purposes are being
addressed is a part of the AHCPR program and policy funding decision
process, as the Administrator seeks to ensure a broad and balanced
portfolio of health services research. (See discussions of
Sec. 67.15(c)(1) and Sec. 67.15(c)(2).)
Section 67.17 Grant Award
Proposed Sec. 67.17(g) regarding supplemental awards has been
reworded to improve clarity.
Proposed Sec. 67.17(h) would have continued to require peer review
of all noncompeting continuation applications for projects with a
project period in excess of 2 years and with direct costs in excess of
the amount specified in section 922(d)(2) of the PHS Act (small grants
currently at $50,000). This was consistent with longstanding AHCPR
requirements and practices. AHCPR believes that, in keeping with the
Administration's Reinventing Government Initiative, it is important to
allow more flexibility in these review
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procedures and to use peer reviewers in the most efficient way. The
final regulations ensure this flexibility by providing that AHCPR may
require peer review of noncompeting continuation applications, but do
not mandate such reviews.
Subpart B
The existing regulations at subpart B pertain to grants for health
services research centers under former section 305(e) of the PHS Act
(originally section 305(d)), which described specific types of research
centers to be supported, and mandated particular requirements for each
center. Pub. L. 101-239 repealed section 305 of the PHS Act in its
entirety and provided broad authority for support to multidisciplinary
health services research centers under Title IX of the PHS Act. See
section 902(d), as amended by Pub. L. 102-410 (42 U.S.C. 299a(d)). Pub.
L. 101-239 also provided broad authority for support of research
centers for the conduct of outcomes research under section 1142(c) of
the Social Security Act (42 U.S.C. 1320b-12(c)(4)). Grants for centers
under Title IX of the PHS Act and section 1142(c) of the Social
Security Act are made in accordance with subpart A. Therefore, the
Department is removing the existing subpart B, which is obsolete, and
adding a new subpart B pertaining to the peer review of contract
proposals as required by section 922(e) of the PHS Act (42 U.S.C. 299c-
1(e)). All other aspects of AHCPR contract administration and
management are conducted in accordance with the Federal Acquisition
Regulations (FAR) and the Health and Human Services Acquisition
Regulations (HHSAR).
Section 922 of the PHS Act requires that technical and scientific
peer review shall be conducted not only with respect to each
application for a grant or cooperative agreement, but also with respect
to each proposal for a contract under Title IX. Section 922(e) further
requires that regulations be issued for the conduct of such peer
review. The new Subpart B satisfies this requirement with respect to
the peer review of contracts. The regulations in this subpart are to be
used in conjunction with the FAR and the HHSAR, which govern all
Department contracts.
The regulations apply to the peer review of contract proposals
under section 1142 of the Social Security Act (42 U.S.C. 1320b-12), as
well as Title IX of the PHS Act. This is consistent with the
interrelationship between the two authorities. The peer review
requirements in Sec. 67.102 are applicable to all contract proposals,
regardless of the projected costs of the contracts. (Section 922(d)(2)
of the PHS Act does not provide for procedural adjustments in the peer
review process for contract proposals as it does for applications for
small grants as set out in Sec. 67.15(b) of subpart A.)
Smoke-Free Workplace
The Department and its Public Health Service agencies strongly
encourage all grant and contract recipients to provide a smoke-free
workplace and promote the non-use of all tobacco products. In addition,
Pub. L. 103-227, The Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or
early childhood development services are provided to children. This is
consistent with the Public Health Service mission to protect and
advance the physical and mental health of the American people.
Executive Order 12866 and Regulatory Flexibility Act
The final regulations have been reviewed in accordance with the
requirements of Executive Order No. 12866, ``Regulatory Planning and
Review.'' The Secretary, therefore, has determined that the regulations
do not constitute a major rule, as defined under the order and, as a
result, have not been reviewed by the Office of Management and Budget.
In addition, pursuant to the provisions of the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.), it is certified that the regulations will
not have a significant economic impact on a substantial number of small
entities. The regulations make minor revisions to the existing grant
and contract procedures, and do not impose any consequential costs on
the grantees or contractors. Therefore, the Secretary has determined
that a regulatory impact analysis is not required.
Paperwork Reduction Act of 1995
The final regulations do not contain any new reporting or
recordkeeping requirements subject to review and clearance under the
Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The
applications used for the programs covered by the regulations at 42 CFR
part 67, subpart A, (PHS Form 398 ``Application for Public Health
Service Grant and HS Form 2590 ``Application for Continuation of Public
Health Service Grant,'' and PHS Form 5161 ``Application for State and
Local Governments''), are approved under OMB Approval Nos. 0925-0001
and 0937-0189.
List of Subjects in 42 CFR Part 67
Grant programs--Health services research, evaluation,
demonstration, and dissemination projects; peer review of grants and
contracts.
Dated: February 14, 1997.
Clifton R. Gaus,
Administrator, Agency for Health Care Policy and Research.
(Catalog of Federal Domestic Assistance No. 93n226--Health Services
Research and Development Grants, and No. 93.180--Medical
Effectiveness Research)
Accordingly, 42 CFR part 67 is revised to read as follows:
Part 67--Agency for Health Care Policy and Research Grants and
Contracts
Subpart A--Research Grants for Health Services Research, Evaluation,
Demonstration, and Dissemination Projects
Sec.
67.10 Purpose and scope.
67.11 Definitions.
67.12 Eligible applicants.
67.13 Eligible projects.
67.14 Application.
67.15 Peer review of applications.
67.16 Evaluation and disposition of applications.
67.17 Grant award.
67.18 Use of project funds.
67.19 Other applicable regulations.
67.20 Confidentiality.
67.21 Control of data and availability of publications.
67.22 Additional conditions.
Subpart B--Peer Review of Contracts for Health Services Research,
Evaluation, Demonstration, and Dissemination Projects
67.101 Purpose and scope.
67.102 Definitions.
67.103 Peer review of contract proposals.
67.104 Confidentiality.
67.105 Control of data and availability of publications.
Authority: Pub. L. 103-43, 107 Stat. 214-215, Pub. L. 102-410,
106 Stat. 2094-2101 and sec. 6103, Pub. L. 101-239, 103 Stat. 2189-
2208, Title IX of the Public Health Service Act (42 U.S.C. 299-299c-
6); and sec. 1142, Social Security Act (42 U.S.C. 1320b-12).
Subpart A--Research Grants for Health Services Research,
Evaluation, Demonstration, and Dissemination Projects
Sec. 67.10 Purpose and scope.
The regulations of this subpart apply to the award by AHCPR of
grants and cooperative agreements under:
(a) Title IX of the Public Health Service Act to support research,
evaluation, demonstration, and dissemination projects, including
conferences, on health care services and systems for the delivery of
such services, as well as to establish and
[[Page 12909]]
operate multidisciplinary health services research centers.
(b) Section 1142 of the Social Security Act to support research on
the outcomes, effectiveness, and appropriateness of health care
services and procedures, including but not limited to, evaluations of
alternative services and procedures; projects to improve methods and
data bases for outcomes, effectiveness, and other research;
dissemination of research information and clinical guidelines,
conferences, and research on dissemination methods.
Sec. 67.11 Definitions.
As used in this subpart--
Administrator means the Administrator and any other officer or
employee of the Agency for Health Care Policy and Research to whom the
authority involved may be delegated.
Agency for Health Care Policy and Research (AHCPR) means that unit
of the Department of Health and Human Services established by section
901 of the Public Health Service Act.
Direct costs means the costs that can be identified specifically
with a particular cost objective, such as compensation of employees for
the time and effort devoted specifically to the approved project, and
the costs of materials acquired, consumed, or expended specifically for
the purpose of the approved project.
Grant means an award of financial assistance as defined in 45 CFR
parts 74 and 92, including cooperative agreements.
Grantee means the organizational entity or individual to which a
grant, including a cooperative agreement, under Title IX of the Public
Health Service Act or section 1142 of the Social Security Act and this
subpart is awarded and which is responsible and accountable both for
the use of the funds provided and for the performance of the grant-
supported project or activities. The grantee is the entire legal entity
even if only a particular component is designated in the award
document.
Nonprofit as applied to a private entity, means that no part of the
net earnings of such entity inures or may lawfully inure to the benefit
of any shareholder or individual.
Peer review group means a panel of experts, established under
section 922(c) of the PHS Act, who by virtue of their training or
experience are eminently qualified to carry out the duties of such peer
review group as set out in this subpart. Officers and employees of the
United States may not constitute more than 25 percent of the membership
of any such group under this subpart.
PHS Act means the Public Health Service Act, as amended.
Principal investigator means a single individual, designated in the
grant application and approved by the Administrator, who is responsible
for the scientific and technical direction of the project.
Social Security Act means the Social Security Act, as amended.
Sec. 67.12 Eligible applicants.
Any public or nonprofit private entity or any individual is
eligible to apply for a grant under this subpart.
Sec. 67.13 Eligible projects.
Projects for research, evaluations, demonstrations, dissemination
of information (including research on dissemination), and conferences,
related to health care services and the delivery of such services, are
eligible for grant support. These include, but are not limited to,
projects in the following categories:
(a) Effectiveness, efficiency, and quality of health care services;
(b) Outcomes of health care services and procedures;
(c) Clinical practice, including primary care and practice-oriented
research;
(d) Health care technologies, facilities, and equipment, including
assessments of health care technologies and innovative approaches to
such assessments, and technology diffusion;
(e) Health care costs and financing, productivity, and market
forces;
(f) Health promotion and disease prevention;
(g) Health statistics and epidemiology;
(h) Medical liability;
(i) AID/HIV infection, particularly with respect to issues of
access and delivery of health care services;
(j) Rural health services;
(k) The health of low-income, minority, elderly, and other
underserved populations, including women and children; and
(l) Information dissemination and research on dissemination
methodologies, directed to health care providers, practitioners,
consumers, educators, review organizations, and others.
Sec. 67.14 Application
(a) To apply for a grant, an entity or individual must submit an
application in the form and at the time that the Administrator
requires. The application must be signed by an individual authorized to
act for the applicant and to assume on behalf of the applicant the
obligations imposed by the PHS Act and the Social Security Act, as
pertinent, the regulations of this subpart, and any additional terms or
conditions of any grant awarded.
(b) In addition to information requested on the application form,
the applicant must provide such other information as the Administrator
may request.
Sec. 67.15 Peer review of applications.
(a) General procedures for peer review. (1) All applications for
support under this subpart will be submitted by the Administrator for
review to a peer review group, in accordance with section 922(a) of the
PHS Act, except that applications eligible for review under section
922(d)(2) of the PHS Act (``small grants'') may be reviewed under
adjusted procedures in accordance with paragraph (b) of this section.
(2) Members of the peer review group will be selected based upon
their training and experience in relevant scientific and technical
fields, taking into account, among other factors:
(i) The level of formal education (e.g., M.A., Ph.D., M.D.,
D.N.Sc.) completed by the individual and/or the individual's pertinent
experience and expertise;
(ii) 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;
(iii) The extent of the professional recognition received by the
individual as reflected by awards and other honors received from
scientific and professional organizations outside the Department of
Health and Human Services;
(iv) The need of the peer review group to include within its
membership experts representing various areas of specialization within
relevant scientific and technical fields, or specific health care
issues; and
(v) Appropriate representation based on gender, racial/ethnic
origin, and geography.
(3) Review by the peer review group under paragraph (a) of this
section is conducted by using the criteria set out in paragraph (c) of
this section.
(4) The peer review group to which an application has been
submitted under paragraph (a) of this section shall make a written
report to the Administrator on each application, which shall contain
the following parts:
(i) The first part of the report shall consist of a factual summary
of the proposed project, including a
[[Page 12910]]
description of its purpose, scientific approach, location, and total
budget.
(ii) The second part of the report shall address the scientific and
technical merit of the proposed project with a critique of the proposed
project with regard to the factors described in paragraphs (c)(1)(i)
through (c)(1)(x) or (c)(2)(i) through (c)(2)(vii) of this section as
applicable. This portion of the report shall include a set of
recommendations to the Administrator with respect to the disposition of
the application based upon its scientific and technical merit. The peer
review panel may recommend to the Administrator that an application:
(A) Be given consideration for funding,
(B) Be deferred for a later decision, pending receipt of additional
information, or
(C) Not be given further consideration.
(iii) For each application recommended for further consideration by
the Administrator, the report shall also provide a priority score based
on the scientific and technical merit of the proposed project, and make
recommendations on the appropriate project period and level of support.
The report may also address, as applicable, the degree to which the
proposed project relates to AHCPR-announced priorities.
(b) Procedural adjustments for small grants. (1) The Administrator
may make adjustments in the peer review procedures established in
accordance with paragraph (a) of this section for grant applications
with total direct costs that do not exceed the amount specified in
section 922(d)(2) of the PHS Act, hereafter referred to as ``small
grants.''
(2) Non-Federal and Federal experts will be selected by the
Administrator for the review of small grant applications on the basis
of their training and experience in particular scientific and technical
fields, their knowledge of health services research and the application
of research findings, and their special knowledge of the issue(s) being
addressed or methods and technology being used in the specific
proposal.
(3) Review of applications for small grants may be by a review
group established in accordance with paragraph (a) of this section, or
by individual field readers, or by an ad hoc group of reviewers.
(4) The review criteria set forth in paragraph (c) of this section
shall be used for the review of small grant applications.
(5) Each reviewer or group of reviewers to whom an application has
been submitted under paragraph (b) of this section shall make a written
report to the Administrator on each application. Each report shall
summarize the findings of the review and provide a recommendation to
the Administrator on whether the application should be given further
consideration. For applications recommended for further consideration,
the report may also address, as applicable, the degree to which the
proposed project relates to AHCPR-announced priorities.
(c) Review criteria. The review criteria set out in this paragraph
apply to both applications reviewed by peer review panels in accordance
with paragraph (a) of this section, and applications for small grants
reviewed in accordance with paragraph (b) of this section.
(1) General review criteria. In carrying out a review under this
section for grants (other than conference grants), the following review
criteria will be taken into account, where appropriate:
(i) The significance and originality from a scientific or technical
standpoint of the goals of the project;
(ii) The adequacy of the methodology proposed to carry out the
project;
(iii) The availability of data or the adequacy of the proposed plan
to collect data required in the analyses;
(iv) The adequacy and appropriateness of the plan for organizing
and carrying out the project;
(v) The qualifications and experience of the principal investigator
and proposed staff;
(vi) The reasonableness of the budget and the time frame for the
project, in relation to the work proposed;
(vii) The adequacy of the facilities and resources available to the
grantee;
(viii) The extent to which women and minorities are adequately
represented in study populations;
(ix) Where an application involves activities which could have an
adverse effect upon humans, animals, or the environment, the adequacy
of the proposed means for protecting against or minimizing such
effects; and
(x) Any additional criteria that may be announced by the
Administrator from time to time for specific categories of grant
applications (e.g., proposed projects for support of research centers)
eligible for support under this subpart.
(xi) In addition to the scientific and technical criteria above,
peer reviewers may be asked to consider the degree to which a proposed
project addresses any special AHCPR priorities that have been announced
by the Administrator, as applicable.
(2) Review criteria for conference grants. In carrying out reviews
of conference grants under paragraphs (a) and (b) of this section, the
following review criteria will be taken into account, as appropriate:
(i) The significance of the proposed conference, specifically the
importance of the issue or problem being addressed, including
methodological or technical issues for dealing with the development,
conduct, or use of health services research;
(ii) The qualifications of the staff involved in planning and
managing the conference;
(iii) The adequacy of the facilities and other resources available
for the conference;
(iv) the appropriateness of the proposed budget, including other
sources of funding;
(v) The extent to which the health concerns of women and minorities
will be addressed in the conference topic(s), as appropriate;
(vi) The plan for evaluating and disseminating the results of the
conference; and
(vii) Any additional criteria that may be announced by the
Administrator.
(viii) In addition to the scientific and technical criteria above,
peer reviewers may be asked to consider the degree to which a proposed
project addresses any special AHCPR priorities that have been announced
by the Administrator, as appropriate.
(d) Conflict of interest. (1) Members of peer review groups will be
screened for potential conflicts of interest prior to appointment and
will be required to follow Department policies and procedures
consistent with the Standards of Ethical Conduct for Employees of the
Executive Branch (5 CFR part 2635), Executive Order 12674 (as modified
by Executive Order 12731).
(2) In addition to any restrictions referenced under paragraph
(d)(1) of this section:
(i) No member of a peer review group (or individual reviewer) may
participate in or be present during any review by such group of a grant
application in which, to the member's knowledge, any of the following
has a financial interest:
(A) The number or his or her spouse, minor child, or partner;
(B) Any organization in which the member is serving as an officer,
director, trustee, general partner, or employee; or
(C) Any organization with which the member is negotiating or has
any arrangement concerning prospective employment or other similar
association, and further;
(ii) In the event that any member of a peer review group or his or
her spouse, parent, child, or partner is currently or expected to be
the principal investigator or member of the staff responsible for
carrying out any
[[Page 12911]]
research or development activities contemplated as part of a grant
application, that member of the group, or the group, may be
disqualified from the review and the review conducted by another group
with the expertise to do so. An ad hoc group selected in accordance
with Sec. 67.15(a), or Sec. 67.15(b) as applicable, may also be used
for the review. Any individual reviewer to whom the conditions of this
paragraph apply would also be disqualified as a reviewer.
(iii) No member of a peer review group or individual may
participate in any review under this subpart of a specific grant
application 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.
(3) Where permissible under the standards and order(s) cited in
paragraph (d)(1) of this section, the Administrator may waive the
requirements in paragraph (d)(2) of this section if it is determined
that there is no other practical means for securing appropriate expert
advice on a particular grant application.
Sec. 67.16 Evaluation and disposition of application.
(a) Evaluation. After appropriate peer review in accordance with
Sec. 67.15, the Administrator will evaluate applications recommended
for further consideration, taking into account, among other factors:
(1) The degree to which the purposes of Title IX of the PHS Act and
section 1142 of the Social Security Act, as applicable, are being
addressed;
(2) Recommendations made by reviewers pursuant to Sec. 67.15;
(3) Any recommendations made by the National Advisory Council for
Health Care Policy, Research, and Evaluation, as applicable;
(4) The appropriateness of the budget;
(5) The extent to which the research proposal and the fiscal plan
provide assurance that effective use will be made of grant funds;
(6) The demonstrated business management capability of the
applicant;
(7) The demonstrated competence and skill of the staff, especially
the senior personnel, in light of the scope of the project;
(8) The probable usefulness of the results of the project for
dealing with national health care issues, policies, and programs; and
(9) The degree to which AHCPR-announced priorities or purposes are
being addressed.
(b) Disposition. On the basis of the evaluation of the application
as provided in paragraph (a) of this section, the Administrator shall:
give consideration for funding, defer for a later decision, pending
receipt of additional information, or give no further consideration for
funding, to any application for a grant under this subpart; except that
the Administrator may not fund an application which has not been
recommended for further consideration as a result of peer review in
accordance with Sec. 67.15. A recommendation against further
consideration shall not preclude reconsideration, if the application is
revised, responding to issues and questions raised during the review,
and resubmitted for peer review at a later date.
Sec. 67.17 Grant award.
(a) Within the limits of available funds, the Administrator may
award grants to those applicants whose projects are being considered
for funding, which in the judgment of the Administrator, will promote
best the purposes of Title IX of the PHS Act and (if applicable)
section 1142 of the Social Security Act, AHCPR priorities, and the
regulations of this subpart.
(b) The Notice of Grant Award specifies how long the Administrator
intends to support the project without requiring the project to
recompete for funds. This period, called the project period, will
usually be for 3-5 years, except for small grants, which usually are 1
year awards. The project period as specified in the Notice of Grant
Award shall begin no later than 9 months following the date of the
award, except that the project period must begin in the same fiscal
year as that from which funds are being awarded.
(c) Upon request from the grantee, Department grants policy permits
an extension of the project period for up to 12 months, without
additional funds, when more time is needed to complete the research.
The Administrator may approve a request for an additional extension of
time based on unusual circumstances with written justification
submitted by the grantee, prior to the completion of the project
period. In no case will an additional extension of more than 12 months
be approved.
(d) Generally, a grant award will be for 1 year, and subsequent
continuation awards will be for 1 year at a time. A grantee must submit
a separate continuation application to have the support continued for
each subsequent year. Decisions regarding continuation awards and the
funding level of such awards will be made after consideration of such
factors as the grantee's progress and management practices and the
availability of funds. In all cases, continuation awards require a
determination by the Administrator that continuation is in the best
interest of the Federal Government.
(e) Neither the approval of any application nor the award of any
grant commits or obligates the Federal Government in any way to make
any additional, supplemental, continuation, or other award with respect
to any approved application.
(f) Small grants. For particular categories of small grants, such
as dissertation research support, the Administrator may establish a
limit on total direct costs to be awarded. Any categorical limits will
be announced in advance of the deadline for receipt of applications for
such small grants.
(g) Supplemental awards. (1) Except for small grants, supplemental
awards that would exceed 20 percent of the AHCPR approved direct costs
of the project during the project period, or that request an increase
in funds to support a change or a significant expansion of the scope of
the project, will be reviewed as competing supplemental grants in
accordance with Sec. 67.15(a). A supplemental award for preparation of
data in suitable form for transmittal in accordance with Sec. 67.21
shall be excluded from the 20 percent aggregate.
(2) In the case of small grants, as defined in section 922(d)(2) of
the PHS Act, the Administrator will not approve a supplemental award
during the project period (excluding any supplemental award for
preparation of data in suitable form for transmittal in accordance with
Sec. 67.21) that will, in the aggregate, exceed 10 percent of the AHCPR
approved direct costs of the project.
(h) Noncompeting continuation awards. Each project with a project
period in excess of 2 years and with direct costs over the project
period in excess of the amount specified in section 922(d)(2) may be
reviewed during the second budget period and during each subsequent
budget period by at least two members of the peer review group that
reviewed the initial application, or individuals who participated in
that review, to the extent practicable. Recommendations to the
Administrator for continuation support will be based upon evaluation
of:
(1) The progress of the project in meeting project objectives;
(2) The appropriateness of the management of the project and
allocation of resources within the project;
(3) The adequacy and appropriateness of the plan for carrying out
the project during the budget period in light of the
[[Page 12912]]
accomplishments during previous budget periods; and
(4) The reasonableness of the proposed budget for the subsequent
budget period.
Sec. 67.18 Use of project funds.
Grant funds must be spent solely for carrying out the approved
project in accordance with Title IX of PHS Act, section 1142 of the
Social Security Act (if applicable), the regulations of this subpart,
the terms and conditions of the award, and the provisions of 45 CFR
part 74, or part 92 for State and local government grantees.
Sec. 67.19 Other applicable regulations.
Several other regulations apply to grants under this subpart. These
include, but are not limited to:
37 CFR Part 401--Inventions and patents
42 CFR Part 50 Subpart A--Responsibility of PHS awardee and
applicant institutions for dealing with and reporting possible
misconduct in science
42 CFR Part 50 Subpart D--Public Health Service grant appeals
procedure
42 CFR Part 50 Subpart F--Responsibility of applicants for promoting
objectivity in research for which PHS funding is sought
45 Part 16--Procedures of the departmental grant appeals board
45 CFR Part 46--Protection of human subjects
45 CFR Part 74--Administration of grants
45 CFR Part 76--Governmentwide debarment and suspension
(nonprocurement) and governmentwide requirements for drug-free
workplace (grants)
45 CFR Part 80--Nondiscrimination under programs receiving Federal
assistance through the Department of Health and Human Services
effectuation of Title VI of the Civil Rights Act of 1964
45 CFR Part 81--Practice and procedure for hearings under Part 80 of
this title
45 CFR Part 84--Nondiscrimination on the basis of handicap in
programs and activities receiving or benefiting from Federal
financial assistance
45 CFR Part 86--Nondiscrimination on the basis of sex in education
programs and activities receiving or benefiting from Federal
financial assistance
45 CFR Part 91--Nondiscrimination on the basis of age in DHHS
programs or activities receiving Federal financial assistance
45 CFR Part 92--Uniform administrative requirements for grants and
cooperative agreements with State and local governments
45 CFR Part 93--New restrictions on lobbying
Sec. 67.20 Confidentiality.
The confidentiality of identifying information obtained in the
course of conducting or supporting grant and cooperative agreement
activities under this subpart is protected by section 903(c) of the PHS
Act. Specifically:
(a) No information obtained in the course of conducting or
supporting grant and cooperative agreement activities under this
subpart, if the entity or individual supplying the information or
described in it is identifiable, may be used for any purpose other than
the purpose for which it was supplied, unless the identifiable entity
or individual supplying the information or described in it has
consented to such other use, in the recorded form and manner as the
Administrator may require; and
(b) No information obtained in the course of grant and cooperative
agreement activities conducted or supported under this subpart maybe
published or released in other form if the individual who supplied the
information or who is described in it is identifiable, unless such
individual has consented, in the recorded form and manner as the
Administrator may require, to such publication or release.
Sec. 67.21 Control of data and availability of publications.
Except as otherwise provided in the terms and conditions of the
award and subject to the confidentiality requirements of section 903(c)
of the PHS Act, section 1142(d) of the Social Security Act, and
Sec. 67.20 of this subpart:
(a) All data collected or assembled for the purpose of carrying out
health services research, evaluation, demonstration, or dissemination
projects supported under this subpart shall be made available to the
Administrator, upon request:
(b) All publications, reports, papers, statistics, or other
materials developed from work supported, in whole or in part, by an
award made under this subpart must be submitted to the Administrator in
a timely manner. All such publications must include an acknowledgement
that such materials are the results of, or describe, a grant activity
supported by AHCPR;
(c) The AHCPR retains a royalty-free, non-exclusive, and
irrevocable license to reproduce, publish, use, or disseminate any
copyrightable material developed in the course of or under a grant for
any purpose consistent with AHCPR's statutory responsibilities, and to
authorize others to do so for the accomplishment of AHCPR purposes; and
(d) Except for identifying information protected by section 903(c)
of the PHS Act, the Administrator, as appropriate, will make
information obtained with AHCPR grant support available, and arrange
for dissemination of such information and material on as broad a basis
as practicable and in such form as to make them as useful as possible
to a variety of audiences, including health care providers,
practitioners, consumers, educators, and policymakers.
Sec. 67.22 Additional conditions.
The Administrator may, with respect to any grant awarded under this
subpart, impose additional conditions prior to or at the time of any
award when in the Administrator's judgment such conditions are
necessary to assure or protect advancement of the approved project, the
interest of the public health, or the conservation of grant funds.
Subpart B--Peer Review of Contracts for Health Services Research,
Evaluation, Demonstration, and Dissemination Projects
Sec. 67.101 Purpose and scope.
(a) The regulations of this subpart apply to the peer review of
contracts under:
(1) Title IX of the Public Health Service Act to support research,
evaluation, demonstration, and dissemination projects, including
conferences, on health care services and systems for the delivery of
such services; and development of clinical practice guidelines, quality
standards, performance measures, and review criteria.
(2) Section 1142 of the Social Security Act to support research on
the outcomes, effectiveness, and appropriateness of health care
services and procedures, including, but not limited to, evaluations of
alternative services and procedures; projects to improve methods and
data bases for outcomes and effectiveness research; dissemination of
research information and clinical practice guidelines, as well as
quality standards, performance measures, and review criteria;
conferences; and research on dissemination methods.
(b) The regulations of this subpart also contain provisions
respecting confidentiality of research data, control of data, and
availability of information.
Sec. 67.102 Definitions.
Contract proposal means a written offer to enter into a contract
submitted to a contracting officer by an individual or non-Federal
organization, and including at a minimum a description of the nature,
purpose, duration, cost of project and methods, personnel, and
facilities to be utilized in carrying out the requirements of the
contract.
Peer review group means a panel of experts, as required by section
922(c) of
[[Page 12913]]
the PHS Act, established to conduct technical and scientific review of
contract proposals and to make recommendations to the Administrator
regarding the merits of such proposals.
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 solicitation. The solicitation
contains information sufficient to enable all offerors to prepare
competitive proposals, and is as complete as possible with respect to:
The 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; and criteria by
which the proposals will be evaluated.
Sec. 67.103 Peer review of contract proposals.
(a) All contract proposals for AHCPR support will be submitted by
the Administrator for review to a peer review group, as required in
section 922(a) of the PHS Act. Proposals will be reviewed in accordance
with the Federal Acquisition Regulations and the Health and Human
Services Acquisition Regulations (48 CFR Ch. I and III) and the
requirements of the pertinent Request for Proposal.
(b) Establishment of peer review groups. In accordance with section
922(c) of the PHS Act, the Administrator shall establish such peer
review groups as may be necessary to review all contract proposals
submitted to AHCPR.
(c) Composition of peer review groups. The peer review groups shall
be composed of individuals, in accordance with section 922(c) of the
PHS Act, as amended, who by virtue of their training or experience are
eminently qualified to carry out the duties of such a peer review
group. Officers and employees of the United States may not constitute
more than 25 percent of the membership of any such group. Members of
the peer review group will be selected based upon their training or
experience in relevant scientific and technical fields, taking into
account, among other factors:
(1) The level of formal education (e.g., M.A., Ph.D., M.D.,
D.N.Sc.) completed by the individual and/or, as appropriate, the
individual's pertinent experience and expertise;
(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) The extent of the professional recognition received by the
individual as reflected by awards and other honors received from
scientific and professional organizations outside the Department of
Health and Human Services;
(4) The need of the peer review group to include in its membership
experts representing various areas of specialization in relevant
scientific and technical fields, or specific health care issues; and
(5) Appropriate representation based on gender, racial/ethnic
origin, and geography, to the extent practicable.
(d) Term of peer review group members. Notwithstanding section
922(c)(3) of the PHS Act, members of peer review groups appointed to
review contract proposals will be appointed to such groups for a
limited period of time, as determined by the Administrator; such as on
an annual basis, or until the peer review of the contract proposals is
completed, or until the expiration of the contract(s) awarded as a
result of the peer review.
(e) Conflict of interest. (1) Members of peer review groups will be
screened for potential conflicts of interest prior to appointment and
will be required to follow Department policies and procedures
consistent with the Standards of Ethical Conduct for Employees of the
Executive Branch (5 CFR part 2635) and Executive Order 12674 (as
modified by Executive Order 12731).
(2) In addition to any restrictions referenced under paragraph
(e)(1) of this section:
(i) No member of a peer review group may participate in or be
present during any review by such group of a contract proposal in
which, to the member's knowledge, any of the following has a financial
interest:
(A) The member or his or her spouse, minor child, or partner;
(B) Any organization in which the member is serving as an officer,
director, trustee, general partner, or employee; or
(C) Any organization with which the member is negotiating or has
any arrangement concerning prospective employment or other similar
association, and further;
(ii) In the event any member of a peer review group or his or her
spouse, parent, child, or partner is currently or expected to be the
project director or member of the staff responsible for carrying out
any contract requirements as specified in the contract proposal, that
member is disqualified and will be replaced as appropriate.
Sec. 67.104 Confidentiality.
Identifying information obtained in the course of conducting AHCPR
contract activities under this subpart is protected by section 903(c)
of the PHS Act. Specifically:
(a) No information obtained in the course of conducting AHCPR
contract activities under this subpart, if the entity or individual
supplying the information or described in it is identifiable, may be
used for any purpose other than the purpose for which it was supplied,
unless the identifiable entity or individual supplying the information
or described in it has consented to such other use, in the recorded
form and manner as the Administrator may require.
(b) No information obtained in the course of conducting AHCPR
contract activities under this subpart may be published or released in
other form if the individual who supplied the information or who is
described in it is identifiable, unless such individual has consented,
in the recorded form and manner as the Administrator may require, to
such publication or release.
Sec. 67.105 Control of data and availability of publications.
(a) Data will be collected, maintained, and supplied as provided in
each contract subject to the confidentiality requirements of section
903(c) of the PHS Act, section 1142(d) of the Social Security Act, and
Sec. 67.104 of this subpart.
(b) All publications, reports, papers, statistics, or other
materials developed from work supported in whole or in part by
contracts under Title IX of the PHS Act or section 1142 of the Social
Security Act, if applicable, must be submitted to the Administrator in
accordance with the terms of the contract. All publications must
include an acknowledgment that such materials are the results of, or
describe, a contractual activity supported by AHCPR.
(c) In accordance with 48 CFR 52.227-14, unless otherwise specified
in the contract, AHCPR will retain a license to use, disclose,
reproduce, prepare derivative works from, distribute copies to the
public, and perform publicly and display publicly any copyrightable
materials produced under a contract for any purpose consistent with
AHCPR's statutory responsibilities, and to have or permit others to do
so for accomplishment of AHCPR purposes.
(d) Except for identifying information protected by section 903(c)
of the PHS Act, the Administrator, as appropriate, will make
information provided in
[[Page 12914]]
accordance with paragraphs (a) and (b) of this section available, and
arrange for dissemination of such information and materials on as broad
a basis as practicable and in such form as to make them as useful as
possible to a variety of audiences, including health care providers,
practitioners, consumers, educators, and policymakers.
[FR Doc. 97-6758 Filed 3-17-97; 8:45 am]
BILLING CODE 4160-90-M
