Health Services Research, Evaluation, Demonstration, and Dissemination Projects; Peer Review of Grants and Contracts

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

[[Page 12908]]

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