12906 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations

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.

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
Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations 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 § 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 § 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

§ 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 § 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 § 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

§ 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 § 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

§ 67.15(c)(1) and § 67.15(c)(2).)

Section 67.17 Grant Award

Proposed § 67.17(g) regarding

supplemental awards has been

reworded to improve clarity.

Proposed § 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
12908 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations

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 § 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 § 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 ProChildren 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

§ 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
Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations 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.

§ 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.

§ 67.12 Eligible applicants.

Any public or nonprofit private entity

or any individual is eligible to apply for

a grant under this subpart.

§ 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.

§ 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.

§ 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
12910 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations

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 AHCPRannounced 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
Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations 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 § 67.15(a), or § 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.

§ 67.16 Evaluation and disposition of

application.

(a) Evaluation. After appropriate peer

review in accordance with § 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 § 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 AHCPRannounced 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 § 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.

§ 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 § 67.15(a). A

supplemental award for preparation of

data in suitable form for transmittal in

accordance with § 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

§ 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
12912 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations

accomplishments during previous

budget periods; and

(4) The reasonableness of the

proposed budget for the subsequent

budget period.

§ 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.

§ 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 drugfree 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

§ 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.

§ 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 § 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.

§ 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

§ 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.

§ 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
Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations 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.

§ 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.

§ 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.

§ 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 § 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
12914 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Rules and Regulations

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