National Research Service Awards

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 66

RIN 0925-AA16

National Research Service Awards

AGENCY: National Institutes of Health, Department of Health and Human

Services.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The National Institutes of Health (NIH) proposes to amend the

regulations governing National Research Service Awards (NRSA) in order

to incorporate changes necessitated by enactment of the Alcohol, Drug

Abuse, and Mental Health Administration (ADAMHA) Reorganization Act of

1992, Public Law 102-321, and the National Institutes of Health

Revitalization Act of 1993, Public Law 103-43.

DATES: Comments on the proposed changes must be received on or before

August 30, 1999 in order to ensure that NIH will be able to consider

the comments in preparing the final rule.

ADDRESSES: Comments should be sent to Jerry Moore, NIH Regulations

Officer, National Institutes of Health, 6011 Executive Blvd., Room 601,

MSC 7669, Rockville, MD 20892.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer,

at the address above, or telephone (301) 496-4607 (not a toll-free

number). For further information about the National Research Service

Awards program contact the Extramural Outreach and Information

Resources Office (EOIRO), Office of Extramural Research, 6701 Rockledge

Drive, Room 6208, MSC 7910, Bethesda, MD 20892-7910, (301) 435-0714

(not a toll-free number). Information may also be obtained by

contacting the EOIRO via its e-mail address

([email protected]) and by browsing the NIH Home Page site on

the World Wide Web (http://www.nih.gov).

SUPPLEMENTARY INFORMATION: The ADAMHA Reorganization Act of 1992, Pub.

L. 102-321, was enacted on July 10, 1992. That Act transferred the

National Institute on Alcohol Abuse and Alcoholism (NIAAA), the

National Institute on Drug Abuse (NIDA), and the National Institute of

Mental Health (NIMH) to NIH, effective October 1, 1992, and provided

for the administration of treatment and service programs under a newly

created Substance Abuse and Mental Health Services Administration

(SAMHSA). In order to avoid confusion between the ADAMHA Minority

Access to Research Careers (MARC) and the NIH MARC program, the name of

the ADAMHA program was changed to Career Opportunities in Research

Education and Training (COR). Currently, the MARC program is

administered by the National Institute of General Medical Sciences

(NIGMS) and the COR program is administered by the NIMH. NIH proposes

revising paragraph (g) of Sec. 66.102 of the existing regulation to

reflect this name change and the current organization locations of the

respective programs.

Subsequently, the National Institutes of Health Revitalization Act

of 1993, Public Law 103-43, was enacted on June 10, 1993. Provisions of

that Act necessitate that NIH make changes in both Subparts A and B of

the current regulations governing the NRSA program.

Section 1601 of Public Law 103-43 directs the Secretary of Health

and Human Services (HHS) to conduct the NRSA program in a manner that

will result in the recruitment of women and individuals from

disadvantaged backgrounds (including racial and ethnic minorities) into

fields of biomedical or behavioral research and the provision of

research training to

[[Page 35120]]

women and those individuals. The United States House of Representatives

report accompanying the NIH Revitalization Act of 1993 suggested that

NIH consider the possibility of permitting part-time research training

for women to keep them from losing training experience while having

child care responsibilities. NIH proposes to revise paragraph (b) of

Sec. 66.103 of the current NRSA regulations and add a new paragraph (c)

to permit individuals, in cases of disability or pressing family need,

part-time research or training. Additionally, paragraph (a) of

Sec. 66.103 would be amended by changing the word ``application'' to

read ``the award'' to reflect the current policy with regard to

eligibility requiring that a recipient must be lawfully admitted to the

United States for permanent residence at the time of the award rather

than at the time of application.

Section 1602 of the NIH Revitalization Act of 1993 substantially

modifies the service payback obligation under the NRSA program. Under

provisions of the new law, only individuals in the first twelve months

of postdoctoral training incur a payback obligation. Additionally,

individuals may pay back this obligation by engaging in service for an

equal period of health-related research or health-related teaching; or,

if individuals receive an NRSA for more than twelve months, each month

beyond 12 months will count toward satisfaction of the repayment

obligation. NIH proposes to amend Sec. 66.105 by revising paragraphs

(a), (b), and (c); revise Sec. 66.110 in its entirety; amend

Sec. 66.111 of subpart A by revising paragraph (a)(1), the introductory

language of paragraph (b), and paragraph (b)(4); and amend Sec. 66.205

of subpart B by revising paragraphs (a)(1) and (b) to reflect these

changes in the payback obligation. Additionally, paragraph (a)(2) would

be amended by changing the word ``application'' to read ``the award''

in order to reflect the current policy with regard to eligibility

requiring that a recipient must be lawfully admitted to the United

States for permanent residence at the time of the award rather than at

the time of application. Paragraph (b) of Sec. 66.205 would be amended

by changing the reference to ``Sec. 66.106(d)'' to read

``Sec. 66.106(e)'' to correct an error in the current text.

In Sec. 66.112, subpart A, the reference to the regulations

pertaining to inventions and patents at 45 CFR parts 6 and 8 would be

removed to reflect the rescinding of parts 6 and 8, effective on

October 22, 1996 (61 FR 54743); and the references to the regulations

pertaining to debarment and suspension at 45 CFR part 76 and the

guidelines for research involving recombinant DNA molecules would be

amended to comply with Federal Register format requirements. The title

of Sec. 66.112 would be amended to reflect that policies, as well as

regulations, are referenced in that section.

In Sec. 66.207, the reference to the regulations pertaining to the

administration of grants at 45 CFR part 74, the reference to the

regulations pertaining to debarment and suspension from eligibility for

financial assistance at 45 CFR part 76, and the reference to the

guidelines for research involving recombinant DNA molecules would be

amended to comply with Federal Register format requirements. Also, a

reference to the regulations to ensure objectivity in PHS-funded

research at 42 CFR part 50, subpart F, would be added to reflect their

applicability to NRSA research training grants and direct fellowship

awards.

Additionally, NIH proposes to revise the Authority section and

correct the references to section 472 of the Public Health Service Act

and the United States Code [42 U.S.C. 289l-1] in Sec. 66.101,

Sec. 66.102(d), Sec. 66.105(b), Sec. 66.106(a)(2), Sec. 66.201, and

66.206(a)(3) to reflect the correct citations.

Finally, Sec. 66.104 would be amended by adding the word ``and''

immediately following the word ``resources'' in paragraph (b)(5) to

correct an error in the current text.

The purpose of this notice is to invite public comment on the

proposed changes to the current NRSA program regulations. The following

statements are provided as information for the public.

The Department strongly encourages all grant recipients to provide

a smoke-free workplace and to promote the nonuse of all tobacco

products, and Public Law 103-227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities that receive Federal funds in

which education, library, day care, health care, and early childhood

development services are provided to children.

Executive Order 12866

This NPRM was reviewed as required under Executive Order 12866 and

was deemed to fall within the scope of the definition of the term

``significant regulatory action'' contained in section 3(f) of the

Order. Consequently, the NPRM was submitted to the Office of Management

and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA)

for the pre-publication review required for all regulatory actions

deemed as ``significant'' under the Order.

Regulatory Flexibility Act

The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that

regulatory actions be analyzed to determine whether they create a

significant impact on a substantial number of small entities. The

Secretary certifies that the proposed changes to the NRSA program

regulations would not have a significant economic impact on a

substantial number of small entities and, therefore, a regulatory

flexibility analysis, as defined under the Regulatory Flexibility Act,

is not required.

Paperwork Reduction Act

This NPRM does not contain any information collection requirements

that are subject to OMB approval under the Paperwork Reduction Act of

1995 (44 U.S.C. chapter 35).

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance (CFDA) numbered program

affected by this NPRM is: 93.186 National Research Service Awards-

Health Service Research Training.

List of Subjects in 42 CFR Part 66

Grant programs--Health research training

Dated: January 13, 1999.

Harold Varmus,

Director, NIH.

Approved: March 11, 1999.

Donna Shalala,

Secretary.

For the reasons set forth in the preamble, part 66, subparts A and

B, of title 42 of the Code of Federal Regulations are proposed to be

amended as set forth below.

PART 66--NATIONAL RESEARCH SERVICE AWARDS

Subpart A--Direct Awards

1. The authority citation of part 66 would be revised to read as

follows:

Authority: 42 U.S.C. 216, 288.

2. Section 66.101 would be revised to read as follows:

Sec. 66.101 Applicability.

The regulations in this subpart apply to National Research Service

Awards made by the Secretary to individuals for research and training

to undertake research, under section 487 of the Public Health Service

Act, as amended (42 U.S.C. 288).

[[Page 35121]]

3. Section 66.102 would be amended by revising paragraphs (d) and

(g) to read as follows:

Sec. 66.102 Definitions.

* * * * *

(d) Award means a National Research Service Award under section 487

of the Act (42 U.S.C. 288).

* * * * *

(g) Predoctoral Training means training at the post-baccalaureate

level in a program leading to the award of a doctor of philosophy of

science, or equivalent degree. For purposes of Awards under the

Minority Access to Research Careers programs of the National Institute

of General Medical Sciences and the Career Opportunities in Research

Education and Training programs of the National Institute of Mental

Health, predoctoral training also means training in a program leading

to the award of a baccalaureate in science or equivalent degree.

* * * * *

4. Section 66.103 would be amended by revising paragraphs (a) and

(b) and adding a new paragraph (c) to read as follows:

Sec. 66.103 Eligibility.

* * * * * *

(a) Be a citizen, noncitizen national of the United States, or

lawfully admitted to the United States for permanent residence at the

time of the award;

(b) Propose to engage in such research, or training to undertake

research, in a program specified in section 487(a)(1)(A) of the Act;

and

(c) Propose to engage in such research or training to undertake

research on a full-time basis except in cases of disability or pressing

family need.

5. Section 66.104 would be amended by adding the word ``and''

immediately following the word ``resources'' in paragraph (b)(5). As

revised, paragraph (b)(5) would read as follows:

Sec. 66.104. Application.

* * * * *

(b) * * *

(5) The availability of necessary resources and facilities at the

institution where the research or training would be conducted.

6. Section 66.105 would be amended by revising paragraphs (a), (b)

introductory text, and (c) to read as follows:

Sec. 66.105 Requirements.

* * * * *

(a) For any Award made for an individual's initial twelve months of

NRSA postdoctoral research or training, the individual has assured the

Secretary, in the form and manner the Secretary may prescribe, that he

or she will satisfy the requirements of Sec. 66.110.

(b) If the proposed research or training would take place at an

institution other than the National Institutes of Health, the

institution has assured the Secretary in the form and manner the

Secretary may prescribe. The assurance shall indicate that:

* * * * *

(c) The individual has assured the Secretary, in the form and

manner the Secretary may prescribe, that the Award to the individual

will not be used to support a residency.

7. Section 66.106 would be amended by revising paragraph (a)(2)

introductory text to read as follows:

Sec. 66.106 Awards.

(a) * * *

(2) Whose proposed research or training would, in the judgment of

the Secretary, best promote the purposes of section 487(a)(1)(A) of the

Act, taking into consideration among other pertinent factors:

* * * * *

8. Section 66.110 would be revised in its entirety to read as

follows:

Sec. 66.110 Service, payback, and recovery requirements.

(a) Each individual who receives an Award for postdoctoral research

or training shall engage in a month of research training, research, or

teaching that is health-related (or any combination thereof) for each

month of support received, up to a maximum of twelve months. Such

period shall be served in accordance with the usual patterns of such

employment or training.

(b) In any case in which an individual receives an Award for more

than twelve months, the thirteenth month and each subsequent month of

performing activities under the Award shall be considered to be

activities toward satisfaction of the requirement established in

paragraph (a) of this section.

(c) Except as provided in Sec. 66.111, an individual subject to the

requirements for service in paragraph (a) of this section must begin to

undertake the service on a continuous basis within two years after the

expiration or termination of his or her Award.

(d) If the individual fails to undertake or perform the service in

accordance with the requirements of this section, the United States

shall be entitled to recover from the individual an amount determined

in accordance with the formula:

[GRAPHIC] [TIFF OMITTED] TP30JN99.000

In which

A is the amount the United States is entitled to recover;

0 is the sum of the total amount paid to the individual for the months

of postdoctoral support up to a maximum of twelve months;

t is total number of months in the individual's service obligation;

and s is the number of months of the obligation served by him or her in

accordance with paragraph (a) or (b) of this section.

(e) Except as provided in Sec. 66.111, the individual shall pay to

the United States any amount which it is entitled to recover under

paragraph (d) within a three-year period beginning on the date the

United States becomes entitled to recover that amount. Interest shall

accrue to the United States until any amount due it under paragraph (d)

is paid. The rate of interest will be fixed by the Secretary of the

Treasury after taking into consideration private consumer rates of

interest prevailing on the date the United States becomes entitled to

recovery.

9. Section 66.111 would be amended by revising paragraphs (a)

introductory text, (b) introductory text, and (c)(4) to read as

follows:

Sec. 66.111 Suspension, waiver, and cancellation.

(a) The Secretary may extend the period for undertaking service

described in Sec. 66.110(c), permit breaks in the continuous service

required under Sec. 66.110(c), or extend the period of repayment under

Sec. 66.110(e) if the Secretary determines that:

* * * * *

(b) The Secretary may waive, in whole or in part, the obligation of

the individual to repay pursuant to Sec. 66.110(d) if the Secretary

determines that:

* * * * *

(c) * * *

(4) The extent to which the individual has been engaged in

activities encompassed by Sec. 66.110(a) and (b);

* * * * *

10. Section 66.112 would be amended by revising the heading;

removing the entry ``45 CFR parts 6 and 8'', revising the entry ``45

CFR part 76'', removing the entry ``48 FR 24556'', and adding the entry

``51 FR 16958 (May 7, 1986)'' to read as follows:

Sec. 66.112 Other HHS regulations and policies that apply.

* * * * *

[[Page 35122]]

45 CFR part 76--Governmentwide debarment and suspension

(nonprocurement) and governmentwide requirements for drug-free

workplace (grants)

51 FR 16958 (May 7, 1986)--NIH Guidelines for Research Involving

Recombinant DNA Molecules. [Note: this policy is subject to change,

and interested persons should contact the Office of Recombinant DNA

Activities, NIH, Suite 323, 6000 Executive Boulevard, MSC 7052,

Bethesda, MD 20892-7052, (301) 496-9838 ( not a toll-free number) to

obtain references to the current version and any amendments.]

Subpart B--Institutional Grants

11. Section 66.201 would be revised to read as follows:

Sec. 66.201 Applicability.

The regulations in this subpart apply to grants under section 487

of the Public Health Service Act, as amended (42 U.S.C. 288), to public

institutions and to nonprofit private institutions to enable those

institutions to make National Research Service Awards to individuals

for research and training to undertake research, in programs specified

in section 487 of the Act.

12. Section 66.205 would be amended by revising paragraphs (a)(1),

(a)(2), and (b) to read as follows:

Sec. 66.205 Requirements.

(a) * * *

(1) For any award made for an individual's initial twelve months of

NRSA postdoctoral research training, the individual has assured the

Secretary, in the form and manner the Secretary may prescribe, that he

or she will satisfy the requirements of Sec. 66.110 of subpart A of

this part;

(2) The individual is a citizen or noncitizen national of the

United States or has been lawfully admitted to the United States for

permanent residence at the time of the award;

* * * * *

(b) No Award shall be made to an individual under such grant which

would provide that individual with aggregate support in excess of five

years for predoctoral training and three years for postdoctoral

training, unless the Secretary for good cause shown as provided in

Sec. 66.106(e) of subpart A of this part, waives the application of the

limitation with respect to that individual;

* * * * *

13. Section 66.206 would be amended by revising paragraph (a)(3)

introductory text to read as follows:

Sec. 66.206 Grant awards.

(a) * * *

(3) Whose proposed programs would, in the judgment of the

Secretary, best promote the purposes of section 487(a)(1)(B) of the

Act, taking into consideration among other pertinent factors:

* * * * *

14. Section 66.207 would be amended by revising the entries for 45

CFR part 74, 45 CFR part 76, and 48 FR 24556; and adding an entry for

42 CFR part 50, subpart F, immediately following the entry ``42 CFR

part 50, subpart D'' and an entry for 51 FR 16958 (May 7, 1986) to read

as follows:

Sec. 66.207 Other HHS regulations and policies that apply.

* * * * *

42 CFR part 50, subpart F--Responsibility of applicants for

promoting objectivity in research for which PHS funding is sought.

* * * * *

45 CFR part 74--Uniform administrative requirements for awards and

subawards to institutions of higher education, hospitals, other

nonprofit organizations, and commercial organizations; and certain

grants and agreements with states, local governments and indian tribal

governments.

* * * * *

45 CFR part 76--Governmentwide debarment and suspension

(nonprocurement) and governmentwide requirements for drug-free

workplace (grants).

* * * * *

51 FR 16958 (May 7, 1986)--NIH Guidelines for Research Involving

Recombinant DNA Molecules. [Note: this policy is subject to change, and

interested persons should contact the Office of Recombinant DNA

Activities, NIH, Suite 323, 6000 Executive Boulevard, MSC 7052,

Bethesda, MD 20892-7052, (301) 496-9838 (not a toll-free number) to

obtain references to the current version and any amendments.]

[FR Doc. 99-16340 Filed 6-29-99; 8:45 am]

BILLING CODE 4140-01-P