[Federal Register Volume 64, Number 125 (Wednesday, June 30, 1999)]
[Proposed Rules]
[Pages 35119-35122]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16340]


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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