[Federal Register Volume 66, Number 105 (Thursday, May 31, 2001)]
[Rules and Regulations]
[Pages 29498-29501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13692]


=======================================================================
-----------------------------------------------------------------------

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: Final rule.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) is amending 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: This final rule is effective on July 2, 2001.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, 
National Institutes of Health, 6011 Executive Blvd., Room 601, MSC 
7669, Rockville, MD 20892, 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, 
Public Law 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) program 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 is 
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 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. We are revising 
paragraph (b) of Sec. 66.103 of the current NRSA regulations and adding 
a new paragraph (c) to permit individuals, in cases of disability or 
pressing family need, part-time research or training. Additionally, we 
are amending paragraph (a) of Sec. 66.103 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. We are amending Sec. 66.105 by revising paragraphs (a), 
(b), and (c); revising Sec. 66.110 in its entirety; amending 
Sec. 66.111 of subpart A by revising paragraph (a)(1), the introductory 
language of paragraph (b), and paragraph (b)(4); and amending 
Sec. 66.205

[[Page 29499]]

of subpart B by revising paragraphs (a)(1) and (b) to reflect these 
changes in the payback obligation. Additionally, we are amending 
paragraph (a)(2) 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. We are amending paragraph (b) of 
Sec. 66.205 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, we are removing the reference to the 
regulations pertaining to inventions and patents at 45 CFR parts 6 and 
8 to reflect the rescinding of parts 6 and 8, effective on October 22, 
1996 (61 FR 54743); and we are amending the references to the 
regulations pertaining to debarment and suspension at 45 CFR part 76 
and the guidelines for research involving recombinant DNA molecules to 
comply with Federal Register format requirements. Additionally, we are 
amending the title of Sec. 66.112 to reflect that policies, as well as 
regulations, are referenced in that section.
    In Sec. 66.207, we are amending 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 to comply with Federal Register format requirements. Also, we 
are adding a reference to the regulations to ensure objectivity in PHS-
funded research at 42 CFR part 50, subpart F, to reflect their 
applicability to NRSA research training grants and direct fellowship 
awards.
    Additionally, we are revising the Authority section and the 
references to section 472 of the Public Health Service Act and the 
United States Code [42 U.S.C. 2891-1] in Sec. 66.101, Sec. 66.102(d), 
Sec. 66.105(b), Sec. 66.106(a)(2), Sec. 66.201, and Sec. 66.206(a)(3) 
to reflect the correct citations.
    Finally, we are amending Sec. 66.104 by adding the word ``and'' 
immediately following the word ``resources'' in paragraph (b)(5) to 
correct an error in the current text.
    We announced our intentions to make these changes to the 
regulations in a notice of proposed rulemaking (NPRM) published in the 
Federal Register on June 30, 1999 (64 FR 35119). No comments were 
received. Consequently, the regulations are the same as those proposed 
in the NPRM.
    We provide the following statements 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 reminds that 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

    Executive Order 12866, Regulatory Planning and Review, requires 
that all regulatory actions reflect the costs and benefits they 
generate, and that they meet certain standards, such as avoiding the 
imposition of unnecessary burdens on the affected public. We reviewed 
the rule as required under Executive Order 12866 and deemed it within 
the scope of the definition of the term ``significant regulatory 
action'' contained in section 3(f) of the Order. Consequently, we 
submitted the rule 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 
``significant'' under the Order.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. chapter 6) requires that 
we analyze regulatory actions to determine whether they create a 
significant impact on a substantial number of small entities. The 
Secretary certifies that the changes in 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.

Executive Order 13132

    Executive Order 13132, Federalism, requires that we consult with 
State and local government officials in the development of regulatory 
policies with federalism implications. We received the rule as required 
under the Order and determined that it does not have any federalism 
implications. The Secretary certifies that the changes in the NRSA 
program regulations will not have an effect on the States or on the 
distribution of power and responsibilities among the various levels of 
government.

Paperwork Reduction Act

    The rule 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 rule 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: November 15, 2000.
Ruth L. Kirschstein,
Principal Deputy Director, NIH.
    Approved: March 13, 2001.
Tommy G. Thompson,
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 revised to read 
as set forth below.

PART 66--NATIONAL RESEARCH SERVICE AWARDS

Subpart A--Direct Awards

    1. The authority citation of part 66 is revised to read as follows:

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

    2. Section 66.101 is 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).

    3. Section 66.102 is 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

[[Page 29500]]

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

    4. Section 66.103 is 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 is amended by adding the word ``and'' immediately 
following the word ``resources'' in paragraph (b)(5). As revised, 
paragraph (b)(5) reads 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 is 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, 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 is 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 as 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 for 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] TR31MY01.005


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) of this section within a three-year period beginning on 
the date the United States becomes entitled to recovery that amount. 
Interest shall accrue to the United States until any amount due it 
under paragraph (d) of the section 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 is 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 is 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.

* * * * *
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 Science Policy, Office of Biotechnology 
Activities, NIH, Suite 302, 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 is revised to read as follows:


Sec. 66.201  Applicability.

    The regulations in this subpart apply to grants under section 487 
of the Public

[[Page 29501]]

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 is amended by revising paragraphs (a)(1) and 
(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 is 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 is amended by revising the references to 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 (non 
procurement) 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 Biotechnology Activities, NIH, Suite 
302, 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. 01-13692 Filed 5-30-01; 8:45 am]
BILLING CODE 4140-01-M