[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
(asknih@odrockm1.od.nih.gov) 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
