Proposed Rule2022-04640
National Institutes of Health Loan Repayment Programs
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 8, 2022
Issuing agencies
Health and Human Services Department
Abstract
The Department of Health and Human Services (HHS or Department), through the National Institutes of Health (NIH), proposes to update the existing regulation for NIH Loan Repayment Programs (LRPs) to reflect the consolidation of NIH LRPs into two programs, the Intramural Loan Repayment Program (for NIH researchers) and the Extramural Loan Repayment Program (for non-NIH researchers); the direct authority of the NIH Director to administer the NIH LRPs (formerly the duty of the Secretary, HHS); and the increase in the annual loan repayment amount from a maximum of $35,000 to a maximum of $50,000.
Full Text
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<title>Federal Register, Volume 87 Issue 45 (Tuesday, March 8, 2022)</title>
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[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Proposed Rules]
[Pages 12919-12923]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04640]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 68
[Docket No. NIH-2020-0001]
RIN 0925-AA68
National Institutes of Health Loan Repayment Programs
AGENCY: National Institutes of Health, HHS.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Department of Health and Human Services (HHS or
Department), through the National Institutes of Health (NIH), proposes
to update the existing regulation for NIH Loan Repayment Programs
(LRPs) to reflect the consolidation of NIH LRPs into two programs, the
Intramural Loan Repayment Program (for NIH researchers) and the
Extramural Loan Repayment Program (for non-NIH researchers); the direct
authority of the NIH Director to administer the NIH LRPs (formerly the
duty of the Secretary, HHS); and the increase in the annual loan
repayment amount from a maximum of $35,000 to a maximum of $50,000.
DATES: Comments must be received on or before May 9, 2022.
ADDRESSES: You may send comments, identified by Docket Number NIH-2020-
0001and/or RIN 0925-AA43, by any of the following methods:
Electronic Submissions
You may send comments electronically in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
Follow the instructions for sending comments.
Written Submissions
You may send written comments in the following ways:
Please allow enough time for mailed comments to be received before
the close of the comment period.
<bullet> Mail (for paper or CD-ROM submissions): Daniel Hernandez,
NIH Regulations Officer, National Institutes of Health, Office of
Management Assessment, Rockledge 1, 6705 Rockledge Drive, Suite 601,
Room 601-T, MSC 7901, Bethesda, Maryland 20892-7901.
<bullet> Hand delivery/courier (for paper or CD-ROM submissions):
Daniel Hernandez, Rockledge 1, 6705 Rockledge Drive, Suite 601, Room
601-T, MSC 7901, Bethesda, Maryland 20892-7901.
Instructions: All submissions received must include the agency name
and docket number or Regulatory Information Number (RIN) for this
rulemaking. All comments will be posted without change to <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>, including any personal information provided.
Docket: For access to the docket to read background documents or
comments received, go to the eRulemaking Portal at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a> and insert the docket number provided in brackets
in the heading on page one of this document into the: ``Search'' box
and follow the prompts.
FOR FURTHER INFORMATION CONTACT: Daniel Hernandez, NIH Regulations
Officer, Office of Management Assessment, NIH, Rockledge 1, 6705
Rockledge Drive, Suite 601, Room 601-T, MSC 7901, Bethesda, Maryland
20892-7901, by email <a href="/cdn-cgi/l/email-protection#197d717c6b7778777d7c6359767d37777071377e766f"><span class="__cf_email__" data-cfemail="d5b1bdb0a7bbb4bbb1b0af95bab1fbbbbcbdfbb2baa3">[email protected]</span></a>, or by telephone 301-435-
3343 (not a toll-free number) for information about the rulemaking
process. For program information contact: Matthew Lockhart, NIH
Division of Loan Repayment, by email <a href="/cdn-cgi/l/email-protection#167b7762627e7361387a79757d7e77646256787f7e38717960"><span class="__cf_email__" data-cfemail="f09d918484989587de9c9f939b98918284b09e9998de979f86">[email protected]</span></a>, or
telephone 866-849-4047. Information regarding the requirements,
application deadline dates, and an on-line application for the NIH Loan
Repayment Programs may be obtained from the NIH Loan Repayment Program
website <a href="https://www.lrp.nih.gov/">https://www.lrp.nih.gov/</a>.
SUPPLEMENTARY INFORMATION:
[[Page 12920]]
I. Background and Statutory Authority
The purpose of the NIH LRP programs is to recruit and retain highly
qualified health professionals as biomedical and behavioral
researchers. The programs offer educational loan repayment for
participants who agree, by written contract, to engage in qualifying
domestic non-profit supported research at a qualifying non-NIH
institution, or as an NIH employee for a minimum of two years (or three
years for the Intramural LRP's general research subcategory).
On December 13, 2016, Congress enacted the 21st Century Cures Act,
Public Law (Pub. L.) 114-255, Section 2022 of which amended the Public
Health Service (PHS) Act to authorize the consolidation of National
Institutes of Health Loan Repayment Programs (LRPs) into the Intramural
Loan Repayment Program and the Extramural Loan Repayment Program.
The legislation also provides the NIH Director with the authority
to establish or eliminate one or more subcategories of the LRPs to
reflect workforce or scientific needs related to biomedical research.
Thus, this statute allows for up to four subcategories for the
Intramural Loan Repayment Program (General, Acquired Immunodeficiency
Syndrome (AIDS), Clinical for Researchers from Disadvantaged
Backgrounds, and one additional subcategory) and up to six
subcategories for the Extramural Loan Repayment Program (Contraception
& Infertility, Pediatric, Clinical, Health Disparities, Clinical for
Researchers from Disadvantaged Backgrounds, and one additional
subcategory).
Furthermore, the 21st Century Cures Act provides the NIH Director
with direct authority to administer the NIH Loan Repayment Programs
(formerly the duty of the Secretary, HHS).
Finally, the legislation authorizes NIH to raise its annual loan
repayment amount to a maximum of $50,000, which reflects a change from
the previous maximum annual loan repayment amount of $35,000.
The PHS Act, as amended, now contains sections 487A (Intramural
loan repayment program; 42 U.S.C. 288-1) and 487B (Extramural loan
repayment program; 42 U.S.C. 288-2), with the removal of previous
sections 464z-5, 487C, 487E, and 487F by the 21st Century Cures Act.
Sections 487A and 487B of the PHS Act authorize the NIH Director to
enter into contracts with qualified health professionals under which
such professionals agree to conduct research in consideration of the
Federal Government agreeing to repay, for each year of such service,
not more than $50,000 of the principal and interest of the qualified
educational loans of such professionals. In return for these loan
repayments, applicants must agree to participate in qualifying research
for an initial period of not less than two years (or a minimum of three
years for the Intramural LRP's general research subcategory), as one of
the following: (1) An NIH employee (for Intramural LRP), or (2) A
health professional engaged in qualifying research supported by a
domestic non-profit foundation, non-profit professional association, or
other non-profit institution (e.g., university), or a U.S. or other
government agency (Federal, State or local).
II. Summary of Proposed Changes
With this notice of proposed rulemaking (NPRM), we propose to
update the existing regulation for NIH LRPs codified at 42 CFR part 68,
and titled National Institutes of Health Loan Repayment Programs, to
reflect the changes in NIH LRPs that resulted from enactment of the
21st Century Cures Act.
Specifically, we propose to amend the authority citation by adding
the United States Code (U.S.C.) citation 42 U.S.C. 216 and removing
U.S.C. citations 42 U.S.C. 254o, 42 U.S. C. 288-3, 42 U.S.C. 288-5, 42
U.S.C. 288-5a, 42 U.S.C. 288-6, and 42 U.S.C.285t-2.
We propose to amend Sec. 68.1 by removing the references to
sections 487C, 487E, 487F and 464z-5 of the Public Health Service Act
(PHS Act), and references to U.S.C. citations 42 U.S.C. 288-3, 42
U.S.C. 288-5, 42 U.S.C. 288-5a, 42 U.S.C. 288-6, and 42 U.S.C. 285t-2;
and by revising the last sentence of the introductory narrative to
indicate that the NIH Loan Repayment Programs include two separate
programs, the Intramural Loan Repayment Program (for NIH researchers)
and the Extramural Loan Repayment Program (for non-NIH researchers).
Additionally, we propose to amend paragraphs (a) and (b) by revising
them and their respective subparagraphs in their entirety to reflect
that there are currently two NIH LRPs, the Intramural LRP with up to
four subcategories and the Extramural LRP with up to six subcategories.
We propose to amend Sec. 68.2 by removing the term ``Secretary,''
adding the term ``Research in Emerging Areas Critical to Human
Health,'' and revising the term ``Nonprofit funding/support to read
``Nonprofit research funding/support.'' We further propose to amend
Sec. 68.2 by revising the definitions for ``Debt threshold,''
``Director,'' ``Educational expenses,'' ``Extramural LRPs,''
``Intramural LRP,'' ``Loan repayment programs,'' ``Participant,''
``Program eligibility date,'' ``Qualified Educational Loans and
Interest/Debt,'' ``Reasonable educational and living expenses,''
``Repayable debt,'' and ``Waiver.''
We propose to amend Sec. 68.5 by revising paragraph (d) to state
that for Extramural LRPs only, individuals who receive any salary
support or participate in research that receives funding support from a
for-profit institution or organization, or Federal Government employees
working more than 20 hours per week are ineligible to participate.
We propose to amend Sec. 68.6 by removing the word ``Secretary''
and adding in its place the words ``NIH Director.''
We propose to amend Sec. 68.7 by revising paragraph (d)(2)(iii) to
state that for the minority health disparities subcategory, at least 50
percent of the contracts are required by statute to be for
appropriately qualified health professionals who are members of a
health disparity population.
We propose to amend Sec. 68.8 by revising paragraph (a) to state
that NIH may pay up to $50,000 per year of a participant's repayable
debt rather than the previous $35,000 per year.
We propose to amend Sec. 68.12 by removing the word ``Secretary''
and adding the words ``NIH Director'' in its place.
The purpose of this NPRM is to invite public comment concerning
these proposed actions. We provide the following as public information.
Regulatory Impact Analysis
We have examined the impacts of this proposed rule under Executive
Order (E.O.) 12866, Regulatory Planning and Review; E.O. 13563,
Improving Regulation and Regulatory Review; E.O. 13132, Federalism; the
Regulatory Flexibility Act (5 U.S.C. 601-612); and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
Executive Orders 12866 and 13563
E.O. 12866 and E.O. 13563 direct Federal agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity) for all
significant regulatory actions. A regulatory impact analysis (RIA) must
be prepared for major rules with economically significant effects ($100
million or more in any one year). Based on our analysis, we believe
that the proposed rulemaking does not
[[Page 12921]]
constitute an economically significant regulatory action.
Executive Order 13132
E.O. 13132, Federalism, requires Federal agencies to consult with
State and local government officials in the development of regulatory
policies with federalism implications. We reviewed the rule as required
under the Order and determined that it does not have any federalism
implications. This rule will not have effect on the States or on the
distribution of power and responsibilities among the various levels of
government.
Regulatory Flexibility Act
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of the
rule on small entities. For the purpose of this analysis, small
entities include small business concerns as defined by the Small
Business Administration (SBA), usually businesses with fewer than 500
employees. Applicants who are eligible to apply for the loan repayment
awards are individuals, not small entities. This rule will not create a
significant impact on a significant number of small entities.
Unfunded Mandates Reform Act of 1995
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
Federal agencies to prepare a written statement which includes an
assessment of anticipated costs and benefits, before proposing ``any
rule that includes any Federal mandate that may result in the
expenditure by State, local, and tribal organizations, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted
annually for inflation with base year of 1995) in any one year.'' The
current inflation-adjusted statutory threshold is approximately $156
million based on the Bureau of Labor Statistics inflation calculator.
This rule will not result in a one-year expenditure that would meet or
exceed that amount. Participation in the NIH loan repayment programs is
voluntary and not mandated.
Paperwork Reduction Act
This proposed rule does not contain any new information collection
requirements which are subject to Office of Management and Budget (OMB)
approval under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter
35). More specifically, Sec. 68.6 is a reporting requirement, but the
specifics of the burden are determined in the approved application
forms used by the NIH Loan Repayment Programs and have been separately
approved by OMB under OMB No. 0925-0361 (expires October 31, 2022).
Additionally, Sec. Sec. 68.3(c) and (e), 68.11(c), 68.14(c) and (d),
and 68.16(a) are reporting requirements and/or recordkeeping
requirements, but they also are covered under OMB No. 0925-0361.
Federal Assistance Listings
The Federal Assistance Listings numbered programs affected by this
proposed rule are:
93.220--NIH Intramural Loan Repayment Program
93.280--NIH Extramural Loan Repayment Program
List of Subjects in 42 CFR Part 68
Health professions; Loan programs--health; Medical research.
For reasons presented in the preamble, the Department of Health and
Human Services proposes to amend title 42 of the Code of Federal
Regulations by revising Part 68, as set forth below.
PART 68--NATIONAL INSTITUTES OF HEALTH (NIH) LOAN REPAYMENT
PROGRAMS (LRPs)
0
1. Revise the authority citation for part 68 to read as follows:
Authority: 42 U.S.C. 216, 42 U.S.C. 288-1, 42 U.S.C. 288-2.
0
2. Revise Sec. 68.1 to read as follows:
Sec. 68.1 What are the scope and purpose of the NIH LRPs?
The regulations of this part apply to the award of educational loan
payments authorized by sections 487A and 487B of the Public Health
Service Act, as amended (42 U.S.C. 288-1, 42 U.S.C. 288-2). The purpose
of these programs is to address the need for biomedical and behavioral
researchers by providing an economic incentive to appropriately
qualified health professionals who are engaged in qualifying research
supported by domestic nonprofit funding or as employees of NIH. The NIH
Loan Repayment Programs include two separate programs, the Intramural
Loan Repayment Program (for NIH researchers) and the Extramural Loan
Repayment Program (for non-NIH researchers).
(a) The Intramural LRP includes subcategories that focus on:
(1) General research, including a program for Accreditation Council
for Graduate Medical Education (ACGME) Fellows;
(2) Research on acquired immune deficiency syndrome;
(3) Clinical research conducted by appropriately qualified health
professionals who are from disadvantaged backgrounds; and
(4) An area of emerging scientific or workforce need.
(b) The Extramural LRP includes subcategories that focus on:
(1) Contraception or infertility research;
(2) Pediatric research, including pediatric pharmacological
research;
(3) Minority health disparities research;
(4) Clinical research;
(5) Clinical research conducted by health professionals from
disadvantaged backgrounds; and
(6) Research in emerging areas critical to human health.
0
3. Amend Sec. 68.2 by:
0
a. Revising the definitions for ``Debt threshold'', ``Director'',
``Educational expense'', ``Extramural LRPs'', ``Individual from
disadvantaged background'', ``Intramural LRPs'', ``Loan repayment
programs (LRPs)'', and ``Loan Repayment Program contract'';
0
b. Removing the term ``Nonprofit funding/support'' and adding in its
place a definition for ``Nonprofit research funding/support'';
0
c. Revising the definitions of ``Participant'', ``Program eligibility
date'', ``Qualified Educational Loans and Interest/Debt'', ``Reasonable
educational and living expenses'', and ``Repayable debt'';
0
d. Adding a definition for ``Research in Emerging Areas Critical to
Human Health'';
0
e. Removing the definition of ``Secretary''; and
0
f. Revising the definition of ``Waiver''.
The revisions and additions read as follows:
Sec. 68.2 Definitions.
* * * * *
Debt threshold means the minimum amount of qualified educational
debt an individual must have, on their program eligibility date, in
order to be eligible for LRP benefits, as established by the NIH
Director.
Director means the Director of the National Institutes of Health
(NIH) or designee.
Educational expenses pertain to costs associated with the pursuit
of the health professional's undergraduate, graduate, and health
professional school's education, including the tuition expenses and
other educational expenses such as living expenses, fees, books,
supplies, educational equipment and materials, and laboratory expenses.
Extramural LRPs refers to those programs for which health
[[Page 12922]]
professionals, who are not NIH employees and have program-specified
degrees and domestic nonprofit support, are eligible to apply. The
Extramural LRP includes subcategories that focus on:
(1) Contraception or infertility research;
(2) Pediatric research, including pediatric pharmacological
research;
(3) Minority health disparities research;
(4) Clinical research;
(5) Clinical research conducted by appropriately qualified health
professionals who are from disadvantaged backgrounds; and
(6) Research in emerging areas critical to human health.
* * * * *
Individual from disadvantaged background means:
(1) Comes from an environment that inhibited the individual from
obtaining the knowledge, skill and ability required to enroll in and
graduate from a health professions school; or
(2) Comes from a family with an annual income below a level based
on low-income thresholds according to family size published by the U.S.
Bureau of the Census, adjusted annually for changes in the Consumer
Price Index, and adjusted by the Secretary of Health and Human Services
(HHS) for use in HHS programs. The Secretary periodically publishes
these income levels in the Federal Register.
* * * * *
Intramural LRPs refers to those programs for which applicants must
be employed by the NIH. The Intramural LRP includes subcategories that
focus on:
(1) General research, including a program for Accreditation Council
for Graduate Medical Education (ACGME) Fellows;
(2) AIDS research;
(3) Clinical research conducted by appropriately qualified health
professionals from disadvantaged backgrounds; and
(4) An area of emerging scientific or workforce need.
* * * * *
Loan Repayment Programs (LRPs) refers to the NIH Loan Repayment
Programs, including those authorized by sections 487A and 487B of the
Act, as amended.
Loan Repayment Program contract refers to the agreement signed by
an applicant and the NIH Director (or an appointed designee). Under
such an agreement, an Intramural LRP applicant agrees to conduct
qualified research as an NIH employee, and an Extramural LRP applicant
agrees to conduct qualified research supported by domestic nonprofit
funding, in exchange for repayment of the applicant's qualified
educational loan(s) for a prescribed period.
* * * * *
Nonprofit research funding/support: applicants must conduct
qualifying research supported by a domestic nonprofit foundation,
nonprofit professional association, or other nonprofit institution
(e.g., university), or a U.S. or other government agency (Federal,
state or local). A domestic foundation, professional association, or
institution is considered to be nonprofit if exempt from Federal tax
under the provisions of Section 501 of the Internal Revenue Code (26
U.S.C. 501).
Participant means an individual whose application to any of the NIH
LRPs has been approved and whose Program contract has been executed by
the NIH Director or designee.
* * * * *
Program eligibility date means the date on which an individual's
LRP contract is executed by the NIH Director or designee.
Qualified Educational Loans and Interest/Debt (see Educational
Expenses) as established by the NIH Director, include Government and
commercial educational loans and interest for:
(1) Undergraduate, graduate, and health professional school tuition
expenses;
(2) Other reasonable educational expenses required by the school(s)
attended, including fees, books, supplies, educational equipment and
materials, and laboratory expenses; and
(3) Reasonable living expenses, including the cost of room and
board, transportation and commuting costs, and other reasonable living
expenses incurred.
Reasonable educational and living expenses means those educational
and living expenses that are equal to or less than the sum of the
school's estimated standard student budget for educational and living
expenses for the degree program and for the year(s) during which the
participant was enrolled in school. If there is no standard budget
available from the school, or if the participant requests repayment for
educational and living expenses that exceed the standard student
budget, reasonableness of educational and living expenses incurred must
be substantiated by additional contemporaneous documentation, as
determined by the Secretary of HHS.
Repayable debt means the proportion, as established by the NIH
Director, of an individual's total qualified educational debt that can
be repaid by an NIH LRP.
Research in Emerging Areas Critical to Human Health refers to
research designed to pursue major opportunities and gaps in biomedical
research and expand research in emerging areas of human health.
Emerging areas are considered new areas of biomedical and biobehavioral
research where a critical mass of capability and expertise is still
emerging across the biomedical and biobehavioral research community.
* * * * *
Waiver means a waiver of the service obligation granted by the NIH
Director when compliance by the participant is impossible or would
involve extreme hardship, or where enforcement with respect to the
individual would be unconscionable. (See Breach of contract.)
* * * * *
0
4. Amend Sec. 68.5 by revising paragraph (d) to read as follows:
Sec. 68.5 Who is ineligible to participate?
* * * * *
(d) For Extramural LRPs only: Individuals who receive any salary
support or participate in research that receives funding support from a
for-profit institution or organization, or Federal Government employees
working more than 20 hours per week;
* * * * *
0
5. Revise Sec. 68.6 to read as follows:
Sec. 68.6 How do individuals apply to participate in the NIH LRPs?
An application for participation in an NIH LRP shall be submitted
to the NIH, which is responsible for the Program's administration, in
such form and manner as the NIH Director prescribes.
0
6. Amend Sec. 68.7 by revising paragraph (d)(2)(iii) to read as
follows:
Sec. 68.7 How are applicants selected to participate in the NIH
LRPs?
* * * * *
(d) * * *
(2) * * *
(iii) For the Health Disparities Research subcategory, at least 50
percent of the contracts are required by statute to be for
appropriately qualified health professionals who are members of a
health disparity population.
0
7. Amend Sec. 68.8 by revising paragraph (a) to read as follows:
Sec. 68.8 What do the NIH LRPs provide to participants?
(a) Loan repayments: For each year of the applicable service period
the individual agrees to serve, the NIH may pay up to $50,000 per year
of a participant's repayable debt.
* * * * *
[[Page 12923]]
0
8. Revise Sec. 68.12 to read as follows:
Sec. 68.12 How does an individual receive loan repayments beyond the
initial applicable contract period?
An individual may apply for a competitive extension contract for at
least a one-year period if the individual is engaged in qualifying
research and satisfies the eligibility requirements specified under
Sec. Sec. 68.3 and 68.4 of this part for the extension period and has
remaining repayable debt as established by the NIH Director.
Xavier Becerra,
Secretary, Health and Human Services.
[FR Doc. 2022-04640 Filed 3-7-22; 8:45 am]
BILLING CODE 4140-01-P
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