[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 [www.gpo.gov]
[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:
     Federal eRulemaking Portal: https://www.regulations.gov/. 
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.
     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.
     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 https://www.regulations.gov/, including any personal information provided.
    Docket: For access to the docket to read background documents or 
comments received, go to the eRulemaking Portal at https://www.regulations.gov/ 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 [email protected], 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 [email protected], 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 https://www.lrp.nih.gov/.

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