[Federal Register Volume 88, Number 16 (Wednesday, January 25, 2023)]
[Rules and Regulations]
[Pages 4735-4739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01240]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 68

[Docket Number--NIH-2020-0001]
RIN 0925-AA68


National Institutes of Health Loan Repayment Programs

AGENCY: National Institutes of Health, HHS.

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services (HHS or 
Department), through the National Institutes of Health (NIH), is 
updating 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: This final rule is effective February 24, 2023.

FOR FURTHER INFORMATION CONTACT: Daniel Hernandez, NIH Regulations 
Officer, Office of Management Assessment, NIH, Rockledge 1, 6705 
Rockledge Drive, Suite 601, Room 601-T, Bethesda, MD 20817, MSC 7901, 
by email at [email protected], or by telephone at 301-435-3343 
(not a toll-free number). 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: 

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

[[Page 4736]]

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).
    HHS announced its intentions to initiate this rulemaking action in 
the notice of proposed rulemaking (NPRM) titled ``National Institutes 
of Health Loan Repayment Programs'' that it published in the Federal 
Register on March 8, 2022 (87 FR 12919-12923). The NPRM provided a 
sixty-day public comment period. The comment period ended May 9, 2022.
    In the NPRM, we proposed updating 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 proposed amending 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. C288-3, 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 proposed amending 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 proposed amending 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 proposed amending 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 proposed amending 
Sec.  68.2 by revising the definitions for ``Debt threshold,'' 
``Director,'' ``Educational expenses,'' ``Extramural LRP,'' 
``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 proposed amending Sec.  68.5 by revising paragraph (d) to state 
that for the Extramural LRP 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 proposed amending Sec.  68.6 by removing the word ``Secretary'' 
and adding in its place the words ``NIH Director.''
    We further proposed amending 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 proposed amending 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.
    Additionally, we proposed amending Sec.  68.12 by removing the word 
``Secretary'' and adding the words ``NIH Director'' in its place.

II. Summary of Public Comments

    We received a total of four public comments in response to the 
NPRM. Two of the comments were duplicates. We read the duplicates and 
considered them, but because they were not directly relevant to this 
rulemaking, they are not discussed.
    A third commenter indicated that she agreed with the rule. 
Additionally, the commenter noted she appreciated the amendment of the 
language to address the Research in Emerging Areas Critical to Human 
Health and Nonprofit research funding/support as a focus of the 
important workforce needed to carry out this work. The commenter 
suggested that the challenge for organizations like NIH and nonprofits 
is attracting top talent to compete with the private biomedical 
research field. Finally, the commenter stated the education required 
and the work that is needed to improve the health of disadvantaged 
communities emphasize the importance of federal loan forgiveness 
programs for graduates who want to give their time and experience to 
public service. The commenter did not suggest any changes to what was 
proposed in the NPRM.
    A fourth commenter stated that she agreed with the proposed change 
of having the NIH LRPs consolidated into two programs. The commenter 
also agreed that the NIH Director should be able to administer the NIH 
LRPs. However, the commenter disagreed with changing the loan repayment 
amount from a maximum of $35,000 per year to a maximum of $50, 000 per 
year. The commenter stated that the maximum loan amount should be 
increased on a smaller scale to reduce government spending. NIH has no 
discretion with respect to the loan repayment amount being increased to 
a maximum of $50,000 per year, because that amount has been established 
in statute with the enactment of the 21st Century Cures Act, Public Law 
(Pub. L.) 114-255. Therefore, we did not consider or adopt the 
suggested change.
    Consequently, we did not make any changes to what we proposed in 
the previous NPRM in response to the four public comments received. 
Thus, the changes being made by this final rule are the same as the 
changes proposed in the previous NPRM except for the additional changes 
made to correct the terms ``Extramural LRPs'' and

[[Page 4737]]

``Intramural LRPs'' in Sec.  68.2, Definitions, to read ``Extramural 
LRP'' and ``Intramural LRP'', respectively. Each Program is a singular 
program with subcategories. Therefore, each term should be singular not 
plural. We made the changes necessary to correct this in the final 
rule.
    We provide the following as public information.

Regulatory Impact Analysis

    We examined the impacts of the final 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, the rule does 
not 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 for 2022 is approximately $165 
million based on the Gross Domestic Product deflator. 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 rule does not contain any new information collection 
requirements that 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 
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 amends 42 CFR part 68 as set forth below.

PART 68--NATIONAL INSTITUTES OF HEALTH (NIH) LOAN REPAYMENT 
PROGRAMS (LRPs)

0
1. The authority citation for part 68 is revised to read as follows:

    Authority:  42 U.S.C. 216, 42 U.S.C. 288-1, 42 U.S.C. 288-2.


0
2. Section 68.1 is revised 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. Section 68.2 is amended by:
0
a. Revising the definitions for ``Debt threshold'', ``Director'', and 
``Educational expense'';
0
b. Removing the definition of ``Extramural LRPs'' and adding the 
definition of ``Extramural LRP'' in its place;

[[Page 4738]]

0
c. Revising the definition of ``Individual from disadvantaged 
background'';
0
d. Removing the definition of ``Intramural LRPs'' and adding the 
definition ``Intramural LRP'' in its place;
0
e. Revising the definitions of ``Loan Repayment Programs (LRPs)'' and 
``Loan Repayment Program contract'';
0
f. Removing the definition of ``Nonprofit funding/support'' and adding 
the definition ``Nonprofit research funding/support'' in its place;
0
g. Revising the definitions of ``Participant'', ``Program eligibility 
date'', ``Qualified Educational Loans and Interest/Debt'', ``Reasonable 
educational and living expenses'', and ``Repayable debt'';
0
h. Adding a definition for ``Research in emerging areas critical to 
human health'' in alphabetical order;
0
i. Removing the definition of ``Secretary''; and
0
j. 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 LRP refers to the program for which health 
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 LRP refers to the program 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 means 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 the definition 
of educational expenses in this section) 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

[[Page 4739]]

respect to the individual would be unconscionable. (See the definition 
of breach of contract in this section.)
* * * * *

0
4. Section 68.5 is amended by revising paragraph (d) to read as 
follows:


Sec.  68.5   Who is ineligible to participate?

* * * * *
    (d) For Extramural LRP 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. Section 68.6 is revised 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. Section 68.7 is amended 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. Section 68.8 is amended 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.
* * * * *

0
8. Section 68.12 is revised 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 for the extension period and has remaining 
repayable debt as established by the NIH Director.

Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-01240 Filed 1-24-23; 8:45 am]
BILLING CODE 4140-01-P