National Institutes of Health Loan Repayment Programs, 12919-12923 [2022-04640]
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VII. Statutory and Executive Order
Reviews
Under the CAA, the Administrator is
required to approve a SIP submission
that complies with the provisions of the
Act and applicable Federal regulations.
42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the
EPA’s role is to approve state choices,
provided that they meet the criteria of
the CAA. Accordingly, this action
merely proposes to approve state law as
meeting Federal requirements and does
not impose additional requirements
beyond those imposed by state law. For
that reason, this action:
• Is not a ‘‘significant regulatory
action’’ subject to review by the Office
of Management and Budget under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011);
• Does not impose an information
collection burden under the provisions
of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.);
• Is certified as not having a
significant economic impact on a
substantial number of small entities
under the Regulatory Flexibility Act (5
U.S.C. 601 et seq.);
• Does not contain any unfunded
mandate or significantly or uniquely
affect small governments, as described
in the Unfunded Mandates Reform Act
of 1995 (Pub. L. 104–4);
• Does not have Federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999);
• Is not an economically significant
regulatory action based on health or
safety risks subject to Executive Order
13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action
subject to Executive Order 13211 (66 FR
28355, May 22, 2001);
• Is not subject to requirements of
section 12(d) of the National
Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) because
application of those requirements would
be inconsistent with the CAA; and
• Does not provide EPA with the
discretionary authority to address, as
appropriate, disproportionate human
health or environmental effects, using
practicable and legally permissible
methods, under Executive Order 12898
(59 FR 7629, February 16, 1994).
In addition, the SIP is not approved
to apply on any Indian reservation land
or in any other area where EPA or an
Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of
Indian country, the proposed rule does
not have tribal implications and will not
impose substantial direct costs on tribal
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governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
List of Subjects
40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Greenhouse gases, Incorporation by
reference, Intergovernmental relations,
Lead, Nitrogen dioxide, Ozone,
Particulate matter, Reporting and
recordkeeping requirements, Sulfur
oxides, Volatile organic compounds.
40 CFR Part 81
Environmental protection, Air
pollution control, National parks, and
Wilderness areas.
Authority: 42 U.S.C. 7401 et seq.
Dated: February 28, 2022.
K.C. Becker,
Regional Administrator, Region 8.
[FR Doc. 2022–04758 Filed 3–7–22; 8:45 am]
BILLING CODE 6560–50–P
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.
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:
SUMMARY:
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12919
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 dhernandez@
od.nih.gov, 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
matthew.lockhart@nih.gov, 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:
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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
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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 nonprofit foundation, non-profit
professional association, or other nonprofit 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 § 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 § 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
§ 68.2 by revising the definitions for
‘‘Debt threshold,’’ ‘‘Director,’’
‘‘Educational expenses,’’ ‘‘Extramural
LRPs,’’ ‘‘Intramural LRP,’’ ‘‘Loan
repayment programs,’’ ‘‘Participant,’’
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‘‘Program eligibility date,’’ ‘‘Qualified
Educational Loans and Interest/Debt,’’
‘‘Reasonable educational and living
expenses,’’ ‘‘Repayable debt,’’ and
‘‘Waiver.’’
We propose to amend § 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 § 68.6 by
removing the word ‘‘Secretary’’ and
adding in its place the words ‘‘NIH
Director.’’
We propose to amend § 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 § 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 § 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
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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.
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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, § 68.6 is
a reporting requirement, but the
specifics of the burden are determined
in the approved application forms used
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by the NIH Loan Repayment Programs
and have been separately approved by
OMB under OMB No. 0925–0361
(expires October 31, 2022).
Additionally, §§ 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)
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.
■
2. Revise § 68.1 to read as follows:
§ 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;
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(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.
■ 3. Amend § 68.2 by:
■ 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’’;
■ b. Removing the term ‘‘Nonprofit
funding/support’’ and adding in its
place a definition for ‘‘Nonprofit
research funding/support’’;
■ c. Revising the definitions of
‘‘Participant’’, ‘‘Program eligibility
date’’, ‘‘Qualified Educational Loans
and Interest/Debt’’, ‘‘Reasonable
educational and living expenses’’, and
‘‘Repayable debt’’;
■ d. Adding a definition for ‘‘Research
in Emerging Areas Critical to Human
Health’’;
■ e. Removing the definition of
‘‘Secretary’’; and
■ f. Revising the definition of ‘‘Waiver’’.
The revisions and additions read as
follows:
§ 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
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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
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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
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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.)
*
*
*
*
*
■ 4. Amend § 68.5 by revising paragraph
(d) to read as follows:
§ 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 forprofit institution or organization, or
Federal Government employees working
more than 20 hours per week;
*
*
*
*
*
■ 5. Revise § 68.6 to read as follows:
§ 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.
■ 6. Amend § 68.7 by revising paragraph
(d)(2)(iii) to read as follows:
§ 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.
■ 7. Amend § 68.8 by revising paragraph
(a) to read as follows:
§ 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.
*
*
*
*
*
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Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Proposed Rules
■
8. Revise § 68.12 to read as follows:
remaining repayable debt as established
by the NIH Director.
§ 68.12 How does an individual receive
loan repayments beyond the initial
applicable contract period?
Xavier Becerra,
Secretary, Health and Human Services.
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 §§ 68.3 and 68.4 of this
part for the extension period and has
12923
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Defense Acquisition Regulations
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Regulation Supplement: United StatesMexico-Canada Agreement (DFARS
Case 2020–D032)
Correction
In Proposed Rule document 2022–
04009, appearing on pages 11002–
11009, in the issue of Monday, February
28, 2022, make the following correction:
On page 11002, in the third column,
after the DATES heading, in the third and
fourth lines, ‘‘May 27, 2022’’ is
corrected to read ‘‘April 29, 2022’’.
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]]>Agencies
[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.
-----------------------------------------------------------------------
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
