National Institutes of Health Loan Repayment Programs, 4735-4739 [2023-01240]
Download as PDF
<![CDATA[
4735
Federal Register / Vol. 88, No. 16 / Wednesday, January 25, 2023 / Rules and Regulations
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act (CRA)
Pursuant to the CRA (5 U.S.C. 801 et
seq.), EPA will submit a report
containing this rule and other required
information to the U.S. Senate, the U.S.
House of Representatives, and the
Comptroller General of the United
States prior to publication of the rule in
the Federal Register. This action is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: January 13, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
2. In § 180.478, in paragraph (a)
amend table 1 by:
■ a. Adding in alphabetical order the
entry ‘‘Pomegranate’’;
■ b. Removing the entry for ‘‘Potato’’
and the footnote; and
■ c. Adding in alphabetical order the
entry ‘‘Tropical and subtropical, small
fruit, edible peel, subgroup 23A’’.
The additions read as follows:
■
§ 180.478
residues
Rimsulfuron; tolerances for
(a) * * *
TABLE 1 TO PARAGRAPH (a)
Parts per
million
Commodity
*
*
*
*
*
*
Pomegranate .......................................................................................................................................................................................
*
*
*
*
*
*
*
Tropical and subtropical, small fruit, edible peel, subgroup 23A ........................................................................................................
*
*
*
*
*
*
*
*
*
[FR Doc. 2023–01131 Filed 1–24–23; 8:45 am]
BILLING CODE 6560–50–P
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.
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
lotter on DSK11XQN23PROD with RULES1
SUMMARY:
VerDate Sep<11>2014
16:12 Jan 24, 2023
Jkt 259001
*
*
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 dhernandez@mail.nih.gov, 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 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:
I. Background and Statutory Authority
The purpose of the NIH LRP programs
is to recruit and retain highly qualified
health professionals as biomedical and
PO 00000
Frm 00015
Fmt 4700
Sfmt 4700
*
0.01
0.01
*
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
E:\FR\FM\25JAR1.SGM
25JAR1
lotter on DSK11XQN23PROD with RULES1
4736
Federal Register / Vol. 88, No. 16 / Wednesday, January 25, 2023 / Rules and Regulations
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 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).
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
VerDate Sep<11>2014
16:12 Jan 24, 2023
Jkt 259001
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 § 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 § 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 § 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 § 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 § 68.6 by
removing the word ‘‘Secretary’’ and
adding in its place the words ‘‘NIH
Director.’’
We further proposed amending § 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 § 68.8 by
revising paragraph (a) to state that NIH
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
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
§ 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
E:\FR\FM\25JAR1.SGM
25JAR1
Federal Register / Vol. 88, No. 16 / Wednesday, January 25, 2023 / Rules and Regulations
‘‘Intramural LRPs’’ in § 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.
lotter on DSK11XQN23PROD with RULES1
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
VerDate Sep<11>2014
16:12 Jan 24, 2023
Jkt 259001
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,
§ 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, §§ 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.
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
4737
PART 68—NATIONAL INSTITUTES OF
HEALTH (NIH) LOAN REPAYMENT
PROGRAMS (LRPs)
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.
2. Section 68.1 is revised 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;
(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. Section 68.2 is amended by:
■ a. Revising the definitions for ‘‘Debt
threshold’’, ‘‘Director’’, and
‘‘Educational expense’’;
■ b. Removing the definition of
‘‘Extramural LRPs’’ and adding the
definition of ‘‘Extramural LRP’’ in its
place;
E:\FR\FM\25JAR1.SGM
25JAR1
4738
Federal Register / Vol. 88, No. 16 / Wednesday, January 25, 2023 / Rules and Regulations
c. Revising the definition of
‘‘Individual from disadvantaged
background’’;
■ d. Removing the definition of
‘‘Intramural LRPs’’ and adding the
definition ‘‘Intramural LRP’’ in its place;
■ e. Revising the definitions of ‘‘Loan
Repayment Programs (LRPs)’’ and ‘‘Loan
Repayment Program contract’’;
■ f. Removing the definition of
‘‘Nonprofit funding/support’’ and
adding the definition ‘‘Nonprofit
research funding/support’’ in its place;
■ g. Revising the definitions of
‘‘Participant’’, ‘‘Program eligibility
date’’, ‘‘Qualified Educational Loans
and Interest/Debt’’, ‘‘Reasonable
educational and living expenses’’, and
‘‘Repayable debt’’;
■ h. Adding a definition for ‘‘Research
in emerging areas critical to human
health’’ in alphabetical order;
■ i. Removing the definition of
‘‘Secretary’’; and
■ j. Revising the definition of ‘‘Waiver’’.
The revisions and additions read as
follows:
■
§ 68.2
Definitions.
lotter on DSK11XQN23PROD with RULES1
*
*
*
*
*
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 programspecified 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.
*
*
*
*
*
VerDate Sep<11>2014
16:12 Jan 24, 2023
Jkt 259001
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).
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
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
E:\FR\FM\25JAR1.SGM
25JAR1
Federal Register / Vol. 88, No. 16 / Wednesday, January 25, 2023 / Rules and Regulations
respect to the individual would be
unconscionable. (See the definition of
breach of contract in this section.)
*
*
*
*
*
4. Section 68.5 is amended by revising
paragraph (d) to read as follows:
■
§ 68.5
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
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 forprofit institution or organization, or
Federal Government employees working
more than 20 hours per week;
*
*
*
*
*
5. Section 68.6 is revised 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. Section 68.7 is amended 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. Section 68.8 is amended 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.
*
*
*
*
*
8. Section 68.12 is revised to read as
follows:
■
lotter on DSK11XQN23PROD with RULES1
§ 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 §§ 68.3 and 68.4 for the
extension period and has remaining
VerDate Sep<11>2014
16:12 Jan 24, 2023
Jkt 259001
DEPARTMENT OF VETERANS
AFFAIRS
48 CFR Parts 802, 804, 811, 812, 824,
839, and 852
RIN 2900–AQ41
VA Acquisition Regulation: Acquisition
of Information Technology; and Other
Contracts for Goods and Services
Involving Information, VA Sensitive
Information, and Information Security;
and Liquidated Damages
Requirements for Data Breach
Department of Veterans Affairs.
Final rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) is issuing a final rule
amending the VA Acquisition
Regulation (VAAR). This rulemaking
revises the VAAR by adding a part
covering Acquisition of Information
Technology and revising coverage
concerning Other Contracts for Goods
and Services involving mandatory
information, privacy, and security
requirements to include policy
concerning VA sensitive personal
information, information security, and
liquidated damages requirements for
data breach in the following parts:
Administrative and Information Matters;
Describing Agency Needs; Protection of
Privacy and Freedom of Information; as
well as Acquisition of Commercial
Products and Commercial Services. It
also revises affected parts concerning
Definitions of Words and Terms, and
Solicitation Provisions and Contract
Clauses.
SUMMARY:
DATES:
Effective February 24, 2023.
Ms.
Glacia A. Holbert, Senior Procurement
Analyst, Procurement Policy and
Warrant Management Services, 003A2A,
810 Vermont Avenue NW, Washington,
DC 20420, (202) 697–3614. (This is not
a toll-free number.)
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Background
VA published a proposed rule in the
Federal Register at 86 FR 64132 on
November 17, 2021, to amend the VAAR
to implement and supplement the
Federal Acquisition Regulation (FAR).
PO 00000
Frm 00019
Fmt 4700
Sfmt 4700
4739
VA provided a 60-day comment period
for the public to respond to the
proposed rule and submit comments.
The public comment period closed on
January 18, 2022. VA received ten
comments from two respondents.
This rulemaking is issued under the
authority of the Office of Federal
Procurement Policy (OFPP) Act which
provides the authority for an agency
head to issue agency acquisition
regulations that implement or
supplement the FAR.
The VAAR has been revised to add
new policy or regulatory requirements,
to update existing policy, and to remove
any redundant guidance where it may
exist in affected parts, and to place
guidance that is applicable only to VA’s
internal operating processes or
procedures in the VA Acquisition
Manual (VAAM).
This rule adopts as a final rule the
proposed rule published in the Federal
Register on November 17, 2021, except
for revisions to respond to the public
comments as discussed below, and
other technical non-substantive changes
to update terminology in accordance
with FAR final rules and other minor
administrative amendments as shown
below.
Discussion and Analysis of Public
Comments
The first respondent references two
VA information technology and security
publications and observed that as the
field of technology grows, fraudulent
activity rises and notes that the
proposed rule provides a layer of
uniform security. The respondent goes
on to note that liquidated damages are
instrumental.
VA appreciates the comment on the
proposed rule. One of the VA
Acquisition Regulation rewrite project
objectives is to incorporate any new
agency-specific regulations or policies
to implement statutory and other
requirements, to ensure VA can
effectively execute its mission to serve
Veterans. VA believes the regulation
appropriately implements specific
liquidated damages statutory
requirements in the event of a data
breach. The comments do not require
the VA to make any revisions to the
proposed rule. Therefore, VA is taking
no action to revise the proposed rule
based on these comments.
Another respondent recommends
revising the proposed notification and
reporting of security and privacy
incidents from ‘‘within 1 hour of
discovery to the contracting officer’’ to
‘‘notification of within 24 hours of
identification’’ as being a more
reasonable timeline.
E:\FR\FM\25JAR1.SGM
25JAR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
