National Institutes of Health Loan Repayment Programs, 20466-20473 [2013-07737]
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‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
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67249, November 9, 2000) do not apply
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Unfunded Mandates Reform Act of 1995
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List of Subjects in 40 CFR Part 180
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Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 28, 2013.
Lois Rossi,
Director, Registration Division, Office of
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Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.568, add alphabetically the
following commodities to the table in
paragraph (a) to read as follows:
■
§ 180.568 Flumioxazin; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
*
*
*
*
Artichoke, globe ........................
*
0.02
*
*
*
*
Cabbage ...................................
Cabbage, Chinese, napa ..........
*
0.02
0.02
*
*
*
*
Olive ..........................................
*
0.02
*
*
*
*
Pomegranate ............................
Prickly pear, fruit .......................
Prickly pear, pads .....................
*
0.02
0.07
0.06
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[FR Doc. 2013–07980 Filed 4–4–13; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 68
[Docket No. NIH–2008–0003]
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VII. Congressional Review Act
RIN 0905–AA43
Pursuant to the Congressional Review
Act (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).
National Institutes of Health Loan
Repayment Programs
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AGENCY:
National Institutes of Health,
HHS.
ACTION:
Final rule.
As a part of the Department
of Health and Human Services (HHS)’s
ongoing retrospective review initiative,
SUMMARY:
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the National Institutes of Health (NIH) is
rescinding the existing regulations for
two of its eight loan repayment
programs and issuing in their place a
new consolidated set of regulations
governing all of the NIH Loan
Repayment Programs (LRPs). There are
currently eight programs, including
three for researchers employed by the
NIH (Intramural LRPs) and five for nonNIH scientists (Extramural LRPs). The
Intramural LRPs include the Loan
Repayment Program for Research with
Respect to Acquired Immune Deficiency
Syndrome (or AIDS Research LRP);
Loan Repayment Program for General
Research (or General Research LRP),
which includes a program for the
Accreditation Council for Graduate
Medical Education (ACGME) Fellows;
and Loan Repayment Program for
Clinical Researchers from
Disadvantaged Backgrounds (or Clinical
Research LRP for Individuals from
Disadvantaged Backgrounds). The
Extramural LRPs include the Loan
Repayment Program for Contraception
and Infertility Research (or
Contraception and Infertility Research
LRP); Loan Repayment Program for
Clinical Researchers from
Disadvantaged Backgrounds (or Clinical
Research LRP for Individuals from
Disadvantaged Backgrounds); Loan
Repayment Program for Clinical
Research (or Clinical Research LRP);
Loan Repayment Program for Pediatric
Research (or Pediatric Research LRP);
and Loan Repayment Program for
Health Disparities Research (or Health
Disparities Research LRP).
DATES: This final rule is effective May 6,
2013.
FOR FURTHER INFORMATION CONTACT: Jerry
Moore, NIH Regulations Officer, Office
of Management Assessment, NIH, 6011
Executive Boulevard, Room 601, MSC
7669, Rockville, MD 20892; by email at
MooreJ@mail.nih.gov; by fax on 301–
402–0169 (not a toll-free number); or by
telephone 301–496–4607 (not a toll-free
number) for information about the
rulemaking process. For program
information, contact: NIH Division of
Loan Repayment by email lrp@nih.gov
or telephone 866–849–4047. For
information regarding the requirements,
the application deadline dates, and an
online application for the NIH Loan
Repayment Programs, refer to the NIH
Loan Repayment Program Web site,
www.lrp.nih.gov.
SUPPLEMENTARY INFORMATION: On
November 4, 1988, Congress enacted the
Health Omnibus Programs Extension of
1988, (Pub. L. 100–607). Title VI of this
law amended the Public Health Service
(PHS) Act by adding section 487A (42
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U.S.C. 288–1) entitled Loan Repayment
Program for Research with Respect to
Acquired Immune Deficiency
Syndrome. Subsequently, in the NIH
Revitalization Act of 1993 (Pub. L. 103–
43), Congress enacted the Loan
Repayment Program for Research with
Respect to Contraception and Infertility
(section 487B; 42 U.S.C. 288–2); the
Loan Repayment Program for Research
Generally (section 487C; 42 U.S.C. 288–
3); and the Loan Repayment Program for
Clinical Researchers from
Disadvantaged Backgrounds (section
487E; 42 U.S.C. 288–5). The Children’s
Health Act of 2000 (Pub. L. 106–310),
which was enacted on October 17, 2000,
added the Pediatric Research Loan
Repayment Program (section 487F; 1 42
U.S.C. 288–6). On November 13, 2000,
the Clinical Research Enhancement Act,
contained in the Public Health
Improvement Act of 2000 (Pub. L. 106–
505), enacted the Loan Repayment
Program for Clinical Research (section
487F; 2 42 U.S.C. 288–5a). On November
22, 2000, the Minority Health and
Health Disparities Research and
Education Act of 2000 (Pub. L. 106–525)
enacted the Loan Repayment Program
for Health Disparities Research (section
485G, re-designated 464z–5 by Pub. L.
111–148; 3 42 U.S.C. 285t–2).
Sections 487A, 487B, 487C, 487E, and
487F of the PHS Act authorize the
Secretary of Health and Human Services
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
$35,000 of the principal and interest of
the qualified educational loans of such
professionals. Section 464z–5 authorizes
the Director, National Institute on
Minority Health and Health Disparities
(NIMHD) to do the same.
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 General
Research LRP) as one of the following:
1 So in law. There are two sections 487F. Section
1002(b) of Public Law 106–310 (114 Stat. 1129),
inserted section 487F above. Subsequently, section
205 of Public Law 106–505 (114 Stat. 2329), which
relates to the Loan Repayment Program for Clinical
Researchers, inserted a section 487F after section
487E.
2 205 of Public Law 106–505 (114 Stat. 2329),
inserted section 487F after section 487E. Previously,
section 1002(b) of Public Law 106–310 (114 Stat.
1129), which relates to the Pediatric Research Loan
Repayment Program, inserted section 487F after
section 487E.
3 Section 485G of the PHS Act, enacted by Public
Law 106–525, was redesignated section 464z-5 by
Public Law 111–148.
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(a) An NIH employee (for Intramural
LRPs), or
(b) A health professional engaged in
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).
The purpose of the LRP programs is
to recruit and retain highly qualified
health professionals as biomedical and
behavioral researchers. LRP programs
offer educational loan repayment for
participants who agree, by written
contract, to engage in qualifying
domestic nonprofit-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
General Research LRP).
Currently, the Clinical Research LRP
for Individuals from Disadvantaged
Backgrounds and the Contraception and
Infertility Research LRP are governed by
their own individual regulations while
the other LRPs are without regulations.
We are consolidating the regulations
into a single set of regulations governing
all the LRPs. More specifically, we are
rescinding the current regulations
codified at 42 CFR Part 68a, entitled
‘‘National Institutes of Health Clinical
Research Loan Repayment Program for
Individuals from Disadvantaged
Backgrounds (CR–LRP),’’ and 42 CFR
Part 68c, entitled ‘‘National Institute of
Child Health and Human Development
Contraception and Infertility Research
Loan Repayment Program,’’ and issuing
a new consolidated set of regulations at
42 CFR Part 68, entitled ‘‘National
Institutes of Health Loan Repayment
Programs (LRPs),’’ to govern each of the
eight individual NIH Loan Repayment
Programs, the three that are for
researchers employed by the NIH
(Intramural LRPs) and the five that are
for non-NIH scientists (Extramural
LRPs). The three Intramural LRPs
include the AIDS Research LRP, General
Research LRP, and Clinical Research
LRP for Individuals from Disadvantaged
Backgrounds. The five Extramural LRPs
include the Contraception and Infertility
Research LRP, Clinical Research LRP for
Individuals from Disadvantaged
Backgrounds, Clinical Research LRP,
Pediatric Research LRP, and Health
Disparities Research LRP.
We announced our intentions to take
these rulemaking actions in the notice of
proposed rulemaking (NPRM) ‘‘National
Institutes of Health Loan Repayment
Programs,’’ that we published in the
Federal Register on February 22, 2012
(77 FR 10455–10461). In the NPRM we
provided a 60-day public comment
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20467
period. The public comment period
expired April 23, 2012. We received
only one public comment. Because the
comment did not address the
regulations per se, but simply
questioned the need for any loan
repayment, we did not view the
comment as relevant to this rulemaking
action. Consequently, the final NIH LRP
regulations that are set forth in this final
rule are essentially identical to the
proposed regulations that we set forth in
the NPRM. We provide the following as
public information.
Regulatory Impact Analysis
We have examined the impacts of this
rule as required by E.O. 12866,
‘‘Regulatory Planning and Review’’
(September 30, 1993), E.O. 13563,
‘‘Improving Regulation and Regulatory
Review’’ (January 18, 2011), the
Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96–354),
section 202 of the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104–4), and
E.O. 13132, ‘‘Federalism’’ (August 4,
1999).
Executive Order 12866
E.O. 12866, as supplemented by
Executive Order 13563, directs 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 and other advantages,
distributive impacts, and equity). 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 the
rulemaking does not constitute an
economically significant regulatory
action.
The 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. The
Secretary certifies that this rule will not
have a significant impact on a
significant number of small entities.
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Rules and Regulations
Section 202(a) of the Unfunded
Mandates Reform Act of 1995
Section 202(a) of the Unfunded
Mandates Reform Act of 1995 requires
that agencies prepare a written
statement that 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 threshold for
2012 is approximately $145.5 million.
The Secretary certifies that this rule
does not mandate any spending by
State, local or tribal government in the
aggregate or by the private sector.
Participation in the NIH loan repayment
programs is voluntary and not
mandated.
Executive Order 13132
E.O. 13132, Federalism, requires that
Federal agencies 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
‘‘federalism implications’’ because it
will not have substantial direct effect on
the states, the relationship between the
National Government and the states, or
on the distribution of power and
responsibilities among the various
levels of government. Accordingly,
under E.O. 13132, no further Agency
action or analysis is required.
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Paperwork Reduction Act
This proposed 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. 35).
More specifically, § 68.6 of this rule 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 approved under OMB
No. 0925–0361, Expiration Date: June
30, 2014. Additionally, §§ 68.3(c),
68.3(e), 68.11(c), 68.14(c), 68.14(d), and
68.16(a) of this rule are reporting
requirements and/or recordkeeping
requirements, but they are also covered
under OMB No. 0925–0361.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic
Assistance numbered programs affected
by the proposed regulations are:
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93.209—Contraception and Infertility
Research Loan Repayment Program
93.220—Clinical Research Loan Repayment
Program for Individuals from
Disadvantaged Backgrounds
93.232—Loan Repayment Program for
General Research
93.280—NIH Loan Repayment Program for
Clinical Researchers
93.285—NIH Pediatric Research Loan
Repayment Program
93.307—Minority Health and Health
Disparities Research
93.308—Extramural Loan Repayment for
Individuals from Disadvantaged
Backgrounds Conducting Clinical
Research
93.936—NIH Acquired Immunodeficiency
Syndrome Research Loan Repayment
Program
List of Subjects
42 CFR Parts 68, 68a, and 68c
Health professions, Loan repayment
programs—health, Medical research.
For reasons presented in the
preamble, and under the authority of 5
U.S.C 301 and 42 U.S.C. 216, HHS
amends Title 42 of the Code of Federal
Regulations by removing parts 68a and
68c and adding part 68 to read as
follows:
PART 68—NATIONAL INSTITUTES OF
HEALTH (NIH) LOAN REPAYMENT
PROGRAMS (LRPs)
Sec.
68.1
What is the scope and purpose of the
NIH LRPs?
68.2 Definitions.
68.3 Who is eligible to apply?
68.4 Who is eligible to participate?
68.5 Who is ineligible to participate?
68.6 How do individuals apply to
participate in the NIH LRPs?
68.7 How are applicants selected to
participate in the NIH LRPs?
68.8 What do the NIH LRPs provide to
participants?
68.9 What loans qualify for repayment?
68.10 What loans are ineligible for
repayment?
68.11 What does an individual have to do
in return for loan repayments received
under the NIH LRPs?
68.12 How does an individual receive loan
repayments beyond the initial applicable
contract period?
68.13 What will happen if an individual
does not comply with the terms and
conditions of participation in the NIH
LRPs?
68.14 Under what circumstances can the
service or payment obligation be
canceled, waived, or suspended?
68.15 When can an NIH LRP payment
obligation be discharged in bankruptcy?
68.16 Additional conditions.
68.17 What other regulations and statutes
apply?
Authority: 42 U.S.C. 254o, 42 U.S.C. 288–
1, 42 U.S.C. 288–2, 42 U.S.C. 288–3, 42
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U.S.C. 288–5, 42 U.S.C. 288–5a, 42 U.S.C.
288–6, 42 U.S.C. 285t–2.
§ 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, 487B,
487C, 487E, 487F,1 and 464z–5 of the
Public Health Service Act (42 U.S.C.
288–1, 42 U.S.C. 288–2, 42 U.S.C. 288–
3, 42 U.S.C. 288–5, 42 U.S.C. 288–5a, 42
U.S.C. 288–6, 42 U.S.C. 285t–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 the NIH. The NIH Loan
Repayment Programs include eight
separate programs, three that are
Intramural (for NIH researchers) and
five that are Extramural (for non-NIH
researchers).
(a) The Intramural LRPs include:
(1) Loan Repayment Program for
Research with Respect to Acquired
Immune Deficiency Syndrome (or AIDS
Research LRP);
(2) Loan Repayment Program for
General Research (or General Research
LRP), including a program for
Accreditation Council for Graduate
Medical Education (ACGME) Fellows;
and
(3) Loan Repayment Program for
Clinical Researchers from
Disadvantaged Backgrounds (or Clinical
Research LRP for Individuals from
Disadvantaged Backgrounds). This
program is also included as a separate
program under the Extramural LRPs.
(b) The Extramural LRPs include:
(1) Loan Repayment Program for
Contraception and Infertility Research
(or Contraception and Infertility
Research LRP);
(2) Loan Repayment Program for
Clinical Researchers from
Disadvantaged Backgrounds (or Clinical
Research LRP for Individuals from
Disadvantaged Backgrounds);
(3) Loan Repayment Program for
Clinical Researchers (or Clinical
Research LRP);
(4) Loan Repayment Program for
Pediatric Research (or Pediatric
Research LRP); and
(5) Loan Repayment Program for
Health Disparities Research (or Health
Disparities Research LRP).
1 There are two sections 487F. Section 1002(b) of
Public Law 106–310 added section 487F, 42 U.S.C.
288–6, the Pediatric Research Loan Repayment
Program. Subsequently, section 205 of Public Law
106–505 also added section 487F, 42 U.S.C. 288–
5a, enacting the Loan Repayment Program for
Clinical Researchers.
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§ 68.2
Definitions.
As used in this part:
Act means the Public Health Service
Act, as amended (42 U.S.C. 201 et seq.).
AIDS Research means research
activities related to the Acquired
Immunodeficiency Syndrome that
qualify for inclusion in the AIDS
Research LRP.
Applicant means an individual who
applies to and meets the eligibility
criteria for the NIH LRPs.
Breach of contract results when a
participant fails to complete the
research service or other obligation(s)
required under the contract and may be
subject to assessment of monetary
damages and penalties as defined by
statute.
Clinical research is patient-oriented
clinical research conducted with human
subjects, or research on the causes and
consequences of disease in human
populations involving material of
human origin (such as tissue specimens
and cognitive phenomena) for which an
investigator or colleague directly
interacts with human subjects in an
outpatient or inpatient setting to clarify
a problem in human physiology,
pathophysiology or disease, or
epidemiologic or behavioral studies,
outcomes research or health services
research, or developing new
technologies, therapeutic interventions,
or clinical trials.
Commercial loans means loans made
for educational purposes by banks,
credit unions, savings and loan
associations, not-for-profit
organizations, insurance companies,
schools, and other financial or credit
institutions that are subject to
examination and supervision in their
capacity as lending institutions by an
agency of the United States or of the
state in which the lender has its
principal place of business.
Contraception research is defined as
research with the ultimate goal of
providing new or improved methods of
preventing pregnancy.
Current payment status means that a
qualified educational loan is not past
due in its payment schedule, as
determined by the lending institution.
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
Secretary.
Director means the Director of the
National Institute on Minority Health
and Health Disparities (NIMHD) or
designee.
Educational expenses means the cost
of the health professional’s
undergraduate, graduate, and health
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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
professionals, who are not NIH
employees and have program-specified
degrees and domestic nonprofit support,
are eligible to apply. The Extramural
LRPs include:
(1) Contraception and Infertility
Research LRP;
(2) Clinical Research LRP for
Individuals from Disadvantaged
Backgrounds;
(3) Clinical Research LRP;
(4) Pediatric Research LRP; and
(5) Health Disparities Research LRP.
General research pertains to research
that falls within the basic science or
clinical research parameters and is not
targeted toward a specific area (e.g.,
AIDS) or type of research (e.g., clinical
research). The focus is on biomedical
and behavioral research studies and
investigations across a variety of
scientific disciplines within the mission
of the NIH.
Government loans means educational
loans made by U.S. Federal, state,
county, or city agencies that are
authorized by law to make such loans.
Health disparities population: a
population is a health disparity
population if, as determined by the
Director after consultation with the
Director of the Agency for Healthcare
Research and Quality, there is a
significant disparity in the overall rate
of disease incidence, prevalence,
morbidity, mortality, or survival rates in
the population as compared to the
health status of the general population.
Individual from disadvantaged
background. (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 for
use in HHS programs. The Secretary
periodically publishes these income
levels in the Federal Register.
Infertility research is defined as
research with the long-range objective of
evaluating, treating, or ameliorating
conditions that result in the failure of
couples to either conceive or bear
young.
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Institute or Center (IC) means an
Institute or Center of the National
Institutes of Health (NIH).
Intramural LRPs refers to those
programs for which applicants must be
employed by the NIH. The intramural
LRPs include:
(1) AIDS Research LRP;
(2) General Research LRP; and
(3) Clinical Research LRP for
Individuals from Disadvantaged
Backgrounds.
Institutional base salary or salary is
the annual income or compensation that
the organization pays for the applicant’s
appointment, whether the time is spent
on research, teaching, patient care, or
other activities.
Living expenses means the reasonable
cost of room and board, transportation
and commuting costs, and other
reasonable costs incurred during an
individual’s attendance at an
educational institution and is part of the
educational loan.
Loan Repayment Programs (LRPs)
refers to the NIH Loan Repayment
Programs, including those authorized by
sections 487A, 487B, 487C, 487E, 487F,
and 464z-5 of the Act, as amended.
Loan Repayment Program contract
refers to the agreement signed by an
applicant and the Secretary or Director
(for the following extramural LRPs:
Health Disparities Research LRP and
Clinical Research LRP for Individuals
from Disadvantaged Backgrounds only).
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.
NIH refers to the National Institutes of
Health.
Nonprofit 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 Secretary or the Director.
Pediatric research is defined as
research directly related to diseases,
disorders, and other conditions in
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children, including pediatric
pharmacology.
Program refers to the NIH Loan
Repayment Program, or LRP.
Program eligibility date means the
date on which an individual’s LRP
contract is executed by the Secretary or
the Director.
Qualified Educational Loans and
Interest/Debt (see Educational
Expenses) as established by the
Secretary, 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.
Repayable debt means the proportion,
as established by the Secretary, of an
individual’s total qualified educational
debt that can be paid by an NIH LRP.
Salary has the same meaning as
institutional base salary.
School means undergraduate,
graduate, and health professions schools
that are accredited by a body or bodies
recognized for accreditation purposes by
the U.S. Secretary of Education.
Secretary means the Secretary of
Health and Human Services or designee.
Service means the Public Health
Service.
State means one of the fifty states, the
District of Columbia, the
Commonwealth of Puerto Rico, the
Northern Mariana Islands, the U.S.
Virgin Islands, Guam, American Samoa,
and the Federated States of Micronesia,
the Republic of the Marshall Islands,
and the Republic of Palau.
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Waiver means a waiver of the service
obligation granted by the Secretary
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.)
Withdrawal means a request by a
participant, prior to the Program making
payments on his or her behalf, for
withdrawal from Program participation.
A withdrawal is without penalty to the
participant and without obligation to
the Program.
§ 68.3
Who is eligible to apply?
To be eligible for consideration for the
NIH LRPs, applicants must meet the
following criteria:
(a) Be citizens, nationals, or
permanent residents of the United
States;
(b) Have the necessary degree from an
accredited institution as determined by
the NIH to be consistent with the needs
of the LRP;
(c)(1) For Intramural LRPs only:
Applicants must be employed by the
NIH and engage in qualified full-time
research as specified by the LRP and be
recommended by the employing IC or
have a firm commitment of employment
from an authorized official of the NIH;
(2) For Extramural LRPs only:
Applicants must be conducting
qualified research for an average of at
least 20 hours per week that is
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);
(d) Have total qualifying educational
loan debt as determined on the program
eligibility date;
(e) The NIH or the employing
institution must provide an assurance
that the applicant will be employed/
appointed and provided research
support for the applicable term of the
LRP contract; and
(f) Recipients of LRP awards must
conduct their research in accordance
with applicable Federal, state, and local
law (e.g., applicable human subject
protection regulations).
(g) For Clinical Research for
Individuals from Disadvantaged
Background only: Individual must be
from a disadvantaged background. (See
§ 68.2, Definitions, Individual from
disadvantaged background.)
§ 68.4
Who is eligible to participate?
To be eligible to participate in the
NIH LRPs, individuals must:
(a) Meet the eligibility requirements
specified in § 68.3 of this part;
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(b) Not be ineligible for participation
as specified in § 68.5 of this part;
(c) Engage in qualified research for the
contractual period;
(d) Engage in such research for the
percentage of time specified for the
particular LRP; and
(e) Comply with all other terms and
conditions of the applicable Loan
Repayment Program.
§ 68.5
Who is ineligible to participate?
The following individuals are
ineligible for NIH LRP participation:
(a) Persons who do not meet the
eligibility requirements as specified
under § 68.3 of this part;
(b) Any individual who has or had a
Federal judgment lien against his/her
property arising from Federal debt;
(c) Persons who owe an obligation of
health professional service to the
Federal Government, a state, or other
entity, unless deferrals or extensions are
granted for the length of the service of
their LRP contract. The following are
examples of programs that have a
service obligation:
(1) Armed Forces (Army, Navy, or Air
Force) Professions Scholarship Program,
(2) Exceptional Financial Need (EFN)
Scholarship Program,
(3) Financial Assistance for
Disadvantaged Health Professions
Students (FADHPS),
(4) Indian Health Service (IHS)
Scholarship Program,
(5) National Health Service Corps
(NHSC) Scholarship Program,
(6) National Research Service Award
(NRSA) Program, and/or Loan
Repayment Programs, NURSE Corps
Scholarship and Loan Repayment
Programs,
(7) NIH Undergraduate Scholarship
Program (UGSP),
(8) Physicians Shortage Area
Scholarship Program,
(9) Primary Care Loan (PCL) Program,
and
(10) Public Health Service
Scholarship (PHS) Program;
(d) For extramural LRPs only:
Individuals who receive any research
funding support or salary from a forprofit institution or organization, or
Federal Government employees working
more than 20 hours per week;
(e) Current recipients of NIH
intramural training awards, e.g., NIH
Intramural Research Training Awards
(IRTA) or Cancer Research Training
Awards (CRTA);
(f) Individuals conducting research for
which funding is precluded by Federal
law, regulation, or HHS/NIH policy or
that does not comply with applicable
Federal, state, and local law regarding
the conduct of the research (e.g.,
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applicable human subject protection
regulations);
(g) Individuals with only ineligible
loans or loans that are not educational;
and
(h) Individuals who do not have
sufficient qualifying educational debt to
meet the debt threshold.
§ 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 Secretary prescribes.
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§ 68.7 How are applicants selected to
participate in the NIH LRPs?
The NIH LRP awards are competitive.
To be selected for participation in an
NIH LRP, applicants must satisfy the
following requirements:
(a) Applicants must meet the
eligibility requirements specified in
§§ 68.3 and 68.4 of this part.
(b) Applicants must not be ineligible
for participation as specified in § 68.5 of
this part.
(c) Upon receipt, applications for any
of the NIH LRPs will be reviewed for
eligibility and completeness by the NIH
Division of Loan Repayment.
Incomplete or ineligible applications
will not be processed or reviewed
further.
(d)(1) Applications for the Intramural
LRPs that are deemed eligible and
complete are submitted to the Loan
Repayment Committee (LRC), which
reviews, ranks, and approves/
disapproves LRP awards. The LRC is
composed of senior intramural
scientists, including basic (bench) and
clinical researchers and science policy
administrators. Since LRP participation
in the Intramural programs is contingent
upon NIH employment, applicants must
be recommended by the employing IC of
the NIH to be considered by the LRC.
(2) Applications for the Extramural
LRPs that are deemed eligible and
complete will be referred by the NIH
Center for Scientific Review (CSR) to an
appropriate NIH IC for peer review. In
evaluating the application, reviewers are
directed to consider the following
components and how they relate to the
likelihood that the applicant will
continue in a research career:
(i) Applicant’s potential to pursue a
career in research as defined by the
appropriate LRP:
(A) Appropriateness of the applicant’s
previous training and experience to
prepare for a research career.
(B) Appropriateness of the proposed
research activities during the LRP
contract to foster a career in research.
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(C) Commitment to a research career,
as reflected by the personal statement of
long-term career goals and plan to
achieve those goals.
(D) Strength of the letters of
recommendations attesting to the
applicant’s potential for a successful
career in research.
(ii) Quality of the overall environment
to prepare the applicant for a research
career:
(A) Quality and availability of
appropriate scientific mentors and
colleagues to help achieve or enhance
the applicant’s research independence,
including the mentors’ record in
mentoring researchers, funding history,
and research productivity.
(B) Quality and appropriateness of
institutional resources and facilities.
(iii) For the Health Disparities
Research LRP, 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.
§ 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 $35,000 per year of a
participant’s repayable debt.
(b) Payments are made directly to a
participant’s lender(s). If there is more
than one outstanding qualified
educational loan, the NIH will repay the
loans in the following order, unless the
NIH determines significant savings
would result from paying loans in a
different order of priority:
(1) Loans guaranteed by the U.S.
Department of Health and Human
Services;
(2) Loans guaranteed by the U.S.
Department of Education;
(3) Loans made or guaranteed by a
state;
(4) Loans made by a school; and
(5) Loans made by other entities.
(c) Tax liability payments: In addition
to the loan repayments, the NIH shall
make tax payments in an amount equal
to 39 percent of the total annual loan
repayment to the Internal Revenue
Service on the participant’s behalf. The
NIH may make additional payments to
those participants who show increased
Federal, State, and/or local taxes as a
result of loan repayments.
(d) Under paragraphs (a), (b), and (c)
of this section, the NIH will make loan
and tax liability payments to the extent
appropriated funds are available for
these purposes.
§ 68.9
What loans qualify for repayment?
The NIH LRPs will repay participants’
lenders the principal, interest, and
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related expenses of qualified U.S.
Government and commercial
educational loans obtained by
participants for the following:
(a) Undergraduate, graduate, and
health professional school tuition
expenses;
(b) Other reasonable educational
expenses required by the school(s)
attended, including fees, books,
supplies, educational equipment and
materials, and laboratory expenses; and
(c) Reasonable living expenses,
including the cost of room and board,
transportation and commuting costs,
and other living expenses, as
determined by the NIH.
§ 68.10 What loans are ineligible for
repayment?
The following loans are ineligible for
repayment under the NIH LRPs:
(a) Loans not obtained from a bank,
credit union, savings and loan
association, not-for-profit organization,
insurance company, school, and other
financial or credit institution that is
subject to examination and supervision
in its capacity as a lending institution
by an agency of the United States or of
the state in which the lender has its
principal place of business;
(b) Loans for which supporting
documentation is not available;
(c) Loans that have been consolidated
with loans of other individuals, such as
spouses or children;
(d) Loans or portions of loans
obtained for educational or living
expenses that exceed the standard of
reasonableness as determined by the
participant’s standard school budget for
the year in which the loan was made
and are not determined by the NIH to
be reasonable based on additional
documentation provided by the
individual;
(e) Loans, financial debts, or service
obligations incurred under the following
programs, or similar programs, which
provide loans, scholarships, loan
repayments, or other awards in
exchange for a future service obligation:
(1) Armed Forces (Army, Navy, or Air
Force) Professions Scholarship Program,
(2) Exceptional Financial Need (EFN)
Scholarship Program,
(3) Financial Assistance for
Disadvantaged Health Professions
Students (FADHPS),
(4) Indian Health Service Scholarship
Program,
(5) National Health Service Corps
Scholarship Program,
(6) National Institutes of Health
Undergraduate Scholarship Program
(UGSP),
(7) National Research Service Award
(NRSA) Program,
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(8) Physicians Shortage Area
Scholarship Program,
(9) Primary Care Loans (PCL), and
(10) Public Health Service
Scholarship Program;
(f) Any loan in default, delinquent, or
not in a current payment status;
(g) Any Federal educational loan
debt—including debt arising from the
conversion of a service obligation to a
loan—that has been in default or written
off as uncollectible is ineligible for
repayment under the Program, even if
currently considered to be in good
standing;
(h) Loan amounts that participants
were due to have been paid prior to the
LRP contract start date;
(i) Parents PLUS loans (except the
Graduate PLUS loans for students);
(j) Loans for which promissory notes
have been signed after the LRP contract
start date (with the exception of
qualifying student loan consolidations);
and
(k) Home equity loans or other
noneducational loans.
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§ 68.11 What does an individual have to do
in return for loan repayments received
under the NIH LRPs?
Individuals must agree to:
(a) Engage in qualified research for the
applicable contract service period;
(b)(1) For Intramural LRPs: Engage in
such research full-time as employees of
NIH, or;
(2) For Extramural LRPs: Engage in
such research for an average of 20 hours
per week 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);
(c) Keep all loan accounts in good
standing, provide timely documentation
as needed, including payment
verification, service verification, change
of research, change of institution, etc.
Failure to provide such documentation
may result in early termination, and the
individual may be subject to statutory
financial penalties; and
(d) Satisfy all of the other terms and
conditions of the LRP and the LRP
Contract (e.g., Obligations of the
Participant). Failure to adhere to the
terms and conditions of the LRP
contract may result in early termination,
and the individual may be subject to
statutory financial penalties.
§ 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
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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
remaining repayable debt as established
by the Secretary.
§ 68.13 What will happen if an individual
does not comply with the terms and
conditions of participation in the NIH LRPs?
Program participants who breach their
Loan Repayment Program Contracts will
be subject to the applicable monetary
payment provisions set forth at section
338E of the Act (42 U.S.C. 254o).
Payment of any amount owed under
section 338E of the Act shall be made
within one year of the date the
participant breached his or her Loan
Repayment Program Contract, unless the
NIH specifically authorizes a longer
period. Terminations will not be
considered a breach of contract in cases
where such terminations are beyond the
control of the participant as follows:
(a) Terminations for convenience of
the government will not be considered
a breach of contract and monetary
damages will not be assessed.
(b) Occasionally, a participant’s
research assignment or funding may
evolve and change to the extent that the
individual is no longer engaged in
approved research. Similarly, the
research needs and priorities of the IC
and/or the NIH may change to the extent
that a determination is made that a
health professional’s skills may be better
utilized in a nonresearch assignment.
Normally, job changes of this nature
will not be considered a breach of
contract on the part of either the NIH or
the participant. Under these
circumstances, the following will apply:
(1) Program participation will cease as
of the date an individual is no longer
engaged in approved research;
(2) Based on the approval of the NIH,
the participant will be released from the
remainder of his or her service
obligation without assessment of
damages or monetary penalties. The
participant in this case will be
permitted to retain all Program benefits
made or owed by the NIH on his/her
behalf up to the date the individual is
no longer engaged in research, less the
pro rata portion of any benefits
advanced beyond the period of
completed service.
§ 68.14 Under what circumstances can the
service or payment obligation be canceled,
waived, or suspended?
(a) Any obligation of a participant for
service or payment will be canceled
upon the death of the participant.
(b)(1) The NIH may waive or suspend
any service or payment obligation
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incurred by the participant upon request
whenever compliance by the
participant:
(i) Is impossible;
(ii) Would involve extreme hardship
to the participant; or
(iii) If enforcement of the service or
payment obligation would be
unconscionable.
(2) The NIH may approve a request for
a suspension of the service or payment
obligations for a period of up to one (1)
year.
(c) Compliance by a participant with
a service or payment obligation will be
considered impossible if the NIH
determines, on the basis of information
and documentation as may be required,
that the participant suffers from a
permanent physical or mental disability
resulting in the inability of the
participant to perform the service or
other activities that would be necessary
to comply with the obligation.
(d) In determining whether to waive
or suspend any or all of the service or
payment obligations of a participant as
imposing an undue hardship and being
against good conscience, the NIH, on the
basis of such information and
documentation as may be required, will
consider:
(1) The participant’s present financial
resources and obligations;
(2) The participant’s estimated future
financial resources and obligations; and
(3) The extent to which the
participant has problems of a personal
nature, such as a physical or mental
disability or terminal illness in the
immediate family, which so intrude on
the participant’s present and future
ability to perform as to raise a
presumption that the individual will be
unable to perform the obligation
incurred.
§ 68.15 When can an NIH LRP payment
obligation be discharged in bankruptcy?
Any payment obligation incurred
under § 68.13 of this part may be
discharged in bankruptcy under Title 11
of the United States Code only if such
discharge is granted after the expiration
of the seven-year period beginning on
the first date that payment is required
and only if the bankruptcy court finds
that a non-discharge of the obligation
would be unconscionable.
§ 68.16
Additional conditions.
(a) When a shortage of funds exists,
participants may be funded only
partially, as determined by the NIH.
However, once an NIH LRP contract has
been signed by both parties, the NIH
will obligate such funds as necessary to
ensure that sufficient funds will be
available to pay benefits for the duration
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of the period of obligated service unless,
by mutual written agreement, the parties
specify otherwise.
(b) Additional conditions may be
imposed as deemed necessary.
§ 68.17 What other regulations and
statutes apply?
Several other regulations and statutes
apply to this part. These include, but are
not necessarily limited to:
(a) Debt Collection Act of 1982 (31
U.S.C. 3701 note);
(b) Fair Credit Reporting Act (15
U.S.C. 1681 et seq.);
(c) Federal Debt Collection Procedures
Act of 1990 (28 U.S.C. 176); and
(d) Privacy Act of 1974 (5 U.S.C.
552a).
Dated: January 16, 2013.
Francis S. Collins,
Director, National Institutes of Health.
Approved: March 27, 2013.
Kathleen Sebelius,
Secretary.
Data Bank, and, once completed, to
cease operations of the Healthcare
Integrity and Protection Data Bank.
Information previously collected and
disclosed to eligible parties through the
HIPDB will then be collected and
disclosed to eligible parties through the
NPDB. This regulatory action
consolidates the collection and
disclosure of information from both data
banks into one part of the CFR.
The effective date of this rule is
May 6, 2013.
DATES:
FOR FURTHER INFORMATION CONTACT:
Director, Division of Practitioner Data
Banks, Bureau of Health Professions,
Health Resources and Services
Administration, Parklawn Building,
5600 Fishers Lane, Room 8–103,
Rockville, MD 20857; telephone
number: (301) 443–2300.
SUPPLEMENTARY INFORMATION:
I. Background
[FR Doc. 2013–07737 Filed 4–4–13; 8:45 am]
BILLING CODE 4140–01–P
A. Legal Authorities Governing the Data
Banks
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The paragraphs below provide a
summary of the legal authorities
governing the NPDB and the HIPDB.
(1) The Health Care Quality
Improvement Act of 1986 (42 U.S.C.
11101 et seq.)
45 CFR Parts 60 and 61
RIN 0906–AA87
National Practitioner Data Bank
Health Resources and Services
Administration (HRSA), HHS.
ACTION: Final rule.
AGENCY:
This final rule revises existing
regulations under sections 401–432 of
the Health Care Quality Improvement
Act of 1986 and section 1921 of the
Social Security Act, governing the
National Practitioner Data Bank, to
incorporate statutory requirements
under the Patient Protection and
Affordable Care Act of 2010 (Affordable
Care Act). The Department of Health
and Human Services (HHS) also is
removing regulations which
implemented the Healthcare Integrity
and Protection Data Bank. Section 6403
of the Affordable Care Act, the statutory
authority for this regulatory action, was
designed to eliminate duplicative data
reporting and access requirements
between the Healthcare Integrity and
Protection Data Bank (HIPDB)
(established under section 1128E of the
Social Security Act) and the National
Practitioner Data Bank (NPDB). It
requires the Secretary to establish a
transition period to transfer all data in
the Healthcare Integrity and Protection
Data Bank to the National Practitioner
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SUMMARY:
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The NPDB was established by the
Health Care Quality Improvement Act of
1986 (HCQIA), as amended (42 U.S.C.
11101 et seq.). The HCQIA authorizes
the NPDB to collect reports of adverse
licensure actions against physicians and
dentists (including revocations,
suspensions, reprimands, censures,
probations, and surrenders); adverse
clinical privileges actions against
physicians and dentists; adverse
professional society membership actions
against physicians and dentists; Drug
Enforcement Administration (DEA)
certification actions; Medicare/Medicaid
exclusions; and medical malpractice
payments made for the benefit of any
health care practitioner. Organizations
that have access to this data system
include hospitals, other health care
entities that have formal peer review
processes and provide health care
services, state medical or dental boards
and other health care practitioner state
boards. Individual practitioners may
self-query. Information under the
HCQIA is reported by medical
malpractice payers, state medical and
dental boards, professional societies
with formal peer review, and hospitals
and other health care entities (such as
health maintenance organizations).
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(2) Section 1921 of the Social Security
Act (42 U.S.C. 1396r–2) (Prior to the
Passage of the Affordable Care Act)
Section 1921 of the Social Security
Act (herein referred to as section 1921),
as amended by section 5(b) of the
Medicare and Medicaid Patient and
Program Protection Act of 1987, Public
Law 100–93, and as amended by the
Omnibus Budget Reconciliation Act of
1990, Public Law 101–508, expanded
the scope of the NPDB. Section 1921
requires each state to adopt a system for
reporting to the Secretary certain
adverse licensure actions taken against
health care practitioners and entities by
any authority of the state responsible for
the licensing of such practitioners or
entities. It also requires each state to
report any negative action or finding
that a state licensing authority, a peer
review organization, or a private
accreditation entity had taken against a
health care practitioner or health care
entity.
Groups with access to this
information include all organizations
eligible to query the NPDB under the
HCQIA (hospitals, other health care
entities that have formal peer review
and provide health care services, state
medical or dental boards, and other
health care practitioner state boards),
other state licensing authorities,
agencies administering government
health care programs (including private
entities administering such programs
under contract), state agencies
administering or supervising the
administration of government health
care programs, state Medicaid fraud
control units, certain law enforcement
agencies, and utilization and quality
control Quality Improvement
Organizations (QIOs). Individual health
care practitioners and entities may selfquery. Information under section 1921
is reported by state licensing and
certification authorities, peer review
organizations, and private accreditation
entities.
Final regulations implementing
section 1921 were issued on January 28,
2010 (75 FR 4656). The NPDB began
collecting and disclosing section 1921
information on March 1, 2010.
(3) Section 1128E of the Social Security
Act (42 U.S.C. 1320a–7e) (Prior to the
Passage of the Affordable Care Act)
Section 1128E of the Social Security
Act (herein referred to as section
1128E), as added by section 221(a) of
the Health Insurance Portability and
Accountability Act of 1996, Public Law
104–191, directed the Secretary to
establish and maintain a national health
care fraud and abuse data collection
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]]>Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Rules and Regulations]
[Pages 20466-20473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07737]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 68
[Docket No. NIH-2008-0003]
RIN 0905-AA43
National Institutes of Health Loan Repayment Programs
AGENCY: National Institutes of Health, HHS.
ACTION: Final rule.
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SUMMARY: As a part of the Department of Health and Human Services
(HHS)'s ongoing retrospective review initiative, the National
Institutes of Health (NIH) is rescinding the existing regulations for
two of its eight loan repayment programs and issuing in their place a
new consolidated set of regulations governing all of the NIH Loan
Repayment Programs (LRPs). There are currently eight programs,
including three for researchers employed by the NIH (Intramural LRPs)
and five for non-NIH scientists (Extramural LRPs). The Intramural LRPs
include the Loan Repayment Program for Research with Respect to
Acquired Immune Deficiency Syndrome (or AIDS Research LRP); Loan
Repayment Program for General Research (or General Research LRP), which
includes a program for the Accreditation Council for Graduate Medical
Education (ACGME) Fellows; and Loan Repayment Program for Clinical
Researchers from Disadvantaged Backgrounds (or Clinical Research LRP
for Individuals from Disadvantaged Backgrounds). The Extramural LRPs
include the Loan Repayment Program for Contraception and Infertility
Research (or Contraception and Infertility Research LRP); Loan
Repayment Program for Clinical Researchers from Disadvantaged
Backgrounds (or Clinical Research LRP for Individuals from
Disadvantaged Backgrounds); Loan Repayment Program for Clinical
Research (or Clinical Research LRP); Loan Repayment Program for
Pediatric Research (or Pediatric Research LRP); and Loan Repayment
Program for Health Disparities Research (or Health Disparities Research
LRP).
DATES: This final rule is effective May 6, 2013.
FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer,
Office of Management Assessment, NIH, 6011 Executive Boulevard, Room
601, MSC 7669, Rockville, MD 20892; by email at MooreJ@mail.nih.gov; by
fax on 301-402-0169 (not a toll-free number); or by telephone 301-496-
4607 (not a toll-free number) for information about the rulemaking
process. For program information, contact: NIH Division of Loan
Repayment by email lrp@nih.gov or telephone 866-849-4047. For
information regarding the requirements, the application deadline dates,
and an online application for the NIH Loan Repayment Programs, refer to
the NIH Loan Repayment Program Web site, www.lrp.nih.gov.
SUPPLEMENTARY INFORMATION: On November 4, 1988, Congress enacted the
Health Omnibus Programs Extension of 1988, (Pub. L. 100-607). Title VI
of this law amended the Public Health Service (PHS) Act by adding
section 487A (42
[[Page 20467]]
U.S.C. 288-1) entitled Loan Repayment Program for Research with Respect
to Acquired Immune Deficiency Syndrome. Subsequently, in the NIH
Revitalization Act of 1993 (Pub. L. 103-43), Congress enacted the Loan
Repayment Program for Research with Respect to Contraception and
Infertility (section 487B; 42 U.S.C. 288-2); the Loan Repayment Program
for Research Generally (section 487C; 42 U.S.C. 288-3); and the Loan
Repayment Program for Clinical Researchers from Disadvantaged
Backgrounds (section 487E; 42 U.S.C. 288-5). The Children's Health Act
of 2000 (Pub. L. 106-310), which was enacted on October 17, 2000, added
the Pediatric Research Loan Repayment Program (section 487F; \1\ 42
U.S.C. 288-6). On November 13, 2000, the Clinical Research Enhancement
Act, contained in the Public Health Improvement Act of 2000 (Pub. L.
106-505), enacted the Loan Repayment Program for Clinical Research
(section 487F; \2\ 42 U.S.C. 288-5a). On November 22, 2000, the
Minority Health and Health Disparities Research and Education Act of
2000 (Pub. L. 106-525) enacted the Loan Repayment Program for Health
Disparities Research (section 485G, re-designated 464z-5 by Pub. L.
111-148; \3\ 42 U.S.C. 285t-2).
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\1\ So in law. There are two sections 487F. Section 1002(b) of
Public Law 106-310 (114 Stat. 1129), inserted section 487F above.
Subsequently, section 205 of Public Law 106-505 (114 Stat. 2329),
which relates to the Loan Repayment Program for Clinical
Researchers, inserted a section 487F after section 487E.
\2\ 205 of Public Law 106-505 (114 Stat. 2329), inserted section
487F after section 487E. Previously, section 1002(b) of Public Law
106-310 (114 Stat. 1129), which relates to the Pediatric Research
Loan Repayment Program, inserted section 487F after section 487E.
\3\ Section 485G of the PHS Act, enacted by Public Law 106-525,
was redesignated section 464z-5 by Public Law 111-148.
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Sections 487A, 487B, 487C, 487E, and 487F of the PHS Act authorize
the Secretary of Health and Human Services 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 $35,000 of the
principal and interest of the qualified educational loans of such
professionals. Section 464z-5 authorizes the Director, National
Institute on Minority Health and Health Disparities (NIMHD) to do the
same.
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 General Research
LRP) as one of the following:
(a) An NIH employee (for Intramural LRPs), or
(b) A health professional engaged in 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).
The purpose of the LRP programs is to recruit and retain highly
qualified health professionals as biomedical and behavioral
researchers. LRP programs offer educational loan repayment for
participants who agree, by written contract, to engage in qualifying
domestic nonprofit-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 General Research LRP).
Currently, the Clinical Research LRP for Individuals from
Disadvantaged Backgrounds and the Contraception and Infertility
Research LRP are governed by their own individual regulations while the
other LRPs are without regulations. We are consolidating the
regulations into a single set of regulations governing all the LRPs.
More specifically, we are rescinding the current regulations codified
at 42 CFR Part 68a, entitled ``National Institutes of Health Clinical
Research Loan Repayment Program for Individuals from Disadvantaged
Backgrounds (CR-LRP),'' and 42 CFR Part 68c, entitled ``National
Institute of Child Health and Human Development Contraception and
Infertility Research Loan Repayment Program,'' and issuing a new
consolidated set of regulations at 42 CFR Part 68, entitled ``National
Institutes of Health Loan Repayment Programs (LRPs),'' to govern each
of the eight individual NIH Loan Repayment Programs, the three that are
for researchers employed by the NIH (Intramural LRPs) and the five that
are for non-NIH scientists (Extramural LRPs). The three Intramural LRPs
include the AIDS Research LRP, General Research LRP, and Clinical
Research LRP for Individuals from Disadvantaged Backgrounds. The five
Extramural LRPs include the Contraception and Infertility Research LRP,
Clinical Research LRP for Individuals from Disadvantaged Backgrounds,
Clinical Research LRP, Pediatric Research LRP, and Health Disparities
Research LRP.
We announced our intentions to take these rulemaking actions in the
notice of proposed rulemaking (NPRM) ``National Institutes of Health
Loan Repayment Programs,'' that we published in the Federal Register on
February 22, 2012 (77 FR 10455-10461). In the NPRM we provided a 60-day
public comment period. The public comment period expired April 23,
2012. We received only one public comment. Because the comment did not
address the regulations per se, but simply questioned the need for any
loan repayment, we did not view the comment as relevant to this
rulemaking action. Consequently, the final NIH LRP regulations that are
set forth in this final rule are essentially identical to the proposed
regulations that we set forth in the NPRM. We provide the following as
public information.
Regulatory Impact Analysis
We have examined the impacts of this rule as required by E.O.
12866, ``Regulatory Planning and Review'' (September 30, 1993), E.O.
13563, ``Improving Regulation and Regulatory Review'' (January 18,
2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub.
L. 96-354), section 202 of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4), and E.O. 13132, ``Federalism'' (August 4, 1999).
Executive Order 12866
E.O. 12866, as supplemented by Executive Order 13563, directs
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 and other advantages,
distributive impacts, and equity). 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 the rulemaking does not constitute an economically significant
regulatory action.
The 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. The Secretary certifies
that this rule will not have a significant impact on a significant
number of small entities.
[[Page 20468]]
Section 202(a) of the Unfunded Mandates Reform Act of 1995
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement that 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 threshold for 2012 is approximately $145.5 million.
The Secretary certifies that this rule does not mandate any spending by
State, local or tribal government in the aggregate or by the private
sector. Participation in the NIH loan repayment programs is voluntary
and not mandated.
Executive Order 13132
E.O. 13132, Federalism, requires that Federal agencies 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 ``federalism
implications'' because it will not have substantial direct effect on
the states, the relationship between the National Government and the
states, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, under E.O. 13132, no further
Agency action or analysis is required.
Paperwork Reduction Act
This proposed 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. 35). More
specifically, Sec. 68.6 of this rule 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 approved
under OMB No. 0925-0361, Expiration Date: June 30, 2014. Additionally,
Sec. Sec. 68.3(c), 68.3(e), 68.11(c), 68.14(c), 68.14(d), and 68.16(a)
of this rule are reporting requirements and/or recordkeeping
requirements, but they are also covered under OMB No. 0925-0361.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbered programs
affected by the proposed regulations are:
93.209--Contraception and Infertility Research Loan Repayment
Program
93.220--Clinical Research Loan Repayment Program for Individuals
from Disadvantaged Backgrounds
93.232--Loan Repayment Program for General Research
93.280--NIH Loan Repayment Program for Clinical Researchers
93.285--NIH Pediatric Research Loan Repayment Program
93.307--Minority Health and Health Disparities Research
93.308--Extramural Loan Repayment for Individuals from Disadvantaged
Backgrounds Conducting Clinical Research
93.936--NIH Acquired Immunodeficiency Syndrome Research Loan
Repayment Program
List of Subjects
42 CFR Parts 68, 68a, and 68c
Health professions, Loan repayment programs--health, Medical
research.
For reasons presented in the preamble, and under the authority of 5
U.S.C 301 and 42 U.S.C. 216, HHS amends Title 42 of the Code of Federal
Regulations by removing parts 68a and 68c and adding part 68 to read as
follows:
PART 68--NATIONAL INSTITUTES OF HEALTH (NIH) LOAN REPAYMENT
PROGRAMS (LRPs)
Sec.
68.1 What is the scope and purpose of the NIH LRPs?
68.2 Definitions.
68.3 Who is eligible to apply?
68.4 Who is eligible to participate?
68.5 Who is ineligible to participate?
68.6 How do individuals apply to participate in the NIH LRPs?
68.7 How are applicants selected to participate in the NIH LRPs?
68.8 What do the NIH LRPs provide to participants?
68.9 What loans qualify for repayment?
68.10 What loans are ineligible for repayment?
68.11 What does an individual have to do in return for loan
repayments received under the NIH LRPs?
68.12 How does an individual receive loan repayments beyond the
initial applicable contract period?
68.13 What will happen if an individual does not comply with the
terms and conditions of participation in the NIH LRPs?
68.14 Under what circumstances can the service or payment obligation
be canceled, waived, or suspended?
68.15 When can an NIH LRP payment obligation be discharged in
bankruptcy?
68.16 Additional conditions.
68.17 What other regulations and statutes apply?
Authority: 42 U.S.C. 254o, 42 U.S.C. 288-1, 42 U.S.C. 288-2, 42
U.S.C. 288-3, 42 U.S.C. 288-5, 42 U.S.C. 288-5a, 42 U.S.C. 288-6, 42
U.S.C. 285t-2.
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, 487B, 487C, 487E, 487F,\1\ and
464z-5 of the Public Health Service Act (42 U.S.C. 288-1, 42 U.S.C.
288-2, 42 U.S.C. 288-3, 42 U.S.C. 288-5, 42 U.S.C. 288-5a, 42 U.S.C.
288-6, 42 U.S.C. 285t-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 the NIH. The NIH Loan Repayment Programs
include eight separate programs, three that are Intramural (for NIH
researchers) and five that are Extramural (for non-NIH researchers).
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\1\ There are two sections 487F. Section 1002(b) of Public Law
106-310 added section 487F, 42 U.S.C. 288-6, the Pediatric Research
Loan Repayment Program. Subsequently, section 205 of Public Law 106-
505 also added section 487F, 42 U.S.C. 288-5a, enacting the Loan
Repayment Program for Clinical Researchers.
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(a) The Intramural LRPs include:
(1) Loan Repayment Program for Research with Respect to Acquired
Immune Deficiency Syndrome (or AIDS Research LRP);
(2) Loan Repayment Program for General Research (or General
Research LRP), including a program for Accreditation Council for
Graduate Medical Education (ACGME) Fellows; and
(3) Loan Repayment Program for Clinical Researchers from
Disadvantaged Backgrounds (or Clinical Research LRP for Individuals
from Disadvantaged Backgrounds). This program is also included as a
separate program under the Extramural LRPs.
(b) The Extramural LRPs include:
(1) Loan Repayment Program for Contraception and Infertility
Research (or Contraception and Infertility Research LRP);
(2) Loan Repayment Program for Clinical Researchers from
Disadvantaged Backgrounds (or Clinical Research LRP for Individuals
from Disadvantaged Backgrounds);
(3) Loan Repayment Program for Clinical Researchers (or Clinical
Research LRP);
(4) Loan Repayment Program for Pediatric Research (or Pediatric
Research LRP); and
(5) Loan Repayment Program for Health Disparities Research (or
Health Disparities Research LRP).
[[Page 20469]]
Sec. 68.2 Definitions.
As used in this part:
Act means the Public Health Service Act, as amended (42 U.S.C. 201
et seq.).
AIDS Research means research activities related to the Acquired
Immunodeficiency Syndrome that qualify for inclusion in the AIDS
Research LRP.
Applicant means an individual who applies to and meets the
eligibility criteria for the NIH LRPs.
Breach of contract results when a participant fails to complete the
research service or other obligation(s) required under the contract and
may be subject to assessment of monetary damages and penalties as
defined by statute.
Clinical research is patient-oriented clinical research conducted
with human subjects, or research on the causes and consequences of
disease in human populations involving material of human origin (such
as tissue specimens and cognitive phenomena) for which an investigator
or colleague directly interacts with human subjects in an outpatient or
inpatient setting to clarify a problem in human physiology,
pathophysiology or disease, or epidemiologic or behavioral studies,
outcomes research or health services research, or developing new
technologies, therapeutic interventions, or clinical trials.
Commercial loans means loans made for educational purposes by
banks, credit unions, savings and loan associations, not-for-profit
organizations, insurance companies, schools, and other financial or
credit institutions that are subject to examination and supervision in
their capacity as lending institutions by an agency of the United
States or of the state in which the lender has its principal place of
business.
Contraception research is defined as research with the ultimate
goal of providing new or improved methods of preventing pregnancy.
Current payment status means that a qualified educational loan is
not past due in its payment schedule, as determined by the lending
institution.
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 Secretary.
Director means the Director of the National Institute on Minority
Health and Health Disparities (NIMHD) or designee.
Educational expenses means the cost 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
professionals, who are not NIH employees and have program-specified
degrees and domestic nonprofit support, are eligible to apply. The
Extramural LRPs include:
(1) Contraception and Infertility Research LRP;
(2) Clinical Research LRP for Individuals from Disadvantaged
Backgrounds;
(3) Clinical Research LRP;
(4) Pediatric Research LRP; and
(5) Health Disparities Research LRP.
General research pertains to research that falls within the basic
science or clinical research parameters and is not targeted toward a
specific area (e.g., AIDS) or type of research (e.g., clinical
research). The focus is on biomedical and behavioral research studies
and investigations across a variety of scientific disciplines within
the mission of the NIH.
Government loans means educational loans made by U.S. Federal,
state, county, or city agencies that are authorized by law to make such
loans.
Health disparities population: a population is a health disparity
population if, as determined by the Director after consultation with
the Director of the Agency for Healthcare Research and Quality, there
is a significant disparity in the overall rate of disease incidence,
prevalence, morbidity, mortality, or survival rates in the population
as compared to the health status of the general population.
Individual from disadvantaged background. (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 for use in HHS programs. The
Secretary periodically publishes these income levels in the Federal
Register.
Infertility research is defined as research with the long-range
objective of evaluating, treating, or ameliorating conditions that
result in the failure of couples to either conceive or bear young.
Institute or Center (IC) means an Institute or Center of the
National Institutes of Health (NIH).
Intramural LRPs refers to those programs for which applicants must
be employed by the NIH. The intramural LRPs include:
(1) AIDS Research LRP;
(2) General Research LRP; and
(3) Clinical Research LRP for Individuals from Disadvantaged
Backgrounds.
Institutional base salary or salary is the annual income or
compensation that the organization pays for the applicant's
appointment, whether the time is spent on research, teaching, patient
care, or other activities.
Living expenses means the reasonable cost of room and board,
transportation and commuting costs, and other reasonable costs incurred
during an individual's attendance at an educational institution and is
part of the educational loan.
Loan Repayment Programs (LRPs) refers to the NIH Loan Repayment
Programs, including those authorized by sections 487A, 487B, 487C,
487E, 487F, and 464z-5 of the Act, as amended.
Loan Repayment Program contract refers to the agreement signed by
an applicant and the Secretary or Director (for the following
extramural LRPs: Health Disparities Research LRP and Clinical Research
LRP for Individuals from Disadvantaged Backgrounds only). 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.
NIH refers to the National Institutes of Health.
Nonprofit 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 Secretary or the Director.
Pediatric research is defined as research directly related to
diseases, disorders, and other conditions in
[[Page 20470]]
children, including pediatric pharmacology.
Program refers to the NIH Loan Repayment Program, or LRP.
Program eligibility date means the date on which an individual's
LRP contract is executed by the Secretary or the Director.
Qualified Educational Loans and Interest/Debt (see Educational
Expenses) as established by the Secretary, 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.
Repayable debt means the proportion, as established by the
Secretary, of an individual's total qualified educational debt that can
be paid by an NIH LRP.
Salary has the same meaning as institutional base salary.
School means undergraduate, graduate, and health professions
schools that are accredited by a body or bodies recognized for
accreditation purposes by the U.S. Secretary of Education.
Secretary means the Secretary of Health and Human Services or
designee.
Service means the Public Health Service.
State means one of the fifty states, the District of Columbia, the
Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S.
Virgin Islands, Guam, American Samoa, and the Federated States of
Micronesia, the Republic of the Marshall Islands, and the Republic of
Palau.
Waiver means a waiver of the service obligation granted by the
Secretary 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.)
Withdrawal means a request by a participant, prior to the Program
making payments on his or her behalf, for withdrawal from Program
participation. A withdrawal is without penalty to the participant and
without obligation to the Program.
Sec. 68.3 Who is eligible to apply?
To be eligible for consideration for the NIH LRPs, applicants must
meet the following criteria:
(a) Be citizens, nationals, or permanent residents of the United
States;
(b) Have the necessary degree from an accredited institution as
determined by the NIH to be consistent with the needs of the LRP;
(c)(1) For Intramural LRPs only: Applicants must be employed by the
NIH and engage in qualified full-time research as specified by the LRP
and be recommended by the employing IC or have a firm commitment of
employment from an authorized official of the NIH;
(2) For Extramural LRPs only: Applicants must be conducting
qualified research for an average of at least 20 hours per week that is
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);
(d) Have total qualifying educational loan debt as determined on
the program eligibility date;
(e) The NIH or the employing institution must provide an assurance
that the applicant will be employed/appointed and provided research
support for the applicable term of the LRP contract; and
(f) Recipients of LRP awards must conduct their research in
accordance with applicable Federal, state, and local law (e.g.,
applicable human subject protection regulations).
(g) For Clinical Research for Individuals from Disadvantaged
Background only: Individual must be from a disadvantaged background.
(See Sec. 68.2, Definitions, Individual from disadvantaged
background.)
Sec. 68.4 Who is eligible to participate?
To be eligible to participate in the NIH LRPs, individuals must:
(a) Meet the eligibility requirements specified in Sec. 68.3 of
this part;
(b) Not be ineligible for participation as specified in Sec. 68.5
of this part;
(c) Engage in qualified research for the contractual period;
(d) Engage in such research for the percentage of time specified
for the particular LRP; and
(e) Comply with all other terms and conditions of the applicable
Loan Repayment Program.
Sec. 68.5 Who is ineligible to participate?
The following individuals are ineligible for NIH LRP participation:
(a) Persons who do not meet the eligibility requirements as
specified under Sec. 68.3 of this part;
(b) Any individual who has or had a Federal judgment lien against
his/her property arising from Federal debt;
(c) Persons who owe an obligation of health professional service to
the Federal Government, a state, or other entity, unless deferrals or
extensions are granted for the length of the service of their LRP
contract. The following are examples of programs that have a service
obligation:
(1) Armed Forces (Army, Navy, or Air Force) Professions Scholarship
Program,
(2) Exceptional Financial Need (EFN) Scholarship Program,
(3) Financial Assistance for Disadvantaged Health Professions
Students (FADHPS),
(4) Indian Health Service (IHS) Scholarship Program,
(5) National Health Service Corps (NHSC) Scholarship Program,
(6) National Research Service Award (NRSA) Program, and/or Loan
Repayment Programs, NURSE Corps Scholarship and Loan Repayment
Programs,
(7) NIH Undergraduate Scholarship Program (UGSP),
(8) Physicians Shortage Area Scholarship Program,
(9) Primary Care Loan (PCL) Program, and
(10) Public Health Service Scholarship (PHS) Program;
(d) For extramural LRPs only: Individuals who receive any research
funding support or salary from a for-profit institution or
organization, or Federal Government employees working more than 20
hours per week;
(e) Current recipients of NIH intramural training awards, e.g., NIH
Intramural Research Training Awards (IRTA) or Cancer Research Training
Awards (CRTA);
(f) Individuals conducting research for which funding is precluded
by Federal law, regulation, or HHS/NIH policy or that does not comply
with applicable Federal, state, and local law regarding the conduct of
the research (e.g.,
[[Page 20471]]
applicable human subject protection regulations);
(g) Individuals with only ineligible loans or loans that are not
educational; and
(h) Individuals who do not have sufficient qualifying educational
debt to meet the debt threshold.
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 Secretary prescribes.
Sec. 68.7 How are applicants selected to participate in the NIH LRPs?
The NIH LRP awards are competitive. To be selected for
participation in an NIH LRP, applicants must satisfy the following
requirements:
(a) Applicants must meet the eligibility requirements specified in
Sec. Sec. 68.3 and 68.4 of this part.
(b) Applicants must not be ineligible for participation as
specified in Sec. 68.5 of this part.
(c) Upon receipt, applications for any of the NIH LRPs will be
reviewed for eligibility and completeness by the NIH Division of Loan
Repayment. Incomplete or ineligible applications will not be processed
or reviewed further.
(d)(1) Applications for the Intramural LRPs that are deemed
eligible and complete are submitted to the Loan Repayment Committee
(LRC), which reviews, ranks, and approves/disapproves LRP awards. The
LRC is composed of senior intramural scientists, including basic
(bench) and clinical researchers and science policy administrators.
Since LRP participation in the Intramural programs is contingent upon
NIH employment, applicants must be recommended by the employing IC of
the NIH to be considered by the LRC.
(2) Applications for the Extramural LRPs that are deemed eligible
and complete will be referred by the NIH Center for Scientific Review
(CSR) to an appropriate NIH IC for peer review. In evaluating the
application, reviewers are directed to consider the following
components and how they relate to the likelihood that the applicant
will continue in a research career:
(i) Applicant's potential to pursue a career in research as defined
by the appropriate LRP:
(A) Appropriateness of the applicant's previous training and
experience to prepare for a research career.
(B) Appropriateness of the proposed research activities during the
LRP contract to foster a career in research.
(C) Commitment to a research career, as reflected by the personal
statement of long-term career goals and plan to achieve those goals.
(D) Strength of the letters of recommendations attesting to the
applicant's potential for a successful career in research.
(ii) Quality of the overall environment to prepare the applicant
for a research career:
(A) Quality and availability of appropriate scientific mentors and
colleagues to help achieve or enhance the applicant's research
independence, including the mentors' record in mentoring researchers,
funding history, and research productivity.
(B) Quality and appropriateness of institutional resources and
facilities.
(iii) For the Health Disparities Research LRP, 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.
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 $35,000 per year
of a participant's repayable debt.
(b) Payments are made directly to a participant's lender(s). If
there is more than one outstanding qualified educational loan, the NIH
will repay the loans in the following order, unless the NIH determines
significant savings would result from paying loans in a different order
of priority:
(1) Loans guaranteed by the U.S. Department of Health and Human
Services;
(2) Loans guaranteed by the U.S. Department of Education;
(3) Loans made or guaranteed by a state;
(4) Loans made by a school; and
(5) Loans made by other entities.
(c) Tax liability payments: In addition to the loan repayments, the
NIH shall make tax payments in an amount equal to 39 percent of the
total annual loan repayment to the Internal Revenue Service on the
participant's behalf. The NIH may make additional payments to those
participants who show increased Federal, State, and/or local taxes as a
result of loan repayments.
(d) Under paragraphs (a), (b), and (c) of this section, the NIH
will make loan and tax liability payments to the extent appropriated
funds are available for these purposes.
Sec. 68.9 What loans qualify for repayment?
The NIH LRPs will repay participants' lenders the principal,
interest, and related expenses of qualified U.S. Government and
commercial educational loans obtained by participants for the
following:
(a) Undergraduate, graduate, and health professional school tuition
expenses;
(b) Other reasonable educational expenses required by the school(s)
attended, including fees, books, supplies, educational equipment and
materials, and laboratory expenses; and
(c) Reasonable living expenses, including the cost of room and
board, transportation and commuting costs, and other living expenses,
as determined by the NIH.
Sec. 68.10 What loans are ineligible for repayment?
The following loans are ineligible for repayment under the NIH
LRPs:
(a) Loans not obtained from a bank, credit union, savings and loan
association, not-for-profit organization, insurance company, school,
and other financial or credit institution that is subject to
examination and supervision in its capacity as a lending institution by
an agency of the United States or of the state in which the lender has
its principal place of business;
(b) Loans for which supporting documentation is not available;
(c) Loans that have been consolidated with loans of other
individuals, such as spouses or children;
(d) Loans or portions of loans obtained for educational or living
expenses that exceed the standard of reasonableness as determined by
the participant's standard school budget for the year in which the loan
was made and are not determined by the NIH to be reasonable based on
additional documentation provided by the individual;
(e) Loans, financial debts, or service obligations incurred under
the following programs, or similar programs, which provide loans,
scholarships, loan repayments, or other awards in exchange for a future
service obligation:
(1) Armed Forces (Army, Navy, or Air Force) Professions Scholarship
Program,
(2) Exceptional Financial Need (EFN) Scholarship Program,
(3) Financial Assistance for Disadvantaged Health Professions
Students (FADHPS),
(4) Indian Health Service Scholarship Program,
(5) National Health Service Corps Scholarship Program,
(6) National Institutes of Health Undergraduate Scholarship Program
(UGSP),
(7) National Research Service Award (NRSA) Program,
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(8) Physicians Shortage Area Scholarship Program,
(9) Primary Care Loans (PCL), and
(10) Public Health Service Scholarship Program;
(f) Any loan in default, delinquent, or not in a current payment
status;
(g) Any Federal educational loan debt--including debt arising from
the conversion of a service obligation to a loan--that has been in
default or written off as uncollectible is ineligible for repayment
under the Program, even if currently considered to be in good standing;
(h) Loan amounts that participants were due to have been paid prior
to the LRP contract start date;
(i) Parents PLUS loans (except the Graduate PLUS loans for
students);
(j) Loans for which promissory notes have been signed after the LRP
contract start date (with the exception of qualifying student loan
consolidations); and
(k) Home equity loans or other noneducational loans.
Sec. 68.11 What does an individual have to do in return for loan
repayments received under the NIH LRPs?
Individuals must agree to:
(a) Engage in qualified research for the applicable contract
service period;
(b)(1) For Intramural LRPs: Engage in such research full-time as
employees of NIH, or;
(2) For Extramural LRPs: Engage in such research for an average of
20 hours per week 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);
(c) Keep all loan accounts in good standing, provide timely
documentation as needed, including payment verification, service
verification, change of research, change of institution, etc. Failure
to provide such documentation may result in early termination, and the
individual may be subject to statutory financial penalties; and
(d) Satisfy all of the other terms and conditions of the LRP and
the LRP Contract (e.g., Obligations of the Participant). Failure to
adhere to the terms and conditions of the LRP contract may result in
early termination, and the individual may be subject to statutory
financial penalties.
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 Secretary.
Sec. 68.13 What will happen if an individual does not comply with the
terms and conditions of participation in the NIH LRPs?
Program participants who breach their Loan Repayment Program
Contracts will be subject to the applicable monetary payment provisions
set forth at section 338E of the Act (42 U.S.C. 254o). Payment of any
amount owed under section 338E of the Act shall be made within one year
of the date the participant breached his or her Loan Repayment Program
Contract, unless the NIH specifically authorizes a longer period.
Terminations will not be considered a breach of contract in cases where
such terminations are beyond the control of the participant as follows:
(a) Terminations for convenience of the government will not be
considered a breach of contract and monetary damages will not be
assessed.
(b) Occasionally, a participant's research assignment or funding
may evolve and change to the extent that the individual is no longer
engaged in approved research. Similarly, the research needs and
priorities of the IC and/or the NIH may change to the extent that a
determination is made that a health professional's skills may be better
utilized in a nonresearch assignment. Normally, job changes of this
nature will not be considered a breach of contract on the part of
either the NIH or the participant. Under these circumstances, the
following will apply:
(1) Program participation will cease as of the date an individual
is no longer engaged in approved research;
(2) Based on the approval of the NIH, the participant will be
released from the remainder of his or her service obligation without
assessment of damages or monetary penalties. The participant in this
case will be permitted to retain all Program benefits made or owed by
the NIH on his/her behalf up to the date the individual is no longer
engaged in research, less the pro rata portion of any benefits advanced
beyond the period of completed service.
Sec. 68.14 Under what circumstances can the service or payment
obligation be canceled, waived, or suspended?
(a) Any obligation of a participant for service or payment will be
canceled upon the death of the participant.
(b)(1) The NIH may waive or suspend any service or payment
obligation incurred by the participant upon request whenever compliance
by the participant:
(i) Is impossible;
(ii) Would involve extreme hardship to the participant; or
(iii) If enforcement of the service or payment obligation would be
unconscionable.
(2) The NIH may approve a request for a suspension of the service
or payment obligations for a period of up to one (1) year.
(c) Compliance by a participant with a service or payment
obligation will be considered impossible if the NIH determines, on the
basis of information and documentation as may be required, that the
participant suffers from a permanent physical or mental disability
resulting in the inability of the participant to perform the service or
other activities that would be necessary to comply with the obligation.
(d) In determining whether to waive or suspend any or all of the
service or payment obligations of a participant as imposing an undue
hardship and being against good conscience, the NIH, on the basis of
such information and documentation as may be required, will consider:
(1) The participant's present financial resources and obligations;
(2) The participant's estimated future financial resources and
obligations; and
(3) The extent to which the participant has problems of a personal
nature, such as a physical or mental disability or terminal illness in
the immediate family, which so intrude on the participant's present and
future ability to perform as to raise a presumption that the individual
will be unable to perform the obligation incurred.
Sec. 68.15 When can an NIH LRP payment obligation be discharged in
bankruptcy?
Any payment obligation incurred under Sec. 68.13 of this part may
be discharged in bankruptcy under Title 11 of the United States Code
only if such discharge is granted after the expiration of the seven-
year period beginning on the first date that payment is required and
only if the bankruptcy court finds that a non-discharge of the
obligation would be unconscionable.
Sec. 68.16 Additional conditions.
(a) When a shortage of funds exists, participants may be funded
only partially, as determined by the NIH. However, once an NIH LRP
contract has been signed by both parties, the NIH will obligate such
funds as necessary to ensure that sufficient funds will be available to
pay benefits for the duration
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of the period of obligated service unless, by mutual written agreement,
the parties specify otherwise.
(b) Additional conditions may be imposed as deemed necessary.
Sec. 68.17 What other regulations and statutes apply?
Several other regulations and statutes apply to this part. These
include, but are not necessarily limited to:
(a) Debt Collection Act of 1982 (31 U.S.C. 3701 note);
(b) Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
(c) Federal Debt Collection Procedures Act of 1990 (28 U.S.C. 176);
and
(d) Privacy Act of 1974 (5 U.S.C. 552a).
Dated: January 16, 2013.
Francis S. Collins,
Director, National Institutes of Health.
Approved: March 27, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-07737 Filed 4-4-13; 8:45 am]
BILLING CODE 4140-01-P
