[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Proposed Rules]
[Pages 10455-10461]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3900]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
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: Notice of proposed rulemaking.
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SUMMARY: The National Institutes of Health (NIH) proposes to rescind
the current regulations governing two of its eight loan repayment
programs and issue 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). This rule compliments efforts afforded by EO
13563.
DATES: Comments must be received on or before April 23, 2012 in order
to ensure that NIH will be able to consider the comments in preparing
the final rule.
ADDRESSES: Persons and organizations interested in submitting comments,
identified by RIN 0925-AA43 and Docket Number NIH-2008-0003, may do so
by any of the following methods:
Electronic Submissions: You may submit electronic comments in the
following way:
Federal eRulemaking Portal: Follow the instructions for
submitting comments.
To ensure timelier processing of comments, NIH is no longer accepting
comments submitted to the agency by email. The NIH encourages you to
continue to submit electronic comments by using the Federal eRulemaking
Portal: http://www.regulations.gov.
Written Submissions: You may submit written comments in the
following ways:
Fax: 301-402-0169.
Mail: Attention Jerry Moore, NIH Regulations Officer,
Office of Management Assessment, NIH, 6011 Executive Boulevard, Suite
601, MSC 7669, Rockville, MD 20852-7669.
Hand delivery/courier (for paper, disk, or CD-ROM
submissions): Attention: Jerry Moore, 6011 Executive Boulevard, Suite
601, Rockville, MD 20852-7669.
Docket: For access to the docket to read background documents or
comments received, go to the eRulemaking Portal and insert the docket
number provided in brackets in the heading on page one of this document
into the ``Search'' box and follow the prompts.
FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer,
Office of Management Assessment, NIH, 6011 Executive Boulevard, Room
601, MSC 7669, Rockville, MD 20892; by email MooreJ@mail.nih.gov; by
fax 301-402-0169; or mailto:MooreJ@mail.nih.gov.mailto:(jm40z@nih.gov)
by telephone 301-496-4607 (not a toll-free number) for information
about the rulemaking process. For program information contact: the NIH
Division of Loan Repayment by email lrp@nih.gov or telephone 866-849-
4047. Information regarding the requirements, application deadline
dates, and an online application for the NIH Loan Repayment Programs
may be obtained from 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, Public Law (Pub. L.) 100-
607, Title VI of which amended the Public Health Service (PHS) Act by
adding section 487A (42 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, redesignated 464z-5; \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\ So in law. There are two sections 487F. Section 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 P.L. 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, and section 464z-5
authorizes the Director, National Institute on Minority Health and
Health Disparities (NIMHD), 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
[[Page 10456]]
interest of the qualified educational loans of such professionals. In
return for these loan repayments, applicants must agree to participate
in qualifying research for an initial period of not less than two years
(or a minimum of three years for the 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 propose to consolidate the
regulations into a single set of regulations governing all the LRPs.
More specifically, we propose to rescind 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 issue 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.
The purpose of this Notice of Proposed Rulemaking (NPRM) is to
invite public comment on the proposed actions. We provide the following
as public information.
Regulatory Impact Analysis
We have examined the impacts of this rule as required by Executive
Order 12866, Regulatory Planning and Review (September 30, 1993),
Executive Order 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 Executive Order 13132 on Federalism
(August 4, 1999).
Executive Order 12866
Executive Order 12866, Regulatory Planning and Review, 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 that the proposed 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.
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 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
Executive Order 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. chapter
35). More specifically, Sec. 68.6 is a reporting requirement, but the
specifics of the burden are determined in the approved application
forms used by the NIH Loan Repayment Programs and have been approved
under OMB No. 0925-0361, Expiration Date: June 30, 2014. Additionally,
Sec. 68.3(c), Sec. 68.3(e), Sec. 68.11(c), Sec. 68.14(c), Sec.
68.14(d), and Sec. 68.16(a) 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
[[Page 10457]]
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 in 42 CFR Part 68
Health professions, Loan repayment programs--health, Medical
research.
For reasons presented in the preamble, it is proposed to amend
title 42 of the Code of Federal Regulations by rescinding the current
regulations at parts 68a and 68c, and adding Part 68 that encompasses
all NIH Loan Repayment Programs, as set forth below.
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 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).
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
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employees and have program-specified degrees and domestic nonprofit
support, are eligible to apply. The Extramural LRPs include the (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 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 NIH. The intramural LRPs include the (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 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
[[Page 10459]]
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;
(b) Not be ineligible for participation as specified in Sec. 68.5;
(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;
(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,
(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., 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. 68.3 and Sec. 68.4.
(b) Applicants must not be ineligible for participation as
specified in Sec. 68.5.
(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,
[[Page 10460]]
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 Sec. 68.8(a), (b), and (c), 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,
(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. 68.3 and Sec. 68.4 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
[[Page 10461]]
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) The NIH may waive or suspend any service or payment obligation
incurred by the participant upon request whenever compliance by the
participant: (1) Is impossible, (2) would involve extreme hardship to
the participant, or (3) if enforcement of the service or payment
obligation would be unconscionable. 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 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 nondischarge 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 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:
Debt Collection Act of 1982 (31 U.S.C. 3701 note);
Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
Federal Debt Collection Procedures Act of 1990 (28 U.S.C. 176); and
Privacy Act of 1974 (5 U.S.C. 552a).
Dated: September 28, 2011.
Francis S. Collins,
Director, NIH, National Institutes of Health.
Approved: February 7, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-3900 Filed 2-21-12; 8:45 am]
BILLING CODE 4140-01-P