[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

[[Page 10458]]

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