Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules 10455 

1So 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. 

2So 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. 

3Section 485G of the PHS Act, enacted by Public 

Law 106–525, was redesignated section 464z–5 by 

P.L. 111–148. 

List of Subjects 

Environmental protection, Bird, Lead, 

Lead fishing sinkers, Lead fishing 

tackle. 

Dated: February 14, 2012. 

James Jones, 

Acting Assistant Administrator, Office of 

Chemical Safety and Pollution Prevention. 

[FR Doc. 2012–4087 Filed 2–21–12; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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). 

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 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
10456 Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules 

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, § 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, § 68.3(c), 

§ 68.3(e), § 68.11(c), § 68.14(c), 

§ 68.14(d), and § 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 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules 10457 

1There 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. 

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. 

§ 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). 

(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). 

§ 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 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
10458 Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules 

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 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules 10459 

participant and without obligation to 

the Program. 

§ 68.3 Who is eligible to apply? 

To be eligible for consideration for the 

NIH LRPs, applicants must meet the 

following criteria: 

(a) Be citizens, nationals, or 

permanent residents of the United 

States; 

(b) Have the necessary degree from an 

accredited institution as determined by 

the NIH to be consistent with the needs 

of the LRP; 

(c)(1) For Intramural LRPs only: 

Applicants must be employed by the 

NIH and engage in qualified full-time 

research as specified by the LRP and be 

recommended by the employing IC or 

have a firm commitment of employment 

from an authorized official of the NIH; 

(2) For Extramural LRPs only: 

Applicants must be conducting 

qualified research for an average of at 

least 20 hours per week that is 

supported by a domestic nonprofit 

foundation, nonprofit professional 

association, or other nonprofit 

institution (e.g., university), or a U.S. or 

other government agency (Federal, State 

or local); 

(d) Have total qualifying educational 

loan debt as determined on the program 

eligibility date; 

(e) The NIH or the employing 

institution must provide an assurance 

that the applicant will be employed/ 

appointed and provided research 

support for the applicable term of the 

LRP contract; and 

(f) Recipients of LRP awards must 

conduct their research in accordance 

with applicable Federal, State, and local 

law (e.g., applicable human subject 

protection regulations). 

(g) For Clinical Research for 

Individuals from Disadvantaged 

Background only: Individual must be 

from a disadvantaged background. (See 

§ 68.2, Definitions, Individual from 

Disadvantaged Background.) 

§ 68.4 Who is eligible to participate? 

To be eligible to participate in the 

NIH LRPs, individuals must: 

(a) Meet the eligibility requirements 

specified in § 68.3; 

(b) Not be ineligible for participation 

as specified in § 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. 

§ 68.5 Who is ineligible to participate? 

The following individuals are 

ineligible for NIH LRP participation: 

(a) Persons who do not meet the 

eligibility requirements as specified 

under § 68.3; 

(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 forprofit institution or organization, or 

Federal Government employees working 

more than 20 hours per week; 

(e) Current recipients of NIH 

intramural training awards, e.g., NIH 

Intramural Research Training Awards 

(IRTA) or Cancer Research Training 

Awards (CRTA); 

(f) Individuals conducting research for 

which funding is precluded by Federal 

law, regulation, or HHS/NIH policy or 

that does not comply with applicable 

Federal, State, and local law regarding 

the conduct of the research (e.g., 

applicable human subject protection 

regulations); 

(g) Individuals with only ineligible 

loans or loans that are not educational; 

and 

(h) Individuals who do not have 

sufficient qualifying educational debt to 

meet the debt threshold. 

§ 68.6 How do individuals apply to 

participate in the NIH LRPs? 

An application for participation in an 

NIH LRP shall be submitted to the NIH, 

which is responsible for the Program’s 

administration, in such form and 

manner as the Secretary prescribes. 

§ 68.7 How are applicants selected to 

participate in the NIH LRPs? 

The NIH LRP awards are competitive. 

To be selected for participation in an 

NIH LRP, applicants must satisfy the 

following requirements: 

(a) Applicants must meet the 

eligibility requirements specified in 

§ 68.3 and § 68.4. 

(b) Applicants must not be ineligible 

for participation as specified in § 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, 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
10460 Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules 

including the mentors’ record in 

mentoring researchers, funding history, 

and research productivity. 

(B) Quality and appropriateness of 

institutional resources and facilities. 

(iii) For the Health Disparities 

Research LRP, at least 50 percent of the 

contracts are required by statute to be 

for appropriately qualified health 

professionals who are members of a 

health disparity population. 

§ 68.8 What do the NIH LRPs provide to 

participants? 

(a) Loan Repayments: For each year of 

the applicable service period the 

individual agrees to serve, the NIH may 

pay up to $35,000 per year of a 

participant’s repayable debt. 

(b) Payments are made directly to a 

participant’s lender(s). If there is more 

than one outstanding qualified 

educational loan, the NIH will repay the 

loans in the following order, unless the 

NIH determines significant savings 

would result from paying loans in a 

different order of priority: 

(1) Loans guaranteed by the U.S. 

Department of Health and Human 

Services; 

(2) Loans guaranteed by the U.S. 

Department of Education; 

(3) Loans made or guaranteed by a 

State; 

(4) Loans made by a school; and 

(5) Loans made by other entities. 

(c) Tax Liability Payments: In 

addition to the loan repayments, the 

NIH shall make tax payments in an 

amount equal to 39 percent of the total 

annual loan repayment to the Internal 

Revenue Service on the participant’s 

behalf. The NIH may make additional 

payments to those participants who 

show increased Federal, State, and/or 

local taxes as a result of loan 

repayments. 

(d) Under § 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. 

§ 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. 

§ 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. 

§ 68.11 What does an individual have to do 

in return for loan repayments received 

under the NIH LRPs? 

Individuals must agree to: 

(a) Engage in qualified research for the 

applicable contract service period; 

(b)(1) For Intramural LRPs: Engage in 

such research full-time as employees of 

NIH, or; (2) For Extramural LRPs: 

Engage in such research for an average 

of 20 hours per week supported by a 

domestic nonprofit foundation, 

nonprofit professional association, or 

other nonprofit institution (e.g., 

university), or a U.S. or other 

government agency (Federal, State or 

local); 

(c) Keep all loan accounts in good 

standing, provide timely documentation 

as needed, including payment 

verification, service verification, change 

of research, change of institution, etc. 

Failure to provide such documentation 

may result in early termination, and the 

individual may be subject to statutory 

financial penalties; and 

(d) Satisfy all of the other terms and 

conditions of the LRP and the LRP 

Contract (e.g., Obligations of the 

Participant). Failure to adhere to the 

terms and conditions of the LRP 

contract may result in early termination, 

and the individual may be subject to 

statutory financial penalties. 

§ 68.12 How does an individual receive 

loan repayments beyond the initial 

applicable contract period? 

An individual may apply for a 

competitive extension contract for at 

least a one-year period if the individual 

is engaged in qualifying research and 

satisfies the eligibility requirements 

specified under § 68.3 and § 68.4 for the 

extension period and has remaining 

repayable debt as established by the 

Secretary. 

§ 68.13 What will happen if an individual 

does not comply with the terms and 

conditions of participation in the NIH LRPs? 

Program participants who breach their 

Loan Repayment Program Contracts will 

be subject to the applicable monetary 

payment provisions set forth at section 

338E of the Act (42 U.S.C. 254o). 

Payment of any amount owed under 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Proposed Rules 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. 

§ 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. 

§ 68.15 When can an NIH LRP payment 

obligation be discharged in bankruptcy? 

Any payment obligation incurred 

under § 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 sevenyear 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. 

§ 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. 

§ 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 

DEPARTMENT OF DEFENSE 

GENERAL SERVICES 

ADMINISTRATION 

NATIONAL AERONAUTICS AND 

SPACE ADMINISTRATION 

48 CFR Parts 31 and 52 

[FAR Case 2011–011; Docket 2011–0011; 

Sequence 1] 

RIN 9000–AM13 

Federal Acquisition Regulation; 

Unallowability of Costs Associated 

With Foreign Contractor Excise Tax 

AGENCIES: Department of Defense (DoD), 

General Services Administration (GSA), 

and National Aeronautics and Space 

Administration (NASA). 

ACTION: Proposed rule. 

SUMMARY: DoD, GSA, and NASA are 

proposing to amend the Federal 

Acquisition Regulation (FAR) to 

implement the requirements of the 

James Zadroga 9/11 Health and 

Compensation Act of 2010 regarding the 

imposition of a 2 percent tax on certain 

foreign procurements. 

DATES: Interested parties should submit 

written comments to the Regulatory 

Secretariat at one of the addressees 

shown below on or before April 23, 

2012 to be considered in the formation 

of the final rule. 

ADDRESSES: Submit comments in 

response to FAR case 2011–011 by any 

of the following methods: 

• Regulations.gov: http:// 

www.regulations.gov. Submit comments 

via the Federal eRulemaking portal by 

inputting ‘‘FAR Case 2011–011’’ under 

the heading ‘‘Enter Keyword or ID’’ and 

selecting ‘‘Search.’’ Select the link 

‘‘Submit a Comment’’ that corresponds 

with ‘‘FAR Case 2011–011.’’ Follow the 

instructions provided at the ‘‘Submit a 

Comment’’ screen. Please include your 

name, company name (if any), and 

‘‘FAR Case 2011–011’’ on your attached 

document. 

• Fax: (202) 501–4067. 

• Mail: General Services 

Administration, Regulatory Secretariat 

(MVCB), Attn: Hada Flowers, 1275 First 


wreier-aviles on DSK5TPTVN1PROD with PROPOSALS