[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Proposed Rules]
[Pages 30531-30535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12180]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 68b

RIN 0925-AA10
[Docket No. NIH-2007-0930]


National Institutes of Health Undergraduate Scholarship Program 
Regarding Professions Needed by National Research Institutes

AGENCY: National Institutes of Health, HHS.

ACTION: Notice of proposed rulemaking.

-----------------------------------------------------------------------

SUMMARY: The National Institutes of Health (NIH) proposes to issue 
regulations to implement provisions of the Public Health Service Act 
authorizing the NIH Undergraduate Scholarship Program Regarding 
Professions Needed by National Research Institutes (UGSP). The purpose 
of the program is to recruit appropriately qualified undergraduate 
students from disadvantaged backgrounds to conduct research in the 
intramural research program as employees of the NIH by providing 
scholarship support.

DATES: Comments must be received on or before July 28, 2014 to ensure 
that the NIH will be able to consider the comments in preparing the 
final rule.

ADDRESSES: Individuals and organizations interested in submitting 
comments, identified by RIN 0925-AA10 and Docket Number NIH-2007-0930, 
may do so by any of the following methods:
    Electronic Submissions. You may submit electronic comments through 
the Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments. The NIH is no longer accepting 
comments submitted to the agency by email.
    Written Submissions. You may send written submissions in the 
following ways:
     Fax: 301-402-0169.
     Mail: Attention: Jerry Moore, NIH Regulations Officer, 
National Institutes of Health, Office of Management Assessment, 6011 
Executive Boulevard, Suite 601, MSC 7669, Rockville, MD 20892.
     Hand Delivery/Courier (for paper, disk, or CD-ROM 
submissions): Attention: Jerry Moore, 6011 Executive Boulevard, Suite 
601, Rockville, MD 20892.
    Instructions for all Comments. All comments received must include 
the agency name, Regulatory Information Number (RIN), and the docket 
number for this rulemaking. All comments received may be posted without 
change, including any personal information provided.
    Docket. For access to the docket to read background documents or 
comments received, go to the eRulemaking.gov Portal and insert into the 
``Search'' box the docket number ``NIH-2007-0930'' and follow the 
prompts.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, 
telephone 301-496-4607 (not a toll-free number).

SUPPLEMENTARY INFORMATION: On June 10, 1993, the NIH Revitalization Act 
of 1993 (Pub. L. 103-43) was enacted. Section 1631 of this law amended 
the Public Health Service (PHS) Act by adding section 487D (42 U.S.C. 
288-4). Section 487D authorizes the Secretary, acting through the 
Director of the NIH, to carry out a program of entering into contracts 
with individuals under which the Director agrees to provide 
scholarships for pursuing, as undergraduates at accredited institutions 
of higher education, academic programs appropriate for careers in 
professions needed by the NIH. In return, the individuals agree to 
serve as employees of the NIH in positions that are needed by the NIH 
and for which the individuals are qualified. The individuals must be 
enrolled or accepted for enrollment as full-time undergraduates at 
accredited institutions of higher education and must be from 
disadvantaged backgrounds. Section 487D of the PHS Act further states 
that, concerning penalties for breach of scholarship contract, the 
provisions of section 338E of the PHS Act shall apply to the program to 
the same extent and in the same manner as such provisions apply to the 
National Health Service Corps Loan Repayment Program established in 
section 338B.
    The 1993 amendment of the PHS act led to the establishment of the 
NIH Undergraduate Scholarship Program Regarding Professions Needed by 
National Research Institutes (UGSP). The purpose of the program, since 
it began selecting participants in 1997, is to recruit appropriately 
qualified undergraduate students from disadvantaged backgrounds to 
conduct research in the intramural research program as employees of the 
NIH by providing scholarship support. The UGSP provides a diverse and 
highly qualified cadre of individuals seeking careers compatible with 
NIH employment opportunities.
    The NIH is proposing to amend title 42 of the Code of Federal 
Regulations by adding Part 68b to govern the administration of the 
UGSP. The proposed rule establishes program regulations necessary to 
implement and enforce important aspects of the UGSP. In general, the 
proposed rule specifies the scope and purpose of the program, the 
eligibility criteria, the application process, the selection criteria, 
and the terms and conditions of the program.
    The rationale used by the NIH in developing the eligibility and 
selection criteria of this proposed rule is explained as follows. For 
eligibility, the definition for ``Individual from

[[Page 30532]]

Disadvantaged Background'' used in section Sec.  68b.2 of this proposed 
rule is the same definition used for other similar programs in the 
Department of Health and Human Services such as the NIH Loan Repayment 
Program and the Health Resources and Services Administration 
Scholarships for Disadvantaged Students Program. That is, an individual 
from a disadvantaged background, as section Sec.  68b.2 states, means 
``an individual who: (1) Comes from an environment that inhibited (but 
did not prevent) him or her from obtaining the knowledge, skills, and 
abilities required to enroll in an undergraduate institution; or (2) 
Comes from a family with an annual income below established low-income 
thresholds. These low-income thresholds are based on 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 all health professions programs.'' Previously, the UGSP used 
this definition, but switched to another definition that did not take 
into consideration any other factors other than economics in defining 
``Individual from a Disadvantaged Background.'' The program used that 
approach for several UGSP cycles and noted a decrease in the 
qualifications of applicants. The NIH believes that returning to the 
original definition, stated above, will ensure the largest, most 
diverse pool of applicants for the UGSP.
    Regarding selection criteria, the applications are prioritized in 
Sec.  68b.5 to give preference to students that have already completed 
two years of undergraduate studies and have excellent grades in the 
core science courses because the NIH wants to ensure a pool of 
candidates that likely possess the traits required to complete their 
undergraduate training and their required service obligation to the 
NIH.
    The NIH invites public comment on the proposed UGSP regulations. 
The following is provided 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 (September 19, 1980, 
5 U.S.C. chapter 6); section 202 of the Unfunded Mandates Reform Act of 
1995 (Pub. L. 104-4); and Executive Order 13132, Federalism (August 4, 
1999).

Executive Order 12866

    Executive Order 12866, supplemented by Executive Order 13563, 
directs agencies to assess all costs and benefits of available 
regulatory alternatives and, if regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety and other advantages, 
distributive impacts, and equity). A regulatory impact analysis must be 
prepared for major rules with economically significant effects ($100 
million or more in any 1 year). Based on our analysis, we believe that 
the proposed rulemaking will not constitute an economically significant 
regulatory action. Therefore, a regulatory assessment is not required.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C., chapter 6) requires 
agencies to analyze 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, usually businesses with fewer than 500 
employees. Applicants who are eligible to apply for the UGSP are 
individuals not small entities. It is certified that this proposed 
rulemaking will not have a significant impact on a significant number 
of small entities. Therefore, a Regulatory Flexibility Analysis is not 
required.

Section 202(a) of the Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
agencies to 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 inflation-
adjusted threshold for 2014 is approximately $141 million. 
Participation in the UGSP is voluntary and not mandated. Therefore, it 
is certified that this proposed rulemaking does not mandate any 
spending by state, local, or tribal government in the aggregate or by 
the private sector.

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. This proposed 
rulemaking has been reviewed as required under the Executive Order and 
it has been determined that the proposed rulemaking does not have any 
federalism implications. It is certified that this proposed rulemaking 
will not have an effect on the States or on the distribution of power 
and responsibilities among the various levels of government.

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). The application and contract forms used by the NIH Undergraduate 
Scholarship Program have been approved by OMB under OMB No. 0925-0299 
(expires August 31, 2016).

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance-numbered program 
affected by the proposed regulations is: 93.187--NIH Undergraduate 
Scholarship Program for Individuals from Disadvantaged Backgrounds

List of Subjects in 42 CFR Part 68b

    Health--medical research; Student aid--education; Education of 
disadvantaged.
    For reasons presented in the preamble, it is proposed to amend 
title 42 of the Code of Federal Regulations by adding a new Part 68b to 
read as set forth below.

PART 68b--NATIONAL INSTITUTES OF HEALTH (NIH) UNDERGRADUATE 
SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY NATIONAL 
RESEARCH INSTITUTES (UGSP)

Sec.
68b.1 What is the scope and purpose of the National Institutes of 
Health Undergraduate Scholarship Program Regarding Professions 
Needed by National Research Institutes?
68b.2 Definitions.
68b.3 Who is eligible to apply for a Scholarship Program award?
68b.4 How is an application made for a Scholarship Program award?
68b.5 How will applicants be selected to participate in the 
Scholarship Program?
68b.6 What will an individual be awarded for participating in the 
Scholarship Program?
68b.7 What does an individual have to do in return for the 
Scholarship Program award?

[[Page 30533]]

68b.8 Under what circumstances can the period of obligated service 
be deferred to complete approved graduate training?
68b.9 What will happen if an individual does not comply with the 
terms and conditions of participating in the Scholarship Program?
68b.10 When can a Scholarship Program payment obligation be 
discharged in bankruptcy?
68b.11 Under what circumstances can the service or payment 
obligation be canceled, waived, or suspended?
68b.12 What other regulations and statutes apply?

    Authority:  42 U.S.C. 288-4.


Sec.  68b.1   What is the scope and purpose of the National Institutes 
of Health Undergraduate Scholarship Program Regarding Professions 
Needed by National Research Institutes?

    These regulations apply to the award of scholarships under the 
National Institutes of Health Undergraduate Scholarship Program 
Regarding Professions Needed by National Research Institutes, 
authorized by section 487D of the Public Health Service Act (42 U.S.C. 
288-4), to undergraduate students attending schools, as the term is 
defined in these regulations. The purpose of this program is to help 
ensure an adequate supply of trained health professionals for the 
National Institutes of Health, which has the mission to uncover new 
knowledge that will lead to better health.


Sec.  68b.2  Definitions.

    As used in this part:
    Academic year means all or part of a 9-month period during which an 
applicant is enrolled in an undergraduate school as a full-time 
student.
    Acceptable level of academic standing means the level at which a 
full-time student retains eligibility to continue in attendance under 
the school's standards and practices.
    Act means the Public Health Service Act, as amended.
    Applicant means an individual who applies to and meets the 
eligibility criteria for the UGSP.
    Application means forms that have been completed in such manner, 
and containing such agreements, assurances, and information, as 
determined to be necessary by the Director.
    Approved graduate training means graduate programs leading to a 
doctoral-level degree (e.g., Ph.D., M.D., D.O., D.D.S., D.V.M., M.D./
Ph.D., and equivalent degrees) in a profession needed by the National 
Institutes of Health.
    Director means the Director of the National Institutes of Health or 
his/her designee.
    Full-time student means an individual registered for a sufficient 
number of credit hours to be classified as full-time, as defined by the 
school attended.
    Individual from Disadvantaged Background means an individual who 
(1) comes from an environment that inhibited (but did not prevent) him 
or her from obtaining the knowledge, skills, and abilities required to 
enroll in an undergraduate institution; or (2) comes from a family with 
an annual income below established low-income thresholds. These low-
income thresholds are based on family size, published by the U.S. 
Bureau of the Census, adjusted annually for changes in the Consumer 
Price Index, and adjusted by the Secretary of Health and Human Services 
for use in the U.S. Department of Health and Human Services' health 
professions programs. The Secretary periodically publishes these income 
levels in the Federal Register.
    Scholarship Program means the National Institutes of Health 
Undergraduate Scholarship Program Regarding Professions Needed by 
National Research Institutes authorized by section 487D of the Act (42 
U.S.C. 288-4).
    Scholarship Program participant or participant means an individual 
whose application to the Scholarship Program has been approved and 
whose contract has been signed by the Director.
    Scholarship Program Review Committee means the committee that 
reviews, ranks, and accepts or declines applications for Program 
participation. This committee also ascertains whether a participant 
will be awarded continued scholarship support after his or her initial 
acceptance.
    School means a 4-year college or university that (a) is accredited 
by an agency recognized by the Commission on Recognition of Post-
Secondary Accreditation and (b) is located in a State.
    State means one of the several U.S. States, the District of 
Columbia, the Commonwealth of Puerto Rico, the Northern Mariana 
Islands, the U.S. Virgin Islands, Guam, American Samoa, Palau, Marshall 
Islands, and the Federated States of Micronesia.


Sec.  68b.3  Who is eligible to apply for a Scholarship Program award?

    (a) To be eligible for a scholarship under this part, applicants 
must meet the following requirements:
    (1) Applicants must be accepted for enrollment, or be enrolled, as 
full-time undergraduate students in a school;
    (2) Applicants must have an overall grade point average of at least 
3.5 or a 3.5 average in their major field of study (on a 4.0 scale) or 
be ranked within the top five percent of their current class (or those 
students entering, if applying in their freshman year);
    (3) Applicants must come from a disadvantaged background as defined 
by Sec.  68b.2;
    (4) Applicants must meet the citizenship requirements for federal 
employment; and
    (5) Applicants must submit an application to participate in the 
Scholarship Program together with a signed contract as outlined in 
sections 487D(a) and (f) of the Act.
    (b) Any applicant who owes an obligation for service to a State or 
other entity under an agreement entered into before filing an 
application under this part is ineligible for an award unless a written 
statement satisfactory to the Director is submitted from the State or 
entity that:
    (1) There is no potential conflict in fulfilling the service 
obligation to the State or entity and the Scholarship Program, and
    (2) The Scholarship Program service obligation will be served 
before the service obligation for professional practice owed to the 
State or entity.


Sec.  68b.4  How is an application made for a Scholarship Program 
award?

    Each individual desiring a scholarship under this part must submit 
an application (including a signed contract as required under section 
487D(a) of the Act) in such form and manner as the Director may 
prescribe.


Sec.  68b.5  How will applicants be selected to participate in the 
Scholarship Program?

    (a) General. In deciding which applications for participation in 
the Scholarship Program will be approved, the Director will place the 
applications into categories based upon the selection priorities 
described in paragraph (b) of this section. Except for renewal awards 
(see paragraph (e) of this section), the Director will then evaluate 
each applicant under paragraph (c) of this section.
    (b) Priorities. (1) First priority will be given to applicants who 
have completed at least 2 years of undergraduate course work, including 
four core science courses, and are classified by their educational 
institutions as juniors or seniors as of the beginning of the academic 
year of scholarship. (Core science courses include, but are not

[[Page 30534]]

limited to, biology, chemistry, physics, and calculus.)
    (2) Second priority will be given to applicants who have completed 
four core science courses, as defined above.
    (3) Third priority will be given to applicants who are matriculated 
freshmen or sophomores.
    (c) Selection. In selecting participants and determining 
continuation of program support, the Director will take into 
consideration those factors determined necessary to ensure effective 
participation in the Scholarship Program. These factors may include, 
but are not limited to:
    (1) Biomedical research experience and performance,
    (2) Academic performance,
    (3) Career goals, and
    (4) Recommendations.
    (d) Duration of Scholarship award. Subject to the availability of 
funds appropriated for the Scholarship Program, the Director may, at 
his/her discretion, award scholarships under this part for a period of 
one, two, or three academic years.
    (e) Continuation of scholarship support. Subject to the 
availability of funds for the Scholarship Program, the Director may 
continue scholarship support if:
    (1) The participant requests a continuation of scholarship support;
    (2) The scholarship will not extend the total period of Scholarship 
Program support beyond 4 years; and
    (3) The participant is eligible for continued participation in the 
Scholarship Program, as determined by the Scholarship Program Review 
Committee.


Sec.  68b.6  What will an individual be awarded for participating in 
the Scholarship Program?

    (a) Amount of scholarship. (1) Subject to a maximum annual award of 
$20,000, a scholarship award for each school year will consist of:
    (i) Tuition;
    (ii) Reasonable educational expenses, including required fees, 
books, supplies, and required educational equipment;
    (iii) Reasonable living expenses for the academic year as 
documented in the school's financial aid budget; and
    (iv) For purposes of this section, ``required fees'' means those 
fees that are charged by the school to all students pursuing a similar 
curriculum, and ``required educational equipment'' means educational 
equipment that must be purchased by all students pursuing a similar 
curriculum at that school.
    (2) The Director may enter into an agreement with the school in 
which the participant is enrolled for the direct payment of tuition and 
reasonable educational expenses on the participant's behalf.
    (b) Payment of scholarship: Leave-of-absence; repeated course work. 
The Director will suspend scholarship payments to or on behalf of a 
participant if the school:
    (1) Approves a leave-of-absence for the participant for health, 
personal, or other reasons; or
    (2) Requires the participant to repeat course work for which the 
Director has previously made scholarship payments under Sec.  68b.6. 
However, if the repeated course work does not delay the participant's 
graduation date, scholarship payments will continue except for any 
additional costs relating to the repeated course work. Any scholarship 
payments suspended under this paragraph will be resumed by the Director 
upon notification by the school that the participant has returned from 
the leave-of-absence or has completed the repeated course work and is 
pursuing as a full-time student the course of study for which the 
scholarship was awarded.


Sec.  68b.7  What does an individual have to do in return for the 
Scholarship Program award?

    (a) General. For each academic year of scholarship support 
received, participants must serve as full-time employees of the 
National Institutes of Health:
    (1) For not less than 10 consecutive weeks of each year during 
which the participant receives the scholarship; and
    (2) For 12 months for each academic year for which the scholarship 
has been provided.
    (b) Beginning of service. The period of obligated service under 
Sec.  68b.7(a)(2) must begin within 60 days of obtaining the 
undergraduate degree, except for participants who receive a deferment 
under section Sec.  68b.8 below.


Sec.  68b.8  Under what circumstances can the period of obligated 
service be deferred to complete approved graduate training?

    (a) Requested deferment. Upon the request of any participant 
receiving an undergraduate degree, the Director may defer the beginning 
date of the obligated service to allow the participant to complete an 
approved graduate training program. Individuals desiring a deferment 
under this part must submit a request in such form and manner as the 
Director may prescribe.
    (b) Altering deferment. Before altering the length or type of 
approved graduate training for which the period of obligated service 
was deferred under paragraph (a) of this section, the participant must 
request and obtain the Director's approval of the alteration.
    (c) Additional terms of deferment. The Director may prescribe 
additional terms and conditions for deferment under paragraphs (a) and 
(b) of this section as necessary to carry out the purposes of the 
Scholarship Program.
    (d) Beginning of service after deferment. Any participant whose 
period of obligated service has been deferred under paragraph (a) of 
this section must begin the obligated service within 30 days of the 
expiration of their deferment.


Sec.  68b.9  What will happen if an individual does not comply with the 
terms and conditions of participating in the Scholarship Program?

    (a) When a participant fails to maintain an acceptable level of 
academic standing, is dismissed from the school for disciplinary 
reasons, or voluntarily terminates the course of study or program for 
which the scholarship was awarded before completing the course of study 
or program, the participant must, instead of performing any service 
obligation, pay to the United States an amount equal to all scholarship 
funds awarded under Sec.  68b.6. Payment of this amount must be made 
within 3 years of the date the participant becomes liable to make 
payment under this paragraph.
    (b) If, for any reason not specified in Sec.  68b.11(b), a 
participant fails to begin or complete the period of obligated service 
incurred under Sec.  68b.7, including failing to comply with the 
applicable terms and conditions of a deferment granted by the Director, 
the participant must pay to the United States an amount determined by 
the penalties set forth in section 487D(e) of the Act. Payment of this 
amount shall be made within one year of the date that the participant 
failed to begin or complete the period of obligated service, as 
determined by the Director.


Sec.  68b.10  When can a Scholarship Program payment obligation be 
discharged in bankruptcy?

    Any payment obligation incurred under Sec.  68b.9 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.

[[Page 30535]]

Sec.  68b.11  Under what circumstances can the service or payment 
obligation be canceled, waived, or suspended?

    (a) Any obligation of a participant for service or payment to the 
federal government under this part will be canceled upon the death of 
the participant.
    (b) The Director may waive or suspend any service or payment 
obligation incurred by the participant upon request whenever compliance 
by the participant:
    (1) Is impossible, or
    (2)(i) Would involve extreme hardship, and
    (ii) If enforcement of the service or payment obligation would be 
unconscionable, as required by section 487 D(e) of the Act, 42 U.S.C. 
288-4(e).
    (c) The Director may approve a request for a suspension of the 
service or payment obligations for a period of one year. A renewal of 
this suspension may also be granted.
    (d) Compliance by a participant with a service or payment 
obligation will be considered impossible if the Director determines, on 
the basis of information and documentation as may be required, that the 
participant suffers from a physical or mental disability resulting in 
the permanent inability of the participant to perform the service or 
other activities that would be necessary to comply with the obligation.
    (e) 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 equity and good conscience, the Director, on 
the basis of 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 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 begin or complete the obligation incurred.


Sec.  68b.12  What other regulations and statutes apply?

    Several other regulations and statutes apply to this part. These 
include, but are not necessarily limited to:
    (a) Debt Collection Act of 1982 (31 U.S.C. 3701 et seq.);
    (b) Debt Collection Improvement Act of 1996 (31 U.S.C. 3701 note);
    (c) Fair Credit Reporting Act (15 U.S.C. 1681 et seq.);
    (d) Federal Debt Collection Procedures Act of 1990 (28 U.S.C. 176); 
and
    (e) Privacy Act of 1974 (5 U.S.C 552a).

    Dated: April 15, 2014.
Francis S. Collins,
Director, National Institutes of Health. Approved:
Kathleen Sebelius,
Secretary.
[FR Doc. 2014-12180 Filed 5-27-14; 8:45 am]
BILLING CODE 4140-01-P