[Federal Register Volume 78, Number 115 (Friday, June 14, 2013)]
[Proposed Rules]
[Pages 35837-35844]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

42 CFR Part 52i

[Docket Number NIH-2007-0931]
RIN 0925-AA61


National Institute on Minority Health and Health Disparities 
Research Endowments

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The National Institutes of Health (NIH) proposes to issue 
regulations governing National Institute on Minority Health and Health 
Disparities (NIMHD) endowment grants awarded to section 736 and section 
464z-4 Centers of Excellence to

[[Page 35838]]

facilitate minority health disparities research and other health 
disparities research.

DATES: Comments must be received on or before August 13, 2013 in order 
to ensure that the NIH will be able to consider the comments when 
preparing the final rule.

ADDRESSES: Individuals and organizations interested in submitting 
comments, identified by RIN 0925-AA47 and Docket No. NIH-2007-0931, may 
do so by any of the following methods:

Electronic Submissions

    You may submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    To ensure timely processing of comments, the 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 (not a toll-free number).
     Mail: Jerry Moore, NIH Regulations Officer, Office of 
Management Assessment, National Institutes of Health, 6011 Executive 
Boulevard, Room 601, MSC 7669, Rockville, MD 20852-7669.
    Instructions: All submissions received must include the agency name 
and docket number and Regulatory Information Number (RIN) 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 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 at the address above or 
telephone 301-496-4607 (not a toll-free number).

SUPPLEMENTARY INFORMATION: Section 464z-3 (42 U.S.C. 285t) of the 
Public Health Service (PHS) Act authorizes the Director of the NIMHD to 
carry out a program to facilitate minority health disparities research 
and other health disparities research by providing research endowments 
to eligible centers of excellence under sections 736 and 464z-4 of the 
PHS Act. The program is called the NIMHD Research Endowment Program 
(Endowment Program). The objective of the Endowment Program is to build 
research and training capacity and infrastructure at eligible section 
736 health professions schools (42 U.S.C. 293) and section 464z-4 
biomedical and behavioral research institutions (42 U.S.C. 285t-1) to 
facilitate minority health and other health disparities research to 
close the disparity gap in the burden of illness and death experienced 
by racial and ethnic minority Americans and other health disparity 
populations. Endowment Program activities may include strengthening the 
research infrastructure through the renovation of facilities, 
purchasing of state-of-the-art instruments and equipment, and enhancing 
information technology; enhancing the academic environment by 
recruiting a diverse faculty and creating relevant courses in such 
topics as research methodology and health disparities as additions to 
the existing curriculum; enhancing recruitment of individuals currently 
underrepresented in the biomedical, clinical, behavioral, and social 
sciences; or other relevant activities.
    Section 464z-4 of the PHS Act authorizes the NIMHD Director to make 
awards to designated biomedical and behavioral research institutions, 
alone or as a participant in a consortium, that meet certain criteria 
for the purpose of assisting the institutions in supporting programs of 
excellence in training for members of health disparity populations or 
other health disparity populations. This program is called the NIMHD 
Center of Excellence for Research and Training. Section 464z-4(f) of 
the PHS Act permits the NIMHD Director to expend a portion of such an 
award for research endowment.
    To be eligible to apply for the Endowment Program, Centers of 
Excellence (funded under section 736 or section 464z-4 of the PHS Act) 
must have an institutional endowment that is equal to or less than 50 
percent of the national median of endowment funds at institutions that 
conduct similar biomedical research and training of health 
professionals. Endowment Program applications filed by institutions 
meeting eligibility requirements undergo peer review by outside experts 
to evaluate the scientific and technical merit of the proposed 
activities and the adequacy of the endowment fund management plan.
    Reviewers use the criteria of significance, investigators, 
innovation, approach, and environment to determine the overall impact 
of the application. After receiving an Endowment Program award, a 
grantee must provide documentation to the NIMHD over a 20-year period 
regarding endowment fund activity, including investments, income, and 
expenditures for activities consistent with its strategic plan.
    With this notice of proposed rulemaking (NPRM), the NIH is 
announcing its proposed regulations governing endowments and inviting 
the public to comment on this proposal.
    This NPRM specifies the endowment research grants or endowment 
portion of an award to which the proposed regulations apply (section 
52i.1), the definitions (section 52i.2), who is eligible (section 
52i.3) and how to apply for a grant under the program (section 52i.5), 
and under what conditions an eligible institution that is a recipient 
may transfer to a foundation a research endowment grant (section 
52i.4). Additionally, the NPRM specifies how endowment grant 
applications will be evaluated (section 52i.6), what is the nature of 
the grants (52i.7), how much endowment fund income a grantee may 
withdraw and for what purpose (sections 52i.9 and 52i.10), what a 
grantee must record and report (section 52i.11), and when and for what 
purposes a grantee may spend the endowment fund corpus (section 52i.8). 
This NPRM also specifies what happens if a grantee fails to administer 
the research endowment grant in accordance with applicable regulations 
(section 52i.12), what other HHS policies and regulations apply 
(section 52i.13), and what additional conditions the NIMHD Director may 
impose when, in his judgment, the conditions are necessary (section 
52i.14).
    The following is provided as public information.

Regulatory Impact Analyses (RIA)

    We have examined the impacts of the this rule as required by 
Executive Order 12866, Regulatory Planning and Review (September 30, 
1993); Executive Order 13563, Improving Regulation and Review (January 
18, 2011); the Regulatory Flexibility Act (5 U.S.C. 601-612); the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4); and Executive 
Order 13132, Federalism (August 4, 1999).

Executive Orders 12866 and 13563

    Executive Order 12866, Regulatory Planning and Review, directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health

[[Page 35839]]

and safety, and other advantages; distributive impacts; and equity). A 
RIA must be prepared for major rules with economically significant 
effects ($100 million or more in one year). Based on our analysis, we 
believe that the proposed rulemaking does not constitute an 
economically significant regulatory action. Additionally, if a 
regulatory action is deemed to fall within the scope of the definition 
of the term ``significant regulatory action'' contained in section 3(f) 
of Executive Order 12866, pre-publication review by the Office of 
Information and Regulatory Affairs (OIRA), Office of Management and 
Budget (OMB) is required. This proposed rule was reviewed under the 
criteria of Executive Order 12866 and was not deemed a ``significant 
regulatory action.''
    Executive Orders 12866 and 13563 direct 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 effects; distributive impacts; and equity). 
Executive Order 13563 emphasizes the importance of quantifying both 
costs and benefits, of reducing costs, of harmonizing rules, and of 
promoting flexibility.

Benefits

    The proposed regulations will add transparency for potential 
applicants regarding who is eligible and how to apply for a grant under 
the program, how grant applications will be evaluated, and under what 
conditions an eligible institution that is a recipient may transfer to 
a foundation a research endowment grant. Additionally, the NPRM 
specifies the nature of the grants, how much endowment fund income a 
grantee may withdraw and for what purpose, what a grantee must record 
and report, and when and for what purposes a grantee may spend the 
endowment fund corpus.
    This NPRM also enhances compliance and effective fiduciary 
responsibilities for the federal government. It specifies what happens 
if a grantee fails to administer the research endowment grant in 
accordance with applicable regulations, what other HHS policies and 
regulations apply, and additional conditions the NIMHD Director may 
impose when, in his judgment, the conditions are necessary. The 
Director may, with respect to any grant award, impose additional 
conditions prior to, or at the time of, any award when in the 
Director's judgment the conditions are necessary to ensure the carrying 
out of the purposes of the award, the interests of the public health, 
or the conservation of grant funds.

Costs

    Based on the provisions of the PHS Act, approximately twelve 
Institutions of Higher Education (IHEs) are eligible for the NIMHD 
Research Endowment Program. Costs for participation can be subdivided 
into those associated with the application process and those required 
for the necessary recordkeeping. The application process includes a 
competitive submission, as well as noncompetitive progress report for 
those institutions awarded funds under the NIMHD Research Endowment 
Program for subsequent years within the project period. Based on 
estimates provided in the PHS 424 instructions, an average application 
should require approximately 22 hours to complete and 15 hours for a 
subsequent progress report, according to the PHS 2590 instructions. The 
contribution of various professional disciplines such as biomedical 
researchers, contract/grants specialists, and technical staff to the 
reporting and recordkeeping requirements varies. Cost estimates are 
based on a blended analysis of institutional salary structure and 
prevailing market conditions for certain categories of personnel. In 
addition, fiscal year 2012 NIH salary limitations were included in the 
derivation of cost estimates, where applicable.

----------------------------------------------------------------------------------------------------------------
                                       Annual number of                       Estimated cost    Estimated annual
                                       respondents \1\    Annual frequency   per response \2\      costs \3\
----------------------------------------------------------------------------------------------------------------
Reporting:
    Sec.   52i.3(b)(2)..............                  4                  1        \4\ $134.60            $538.40
    Sec.   52i.4(a).................                  4                  1          \5\ 33.65             134.60
    Sec.   52i.4(c).................                  4                  1          \6\ 33.65             134.60
    Sec.   52i.5(a).................                  4                  1       \7\ 3,602.00          14,408.00
    Sec.   52i.9(b).................                  4                  1         \8\ 345.56           1,382.24
    Sec.   52i.11(b)................                 12                  1       \9\ 1,775.00          21,300.00
    Sec.   52i.11(d)................                 12                  1        \10\ 200.00           2,400.00
                                     ---------------------------------------------------------------------------
        Subtotal....................  .................  .................  .................          40,297.84
Recordkeeping:
    Sec.   52i.10...................                 12                  1        \11\ 400.00           4,800.00
    Sec.   52i.11(a)(1).............                 12                  1         \12\ 67.30             807.60
    Sec.   52i.11(a)(2).............                 12                  1         \13\ 67.30             807.60
    Sec.   52i.11(a)(3).............                 12                  1         \14\ 67.30             807.60
    Sec.   52i.11(a)(4).............                 12                  1         \15\ 67.30             807.60
    Sec.   52i.11(b)................                 12                  1        \16\ 269.20           3,230.40
                                     ---------------------------------------------------------------------------
        Subtotal....................  .................  .................  .................          11,260.80
                                     ---------------------------------------------------------------------------
            Total...................  .................  .................  .................          51,558.64
----------------------------------------------------------------------------------------------------------------
\1\ There is currently a total of twelve institutions eligible for the NIMHD Research Endowment Program.
  Historically, requests for applications are solicited every three years.
\2\ Average burden hours x average cost per hour.
\3\ Annual number of respondents x cost per response.
\4,5,6\ Based on contracts/grants staff at $33.65/hour.
\7\ Based on the contributions of the principal investigator at $86.39/hour, participating faculty at $72.12/
  hour, contracts/grants staff at $33.65/hour, financial investment advisor at $200/hour, and administrative
  support at $16.83/hour.
\8\ Based on principal investigator at $86.39/hour.
\9\ Based on the contributions of the principal investigator at $86.39/hour, participating faculty at $72.12/
  hour, contracts/grants staff at $33.65/hour, financial investment advisor at $200/hour, and administrative
  support at $16.83/hour.
\10\ Based on financial analyst/auditor at $100/hour.
\11\ Based on financial investment advisor at $200/hour.

[[Page 35840]]

 
\12,13,14,15\ Based on contracts/grants staff at $33.65/hour.
\16\ Based on contracts/grants staff at $33.65/hour.

Alternatives

    The unique and complex nature of the NIMHD Research Endowment 
Program with regard to the management of endowment funds, restrictive 
nature of expenditures, and strict reporting provides a challenge to 
the necessary federal oversight. The proposed draft rule provides the 
guidelines for the creation of an operation structure of the 
institutional program. The implementation of the draft rule would 
provide clarity to eligible and participating institutions with regard 
to expectations as a grantee under the program, as well as enhance the 
ability of the federal government to ensure the grantees are in 
compliance with all the applicable provisions of the statute.

The Regulatory Flexibility Act

    The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies 
to analyze regulatory options that would minimize any significant 
impact of the rule on small entities. For the purposes of this 
analysis, small entities include small business concerns as defined by 
the Small Business Administration, usually businesses with fewer than 
500 employees. Eligibility requirements of the Research Endowment 
program, as codified in Public Law 111-148, limits the universe of 
potential applicants to approximately twelve IHEs. Utilizing sources of 
information such as local business bureaus, workforce statistics, and 
institution Web sites, a reasonable determination was made as to the 
approximate number of employees at eligible institutions. The range 
estimates are from 175-550 for the smallest institution to 3,976 for 
the largest. Consequently, less than 10 percent of these eligible IHEs 
have fewer than 500 employees. Accordingly, the Secretary certifies 
than any final rule resulting from this proposed rule will not have a 
significant impact on a significant number of small entities.

Unfunded Mandates Reform Act of 1995

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which 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 governments, 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 1 year.'' The current 
inflation-adjusted statutory threshold is approximately $139 million 
based on the Bureau of Labor Statistics inflation calculator. 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 NIMHD Research Endowment Program is 
voluntary and not mandated.

Executive Order 13132

    Executive Order 13132, Federalism, requires federal agencies to 
consult with state and local government officials in the development of 
regulatory policies with federalism implications. The Secretary 
reviewed the proposed rule as required under the Executive Order and 
determined that it does not have federalism implications. The Secretary 
certifies that the proposed rule 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 contains requirements that are subject to OMB 
approval under the Paperwork Reduction Act of 1995, as amended (44 
U.S.C. chapter 35). Sections 52i.3(b)(2), 52i.4(a), 52i.4(c), 52i.5(a), 
52i.9, 52i.11(b), and 52i.11(d) contain reporting and information 
collection requirements that are subject to OMB approval under the 
Paperwork Reduction Act. Sections 52i.10, 52i.11(a)(1), 52i.11(a)(2), 
52i.11(a)(3), 52i.11(a)(4), and 52i.11(b) contain recordkeeping 
requirements that are subject to OMB review under the Paperwork 
Reduction Act. The title, description, and respondent description of 
the information collection and recordkeeping requirements contained in 
this proposed rule have been submitted to OMB for review. Other 
organizations and individuals desiring to submit comments on the 
information collection and recordkeeping requirements, including the 
burden estimates provided, should send their comments to: (1) Seleda 
Perryman, Project Clearance Officer, National Institutes of Health, 
Rockledge Center 1, 6705 Rockledge Drive, Room 3509, Bethesda, MD 
29817, telephone 301-594-7949 (not a toll-free number); and (2) the 
Office of Information and Regulatory Affairs, OMB, OIRA_submission@omb.eop or by fax to 202-395-6974, and mark ``Attention: 
Desk Officer for the National Institutes of Health, Department of 
Health and Human Services.'' After we obtain OMB approval, we will 
publish the OMB control number in the Federal Register.
    Title: National Institute on Minority Health and Health Disparities 
Research Endowments.
    Description: The NIMHD Research Endowment Program builds research 
capacity and research infrastructure in order to facilitate minority 
health research and research regarding other health disparity 
populations at eligible institutions under sections 736 and 464z-4 of 
the PHS Act.
    Respondent Description: Institutions currently funded under Section 
736 or Section 464z-4 of the Public Health Service Act (PHS Act).

              Estimated Annual Reporting and Recordkeeping Burden NIMHD Research Endowment Program
----------------------------------------------------------------------------------------------------------------
                                                                                                 Annual burden
                                       Annual number of   Annual frequency    Average burden       hours per
                                         respondents                              hours          response \17\
----------------------------------------------------------------------------------------------------------------
Reporting:
    Sec.   52i.3(b)(2)..............                  4                  1                  4                 16
    Sec.   52i.4(a).................                  4                  1                  1                  4
    Sec.   52i.4(c).................                  4                  1                  1                  4
    Sec.   52i.5(a).................                  4                  1                 22                 88
    Sec.   52i.9(b).................                  4                  1                  4                 16
    Sec.   52i.11(b)................                 12                  1                 15                180
    Sec.   52i.11(d)................                 12                  1                  2                 24
                                     ---------------------------------------------------------------------------
    Subtotal........................  .................  .................                 49                332

[[Page 35841]]

 
    Recordkeeping:..................
    Sec.   52i.10...................                 12                  1                  2                 24
    Sec.   52i.11(a)(1).............                 12                  1                  2                 24
    Sec.   52i.11(a)(2).............                 12                  1                  2                 24
    Sec.   52i.11(a)(3).............                 12                  1                  2                 24
    Sec.   52i.11(a)(4).............                 12                  1                  2                 24
    Sec.   52i.11(b)................                 12                  1                  8                 96
                                     ---------------------------------------------------------------------------
        Subtotal....................  .................  .................                 18                216
                                     ---------------------------------------------------------------------------
            Total...................  .................  .................                 67                548
----------------------------------------------------------------------------------------------------------------
\17\ Annual number of respondents x annual frequency x average burden hours.

Catalogue of Federal Domestic Assistance

    The Catalogue of Federal Domestic Assistance-numbered program 
applicable to this rule is: 93.307--Minority Health and Health 
Disparities Research

List of Subjects in 42 CFR Part 52i

    Grant programs--Health, medical research.
    For reasons described in the preamble, it is proposed to amend 
title 42 of the Code of Federal Regulations by adding part 52i to read 
as follows.

PART 52i--NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH 
DISPARITIES RESEARCH ENDOWMENT PROGRAMS

Sec.
52i.1 To what programs does this part apply?
52i.2 Definitions.
52i.3 Who is eligible to apply?
52i.4 Under what conditions may an eligible institution designate a 
foundation as the recipient of a research endowment grant?
52i.5 How to apply for a grant.
52i.6 Evaluation and disposition of research endowment grant 
applications.
52i.7 Grant awards.
52i.8 When and for what purposes may a grantee spend the endowment 
fund corpus?
52i.9 How much endowment fund income may a grantee spend and for 
what purposes?
52i.10 How shall a grantee calculate the amount of endowment fund 
income that it may withdraw and spend?
52i.11 What shall a grantee record and report?
52i.12 What happens if a grantee fails to administer the research 
endowment grant in accordance with applicable regulations?
52i.13 Other HHS policies and regulations that apply.
52i.14 Additional conditions.

     Authority: 42 U.S.C. 216, 285t-285t-1.


Sec.  52i.1  To what programs does this part apply?

    This part applies to grants awarded under section 464z-3(h) of the 
Public Health Service Act (the Act), which authorizes the Director of 
the National Institute on Minority Health and Health Disparities 
(NIMHD) to carry out a program of research endowment grants to eligible 
institutions to facilitate minority health and health disparities 
research (the NIMHD Research Endowment Program), and, with the 
exception of Sec. Sec.  52i.5 and 52i.6, applies to that portion of an 
award made under section 464z-4(f) of the Act authorized by the NIMHD 
Director for research endowment.


Sec.  52i.2  Definitions.

    As used in this part:
    Act means the Public Health Service Act, as amended (42 U.S.C. 201 
et seq.).
    Center of Excellence means, for purposes of grants authorized by 
section 464z-3(h) of the Act, an institution designated as a Center of 
Excellence and receiving a grant under section 736 (42 U.S.C. 293) or 
section 464z-4 (42 U.S.C. 285t-1) of the Act.
    Director means the Director, NIMHD, of the National Institutes of 
Health.
    Endowment fund means a fund that is established by state law, by an 
institution, or by a foundation associated with an institution that is 
exempt from taxation and is maintained for the purpose of generating 
income for the support of minority and health disparities research or 
research training if the funds are from a grant made under section 
464z-4 of the Act. The principal or corpus of the fund may not be spent 
except as noted in Sec.  52i.8(b).
    Endowment fund corpus means an amount equal to the total grant 
funds awarded under this part or equal to the amount designated as 
endowment under section 464z-4 of the Act.
    Endowment fund income means the income generated from investing the 
corpus, i.e., the amount of which exceeds the endowment fund corpus.
    Health disparity population means a population that, as determined 
by the Director of the NIMHD after consultation with the Director of 
the Agency for Healthcare Research and Quality, has 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.
    Health disparities research means basic, clinical, and behavioral 
research on health disparity populations (including individual members 
and communities of such populations) that relates to health 
disparities, including the causes of such disparities and methods to 
prevent, diagnose, and treat such disparities.
    Health disparity students means students of minority health 
disparity populations or other health disparities populations.
    Institutional endowment (IE) means the corporate or system-wide 
endowment fund that is the sum total of the endowment assets of all 
campuses and their components. This includes, but is not limited to, 
endowments managed by an institution's foundations/associations as well 
as state university systems.
    Institution system-wide means all campuses and components.
    Minority health conditions means, with respect to individuals who 
are members of minority groups, all diseases, disorders, and conditions 
(including with respect to mental health and substance abuse):
    (1) Unique to, more serious, or more prevalent in such individuals;
    (2) For which the factors of medical risk or types of medical 
intervention may be different for such individuals, or for which it is 
unknown whether such

[[Page 35842]]

factors or types are different for such individuals; or
    (3) With respect to which there has been insufficient research 
involving such individuals as subjects or insufficient data on such 
individuals.
    Minority health disparities research means basic, clinical, and 
behavioral research on minority health conditions, including research 
to prevent, diagnose, and treat such conditions.
    Racial and ethnic minority or minority group means American Indians 
(including Alaska Natives, Eskimos, and Aleuts), Asian Americans, 
Native Hawaiians and other Pacific Islanders, Blacks, and Hispanics. 
Hispanic means individuals whose origin is Mexican, Puerto Rican, 
Cuban, Central or South American, or other Spanish culture or origin.
    Secretary means the Secretary of Health and Human Services and any 
other officer or employee of the Department of Health and Human 
Services to whom the authority involved has been delegated.


Sec.  52i.3  Who is eligible to apply?

    (a) To be eligible for a grant under section 464z-3(h) of the Act 
an applicant:
    (1) Must be a Center of Excellence under section 736 (42 U.S.C. 
293) or section 464z-4 (42 U.S.C. 285t-1) of the Act, and
    (2) Must have an institutional endowment that is equal to or less 
than 50 percent of the national median of endowment funds at 
institutions that conduct similar biomedical research and training of 
health professionals.
    (b) To be eligible for a portion of a grant award to be expended as 
a research endowment under section 464z-4(f) of the Act, an applicant:
    (1) Must be a designated biomedical and behavioral research 
institution under section 464z-4 of the Act, and
    (2) Must submit those materials prescribed by the Director, NIMHD.


Sec.  52i.4  Under what conditions may an eligible institution 
designate a foundation as the recipient of a research endowment grant?

    A number of universities and other organizations have established 
closely affiliated, but separately incorporated, organizations to 
facilitate the administration of research and other programs supported 
by federal funds. Such legally independent entities are often referred 
to as ``foundations,'' although this term does not necessarily appear 
in the name of the organization. An institution awarded an endowment 
grant under section 464z-3(h) of the Act or using designated grant 
funds for endowment purposes under section 464z-4(f) of the Act may 
designate a foundation associated with the institution to receive the 
endowment funds only for investment purposes if:
    (a) The institution assures in its application that the foundation 
is legally authorized to receive the endowment funds and to administer 
the endowment funds in accordance with the regulations set forth in 
this part;
    (b) The foundation agrees to administer the endowment funds in 
accordance with the regulations in this part;
    (c) The institution agrees to be liable for any violation by the 
foundation of any applicable regulation, including any violation 
resulting in monetary liability; and
    (d) The grantee institution has control and is responsible for the 
administration of the grant accounts.


Sec.  52i.5  How to apply for a grant.

    (a) Each institution interested in applying for a grant under 
section 464z-3(h) of the Act must submit an application at such time 
and in such form and manner as the Secretary may prescribe.
    (b) An institution described in Sec.  52i.3 that has received a 
grant under this part may apply for another grant under this part if:
    (1)(i) The institution still meets the eligibility requirements in 
Sec.  52i.3; and
    (ii) The institution is in the last year of funding provided by NIH 
under this part; or
    (2) The institution no longer has an active grant under this part 
from NIH.


Sec.  52i.6  Evaluation and award of research endowment grant 
applications.

    All applications filed in accordance with this part and meeting the 
minimal eligibility requirements shall be evaluated and recommended by 
technical and scientific peer review. The review evaluation shall take 
into account, among other pertinent factors:
    (a) The scientific and technical merit of the proposed project to 
facilitate minority health disparities research and other health 
disparities research;
    (b) The likelihood of its producing meaningful results;
    (c) The adequacy of the applicant's resources available for the 
project; and
    (d) The adequacy of the applicant's plan for managing the endowment 
fund.


Sec.  52i.7  Grant awards.

    (a) Within the limits of funds, and upon such review and 
recommendation as may be required by law, the Director shall award a 
grant to those applicants whose approved projects will in the 
Director's judgment best promote the purposes of this part.
    (b) An institution described in Sec.  52i.3 that receives a grant 
under this part or an institution described in section 464z-4(f) of the 
Act authorized to use grant funds for endowment purposes shall follow 
the spending rules under the law of the state in which the institution 
is located and the spending rules/policies adopted by the recipient 
institution, provided that such spending rules are not inconsistent 
with applicable federal regulations/policies.
    (c) Grants awarded under this part or grant funds designated for 
endowment purposes as described under section 464z-4(f) of the Act must 
be invested no later than 90 days after the start date of the grant.
    (d) The institution, in investing the endowment fund established 
under this section, shall exercise the judgment and care, under the 
circumstances then prevailing, that a person of prudence, discretion, 
and intelligence would exercise in the management of such person's own 
affairs and avoid all appearances of conflict of interest in the 
management of this fund.
    (e) The total amount of an endowment grant under this part or the 
designated amount of the grant under section 464z-4(f) of the Act must 
be maintained as corpus by the institution for 20 years from the date 
of award.
    (f) In the case of situations in which investment conditions result 
in the corpus referred to in paragraph (e) of this section having a net 
market value less than the value of the funds at the time of their 
receipt, appropriate actions must be taken (e.g., careful review of the 
investment strategy) in order to preserve the value of the endowment 
corpus.
    (g) An institution described in Sec.  52i.3 receiving an endowment 
grant under section 464z-3(h) of the Act may not simultaneously receive 
endowment funds under section 464z-4(f) of the Act.
    (h) Consistent with section 464z-4(f) of the Act, the Director, 
NIMHD, may designate for a research endowment some of the funds awarded 
to a Center of Excellence for research education and training.


Sec.  52i.8  When and for what purposes may a grantee spend the 
endowment fund corpus?

    (a) A grantee may not withdraw or spend any part of the endowment 
fund corpus for a total of 20 years from the date of the original grant 
award.
    (b) At the end of the 20-year period, during which the endowment 
corpus must be maintained, the grantee institution is encouraged to 
preserve the

[[Page 35843]]

endowment fund corpus but may use the endowment fund corpus for any 
purpose that expands or develops the institution's minority health and/
or health disparities research and/or training capacity.


Sec.  52i.9  How much endowment fund income may a grantee spend and for 
what purposes?

    (a) Any endowment income realized in the initial year following the 
grant award under this part shall not be expended to support 
programmatic activities until after conclusion of the initial year of 
the grant.
    (b) After the first year of the grant, a grantee awarded funds 
under this part may spend endowment income realized from funds it 
receives solely in accordance with the regulations of this part, the 
terms and conditions of the award, NIMHD policies and procedures, and 
the grantee's strategic plan that has been approved by the NIMHD and 
includes priorities for the use of the endowment fund income.


Sec.  52i.10  How shall a grantee calculate the amount of endowment 
fund income that it may withdraw and spend?

    A grantee awarded funds under this part shall calculate the amount 
of endowment fund income that it may withdraw and spend at a particular 
time as follows:
    (a) On each date that the grantee plans a withdrawal of endowment 
fund income, the grantee must determine the amount of the income by 
calculating the value of the fund that exceeds the endowment fund 
corpus.
    (b) If the total value of the endowment fund exceeds the endowment 
fund corpus, the grantee may withdraw and spend the excess amount, 
i.e., the endowment fund income, in accordance with Sec.  52i.9.


Sec.  52i.11  What shall a grantee record and report?

    A grantee awarded funds under this part shall:
    (a) Maintain appropriate records in compliance with this part and 
other requirements as referenced in terms of the award, including 
documentation of:
    (1) The type and amount of investments of the endowment fund;
    (2) The amount of endowment fund income and corpus;
    (3) The amount and purpose of expenditures of endowment fund 
income; and
    (4) The expenses and charges associated with the management of the 
endowment funds if such expenses and charges were paid from the grant 
funds.
    (b) Retain records in accordance with 45 CFR 74.53. The endowment 
fund corpus, fund income, and fund expenditures must be reported over a 
20-year period, and supporting records are to be retained for 3 years 
after the submission of the final report to the NIMHD;
    (c) Permit authorized officials the authority to conduct a review, 
as set forth in 45 CFR 74.53(e) (which states that the Department of 
Health and Human Services (HHS) awarding agencies, the HHS Inspector 
General, the U.S. Comptroller General, and any of their duly authorized 
representatives ``have the right of timely and unrestricted access to 
any books, documents, papers, or other records of recipients that are 
pertinent to the awards, in order to make audits, examinations, 
excerpts, transcripts, or copies of such documents''); and
    (d) Submit Financial Status Reports, as set forth in 45 CFR 74.52, 
as required by the NIMHD and in the form prescribed. A final Financial 
Status Report shall be required 20 years after the date of the original 
grant award.


Sec.  52i.12  What happens if a grantee fails to administer the 
research endowment grant in accordance with applicable regulations?

    (a) The Director, after giving notice and an opportunity for a 
hearing, may authorize the termination of a grant awarded and/or 
recovery of funds under this part during the 20-year period if the 
grantee:
    (1) Withdraws or spends any part of the endowment fund corpus in 
violation of this part;
    (2) Spends any portion of the endowment fund income not permitted 
to be spent in this part;
    (3) Fails to invest the endowment fund corpus in accordance with 
the investment standards set forth in this part;
    (4) Fails to meet the requirements in Sec.  52i.7; or
    (5) Otherwise fails to comply with the terms and conditions of the 
award.
    (b) Recovery of funds may include up to the amount of endowment 
awards plus any income earned.


Sec.  52i.13  Other HHS policies and regulations that apply.

    Several other regulations and policies apply to grants under this 
part. These include, but are not limited to:
    (a) 2 CFR part 376--HHS Nonprocurement debarment and suspension
    (b) 42 CFR part 50, Subpart A--Responsibilities of PHS awardee and 
applicant institutions for dealing with and reporting possible 
misconduct in science
    (c) 42 CFR part 50, Subpart D--Public Health Service grant appeals 
procedures
    (d) 45 CFR part 16--Procedures of the Departmental Grant Appeals 
Board
    (e) 45 CFR part 46--Protection of human subjects
    (f) 45 CFR part 74--Uniform administrative requirements for awards 
and subawards to institutions of higher education, hospitals, other 
nonprofit organizations, and commercial organizations; and certain 
grants and agreements with states, local governments, and Indian tribal 
governments
    (g) 45 CFR part 80--Nondiscrimination under programs receiving 
federal assistance through the Department of Health and Human 
Services--Effectuation of Title VI of the Civil Rights Act of 1964
    (h) 45 CFR part 81--Practice and procedure for hearings under part 
80 of this title
    (i) 45 CFR part 82--Government-wide requirements for drug-free 
workplace (financial assistance)
    (j) 45 CFR part 84--Nondiscrimination on the basis of handicap in 
programs and activities receiving or benefiting from federal financial 
assistance
    (k) 45 CFR part 86--Nondiscrimination on the basis of sex in 
education programs and activities receiving or benefiting from federal 
financial assistance
    (l) 45 CFR part 91--Nondiscrimination on the basis of age in HHS 
programs and activities receiving federal financial assistance
    (m) 45 CFR part 92--Uniform administrative requirements for grants 
and cooperative agreements to state and local government
    (n) 45 CFR part 93--New restrictions on lobbying
    (o) 59 FR 34496 (July 5, 1994)--NIH Guidelines for Research 
Involving Recombinant DNA Molecules. [Note: This policy is subject to 
change, and interested persons should contact the Office of 
Biotechnology Activities, NIH, Rockledge 1, 6705 Rockledge Drive, Suite 
750, MSC 7985, Bethesda, MD 20892 (telephone 301-435-2152, not a toll-
free number), to obtain references to the current version and any 
amendments. Information may be obtained also by contacting the Office 
of Biotechnology Activities via email at oba@od.nih.gov and via the OBA 
Web site at http://www4.od.nih.gov/oba.]
    (p) 59 FR 14508 (March 28, 1994)--NIH Guidelines on the Inclusion 
of Women and Minorities as Subjects in Clinical Research. [Note: This 
policy is subject to change, and interested persons should contact the 
Office of Research on Women's Health, NIH, Suite 400, 6707 Democracy 
Boulevard,

[[Page 35844]]

MSC 5484, Bethesda, MD 20892-5484 (telephone 301-402-1770, not a toll-
free number), to obtain references to the current version and any 
amendments. Information may be obtained also by contacting the Office 
of Research on Women's Health Web site at http://ORWH.od.nih.gov.]
    (q) NIH Grants Policy Statement (October 1, 2012). This version is 
located on the NIH Web site at http://grants.nih.gov/grants/policy/nihgps_2012/index.htm. [Note: This policy is subject to change, and 
interested persons should contact the Office of Policy for Extramural 
Research Administration (OPERA), Office of Extramural Research, NIH, 
6701 Rockledge Drive, Suite 350, MSC 7974, Bethesda, MD 20892-7974 
(telephone 301-435-0938 or toll-free 800-518-4726), to obtain 
references to the current version and any amendments. Information may 
be obtained also by contacting the OPERA Division of Grants Policy via 
email at GrantsPolicy@mail.nih.gov. Previous versions of the NIH Grants 
Policy Statement are archived at http://grants.nih.gov/grants/policy/policy.htm.]
    (r) Public Health Service Policy on Humane Care and Use of 
Laboratory Animals, Office of Laboratory Animal Welfare, NIH (Revised 
August 2002). [Note: This policy is subject to change, and interested 
persons should contact the Office of Laboratory Animal Welfare, NIH, 
Rockledge 1, Suite 360, MSC 7982, 6705 Rockledge Drive, Bethesda, MD 
20892-7982 (telephone 301-594-2382, not a toll-free number), to obtain 
references to the current version and any amendments. Information may 
be obtained also via the OLAW Web site at http://grants.nih.gov/grants/olaw/olaw.htm.]


Sec.  52i.14  Additional conditions.

    The Director may, with respect to any grant award, impose 
additional conditions prior to, or at the time of, any award when in 
the Director's judgment the conditions are necessary to ensure the 
carrying out of the purposes of the award, the interests of the public 
health, or the conservation of grant funds.

    Dated: February 19, 2013.
Francis S. Collins,
Director, National Institutes of Health.
    Approved: May 2, 2013.
Kathleen Sebelius,
Secretary.
[FR Doc. 2013-13991 Filed 6-13-13; 8:45 am]
BILLING CODE 4140-01-P