[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Rules and Regulations]
[Pages 53739-53747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22018]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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: Final rule.

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SUMMARY: The National Institutes of Health (NIH), through the 
Department of Health and Human Services (HHS), is issuing regulations 
governing the National Institute on Minority Health and Health 
Disparities (NIMHD) endowment grants awarded to section 736 and section 
464z-4 Centers of Excellence to facilitate minority health disparities 
research and other health disparities research.

DATES: This final rule is effective October 8, 2015.

FOR FURTHER INFORMATION CONTACT: Jerry Moore, NIH Regulations Officer, 
Office of Management Assessment, NIH, 6011 Executive Boulevard, Room 
601, MSC 7669, Rockville, MD 20852; by email at [email protected]; by 
fax on 301-401-0169 (not a toll free number); or by telephone on 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

[[Page 53740]]

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 individuals who are members of minority 
health disparity populations or other health disparity populations. 
This program is called the NIMHD Centers of Excellence Program. 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.
    This final rule specifies the endowment research grants or 
endowment portion of an award to which the 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 final rule specifies how endowment grant 
applications will be evaluated (section 52i.6), the nature of the grant 
awards (52i.7), how much endowment fund income a grantee may withdraw 
and spend 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 final rule 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 the Director's judgment, the conditions 
are necessary (section 52i.14).
    NIH announced its intentions to take this rulemaking action, 
through HHS, in the notice of proposed rulemaking (NPRM) titled 
``National Institute on Minority Health and Health Disparities Research 
Endowments'' published in the Federal Register on June 14, 2013 (78 FR 
35837-35844). In the NPRM, we provided a sixty day public comment 
period. The comment period expired August 13, 2013. We received a total 
of five comments, two of which were identical.
    Three respondents, two of whom submitted identical comments, 
expressed general support for the regulations. One of these respondents 
cited the importance of clarity regarding eligibility, the application 
process, and other required terms and conditions. The other two 
respondents discussed health disparities in the United States and 
research as a means to support health equity for all people in the 
United States. These supportive comments did not result in any 
necessary changes to this final rule.
    One respondent stated that the Department of Health and Human 
Services (HHS) should require all municipalities and States that 
receive Federal funds from HHS for the provision of health care to 
notify HHS of the reasons for not considering or exploring solicited or 
non-solicited health disparities proposals they have received within 90 
days. Since this comment is not related to any of the provisions of the 
Endowment Program, we did not consider the comment relevant to this 
rulemaking.
    A fifth respondent provided comments addressing a number of issues 
relevant to the rulemaking, which are discussed below. This respondent 
requested clarification of the definition of a ``Center of 
Excellence,'' specifically, whether the act of receiving funds under 
section 736 or section 464z-4 is necessary for an institution to meet 
the definition of a Center of Excellence for purposes of the Endowment 
Program. The designation as a Center of Excellence for the purposes of 
the Endowment Program requires both receiving funding under section 736 
or section 464z-4 of the Public Health Service Act and meeting certain 
specific nonfinancial institutional operational requirements as 
specified in section 736(c)(2)-(5) or section 464z-4(c)(1), 
respectively. The funding component of the definition in section 52i.2 
is intended to clarify that an institution must be an active Center of 
Excellence under section 736 or section 464z-4 to be eligible for an 
endowment grant under this program. An institution is not eligible 
merely because it may be able to satisfy the nonfinancial requirements 
to qualify for funding under section 736 or section 464z-4.
    This respondent also requested that institutions be allowed to 
apply for another Endowment Program grant prior to their last year of 
funding. We disagree with the comment. The intent of the language in 
the regulation is to prevent an eligible entity with an active award 
from having more than a single endowment grant at any given time.
    This respondent additionally inquired whether awardee institutions 
may now directly conduct health disparities research projects instead 
of capacity building for the conduct of research projects because 
Endowment Program applications undergo scientific peer review. This is 
not the case. At the NIH, the peer review of applications determines 
the technical and scientific merit of the proposed project. The process 
of peer review does not in itself convey any meaning regarding the 
particular activities allowed under a grant program. The Endowment 
Program supports the development of research infrastructure and 
capacity which is the underpinning of the conduct of research projects.
    This respondent raised concerns regarding the scientific peer 
review of applications and the expertise of the members of the review 
groups, suggesting that applicants be able to suggest potential 
candidates for each review group. We disagree with the comment. One of 
the hallmarks of the NIH is objective, peer review of applications for 
financial support. The organizational units within NIH that are 
responsible for the review of applications take deliberate steps to 
ensure that the reviewers have the appropriate expertise for the

[[Page 53741]]

applications to be reviewed. Allowing applicants to suggest potential 
reviewers would interfere with NIH procedures designed to prevent 
possible financial and scientific conflicts of interest in the review 
of applications.
    This respondent also expressed the belief that requiring the 
endowment fund corpus to be maintained for 20 years after the end of 
the award period is too restrictive, suggesting that awardees be given 
greater flexibility and allowed to expend a proportion of the endowment 
fund corpus earlier than 20 years. We disagree with the comment. 
Institutional endowments, in general, are designed to create a long-
term asset capable of generating income for an extended period of time. 
Since the focus of the Endowment Program is to build institutional 
capacity and infrastructure to conduct health disparities research, any 
diminution of the endowment corpus in the short-term would be at odds 
with the goals and objectives of the Endowment Program.
    This respondent requested clarity on what actions would satisfy the 
requirement that awardees take ``appropriate actions'' in cases where 
the investments have eroded into the value of the endowment corpus. We 
have not specified a strict definition for ``appropriate actions'' in 
order to allow each institution the flexibility to manage their 
endowment funds effectively. Certainly, a review and change of 
investment strategy to a more conservative approach would be an option. 
A temporary suspension of investment due to adverse market conditions 
could also be an appropriate action. We did not want to be 
prescriptive, but would expect actions to be reasonable and consistent 
with prevailing practices in the management of institutional 
endowments.
    This respondent also inquired as to whether management costs for 
the endowment fund can be paid from the endowment fund itself. Section 
52i.11(a)(4) of the proposed rule provided that expenses and charges 
associated with the management of the endowment funds may be paid from 
``the grant funds.'' Since the endowment fund corpus cannot be used for 
this purpose, section 52i.11(a)(4) has been amended to replace ``the 
grant funds'' with ``endowment fund income'' to clarify the issue. 
Awardees are expected to ensure that those costs are appropriately 
recorded.
    This respondent suggested adding a reference to an ``institution's 
policies and procedures'' to section 52i.9(b) regarding the expenditure 
of endowment fund income. We disagree with the comment. Section 
52i.7(b) already specifies the need for the awardee to adhere to the 
institution's spending rules and policies, provided that such spending 
rules are not inconsistent with applicable federal regulations and 
policies.
    This respondent requested clarification on the timing for the 
filing of the final Financial Status Report under section 52.11(d). 
Upon approval of an application for the Endowment Program, NIMHD agrees 
to provide financial support for a specified project period, usually 
five years. Due to the unique nature of the program, it is reasonable 
for the long-term reporting requirement to begin at the end of the 
project period. To clarify the filing requirement, section 52i.11(d) 
has been amended to replace ``date of the original award'' with ``end 
of the project period.'' In addition, sections 52i.7(e) and 52i.8(a) 
have been amended in a consistent manner to replace ``date of award'' 
with ``end of the project period.''
    Finally, with regard to actions that may be taken if a grantee 
fails to administer the endowment in accordance to the regulations, 
this respondent believes that the awardee should be given an 
opportunity to rectify an error, unless such an error or failure was 
intentional. We agree with the comment with the following 
qualification. The specific language in section 52i.12 is consistent 
with the financial stewardship responsibilities of the Federal 
government. The opportunity for a full and fair hearing is provided and 
the Director of NIMHD has discretion regarding any action to be taken 
depending on the circumstances of the breach in responsibilities. 
Limiting the range of actions available to the NIH in situations of an 
awardee's poor endowment fund management, even if non-intentional, 
would not be appropriate.
    The published NPRM contained two typographical errors that have 
been corrected in this final rule. First, under the definition of 
``endowment fund'' in section 52i.2, the reference to ``section 464z-
4'' should have been ``section 464z-3'' of the PHS Act. Second, in the 
discussion of the sections of the proposed regulations that contain 
requirements subject to the Paperwork Reduction Act of 1995, the 
reference to section ``52i.9'' should have been specified as section 
``52i.9(b)''. That error has been corrected in the final rule, 
consistent with the correct identification of section 52i.9(b) in the 
Reporting part of the Estimated Annual Reporting and Recordkeeping 
Burden table included in the NPRM and this final rule. The published 
NPRM contained a table on the cost burdens for reporting and 
recordkeeping for the NIMHD Research Endowment Program. In the final 
rule it has been labeled ``ESTIMATED ANNUALIZED COST BURDEN TO THE 
RESPONDENTS FOR REPORTING AND RECORDKEEPING UNDER THE NIMHD RESEARCH 
ENDOWMENT PROGRAM.'' An additional column (designated as the 4th) was 
added to the table as ``Average Burden per Respondents (in hours)'' and 
columns 1, 2 3, 5, and 6 were re-titled as ``Final Rule Citations,'' 
``Number of Respondents,'' Number of Responses per Respondent,'' 
``Hourly Wage Rate,'' and ``Total Cost Burden,'' respectively. The 
dollar amounts in the Hourly Wage Rate column were edited to reflect 
the actual cost per hour for responses. In addition, the footnotes for 
the table were edited to be consistent with the table.
    The Regulatory Flexibility Act section of the final rule has been 
revised to clarify that while all eligible institutions are considered 
small entities, the impact of the final rule will not exceed five 
percent of revenues of the entities.

Regulatory Impact Analyses (RIA)

    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 (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 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 one year). Based on our analysis, we believe 
that the final rule 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 
final

[[Page 53742]]

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 final rule 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 final rule 
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 final rule 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 the Director's 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.

  Estimated Annualized Cost Burden to the Respondents for Reporting and Recordkeeping Under the NIMHD Research
                                                Endowment Program
----------------------------------------------------------------------------------------------------------------
                                                                  Average burden
                                     Number of       Number of          per         Hourly wage     Total cost
      Final rule citations          respondents    responses per    respondents      rate \2\       burden \3\
                                        \1\         respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Reporting:
    Sec.   52i.3(b)(2)..........               4               1               4      \4\ $33.65         $538.40
    Sec.   52i.4(a).............               4               1               1       \5\ 33.65          134.60
    Sec.   52i.4(c).............               4               1               1       \6\ 33.65          134.60
    Sec.   52i.5(a).............               4               1              22      \7\ 163.73       14,408.00
    Sec.   52i.9(b).............               4               1               4       \8\ 86.39        1,382.24
    Sec.   52i.11(b)............              12               1              15      \9\ 118.33       21,300.00
    Sec.   52i.11(d)............              12               1               2     \10\ 100.00        2,400.00
                                 -------------------------------------------------------------------------------
        Subtotal................  ..............  ..............              49  ..............       40,297.84
Recordkeeping:
    Sec.   52i.10...............              12               1               2     \11\ 200.00        4,800.00
    Sec.   52i.11(a)(1).........              12               1               2      \12\ 33.65          807.60
    Sec.   52i.11(a)(2).........              12               1               2      \13\ 33.65          807.60
    Sec.   52i.11(a)(3).........              12               1               2      \14\ 33.65          807.60
    Sec.   52i.11(a)(4).........              12               1               2      \15\ 33.65          807.60
    Sec.   52i.11(b)............              12               1               8      \16\ 33.65        3,230.40
        Subtotal................  ..............  ..............              18  ..............       11,260.80
                                 -------------------------------------------------------------------------------
            Total...............  ..............  ..............              67  ..............       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 cost per hour.
\3\ Number of respondents x average burden per response x hourly wage rate.
4 5 6 Based on contracts/grants staff costs.
\7\ Based on the contributions of the principal investigator, participating faculty, contracts/grants staff,
  financial investment advisors, and administrative support. Aggregate cost is $173.73/hour.
\8\ Based on principal investigator costs.
\9\ Based on the contributions of the principal investigator, participating faculty, contracts/grants staff,
  financial investment advisors, and administrative support. Aggregate cost is $118.33/hour.
\10\ Based on financial analyst/auditor costs.
\11\ Based on financial investment advisor costs.
12 13 14 15 16 Based on contracts/grants staff costs.


[[Page 53743]]

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 final rule provides the guidelines 
for the creation of an operation structure of the institutional 
program. The implementation of the final rule will 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. Also a nonprofit entity is defined by the Regulatory 
Flexibility Act as small if it is not dominant in its field, regardless 
of the number of employees. Eligibility requirements of the Research 
Endowment program, as codified in Public Law 111-148, limits the 
universe of potential applicants to approximately twelve institutions 
of higher education (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 and none 
are considered dominant in their field. While all eligible institutions 
are considered small entities, the impact of the final rule will not 
exceed five percent of revenues of the entities. Accordingly, the 
Secretary certifies that this 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 $141 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 this rule as required under the Executive Order and determined 
that it does not have federalism implications. The Secretary certifies 
that this 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 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(b), 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, program description, and respondent 
description of the information collection and recordkeeping 
requirements contained in this rule will be submitted to OMB for 
review. Organizations and individuals can submit comments on the 
information collection and recordkeeping requirements, including the 
burden estimates, 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, [email protected] 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 Annualized Reporting and Recordkeeping Burden NIMHD Research Endowment Program
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
                    Citations                        Number of     responses per  per respondent   Total burden
                                                    respondents     respondent      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
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
Recordkeeping:
    Sec.   52i.10...............................              12               1               2              24

[[Page 53744]]

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

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, title 42 of the Code of 
Federal Regulations is amended 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-3 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 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 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 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 factors or types are different for such 
individuals; or

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    (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 end of 
the project period.
    (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 end of the project period.
    (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 endowment fund corpus but may use the endowment fund 
corpus for any

[[Page 53746]]

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 endowment 
fund income.
    (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 end of the project 
period.


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 D--Public Health Service grant appeals 
procedure.
    (c) 42 CFR part 93--Public Health Service policies on research 
misconduct.
    (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 chapter.
    (i) 2 CFR part 382--Requirements for drug-free workplace (financial 
assistance).
    (j) 45 CFR part 84--Nondiscrimination on the basis of handicap in 
programs or activities receiving federal financial assistance.
    (k) 45 CFR part 86--Nondiscrimination on the basis of sex in 
education programs or activities receiving federal financial 
assistance.
    (l) 45 CFR part 91--Nondiscrimination on the basis of age in 
programs or activities receiving federal financial assistance from HHS.
    (m) 45 CFR part 92--Uniform administrative requirements for grants 
and cooperative agreements to State, local, and tribal governments.
    (n) 45 CFR part 93--New restrictions on lobbying.
    (o) NIH Guidelines for Research Involving Recombinant or Synthetic 
Nucleic Acid Molecules at http://osp.od.nih.gov/sites/default/files/NIH_Guidelines_0.pdf. Further information may be obtained from the NIH 
Office of Biotechnology Activities via email at [email protected] or 
the OBA Web site at http://osp.od.nih.gov/office-biotechnology-activities.
    (p) NIH Guidelines on the Inclusion of Women and Minorities as 
Subjects in Clinical Research at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html. Further information may be obtained 
from the NIH Office of Research on Women's Health via email at 
[email protected] or the ORWH Web site at http://ORWH.od.nih.gov.
    (q) NIH Grants Policy Statement (October 1, 2013). This version is 
located on the NIH Web site at http://grants.nih.gov/grants/policy/nihgps_2013. [Note: this policy is subject to change, and interested 
persons should contact the Office of Policy for Extramural Research 
Administration

[[Page 53747]]

(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 [email protected]. 
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: August 13, 2015.
Francis S. Collins,
Director, National Institutes of Health.
    Approved: August 24, 2015.
Sylvia M. Burrell,
Secretary, Department of Health and Human Services.
[FR Doc. 2015-22018 Filed 9-4-15; 8:45 am]
 BILLING CODE 4140-01-P