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42 U.S.C. § 281 — Organization of National Institutes of
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Page 627
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 281
(C) Open meetings
The meetings under subparagraphs (A) and
(B) shall be open to the public.
(4) Annual report
Not later than 18 months after July 2, 2024,
and every year thereafter, the Advisory Coun-
cil shall provide to the Secretary and Congress
a report containing—
(A) a list of all federally-funded efforts in
Parkinson’s research, prevention, diagnosis,
treatment, clinical care, and institutional-,
home-, and community-based programs and
the outcomes of such efforts;
(B) recommendations for priority actions
to expand, eliminate, coordinate, refocus,
streamline, or condense Federal programs
based on each program’s performance, mis-
sion, scope, and purpose;
(C) recommendations to—
(i) reduce the financial impact of Parkin-
son’s on families living with Parkinson’s;
(ii) improve health outcomes for, and the
quality of life of, individuals living with
Parkinson’s;
(iii)
prevent
Parkinson’s,
ameliorate
symptoms, and slow or stop progression;
(iv) improve the quality of care provided
to beneficiaries with Parkinson’s who re-
ceive coverage through a federally-funded
health care program, such as the Medicare
program under title XVIII of the Social
Security Act [42 U.S.C. 1395 et seq.] or the
Medicaid program under title XIX of such
Act [42 U.S.C. 1396 et seq.];
(v) research the association between en-
vironmental triggers and Parkinson’s to
help reduce exposure to potential triggers;
and
(vi) research and better understand the
underlying factors contributing to Parkin-
son’s;
(D) priority actions to improve all feder-
ally-funded efforts in Parkinson’s research,
prevention, diagnosis, treatment, clinical
care, and institutional-, home-, and commu-
nity-based programs;
(E) an evalu
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Page 627
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 281
(C) Open meetings
The meetings under subparagraphs (A) and
(B) shall be open to the public.
(4) Annual report
Not later than 18 months after July 2, 2024,
and every year thereafter, the Advisory Coun-
cil shall provide to the Secretary and Congress
a report containing—
(A) a list of all federally-funded efforts in
Parkinson’s research, prevention, diagnosis,
treatment, clinical care, and institutional-,
home-, and community-based programs and
the outcomes of such efforts;
(B) recommendations for priority actions
to expand, eliminate, coordinate, refocus,
streamline, or condense Federal programs
based on each program’s performance, mis-
sion, scope, and purpose;
(C) recommendations to—
(i) reduce the financial impact of Parkin-
son’s on families living with Parkinson’s;
(ii) improve health outcomes for, and the
quality of life of, individuals living with
Parkinson’s;
(iii)
prevent
Parkinson’s,
ameliorate
symptoms, and slow or stop progression;
(iv) improve the quality of care provided
to beneficiaries with Parkinson’s who re-
ceive coverage through a federally-funded
health care program, such as the Medicare
program under title XVIII of the Social
Security Act [42 U.S.C. 1395 et seq.] or the
Medicaid program under title XIX of such
Act [42 U.S.C. 1396 et seq.];
(v) research the association between en-
vironmental triggers and Parkinson’s to
help reduce exposure to potential triggers;
and
(vi) research and better understand the
underlying factors contributing to Parkin-
son’s;
(D) priority actions to improve all feder-
ally-funded efforts in Parkinson’s research,
prevention, diagnosis, treatment, clinical
care, and institutional-, home-, and commu-
nity-based programs;
(E) an evaluation of the implementation,
including outcomes, of the national plan
under subsection (c)(1); and
(F) implementation steps to address the
recommendations and priority actions under
subparagraphs (B), (C), and (D), based in part
on the evaluation under subparagraph (E).
(5) Termination
The Advisory Council shall terminate at the
end of calendar year 2035.
(f) Information sharing
Each Federal department and agency that has
information relating to Parkinson’s shall share
such information with the Secretary consistent
with the statutory obligations of such depart-
ment or agency regarding disclosure of informa-
tion, as necessary to enable the Secretary to
complete a report under subsection (e)(4).
(g) Sunset
The section shall cease to be effective at the
end of calendar year 2035.
(July 1, 1944, ch. 373, title III, § 399OO, as added
Pub. L. 118–66, § 2, July 2, 2024, 138 Stat. 1443.)
Editorial Notes
REFERENCES IN TEXT
The Social Security Act, referred to in subsec.
(e)(4)(C)(iv), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Ti-
tles XVIII and XIX of the Act are classified generally
to subchapters XVIII (§ 1395 et seq.) and XIX (§ 1396 et
seq.), respectively, of chapter 7 of this title. For com-
plete classification of this Act to the Code, see section
1305 of this title and Tables.
SUBCHAPTER III—NATIONAL RESEARCH
INSTITUTES
Editorial Notes
CODIFICATION
Title IV of the Public Health Service Act, comprising
this subchapter, was originally enacted by act July 1,
1944, ch. 373, 58 Stat. 707, at which time title IV related
solely to the National Cancer Institute. Because of the
extensive amendments, reorganization of the subject
matter, and expansion of title IV by the acts listed
below, title IV is shown herein as having been added by
Pub. L. 99–158, without reference to intervening amend-
ments.
The provisions of title IV as originally enacted were
subsequently redesignated as part A of title IV and
amended, and parts B to I of title IV were added and
amended by the following acts: June 16, 1948, ch. 481, 62
Stat. 464; June 24, 1948, ch. 621, 62 Stat. 598; Aug. 15,
1950, ch. 714, 64 Stat. 443; Oct. 5, 1961, Pub. L. 87–395, 75
Stat. 824; Oct. 17, 1962, Pub. L. 87–838, 76 Stat. 1072; Aug.
16, 1968, Pub. L. 90–489, 82 Stat. 771; Oct. 30, 1970, Pub.
L. 91–515, 84 Stat. 1297; Dec. 23, 1971, Pub. L. 92–218, 85
Stat. 778; May 19, 1972, Pub. L. 92–305, 86 Stat. 162; Sept.
19, 1972, Pub. L. 92–423, 86 Stat. 679; Apr. 22, 1974, Pub.
L. 93–270, 88 Stat. 90; May 14, 1974, Pub. L. 93–282, 88
Stat. 126; May 31, 1974, Pub. L. 93–296, 88 Stat. 184; July
12, 1974, Pub. L. 93–348, 88 Stat. 342; July 23, 1974, Pub.
L. 93–352, 88 Stat. 358; July 23, 1974, Pub. L. 93–354, 88
Stat. 373; Jan. 4, 1975, Pub. L. 93–640, 88 Stat. 2217; July
29, 1975, Pub. L. 94–63, 89 Stat. 304; Nov. 28, 1975, Pub. L.
94–135, 89 Stat. 713; Apr. 21, 1976, Pub. L. 94–273, 90 Stat.
375; Apr. 22, 1976, Pub. L. 94–278, 90 Stat. 401; Oct. 19,
1976, Pub. L. 94–562, 90 Stat. 2645; Aug. 1, 1977, Pub. L.
95–83, 91 Stat. 383; Nov. 9, 1978, Pub. L. 95–622, 92 Stat.
3412; Nov. 9, 1978, Pub. L. 95–623, 92 Stat. 3443; July 10,
1979, Pub. L. 96–32, 93 Stat. 82; Oct. 7, 1980, Pub. L.
96–398, 94 Stat. 1564; Dec. 17, 1980, Pub. L. 96–538, 94 Stat.
3183; Aug. 13, 1981, Pub. L. 97–35, 95 Stat. 358; Apr. 26,
1984, Pub. L. 98–24, 97 Stat. 175.
Title IV was subsequently amended generally and
completely reorganized by Pub. L. 99–158, § 2, Nov. 20,
1985, 99 Stat. 822.
PART A—NATIONAL INSTITUTES OF HEALTH
§ 281. Organization of National Institutes of
Health
(a) Relation to Public Health Service
The National Institutes of Health is an agency
of the Service.
(b) National research institutes and national cen-
ters
The following agencies of the National Insti-
tutes of Health are national research institutes
or national centers:
(1) The National Cancer Institute.
(2) The National Heart, Lung, and Blood In-
stitute.
(3) The National Institute of Diabetes and
Digestive and Kidney Diseases.
(4) The National Institute of Arthritis and
Musculoskeletal and Skin Diseases.
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TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 281
(5) The National Institute on Aging.
(6) The National Institute of Allergy and In-
fectious Diseases.
(7) The Eunice Kennedy Shriver National In-
stitute of Child Health and Human Develop-
ment.
(8) The National Institute of Dental and
Craniofacial Research.
(9) The National Eye Institute.
(10) The National Institute of Neurological
Disorders and Stroke.
(11) The National Institute on Deafness and
Other Communication Disorders.
(12) The National Institute on Alcohol Abuse
and Alcoholism.
(13) The National Institute on Drug Abuse.
(14) The National Institute of Mental Health.
(15) The National Institute of General Med-
ical Sciences.
(16) The National Institute of Environmental
Health Sciences.
(17) The National Institute of Nursing Re-
search.
(18) The National Institute of Biomedical
Imaging and Bioengineering.
(19) The National Human Genome Research
Institute.
(20) The National Library of Medicine.
(21) The National Center for Advancing
Translational Sciences.
(22) The John E. Fogarty International Cen-
ter
for
Advanced
Study
in
the
Health
Sciences.
(23) The National Center for Complementary
and Integrative Health.
(24) The National Institute on Minority
Health and Health Disparities.
(25) Any other national center that, as an
agency separate from any national research
institute, was established within the National
Institutes of Health as of the day before Janu-
ary 15, 2007.
(c) Division of Program Coordination, Planning,
and Strategic Initiatives
(1) In general
Within the Office of the Director of the Na-
tional Institutes of Health, there shall be a Di-
vision of Program Coordination, Planning, and
Strategic Initiatives (referred to in this sub-
section as the ‘‘Division’’).
(2) Offices within Division
(A) Offices
The following offices are within the Divi-
sion: The Office of AIDS Research, the Office
of Research on Women’s Health, the Office of
Behavioral and Social Sciences Research,
the Office of Disease Prevention, the Office
of Dietary Supplements, and any other office
located within the Office of the Director of
NIH as of the day before January 15, 2007. In
addition to such offices, the Director of NIH
may establish within the Division such addi-
tional offices or other administrative units
as the Director determines to be appro-
priate.
(B) Authorities
Each office in the Division—
(i) shall continue to carry out the au-
thorities that were in effect for the office
before January 15, 2007; and
(ii) shall, as determined appropriate by
the Director of NIH, support the Division
with respect to the authorities described
in section 282(b)(7) of this title.
(d) Organization
(1) Number of institutes and centers
In the National Institutes of Health, the
number of national research institutes and na-
tional centers may not exceed a total of 27, in-
cluding any such institutes or centers estab-
lished under authority of paragraph (2) or
under authority of this subchapter as in effect
on the day before January 15, 2007.
(2) Reorganization of institutes
(A) In general
The Secretary may establish in the Na-
tional Institutes of Health one or more addi-
tional national research institutes to con-
duct and support research, training, health
information, and other programs with re-
spect to any particular disease or groups of
diseases or any other aspect of human health
if—
(i) the Secretary determines that an ad-
ditional institute is necessary to carry out
such activities; and
(ii) the additional institute is not estab-
lished before the expiration of 180 days
after the Secretary has provided the Com-
mittee on Energy and Commerce of the
House of Representatives and the Com-
mittee on Health, Education, Labor, and
Pensions of the Senate written notice of
the determination made under clause (i)
with respect to the institute.
(B) Additional authority
The Secretary may reorganize the func-
tions of any national research institute and
may abolish any national research institute
if the Secretary determines that the insti-
tute is no longer required. A reorganization
or abolition may not take effect under this
paragraph before the expiration of 180 days
after the Secretary has provided the Com-
mittee on Energy and Commerce of the
House of Representatives and the Committee
on Health, Education, Labor, and Pensions
of the Senate written notice of the reorga-
nization or abolition.
(3) Reorganization of Office of Director
Notwithstanding subsection (c), the Director
of NIH may, after a series of public hearings,
and with the approval of the Secretary, reor-
ganize the offices within the Office of the Di-
rector, including the addition, removal, or
transfer of functions of such offices, and the
establishment or termination of such offices,
if the Director determines that the overall
management and operation of programs and
activities conducted or supported by such of-
fices would be more efficiently carried out
under such a reorganization.
(4) Internal reorganization of institutes and
centers
Notwithstanding any conflicting provisions
of this subchapter, the director of a national
research institute or a national center may,
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TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 281
after a series of public hearings and with the
approval of the Director of NIH, reorganize the
divisions, centers, or other administrative
units within such institute or center, includ-
ing the addition, removal, or transfer of func-
tions of such units, and the establishment or
termination of such units, if the director of
such institute or center determines that the
overall management and operation of pro-
grams and activities conducted or supported
by such divisions, centers, or other units
would be more efficiently carried out under
such a reorganization.
(e) Scientific Management Review Board for
periodic organizational reviews
(1) In general
Not later than 60 days after January 15, 2007,
the Secretary shall establish an advisory
council within the National Institutes of
Health to be known as the Scientific Manage-
ment Review Board (referred to in this sub-
section as the ‘‘Board’’).
(2) Duties
(A) Reports on organizational issues
The Board shall provide advice to the ap-
propriate officials under subsection (d) re-
garding the use of the authorities estab-
lished in paragraphs (2), (3), and (4) of such
subsection to reorganize the National Insti-
tutes of Health (referred to in this sub-
section as ‘‘organizational authorities’’). Not
less frequently than once each 7 years, the
Board shall—
(i) determine whether and to what extent
the organizational authorities should be
used; and
(ii) issue a report providing the rec-
ommendations of the Board regarding the
use of the authorities and the reasons un-
derlying the recommendations.
(B) Certain responsibilities regarding reports
The activities of the Board with respect to
a report under subparagraph (A) shall in-
clude the following:
(i) Reviewing the research portfolio of
the National Institutes of Health (referred
to in this subsection as ‘‘NIH’’) in order to
determine the progress and effectiveness
and value of the portfolio and the alloca-
tion among the portfolio activities of the
resources of NIH.
(ii) Determining pending scientific op-
portunities, and public health needs, with
respect to research within the jurisdiction
of NIH.
(iii) For any proposal for organizational
changes to which the Board gives signifi-
cant consideration as a possible rec-
ommendation in such report—
(I) analyzing the budgetary and oper-
ational consequences of the proposed
changes;
(II) taking into account historical
funding and support for research activi-
ties at national research institutes and
centers that have been established re-
cently relative to national research in-
stitutes and centers that have been in
existence for more than two decades;
(III) estimating the level of resources
needed
to
implement
the
proposed
changes;
(IV) assuming the proposed changes
will be made and making a recommenda-
tion for the allocation of the resources of
NIH among the national research insti-
tutes and national centers; and
(V) analyzing the consequences for the
progress of research in the areas affected
by the proposed changes.
(C) Consultation
In carrying out subparagraph (A), the
Board shall consult with—
(i) the heads of national research insti-
tutes and national centers whose directors
are not members of the Board;
(ii) other scientific leaders who are offi-
cers or employees of NIH and are not mem-
bers of the Board;
(iii) advisory councils of the national re-
search institutes and national centers;
(iv) organizations representing the sci-
entific community; and
(v) organizations representing patients.
(3) Composition of Board
The Board shall consist of the Director of
NIH, who shall be a permanent nonvoting
member on an ex officio basis, and an odd
number of additional members, not to exceed
21, all of whom shall be voting members. The
voting members of the Board shall be the fol-
lowing:
(A) Not fewer than 9 officials who are di-
rectors of national research institutes or na-
tional centers. The Secretary shall designate
such officials for membership and shall en-
sure that the group of officials so designated
includes directors of—
(i) national research institutes whose
budgets are substantial relative to a ma-
jority of the other institutes;
(ii) national research institutes whose
budgets are small relative to a majority of
the other institutes;
(iii) national research institutes that
have been in existence for a substantial pe-
riod of time without significant organiza-
tional change under subsection (d);
(iv) as applicable, national research in-
stitutes that have undergone significant
organization changes under such sub-
section, or that have been established
under such subsection, other than national
research institutes for which such changes
have been in place for a substantial period
of time; and
(v) national centers.
(B) Members appointed by the Secretary
from among individuals who are not officers
or employees of the United States. Such
members shall include—
(i) individuals representing the interests
of public or private institutions of higher
education that have historically received
funds from NIH to conduct research; and
(ii) individuals representing the interests
of private entities that have received funds
from NIH to conduct research or that have
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TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 281
broad expertise regarding how the Na-
tional Institutes of Health functions, ex-
clusive of private entities to which clause
(i) applies.
(4) Chair
The Chair of the Board shall be selected by
the Secretary from among the members of the
Board appointed under paragraph (3)(B). The
term of office of the Chair shall be 2 years.
(5) Meetings
(A) In general
The Board shall meet at the call of the
Chair or upon the request of the Director of
NIH, but not fewer than 5 times with respect
to issuing any particular report under para-
graph (2)(A). The location of the meetings of
the Board is subject to the approval of the
Director of NIH.
(B) Particular forums
Of the meetings held under subparagraph
(A) with respect to a report under paragraph
(2)(A)—
(i) one or more shall be directed toward
the scientific community to address sci-
entific needs and opportunities related to
proposals for organizational changes under
subsection (d), or as the case may be, re-
lated to a proposal that no such changes be
made; and
(ii) one or more shall be directed toward
consumer organizations to address the
needs and opportunities of patients and
their families with respect to proposals re-
ferred to in clause (i).
(C) Availability of information from forums
For each meeting under subparagraph (B),
the Director of NIH shall post on the Inter-
net site of the National Institutes of Health
a summary of the proceedings.
(6) Compensation; term of office
The provisions of subsections (b)(4) and (c) of
section 284a of this title apply with respect to
the Board to the same extent and in the same
manner as such provisions apply with respect
to an advisory council referred to in such sub-
sections, except that the reference in such
subsection (c) to 4 years regarding the term of
an appointed member is deemed to be a ref-
erence to 5 years.
(7) Reports
(A) Recommendations for changes
Each report under paragraph (2)(A) shall
be submitted to—
(i) the Committee on Energy and Com-
merce and the Committee on Appropria-
tions of the House of Representatives;
(ii) the Committee on Health, Education,
Labor, and Pensions and the Committee on
Appropriations of the Senate;
(iii) the Secretary; and
(iv) officials with organizational authori-
ties, other than any such official who
served as a member of the Board with re-
spect to the report involved.
(B) Availability to public
The Director of NIH shall post each report
under paragraph (2) on the Internet site of
the National Institutes of Health.
(C) Report on Board activities
Not later than 18 months after January 15,
2007, the Board shall submit to the commit-
tees specified in subparagraph (A) a report
describing the activities of the Board.
(f) Organizational changes per recommendation
of Scientific Management Review Board
(1) In general
With respect to an official who has organiza-
tional authorities within the meaning of sub-
section (e)(2)(A), if a recommendation to the
official for an organizational change is made
in a report under such subsection, the official
shall, except as provided in paragraphs (2), (3),
and (4) of this subsection, make the change in
accordance with the following:
(A) Not later than 100 days after the report
is submitted under subsection (e)(7)(A), the
official shall initiate the applicable public
process required in subsection (d) toward
making the change.
(B) The change shall be fully implemented
not later than the expiration of the 3-year
period beginning on the date on which such
process is initiated.
(2) Inapplicability to certain reorganizations
Paragraph (1) does not apply to a rec-
ommendation made in a report under sub-
section (e)(2)(A) if the recommendation is for—
(A) an organizational change under sub-
section (d)(2) that constitutes the establish-
ment, termination, or consolidation of one
or more national research institutes or na-
tional centers; or
(B) an organizational change under sub-
section (d)(3).
(3) Objection by Director of NIH
(A) In general
Paragraph (1) does not apply to a rec-
ommendation for an organizational change
made in a report under subsection (e)(2)(A)
if, not later than 90 days after the report is
submitted under subsection (e)(7)(A), the Di-
rector of NIH submits to the committees
specified in such subsection a report pro-
viding that the Director objects to the
change, which report includes the reasons
underlying the objection.
(B) Scope of objection
For purposes of subparagraph (A), an ob-
jection by the Director of NIH may be made
to the entirety of a recommended organiza-
tional change or to 1 or more aspects of the
change. Any aspect of a change not objected
to by the Director in a report under subpara-
graph (A) shall be implemented in accord-
ance with paragraph (1).
(4) Congressional review
An organizational change under subsection
(d)(2) that is initiated pursuant to paragraph
(1) shall be carried out by regulation in ac-
cordance with the procedures for substantive
rules under section 553 of title 5. A rule under
the preceding sentence shall be considered a
major rule for purposes of chapter 8 of such
title (relating to congressional review of agen-
cy rulemaking).
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TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 281
(g) Definitions
For purposes of this subchapter:
(1) The term ‘‘Director of NIH’’ means the
Director of the National Institutes of Health.
(2) The terms ‘‘national research institute’’
and ‘‘national center’’ mean an agency of the
National Institutes of Health that is—
(A) listed in subsection (b) and not termi-
nated under subsection (d)(2)(A); or
(B) established by the Director of NIH
under such subsection.
(h) References to NIH
For purposes of this subchapter, a reference to
the National Institutes of Health includes its
agencies.
(July 1, 1944, ch. 373, title IV, § 401, as added Pub.
L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 822; amended
Pub. L. 100–553, § 2(1), Oct. 28, 1988, 102 Stat. 2769;
Pub. L. 100–607, title I, § 101(1), Nov. 4, 1988, 102
Stat. 3048; Pub. L. 100–690, title II, § 2613(b)(2),
Nov. 18, 1988, 102 Stat. 4238; Pub. L. 102–321, title
I, § 121(a), July 10, 1992, 106 Stat. 358; Pub. L.
103–43, title XV, §§ 1501(1), 1511(b)(1), 1521(1), June
10, 1993, 107 Stat. 172, 179, 180; Pub. L. 103–417,
§ 13(b), Oct. 25, 1994, 108 Stat. 4335; Pub. L.
105–277, div. A, § 101(f) [title II, § 212, title VI,
§ 601(k)], Oct. 21, 1998, 112 Stat. 2681–337, 2681–359,
2681–388; Pub. L. 106–525, title I, § 101(b)(1), Nov.
22, 2000, 114 Stat. 2501; Pub. L. 106–580, § 3(e), Dec.
29, 2000, 114 Stat. 3091; Pub. L. 109–482, title I,
§§ 101(a), (b), 108(a), Jan. 15, 2007, 120 Stat. 3675,
3676, 3697; Pub. L. 110–154, § 1(b)(1), Dec. 21, 2007,
121
Stat.
1827;
Pub.
L.
111–148,
title
X,
§ 10334(c)(3)(A), Mar. 23, 2010, 124 Stat. 974; Pub.
L. 112–74, div. F, title II, § 221(a)(2), (c)(2)(B), Dec.
23, 2011, 125 Stat. 1087, 1089; Pub. L. 113–235, div.
G, title II, § 224(1), Dec. 16, 2014, 128 Stat. 2490.)
Editorial Notes
AMENDMENTS
2014—Subsec. (b)(23). Pub. L. 113–235 substituted ‘‘Na-
tional Center for Complementary and Integrative
Health’’ for ‘‘National Center for Complementary and
Alternative Medicine’’.
2011—Subsec. (b)(21). Pub. L. 112–74, § 221(a)(2), sub-
stituted ‘‘National Center for Advancing Translational
Sciences’’ for ‘‘National Center for Research Re-
sources’’.
Subsec. (c)(2)(A). Pub. L. 112–74, § 221(c)(2)(B), struck
out ‘‘the Office of Rare Diseases,’’ after ‘‘the Office of
Dietary Supplements,’’.
2010—Subsec. (b)(24). Pub. L. 111–148 substituted ‘‘In-
stitute’’ for ‘‘Center’’.
2007—Subsec. (b)(7). Pub. L. 110–154 substituted ‘‘Eu-
nice Kennedy Shriver National Institute of Child
Health and Human Development’’ for ‘‘National Insti-
tute of Child Health and Human Development’’.
Pub. L. 109–482, § 101(a), reenacted section catchline
without change and amended text generally, sub-
stituting provisions consisting of subsecs. (a) to (d)(1)
for former subsecs. (a) to (d) which related to: in sub-
sec. (a), relationship to Public Health Service; in sub-
sec. (b), list of national research institutes that were
agencies; in subsec. (c), establishment of additional in-
stitutes and reorganization or abolition of institutes;
and, in subsec. (d), definition of ‘‘national research in-
stitute’’. See below.
Subsec. (d)(2). Pub. L. 109–482, § 108(a), added after
subsec. (d)(1) provisions identical to text of subsec. (c)
prior to amendment by Pub. L. 109–482, § 101(a), redesig-
nated such provisions as par. (2), added par. heading, re-
designated former pars. (1) and (2) as subpars. (A) and
(B), respectively, added subpar. headings, in subpar.
(A), redesignated former subpars. (A) and (B) as cls. (i)
and (ii), respectively, in cl. (ii), substituted ‘‘Health,
Education, Labor, and Pensions’’ for ‘‘Labor and
Human Resources’’ and ‘‘clause (i)’’ for ‘‘subparagraph
(A)’’, and, in subpar. (B), substituted ‘‘Health, Edu-
cation, Labor, and Pensions’’ for ‘‘Labor and Human
Resources’’.
Subsec. (d)(3), (4). Pub. L. 109–482, § 101(b)(1), added
pars. (3) and (4).
Subsecs. (e) to (h). Pub. L. 109–482, § 101(b)(2), added
subsecs. (e) to (h).
2000—Subsec. (b)(1)(R). Pub. L. 106–580 added subpar.
(R).
Subsec. (b)(2)(F). Pub. L. 106–525, § 101(b)(1)(A), re-
aligned margins.
Subsec. (b)(2)(G). Pub. L. 106–525, § 101(b)(1)(B), added
subpar. (G).
1998—Subsec. (b)(1)(H). Pub. L. 105–277, § 101(f) [title II,
§ 212], substituted ‘‘National Institute of Dental and
Craniofacial Research’’ for ‘‘National Institute of Den-
tal Research’’.
Subsec. (b)(2)(F). Pub. L. 105–277, § 101(f) [title VI,
§ 601(k)], added subpar. (F).
1994—Subsec. (b)(2)(E). Pub. L. 103–417 added subpar.
(E).
1993—Subsec. (b)(1)(Q). Pub. L. 103–43, § 1511(b)(1)(A),
added subpar. (Q).
Subsec. (b)(2)(B). Pub. L. 103–43, § 1501(1), amended
subpar. (B) generally, substituting ‘‘National Center for
Research Resources’’ for ‘‘Division of Research Re-
sources’’.
Subsec. (b)(2)(D). Pub. L. 103–43, §§ 1511(b)(1)(B),
1521(1), added subpar. (D) and struck out former subpar.
(D) which read as follows: ‘‘The National Center for
Nursing Research.’’
1992—Subsec. (b)(1)(N) to (P). Pub. L. 102–321 added
subpars. (N) to (P).
1988—Subsec. (b)(1)(J), (M). Pub. L. 100–553 and Pub.
L. 100–607 made identical amendments, striking out
‘‘and Communicative’’ after ‘‘Neurological’’ in subpar.
(J), and adding subpar. (M). Pub. L. 100–690 amended
subsec. (b)(1) to read as if the amendments by Pub. L.
100–607 had not been enacted.
Statutory Notes and Related Subsidiaries
EFFECTIVE DATE OF 2007 AMENDMENT
Pub. L. 109–482, title I, § 109, Jan. 15, 2007, 120 Stat.
3697, provided that: ‘‘This title [see Tables for classi-
fication] and the amendments made by this title apply
only with respect to amounts appropriated for fiscal
year 2007 or subsequent fiscal years.’’
EFFECTIVE DATE OF 2000 AMENDMENT
Pub. L. 106–525, title VI, § 603, Nov. 22, 2000, 114 Stat.
2511, provided that: ‘‘This Act [enacting subpart 6
(§ 287c–31 et seq.) of part E of this subchapter and sec-
tions 293e, 296e–1, and 299a–1 of this title, amending sec-
tions 281, 296f, 299a, 299c–6, and 300u–6 of this title, re-
pealing section 283b of this title, and enacting provi-
sions set out as notes under sections 201, 287c–31, 293e,
and 3501 of this title] and the amendments made by this
Act take effect October 1, 2000, or upon the date of the
enactment of this Act [Nov. 22, 2000], whichever occurs
later.’’
EFFECTIVE DATE OF 1992 AMENDMENT
Amendment by Pub. L. 102–321 effective Oct. 1, 1992,
with provision for programs providing financial assist-
ance, see section 801(c), (d) of Pub. L. 102–321, set out as
a note under section 236 of this title.
EFFECTIVE DATE OF 1988 AMENDMENT
For effective date of amendment by Pub. L. 100–690,
see section 2613(b)(1) of Pub. L. 100–690, set out as an Ef-
fect of Enactment of Similar Provisions note under sec-
tion 285m of this title.
CONSTRUCTION OF 2007 AMENDMENT
Pub. L. 109–482, title I, § 102(g), Jan. 15, 2007, 120 Stat.
3685, provided that: ‘‘This Act [see Tables for classifica-
Page 632
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 282
tion] and the amendments made by this Act may not be
construed as affecting the authorities of the national
research institutes and national centers that were in
effect under the Public Health Service Act [42 U.S.C.
201 et seq.] on the day before the date of the enactment
of this Act [Jan. 15, 2007], subject to the authorities of
the Secretary of Health and Human Services and the
Director of NIH under section 401 of the Public Health
Service Act [42 U.S.C. 281] (as amended by section 101
of this Act). For purposes of the preceding sentence,
the terms ‘national research institute’, ‘national cen-
ter’, and ‘Director of NIH’ have the meanings given
such terms in such section 401.’’
STUDY OF THE USE OF CENTERS OF EXCELLENCE AT
THE NATIONAL INSTITUTES OF HEALTH
Pub. L. 107–84, § 7, Dec. 18, 2001, 115 Stat. 829, required
the Secretary of Health and Human Services to con-
tract, not later than 60 days after Dec. 18, 2001, with the
Institute of Medicine to conduct a study on the impact
of, need for, and other issues associated with Centers of
Excellence at the National Institutes of Health and
complete the study and submit a report not later than
one year after the date of the contract.
REPORT
ON MEDICAL USES
OF BIOLOGICAL AGENTS
IN
DEVELOPMENT
OF
DEFENSES
AGAINST
BIOLOGICAL
WARFARE
Pub. L. 103–43, title XIX, § 1904, June 10, 1993, 107 Stat.
203, directed Secretary of Health and Human Services,
in consultation with Secretary of Defense and with
heads of other appropriate executive agencies, to report
to Congress, not later than 12 months after June 10,
1993, on the appropriateness and impact of the National
Institutes of Health assuming responsibility for the
conduct of all Federal research, development, testing,
and evaluation functions relating to medical counter-
measures against biowarfare threat agents.
RESEARCH ON LUPUS ERYTHEMATOSUS
Pub. L. 99–158, § 5, Nov. 20, 1985, 99 Stat. 880, as amend-
ed by Pub. L. 102–531, title III, § 312(f), Oct. 27, 1992, 106
Stat. 3506, directed Secretary of Health and Human Re-
sources to establish a Lupus Erythematosus Coordi-
nating Committee to plan, develop, coordinate, and im-
plement comprehensive Federal initiatives in research
on Lupus Erythematosus, provided for composition of
committee and meetings, and directed Committee to
prepare a report for Congress on its activities, to be
submitted not later than 18 months after Nov. 20, 1985,
with Committee to terminate one month after the re-
port was submitted.
INTERAGENCY COMMITTEE ON LEARNING DISABILITIES
Pub. L. 99–158, § 9, Nov. 20, 1985, 99 Stat. 882, directed
Director of the National Institutes of Health, not later
than 90 days after Nov. 20, 1985, to establish an Inter-
agency Committee on Learning Disabilities to review
and assess Federal research priorities, activities, and
findings regarding learning disabilities (including cen-
tral nervous system dysfunction in children), provided
for composition of the Committee, directed Committee
to report to Congress on its activities not later than 18
months after Nov. 20, 1985, and provided that the Com-
mittee terminate 90 days after submission of the re-
port.
§ 282. Director of National Institutes of Health
(a) Appointment
The National Institutes of Health shall be
headed by the Director of NIH who shall be ap-
pointed by the President by and with the advice
and consent of the Senate. The Director of NIH
shall perform functions as provided under sub-
section (b) and as the Secretary may otherwise
prescribe.
(b) Duties and authority
In carrying out the purposes of section 241 of
this title, the Secretary, acting through the Di-
rector of NIH—
(1) shall carry out this subchapter, including
being responsible for the overall direction of
the National Institutes of Health and for the
establishment and implementation of general
policies respecting the management and oper-
ation of programs and activities within the
National Institutes of Health;
(2) shall coordinate and oversee the oper-
ation of the national research institutes, na-
tional centers, and administrative entities
within the National Institutes of Health;
(3) shall, in consultation with the heads of
the national research institutes and national
centers, be responsible for program coordina-
tion across the national research institutes
and national centers, including conducting
priority-setting reviews, to ensure that the re-
search portfolio of the National Institutes of
Health is balanced and free of unnecessary du-
plication, and takes advantage of collabo-
rative, cross-cutting research;
(4) shall assemble accurate data to be used
to assess research priorities, including—
(A) information to better evaluate sci-
entific opportunity, public health burdens,
and progress in reducing health disparities;
and
(B) data on study populations of clinical
research, funded by or conducted at each na-
tional research institute and national cen-
ter, which—
(i) specifies the inclusion of—
(I) women;
(II) members of minority groups;
(III) relevant age categories, including
pediatric subgroups; and
(IV) other demographic variables as
the Director of the National Institutes of
Health determines appropriate;
(ii) is disaggregated by research area,
condition, and disease categories; and
(iii) is to be made publicly available on
the Internet website of the National Insti-
tutes of Health;
(5) shall ensure that scientifically based
strategic planning is implemented in support
of research priorities as determined by the
agencies of the National Institutes of Health,
and through the development, implementa-
tion, and updating of the strategic plan devel-
oped under subsection (m);
(6) shall ensure that the resources of the Na-
tional Institutes of Health are sufficiently al-
located for research projects identified in stra-
tegic plans;
(7)(A) shall, through the Division of Program
Coordination, Planning, and Strategic Initia-
tives—
(i) identify research that represents impor-
tant areas of emerging scientific opportuni-
ties, rising public health challenges, or
knowledge gaps that deserve special empha-
sis and would benefit from conducting or
supporting additional research that involves
collaboration between 2 or more national re-
search institutes or national centers, or
Cross-references
Connections may be documented source relationships, shared citations or nearby passages. Each explains its basis; a connection alone does not establish applicability to your situation.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Conditions of participation; protection of individual rights; notification of State entities; use of home health aides; medical equipment; individual’s plan of care; compliance with Federal, State, and local laws and regulations** The conditions of participation that a home health agency is required to meet under this subsection are as follows:
(1) The agency protects and promotes the rights of each individual under its care, including each of the following rights:
(A) The right to be fully informed in advance about the care and treatment to be provided by the agency, to be fully informed in advance of any changes in the care or treatment to be provided by the agency that may affect the individual’s well-being, and (except with respect to an individual adjudged incompetent) to participate in planning care and treatment or changes in care or treatment.
(B) The right to voice grievances with respect to treatment or care that is (or fails to be) furnished without discrimination or reprisal for voicing grievances.
(C) The right to confidentiality of the clinical records described in section 1395x(o)(3) of this title.
(D) The right to have one’s property treated with respect.
(E) The right to be fully informed orally and in writing (in advance of coming under the care of the agency) of—
(i) all items and services furnished by (or under arrangements with) the agency for which payment may be made under this subchapter,
(ii) the coverage available for such items and services under this subchapter, subchapter XIX, and any other Federal program of which the agency is reasonably aware,
(iii) any charges for items and services not covered under this subchapter and any charges the individual may have to pay with respect to items and services furn
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1395
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 1395. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 2893
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 1395a
(i) shared savings and competitive bidding in FFS
Medicare;
(ii) use of MA-negotiated rates to set FFS Medicare
rates; and
(iii) novel approaches to information development
and sharing that may enable markets to lower cost and
improve quality for FFS Medicare beneficiaries.
SEC. 10. Reducing Obstacles to Improved Patient Care.
Within 1 year of the date of this order, the Secretary
shall propose regulatory changes to the Medicare pro-
gram to reduce the burden on providers and eliminate
regulations that create inefficiencies or otherwise un-
dermine patient outcomes.
SEC. 11. Maximizing Freedom for Medicare Patients and
Providers. (a) Within 180 days of the date of this order,
the Secretary, in coordination with the Commissioner
of Social Security, shall revise current rules or policies
to preserve the Social Security retirement insurance
benefits of seniors who choose not to receive benefits
under Medicare Part A, and propose other administra-
tive improvements to Medicare enrollment processes
for beneficiaries.
(b) Within 1 year of the date of this order, the Sec-
retary shall identify and remove unnecessary barriers
to private contracts that allow Medicare beneficiaries
to obtain the care of their choice and facilitate the de-
velopment of market-driven prices.
SEC. 12. General Provisions. (a) Nothing in this order
shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive de-
partment or agency, or the head thereof; or
(ii) the functions of the Director of the Office of Man-
agement and Budget relating to budgetary, administra-
tive, or legislative proposals.
(b) This order shall be implemented consistent with
applicable law and subject to the
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 1395
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 1395. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Establishment** There is hereby established the Medicaid and CHIP Payment and Access Commission (in this section referred to as “MACPAC”).
**(b) Duties**
(1) **Review of access policies for all States and annual reports** — MACPAC shall—
(A) review policies of the Medicaid program established under this subchapter (in this section referred to as “Medicaid”) and the State Children’s Health Insurance Program established under subchapter XXI (in this section referred to as “CHIP”) affecting access to covered items and services, including topics described in paragraph (2);
(B) make recommendations to Congress, the Secretary, and States concerning such access policies;
(C) by not later than March 15 of each year (beginning with 2010), submit a report to Congress containing the results of such reviews and MACPAC’s recommendations concerning such policies; and
(D) by not later than June 15 of each year (beginning with 2010), submit a report to Congress containing an examination of issues affecting Medicaid and CHIP, including the implications of changes in health care delivery in the United States and in the market for health care services on such programs.
(2) **Specific topics to be reviewed** — Specifically, MACPAC shall review and assess the following:
(A) *Medicaid and CHIP payment policies* — Payment policies under Medicaid and CHIP, including—
(i) the factors affecting expenditures for the efficient provision of items and services in different sectors, including the process for updating payments to medical, dental, and health professionals, hospitals, residential and long-term care providers, providers of home and community based services, Federally-qualified health centers and rural health clinics, managed care entities, and providers of ot
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 1396
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 1396. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 4009
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 1396
of the enactment of this Act [Oct. 6, 2014], the Sec-
retary shall develop and report to Congress on a stra-
tegic plan for collecting or otherwise accessing data on
race and ethnicity for purposes of specifying quality
measures and resource use and other measures under
subsections (c) and (d) of section 1899B of the Social Se-
curity Act, as added by subsection (a), and, as the Sec-
retary determines appropriate, other similar provisions
of, including payment adjustments under, title XVIII of
such Act (42 U.S.C. 1395 et seq.).’’
SUBCHAPTER XIX—GRANTS TO STATES
FOR MEDICAL ASSISTANCE PROGRAMS
§ 1396. Medicaid and CHIP Payment and Access
Commission
(a) Establishment
There is hereby established the Medicaid and
CHIP Payment and Access Commission (in this
section referred to as ‘‘MACPAC’’).
(b) Duties
(1) Review of access policies for all States and
annual reports
MACPAC shall—
(A) review policies of the Medicaid pro-
gram established under this subchapter (in
this section referred to as ‘‘Medicaid’’) and
the State Children’s Health Insurance Pro-
gram established under subchapter XXI (in
this section referred to as ‘‘CHIP’’) affecting
access to covered items and services, includ-
ing topics described in paragraph (2);
(B) make recommendations to Congress,
the Secretary, and States concerning such
access policies;
(C) by not later than March 15 of each year
(beginning with 2010), submit a report to
Congress containing the results of such re-
views and MACPAC’s recommendations con-
cerning such policies; and
(D) by not later than June 15 of each year
(beginning with 2010), submit a report to
Congress
containing
an
examination
of
issues affecting Medicaid and CHIP, includ-
ing the impli
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 1396
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 1396. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 201
Stored review status: release_metadata_unconfirmed. The source passage cites 42 U.S.C. § 201. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
Page 35
TITLE 42—THE PUBLIC HEALTH AND WELFARE
§ 201
1 See References in Text note below.
Sec.
300jj–34.
Competitive grants to States and Indian
tribes for the development of loan pro-
grams to facilitate the widespread
adoption of certified EHR technology.
300jj–35.
Demonstration program to integrate in-
formation
technology
into
clinical
education.
300jj–36.
Information technology professionals in
health care.
300jj–37.
General grant and loan provisions.
300jj–38.
Authorization for appropriations.
PART C—OTHER PROVISIONS
300jj–51.
Health information technology enroll-
ment standards and protocols.
300jj–52.
Information blocking.
SUBCHAPTER XXIX—DATA COLLECTION,
ANALYSIS, AND QUALITY
300kk.
Data collection, analysis, and quality.
SUBCHAPTER XXX—COMMUNITY LIVING
ASSISTANCE SERVICES AND SUPPORTS
300ll to 300ll–9. Repealed.
SUBCHAPTER XXXI—WORLD TRADE CENTER
HEALTH PROGRAM
PART A—ESTABLISHMENT OF PROGRAM; ADVISORY
COMMITTEE
300mm.
Establishment of World Trade Center
Health Program.
300mm–1.
WTC Health Program Scientific/Tech-
nical
Advisory
Committee;
WTC
Health Program Steering Committees.
300mm–2.
Education and outreach.
300mm–3.
Uniform data collection and analysis.
300mm–4.
Clinical Centers of Excellence and Data
Centers.
300mm–5.
Definitions.
PART B—PROGRAM OF MONITORING, INITIAL HEALTH
EVALUATIONS, AND TREATMENT
SUBPART 1—WTC RESPONDERS
300mm–21.
Identification of WTC responders and
provision of WTC-related monitoring
services.
300mm–22.
Treatment of enrolled WTC responders
for WTC-related health conditions.
300mm–23.
National arrangement for benefits for el-
igible individuals outside New York.
SUBPART 2—WTC SURVIVORS
300mm–31.
Identification and initial health evalua-
tion of screening-eligible and
Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 201
Stored review status: historical_2024_not_currentness_verified. The source passage cites 42 U.S.C. § 201. This identifies an authority to review, not proof of applicability.
Federal law — U.S. Code and appendices · legal_authorities
**(a) Relation to Public Health Service** The National Institutes of Health is an agency of the Service.
**(b) National research institutes and national centers** The following agencies of the National Institutes of Health are national research institutes or national centers:
(1) The National Cancer Institute.
(2) The National Heart, Lung, and Blood Institute.
(3) The National Institute of Diabetes and Digestive and Kidney Diseases.
(4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases.
(5) The National Institute on Aging.
(6) The National Institute of Allergy and Infectious Diseases.
(7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development.
(8) The National Institute of Dental and Craniofacial Research.
(9) The National Eye Institute.
(10) The National Institute of Neurological Disorders and Stroke.
(11) The National Institute on Deafness and Other Communication Disorders.
(12) The National Institute on Alcohol Abuse and Alcoholism.
(13) The National Institute on Drug Abuse.
(14) The National Institute of Mental Health.
(15) The National Institute of General Medical Sciences.
(16) The National Institute of Environmental Health Sciences.
(17) The National Institute of Nursing Research.
(18) The National Institute of Biomedical Imaging and Bioengineering.
(19) The National Human Genome Research Institute.
(20) The National Library of Medicine.
(21) The National Center for Advancing Translational Sciences.
(22) The John E. Fogarty International Center for Advanced Study in the Health Sciences.
(23) The National Center for Complementary and Integrative Health.
(24) The National Institute on Minority Health and Health Disparities.
(25) Any other national center that, as an agency separate from
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 281
Stored review status: release_metadata_unconfirmed. Same stored citation; legal effect and authority still require review.