I

117TH CONGRESS
2D SESSION

H. R. 6584

To direct the Commissioner of Food and Drugs to amend certain regulations
to increase clinical trial diversity, and for other purposes.

IN THE HOUSE OF REPRESENTATIVESFEBRUARY 3, 2022
Ms. ESHOO (for herself, Mr. FITZPATRICK, and Ms. KELLY of Illinois) introduced the following bill; which was referred to the Committee on Energy
and Commerce

A BILLTo direct the Commissioner of Food and Drugs to amend
certain regulations to increase clinical trial diversity, andfor other purposes.
1

Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled,
3

SECTION 1. SHORT TITLE.

4This Act may be cited as the ‘‘Diverse and Equitable

5 Participation in Clinical Trials Act’’ or the ‘‘DEPICT

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6 Act’’.

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SEC. 2. PREMARKET REPORTING OF DIVERSITY PLANS FOR

2

CLINICAL TRIALS AND STUDIES.

3(a) DRUGS.—The Commissioner of Food and Drugs

4 shall issue regulations revising part 312 of title 21, Code
5 of Federal Regulations, to require sponsors of applications
6 for an exemption for investigational use of a drug to in7 clude—
8(1) in any such application—

9(A) the estimated prevalence in the United

10

States of the disease or condition for which the

11

drug

12

disaggregated by demographic subgroup, where

13

such data is available, including age group, sex,

14

race, and ethnicity;

15

being

developedorinvestigated,(B) the sponsor’s targets for enrollment in

16

the

17

disaggregated by age group, sex, race, and eth-18

nicity;clinical

trial

or

trials(C) the rationale for the sponsor’s enroll-

20

ment targets referred to in subparagraph (B),21

which may include—(i) the estimated prevalence referred23

to in subparagraph (A);24(ii) what is known about the disease25

or condition for which the drug is being

26

developed or investigated;•HR 6584 IH

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(iii) any relevant pharmacokinetic or

2

pharmacogenomic data;

3(iv) what is known about the patient

4

population, including co-morbidities and5

potential barriers to enrolling diverse par-6

ticipants, such as patient population size

7

and geographic location; and8(v) any other data or information the9sponsors deems relevant to selecting appro-

10

priate enrollment targets, disaggregated by

11

demographic subgroup; and

12(D) a diversity action plan for how the13

sponsor will meet such targets, including demo-

14graphic-specific outreach and enrollment strate-

15

gies, study-site selection, clinical trial inclusion

16

and exclusion practices, and any diversity train-

17

ing for trial personnel; and18(2) in an annual report described in section

19

312.33 of title 21, Code of Federal Regulations—

20(A) the sponsor’s progress in meeting thepamtmann on DSKBC07HB2PROD with BILLS

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targets referred to in paragraph (1)(B); and22(B) if the sponsor does not expect to meet

23

those targets referred to in paragraph (1)(B)—•HR 6584 IH
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(i) any updates needed to be made to2

the diversity action plan referred to in

3paragraph (1)(D) to meet such targets; or4(ii) the sponsor’s justification for why

5

the sponsor does not expect to meet such6

targets, including—7(I) any factors outside of the8sponsor’s control, including a lack of

9retention of participants;

10(II) any differences in the enroll-

11

ment targets, disaggregated by demo-

12graphic subgroup, and actual enroll-

13

ment that the sponsor determines are

14

insignificant in nature;

15(III) potential for selection bias;

16

and

17

(IV) information not available to18

the sponsor at the time such targets

19

were chosen, but that impacted enroll-

20

ment of diverse participants.

21(b) DEVICES.—The Commissioner of Food and

22 Drugs shall issue regulations revising part 812 of title 21,

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23 Code of Federal Regulations, to require sponsors of appli24 cations for an exemption for investigational use of a device
25 to include—•HR 6584 IH
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(1) in any such application—

2(A) a description of the patient population3

in the United States expected to use the device,4

disaggregated by demographic subgroup, where

5such data is available, including age group, sex,

6

race, and ethnicity;

7(B) the sponsor’s targets for enrollment in

8

the

9

disaggregated by age group, sex, race, and eth-10

nicity;trial

ortrials(C) the rationale for the sponsor’s enroll-

12

ment targets referred to in subparagraph (B),13

which may include—(i) the estimated prevalence referred15

to in subparagraph (A);16(ii) what is known about the disease17

or condition for which the drug is being

18

developed or investigated;

19(iii) any relevant pharmacokinetic or

20

pharmacogenomic data;

21(iv) what is known about the patient

22

population, including co-morbidities and23

potential barriers to enrolling diverse par-24

ticipants, such as patient population size

25

and geographic location; and•HR 6584 IH
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involved,

11

14

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clinical

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61(v) any other data or information the2sponsors deems relevant to selecting appro-3

priate enrollment targets, disaggregated by

4

demographic subgroup; and5(D) a diversity action plan for how the6sponsor will meet such targets, including demo-

7graphic-specific outreach and enrollment strate-

8gies, study-site selection, clinical trial inclusion

9and exclusion practices, and any diversity train-

10

ing for trial personnel; and11(2) in an annual report described in section

12812.150 of title 21, Code of Federal Regulations—

13(A) the sponsor’s progress in meeting

14

those targets referred to in paragraph (1)(B);

15

and

16

(B) if the sponsor does not expect to meet

17

those targets referred to in paragraph (1)(B)—18(i) any updates needed to be made to19

the diversity action plan referred to in

20

paragraph (1)(D) to meet such targets; or21(ii) the sponsor’s justification for why

22

the sponsor does not expect to meet such23

targets, including—•HR 6584 IH
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(I) any factors outside of the2sponsor’s control, including a lack of

3

retention of participants;

4(II) any differences in the enroll-5

ment targets, disaggregated by demo-

6graphic subgroup, and actual enroll-

7

ment that the sponsor determines are

8

insignificant in nature;9(III) potential for selection bias;

10

and

11

(IV) information not available to12

the sponsor at the time such targets

13

were chosen, but that impacted enroll-

14

ment of diverse participants.

15(c) ADDITIONAL CLINICAL TRIAL DATA.—The Com-

16 missioner of Food and Drugs shall issue regulations revis17 ing sections 807.92 and 814.20 of title 21, Code of Fed18 eral Regulations, to require that applications for devices
19 approved under section 515 of the Federal Food, Drug,
20 and Cosmetic Act (21 U.S.C. 360e) and devices cleared
21 under section 510(k) of such Act (21 U.S.C. 360(k))

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22 whose submission includes clinical data—
23(1) a description of the patient population in24

the United States expected to use the device,25

disaggregated by demographic subgroup, where such

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data is available, including age group, sex, race, and2

ethnicity; and3(2) in summarizing the clinical investigations

4

involving human subjects in such applications, a de-5

scription of study subjects by demographic sub-6group, including age group, sex, race, and ethnicity.

7(d) DEADLINE FOR PROMULGATION.—The Commis-

8 sioner of Food and Drugs shall issue—
9(1) any proposed rules required under this sec-

10

tion not later than 2 years after the date of the en-

11

actment of this Act; and

12(2) any final rules required under this section

13

not later than 3 years after the date of the enact-

14

ment of this Act.

15

SEC. 3. FDA AUTHORITY TO MANDATE POSTAPPROVAL16

STUDIES OR POSTMARKET SURVEILLANCE

17

DUE TO INSUFFICIENT DEMOGRAPHIC SUB-

18

GROUP DATA.

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19(a) DRUGS.—

20(1) IN GENERAL.—Section 505(o)(3)(B) of the

21

Federal Food, Drug, and Cosmetic Act (21 U.S.C.

22355(o)(3)(B)) is amended by adding at the end the23

following:•HR 6584 IH
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‘‘(iv) To provide safety and effective-

2

ness data for the drug involved for a demo-

3graphic subgroup or subgroups, if—

4‘‘(I) the clinical trials conducted5

in support of the approval of the drug

6

did not meet the applicable targets of7enrollment, as described in section 2

8of the DEPICT Act; and9‘‘(II) in the judgment of the Sec-10

retary, additional data could inform

11

drug labeling.’’.

12(2) WAIVER.—Section 505(o)(3)(D) of the Fed-13eral Food, Drug, and Cosmetic Act (21 U.S.C.

14355(o)(3)(D)) is amended by adding at the end the15following:

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16‘‘(iii) CLINICAL TRIAL DIVERSITY EN-

17

ROLLMENT.—The

18

quire postapproval studies or postapproval

19

clinical trials for the purpose specified

20

under subparagraph (B)(iv) if the sponsor

21

provides to the Secretary a sufficient jus-

22tification for not meeting the enrollment

23

targets referred to in such subparagraph,24

which may include—

Secretary may not re-•HR 6584 IH
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‘‘(I) factors outside of the spon-2

sor’s control, such as a lack of reten-

3tion of participants;

4‘‘(II) differences in the enroll-5

ment targets, disaggregated by demo-

6graphic subgroup, and actual enroll-

7

ment that are determined by the Sec-8

retary to be insignificant in nature;

9‘‘(III) information not available

10

to the sponsor at the time such enroll-

11

ment targets were chosen, but that12

impacted enrollment of diverse partici-

13

pants;

14‘‘(IV) potential for selection bias;

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15

and

16

‘‘(V) any other reason that the17

Secretary determines is sufficient jus-

18tification.’’.

19(3) USE OF REAL WORLD EVIDENCE.—Section

20505(o)(3) of the Federal Food, Drug, and Cosmetic21

Act (21 U.S.C. 355(o)(3)) is amended by adding at

22

the end the following:

23‘‘(G) USE OF REAL WORLD EVIDENCE.—

24

Real world evidence (as defined in section•HR 6584 IH
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1

505F(b)) may be used to support or satisfy the2requirements under this paragraph.’’.

3(b) DEVICES.—Section 522(a)(1) of the Federal

4 Food, Drug, and Cosmetic Act (21 U.S.C. 360l(a)(1)(A))
5 is amended—
6(1) in subparagraph (A)—7(A) in clause (ii), by striking ‘‘or’’ at the

8

end;

9

(B) in clause (iii)(II), by striking ‘‘facil-

10

ity.’’ and inserting ‘‘facility; or’’; and11(C) by adding at the end the following:

12‘‘(iv) with respect to which—13‘‘(I) clinical studies submitted to

14

support that approval or clearance did

15

not meet the applicable targets of en-16

rollment, as described in section 2 of17

the DEPICT Act; and18‘‘(II) with respect to which a jus-

19

tification described in subparagraph

20(D) is not provided.’’; andpamtmann on DSKBC07HB2PROD with BILLS

21(2) by adding at the end the following:

22‘‘(C) USE OF REAL WORLD EVIDENCE.—

23

Real world evidence (as defined in section

24505F(b)) may be used to support or satisfy the25

requirements under this paragraph.

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121‘‘(D) CLINICAL TRIAL DIVERSITY ENROLL-

2

MENT.—The Secretary may not require a man-3

ufacturer to conduct postmarket surveillance

4

under subparagraph (A) with respect to a de-5

vice for the purpose specified in clause (iv) of

6such subparagraph if the manufacturer provides

7

to the Secretary a sufficient justification for not

8

meeting the enrollment targets referred to in9such subparagraph, which may include—

10‘‘(i) factors outside of the manufac-

11

turer’s control, such as a lack of retention

12of participants;

13‘‘(ii) differences in the enrollment tar-

14

gets, disaggregated by demographic sub-15

group, and actual enrollment that are de-16

termined by the Secretary to be insignifi-

17

cant in nature;

18‘‘(iii) information not available to the19

manufacturer at the time such enrollment

20

targets were chosen, but that impacted en-21

rollment of diverse participants;

22‘‘(iv) potential for selection bias; and23‘‘(v) any other reason that the Sec-24

retary determines is sufficient justifica-

25

tion.’’.

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(c) REPORTS FOR CERTAIN DEVICES.—The Commis-

2 sioner of Food and Drugs shall issue regulations revising
3 section 814.84 of title 21, Code of Federal Regulations,
4 to require holders of an application approved under section
5 515 of the Federal Food, Drug, and Cosmetic Act (216 U.S.C. 360e) to include in the reports submitted under
7 such section 814.84, to the extent possible, any data not
8 previously submitted under such section 814.84 that may
9 inform the safety and effectiveness of the device involved
10 in underrepresented demographic subgroups.
11(d) REGISTRY AND RESULTS DATA BANK INCLU-

12

SION.—Section 402(j)(1)(A) of the Public Health Service

13 Act (282(j)(1)(A)) is amended—
14(1) in clause (ii)—

15(A) in subclause (I), by striking ‘‘and’’ at16

the end;pamtmann on DSKBC07HB2PROD with BILLS17(B) in subclause (II), by striking the pe-

18

riod at the end and inserting ‘‘; and’’; and19(C) by adding at the end the following:

20‘‘(III) postmarket surveillance for21

any device as required under clause

22(iv) of section 522(a)(1)(A) of the

23

Federal Food, Drug, and Cosmetic

24Act.’’; and•HR 6584 IH
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141(2) in clause (iii)(I), by striking the period at2

the end and inserting the following: ‘‘, including any

3

postapproval study or postapproval clinical trial for4

a drug as required under section 505(o)(3)(B)(iv) of5

the Federal Food, Drug, and Cosmetic Act.’’.

6(e) PUBLIC MEETING.—

7(1) IN GENERAL.—Not later than 270 days

8

after the date of enactment of this Act, the Sec-9

retary, acting through the Commissioner of Food

10and Drugs, and in consultation with drug sponsors,

11

medical device manufacturers, patients, and other12

stakeholders, shall convene a public meeting to con-13

sider the ways by which—

14(A) drug sponsors and medical device man-15

ufacturers may disseminate information to the16

public on clinical trial enrollment demographic

17

data in a timely and accessible manner;

18(B) drug and device sponsors, in consulta-

19

tion with the Commissioner of Food and Drugs,

20

may publicly disseminate information on sub-21

group analyses conducted by the sponsors in

22cases where—

23(i) such data is not sufficient for the24

purpose of updating drug and device la-25bels; or•HR 6584 IH
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(ii) such analyses do not show signifi-

2cant differences between demographic sub-3groups; and4(C) drug and device sponsors, in consulta-

5tion with the Commissioner of Food and Drugs,

6

may collect and publicly disseminate real world

7

evidence that may provide information on the8safety and effectiveness of drugs or devices for9

a demographic subgroup or subgroups.

10(2) REPORT.—Not later than 180 days after11

the date on which the public meeting is convened

12

under paragraph (1), the Secretary shall make avail-13

able on the website of the Food and Drug Adminis-

14

tration a report on the topics discussed at such

15

meeting. The report shall include a summary of, and16

response to, recommendations raised in such meet-

17

ing.

18

SEC. 4. ANNUAL REPORT ON PROGRESS TO INCREASE DI-

19
20

VERSITY IN CLINICAL TRIALS AND STUDIES.

(a) IN GENERAL.—Beginning not later than 2 years

21 after the date of the enactment of this Act, and each year
22 thereafter, the Secretary of Health and Human Services,pamtmann on DSKBC07HB2PROD with BILLS

23 acting through the Commissioner of Food and Drugs,
24 shall submit to Congress, and publish on the public
25 website of the Food and Drug Administration, a report•HR 6584 IH
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1 that addresses progress on increasing diversity in clinical2 trial and study enrollment.
3(b) CONTENTS OF REPORT.—The report submitted

4 under subsection (a) shall include, with respect to applica5 tions for drugs or devices approved or cleared under sec6 tion 505, 510(k), or 515 of the Federal Food, Drug, and7 Cosmetic Act (21 U.S.C. 355, 360(k), or 360e) or licensed
8 under section 351 of the Public Health Service Act (429 U.S.C. 262) during the calendar year that immediately

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10 precedes the year in which the report is submitted—
11(1) an analysis of the extent to which clinical

12

trials conducted with respect to such applications

13

have met the demographic subgroup enrollment tar-

14

gets for clinical trials and studies required by the15

regulations amended pursuant to section 2 and the16amendments made by section 3;

17(2) the frequency with which enrollment targets

18

by demographic subgroup set for a clinical trial con-19

ducted under an exemption for investigational use of20

a drug under section 505(i) of the Federal Food,

21

Drug, and Cosmetic Act (21 U.S.C. 355(i)) or sec-

22

tion 351 of the Public Health Service Act (4223

U.S.C. 262) or an exemption for investigational use

24

of a device under section 520(g) of the Federal

25

Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g))•HR 6584 IH
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do not adequately reflect the incidence in the United

2States population of the disease or condition being

3

studied in the clinical trial and a summary of the ra-

4tionales provided for enrollment targets by demo-

5graphic subgroup in such cases;

6(3) a summary of the justifications sponsors

7

provided in the cases where sponsors did not meet8

the enrollment targets specified pursuant to section

92, disaggregated by demographic subgroup; and

10(4) the Secretary’s recommendations, as appro-

11

priate, for strategies presented in such diversity

12

plans to attain enrollment targets that should be

13

adopted by sponsors as best practices.

14(c) POSTMARKET STUDIES.—Beginning 3 years after

15 the first instance in which the Secretary requires the spon16 sor of an application for a drug or device approved or
17 cleared under section 505, 510(k), or 515 of the Federal
18 Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360(k),19 or 360e) or licensed under section 351 of the Public
20 Health Service Act (42 U.S.C. 262) to conduct postmarket
21 studies or postmarket surveillance under clause (iv) of sec22 tion 505(o)(3)(B) and clause (iv) of section 522(a)(1)(A)pamtmann on DSKBC07HB2PROD with BILLS

23 of the Federal Food, Drug, and Cosmetic Act (as added
24 by subsections (a) and (b) of section 3), and each year

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1 thereafter, the report submitted under subsection (a) shallpamtmann on DSKBC07HB2PROD with BILLS

2 also include—3(1) the number of such applications that were4

required to initiate postmarket studies or surveil-

5

lance in the previous calendar year under clause (iv)6of section 505(o)(3)(B) and clause (iv) of section

7

522(a)(1)(A) of the Federal Food, Drug, and Cos-

8

metic Act (as added by subsections (a) and (b) of

9section 3), the numbers of such applications that

10

have, as of the end of the calendar year immediately

11

preceding the year in which the report is submitted,

12

in-progress postmarket requirements, and the num-13

ber of such applications that have completed

14

postmarket requirements for each year, beginning on

15

the date of the enactment of this Act;16(2) an analysis of the average amount of time17

for completion of such postmarket requirements,

18

disaggregated by type of application and type of19

postmarket requirement;20(3) an analysis of how the imposition of such21

postmarket requirements has impacted the avail-22

ability of demographic subgroup-specific safety and23

efficacy data for drugs, biologics, and devices; and24(4) the Secretary’s recommendations, as appro-

25

priate, for additional guidance or postmarket re-•HR 6584 IH
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1

quirements to facilitate the collection and reporting2of representative demographic subgroup data in sup-3

port of applications for the approval or clearance of,4or updates to the labeling of, drugs and devices

5

under section 505, 510(k), or 515 of the Federal

6

Food, Drug, and Cosmetic Act (21 U.S.C. 355,7

360(k), or 360e) or licensure of biological products

8

under section 351 of the Public Health Service Act

9(42 U.S.C. 262).

10(d) CONFIDENTIALITY.—Nothing in this section shall

11 be construed as authorizing the Secretary to disclose any
12 information that is a trade secret or confidential informa13 tion subject to section 552(b)(4) of title 5, United States
14 Code, or section 1905 of title 18, United States Code.
15

SEC. 5. PUBLIC MEETING ON CLINICAL TRIAL FLEXIBILI-16

TIES INITIATED IN RESPONSE TO COVID–19

17

PANDEMIC.

18(a) IN GENERAL.—Not later than 180 days after the

19 date on which the COVID–19 emergency period ends, the
20 Secretary of Health and Human Services shall convene a
21 public meeting to discuss the regulatory flexibilities adopt22 ed by the Food and Drug Administration during thepamtmann on DSKBC07HB2PROD with BILLS

23 COVID–19 emergency period to mitigate disruption of
24 clinical studies and clinical trials, including flexibilities de25 tailed in the March 2020 guidance entitled ‘‘Conduct of•HR 6584 IH
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1 Clinical Trials of Medical Products During the COVID2 19 Public Health Emergency, Guidance for Industry, In3 vestigators, and Institutional Review Boards’’, and any
4 subsequent updates to such guidance. The Secretary shall
5 invite to such meeting representatives from the pharma6 ceutical and medical device industries who sponsored clin7 ical trials and clinical studies during the COVID–19 emer8 gency period and organizations representing patients.
9(b) TOPICS.—Not later than 90 days after the date

10 on which the public meeting under subsection (a) is con11 vened, the Secretary shall make available on the public
12 website of the Food and Drug Administration a report on
13 the topics discussed at such meeting. Such topics shall in-

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14 clude discussion of—
15(1) the actions drug sponsors took to utilize

16such regulatory flexibilities and the frequency at

17which such flexibilities were employed;

18(2) the characteristics of the sponsors, trials,

19

and patient populations impacted by such regulatory

20

flexibilities;

21(3) a consideration of how regulatory flexibili-

22ties to mitigate disruption of clinical trials during

23

the COVID–19 emergency period, including decen-

24

tralized clinical trials, may have affected access to25clinical studies and trials for certain patient popu-•HR 6584 IH
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1

lations, especially unrepresented racial and ethnic

2

minorities; and3(4) recommendations for incorporating certain

4

clinical trial disruption mitigation flexibilities into5

current or additional guidance to improve clinical

6

trial access and enrollment of diverse patient popu-

7

lations.

8(c) COVID–19 EMERGENCY PERIOD DEFINED.—In

9 this section, the term ‘‘COVID–19 emergency period’’ has
10 the meaning given the term ‘‘emergency period’’ in section
11 1135(g)(1)(B) of the Social Security Act (42 U.S.C.
12 1320b–5(g)(1)(B)).
13

SEC. 6. COMMUNITY ENGAGEMENT AND OUTREACH TO IM-

14

PROVE INCLUSION OF UNDERREPRESENTED

15

MINORITIES IN CLINICAL TRIALS AND RE-

16

SEARCH.

17(a) IN GENERAL.—The Secretary of Health and

18 Human Services, acting through the Director of the Na19 tional Institutes of Health, shall conduct, coordinate, and20 support activities for purposes of community engagement
21 with, and outreach to, underserved communities to facili22 tate inclusion of underrepresented minorities in clinical re-pamtmann on DSKBC07HB2PROD with BILLS

23 search and clinical trials.

•HR 6584 IH
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1

(b) ACTIVITIES.—Activities conducted, coordinated,

2 or supported under this section may be for any of the fol3 lowing purposes:
4(1) Developing and disseminating best practices

5

for community engagement and outreach and for in-

6

clusive participation in clinical research and trials.

78(2) Creating and providing tools and educational resources—

9(A) to facilitate adoption of such best prac-

10

tices by researchers and clinical trial sponsors;

11

and

12

(B) to encourage awareness of, and partici-

13

pation in, clinical trials and research among

14

underrepresented minorities.

15(3) Engaging community stakeholders in under-

16

represented racial and ethnic minority communities

17

and fostering partnerships with community-based or-18

ganizations serving underrepresented racial and eth-19

nical minority populations to encourage participation

20

in clinical trials and research.

pamtmann on DSKBC07HB2PROD with BILLS

21(4) Conducting and supporting community en-

22gagement research.

23(c) SUPPLEMENT, NOT SUPPLANT.—Grants under

24 this subsection shall be used to supplement and not sup25 plant existing initiatives and programs at the National In•HR 6584 IH
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1 stitutes of Health to improve diversity in clinical trials and2 research.
3

SEC. 7. GRANTS TO INCREASE THE CAPACITY OF COMMU-

4NITY HEALTH CENTERS TO PARTICIPATE IN

5

CLINICAL TRIALS AND RESEARCH.

6(a) IN GENERAL.—The Secretary of Health and7 Human Services, acting through the Administrator of the
8 Health Resources and Services Administration and in con9 sultation with the Director of the National Institutes of
10 Health, shall award grants to, and enter into cooperative
11 agreements with, qualified entities to increase capacity at
12 such qualified entities to participate in clinical trials andpamtmann on DSKBC07HB2PROD with BILLS

13 research by—
14(1) enhancing and expanding infrastructure at

15

community health centers to support participation in16

clinical trials and research, including information

17

technology improvements and the hiring and train-18

ing of healthcare personnel, such as patient naviga-

19

tors and culturally trained site personnel to conduct,

20

or recruit for, clinical trials;

21(2) reimbursing administrative costs and pa-

22tient care costs incurred by qualified entities in the23

course of clinical research and trials that are not24

otherwise reimbursable by existing payers; and•HR 6584 IH
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1

(3) implementing community education and2outreach strategies.

3(b) QUALIFIED ENTITIES DEFINED.—In this section,

4 the term ‘‘qualified entity’’ means—5(1) rural health clinics, as defined in section6

1861(aa)(2) of the Social Security Act (42 U.S.C.

7

1395x(aa)(2));8(2) federally-qualified health centers described

9

in section 1861(aa)(4)(B) of the Social Security Act

10(42 U.S.C. 1395x(aa)(4)(B));11(3) facilities operated by the Indian Health

12Service, an Indian Tribe, Tribal Organization, or an

13

Urban Indian organization, as those terms are de-14

fined in section 4 of the Indian Health Care Im-

15

provement Act (25 U.S.C. 1603); and

16(4) entities eligible to receive funds under sec-

17

tion 330 of the Public Health Service Act (4218

U.S.C. 254b).

19

SEC. 8. AUTHORIZATION OF APPROPRIATIONS.

20

There is authorized to be appropriated to carry out

21 this Act, $100,000,000 for the period of fiscal years 2022
22 through 2025.

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