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 REPRESENTATIVES 

FEBRUARY 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 BILL 

To direct the Commissioner of Food and Drugs to amend 

certain regulations to increase clinical trial diversity, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

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

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

6 Act’’. 


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1 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 is being developed or investigated, 

12 disaggregated by demographic subgroup, where 

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

14 race, and ethnicity; 

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

16 the clinical trial or trials involved, 

17 disaggregated by age group, sex, race, and eth18 nicity; 

19 (C) the rationale for the sponsor’s enroll20 ment targets referred to in subparagraph (B), 

21 which may include— 

22 (i) the estimated prevalence referred 

23 to in subparagraph (A); 

24 (ii) what is known about the disease 

25 or condition for which the drug is being 

26 developed or investigated; 


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1 (iii) any relevant pharmacokinetic or 

2 pharmacogenomic data; 

3 (iv) what is known about the patient 

4 population, including co-morbidities and 

5 potential barriers to enrolling diverse par6 ticipants, such as patient population size 

7 and geographic location; and 

8 (v) any other data or information the 

9 sponsors deems relevant to selecting appro10 priate enrollment targets, disaggregated by 

11 demographic subgroup; and 

12 (D) a diversity action plan for how the 

13 sponsor will meet such targets, including demo14 graphic-specific outreach and enrollment strate15 gies, study-site selection, clinical trial inclusion 

16 and exclusion practices, and any diversity train17 ing for trial personnel; and 

18 (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 the 

21 targets referred to in paragraph (1)(B); and 

22 (B) if the sponsor does not expect to meet 

23 those targets referred to in paragraph (1)(B)— 


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1 (i) any updates needed to be made to 

2 the diversity action plan referred to in 

3 paragraph (1)(D) to meet such targets; or 

4 (ii) the sponsor’s justification for why 

5 the sponsor does not expect to meet such 

6 targets, including— 

7 (I) any factors outside of the 

8 sponsor’s control, including a lack of 

9 retention of participants; 

10 (II) any differences in the enroll11 ment targets, disaggregated by demo12 graphic subgroup, and actual enroll13 ment that the sponsor determines are 

14 insignificant in nature; 

15 (III) potential for selection bias; 

16 and 

17 (IV) information not available to 

18 the sponsor at the time such targets 

19 were chosen, but that impacted enroll20 ment of diverse participants. 

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

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

23 Code of Federal Regulations, to require sponsors of appli24 cations for an exemption for investigational use of a device 

25 to include— 


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1 (1) in any such application— 

2 (A) a description of the patient population 

3 in the United States expected to use the device, 

4 disaggregated by demographic subgroup, where 

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

6 race, and ethnicity; 

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

8 the clinical trial or trials involved, 

9 disaggregated by age group, sex, race, and eth10 nicity; 

11 (C) the rationale for the sponsor’s enroll12 ment targets referred to in subparagraph (B), 

13 which may include— 

14 (i) the estimated prevalence referred 

15 to in subparagraph (A); 

16 (ii) what is known about the disease 

17 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 and 

23 potential barriers to enrolling diverse par24 ticipants, such as patient population size 

25 and geographic location; and 


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1 (v) any other data or information the 

2 sponsors deems relevant to selecting appro3 priate enrollment targets, disaggregated by 

4 demographic subgroup; and 

5 (D) a diversity action plan for how the 

6 sponsor will meet such targets, including demo7 graphic-specific outreach and enrollment strate8 gies, study-site selection, clinical trial inclusion 

9 and exclusion practices, and any diversity train10 ing for trial personnel; and 

11 (2) in an annual report described in section 

12 812.150 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 to 

19 the diversity action plan referred to in 

20 paragraph (1)(D) to meet such targets; or 

21 (ii) the sponsor’s justification for why 

22 the sponsor does not expect to meet such 

23 targets, including— 


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1 (I) any factors outside of the 

2 sponsor’s control, including a lack of 

3 retention of participants; 

4 (II) any differences in the enroll5 ment targets, disaggregated by demo6 graphic subgroup, and actual enroll7 ment that the sponsor determines are 

8 insignificant in nature; 

9 (III) potential for selection bias; 

10 and 

11 (IV) information not available to 

12 the sponsor at the time such targets 

13 were chosen, but that impacted enroll14 ment of diverse participants. 

15 (c) ADDITIONAL CLINICAL TRIAL DATA.—The Com16 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)) 

22 whose submission includes clinical data— 

23 (1) a description of the patient population in 

24 the United States expected to use the device, 

25 disaggregated by demographic subgroup, where such 


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1 data is available, including age group, sex, race, and 

2 ethnicity; and 

3 (2) in summarizing the clinical investigations 

4 involving human subjects in such applications, a de5 scription of study subjects by demographic sub6 group, including age group, sex, race, and ethnicity. 

7 (d) DEADLINE FOR PROMULGATION.—The Commis8 sioner of Food and Drugs shall issue— 

9 (1) any proposed rules required under this sec10 tion not later than 2 years after the date of the en11 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 enact14 ment of this Act. 

15 SEC. 3. FDA AUTHORITY TO MANDATE POSTAPPROVAL 

16 STUDIES OR POSTMARKET SURVEILLANCE 

17 DUE TO INSUFFICIENT DEMOGRAPHIC SUB18 GROUP DATA. 

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. 

22 355(o)(3)(B)) is amended by adding at the end the 

23 following: 


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1 ‘‘(iv) To provide safety and effective2 ness data for the drug involved for a demo3 graphic subgroup or subgroups, if— 

4 ‘‘(I) the clinical trials conducted 

5 in support of the approval of the drug 

6 did not meet the applicable targets of 

7 enrollment, as described in section 2 

8 of the DEPICT Act; and 

9 ‘‘(II) in the judgment of the Sec10 retary, additional data could inform 

11 drug labeling.’’. 

12 (2) WAIVER.—Section 505(o)(3)(D) of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

14 355(o)(3)(D)) is amended by adding at the end the 

15 following: 

16 ‘‘(iii) CLINICAL TRIAL DIVERSITY EN17 ROLLMENT.—The Secretary may not re18 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 jus22 tification for not meeting the enrollment 

23 targets referred to in such subparagraph, 

24 which may include— 


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1 ‘‘(I) factors outside of the spon2 sor’s control, such as a lack of reten3 tion of participants; 

4 ‘‘(II) differences in the enroll5 ment targets, disaggregated by demo6 graphic subgroup, and actual enroll7 ment that are determined by the Sec8 retary to be insignificant in nature; 

9 ‘‘(III) information not available 

10 to the sponsor at the time such enroll11 ment targets were chosen, but that 

12 impacted enrollment of diverse partici13 pants; 

14 ‘‘(IV) potential for selection bias; 

15 and 

16 ‘‘(V) any other reason that the 

17 Secretary determines is sufficient jus18 tification.’’. 

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

20 505(o)(3) of the Federal Food, Drug, and Cosmetic 

21 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 


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1 505F(b)) may be used to support or satisfy the 

2 requirements 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 ‘‘facil10 ity.’’ and inserting ‘‘facility; or’’; and 

11 (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 en16 rollment, as described in section 2 of 

17 the DEPICT Act; and 

18 ‘‘(II) with respect to which a jus19 tification described in subparagraph 

20 (D) is not provided.’’; and 

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

22 ‘‘(C) USE OF REAL WORLD EVIDENCE.— 

23 Real world evidence (as defined in section 

24 505F(b)) may be used to support or satisfy the 

25 requirements under this paragraph. 


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1 ‘‘(D) CLINICAL TRIAL DIVERSITY ENROLL2 MENT.—The Secretary may not require a man3 ufacturer to conduct postmarket surveillance 

4 under subparagraph (A) with respect to a de5 vice for the purpose specified in clause (iv) of 

6 such subparagraph if the manufacturer provides 

7 to the Secretary a sufficient justification for not 

8 meeting the enrollment targets referred to in 

9 such subparagraph, which may include— 

10 ‘‘(i) factors outside of the manufac11 turer’s control, such as a lack of retention 

12 of participants; 

13 ‘‘(ii) differences in the enrollment tar14 gets, disaggregated by demographic sub15 group, and actual enrollment that are de16 termined by the Secretary to be insignifi17 cant in nature; 

18 ‘‘(iii) information not available to the 

19 manufacturer at the time such enrollment 

20 targets were chosen, but that impacted en21 rollment of diverse participants; 

22 ‘‘(iv) potential for selection bias; and 

23 ‘‘(v) any other reason that the Sec24 retary determines is sufficient justifica25 tion.’’. 


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1 (c) REPORTS FOR CERTAIN DEVICES.—The Commis2 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 (21 

6 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 INCLU12 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’’ at 

16 the end; 

17 (B) in subclause (II), by striking the pe18 riod at the end and inserting ‘‘; and’’; and 

19 (C) by adding at the end the following: 

20 ‘‘(III) postmarket surveillance for 

21 any device as required under clause 

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

23 Federal Food, Drug, and Cosmetic 

24 Act.’’; and 


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1 (2) in clause (iii)(I), by striking the period at 

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

3 postapproval study or postapproval clinical trial for 

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

5 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 Sec9 retary, acting through the Commissioner of Food 

10 and Drugs, and in consultation with drug sponsors, 

11 medical device manufacturers, patients, and other 

12 stakeholders, shall convene a public meeting to con13 sider the ways by which— 

14 (A) drug sponsors and medical device man15 ufacturers may disseminate information to the 

16 public on clinical trial enrollment demographic 

17 data in a timely and accessible manner; 

18 (B) drug and device sponsors, in consulta19 tion with the Commissioner of Food and Drugs, 

20 may publicly disseminate information on sub21 group analyses conducted by the sponsors in 

22 cases where— 

23 (i) such data is not sufficient for the 

24 purpose of updating drug and device la25 bels; or 


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1 (ii) such analyses do not show signifi2 cant differences between demographic sub3 groups; and 

4 (C) drug and device sponsors, in consulta5 tion with the Commissioner of Food and Drugs, 

6 may collect and publicly disseminate real world 

7 evidence that may provide information on the 

8 safety and effectiveness of drugs or devices for 

9 a demographic subgroup or subgroups. 

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

11 the date on which the public meeting is convened 

12 under paragraph (1), the Secretary shall make avail13 able on the website of the Food and Drug Adminis14 tration a report on the topics discussed at such 

15 meeting. The report shall include a summary of, and 

16 response to, recommendations raised in such meet17 ing. 

18 SEC. 4. ANNUAL REPORT ON PROGRESS TO INCREASE DI19 VERSITY IN CLINICAL TRIALS AND STUDIES. 

20 (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, 

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 


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1 that addresses progress on increasing diversity in clinical 

2 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, and 

7 Cosmetic Act (21 U.S.C. 355, 360(k), or 360e) or licensed 

8 under section 351 of the Public Health Service Act (42 

9 U.S.C. 262) during the calendar year that immediately 

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 tar14 gets for clinical trials and studies required by the 

15 regulations amended pursuant to section 2 and the 

16 amendments made by section 3; 

17 (2) the frequency with which enrollment targets 

18 by demographic subgroup set for a clinical trial con19 ducted under an exemption for investigational use of 

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

21 Drug, and Cosmetic Act (21 U.S.C. 355(i)) or sec22 tion 351 of the Public Health Service Act (42 

23 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)) 


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1 do not adequately reflect the incidence in the United 

2 States population of the disease or condition being 

3 studied in the clinical trial and a summary of the ra4 tionales provided for enrollment targets by demo5 graphic subgroup in such cases; 

6 (3) a summary of the justifications sponsors 

7 provided in the cases where sponsors did not meet 

8 the enrollment targets specified pursuant to section 

9 2, disaggregated by demographic subgroup; and 

10 (4) the Secretary’s recommendations, as appro11 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) 

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) shall 

2 also include— 

3 (1) the number of such applications that were 

4 required to initiate postmarket studies or surveil5 lance in the previous calendar year under clause (iv) 

6 of section 505(o)(3)(B) and clause (iv) of section 

7 522(a)(1)(A) of the Federal Food, Drug, and Cos8 metic Act (as added by subsections (a) and (b) of 

9 section 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 num13 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 time 

17 for completion of such postmarket requirements, 

18 disaggregated by type of application and type of 

19 postmarket requirement; 

20 (3) an analysis of how the imposition of such 

21 postmarket requirements has impacted the avail22 ability of demographic subgroup-specific safety and 

23 efficacy data for drugs, biologics, and devices; and 

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1 quirements to facilitate the collection and reporting 

2 of representative demographic subgroup data in sup3 port of applications for the approval or clearance of, 

4 or 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 FLEXIBILI16 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 the 

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 


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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 in14 clude discussion of— 

15 (1) the actions drug sponsors took to utilize 

16 such regulatory flexibilities and the frequency at 

17 which 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 flexibili22 ties to mitigate disruption of clinical trials during 

23 the COVID–19 emergency period, including decen24 tralized clinical trials, may have affected access to 

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1 lations, especially unrepresented racial and ethnic 

2 minorities; and 

3 (4) recommendations for incorporating certain 

4 clinical trial disruption mitigation flexibilities into 

5 current or additional guidance to improve clinical 

6 trial access and enrollment of diverse patient popu7 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 IM14 PROVE INCLUSION OF UNDERREPRESENTED 

15 MINORITIES IN CLINICAL TRIALS AND RE16 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, and 

20 support activities for purposes of community engagement 

21 with, and outreach to, underserved communities to facili22 tate inclusion of underrepresented minorities in clinical re23 search and clinical trials. 


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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 in6 clusive participation in clinical research and trials. 

7 (2) Creating and providing tools and edu8 cational resources— 

9 (A) to facilitate adoption of such best prac10 tices by researchers and clinical trial sponsors; 

11 and 

12 (B) to encourage awareness of, and partici13 pation in, clinical trials and research among 

14 underrepresented minorities. 

15 (3) Engaging community stakeholders in under16 represented racial and ethnic minority communities 

17 and fostering partnerships with community-based or18 ganizations serving underrepresented racial and eth19 nical minority populations to encourage participation 

20 in clinical trials and research. 

21 (4) Conducting and supporting community en22 gagement 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 InVerDate Sep 11 2014 18:00 Feb 09, 2022 Jkt 029200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\H6584.IH H6584

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1 stitutes of Health to improve diversity in clinical trials and 

2 research. 

3 SEC. 7. GRANTS TO INCREASE THE CAPACITY OF COMMU4 NITY HEALTH CENTERS TO PARTICIPATE IN 

5 CLINICAL TRIALS AND RESEARCH. 

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

7 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 and 

13 research by— 

14 (1) enhancing and expanding infrastructure at 

15 community health centers to support participation in 

16 clinical trials and research, including information 

17 technology improvements and the hiring and train18 ing of healthcare personnel, such as patient naviga19 tors and culturally trained site personnel to conduct, 

20 or recruit for, clinical trials; 

21 (2) reimbursing administrative costs and pa22 tient care costs incurred by qualified entities in the 

23 course of clinical research and trials that are not 

24 otherwise reimbursable by existing payers; and 


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1 (3) implementing community education and 

2 outreach strategies. 

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

4 the term ‘‘qualified entity’’ means— 

5 (1) rural health clinics, as defined in section 

6 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 

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

13 Urban Indian organization, as those terms are de14 fined in section 4 of the Indian Health Care Im15 provement Act (25 U.S.C. 1603); and 

16 (4) entities eligible to receive funds under sec17 tion 330 of the Public Health Service Act (42 

18 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. 

Æ 


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