I 

118TH CONGRESS 

2D SESSION H. R. 9942 

To support the development, licensing, and initial manufacturing of a human 

vaccine for valley fever. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 8, 2024 

Mr. DUARTE (for himself, Mr. STANTON, Mr. SCHWEIKERT, Mr. COSTA, Mr. 

VALADAO, Ms. TOKUDA, and Mr. OBERNOLTE) introduced the following 

bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To support the development, licensing, and initial 

manufacturing of a human vaccine for valley fever. 

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 ‘‘Valley Fever Aware5 ness and Vaccine Development and Manufacturing Act of 

6 2024’’. 

7 SEC. 2. VALLEY FEVER VACCINE NATIONAL STRATEGY. 

8 (a) WHOLE OF GOVERNMENT APPROACH.— 

9 (1) IN GENERAL.—The Secretary shall coordi10 nate with the relevant agency heads to support the 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
2 

•HR 9942 IH

1 development, licensing, and initial manufacturing of 

2 a human vaccine for valley fever. 

3 (2) CONSULTATION.—In implementing para4 graph (1), the Secretary shall consult with expert 

5 stakeholders on valley fever and vaccine development 

6 and manufacturing. 

7 (3) VACCINE COORDINATOR.— 

8 (A) APPOINTMENT.—Not later than 60 

9 days after the date of the enactment of this sec10 tion, the Secretary shall appoint a Vaccine Co11 ordinator from among the officials at the Food 

12 and Drug Administration or the National Insti13 tutes of Health. 

14 (B) DUTIES.—The Vaccine Coordinator 

15 shall— 

16 (i) act as a single point of contact 

17 within the Federal Government on matters 

18 related to implementing this section; 

19 (ii) not later 180 days after the date 

20 of the enactment of this section, and every 

21 180 days thereafter, publish on the inter22 net website of the Department of Health 

23 and Human Services a report that de24 scribes all of the activities undertaken pur25 suant to this section; 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
3 

•HR 9942 IH

1 (iii) not later than six months after 

2 the date of the enactment of this section, 

3 and every six months thereafter, convene a 

4 meeting with the relevant agency heads 

5 and expert stakeholders to advance the de6 velopment, approval, and manufacturing of 

7 a valley fever vaccine; and 

8 (iv) identify ways to— 

9 (I) expedite regulatory review 

10 and licensing of a safe and effective 

11 valley fever vaccine, consistent with 

12 applicable safety and other require13 ments; and 

14 (II) to advance the development, 

15 licensing, and manufacturing of such 

16 a vaccine. 

17 (b) VALLEY FEVER VACCINE DEVELOPMENT NA18 TIONAL STRATEGY.— 

19 (1) IN GENERAL.—Not later than one year 

20 after the date of the enactment of this section, the 

21 Secretary, acting through the Vaccine Coordinator 

22 and in consultation with the relevant agency heads 

23 and expert stakeholders, shall develop and publish 

24 on the internet website of the Department of Health 

25 and Human Services a national strategy to develop, 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
4 

•HR 9942 IH

1 license, and manufacture a valley fever vaccine by no 

2 later than January 1, 2034. 

3 (2) CONTENT.—The national strategy shall con4 tain— 

5 (A) a statement of science on valley fever, 

6 including current efforts to develop a valley 

7 fever vaccine; 

8 (B) an assessment of the status of valley 

9 fever vaccine development and manufacturing, 

10 including vaccine market viability; 

11 (C) an overview of Federal research fund12 ing made available over the 10 years preceding 

13 the date of the enactment of this section to sup14 port valley fever vaccine development, including 

15 pre-clinical and clinical work, licensing, and 

16 manufacturing; 

17 (D) identifiable and achievable benchmarks 

18 for vaccine development and manufacturing, in19 cluding a timeline for valley fever vaccine devel20 opment and manufacturing consistent with the 

21 timeline in paragraph (1); 

22 (E) Federal, State, and local funding pri23 orities and opportunities that actively support 

24 the development or manufacturing of a valley 

25 fever vaccine; 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
5 

•HR 9942 IH

1 (F) recommendations for coordination be2 tween Federal agencies and departments to re3 duce any overlap with respect to valley fever 

4 vaccine development and manufacturing re5 views, permits, and licensing; 

6 (G) recommendations on actions Federal 

7 agencies and departments may take to expedite 

8 the development or manufacturing of a valley 

9 fever vaccine that do not require congressional 

10 authorization; 

11 (H) recommendations on actions that Con12 gress may take to expedite the development and 

13 manufacturing of a valley fever vaccine; and 

14 (I) an assessment of— 

15 (i) the prevalence of valley fever in the 

16 United States; 

17 (ii) the cost associated with treating 

18 valley fever in the United States; and 

19 (iii) the economic impact of valley 

20 fever in the United States. 

21 (3) PUBLIC COMMENT.— 

22 (A) IN GENERAL.—Not later than six 

23 months after the date of the enactment of this 

24 section, the Secretary shall publish a proposed 

25 draft of the national strategy in the Federal 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
6 

•HR 9942 IH

1 Register and provide an opportunity for public 

2 comment on such national strategy. 

3 (B) CONSIDERATION OF COMMENTS.—In 

4 finalizing the national strategy, the Secretary 

5 shall consider public comments received pursu6 ant to subparagraph (A). 

7 (4) EXPERT CONSULTATION.—In developing the 

8 national strategy, the Secretary, acting through the 

9 Vaccine Coordinator, shall— 

10 (A) consult with the relevant agency heads 

11 and expert stakeholders; and 

12 (B) hold not less than two in-person meet13 ings with the relevant agency heads and expert 

14 stakeholders, of which one shall be conducted 

15 prior to receiving public comments on the na16 tional strategy and one shall be conducted after 

17 such public comments are received. 

18 SEC. 3. GUIDANCE ON DEVELOPMENT, MANUFACTURING, 

19 AND APPROVAL OF VALLEY FEVER VACCINE. 

20 The Director of the National Institutes of Health, the 

21 Commissioner of Food and Drugs, and the Director of the 

22 Centers for Disease Control and Prevention shall issue 

23 guidance on the development and manufacturing of a val24 ley fever vaccine and approval for use of such vaccine, as 

25 applicable. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
7 

•HR 9942 IH

1 SEC. 4. VACCINE DEVELOPMENT AND MANUFACTURING. 

2 (a) VACCINE DEVELOPMENT PROGRAM.— 

3 (1) IN GENERAL.—The Secretary, acting 

4 through the Vaccine Coordinator and in consultation 

5 with the relevant agency heads, shall carry out a 

6 program of— 

7 (A) entering into contracts with eligible en8 tities to support and advance the development 

9 of a valley fever vaccine; or 

10 (B) awarding grants to eligible entities 

11 under paragraph (2). 

12 (2) GRANT PROGRAM.— 

13 (A) IN GENERAL.—The Secretary may 

14 award grants pursuant to paragraph (1)(B) to 

15 support and advance the development of a val16 ley fever vaccine. 

17 (B) PRIORITY.—In awarding grants under 

18 subparagraph (A), the Secretary shall give pri19 ority to applicants that have commenced Phase 

20 1, 2, or 3 clinical trials on a valley fever vac21 cine. 

22 (C) AWARD AMOUNT.—The amount of a 

23 grant under this paragraph shall be not less 

24 than $500,000 and not more than $2,500,000. 

25 (3) COMMENCEMENT.—Not later than 180 days 

26 after the date of the enactment of this section, the 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
8 

•HR 9942 IH

1 Secretary shall commence the program under para2 graph (1). 

3 (4) CONSULTATION REQUIREMENT.—In car4 rying out this subsection, the Secretary shall consult 

5 with physicians, medical providers, scientists, re6 searchers, nonprofit entities, advocacy groups, and 

7 other individuals with expertise in valley fever re8 search and vaccine development. 

9 (b) VACCINE MANUFACTURING PROGRAM.— 

10 (1) IN GENERAL.—The Secretary, acting 

11 through the Vaccine Coordinator and in consultation 

12 with the relevant agency heads, shall— 

13 (A) enter into contracts with eligible enti14 ties to support and advance the manufacturing 

15 of a valley fever vaccine; or 

16 (B) award grants to eligible entities under 

17 paragraph (2). 

18 (2) GRANT PROGRAM.— 

19 (A) IN GENERAL.—The Secretary may 

20 award grants pursuant to paragraph (1)(B) to 

21 support and advance the manufacturing of a 

22 valley fever vaccine. 

23 (B) AWARD AMOUNT.—The amount of a 

24 grant under this paragraph shall be not less 

25 than $500,000 and not more than $5,000,000. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
9 

•HR 9942 IH

1 (3) COMMENCEMENT.—Not later than 180 days 

2 after the date of the enactment of this section, the 

3 Secretary shall commence the programs under para4 graph (1). 

5 (4) CONSULTATION REQUIREMENT.—In car6 rying out this subsection, the Secretary shall consult 

7 with vaccine manufacturing experts and other indi8 viduals with expertise in valley fever research and 

9 vaccine manufacturing. 

10 SEC. 5. AUTHORIZATION OF APPROPRIATIONS. 

11 There are authorized to be appropriated to the Sec12 retary— 

13 (1) $1,000,000 for fiscal year 2026 to carry out 

14 section 2(b); 

15 (2) $25,000,000 for the period of fiscal years 

16 2025 through 2030 to carry out section 4(a); and 

17 (3) $25,000,000 for the period of fiscal years 

18 2025 through 2030 to carry out section 4(b). 

19 SEC. 6. NATIONAL VALLEY FEVER REGISTRY. 

20 Part P of title III of the Public Health Service Act 

21 (42 U.S.C. 280g et seq.) is amended by adding at the end 

22 the following: 

23 ‘‘SEC. 399V–8. NATIONAL VALLEY FEVER REGISTRY. 

24 ‘‘(a) DATA COLLECTION AND REGISTRY.— 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
10 

•HR 9942 IH

1 ‘‘(1) IN GENERAL.—The Secretary, acting 

2 through the Director of the Centers for Disease 

3 Control and Prevention, if scientifically advisable, 

4 may— 

5 ‘‘(A) carry out a system to collect non-per6 sonally identifiable voluntary data on coccidioi7 domycosis (referred to in this section as ‘valley 

8 fever’) and other fungal diseases that can be 

9 confused with valley fever or misdiagnosed as 

10 valley fever, including information with respect 

11 to the incidence and prevalence of such diseases 

12 in the United States; and 

13 ‘‘(B) maintain a national registry (referred 

14 to in this section as the ‘National Valley Fever 

15 Registry’) for the collection and storage of the 

16 data collected pursuant to subparagraph (A) to 

17 develop a population-based registry of cases in 

18 the United States of valley fever and other 

19 fungal diseases that can be confused with valley 

20 fever or misdiagnosed as valley fever. 

21 ‘‘(2) REQUIRED COMMENCEMENT TIMING.—The 

22 authority to commence activities under paragraph 

23 (1) shall terminate on the date that is one year after 

24 the receipt of the report described in subsection 

25 (b)(4). 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
11 

•HR 9942 IH

1 ‘‘(b) ADVISORY COMMITTEE.— 

2 ‘‘(1) ESTABLISHMENT.—Not later than 180 

3 days after the date of the enactment of this section, 

4 the Secretary, acting through the Director of the 

5 Centers for Disease Control and Prevention, shall 

6 establish the Advisory Committee on the National 

7 Valley Fever Registry (referred to in this section as 

8 the ‘Advisory Committee’). 

9 ‘‘(2) MEMBERSHIP.—The Advisory Committee 

10 shall be composed of not more than 27 members to 

11 be appointed by the Secretary, acting through the 

12 Director of Centers for Disease Control and Preven13 tion, of which— 

14 ‘‘(A) two-thirds of the members of the Ad15 visory Committee shall represent Federal agen16 cies, including at least— 

17 ‘‘(i) two members representing the 

18 National Institutes of Health, to include, 

19 upon the recommendation of the Director 

20 of the National Institutes of Health, one 

21 such member representing the National In22 stitute of Allergy and Infectious Diseases; 

23 ‘‘(ii) one member representing the De24 partment of Defense; 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
12 

•HR 9942 IH

1 ‘‘(iii) one member representing the 

2 Centers for Disease Control and Preven3 tion; 

4 ‘‘(iv) one member who is a clinician 

5 with expertise on valley fever and related 

6 diseases; 

7 ‘‘(v) one member who is an epi8 demiologist with experience in data reg9 istries; 

10 ‘‘(vi) one member who is a statisti11 cian; 

12 ‘‘(vii) one member who is an ethicist; 

13 and 

14 ‘‘(viii) one member who is an expert 

15 in privacy regulations under the Health In16 surance Portability and Accountability Act 

17 of 1996 (42 U.S.C. 1320d–6); and 

18 ‘‘(B) one-third of the members of the Advi19 sory Committee shall be members of the public, 

20 including at least— 

21 ‘‘(i) one member representing national 

22 and voluntary health associations; 

23 ‘‘(ii) one member representing pa24 tients with valley fever or their family 

25 members; 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
13 

•HR 9942 IH

1 ‘‘(iii) one member representing clini2 cians with expertise on valley fever and re3 lated diseases; 

4 ‘‘(iv) one member representing epi5 demiologists with expertise in data reg6 istries; and 

7 ‘‘(v) one member representing individ8 uals with an interest in developing and 

9 maintaining the National Valley Fever 

10 Registry. 

11 ‘‘(3) DUTIES.—The Advisory Committee 

12 shall— 

13 ‘‘(A) review information and make rec14 ommendations to the Secretary concerning— 

15 ‘‘(i) the development and maintenance 

16 of the National Valley Fever Registry; 

17 ‘‘(ii) the type of information to be col18 lected and stored in the National Valley 

19 Fever Registry; 

20 ‘‘(iii) the manner in which such data 

21 is to be collected; 

22 ‘‘(iv) the use and availability of such 

23 data including guidelines for such use; and 

24 ‘‘(v) the collection of information 

25 about diseases and disorders that primarily 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
14 

•HR 9942 IH

1 affect motor neurons that are considered 

2 essential to furthering the study and cure 

3 of valley fever; and 

4 ‘‘(B) oversee the National Valley Fever 

5 Registry, if the Secretary establishes the Na6 tional Valley Fever Registry. 

7 ‘‘(4) REPORT.—Not later than 270 days after 

8 the date on which the Advisory Committee is estab9 lished, the Advisory Committee shall submit a report 

10 to the Secretary containing the information reviewed 

11 and each recommendation made under paragraph 

12 (3)(A). 

13 ‘‘(5) TERMINATION.—The Advisory Committee 

14 shall terminate on the date that is seven years after 

15 the date on which the report required under para16 graph (4) is submitted. 

17 ‘‘(c) GRANTS.— 

18 ‘‘(1) IN GENERAL.—The Secretary, acting 

19 through the Director of the Centers for Disease 

20 Control and Prevention, may award grants to, and 

21 enter into contracts and cooperative agreements 

22 with, public or private nonprofit entities for the col23 lection, analysis, and reporting of data on valley 

24 fever and other fungal diseases that can be confused 

25 with valley fever or misdiagnosed as valley fever. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
15 

•HR 9942 IH

1 ‘‘(2) COMMENCEMENT.—After receiving the re2 port under subsection (b)(4), the Secretary may 

3 commence making awards under paragraph (1). 

4 ‘‘(d) COORDINATION WITH FEDERAL, STATE, AND

5 LOCAL REGISTRIES.— 

6 ‘‘(1) IN GENERAL.—In establishing the Na7 tional Valley Fever Registry, the Secretary, acting 

8 through the Director of the Centers for Disease 

9 Control and Prevention, may— 

10 ‘‘(A) identify, build upon, expand, and co11 ordinate among existing data, surveys, reg12 istries, and other Federal public health and en13 vironmental infrastructure wherever possible, 

14 which may include— 

15 ‘‘(i) any registry previously supported 

16 by the Centers for Disease Control and 

17 Prevention; 

18 ‘‘(ii) State-based valley fever reg19 istries; 

20 ‘‘(iii) the National Vital Statistics 

21 System of the National Center for Health 

22 Statistics; and 

23 ‘‘(iv) any other existing or relevant 

24 databases that collect or maintain informaVerDate Sep 11 2014 05:49 Oct 22, 2024 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\H9942.IH H9942

kjohnson on DSK7ZCZBW3PROD with $$_JOB
16 

•HR 9942 IH

1 tion on each fungal disease recommended 

2 by the Advisory Committee; and 

3 ‘‘(B) provide for research access to valley 

4 fever data, as recommended by the Advisory 

5 Committee, to the extent permitted by applica6 ble statutes and regulations and in a manner 

7 that protects privacy consistent with applicable 

8 privacy statutes and regulations. 

9 ‘‘(2) COORDINATION WITH THE NATIONAL IN10 STITUTES OF HEALTH.—Consistent with applicable 

11 privacy statutes and regulations, the Secretary may 

12 ensure that epidemiological and other types of infor13 mation obtained under subsection (a) is made avail14 able to the Director of the National Institutes of 

15 Health. 

16 ‘‘(e) NATIONAL AND VOLUNTARY HEALTH ASSOCIA17 TIONS DEFINED.—In this section, the term ‘national and 

18 voluntary health associations’ means a national nonprofit 

19 organization with chapters or other affiliated organiza20 tions in States throughout the United States that have— 

21 ‘‘(1) experience serving the population of indi22 viduals with valley fever; and 

23 ‘‘(2) have demonstrated experience in valley 

24 fever research, care, and patient services.’’. 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
17 

•HR 9942 IH

1 SEC. 7. DEFINITIONS. 

2 In this Act— 

3 (1) the term ‘‘eligible entity’’ means— 

4 (A) an academic institution; 

5 (B) a nonprofit organization; 

6 (C) a State or local government; and 

7 (D) a private entity; 

8 (2) the term ‘‘expert stakeholders’’ means aca9 demic institutions, advocacy groups, clinicians, pa10 tient groups, researchers, public health officials, sci11 entists, and vaccine manufactures with expertise in 

12 valley fever, vaccine development, or vaccine manu13 facturing; 

14 (3) the term ‘‘relevant agency heads’’ means— 

15 (A) the Director of the National Institutes 

16 of Health; 

17 (B) the Director of the Biomedical Ad18 vanced Research and Development Authority; 

19 (C) the Commissioner of Food and Drugs; 

20 and 

21 (D) such other heads of Federal agencies 

22 and departments as the Secretary determines 

23 relevant; 

24 (4) the term ‘‘Secretary’’ means the Secretary 

25 of Health and Human Services; 


kjohnson on DSK7ZCZBW3PROD with $$_JOB
18 

•HR 9942 IH

1 (5) the term ‘‘valley fever’’ means coccidioi2 domycosis; and 

3 (6) the term ‘‘Vaccine Coordinator’’ means the 

4 valley fever vaccine development coordinator ap5 pointed under section 2(a)(3). 

Æ 


kjohnson on DSK7ZCZBW3PROD with $$_JOB