I 

117TH CONGRESS 

2D SESSION H. R. 7035 

To amend the Federal Food, Drug, and Cosmetic Act to require prompt 

reports of marketing status by holders of approved applications for biological products, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 9, 2022 

Ms. MANNING (for herself and Mr. HUDSON) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

require prompt reports of marketing status by holders 

of approved applications for biological products, 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 ‘‘Biologics Market 

5 Transparency Act of 2022’’. 


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1 SEC. 2. PROMPT REPORTS OF MARKETING STATUS BY 

2 HOLDERS OF APPROVED APPLICATIONS FOR 

3 BIOLOGICAL PRODUCTS. 

4 (a) IN GENERAL.—Section 506I of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 356i) is amended— 

6 (1) in subsection (a)— 

7 (A) by striking ‘‘The holder of an applica8 tion approved under subsection (c) or (j) of sec9 tion 505’’ and inserting ‘‘The holder of an ap10 plication approved under subsection (c) or (j) of 

11 section 505 of this Act or subsection (a) or (k) 

12 of section 351 of the Public Health Service 

13 Act’’; and 

14 (B) in paragraph (3), by striking ‘‘or ab15 breviated application number’’ and inserting ‘‘, 

16 abbreviated application number, or biologics li17 cense application number’’; and 

18 (2) in subsection (b)— 

19 (A) by striking ‘‘The holder of an applica20 tion approved under subsection (c) or (j)’’ and 

21 inserting ‘‘The holder of an application ap22 proved under subsection (c) or (j) of section 

23 505 of this Act or subsection (a) or (k) of sec24 tion 351 of the Public Health Service Act’’; and 

25 (B) in paragraph (2), by striking ‘‘or ab26 breviated application number’’ and inserting ‘‘, 


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1 abbreviated application number, or biologics li2 cense application number’’. 

3 (b) ADDITIONAL ONE-TIME REPORT.—Subsection 

4 (c) of section 506I of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 356i) is amended to read as follows: 

6 ‘‘(c) ADDITIONAL ONE-TIME REPORT.—Within 180 

7 days of the date of enactment of the Biologics Market 

8 Transparency Act of 2022, all holders of applications ap9 proved under subsection (a) or (k) of section 351 of the 

10 Public Health Service Act shall review the information in 

11 the list published under section 351(k)(9)(A) and shall 

12 submit a written notice to the Secretary— 

13 ‘‘(1) stating that all of the application holder’s 

14 biological products in the list published under sec15 tion 351(k)(9)(a) that are not listed as discontinued 

16 are available for sale; or 

17 ‘‘(2) including the information required pursu18 ant to subsection (a) or (b), as applicable, for each 

19 of the application holder’s biological products that 

20 are in the list published under section 351(k)(9)(a) 

21 and not listed as discontinued, but have been with22 drawn from sale or never have been available for 

23 sale.’’. 


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1 (c) PURPLE BOOK.—Subsections (d) and (e) of sec2 tion 506I of the Federal Food, Drug, and Cosmetic Act 

3 (21 U.S.C. 356i) are each amended— 

4 (1) by striking ‘‘the list published under sub5 section 505(j)(7)(A)’’ and inserting ‘‘the list pub6 lished under section 505(j)(7)(A) of this Act or sec7 tion 351(k)(9)(A) of the Public Health Service Act, 

8 as applicable,’’; and 

9 (2) by striking ‘‘in accordance with subsection 

10 505(j)(7)(C)’’ and inserting ‘‘in accordance with sec11 tion 505(j)(7)(C) of this Act or section 351(k)(9)(B) 

12 of the Public Health Service Act (as applicable)’’. 

Æ 


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