I 

117TH CONGRESS 

2D SESSION H. R. 7032 

To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(j)) with respect to a process to inform persons submitting 

an abbreviated application for a new drug whether the new drug is 

qualitatively or quantitatively the same as a listed drug, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 9, 2022 

Ms. KUSTER introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL 

To amend section 505(j) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 355(j)) with respect to a process to inform persons submitting an abbreviated application for a new drug whether the new drug is qualitatively 

or quantitatively the same as a listed drug, 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 ‘‘Increasing Trans5 parency in Generic Drug Applications Act of 2022’’. 


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1 SEC. 2. DETERMINING WHETHER PROPOSED NEW GENERIC 

2 DRUGS ARE QUALITATIVELY OR QUAN3 TITATIVELY THE SAME AS THE LISTED DRUG. 

4 (a) IN GENERAL.—Section 505(j)(3) of the Federal 

5 Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(3)) is 

6 amended by adding at the end the following: 

7 ‘‘(H)(i) Upon request (in controlled correspondence 

8 or otherwise) by a person that has submitted or intends 

9 to submit an abbreviated application for a new drug under 

10 this subsection or on the Secretary’s own initiative during 

11 the review of such abbreviated application, the Secretary 

12 shall inform the person whether such new drug is quali13 tatively and quantitatively the same as the listed drug. 

14 ‘‘(ii) If the Secretary determines that such new drug 

15 is not qualitatively or quantitatively the same as the listed 

16 drug, the Secretary shall identify and disclose to the per17 son— 

18 ‘‘(I) the ingredient or ingredients that cause the 

19 new drug not to be qualitatively or quantitatively the 

20 same as the listed drug; and 

21 ‘‘(II) the quantity or proportion of any ingre22 dient in the listed drug for which there is an identi23 fied quantitative deviation. 

24 ‘‘(iii) If the Secretary determines that such new drug 

25 is qualitatively and quantitatively the same as the listed 

26 drug, the Secretary shall not change or rescind such deterVerDate Sep 11 2014 05:28 Apr 07, 2022 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H7032.IH H7032

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1 mination after the submission of an abbreviated applica2 tion for such new drug under this subsection unless— 

3 ‘‘(I) the formulation of the listed drug has been 

4 changed and the Secretary has determined that the 

5 prior listed drug formulation was withdrawn for rea6 sons of safety or effectiveness; or 

7 ‘‘(II) the Secretary makes a written determina8 tion that the prior determination must be changed 

9 because an error has been identified. 

10 ‘‘(iv) If the Secretary makes a written determination 

11 described in clause (iii)(II), the Secretary shall provide no12 tice and a copy of the written determination to the person 

13 making the request under clause (i). 

14 ‘‘(v) The disclosures required by this subparagraph 

15 are disclosures authorized by law under section 1905 of 

16 title 18, United States Code.’’. 

17 (b) GUIDANCE.— 

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

19 after the date of enactment of this Act, the Sec20 retary of Health and Human Services shall issue 

21 guidance describing how the Secretary will deter22 mine whether a new drug is qualitatively and quan23 titatively the same as the listed drug (as such terms 

24 are used in section 505(j)(3)(H) of the Federal 

25 Food, Drug, and Cosmetic Act, as added by subVerDate Sep 11 2014 05:28 Apr 07, 2022 Jkt 029200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H7032.IH H7032

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1 section (a)), including with respect to assessing pH 

2 adjusters. 

3 (2) PROCESS.—In issuing guidance as required 

4 by paragraph (1), the Secretary of Health and 

5 Human Services shall— 

6 (A) publish draft guidance; 

7 (B) provide a period of at least 60 days for 

8 comment on the draft guidance; and 

9 (C) after considering any comments re10 ceived, publish final guidance. 

11 (c) APPLICABILITY.—Section 505(j)(3)(H) of the 

12 Federal Food, Drug, and Cosmetic Act, as added by sub13 section (a), applies beginning on the date of enactment 

14 of this Act, irrespective of the date on which the guidance 

15 required by subsection (b) is finalized. 

Æ 


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