[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4134 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 4134

    To amend the Federal Food, Drug, and Cosmetic Act to direct the 
Secretary of Health and Human Services to establish a process to allow 
   the holders of abbreviated new drug applications to make labeling 
 changes to include new or updated safety-related information, and for 
                            other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 14, 2023

Mr. Schiff (for himself and Ms. Kuster) 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 direct the 
Secretary of Health and Human Services to establish a process to allow 
   the holders of abbreviated new drug applications to make labeling 
 changes to include new or updated safety-related information, and for 
                            other purposes.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Updated Drug Labeling for Patient 
Safety Act''.

SEC. 2. SAFETY LABELING CHANGES INITIATED BY ANDA HOLDERS.

    (a) In General.--Section 505(j) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)) is amended by adding at the end the 
following:
    ``(14) Notwithstanding paragraph (2)(A)(v), the Secretary shall 
establish a process to allow the holder of an abbreviated new drug 
application to change the labeling of the drug that is the subject of 
the application to include new or updated safety-related information, 
including a process to make such changes prior to being approved by the 
Secretary.''.
    (b) Regulations.--
            (1) In general.--Not later than 18 months after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall issue a final rule to implement paragraph (14) 
        of section 505(j) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355(j)), as added by subsection (a).
            (2) Contents.--The final rule issued under paragraph (1) 
        shall include a process for conforming the labeling of a drug 
        that is labeled pursuant to such paragraph (14), the listed 
        drug (as such term is used in such section 505(j)), and other 
        drugs approved under such section 505(j) that reference such 
        listed drug.
            (3) Effective date.--The final rule issued under paragraph 
        (1) shall become effective not later than 180 days after the 
        date on which such final rule is issued.
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