Over-the-Counter Monograph Drug User Fee Amendments
[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [H.R. 4273 Reported in House (RH)] <DOC> Union Calendar No. 254 119th CONGRESS 1st Session H. R. 4273 [Report No. 119-300] To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, and for other purposes. _______________________________________________________________________ IN THE HOUSE OF REPRESENTATIVES July 2, 2025 Mr. Latta (for himself, Ms. DeGette, Mr. Crenshaw, and Mrs. Dingell) introduced the following bill; which was referred to the Committee on Energy and Commerce September 17, 2025 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed [Strike out all after the enacting clause and insert the part printed in italic] [For text of introduced bill, see copy of bill as introduced on July 2, 2025] _______________________________________________________________________ A BILL To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user fee program for over-the-counter monograph drugs, 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 ``Over-the-Counter Monograph Drug User Fee Amendments''. SEC. 2. FINDING. Congress finds that the fees authorized by the amendments made in this Act will be dedicated to OTC monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-71 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record. SEC. 3. DEFI
Health
User charges and fees
Congressional oversight
Drug safety, medical device, and laboratory regulation
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