Mikaela Naylon Give Kids a Chance Act of 2025

[Congressional Bills 119th Congress] [From the U.S. Government Publishing Office] [S. 3302 Introduced in Senate (IS)] <DOC> 119th CONGRESS 1st Session S. 3302 To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, and for other purposes. _______________________________________________________________________ IN THE SENATE OF THE UNITED STATES December 2, 2025 Mr. Mullin (for himself, Mr. Bennet, Ms. Klobuchar, Mrs. Shaheen, Mr. Marshall, Mr. Scott of Florida, Ms. Collins, Mr. Coons, Mrs. Capito, Mr. Kelly, Mr. Husted, Mr. Kim, Mr. Sheehy, Mrs. Moody, Mr. Hickenlooper, Ms. Duckworth, Mr. Boozman, Mr. Schiff, Mr. Kennedy, Mr. Reed, Mr. Schmitt, Mr. Markey, Mr. Booker, and Mr. Justice) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to molecularly targeted pediatric cancer investigations, 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 ``Mikaela Naylon Give Kids a Chance Act of 2025''. SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES OF FOOD AND DRUG ADMINISTRATION REGARDING MOLECULARLY TARGETED CANCER DRUGS. (a) In General.-- (1) Additional active ingredient for application drug; limitation regarding novel-combination application drug.-- Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(3)) is amended-- (A) by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively; and (B) by striking subparagraph (A) and inserting the following: ``(A) In general.--For purposes of paragraph (1)(B), the investigation described in this paragraph is a molecularly targeted pediatric cancer inv