H.R. 3433 — what changed

added “(A) In general—For purposes of paragraph (1)(B), the investigation described in this paragraph is (as determined by the Secretary) a molecularly targeted pediatric cancer investigation of—

added “(i) the drug or biological product for which the application referred to in such paragraph is submitted; or

added “(ii) such drug or biological product in combination with—

added “(I) an active ingredient of a drug or biological product—

added “(aa) for which an approved application under section 505(j) under this Act or under section 351(k) of the Public Health Service Act is in effect; and

added “(bb) that is determined by the Secretary to be the standard of care for treating a pediatric cancer; or

added “(II) an active ingredient of a drug or biological product—

added “(aa) for which an approved application under section 505(b) of this Act or section 351(a) of the Public Health Service Act to treat an adult cancer is in effect and is held by the same person submitting the application under paragraph (1)(B); and

added “(bb) that is directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.

added “(B) Additional requirements

added “(i) Design of investigation—A molecularly targeted pediatric cancer investigation referred to in subparagraph (A) shall be designed to yield clinically meaningful pediatric study data that is gathered using appropriate formulations for each age group for which the study is required, regarding dosing, safety, and preliminary efficacy to inform potential pediatric labeling.

added “(ii) Limitation—An investigation described in subparagraph (A)(ii) may be required only if the drug or biological product for which the application referred to in paragraph (1)(B) contains either—

added “(I) a single new active ingredient; or

added “(II) more than one active ingredient, if an application for the combination of active ingredients has not previously been approved but each active ingredient has been previously approved to treat an adult cancer.

added “(iii) Results of already-completed preclinical studies of application drug—The Secretary may require that reports on an investigation required pursuant to paragraph (1)(B) include the results of all preclinical studies on which the decision to conduct such investigation was based.

added “(iv) Rule of construction regarding inactive ingredients—With respect to a combination of active ingredients referred to in subparagraph (A)(ii), such subparagraph shall not be construed as addressing the use of inactive ingredients with such combination.”

added “(C) Rule of construction—No application that is subject to the requirements of subparagraph (B) shall be subject to the requirements of subparagraph (A), and no application (or supplement to an application) that is subject to the requirements of subparagraph (A) shall be subject to the requirements of subparagraph (B).”

added “(3) Limitation—The Secretary shall not issue enforcement actions under section 303 for failures under this subsection in the case of a drug or biological product that is no longer marketed.”

added “(4) Due diligence—Before the Secretary may conclude that a person failed to submit or otherwise meet a requirement as described in the matter preceding paragraph (1), the Secretary shall—

added “(A) issue a noncompliance letter pursuant to paragraph (1);

added “(B) provide such person with a 45-day period beginning on the date of receipt of such noncompliance letter to respond in writing as set forth in such paragraph; and

added “(C) after reviewing such written response, determine whether the person demonstrated a lack of due diligence in satisfying such requirement.”

added Section 508(b) of the Food and Drug Administration Safety and Innovation Act (21 U.S.C. 355c–1(b)) is amended—

added “(17) a listing of penalties, settlements, or payments under section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353) for failure to comply with requirements under such section 505B, including, for each penalty, settlement, or payment, the name of the drug, the sponsor thereof, and the amount of the penalty, settlement, or payment imposed; and”

added “(f) Approved use or indication defined—In this section, the term approved use or indication means the use or indication approved under section 505 of this Act or licensed under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or condition.”

added Section 409I(d) of the Public Health Service Act (42 U.S.C. 284m(d)) is amended to read as follows:

added “(d) Funding—Of the amount made available for pediatric research to each national research institute and national center under this title for each of fiscal years 2025, 2026, and 2027, the Director of NIH is authorized to make available up to one percent of such amount for pediatric research under this section.”

added “1015. Abraham Accords Office

added “(a) In general—The Secretary, acting through the Commissioner of Food and Drugs, shall establish within the Food and Drug Administration an office, to be known as the Abraham Accords Office, to be headed by a director.

added “(b) Office—Not later than two years after the date of enactment of this section, the Secretary shall—

added “(1) in consultation with the governments of Abraham Accords countries, as well as appropriate United States Government diplomatic and security personnel—

added “(A) select the location of the Abraham Accords Office in an Abraham Accords country; and

added “(B) establish such office; and

added “(2) assign to such office such personnel of the Food and Drug Administration as the Secretary determines necessary to carry out the functions of such office.

added “(c) Duties—The Secretary, acting through the Director of the Abraham Accords Office, shall—

added “(1) after the Abraham Accords Office is established—

added “(A) as part of the Food and Drug Administration’s work to strengthen the international oversight of regulated commodities, provide technical assistance to regulatory partners in Abraham Accords countries on strengthening regulatory oversight and converging regulatory requirements for the oversight of regulated products, including good manufacturing practices and other issues relevant to manufacturing medical products that are regulated by the Food and Drug Administration;

added “(B) facilitate interactions between the Food and Drug Administration and interested parties in Abraham Accords countries, including by sharing relevant information regarding United States regulatory pathways with such parties; and

added “(C) facilitate feedback between the Food and Drug Administration and such parties located within Abraham Accords countries prior to submission of an application under section 505(b), 505(j), or 515 of this Act or section 351(a) or 351(k) of the Public Health Service Act, or a notification under section 510(k) of this Act, such as feedback on research, development, and manufacturing of drugs, biologics, and medical devices; and

added “(2) carry out other functions and activities as the Secretary determines to be necessary to carry out this section.

added “(d) Abraham Accords country defined—In this section, the term Abraham Accords country means a country identified by the Department of State as having signed the Abraham Accords Declaration.”

added Section 372 of the Public Health Service Act (42 U.S.C. 274) is amended by adding at the end the following:

added “(d) Registration fees

added “(1) In general—The Secretary may collect registration fees from any member of the Organ Procurement and Transplantation Network for each transplant candidate such member places on the list described in subsection (b)(2)(A)(i). Such registration fees shall only be collected and distributed to support the operation of the Organ Procurement and Transplantation Network. Such registration fees are authorized to remain available until expended.

added “(2) Collection—The Secretary may collect the registration fees under paragraph (1) directly or through awards made under subsection (b)(1)(A).

added “(3) Distribution—The Secretary may distribute such fees among the awardees described in subsection (b)(1)(A).

added “(4) Transparency—The Secretary shall—

added “(A) promptly post on the Internet website of the Organ Procurement and Transplant Network—

added “(i) the amount of registration fees collected under this subsection from each member of the Organ Procurement and Transplantation Network; and

added “(ii) a list of activities such fees are used to support; and

added “(B) update the information posted pursuant to subparagraph (A), as applicable for each calendar quarter for which fees are collected under paragraph (1).

added “(5) GAO review—Not later than 2 years after the date of enactment of this subsection, the Comptroller General of the United States shall, to the extent data are available—

added “(A) conduct a review concerning the activities under this subsection; and

added “(B) submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Finance of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on such review, including related recommendations, as applicable.”