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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6972 Introduced in House (IH)]

<DOC>

117th CONGRESS
  2d Session
                                H. R. 6972

    To amend the Federal Food, Drug, and Cosmetic Act to establish 
 additional authorities of the Food and Drug Administration regarding 
 the conduct of pediatric investigations of molecularly targeted drugs 
                to treat cancer, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 8, 2022

 Mr. Butterfield (for himself and Mr. McCaul) 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 establish 
 additional authorities of the Food and Drug Administration regarding 
 the conduct of pediatric investigations of molecularly targeted drugs 
                to treat cancer, 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 ``Give Kids a Chance Act of 2022''.

SEC. 2. RESEARCH INTO PEDIATRIC USES OF DRUGS; ADDITIONAL AUTHORITIES 
              OF FOOD AND DRUG ADMINISTRATION REGARDING MOLECULARLY 
              TARGETED CANCER DRUGS.

    (a) In General.--
            (1) Authority regarding investigation of novel combination 
        drugs.--Section 505B(a)(1)(B) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355c(a)(1)(B)) is amended, in the 
        matter preceding clause (i), by inserting after ``Public Health 
        Service Act,'' the following: ``or an application under such 
        section 505 or such section 351 for a drug or biological 
        product that contains a novel combination of two or more active 
        ingredients (subject to paragraph (3)(B)(iii))''.
            (2) 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 (as determined by the Secretary) a molecularly 
                targeted pediatric cancer investigation of--
                            ``(i) the drug or biological product for 
                        which the application referred to in such 
                        paragraph is submitted; or
                            ``(ii) the active ingredient or ingredients 
                        of such drug or biological product in 
                        combination with--
                                    ``(I) an active ingredient of a 
                                drug for which an approved application 
                                under section 505(j) is in effect or an 
                                active ingredient of a biological 
                                product for which an approved 
                                application under section 351(k) of the 
                                Public Health Service Act is in effect, 
                                which drug or biological product is 
                                determined by the Secretary to be the 
                                standard of care for treating a 
                                pediatric cancer;
                                    ``(II) an active ingredient of a 
                                drug for which an approved application 
                                under section 505(b) is in effect to 
                                treat an adult cancer, or an active 
                                ingredient of a biological product for 
                                which an approved application under 
                                section 351(a) of the Public Health 
                                Service Act is in effect to treat an 
                                adult cancer, which approved 
                                application is held by the same person 
                                submitting the application referred to 
                                in paragraph (1)(B); or
                                    ``(III) an active ingredient of a 
                                drug or biological product for which 
                                there is in effect an exemption for 
                                investigational use under section 
                                505(i), which drug or biological 
                                product is under such exemption being 
                                studied jointly by the person 
                                submitting the application referred to 
                                in paragraph (1)(B) and by another 
                                person pursuant to an agreement between 
                                such persons.
                    ``(B) Additional requirements.--
                            ``(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, gathered using 
                        appropriate formulations for each age group for 
                        which the study is required, regarding dosing, 
                        safety, and preliminary efficacy.
                            ``(ii) Purpose of investigation.--The 
                        purpose of a molecularly targeted pediatric 
                        cancer investigation referred to in 
                        subparagraph (A) shall be--
                                    ``(I) in the case of such an 
                                investigation conducted with respect to 
                                a drug or biological product referred 
                                to in clause (i) of such subparagraph, 
                                to inform potential pediatric labeling 
                                of the drug or biological product for 
                                which the application referred to in 
                                paragraph (1)(B) is submitted; and
                                    ``(II) in the case of such an 
                                investigation conducted with respect to 
                                a combination of active ingredients 
                                described to in clause (ii) of such 
                                subparagraph, to assist in determining 
                                the relevance of its molecular target 
                                to the growth or progression of a 
                                pediatric cancer.
                            ``(iii) Limitation regarding investigation 
                        of novel combination.--For purposes of 
                        paragraph (1)(B), a novel combination is a 
                        combination of two or more active ingredients 
                        for which an application under section 505 of 
                        this Act or section 351 of the Public Health 
                        Service Act for such combination has not 
                        previously been approved. A pediatric 
                        investigation under this paragraph of such 
                        novel combination is required only if each of 
                        the active ingredients in the combination has 
                        been approved under such section 505 or such 
                        section 351 to treat an adult cancer.
                            ``(iv) Preclinical data.--The Secretary may 
                        require that reports on an investigation 
                        required pursuant to paragraph (1)(B) shall 
                        include the results of all preclinical studies 
                        on which the decision to conduct such 
                        investigation was based.
                            ``(v) Rule of construction regarding 
                        inactive ingredients.--With respect to a 
                        combination of active ingredients referred to 
                        in subparagraph (A)(ii), such subparagraph may 
                        not be construed as addressing the use of 
                        inactive ingredients with such combination.''.
            (3) Clarifying applicability of certain provisions.--
        Section 505B(a)(3) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 355c(a)(3)), as amended by paragraph (2), is further 
        amended by adding at the end the following:
                    ``(E) Internal committee review; labeling changes; 
                dissemination of information; adverse events; scope of 
                authority.--Subsections (f) through (j) shall apply 
                with respect to investigations described in this 
                paragraph to the same extent and in the same manner as 
                such subsections apply with respect to the assessments 
                required under paragraph (1)(A), except that subsection 
                (g) does not apply with respect to an investigation 
                referred to in subparagraph (A)(ii) of this 
                paragraph.''.
            (4) Conforming amendments.--Section 505B(a) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)) is amended--
                    (A) in paragraph (3)(C), as redesignated by 
                paragraph (2)(A) of this subsection, by striking 
                ``investigations described in this paragraph'' and 
                inserting ``investigations referred to in subparagraph 
                (A)(i)'';
                    (B) in paragraph (3)(D), as redesignated by 
                paragraph (2)(A) of this subsection, by striking ``the 
                assessments under paragraph (2)(B)'' and inserting 
                ``the assessments required under paragraph (1)(A)''; 
                and
                    (C) in paragraph (5)(D), by inserting before the 
                period at the end the following: ``, except this 
                subparagraph is not applicable to an investigation 
                referred to in paragraph (3)(A)(ii)''.
    (b) Authority Regarding Preclinical Studies.--Section 505B(a)(1) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(a)(1)), as 
amended by subsection (a)(1), is further amended by adding at the end 
the following:
                    ``(C) Preclinical studies generally.--
                            ``(i) In general.--With respect to an 
                        application for an exemption for 
                        investigational use under section 505(i) for a 
                        drug or biological product that is intended for 
                        the treatment of an adult cancer, the Secretary 
                        may require, as a condition of permitting the 
                        exemption to go into effect, that the sponsor 
                        involved enter into an agreement with the 
                        Secretary to conduct not more than two 
                        preclinical studies of the drug or biological 
                        product in order to assist in determining the 
                        relevance of its molecular target to the growth 
                        or progression of a pediatric cancer.
                            ``(ii) Timeframe for preclinical studies.--
                        With respect to the drug or biological product 
                        involved, an agreement under clause (i) for a 
                        preclinical study shall specify the date by 
                        which an initial plan for the study will be 
                        submitted to the Secretary except that the 
                        Secretary may not require the submission of 
                        such plan any earlier than one year after the 
                        exemption referred to in clause (i) goes into 
                        effect. The results of the preclinical study 
                        shall be submitted to the Secretary in 
                        accordance with a timeframe to which the 
                        Secretary and the sponsor involved have agreed. 
                        Such timeframe shall provide for deferrals 
                        equivalent to deferrals under paragraph (4).''.
    (c) Applicability.--The amendments made by this section apply with 
respect to any application under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)), any application under 
section 505 of such Act (21 U.S.C. 355), and any application under 
section 351(a) of the Public Health Service Act (42 U.S.C. 262), that 
is submitted on or after the expiration of the 3-year period beginning 
on the date of the enactment of this Act.
                                 <all>
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