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42 U.S.C. § 284m–1 — Pediatric Advisory Committee
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary of Health and Human Services shall, under [section 217a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section217a&num=0&edition=prelim) or other appropriate authority, convene and consult an advisory committee on pediatric therapeutics (including drugs and biological products) and medical devices (referred to in this section as the “advisory committee”).
**(b) Purpose**
(1) **In general** — The advisory committee shall advise and make recommendations to the Secretary, through the Commissioner of Food and Drugs, on matters relating to pediatric therapeutics (including drugs and biological products) and medical devices.
(2) **Matters included** — The matters referred to in paragraph (1) include—
(A) pediatric research conducted under sections 262, 284m, and 290b of this title and sections 351, 352, 355, 355a, 355c, 360(k), 360e, and 360j(m) of title 21;
(B) identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;
(C) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices; and
(D) the development of countermeasures (as defined in [section 360bbb–4(a) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb–4/a&num=0&edition=prelim)) for pediatric populations.
**(c) Composition** The advisory committee shall include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by
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Stable record: federal_law:legal_authorities:record_usc_76aa53ba611b75c0ee376a29
Source file: Laws/federal/codes/united-states-code/title-42/section-284m1-pediatric-advisory-committee--e9d48b52a4.md
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Source location: Title 42, Chapter 6A, § 284m–1; chapter-6a-public-health-service.md
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**(a) In general** The Secretary of Health and Human Services shall, under [section 217a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section217a&num=0&edition=prelim) or other appropriate authority, convene and consult an advisory committee on pediatric therapeutics (including drugs and biological products) and medical devices (referred to in this section as the “advisory committee”).
**(b) Purpose**
(1) **In general** — The advisory committee shall advise and make recommendations to the Secretary, through the Commissioner of Food and Drugs, on matters relating to pediatric therapeutics (including drugs and biological products) and medical devices.
(2) **Matters included** — The matters referred to in paragraph (1) include—
(A) pediatric research conducted under sections 262, 284m, and 290b of this title and sections 351, 352, 355, 355a, 355c, 360(k), 360e, and 360j(m) of title 21;
(B) identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;
(C) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices; and
(D) the development of countermeasures (as defined in [section 360bbb–4(a) of title 21](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb–4/a&num=0&edition=prelim)) for pediatric populations.
**(c) Composition** The advisory committee shall include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by the Secretary.
**(d) Continuation of Operation of Committee** Notwithstanding [section 1013 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section1013&num=0&edition=prelim), the advisory committee shall continue to operate to carry out the advisory committee’s responsibilities under sections 355a, 355c, and 360j(m) of title 21.
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Federal law — U.S. Code and appendices · legal_authorities
In time of war, or of emergency proclaimed by the President, he may utilize the Service to such extent and in such manner as shall in his judgment promote the public interest. In time of war, or of emergency involving the national defense proclaimed by the President, he may by Executive order declare the commissioned corps of the Service to be a military service. Upon such declaration, and during the period of such war or such emergency or such part thereof as the President shall prescribe, the commissioned corps (a) shall constitute a branch of the land and naval forces of the United States, (b) shall, to the extent prescribed by regulations of the President, be subject to the Uniform Code of Military Justice [[10 U.S.C. 801](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section801&num=0&edition=prelim) et seq.], and (c) shall continue to operate as part of the Service except to the extent that the President may direct as Commander in Chief.
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 217a
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Federal law — U.S. Code and appendices · legal_authorities
**(a) New drugs and biological products**
(1) **In general**
(A) *General requirements* — Except with respect to an application for which subparagraph (B) applies, a person that submits, on or after September 27, 2007, an application (or supplement to an application) for a drug—
(i) under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration; or
(ii) under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration,
shall submit with the application the assessments described in paragraph (2).
(B) *Certain molecularly targeted cancer indications* — A person that submits, on or after the date that is 3 years after August 18, 2017, an original application for a new active ingredient under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim), shall submit with the application reports on the investigation described in paragraph (3) if the drug or biological product that is the subject of the application is—
(i) intended for the treatment of an adult cancer; and
(ii) directed at a molecular target that the Secretary determines to be substantially relevant to the growth or progression of a pediatric cancer.
(2) **Assessments**
(A) *In general* — The assessments referred to in
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355c
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In General.—**
(1) **Advisory committees in existence on january 5, 1973.—** — Each advisory committee that is in existence on January 5, 1973, shall terminate not later than the expiration of the 2-year period following that date unless—
(A) in the case of an advisory committee established by the President or an officer of the Federal Government, such advisory committee is renewed by the President or that officer by appropriate action prior to the expiration of such 2-year period; or
(B) in the case of an advisory committee established by an Act of Congress, its duration is otherwise provided for by law.
(2) **Advisory committees established after january 5, 1973.—** — Each advisory committee established after January 5, 1973, shall terminate not later than the expiration of the 2-year period beginning on the date of its establishment unless—
(A) in the case of an advisory committee established by the President or an officer of the Federal Government 11 So in original. Probably should be followed by a comma. such advisory committee is renewed by the President or such officer by appropriate action prior to the end of such period; or
(B) in the case of an advisory committee established by an Act of Congress, its duration is otherwise provided for by law.
**(b) Charters.—**
(1) **Upon renewal.—** — Upon the renewal of an advisory committee, the advisory committee shall file a charter in accordance with [section 1008(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section1008/c&num=0&edition=prelim).
(2) **Upon expiration of successive 2-year periods.—** — An advisory committee established by an Act of Congress shall file a charter in accordance with [section 1008(c) of this title](https://uscode.house.gov/view.x
Source: Supplied U.S. Code snapshot — release unconfirmed · 5 U.S.C. § 1013
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Federal law — U.S. Code and appendices · legal_authorities
**(a) List of priority issues in pediatric therapeutics**
(1) **In general** — Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs, biological products, or indications that require study. The list shall be revised every three years.
(2) **Consideration of available information** — In developing and prioritizing the list under paragraph (1), the Secretary—
(A) shall consider—
(i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;
(ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, and identification of biomarkers for such diseases, disorders, or conditions, may be beneficial in pediatric populations; and
(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and
(B) may consider the availability of qualified countermeasures (as defined in [section 247d–6a of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6a&num=0&edition=prelim)), security countermeasures (as defined in [section 247d–6b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section247d-6b&num=0&edition=prelim)), and qualified pandemic or epidemic products (as defined in [section 247d–6d of this title]
Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 284m
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