Source: http://www4.law.cornell.edu/uscode/text/42/284m?quicktabs_8=0
Timestamp: 2013-12-11 08:39:05
Document Index: 219431745

Matched Legal Cases: ['§ 284', '§ 284', '§ 284', '§ 409', '§ 3', '§ 3', '§ 103', '§ 502', '§ 7002', '§ 301', '§ 14', '§ 3', '§ 306', '§ 502', '§ 284', '§ 284', '§ 284']

42 USC § 284m - Program for pediatric studies of drugs | Title 42 - The Public Health and Welfare | U.S. Code | LII / Legal Information Institute
USC › Title 42 › Chapter 6A › Subchapter III › Part B › § 284m	prevnext
42 USC § 284m - Program for pediatric studies of drugs
Consideration of available information In developing and prioritizing the list under paragraph (1), the Secretary shall consider—
Pediatric studies and research The Secretary, acting through the National Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues described in subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to award funds under this subsection.
Process for proposed pediatric study requests and labeling changes (1)
Submission of proposed pediatric study request The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) ofsection 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], or section 262
(m) of this title, including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which—
there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355
(j)] or section 262
(k) of this title; or
there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355
(b)(1)], and every three-year and five-year period referred to in subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E)(iv), (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) ofsection 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], or applicable twelve-year period referred to in section 262
(k)(7) of this title, and any seven-year period referred to in section 527 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360cc] has ended for at least one form of the drug; and
Written request to holders of approved applications The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) to all holders of an approved application for the drug. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (b) or (c) ofsection 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a] or section 262
(m) of this title, including with respect to information provided on the pediatric studies to be conducted pursuant to the request and using appropriate formulations for each age group for which the study is requested.
Requests for proposals If the Commissioner of Food and Drugs does not receive a response to a written request issued under paragraph (2) not later than 30 days after the date on which a request was issued, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a request for proposals to conduct the pediatric studies described in the written request in accordance with subsection (b).
Disqualification A holder that receives a first right of refusal shall not be entitled to respond to a request for proposals under paragraph (3).
Contracts, grants, or other funding mechanisms A contract, grant, or other funding may be awarded under this section only if a proposal is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
Reporting of studies (A)
In general On completion of a pediatric study in accordance with an award under this section, a report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of Food and Drugs. The report shall include all data generated in connection with the study, including a written request if issued.
Availability of reports Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a
(d)(4)]) and shall be assigned a docket number by the Commissioner of Food and Drugs. An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the written comments shall become part of the docket file with respect to each of the drugs.
Action by Commissioner The Commissioner of Food and Drugs shall take appropriate action in response to the reports submitted under subparagraph (A) in accordance with paragraph (7).
Requests for labeling change During the 180-day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall—
Referral to Pediatric Advisory Committee If, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request to the Pediatric Advisory Committee.
Action by the Pediatric Advisory Committee Not later than 90 days after receiving a referral under subparagraph (A), the Pediatric Advisory Committee shall—
FDA determination Not later than 30 days after receiving a recommendation from the Pediatric Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate.
Failure to agree If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner of Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
No effect on authority Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] when a drug lacks appropriate pediatric labeling. Neither course of action (the Pediatric Advisory Committee process or an enforcement action referred to in the preceding sentence) shall preclude, delay, or serve as the basis to stay the other course of action.
Dissemination of pediatric information Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health, shall study the feasibility of establishing a compilation of information on pediatric drug use and report the findings to Congress.
In general There are authorized to be appropriated to carry out this section, $25,000,000 for each of fiscal years 2013 through 2017.
Availability Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.
Submission of proposed pediatric study request The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) ofsection 505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355a], including with respect to the information provided on the pediatric studies to be conducted pursuant to the request. The Director of the National Institutes of Health may submit a proposed pediatric study request for a drug for which—
(j)]; or
there is no patent protection or market exclusivity protection for at least one form of the drug under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.]; and
Written request to holders of approved applications for drugs lacking exclusivity The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) to all holders of an approved application for the drug under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355]. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (b) or (c) ofsection 505A of such Act [21 U.S.C. 355a], including with respect to information provided on the pediatric studies to be conducted pursuant to the request and using appropriate formulations for each age group for which the study is requested.
(July 1, 1944, ch. 373, title IV, § 409I, as added Pub. L. 107–109, § 3(3),Jan. 4, 2002, 115 Stat. 1408; amended Pub. L. 108–155, § 3(b)(6),Dec. 3, 2003, 117 Stat. 1942; Pub. L. 109–482, title I, § 103(b)(14),Jan. 15, 2007, 120 Stat. 3687; Pub. L. 110–85, title V, § 502(b),Sept. 27, 2007, 121 Stat. 886; Pub. L. 111–148, title VII, § 7002(g)(2)(A),Mar. 23, 2010, 124 Stat. 820.)
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(1)(B), (10), (11), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
2010—Subsec. (a)(1). Pub. L. 111–148inserted “, biological products,” after “including drugs”.
2007—Pub. L. 110–85amended section generally. Prior to amendment, section related to development of list of drugs for which pediatric studies are needed, award of contracts for pediatric studies, process for requesting contract proposals to conduct certain pediatric studies, reporting of completed studies, requests for labeling changes and dispute resolution, and recommendation by the Secretary for formulation changes.
Subsec. (d). Pub. L. 109–482struck out subsec. (d) which related to authorization and availability of appropriations.
2003—Subsec. (c)(8), (9), (11). Pub. L. 108–155struck out “Advisory Subcommittee of the Anti-Infective Drugs” before “Advisory Committee” wherever appearing.
Pub. L. 107–109, § 14,Jan. 4, 2002, 115 Stat. 1419, as amended by Pub. L. 108–155, § 3(b)(2),Dec. 3, 2003, 117 Stat. 1941; Pub. L. 110–85, title III, § 306(b), title V, § 502(d),Sept. 27, 2007, 121 Stat. 865, 889, provided that:
“(a) In General.—The Secretary of Health and Human Services shall, under section 222 of the Public Health Service Act (42 U.S.C. 217a) 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’).
“(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 351, 409I, and 499 of the Public Health Service Act [42 U.S.C. 262, 284m, and 290b] and sections 501, 502, 505, 505A, 505B, 510(k), 515, and 520(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351, 352, 355, 355a, 355c, 360
(k), 360e, and 360j
(m)];
“(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; [and]
“(C) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices.
“(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 14 of the Federal Advisory Committee Act [5 U.S.C. App.], the advisory committee shall continue to operate during the five-year period beginning on the date of the enactment of the Best Pharmaceuticals for Children Act of 2007 [Sept. 27, 2007].”
42 USCDescription of ChangeSession YearPublic LawStatutes at Large § 284m2012112-144 [Sec.] 509(d)126 Stat. 1049 § 284m2012112-144 [Sec.] 507(d)126 Stat. 1045 § 284mnt2012112-144 [Sec.] 507(a)126 Stat. 1045 LII has no control over and does not endorse any external Internet site that contains links to or references LII.