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21 U.S.C. § 394 — Scientific review groups
Federal law — U.S. Code and appendices · legal_authorities
Without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may—
(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this chapter); and
(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.
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Stable record: federal_law:legal_authorities:record_usc_850594509ed1415dae744e6a
Source file: Laws/federal/codes/united-states-code/title-21/section-394-scientific-review-groups--947477de33.md
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Source location: Title 21, Chapter 9, § 394; chapter-009-federal-food-drug-and-cosmetic-act.md
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Without regard to the provisions of title 5 governing appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may—
(1) establish such technical and scientific review groups as are needed to carry out the functions of the Food and Drug Administration (including functions prescribed under this chapter); and
(2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Necessity of effective approval of application** No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application filed pursuant to subsection (b) or (j) is effective with respect to such drug.
**(b) Filing application; contents**
(1)
(A) Any person may file with the Secretary an application with respect to any drug subject to the provisions of subsection (a). Such persons shall submit to the Secretary as part of the application—
(i) full reports of investigations which have been made to show whether such drug is safe for use and whether such drug is effective in use;
(ii) a full list of the articles used as components of such drug;
(iii) a full statement of the composition of such drug;
(iv) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug;
(v) such samples of such drug and of the articles used as components thereof as the Secretary may require;
(vi) specimens of the labeling proposed to be used for such drug;
(vii) any assessments required under [section 355c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim); and
(viii) the patent number and expiration date of each patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug, and that—
(I) claims the drug for which the applicant submitted the application and is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent; or
(II) claims a method of using such drug for which approv
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 355
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Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** A tobacco product shall be deemed to be misbranded—
(1) if its labeling is false or misleading in any particular;
(2) if in package form unless it bears a label containing—
(A) the name and place of business of the tobacco product manufacturer, packer, or distributor;
(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;
(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and
(D) the statement required under [section 387t(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387t/a&num=0&edition=prelim),
except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary;
(3) if any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(4) if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;
(5) if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regula
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387c
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Requirement** Each tobacco product manufacturer or importer, or agents thereof, shall submit to the Secretary the following information:
(1) Not later than 6 months after June 22, 2009, a listing of all ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each brand and subbrand.
(2) A description of the content, delivery, and form of nicotine in each tobacco product measured in milligrams of nicotine in accordance with regulations promulgated by the Secretary in accordance with [section 1333(e) of title 15](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1333/e&num=0&edition=prelim).
(3) Beginning 3 years after June 22, 2009, a listing of all constituents, including smoke constituents as applicable, identified by the Secretary as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product, by brand and by quantity in each brand and subbrand. Effective beginning 3 years after June 22, 2009, the manufacturer, importer, or agent shall comply with regulations promulgated under section 387o of this title in reporting information under this paragraph, where applicable.
(4) Beginning 6 months after June 22, 2009, all documents developed after June 22, 2009 that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.
**(b) Data submission** At the request of the Secretary, each tobacco product manufacturer or importer of tobacco products, or agents thereof, shall submit the fo
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 387d
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Federal law — U.S. Code and appendices · legal_authorities
Page 706
TITLE 21—FOOD AND DRUGS
§ 393a
ment poses a threat to human health, the Secretary
shall promulgate regulations restricting the sale of
mercury intended for such use. At a minimum, such
regulations shall be designed to protect the health of
children and other sensitive populations from adverse
effects resulting from exposure to, or ingestion or in-
halation of, mercury. Such regulations, to the extent
feasible, should not unnecessarily interfere with the
availability of mercury for use in religious cere-
monies.’’
MANAGEMENT ACTIVITIES STUDY
Pub. L. 102–571, title II, § 205, Oct. 29, 1992, 106 Stat.
4502, directed Comptroller General to conduct a study
of management of activities of the Food and Drug Ad-
ministration that are related to dietary supplements of
vitamins, minerals, herbs, or other similar nutritional
substances and submit an interim report to Congress,
not later than 6 months after Oct. 29, 1992, with a final
report to be submitted not later than 12 months after
Oct. 29, 1992.
CONGRESSIONAL FINDINGS
Pub. L. 100–607, title V, § 502, Nov. 4, 1988, 102 Stat.
3120, provided that: ‘‘Congress finds that—
‘‘(1) the public health has been effectively protected
by the presence of the Food and Drug Administration
during the last eighty years;
‘‘(2) the presence and importance of the Food and
Drug Administration must be guaranteed; and
‘‘(3) the independence and integrity of the Food and
Drug Administration need to be enhanced in order to
ensure the continuing protection of the public
health.’’
§ 393a. Office of Pediatric Therapeutics
(a) Establishment
The Secretary of Health and Human Services
shall establish an Office of Pediatric Thera-
peutics within the Food and Drug Administra-
tion.
(b) Duties
The Office of Pediatric The
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 394
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