Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=pt21.1.25&rgn=div5
Timestamp: 2020-02-19 12:13:27
Document Index: 777256189

Matched Legal Cases: ['§25', 'arts 1500', 'art 30', '§25', '§514', '§510', '§558', '§514', '§1107', 'art 20', '§312', 'art 1503', 'art 20', '§312']

§25.35 Tobacco product applications.
The National Environmental Policy Act of 1969 (NEPA), as amended, directs that, to the fullest extent possible, the policies, regulations, and public laws of the United States shall be interpreted and administered in accordance with the policies set forth in NEPA. All agencies of the Federal Government shall comply with the procedures in section 102(2) of NEPA except where compliance would be inconsistent with other statutory requirements. The regulations in this part implement section 102(2) of NEPA in a manner that is consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. This part also supplements the regulations for implementing the procedural provisions of NEPA that were published by the Council on Environmental Quality (CEQ) in 40 CFR parts 1500 through 1508 and the procedures included in the “HHS General Administration Manual, part 30: Environmental Protection” (45 FR 76519 to 76534, November 19, 1980).
(4) Increased use of a drug or biologic product may occur if the drug will be administered at higher dosage levels, for longer duration or for different indications than were previously in effect, or if the drug is a new molecular entity. The term “use” also encompasses disposal of FDA-regulated articles by consumers.
(1) CEQ—Council on Environmental Quality.
(2) CGMP—Current good manufacturing practice.
(3) EA—Environmental assessment.
(4) EIS—Environmental impact statement.
(5) The act—Federal Food, Drug, and Cosmetic Act.
(6) FIFRA—Federal Insecticide, Fungicide, and Rodenticide Act.
(7) FONSI—Finding of no significant impact.
(8) GLP—Good laboratory practice.
(9) GRAS—Generally recognized as safe.
(10) HACCP—Hazard analysis critical control point.
(11) IDE—Investigational device exemption.
(12) IND—Investigational new drug application.
(13) INAD—Investigational new animal drug application.
(14) NADA—New animal drug application.
(15) NDA—New drug application.
(16) NEPA—National Environmental Policy Act of 1969.
(17) OTC—Over-the-counter.
(18) PDP—Product development protocol.
(19) PMA—Premarket approval application.
The classes of actions listed in this section and §§25.31 through 25.35 are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:
(4) Changes specified in §514.8(b)(3), (b)(4), or (c)(3) of this chapter;
(6) A previously approved animal drug to be contained in medicated feed blocks under §510.455 of this chapter or as a liquid feed supplement under §558.5 of this chapter; or
(7) Approval of a drug for use in animal feeds if such drug has been approved under §514.2 or 514.9 of this chapter for other uses.
(e) Rescission of an order granting an exemption request under §1107.1 of this chapter.
(b) Many FDA actions involving investigations, review, and approval or market authorization of applications, and premarket notifications for human drugs, animal drugs, biologic products, devices, and tobacco products are protected from disclosure under the Trade Secret Act, 18 U.S.C. 1905, and section 301(j) of the Federal Food, Drug, and Cosmetic Act. These actions are also protected from disclosure under FDA's regulations including part 20, §§312.130(a), 314.430(b), 514.11(b), 514.12(a), 601.50(a), 601.51(a), 807.95(b), 812.38(a), and 814.9(b) of this chapter. Even the existence of applications for human drugs, animal drugs, biologic products, devices, and tobacco products is protected from disclosure under these regulations. Therefore, unless the existence of applications for human drugs, animal drugs, biologic products, tobacco products, or premarket notification for devices has been made publicly available, the release of the environmental document before approval or authorization of human drugs, animal drugs, biologic products, devices and tobacco products is inconsistent with statutory requirements imposed on FDA. Appropriate environmental documents, comments, and responses will be included in the administrative record to the extent allowed by applicable laws.
(c) In those cases where the existence of applications and premarket notifications for drugs, animal drugs, biologic products, devices, or tobacco products has already been disclosed before the Agency approves the action, the Agency will ensure appropriate public involvement consistent with 40 CFR 1506.6 and part 1503 in preparing and implementing the NEPA procedures related to preparing EISs while following its own disclosure requirements including those listed in part 20 and §§312.130(b), 314.430(d), 514.11(d), 514.12(b), 601.51(d), 807.95(e), 812.38(b), and 814.9(d) of this chapter.
(a) In accordance with Executive Order 12114, “Environmental Effects Abroad of Major Federal Actions” of January 4, 1979 (44 FR 1957, January 9, 1979), the responsible agency official, in analyzing actions under his or her program, shall consider the environmental effects abroad, including whether the actions involve: