21 CFR § 25.20 - Actions requiring preparation of an environmental assessment.

§ 25.20 Actions requiring preparation of an environmental assessment.

Any proposed action of a type specified in this section normally requires at least the preparation of an EA, unless it is an action in a specific class that qualifies for exclusion under §§ 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35:

(a) Major recommendations or reports made to Congress on proposals for legislation in instances where the agency has primary responsibility for the subject matter involved.

(b) Destruction or other disposition of articles condemned after seizure or whose distribution or use has been enjoined, unless categorically excluded in §§ 25.30(d) or 25.32(h).

(c) Destruction or other disposition of articles following detention or recall at agency request, unless categorically excluded in §§ 25.30(d) or 25.32(h).

(d) Disposition of FDA laboratory waste materials, unless categorically excluded in § 25.30(m).

(e) Intramural and extramural research supported in whole or in part through contracts, other agreements, or grants, unless categorically excluded in § 25.30 (e) or (f).

(f) Establishment by regulation of labeling requirements, a standard, or a monograph, unless categorically excluded in §§ 25.30(k) or 25.31 (a), (b), (c), (h), (i), or (j), or 25.32 (a) or (p).

(g) Issuance, amendment, and enforcement of FDA regulations, or an exemption or variance from FDA regulations, unless categorically excluded in § 25.30 (h), (i), or (j), or § 25.32 (e), (g), (n), or (p).

(h) Withdrawal of existing approvals of FDA-approved articles, unless categorically excluded in §§ 25.31 (d) or (k), 25.32(m), or 25.33 (g) or (h).

(i) Approval of food additive petitions and color additive petitions, approval of requests for exemptions for investigational use of food additives, the granting of requests for exemption from regulation as a food additive under § 170.39 of this chapter, and allowing notifications submitted under 21 U.S.C. 348(h) to become effective, unless categorically excluded in § 25.32(b), (c), (i), (j), (k), (l), (o), (q), or (r).

(j) Establishment of a tolerance for unavoidable poisonous or deleterious substances in food or in packaging materials to be used for food.

(k) Establishment or amendment of a regulation for a food substance as GRAS under the conditions of its intended use for humans or animals under parts 182, 184, 186, 582, or 584 of this chapter, or establishment or amendment of a regulation for a prior-sanctioned food ingredient, as defined in §§ 170.3(l) and 181.5(a) of this chapter, unless categorically excluded in § 25.32(f), (i), (j), (k), or (r).

(l) Approval of NDA's, abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, and actions on IND's, unless categorically excluded in § 25.31 (a), (b), (c), (e), or (l).

(m) Approval of NADA's, abbreviated applications, supplements, actions on INAD's, and granting of requests for determination of eligibility for indexing, unless categorically excluded under § 25.33 (a), (c), (d), or (e).

(n) Approval of PMA's for medical devices, notices of completion of PDP's for medical devices, authorizations to commence clinical investigation under an approved PDP, or applications for an IDE, unless categorically excluded in § 25.34.

(o) Issuance of an order finding a tobacco product substantially equivalent under the Federal Food, Drug, and Cosmetic Act, or granting of a request for an exemption under 21 CFR part 1107 from the requirement of demonstrating substantial equivalence, unless categorically excluded under § 25.35.

(p) Issuance of an order authorizing marketing of a new tobacco product under section 910 of the Federal Food, Drug, and Cosmetic Act or an order authorizing marketing of a modified risk tobacco product under section 911 of the Federal Food, Drug, and Cosmetic Act, unless categorically excluded under § 25.35.

[62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000; 72 FR 69118, Dec. 6, 2007; 80 FR 57535, Sept. 24, 2015; 81 FR 55047, Aug. 17, 2016]