Any proposed action of a type specified in this section ordinarily requires at least the preparation of an EA, unless it is an action in a specific class that qualifies for exclusion under Sec. Sec. 25.30, 25.31, 25.32, 25.33, or 25.34:
(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 Sec. Sec. 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 Sec. Sec. 25.30(d) or 25.32(h).
(d) Disposition of FDA laboratory waste materials, unless categorically excluded in Sec. 25.30(m).
(e) Intramural and extramural research supported in whole or in part through contracts, other agreements, or grants, unless categorically excluded in Sec. 25.30 (e) or (f).
(f) Establishment by regulation of labeling requirements, a standard, or a monograph, unless categorically excluded in Sec. Sec. 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 Sec. 25.30 (h), (i), or (j), or Sec. 25.32 (e), (g), (n), or (p).
(h) Withdrawal of existing approvals of FDA-approved articles, unless categorically excluded in Sec. Sec. 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 Sec. 170.39 of this chapter, and allowing notifications submitted under 21 U.S.C. 348(h) to become effective, unless categorically excluded in Sec. 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) Affirmation of a food substance as GRAS for humans or animals, on FDA's initiative or in response to a petition, under parts 182, 184, 186, or 582 of this chapter and establishment or amendment of a regulation for a prior-sanctioned food ingredient, as defined in Sec. Sec. 170.3(l) and 181.5(a) of this chapter, unless categorically excluded in Sec. 25.32 (f), (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 Sec. 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 Sec. 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 Sec. 25.34. [62 FR 40592, July 29, 1997, as amended at 65 FR 30355, May 11, 2000; 72 FR 69118, Dec. 6, 2007]