§ 25.31 - Human drugs and biologics.

§ 25.31 Human drugs and biologics.

The classes of actions listed in this section are categorically excluded and, therefore, ordinarily do not require the preparation of an EA or an EIS:

(a) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, if the action does not increase the use of the active moiety.

(b) Action on an NDA, abbreviated application, or a supplement to such applications, or action on an OTC monograph, if the action increases the use of the active moiety, but the estimated concentration of the substance at the point of entry into the aquatic environment will be below 1 part per billion.

(c) Action on an NDA, abbreviated application, application for marketing approval of a biologic product, or a supplement to such applications, or action on an OTC monograph, for substances that occur naturally in the environment when the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment.

(d) Withdrawal of approval of an NDA or an abbreviated application.

(e) Action on an IND.

(f) Testing and release by the Food and Drug Administration of lots or batches of a licensed biologic product.

(g) Establishment of bioequivalence requirements for a human drug or a comparability determination for a biologic product subject to licensing.

(h) Issuance, revocation, or amendment of a standard for a biologic product.

(i) Revocation of a license for a biologic product.

(j) Action on an application for marketing approval for marketing of a biologic product for transfusable human blood or blood components and plasma.

[62 FR 40592, July 29, 1997, as amended at 63 FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999; 70 FR 14980, Mar. 24, 2005]