[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.31]

[Page 246]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents
 
                    Subpart C--Categorical Exclusions
 
Sec. 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 Center for Biologics Evaluation and 
Research 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]