[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.31]
[Page 239-240]
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.
[[Page 240]]
(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]
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