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OPS Environmental Impact Review at CDER: ENVIRONMENTAL IMPACT: CLAIMS FOR CATEGORICAL EXCLUSION

Categorical Exclusions (21 CFR 25.31)

 The following categorical exclusions are available for human drugs and biologics:

 Actions on (1) NDAs, abbreviated applications, applications for marketing approval of a biologic product, and supplements to such applications if FDA's approval of the application does not increase the use of the active moiety (21 CFR 25.31(a));

(2) NDAs, abbreviated applications, and supplements to such applications if FDA's approval of the application 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 (ppb) (21 CFR 25.31(b));

(3) NDAs, abbreviated applications, applications for marketing approval of a biologic product, and supplements to such applications for substances that occur naturally in the environment when the approval of the application does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment (21 CFR 25.31(c)); 

(4) INDs (21 CFR 25.31(e)); and

(5) applications for marketing approval of a biologic product for transfusable human blood or blood components and plasma (21 CFR 25.31(j)).

Claiming a Categorical Exclusion

To claim a categorical exclusion the applicant must state that the action requested qualifies for a categorical exclusion, citing the particular categorical exclusion that is claimed, and states that to the applicant’s knowledge, no extraordinary circumstances exist (see 21 CFR 25.15(d), below).  To facilitate Center review, when submitting a claim of categorical exclusion, the sponsor should provide information to support the specific requested exclusion (e.g., calculation of estimated environmental concentrations).

Typically, the following statement is provided:

 Applicant's name claims that approval of this (A)NDA qualifies for a categorical exclusion in accordance with 21 CFR 25.31(x) and that, to the best of the applicant's knowledge, no extraordinary circumstances exist which may significantly affect the quality of the human environment.

Section.21 CFR 25.21 Extraordinary circumstances.

As required under 40 CFR 1508.4, FDA will require at least an EA for any specific action that ordinarily would be excluded if extraordinary circumstances indicate that the specific proposed action may significantly affect the quality of the human environment (see 40 CFR 1508.27 for examples of significant impacts). Examples of such extraordinary circumstances include:

            (a) Actions for which available data establish that, at the expected level of exposure, there is the potential for serious harm to the environment; and

            (b) Actions that adversely affect a species or the critical habitat of a species determined under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Flora and Fauna to be endangered or threatened or wild flora or fauna that are entitled to special protection under some other Federal law.

Drug or Biologic Products Derived from Plants or Animals

In addition, for actions where the drug or biologic product is derived from plants or animals, CDER request that the applicant provide the following information with the claim, or specifically identify where the information can be located (e.g., page number of application):

(1) biological identification (i.e., common names, synonyms, variety, species, genus and family);

(2) a statement as to whether wild or cultivated specimens are used;

(3) the geographic region (e.g., country, state, province) where the biomass is obtained; and

(4) a statement indicating :

(a) whether the species is determined under the Endangered Species Act or the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) to be endangered or threatened,

(b) whether the species is entitled to special protection under some other Federal law or international treaty to which the United States is a party

(c) whether the species is the critical habitat of a species that has been determined to be endangered or threatened under the Endangered Species Act or CITES

(d) whether the species is the critical habitat of a species entitled to special protection under some other Federal law or international treaty to which the United States is a party.

 

Date created: February 6, 2006, updated April 9, 2008