Categorical exclusion

Environmental assessment or request for categorical exclusion Statements of claimed exclusivity and associated certifications b Prescribing information 0. Annotated labeling text d. Labeling comparison (for ANDA)... 

An environmental impact analysis or claim for categorical exclusion from the requirement to prepare such an analysis... 

Item 7 also requires submission of either a claim of categorical exclusion from the requirement to submit an environmental assessment or an environmental assessment [21 CFR 25.15(a)], When... 

Company name] certifies that [drug or biologic name] is intended for use in clinical studies in which waste will be controlled and the amount of waste expected to enter the environment is expected to be nontoxic. Therefore, in accordance with 21 CFR 25.31, we request categorical exclusion from providing an environmental assessment. 

Any submission requiring action by the FDA must include either an environmental assessment (EA) or a claim of categorical exclusion from the requirement for an EA. INDs are frequently submitted with a request for categorical exclusion from EA, since they generally involve relatively small amounts of drug and treatment of a limited number of recipients such that the environmental exposure is usually low. 

Subpart (e)—Environmental Analysis Requirements A claim for categorical exclusion under 21 CFR Section 25.30 or 25.31 or an environmental assessment under 21 CFR Section 25.40 should be provided. 

If an environmental assessment is required, it should be prepared as outlined in the federal regulations (21 CFR 25). It should include a description of the action being considered and address all components involved in the manufacture and disposal of the product. A statement of exemption under a categorical exclusion may be provided if applicable. 

The Agency will not accept an FCN, a TOR exemption submission, or a petition for review if the environmental component is missing or deficient (21 CFR 25.15) thus, every FCN, petition, and TOR exemption submission must contain either an environmental assessment or a claim of categorical exclusion from the need to prepare an environmental assessment. The discussion below on FCNs is also applicable to TOR exemption submissions and petitions. 

A claim of categorical exclusion applies to Agency actions that do not individually or cumulatively affect the quality of the human environment. An adequate claim of categorical exclusion (definition codified in 21 CFR 25.15) must include a citation of the CFR section under which the exclusion is warranted (Table 2.9), a statement of compliance with the categorical... 

Table 2.9 Claims of categorical exclusions applicable to food-contact materials Title 21, Parts 25, Section 32 of the Code of Federal Regulations (denoted as 21 CFR 25.32)...

When a proposed use in an FCN does not qualify for a claim of categorical exclusion or when extraordinary circumstances exist, as determined by the notifier or the Agency, the FCN must contain an adequate environmental assessment as defined under 21 CFR 25.40. An adequate environmental assessment is one that addresses the relevant environmental issues and contains sufficient information to enable the Agency to determine whether the proposed action may significantly affect the quality of the human environment. It must contain a brief discussion for the need for the proposed action, of introductions, fate, and effects of the substances in the environment, of alternatives to the proposed action, and the environmental impact of the proposed use as a result of use and disposal of the substance. The environmental guidance on FDA s web site contains additional recommendations for inclusion in an environmental assessment. 

Environmental assessment The FDA believes that the great majority of products will qualify for a categorical exclusion. Sponsors who believe that their investigational product meets the exclusion categories under 21 CFR 25.24 should submit a statement certifying that their product meets the exclusion requirements and request a categorical exclusion on that basis. (For INDs submitted to CDER, it is recommended to review the... 

ENVIRONMENTAL ASSESSMENT (21 CFR 25.31). If an applicant believes that the device qualifies for an exemption, they must provide information that establishes to the FDA s satisfaction that the device meets the criteria for a categorical exclusion (21 CFR 25.24). The majority of PMA applications have been granted categorical exclusion. The submission of an environmental assessment in a separate volume will expedite FDA review. Three copies are needed. 

A claim for Categorical Exclusion from submission or submission of Environmental Assessment. The FDA believes that the great majority of drug products should qualify for a categorical exclusion. 

Categorical Exclusion A project may not be required to provide a detailed environmental analysis if it meets certain criteria proving it will have no significant environmental impact. 

Categorical Exclusion, dated January 15, 1992, which documents that the work performed during the routine maintenance of buildings, facilities, and structures, does not require an EA or an EIS. 

---