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Executive Summary

ENVIRONMENTAL IMPACT ASSESSMENTS WILL NOT BE REQUIRED FOR ANDAs or for the establishment of bioequivalence requirements for marketed drug products "if there is no change in the existing levels of use or intended uses of the products," FDA announced in an April 26 Federal Register notice. The two actions were among several categorical exclusions from environmental impact assessments outlined in FDA's revised regulations for preparing such documents. Other actions that are categorically excluded from environmental assessment include: supplements and amendments to NDAs in cases where "the proposed approval provides that the drug will not be administered at higher dosages, for longer duration, or for different indications that were previously in effect;" testing and certification of batches of antibiotics and insulin; "promulgation of a monograph for a 'not new' drug, antibiotic drug, or OTC drug if the drug is already marketed for the proposed use and data available to the agency do not establish that the drug may be toxic to organisms in the environment," and certain good laboratory practice regulations. FDA's previous regulation classified regulatory actions as either exempted from environmental review, conditionally exempted from detailed environmental analysis or requiring an environmental impact assessment. The new policy of categorical exclusions includes all previous exemptions and most conditional exemptions with the exception of some of the actions described in previous regulations. FDA said that although the agency has been unable to grant categorical exclusions for these actions, it "has granted more limited regulatory relief by providing for abbreviated environmental assessments" for some types of actions specified in separate regs. The new regulation also revises the reporting format, replacing the Environmental Impact Analysis Report (EIAR) with an Environment Assessment. FDA explained that the EIAR format "required applicants and petitioners to address such topics as 'pollution,' 'toxic substances,' and 'human values' without guidance as to when or in what manner these topics were to be addressed." The agency said it began to provide EIAR preparers with guidance in 1977 in the form of an Environmental Impact Operational Directive. The Environmental Assessment format adopts the format of the operational directive. The environmental impact of a petition or application must be assessed by the petitioner or applicant. For FDA-initiated actions, the agency prepares environmental documents and determines whether an action is eligible for categorical exclusion. The agency said it "encourages industry to consult with the agency before submitting applications or petitions to prevent overlooking applicable categorical exclusions, to obtain guidance in the preparation of environmental assessments and to acquire relevant data."

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