{"abstract":"The Food and Drug Administration (FDA) is amending its regulations governing compliance with the National Environmental Policy Act of 1969 (NEPA) as implemented by the regulations of the Council on Environmental Quality (CEQ). The primary purpose of this final rule is to increase the efficiency of FDA's implementation of NEPA and to reduce the number of NEPA evaluations by providing for categorical exclusions for additional classes of actions that do not individually or cumulatively have a significant effect on the human environment and for which, therefore, neither an environmental impact statement (EIS) nor an environmental assessment (EA) is required. FDA is also amending its regulations to make its NEPA procedures more concise and understandable to the public and to reflect current FDA policy with respect to environmental considerations. The amendments to FDA's regulations governing compliance with NEPA reflect FDA's continuing review of its policies and procedures to determine whether revisions are necessary to ensure full compliance with the purpose and provisions of NEPA and implement the President's reinventing Government initiatives announced in ``Reinventing Drug and Medical Device Regulations,'' April 1995, and ``Reinventing Food Regulations,'' January 1996.","action":"Final rule.","agencies":[{"raw_name":"Final Rule"},{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1997/07/29/97-19566.html","cfr_references":[{"chapter":null,"citation_url":null,"part":null,"title":21},{"chapter":null,"citation_url":null,"part":10,"title":21},{"chapter":null,"citation_url":null,"part":20,"title":21},{"chapter":null,"citation_url":null,"part":25,"title":21},{"chapter":null,"citation_url":null,"part":71,"title":21},{"chapter":null,"citation_url":null,"part":101,"title":21},{"chapter":null,"citation_url":null,"part":170,"title":21},{"chapter":null,"citation_url":null,"part":171,"title":21},{"chapter":null,"citation_url":null,"part":312,"title":21},{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":511,"title":21},{"chapter":null,"citation_url":null,"part":514,"title":21}],"citation":"62 FR 40570","comment_url":null,"comments_close_on":"1997-08-28","correction_of":null,"corrections":[],"dates":"The regulations are effective on August 28, 1997. For applications or petitions pending before the agency on August 28, 1997, for which the agency has not signed a finding of no significant impact (FONSI) on or before August 28, 1997, the applicant or petitioner may submit an amendment to the application or petition under 21 CFR 10.30(g), 71.6(b), 171.6, 314.60, 514.6, 571.6, 601.2 or 814.37 claiming a categorical exclusion in accordance with Sec. 25.15(d) of this final rule. The applicant or petitioner should state in the amendment that the applicant or petitioner waives the claim for categorical exclusion if a FONSI has been signed on or before August 28, 1997.","disposition_notes":null,"docket_ids":["Docket No. 96N-0057"],"dockets":[],"document_number":"97-19566","effective_on":"1997-08-28","end_page":40600,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1997/07/29/97-19566/national-environmental-policy-act-revision-of-policies-and-procedures","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/97-19566?publication_date=1997-07-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1997-07-29/97-19566/mods.xml","not_received_for_publication":null,"page_length":31,"page_views":{"count":478,"last_updated":"2026-07-26 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1997-07-29/pdf/97-19566.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1997-07-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1997/07/29/97-19566.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":40570,"subtype":null,"title":"National Environmental Policy Act; Revision of Policies and Procedures","toc_doc":null,"toc_subject":null,"topics":[],"type":"Rule","volume":62}