United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 1997_register executive 2010-09-24 article Part II Rules and Regulations D09002ee1be36547a D09002ee1be36597a United States Final Rule originator org United States Government Agency or Subagency United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 62 FR 40570 https://www.govinfo.gov/app/details/FR-1997-07-29/97-19566 97-19566 fr29jy97-16 4160-01-P Docket No. 96N-0057 https://www.govinfo.gov/app/details/FR-1997-07-29/97-19566 https://www.govinfo.gov/content/pkg/FR-1997-07-29/html/97-19566.htm https://www.govinfo.gov/content/pkg/FR-1997-07-29/pdf/97-19566.pdf 31 p. 40570 40600 62 FR 40570 Title 21 Part 21 CFR Part Title 21 Part 10 21 CFR Part 10 Title 21 Part 101 21 CFR Part 101 Title 21 Part 170 21 CFR Part 170 Title 21 Part 171 21 CFR Part 171 Title 21 Part 20 21 CFR Part 20 Title 21 Part 25 21 CFR Part 25 Title 21 Part 312 21 CFR Part 312 Title 21 Part 314 21 CFR Part 314 Title 21 Part 511 21 CFR Part 511 Title 21 Part 514 21 CFR Part 514 Title 21 Part 71 21 CFR Part 71 National Environmental Policy Act; Revision of Policies and Procedures; Federal Register Vol. 62, Issue RULE 97-19566 II Final Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1997-08-28 1997-08-28 Docket No. 96N-0057 4160-01-P 97-19566 Final rule.

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.

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. Vol. 62, no. 145 Office of the Federal Register, National Archives and Records Administration 1997-07-29 continuing daily deposited born digital 309 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1997-07-29 P0b002ee180a48bea 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr29jy97 https://www.govinfo.gov/app/details/FR-1997-07-29 https://www.govinfo.gov/content/pkg/FR-1997-07-29/pdf/FR-1997-07-29.pdf fdlp 40427 40726 DGPO 2010-09-24 2023-05-17 FR-1997-07-29 machine generated eng FR FR-1997-07-29 62 145