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 1999_register executive 2010-09-24 article Rules and Regulations D09002ee1bdfe3ff5 D09002ee1bdfe407a 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Agency or Subagency The Food and Drug Administration (FDA) is amending its regulations to remove references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDA is also removing references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule. 64 FR 396 https://www.govinfo.gov/app/details/FR-1999-01-05/99-140 99-140 fr05ja99-7 4160-01-F Docket No. 98N-0720 https://www.govinfo.gov/app/details/FR-1999-01-05/99-140 https://www.govinfo.gov/content/pkg/FR-1999-01-05/html/99-140.htm https://www.govinfo.gov/content/pkg/FR-1999-01-05/pdf/99-140.pdf 9 p. 396 404 64 FR 396 Title 21 Part 10 21 CFR Part 10 Title 21 Part 12 21 CFR Part 12 Title 21 Part 16 21 CFR Part 16 Title 21 Part 2 21 CFR Part 2 Title 21 Part 20 21 CFR Part 20 Title 21 Part 25 21 CFR Part 25 Title 21 Part 3 21 CFR Part 3 Title 21 Part 5 21 CFR Part 5 Title 21 Part 50 21 CFR Part 50 Title 21 Part 54 21 CFR Part 54 Title 21 Part 56 21 CFR Part 56 Title 21 Part 58 21 CFR Part 58 Title 21 Part 60 21 CFR Part 60 Title 21 Part 70 21 CFR Part 70 Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Federal Register Vol. 64, Issue RULE 99-140 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1999-05-20 1999-04-20 Docket No. 98N-0720 4160-01-F 99-140 Direct final rule.

The Food and Drug Administration (FDA) is amending its regulations to remove references to the repealed statutory provision of the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified antibiotic drugs. FDA is also removing references to the repealed antibiotic monograph regulations and to those regulations dealing with antibiotic applications. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comment and withdraws the direct final rule.

This rule is effective May 20, 1999. Submit written comments on or before March 22, 1999. If no timely significant adverse comments are received, the agency will publish a document in the Federal Register before April 20, 1999, confirming the effective date of the direct final rule. The agency intends to make the direct final rule effective 30 days after publication of the confirmation document in the Federal Register. If timely significant adverse comments are received, the agency will publish a document of significant adverse comment in the Federal Register withdrawing this direct final rule before April 20, 1999. For human drugs, Christine F. Rogers or Wayne H. Mitchell, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. Vol. 64, no. 2 Office of the Federal Register, National Archives and Records Administration 1999-01-05 continuing daily deposited born digital 353 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1999-01-05 P0b002ee180a502f2 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr05ja99 https://www.govinfo.gov/app/details/FR-1999-01-05 https://www.govinfo.gov/content/pkg/FR-1999-01-05/pdf/FR-1999-01-05.pdf fdlp 385 729 DGPO 2010-09-24 2023-05-05 FR-1999-01-05 machine generated eng FR FR-1999-01-05 64 2