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 1998_register executive 2010-09-24 article Rules and Regulations D09002ee1bdffedaa D09002ee1bdffeebe 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 repealing its regulations governing certification of drugs containing insulin and making conforming amendments to other sections of its regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act. FDA is using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. Most of the amendments in this rule are a direct result of the repeal of the statutory certification provision. The remainder of the amendments repeal or update out-of-date, noncontroversial regulations dealing with insulin. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives significant adverse comments and withdraws this direct final rule. 63 FR 26694 https://www.govinfo.gov/app/details/FR-1998-05-13/98-12452 98-12452 fr13my98-48 4160-01-F Docket No. 98N-0210 https://www.govinfo.gov/app/details/FR-1998-05-13/98-12452 https://www.govinfo.gov/content/pkg/FR-1998-05-13/html/98-12452.htm https://www.govinfo.gov/content/pkg/FR-1998-05-13/pdf/98-12452.pdf 6 p. 26694 26699 63 FR 26694 Title 21 Part 10 21 CFR Part 10 Title 21 Part 16 21 CFR Part 16 Title 21 Part 200 21 CFR Part 200 Title 21 Part 201 21 CFR Part 201 Title 21 Part 207 21 CFR Part 207 Title 21 Part 210 21 CFR Part 210 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 56 21 CFR Part 56 Title 21 Part 58 21 CFR Part 58 Title 21 Part 71 21 CFR Part 71 Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin; Federal Register Vol. 63, Issue RULE 98-12452 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1998-09-25 1998-08-26 Docket No. 98N-0210 4160-01-F 98-12452 Direct final rule.

The Food and Drug Administration (FDA) is repealing its regulations governing certification of drugs containing insulin and making conforming amendments to other sections of its regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act. FDA is using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. Most of the amendments in this rule are a direct result of the repeal of the statutory certification provision. The remainder of the amendments repeal or update out-of-date, noncontroversial regulations dealing with insulin. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives significant adverse comments and withdraws this direct final rule.

This regulation is effective September 25, 1998. Submit written comments on or before July 27, 1998. If no timely significant adverse comments are received, the agency will publish a document in the Federal Register before August 26, 1998, confirming the effective date of the direct final rule. 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 August 25, 1998. 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. 63, no. 92 Office of the Federal Register, National Archives and Records Administration 1998-05-13 continuing daily deposited born digital 299 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1998-05-13 P0b002ee180a5d043 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13my98 https://www.govinfo.gov/app/details/FR-1998-05-13 https://www.govinfo.gov/content/pkg/FR-1998-05-13/pdf/FR-1998-05-13.pdf fdlp 26421 26709 DGPO 2010-09-24 2023-05-06 FR-1998-05-13 machine generated eng FR FR-1998-05-13 63 92