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 1995_register executive 2010-09-25 article Part III Rules and Regulations D09002ee1be05bf7f D09002ee1be05c029 United States Notice 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 issuing final regulations to establish hearing procedures for use when FDA proposes the imposition of administrative civil money penalties. This rule implements the civil money penalty provisions of several statutes: the National Childhood Vaccine Injury Act of 1986 (NCVIA), the Prescription Drug Marketing Act of 1988 (PDMA), the Safe Medical Devices Act of 1990 (SMDA), the Generic Drug Enforcement Act of 1992 (GDEA), and the Mammography Quality Standards Act of 1992 (MQSA). 60 FR 38612 https://www.govinfo.gov/app/details/FR-1995-07-27/95-18325 95-18325 fr27jy95-17 RIN 0905-AD59 4160-01-P Docket No. 91N-0447 https://www.govinfo.gov/app/details/FR-1995-07-27/95-18325 https://www.govinfo.gov/content/pkg/FR-1995-07-27/html/95-18325.htm https://www.govinfo.gov/content/pkg/FR-1995-07-27/pdf/95-18325.pdf 22 p. 38612 38633 60 FR 38612 Title 21 Part 10 21 CFR Part 10 Title 21 Part 17 21 CFR Part 17 Title 21 Part 20 21 CFR Part 20 Title 21 Part 5 21 CFR Part 5 Title 21 Part 5et al. 21 CFR Part 5et al. RIN 0905-AD59 Civil Money Penalties: Biologics, Drugs, and Medical Devices; Federal Register Vol. 60, Issue RULE 95-18325 III Notice DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. 91N-0447 4160-01-P 95-18325 Final rule.

The Food and Drug Administration (FDA) is issuing final regulations to establish hearing procedures for use when FDA proposes the imposition of administrative civil money penalties. This rule implements the civil money penalty provisions of several statutes: the National Childhood Vaccine Injury Act of 1986 (NCVIA), the Prescription Drug Marketing Act of 1988 (PDMA), the Safe Medical Devices Act of 1990 (SMDA), the Generic Drug Enforcement Act of 1992 (GDEA), and the Mammography Quality Standards Act of 1992 (MQSA).

August 28, 1995. Joseph M. Sheehan, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 2098 Gaither Rd., Rockville MD 20850, 301-594-4765. Vol. 60, no. 144 Office of the Federal Register, National Archives and Records Administration 1995-07-27 continuing daily deposited born digital 198 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-1995-07-27 P0b002ee180a8e49c 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27jy95 https://www.govinfo.gov/app/details/FR-1995-07-27 https://www.govinfo.gov/content/pkg/FR-1995-07-27/pdf/FR-1995-07-27.pdf fdlp 38475 38663 DGPO 2010-09-25 2023-05-07 FR-1995-07-27 machine generated eng FR FR-1995-07-27 60 144