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2013-07-13
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Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability
Notices
D09002ee1bdc9f98c
D09002ee1bdc9fa07
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act (FD&C Act) concerning inspections that would make a drug adulterated. This guidance defines, by way of example, the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
78 FR 42387
https://www.govinfo.gov/app/details/FR-2013-07-15/2013-16841
2013-16841
fr15jy13-118
4160-01-P
Docket No. FDA-2013-D-0710
https://www.govinfo.gov/app/details/FR-2013-07-15/2013-16841
https://www.govinfo.gov/content/pkg/FR-2013-07-15/html/2013-16841.htm
https://www.govinfo.gov/content/pkg/FR-2013-07-15/pdf/2013-16841.pdf
1 p.
42387
42387
78 FR 42387
Draft Guidance for Industry on Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Availability; Federal Register Vol. 78, Issue
NOTICE
2013-16841
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-D-0710
4160-01-P
2013-16841
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.'' The Food and Drug Administration Safety and Innovation Act (FDASIA) added a new provision to the Food, Drug, and Cosmetic Act (FD&C Act) concerning inspections that would make a drug adulterated. This guidance defines, by way of example, the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 13, 2013.
Emily M. Leongini, Office of Policy and Risk Management, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4339, Silver Spring, MD 20903, 301-796-5300.
Draft Guidance for Industry and Staff:
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
,
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122044.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 135
Office of the Federal Register, National Archives and Records Administration
2013-07-15
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2013-07-15
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https://www.govinfo.gov/app/details/FR-2013-07-15
https://www.govinfo.gov/content/pkg/FR-2013-07-15/pdf/FR-2013-07-15.pdf
https://www.govinfo.gov/content/pkg/FR-2013-07-15/xml/FR-2013-07-15.xml
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