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2013-12-24
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Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance)
Notices
D09002ee1bdc87cd5
D09002ee1bdc881ac
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of rapid response surveys to obtain data on safety information to support quick turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals, and other user facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers, when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
78 FR 77686
https://www.govinfo.gov/app/details/FR-2013-12-24/2013-30630
2013-30630
fr24de13-84
4160-01-P
Docket No. FDA-2013-N-1496
https://www.govinfo.gov/app/details/FR-2013-12-24/2013-30630
https://www.govinfo.gov/content/pkg/FR-2013-12-24/html/2013-30630.htm
https://www.govinfo.gov/content/pkg/FR-2013-12-24/pdf/2013-30630.pdf
2 p.
77686
77687
78 FR 77686
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys (Generic Clearance); Federal Register Vol. 78, Issue
NOTICE
2013-30630
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-02-24
Docket No. FDA-2013-N-1496
4160-01-P
2013-30630
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of rapid response surveys to obtain data on safety information to support quick turnaround decisionmaking about potential safety problems or risk management solutions from health care professionals, hospitals, and other user facilities (e.g., nursing homes, etc.); consumers; manufacturers of biologics, drugs, and medical devices; distributors; and importers, when FDA must quickly determine whether or not a problem with a biologic, drug, or medical device impacts the public health.
Submit either electronic or written comments on the collection of information by February 24, 2014.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov.
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Rapid Response Surveys
,
PRAStaff@fda.hhs.gov
http://www.regulations.gov
Federal Register
Vol. 78, no. 247
Office of the Federal Register, National Archives and Records Administration
2013-12-24
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2013-12-24
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https://www.govinfo.gov/app/details/FR-2013-12-24
https://www.govinfo.gov/content/pkg/FR-2013-12-24/pdf/FR-2013-12-24.pdf
https://www.govinfo.gov/content/pkg/FR-2013-12-24/xml/FR-2013-12-24.xml
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2013-12-24
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FR-2013-12-24
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FR-2013-12-24
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