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2013-06-28
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Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products
Notices
D09002ee1bdca076a
D09002ee1bdca07f1
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 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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an electronic process for submitting reports of corrections and removals (806 reports) that are associated with medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health (CDRH). The electronic process is expected to both enhance consistency of submission data and speed submission processing.
78 FR 38992
https://www.govinfo.gov/app/details/FR-2013-06-28/2013-15468
2013-15468
fr28jn13-76
4160-01-P
Docket No. FDA-2013-N-0723
https://www.govinfo.gov/app/details/FR-2013-06-28/2013-15468
https://www.govinfo.gov/content/pkg/FR-2013-06-28/html/2013-15468.htm
https://www.govinfo.gov/content/pkg/FR-2013-06-28/pdf/2013-15468.pdf
2 p.
38992
38993
78 FR 38992
Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products; Federal Register Vol. 78, Issue
NOTICE
2013-15468
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2013-08-27
Docket No. FDA-2013-N-0723
4160-01-P
2013-15468
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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an electronic process for submitting reports of corrections and removals (806 reports) that are associated with medical and radiation emitting products regulated by FDA's Center for Devices and Radiological Health (CDRH). The electronic process is expected to both enhance consistency of submission data and speed submission processing.
Submit either electronic or written comments on the collection of information by August 27, 2013.
Regarding the collection of information: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov.
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products
,
Daniel.Gittleson@fda.hhs.gov
dsmica@fda.hhs.gov
esgreg@gnsi.com
Ronny.Brown@fda.hhs.gov
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 125
Office of the Federal Register, National Archives and Records Administration
2013-06-28
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2013-06-28
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https://www.govinfo.gov/app/details/FR-2013-06-28
https://www.govinfo.gov/content/pkg/FR-2013-06-28/pdf/FR-2013-06-28.pdf
https://www.govinfo.gov/content/pkg/FR-2013-06-28/xml/FR-2013-06-28.xml
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