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Regulatory Information
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2014-07-09
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Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
Notices
D09002ee1bdc40076
D09002ee1bdc400ff
United States
Department of Health and Human Services
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org
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 requirements for certain FDA applications or submissions to be accompanied by a certification, Form FDA 3674, to ensure all applicable statutory requirements have been met.
79 FR 38905
https://www.govinfo.gov/app/details/FR-2014-07-09/2014-15992
2014-15992
fr09jy14-75
4164-01-P
Docket No. FDA-2008-N-0144
https://www.govinfo.gov/app/details/FR-2014-07-09/2014-15992
https://www.govinfo.gov/content/pkg/FR-2014-07-09/html/2014-15992.htm
https://www.govinfo.gov/content/pkg/FR-2014-07-09/pdf/2014-15992.pdf
4 p.
38905
38908
79 FR 38905
Agency Information Collection Activities; Proposed Collection; Comment Request; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Federal Register Vol. 79, Issue
NOTICE
2014-15992
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-09-08
Docket No. FDA-2008-N-0144
4164-01-P
2014-15992
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 requirements for certain FDA applications or submissions to be accompanied by a certification, Form FDA 3674, to ensure all applicable statutory requirements have been met.
Submit either electronic or written comments on the collection of information by September 8, 2014.
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Certification to Accompany Drug, Biological Product, and Device Applications or Submissions
,
PRAStaff@fda.hhs.gov
http://www.clinicaltrials.gov/
http://www.fda.gov/regulatoryInformation/guidances/ucm125335.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 131
Office of the Federal Register, National Archives and Records Administration
2014-07-09
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549 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2014-07-09
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https://www.govinfo.gov/app/details/FR-2014-07-09
https://www.govinfo.gov/content/pkg/FR-2014-07-09/pdf/FR-2014-07-09.pdf
https://www.govinfo.gov/content/pkg/FR-2014-07-09/xml/FR-2014-07-09.xml
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