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2015-02-02
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Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications
Notices
D09002ee1c1745604
D09002ee1c1745685
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 information collection in an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product.
80 FR 5761
https://www.govinfo.gov/app/details/FR-2015-02-03/2015-02025
2015-02025
fr03fe15-53
4164-01-P
Docket No. FDA-2012-N-0129
https://www.govinfo.gov/app/details/FR-2015-02-03/2015-02025
https://www.govinfo.gov/content/pkg/FR-2015-02-03/html/2015-02025.htm
https://www.govinfo.gov/content/pkg/FR-2015-02-03/pdf/2015-02025.pdf
3 p.
5761
5763
80 FR 5761
Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications; Federal Register Vol. 80, Issue
NOTICE
2015-02025
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2015-04-06
Docket No. FDA-2012-N-0129
4164-01-P
2015-02025
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 information collection in an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product.
Submit either electronic or written comments on the collection of information by April 6, 2015.
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:
General Licensing Provisions; Section 351(k) Biosimilar Applications
,
PRAStaff@fda.hhs.gov
http://www.regulations.gov
Federal Register
Vol. 80, no. 22
Office of the Federal Register, National Archives and Records Administration
2015-02-03
continuing
daily
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born digital
239 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-02-03
P0b002ee18af6f433
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr03fe15
https://www.govinfo.gov/app/details/FR-2015-02-03
https://www.govinfo.gov/content/pkg/FR-2015-02-03/pdf/FR-2015-02-03.pdf
https://www.govinfo.gov/content/pkg/FR-2015-02-03/xml/FR-2015-02-03.xml
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DGPO
2015-02-02
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FR-2015-02-03
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FR
FR-2015-02-03
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