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2021-06-10
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Agency Information Collection Activities; Proposed Collection; Comment Request; Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites
Notices
D09002ee1ae85e402
D09002ee1ae85e47c
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed study entitled ``Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug websites.''
86 FR 31323
https://www.govinfo.gov/app/details/FR-2021-06-11/2021-12264
2021-12264
fr11jn21-76
4164-01-P
Docket No. FDA-2021-N-0371
https://www.govinfo.gov/app/details/FR-2021-06-11/2021-12264
https://www.govinfo.gov/content/pkg/FR-2021-06-11/html/2021-12264.htm
https://www.govinfo.gov/content/pkg/FR-2021-06-11/pdf/2021-12264.pdf
5 p.
31323
31327
86 FR 31323
Agency Information Collection Activities; Proposed Collection; Comment Request; Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites; Federal Register Vol. 86, Issue
NOTICE
2021-12264
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2021-08-10
Docket No. FDA-2021-N-0371
4164-01-P
2021-12264
Notice.
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed study entitled ``Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug websites.''
Submit either electronic or written comments on the collection of information by August 10, 2021.
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, PRAStaff@fda.hhs.gov. The questionnaire is available upon request from DTCResearch@fda.hhs.gov.
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Accelerated Approval Disclosures on Direct-to-Consumer Prescription Drug Websites,
DTCResearch@fda.hhs.gov
PRAStaff@fda.hhs.gov
https://doi.org/10.1002/pds.4664
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM390058.pdf
https://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 86, no. 111
Office of the Federal Register, National Archives and Records Administration
2021-06-11
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349 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2021-06-11
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0042-1219
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https://www.govinfo.gov/app/details/FR-2021-06-11
https://www.govinfo.gov/content/pkg/FR-2021-06-11/pdf/FR-2021-06-11.pdf
https://www.govinfo.gov/content/pkg/FR-2021-06-11/xml/FR-2021-06-11.xml
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