United States Government Publishing Office
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Regulatory Information
2020_register
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2020-03-18
article
Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of Comment Period
Notices
D09002ee1bdb5da85
D09002ee1bdb5dadd
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(FDA or the Agency) is reopening the comment period for the notice entitled ``Development of a Shared System REMS; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of June 1, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.
85 FR 15788
https://www.govinfo.gov/app/details/FR-2020-03-19/2020-05712
2020-05712
fr19mr20-44
4164-01-P
Docket No. FDA-2018-D-1041
https://www.govinfo.gov/app/details/FR-2020-03-19/2020-05712
https://www.govinfo.gov/content/pkg/FR-2020-03-19/html/2020-05712.htm
https://www.govinfo.gov/content/pkg/FR-2020-03-19/pdf/2020-05712.pdf
2 p.
15788
15789
85 FR 15788
Development of a Shared System Risk Evaluation and Mitigation Strategy; Draft Guidance for Industry; Availability; Reopening of Comment Period; Federal Register Vol. 85, Issue
NOTICE
2020-05712
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-05-18
Docket No. FDA-2018-D-1041
4164-01-P
2020-05712
Notice of availability; reopening of the comment period.
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notice entitled ``Development of a Shared System REMS; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of June 1, 2018. The Agency is taking this action to allow interested persons additional time to submit comments.
FDA is reopening the comment period for the notice published on June 1, 2018 (83 FR 25468). Submit either electronic or written comments on the draft guidance by May 18, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Lubna Merchant, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993, 301-796- 3600; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 54
Office of the Federal Register, National Archives and Records Administration
2020-03-19
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205 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2020-03-19
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0042-1219
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https://www.govinfo.gov/app/details/FR-2020-03-19
https://www.govinfo.gov/content/pkg/FR-2020-03-19/pdf/FR-2020-03-19.pdf
https://www.govinfo.gov/content/pkg/FR-2020-03-19/xml/FR-2020-03-19.xml
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2020-03-18
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FR-2020-03-19
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FR-2020-03-19
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