Document ID: FDA-2017-D-4303-0001
Agency: fda
Document Type: Notice
Title: Providing Regulatory Submissions in Electronic Format—Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Draft Guidance for Industry; Availability; Correction
Posted Date: 2019-07-05T04:00Z

[Federal Register Volume 84, Number 129 (Friday, July 5, 2019)]
[Notices]
[Page 32189]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14362]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-4303]

Providing Regulatory Submissions in Electronic Format--Content of 
the Risk Evaluation and Mitigation Strategies Document Using Structured 
Product Labeling; Draft Guidance for Industry; Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Providing Regulatory Submissions in Electronic Format--
Content of the Risk Evaluation and Mitigation Strategies Document Using 
Structured Product Labeling; Draft Guidance for Industry; 
Availability'' that appeared in the Federal Register of September 5, 
2017. The document announced the availability of a guidance for 
industry. The document was published with the incorrect docket number. 
This document corrects that error. Previously submitted comments will 
be transferred to the correct docket number.

FOR FURTHER INFORMATION CONTACT: Lisa Granger, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, 
Silver Spring, MD 20993-0002, 301-796-9115.

SUPPLEMENTARY INFORMATION: In the Federal Register of Tuesday, 
September 5, 2017 (82 FR 41968), in FR Doc. 2017-18506, the following 
correction is made:
    On page 41968, in the first column, in the header of the document, 
and in the second column, under Instructions, ``[Docket No. FDA-2017-E-
4282]'' is corrected to read ``[Docket No. FDA-2017-D-4303].''

    Dated: July 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14362 Filed 7-3-19; 8:45 am]
BILLING CODE 4164-01-P