Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections

Federal Register, Volume 79 Issue 173 (Monday, September 8, 2014)

Federal Register Volume 79, Number 173 (Monday, September 8, 2014)

Rules and Regulations

Page 53134

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2014-21267

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310, 314, 329, and 600

Docket No. FDA-2008-N-0334

RIN 0910-AF96

Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; corrections.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a document entitled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction'' that appeared in the Federal Register of August 14, 2014 (79 FR 47655). The document published without the required RIN number and in the Notice category. This document corrects those errors.

DATES: Effective Date: September 8, 2014.

FOR FURTHER INFORMATION CONTACT: Jean Chung, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4466, Silver Spring, MD 20993-0002, 301-796-1874; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 14, 2014, in FR Doc. 2014-19255, the following correction is made:

1. On page 47655, in the first column, add the heading ``RIN 0910-

AF96'' between the Docket No. and the title of the document.

Dated: September 2, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

FR Doc. 2014-21267 Filed 9-5-14; 8:45 am

BILLING CODE 4164-01-P