Document ID: FDA-2008-N-0334-0013
Agency: fda
Document Type: Rule
Title: Postmarketing Safety Reports for Human Drug and Biological Products;
Electronic Submission Requirements; Correction
Posted Date: 2014-09-08T04:00Z

[Federal Register Volume 79, Number 173 (Monday, September 8, 2014)]
[Rules and Regulations]
[Pages 53133-53134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-21266]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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[[Page 53134]]

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
rule entitled ``Postmarketing Safety Reports for Human Drug and 
Biological Products; Electronic Submission Requirements'' that appeared 
in the Federal Register of June 10, 2014 (79 FR 33072). The document 
amended FDA's postmarketing safety reporting regulations for human drug 
and biological products to require that persons subject to mandatory 
reporting requirements submit safety reports in an electronic format 
that FDA can process, review, and archive. The document was published 
with an incorrect RIN number. This document corrects the error.

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 June 10, 2014, in 
FR Doc. 2014-13480, the following correction is made:
    1. On page 33073, in the third column, the RIN number heading is 
corrected to read ``RIN 0910-AF96''.

    Dated: September 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-21266 Filed 9-5-14; 8:45 am]
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