Document ID: FDA-2008-N-0334-0012
Agency: fda
Document Type: Notice
Title: Postmarketing Safety Reports for Human Drug and Biological Products;
Electronic Submission Requirements; Correction
Posted Date: 2014-08-14T04:00Z

[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Notices]
[Page 47655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19255]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0334]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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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 incorrect information regarding the availability of the 
International Conference on Harmonization's (ICH) data elements for 
postmarketing safety reports. The document also published with an 
incorrect statement regarding the impact of the final rule on small 
entities. This document corrects those errors.

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 corrections are made:
    1. On page 33074, in the first column, under ``Introduction'', 
footnote 6 is corrected to read: ``ICH data elements for postmarketing 
safety reports are provided in the guidance for industry entitled `E2B 
Electronic Transmission of Individual Case Safety Reports 
Implementation Guide--Data Elements and Message Specification,' 
available at http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm.''
    2. On page 33084, in the second column, under ``Analysis of 
Impacts'', the first full sentence is corrected to read: ``Because the 
average small entity submits few safety reports and the Agency's Web-
based system for submitting reports electronically will require little 
additional cost per report, the Agency certifies that this final rule 
will not have a significant economic impact on a substantial number of 
small entities.''

    Dated: August 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-19255 Filed 8-13-14; 8:45 am]
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