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

---
identifier: "/us/fr/2014-21267"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections"
title_number: 0
title_name: "Federal Register"
section_number: "2014-21267"
section_name: "Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections"
positive_law: false
currency: "2014-09-08"
last_updated: "2014-09-08"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2014-21267"
document_type: "rule"
publication_date: "2014-09-08"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
cfr_references:
  - "21 CFR Part 310"
  - "21 CFR Part 314"
  - "21 CFR Part 329"
  - "21 CFR Part 600"
rin: "0910-AF96"
fr_citation: "79 FR 53134"
fr_volume: 79
docket_ids:
  - "Docket No. FDA-2008-N-0334"
effective_date: "2014-09-08"
fr_action: "Final rule; corrections."
---


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

**AGENCY:**

Food and Drug Administration, HHS.

**ACTION:**

Final rule; corrections.

**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.