[Federal Register Volume 59, Number 227 (Monday, November 28, 1994)]
[Unknown Section]
[Page ]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29114]


[Federal Register: November 28, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20, 310, 312, 314, and 600

[Docket No. 93N-0181]


Adverse Experience Reporting Requirements for Human Drug and 
Licensed Biological Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a 
proposal that appeared in the Federal Register of October 27, 1994 (59 
FR 54046). That document proposed to amend FDA's current adverse 
experience reporting regulations for human drugs and biological 
products. The document was published with two errors. This document 
corrects those errors.

FOR FURTHER INFORMATION CONTACT: Howard P. Muller, Center for Drug 
Evaluation and Research (HFD-362), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1049.

SUPPLEMENTARY INFORMATION: In FR Doc. 94-26483 appearing on page 54046 
in the Federal Register of October 27, 1994, the following corrections 
are made:
    1. On page 54059, in the third column, under amendment 15, in the 
ninth line the words ``the second sentence in paragraph (d)(1)'' are 
corrected to read ``the third sentence in paragraph (d)(1)''.


Sec. 314.80  [Corrected]

    2. On page 54061, in the third column, in Sec. 314.80 Postmarketing 
reporting of adverse drug experiences, in paragraph (d)(1), in line 8, 
the words ``either as case reports or as the result of a formal 
clinical trial'' are corrected to read ``either as the result of a 
formal clinical trial, or from epidemiological studies or analyses of 
experience in a monitored series of patients.''

    Dated: November 18, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-29114 Filed 11-25-94; 8:45 am]
BILLING CODE 4160-01-F