94-29114. Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products; Correction  

  • [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
    
    
    

Document Information

Published:
11/28/1994
Department:
Food and Drug Administration
Entry Type:
Uncategorized Document
Action:
Proposed rule; correction.
Document Number:
94-29114
Pages:
0-0 (None pages)
Docket Numbers:
Federal Register: November 28, 1994, Docket No. 93N-0181