[Federal Register Volume 60, Number 13 (Friday, January 20, 1995)]
[Proposed Rules]
[Pages 4131-4132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1436]



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[[Page 4132]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. 93N-0181]


Adverse Experience Reporting Requirements for Human Drug; 
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 
proposed rule that appeared in the Federal Register of October 27, 1994 
(59 FR 54046). The document proposed to amend its current adverse 
experience reporting regulations for human drug products and for 
licensed biological products. The document was published with an error 
in the codified section. This document corrects that error.

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.
    In FR Doc. 94-26483, appearing on page 54046 in the Federal 
Register of October 27, 1994, the following correction is made:

Sec. 310.305  [Corrected]

    On page 54056, in the second column, in Sec. 310.305, paragraph 
(b)(2) is corrected to read as follows:


Sec. 310.305  Records and reports concerning adverse drug experiences 
on marketed prescription drugs for human use without approved new drug 
applications.

* * * * *
    (b) * * *
    (2) Adverse drug experience means any adverse event associated with 
the use of a drug in humans, whether or not considered drug related, 
including the following: An adverse event occurring in the course of 
the use of a drug product in professional practice; an adverse event 
occurring from drug overdose, whether accidental or intentional; an 
adverse event occurring from drug abuse; an adverse event occurring 
from drug withdrawal; and any failure of expected pharmacological 
action.
* * * * *

    Dated: January 5, 1995.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 95-1436 Filed 1-19-95; 8:45 am]
BILLING CODE 4160-01-F