[Federal Register Volume 60, Number 16 (Wednesday, January 25, 1995)]
[Notices]
[Page 4921]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1767]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94D-0300]


International Harmonization; Draft Policy on Standards; 
Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of November 28, 1994 (59 FR 
60870). The document provided a draft policy statement of the agency's 
development and use of standards with respect to international 
harmonization of regulatory requirements and guidelines. Specifically, 
the draft policy addressed the conditions under which FDA participates 
with standards bodies outside of FDA, domestic or international, in the 
development of standards applicable to products regulated by FDA. The 
document was published with some typographical and inadvertent errors. 
This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: Linda Horton, International Policy 
Staff (HF-23), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-2831.
    In FR Doc. 94-29116, appearing on page 60870, in the Federal 
Register of November 28, 1994, the following corrections are made:
    1. On page 60872, in the second column, in the eighth line from the 
bottom, the word ``Biologic'' is corrected to read ``Biologics''; in 
the third column, in the first full paragraph, in the 21st line, the 
acronym ``(PhMA)'' is corrected to read ``(PhRMA)''; and in the same 
column, beginning in the second line from the bottom, the words 
``standardizing the safety-related terminology used in adverse 
experience reporting'' are corrected to read ``standardizing medical 
definitions and adverse experience reporting''.
    2. On page 60873, in the first column, in the first full paragraph, 
in the fourth line from the bottom of the paragraph, the word 
``Device'' is corrected to read ``Devices''.

    Dated: January 18, 1995.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 95-1767 Filed 1-24-95; 8:45 am]
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