[Federal Register: July 23, 2003 (Volume 68, Number 141)]
[Notices]               
[Page 43534]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jy03-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0069]

 
Agency Emergency Processing Under OMB Review; Submission of 
Validation Data for Reprocessed Single-Use Devices; 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 July 8, 2003 (68 FR 40676). 
The notice announced that a proposed collection of information had been 
submitted to the Office of Management and Budget (OMB) for emergency 
processing under the Paperwork Reduction Act of 1995 (the PRA). The 
proposed collection of information will be used by FDA to determine 
whether reprocessed single-use devices are substantially equivalent to 
legally marketed predicate devices. The document was inadvertently 
published with an error. This document corrects that error.

FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and 
Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION: In FR Doc. 03-17136, appearing on page 40676 
in the Federal Register of Tuesday, July 8, 2003, the following 
correction is made:
    1. On page 40677, in the first column, under ADDRESSES, in the 
eighth line, ``electronically mailed to sshapiro@omb.eop.gov or faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Stuart 
Shapiro'' is corrected to read ``faxed to the Office of Information and 
Regulatory Affairs, OMB, Attn: Fumie Yokota''.

    Dated: July 17, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-18692 Filed 7-22-03; 8:45 am]

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