03-18692. 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.

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 [e-mail] 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.