[Federal Register Volume 66, Number 123 (Tuesday, June 26, 2001)]
[Notices]
[Page 33966]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0232]


Medical Devices Premarket Guidance: Reprocessing and Reuse of 
Single-Use Devices; Draft Guidance for Industry and FDA Staff; 
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 June 1, 2001 (66 FR 29822). 
The document announced the availability of the draft guidance entitled 
``Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; 
Draft Guidance for Industry and FDA Staff.'' The document published 
inadvertently omitting the address for the Dockets Management Branch. 
This document corrects that error.

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

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, June 1, 
2001, in FR Doc. 01-13731, on page 29822, in the third column, correct 
the ADDRESSES caption to read:

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Premarket 
Guidance: Reprocessing and Reuse of Single-Use Devices; Draft 
Guidance for Industry and FDA Staff'' to the Division of Small 
Manufacturers Assistance (HFZ-220), Center for Devices and 
Radiological Health, Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. Send two self-addressed adhesive labels to 
assist that office in processing your request, or fax your request 
to 301-443-8818. Submit written comments concerning this draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance document.

    Dated: June 19, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15911 Filed 6-25-01; 8:45 am]
BILLING CODE 4160-01-S