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Notice

Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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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 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 The document announced the availability of the draft guidance entitled “Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff.”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.

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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.

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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ADDRESSES: Submit written requests for single copies on a 3.5′′ diskette of the draft guidance document entitled “Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff” to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug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 Submit written comments concerning this draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document.

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Dated: June 19, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

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[FR Doc. 01-15911 Filed 6-25-01; 8:45 am]

BILLING CODE 4160-01-S