01-15911. Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction

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 The document announced the availability of the draft guidance entitled “Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff.”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

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ADDRESSES: Submit written requests for single copies on a 3.5′′ diskette of the draft guidance document entitled “Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff” to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug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 Submit written comments concerning this draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document.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