66 FR 123 pg. 33966 - Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction
Type: NOTICEVolume: 66Number: 123Page: 33966
Docket number: [Docket No. 01D-0232]
FR document: [FR Doc. 01-15911 Filed 6-25-01; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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Medical Devices Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff; Availability; Correction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.
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 The document announced the availability of the draft guidance entitled "Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff."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ADDRESSES: Submit written requests for single copies on a 3.5'' diskette of the draft guidance document entitled "Premarket Guidance: Reprocessing and Reuse of Single-Use Devices; Draft Guidance for Industry and FDA Staff" to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug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 Submit written comments concerning this draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance document.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