[Federal Register Volume 64, Number 208 (Thursday, October 28, 1999)]
[Notices]
[Pages 58070-58071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-28110]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-2335]
Medical Gloves; Draft Guidance Manual; Availability; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to January
27, 2000, the comment period for the draft guidance entitled ``Medical
Glove Guidance Manual.'' FDA published a notice of availability of the
draft guidance in the Federal Register of July 30, 1999 (64 FR 41744).
The agency is taking this action to harmonize the comment period for
the draft guidance with the extension of the comment period for the
proposed rule on the reclassification of surgeon's and patient
examination gloves (64 FR 41710, July 30, 1999). The document
announcing the extension of that comment period for the proposed rule
is published elsewhere in this issue of the Federal Register. The
draft guidance is a proposed special control for that reclassification.
This extension of the comment period is intended to allow interested
persons additional time to submit comments on the draft guidance.
DATES: Written comments by January 27, 2000.
ADDRESSES: Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
[[Page 58071]]
FOR FURTHER INFORMATION CONTACT: Arthur K. Yellin, Center for Devices
and Radiological Health (HFZ-200), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 800-638-2041, ext. 146 or 301-443-
6597, ext. 146.
SUPPLEMENTARY INFORMATION:
I. Extension of Comment Period
In the Federal Register of July 30, 1999, FDA published a notice
of availability of the draft guidance entitled ``Medical Glove Guidance
Manual.'' The draft guidance is intended to provide current information
to assist manufacturers and others in obtaining marketing clearance,
applying manufacturing and design controls, and properly labeling
medical gloves. FDA also proposes to use the ``Medical Glove Guidance
Manual'' as a special control in its proposed reclassification of
surgeon's and patient examination gloves (64 FR 41710 at 41714).
Elsewhere in this issue of the Federal Register, FDA is
announcing an extension of the comment period for the proposed rule on
the reclassification of surgeon's and patient examination gloves.
Because FDA has proposed that the ``Medical Glove Guidance Manual'' be
a special control in that proposed reclassification, FDA wanted to
harmonize the comment periods. Consequently, FDA is extending the
comment period on the draft guidance for 90 additional days.
II. Comments
Interested persons may, on or before January 27, 2000, submit to
the Dockets Management Branch (address above) written comments
regarding the draft guidance. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: October 21, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-28110 Filed 10-27-99; 8:45 am]
BILLING CODE 4160-01-F
