Medical Gloves; Draft Guidance Manual; Availability; Extension of Comment Period

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Medical Gloves; Draft Guidance Manual; Availability; Extension of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27, 2000, the comment period for the draft guidance entitled ``Medical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draft guidance in the Federal Register of July 30, 1999 (64 FR 41744).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the draft guidance with the extension of the comment period for the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draft guidance is a proposed special control for that reclassification.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persons additional time to submit comments on the draft guidance.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ADDRESSES: Submit written comments on the draft guidance to the Dockets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of availability of the draft guidance entitled ``Medical Glove Guidance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 The draft guidance is intended to provide current information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