[Federal Register: April 13, 2004 (Volume 69, Number 71)]
[Notices]               
[Page 19435-19436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ap04-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999D-2335]

 
Guidance for Industry and Food and Drug Administration Staff; 
Premarket Approval Applications for Absorbable Powder for Lubricating a 
Surgeon's Glove; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Premarket Approval Applications 
(PMA) for Absorbable Powder for Lubricating a Surgeon's Glove.'' This 
guidance describes the information FDA recommends that you provide in a 
PMA for absorbable powder for lubricating a surgeon's glove.

DATES: Submit written or electronic comments on this guidance at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the

[[Page 19436]]

guidance document entitled ``Premarket Approval Applications (PMA) for 
Absorbable Powder for Lubricating a Surgeon's Glove'' to the Division 
of Small Manufacturers, International, and Consumer Assistance (HFZ-
220), Center for Devices and Radiological Health, Food and Drug 
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the 

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 30, 1999 (64 FR 41744), FDA 
announced the availability of a draft guidance for comment entitled 
``Medical Glove Guidance Manual.'' (See http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/dsma/135.html
 for the draft guidance.) Elsewhere in the same issue of the 

Federal Register (64 FR 41710), FDA proposed that the 1999 draft 
guidance serve as a special control for class II gloves. However, 
chapter 4 of the 1999 draft guidance contained a section that discussed 
PMAs for absorbable powder for lubricating surgeon's gloves. Because 
the section discussing PMAs for absorbable powder is not relevant to 
class II gloves, FDA is removing this section and issuing it as a 
separate guidance document. FDA did not receive any comments on this 
section of the 1999 draft guidance. Because the recommendations in this 
section were available in draft form for comment, FDA is issuing this 
guidance as a final document. As with any guidance, however, you may 
submit comments at any time.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on PMAs for absorbable powder for lubricating 
a surgeon's glove. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statute and regulations.

III. Electronic Access

    To receive ``Premarket Approval Applications (PMA) for Absorbable 
Powder for Lubricating a Surgeon's Glove'' by fax machine, call the 
Center for Devices and Radiological Health (CDRH) Facts-On-Demand 
system at 800-899-0381, or 301-827-0111 from a touch-tone telephone. 
Press 1 to enter the system. At the second voice prompt, press 1 to 
order a document. Enter the document number (1230) followed by the 
pound sign (). Follow the remaining voice prompts to complete 
your request.
    Persons interested in obtaining a copy of the guidance may also do 
so by using the Internet. CDRH maintains an entry on the Internet for 
easy access to information including text, graphics, and files that may 
be downloaded to a personal computer with Internet access. Updated on a 
regular basis, the CDRH home page includes device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available on the Division of Dockets 
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.


IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 USC 3501-3520). The 
collections of information addressed in the guidance document have been 
approved by OMB in accordance with the PRA under the regulations 
governing premarket approval applications (21 CFR part 814, OMB control 
number 0910-0231). The labeling provisions addressed in the guidance 
have been approved by OMB under the PRA, OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding the guidance 
at any time. Submit a single copy of electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Submit two paper copies of any mailed 

comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Comments received may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 30, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices 
and Radiological Health.
[FR Doc. 04-8306 Filed 4-12-04; 8:45 am]

BILLING CODE 4160-01-S