69 FR 71 pgs. 19435-19436 - Guidance for Industry and Food and Drug Administration Staff;Premarket Approval Applications for Absorbable Powder for Lubricating aSurgeon's Glove; Availability
Type: NOTICEVolume: 69Number: 71Pages: 19435 - 19436
Docket number: [Docket No. 1999D-2335]
FR document: [FR Doc. 04-8306 Filed 4-12-04; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 aSurgeon's Glove; Availability
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing the availability ofthe guidance entitled "Premarket Approval Applications (PMA) forAbsorbable Powder for Lubricating a Surgeon's Glove." This guidancedescribes the information FDA recommends that you provide in a PMA forabsorbable powder for lubricating a surgeon's glove.
DATES:
Submit written or electronic comments on this guidance at anytime.
ADDRESSES:
Submit written requests for single copies on a 3.5? diskette ofthe guidance document entitled "Premarket Approval Applications (PMA)for Absorbable Powder for Lubricating a Surgeon's Glove" to theDivision of Small Manufacturers, International, and Consumer Assistance(HFZ-220), Center for Devices and Radiological Health, Food and DrugAdministration, 1350 Piccard Dr., Rockville, MD 20850. Send oneself-addressed adhesive label to assist that office in processing yourrequest, or fax your request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronicaccess to the guidance.
Submit written comments concerning this guidance to the Division ofDockets Management (HFA-305), Food and Drug Administration, 5630Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments . Identify comments withthe docket number found in brackets in the heading of thisdocument.
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In the Federal Register of July 30, 1999 (64 FR 41744),FDA announced the availability of a draft guidance for comment entitled"Medical Glove Guidance Manual."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://www.fda.gov/cdrh/dsma/135.html for the draft guidance.)Elsewhere in the same issue of the Federal Register (64 FR41710), FDA proposed that the 1999 draft guidance serve as a specialcontrol for class II gloves. However, chapter 4 of the 1999 draft guidancecontained a section that discussed PMAs for absorbable powder forlubricating surgeon's gloves. Because the section discussing PMAs forabsorbable powder is not relevant to class II gloves, FDA is removing thissection and issuing it as a separate guidance document. FDA did notreceive any comments on this section of the 1999 draft guidance. Becausethe recommendations in this section were available in draft form forcomment, FDA is issuing this guidance as a final document. As with anyguidance, however, you may submit comments at any time.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidancepractices regulation (21 CFR 10.115). The guidance represents the agency'scurrent thinking on PMAs for absorbable powder for lubricating a surgeon'sglove. It does not create or confer any rights for or on any person anddoes not operate to bind FDA or the public. An alternative approach may beused if such approach satisfies the requirements of the applicable statuteand regulations.
III. Electronic Access
To receive "Premarket Approval Applications (PMA) for AbsorbablePowder for Lubricating a Surgeon's Glove" by fax machine, call theCenter for Devices and Radiological Health (CDRH) Facts-On-Demand system at800-899-0381, or 301-827-0111 from a touch-tonetelephone. Press 1 to enter the system. At the second voice prompt, press1 to order a document. Enter the document number (1230) followed by thepound sign (#). Follow the remaining voice prompts to complete yourrequest.
Persons interested in obtaining a copy of the guidance may also do so byusing the Internet. CDRH maintains an entry on the Internet for easyaccess to information including text, graphics, and files that may bedownloaded to a personal computer with Internet access. Updated on aregular 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 andelectronic submissions, Mammography Matters, and other device-orientedinformation. The CDRH Web site may be accessed at http://www.fda.gov/cdrh . A search capability for all CDRHguidance documents is available at http://www.fda.gov/cdrh/guidance.html . Guidance documents arealso available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets .
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that aresubject to review by the Office of Management and Budget (OMB) under thePaperwork Reduction Act of 1995 (the PRA) (44 USC 3501-3520). Thecollections of information addressed in the guidance document have beenapproved by OMB in accordance with the PRA under the regulations governingpremarket approval applications (21 CFR part 814, OMB control number0910-0231). The labeling provisions addressed in the guidance havebeen 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 theguidance at any time. Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments . Submit two paper copiesof any mailed comments, except that individuals may submit one paper copy.Comments are to be identified with the docket number found in brackets inthe heading of this document. Comments received may be seen in theDivision of Dockets Management between 9 a.m. and 4 p.m., Monday throughFriday.
Dated: March 30, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center forDevices and Radiological Health.
[FR Doc. 04-8306 Filed 4-12-04; 8:45 am]
BILLING CODE 4160-01-S