[Federal Register Volume 67, Number 204 (Tuesday, October 22, 2002)]
[Notices]
[Pages 64901-64902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26817]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0371]


Draft Guidance for Industry on Class II Special Controls Guidance 
Document: Human Dura Mater; 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availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: Human Dura Mater; Draft Guidance for Industry and 
FDA.'' Elsewhere in this issue of the Federal Register, FDA is issuing 
a proposed rule to classify human dura mater into class II (special 
controls). This draft guidance document was developed as the special 
controls guidance. It also updates the

[[Page 64902]]

information in the ``Guidance for the Preparation of a Premarket 
Notification Application for Processed Human Dura Mater'' issued on 
October 14, 1999. This guidance is neither final nor is it in effect at 
this time.

DATES: Submit written or electronic comments on this draft guidance by 
January 21, 2003.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Class II Special 
Controls Guidance Document: Human Dura Mater; Draft Guidance for 
Industry and FDA'' 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 two self-addressed labels to assist that 
office in processing your request, or fax your request to 301-443-8818. 
Submit written comments concerning this guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Comments should be identified with 
the docket number found in brackets in the heading of this document. 
See the SUPPLEMENTARY INFORMATION section for information on electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090.

SUPPLEMENTARY INFORMATION:

I. Background

    At a public meeting held on September 16 and 17, 1999, the 
Neurological Devices Panel (the Panel) recommended that human dura 
mater be classified into class II. The Panel also commented on the 
information in the ``Guidance for the Preparation of a Premarket 
Notification Application for Processed Human Dura Mater'' that was 
issued on July 31, 1999, and was subsequently reformatted and reissued 
with the same title on October 14, 1999. The draft guidance entitled 
``Class II Special Controls Guidance Document: Human Dura Mater; Draft 
Guidance for Industry and FDA'' was developed as a special controls 
guidance to support the classification of human dura mater into class 
II and to update and supersede the information in the October 14, 1999, 
guidance document. Following the effective date of a final rule 
classifying the device, any firm submitting a 510(k) premarket 
notification for human dura mater will need to address the issues 
covered in the special control guidance. However, the firm need only 
show that its device meets the recommendations of the guidance or in 
some other way provides equivalent assurances of safety and 
effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices (GGP) regulation (21 CFR 10.115). This draft 
guidance document represents the agency's current thinking on special 
controls for human dura mater. 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 
applicable statutes and regulations. This draft guidance document is 
issued as a level 1 guidance consistent with the GGP regulations.

III. Electronic Access

    In order to receive a copy of the ``Class II Special Controls 
Guidance Document: Human Dura Mater; Draft Guidance for Industry and 
FDA'' via your fax machine, call the 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 (054) followed by the pound sign 
(). Follow the remaining voice prompts to complete your 
request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. CDRH maintains an entry on the Internet 
for easy access to information, including the 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 the human dura 
mater guidance document, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.

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 (44 U.S.C. 3501-3520). The 
collections of information in sections 3 and 7 through 12 of this 
guidance were approved under OMB control number 0910-0120.

V. Comments

    You may submit to the Dockets Management Branch (see ADDRESSES) 
written or electronic comments on ``Class II Special Controls Guidance 
Document: Human Dura Mater; Draft Guidance for Industry and FDA.'' You 
must submit three copies of any comments. Individuals may submit one 
copy. You must identify comments with the docket number found in 
brackets in the heading of this document. Comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

    Dated: September 30, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26817 Filed 10-21-02; 8:45 am]
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