[Federal Register Volume 68, Number 243 (Thursday, December 18, 2003)]
[Notices]
[Pages 70513-70514]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31175]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0371]


Class II Special Controls Guidance Document: Human Dura Mater; 
Guidance for Industry and FDA; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Class II Special Controls 
Guidance Document: Human Dura Mater.'' This guidance document describes 
a means

[[Page 70514]]

by which human dura mater may comply with the requirement of special 
controls for class II devices. Elsewhere in this issue of the Federal 
Register, FDA is publishing a final rule to classify this device type 
into class II (special controls).

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

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: Human Dura Mater'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health (CDRH), 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. 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://www.fda.gov/dockets/ecomments. 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

    In the Federal Register of October 22, 2002 (67 FR 64835), FDA 
published a proposed rule to classify human dura mater into class II 
(special controls). FDA identified the draft guidance document entitled 
``Class II Special Controls Guidance Document: Human Dura Mater; Draft 
Guidance for Industry and FDA'' as the special control, in conjunction 
with general controls, that is capable of providing reasonable 
assurance of safety and effectiveness for this device.
    FDA invited interested persons to comment on the draft guidance by 
January 21, 2003. FDA received one comment that informed the agency of 
research findings concerning Creutzfeldt-Jakob Disease. The comment did 
not express any opinion on the guidance.

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 the human dura mater device. 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. 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 notification submissions (21 CFR part 807, subpart 
E; OMB Control No. 0910-0120). The labeling provisions addressed in the 
guidance have been approved by OMB under the PRA under OMB Control No. 
0910-0485.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. Two copies of mailed 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. The 
guidance and received comments are available for public examination in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    To receive a copy of ``Class II Special Controls Guidance Document: 
Human Dura Mater'' by 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 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://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

    Dated: December 5, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiologiccal Health.
[FR Doc. 03-31175 Filed 12-17-03; 8:45 am]
BILLING CODE 4160-01-S