[Federal Register: August 3, 2007 (Volume 72, Number 149)]
[Notices]
[Page 43282]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03au07-76]
[[Page 43282]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0268]
Guidance for Industry and Food and Drug Administration Staff;
``Class II Special Controls Guidance Document: Absorbable
Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA
Technology;'' 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 ``Class II Special Controls
Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture
Produced by Recombinant DNA Technology.'' This guidance document
describes a means by which the absorbable poly(hydroxybutyrate)
surgical suture produced by recombinant deoxyribonucleic acid (DNA)
technology 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 these device types into class II
(special controls).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by
Recombinant DNA Technology'' 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
240-276-3151. 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: Nada O. Hanafi, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3555.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance describes a means by which the absorbable
poly(hydroxybutyrate) surgical suture produced by recombinant DNA
technology may comply with the requirement of special controls for
class II devices. An absorbable poly(hydroxybutyrate) surgical suture
is an absorbable surgical suture made of material isolated from
prokaryotic cells produced by recombinant DNA technology. The device is
intended for use in general soft tissue approximation and ligation.
This guidance describes FDA's recommendations regarding physical and
performance characteristics, biocompatibility, sterility, expiration
dating, and labeling.
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 absorbable poly(hydroxybutyrate) surgical
sutures produced by recombinant DNA technology. 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
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by
Recombinant DNA Technology,'' you may either send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 240-276-3151 to receive a hard copy. Please use
the document number 1629 to identify the guidance you are requesting.
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 refers to previously approved collections of
information found in FDA regulations. These collections of information
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 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; the collections
of information in 21 CFR parts 56 and 50 have been approved under OMB
control number 0910-0014.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or 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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: July 23, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-15063 Filed 8-2-07; 8:45 am]
BILLING CODE 4160-01-S