[Federal Register: March 16, 2004 (Volume 69, Number 51)]
[Notices]
[Page 12337-12338]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr04-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0082]
Guidance for Industry and Food and Drug Administration Staff:
Class II Special Controls Guidance Document: Factor V Leiden DNA
Mutation Detection Systems; 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: Factor V Leiden DNA Mutation Detection Systems.''
This guidance document describes a means by which Factor V Leiden
deoxyribonucleic acid (DNA) mutation detection systems 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 the Factor V Leiden DNA mutation detection system into class
II (special controls). This guidance document is immediately in effect
as the special control for Factor V Leiden DNA mutation detection
systems, but it remains subject to comment in accordance with the
agency's good guidance practices regulation (GGPs).
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 guidance document entitled ``Class II Special Controls
Guidance Document: Factor V Leiden DNA Mutation Detection Systems'' 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: Elizabeth Mansfield, Center for
Devices and Radiological Health (HFZ-440), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1293.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying the Factor V Leiden DNA mutation detection
system into class II (special controls) under section 513(f)(2) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)).
This guidance document will serve as the special control for Factor V
Leiden DNA mutation detection systems. Section 513(f)(2) of the act
provides that any person who submits a premarket notification under
section 510(k) of the act (21 U.S.C. 360(k)) for a device that has not
previously been classified may, within 30 days after receiving a
written notice of the classification of the device in class III under
section 513(f)(1) of the act, request FDA to classify the device under
the criteria set forth in section 513(a)(1) of the act. FDA shall,
within 60 days of receiving such a request, classify the device by
written order. This classification shall be the initial classification
of the device. Within 30 days after the issuance of an order
classifying the device, FDA must publish a notice in the Federal
Register announcing such classification. Because of the timeframes
established by section 513(f)(2) of the act, FDA has determined, under
Sec. 10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible to
allow for public participation before issuing this guidance as a final
guidance document. Therefore, FDA is issuing this guidance document as
a level 1 guidance document that is immediately in effect. FDA will
consider any comments we receive in response to this notice to
determine whether to amend the guidance document.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGPs. The
guidance represents the agency's current thinking on Factor V Leiden
DNA mutation detection systems. 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 ``Class II Special Controls Guidance Document: Factor V
Leiden DNA Mutation Detection Systems'' by fax machine, call FDA's
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 (1236) followed by the
pound sign ([numsign]). 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
[[Page 12338]]
personal computer with Internet access. 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.
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 USC 3501-3520) (the PRA). 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 number. 0910-0120). The labeling provisions addressed in
the guidance have been approved by OMB under the PRA under OMB control
number 0910-0485.
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 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 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 5, 2004.
Beverly Chernaik Rothstein,
Acting Deputy Director for Policy and Regulations, Center for Devices
and Radiological Health.
[FR Doc. 04-5865 Filed 3-15-04; 8:45 am]
BILLING CODE 4160-01-S