[Federal Register Volume 69, Number 51 (Tuesday, March 16, 2004)]
[Notices]
[Pages 12337-12338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5865]


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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://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://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://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