[Federal Register Volume 74, Number 1 (Friday, January 2, 2009)]
[Notices]
[Pages 109-110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-31214]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0516]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Nucleic Acid Amplification 
Assay for the Detection of Enterovirus RNA; 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: Nucleic Acid Amplification Assay for the Detection 
of Enterovirus RNA.'' This guidance document describes a means by which 
an enterovirus nucleic acid assay 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 codifying the 
classification of the enterovirus nucleic acid assays into class II 
(special controls). This guidance document is immediately in effect as 
the special control for an enterovirus nucleic acid assay, but it 
remains subject to comment in accordance with the agency's good 
guidance practices (GGPs).

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: 
Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA'' 
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://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Uwe Scherf, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0725.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule codifying the classification of the enterovirus nucleic 
acid assays 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 an enterovirus nucleic acid assay device. 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 an order 
classifying 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. 
Consistent with the statute, on March 16, 2007, FDA issued an order 
classifying the enterovirus nucleic acid assay into class II with 
special controls. Because the device has been classified into class II 
with the guidance document as a special control, 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 implementing this 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 that are received 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 good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
agency's current thinking on nucleic acid amplification assays for the 
detection of enterovirus RNA. 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: Nucleic Acid Amplification Assay for the Detection of 
Enterovirus RNA,'' you may either send an e-mail request to 
[email protected] 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 1665 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://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 at http://www.regulations.gov.

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 USC 3501-3520) (the PRA). 
The collections of information in part 807 (21 CFR part 807), subpart E 
including Sec.  807.87, have been approved under OMB Control No. 0910-
0120; the collections of information in 21 CFR part 812 have been 
approved under OMB Control No. 0910-0078; the collections of 
information in 21 CFR parts 50 and 56 have been approved under OMB 
Control No. 0910-0130; and the collections of information in 21 CFR 
809.10 have been approved under OMB Control No. 0910-0485. In addition, 
FDA concludes that the labeling statement in Section 7, Intended Use, 
of the guidance does not constitute a ``collection of information'' 
under the PRA. Rather, this labeling statement is ``public disclosure 
of information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

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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. Revised comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 16, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-31214 Filed 12-31-08; 8:45 am]
BILLING CODE 4160-01-S