[Federal Register: January 2, 2009 (Volume 74, Number 1)]
[Notices]
[Page 109-110]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ja09-31]
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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
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 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