[Federal Register Volume 71, Number 55 (Wednesday, March 22, 2006)]
[Notices]
[Pages 14534-14535]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-2743]



[[Page 14534]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006D-0099]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Reagents for Detection of 
Specific Novel Influenza A Viruses: 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: Reagents for Detection of Specific Novel Influenza A 
Viruses''. This guidance document describes a means by which Reagents 
for detection of specific novel influenza A viruses 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 Reagents for detection of specific novel influenza A viruses 
into class II (special controls). This guidance document is immediately 
in effect as a special control for Reagents for detection of specific 
novel influenza A viruses, 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.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Class II Special Controls 
Guidance Document: Reagents for Detection of Specific Novel Influenza A 
Viruses'' 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: Claudia Gaffey, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 240-276-0496.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying Reagents for detection of specific novel 
influenza A viruses 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 notice announces the guidance document that 
will serve as a special control for Reagents for detection of specific 
novel influenza A viruses. An additional special control is established 
in 21 CFR 866.3332. 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. 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 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 Reagents for detection of specific novel 
influenza A viruses. 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: Reagents 
for Detection of Specific Novel Influenza A Viruses'' by fax machine, 
call the 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 
1596 followed by the pound sign (). 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 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 on the Division of Dockets 
Management Internet site at http://www.fda.gov/ohrms/dockets.

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 U.S.C. 3501-3520). The 
collections of information in this guidance were approved under OMB 
control numbers 0910-0485, 0910-0120, 0910-0073 and 0910-0584 and 
expires on September 30, 2006.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(See ADDRESSES), written or electronic comments regarding this 
document. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Submit two paper copies of any mailed comments, except that 
individuals may submit one 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.


[[Page 14535]]


    Dated: March 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-2743 Filed 3-21-06; 8:45 am]
BILLING CODE 4160-01-Ss