Document ID: FDA-2012-D-0167-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Staff; Class II Special Controls; Norovirus Serological Reagents:  Availability
Posted Date: 2012-03-09T05:00Z

[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14403-14404]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5674]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0167]

Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Norovirus Serological 
Reagents; 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 document entitled ``Class II Special 
Controls Guidance Document: Norovirus Serological Reagents.'' This 
guidance document describes a means by which norovirus serological 
reagents may comply with the requirement of special controls for class 
II devices. This guidance document is to be implemented immediately as 
the special control for norovirus serological reagents.

DATES: Submit either electronic or written comments on this guidance at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Norovirus Serological Reagents'' to the Division of Small 
Manufacturers, International and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Steven Gitterman, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave, Bldg. 66, Rm. 5518, Silver Spring, MD 20993-0002, 301-
796-6694.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying norovirus serological reagents into class II 
(special controls) under section 513(f)(2) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(2)). This guidance 
document will serve as the special control for norovirus serological 
reagents. Section 513(f)(2) of the FD&C Act provides that any person 
who submits a premarket notification under section 510(k) of the FD&C 
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 FD&C Act (21 U.S.C. 
360c(f)(1)), request FDA to classify the device under the criteria set 
forth in section 513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). FDA 
will, 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 this classification.

II. Significance of Special Controls Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance is being 
implemented without prior public comment because the Agency has 
determined that prior public participation is not feasible or 
appropriate (21 CFR 10.115(g)(2)). Because of the timeframes 
established by section 513(f)(2) of the FD&C Act, FDA has determined 
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 
for immediate implementation. Although this guidance document is 
immediately in effect, it remains subject to comment in accordance with 
the Agency's good guidance practices.
    FDA believes that adherence to the recommendations described in 
this guidance document, in addition to the general controls, will 
provide reasonable assurance of the safety and effectiveness of 
norovirus serological reagents classified under Sec.  866.3395 (21 CFR 
866.3395). In order to be classified as a class II device under Sec.  
866.3395, a norovirus serological reagents must comply with the 
requirements of special controls; manufacturers must address the issues 
requiring special controls as identified in the guidance document, 
either by following the recommendations in the guidance document or by 
some other means that provides equivalent assurances of safety and 
effectiveness.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Class II Special Controls Guidance Document: Norovirus Serological 
Reagents,'' you may either send an email request to dsmica@fda.hhs.gov 
to receive an electronic copy of the document or send a fax request to 
301-847-8149 to receive a hard copy. Please use the document number 
1767 to identify the guidance you are requesting.

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 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120 and the collections of 
information in 21 CFR part 801 and 21 CFR 809.10 have been approved 
under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division

[[Page 14404]]

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 5, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-5674 Filed 3-8-12; 8:45 am]
BILLING CODE 4160-01-P