[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14403-14404]
From the Federal Register Online via the Government Publishing 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 [email protected]
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]
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