[Federal Register Volume 74, Number 196 (Tuesday, October 13, 2009)]
[Notices]
[Pages 52493-52494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24544]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0484]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance on Reagents for Detection of Specific Novel 
Influenza A Viruses

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on guidance on reagents for 
detection of specific novel influenza A viruses.

DATES: Submit written or electronic comments on the collection of 
information by December 14, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget

[[Page 52494]]

(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Guidance on Reagents For Detection of Specific Novel Influenza A 
Viruses-21 CFR 866.3332-(OMB Control Number 0910-0584)-Extension

    In accordance with section 513 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c), FDA evaluated an application 
for an in vitro diagnostic device for detection of influenza subtype H5 
(Asian lineage), commonly known as avian flu. FDA concluded that this 
device is properly classified into class II in accordance with 21 
U.S.C. 360c(a)(1)(B), because it is a device for which the general 
controls by themselves are insufficient to provide reasonable assurance 
of the safety and effectiveness of the device, but there is sufficient 
information to establish special controls to provide such assurance.
    The statute permits FDA to establish as special controls many 
different things, including postmarket surveillance, development and 
dissemination of guidance recommendations, and ``other appropriate 
actions as the Secretary deems necessary'' (21 U.S.C. 360c(a)(1)(B)). 
This information collection is a measure that FDA determined to be 
necessary to provide reasonable assurance of safety and effectiveness 
of reagents for detection of specific novel influenza A viruses.
    FDA issued an order classifying the H5 (Asian lineage) diagnostic 
device into class II on February 3, 2006, establishing the special 
controls necessary to provide reasonable assurance of the safety and 
effectiveness of that device and similar future devices. The new 
classification will be codified in 21 CFR 866.3332, a regulation that 
will describe the new classification for reagents for detection of 
specific novel influenza A viruses and set forth the special controls 
that help to provide a reasonable assurance of the safety and 
effectiveness of devices classified under that regulation. The 
regulation will refer to the special controls guidance document 
entitled ``Class II Special Controls Guidance Document: Reagents for 
Detection of Specific Novel Influenza A Viruses,'' which provides 
recommendations for measures to help provide a reasonable assurance of 
safety and effectiveness for these reagents.
    The guidance document recommends that sponsors obtain and analyze 
postmarket data to ensure the continued reliability of their device in 
detecting the specific novel influenza A virus that it is intended to 
detect, particularly given the propensity for influenza viruses to 
mutate and the potential for changes in disease prevalence over time. 
As updated sequences for novel influenza A viruses become available 
from the World Health Organization, National Institutes of Health, and 
other public health entities, sponsors of reagents for detection of 
specific novel influenza A viruses will collect this information, 
compare them with the primer/probe sequences in their devices, and 
incorporate the result of these analyses into their quality management 
system, as required by 21 CFR 820.100(a)(1). These analyses will be 
evaluated against the device design validation and risk analysis 
required by 21 CFR 820.30(g), to determine if any design changes may be 
necessary.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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Section of the Federal Food, Drug, and        No. of        Annual Frequency     Total Annual        Hours per                         Total Operating &
             Cosmetic Act                  Respondents        per Response        Responses           Response         Total Hours     Maintenance Costs
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513                                                    10                  2                 20                 10                200             $5,000
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    FDA estimates that 10 respondents will be affected annually. Each 
respondent will collect this information twice per year, estimated to 
take 10 hours. This results in a total data collection burden of 200 
hours (10 x 20= 200). FDA estimates that cost of developing standard 
operating procedures for each data collection is $500 (10 hours of work 
at $50/hour). This results in a total cost to industry of $5,000 ($500 
x 10 respondents).
    The guidance also refers to previously approved information 
collections found in FDA regulations. The information collections in 21 
CFR part 820 have been approved under OMB control number 0910-0073.

    Dated: October 5, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24544 Filed 10-9-09; 8:45 am]
BILLING CODE 4160-01-S