Document ID: FDA-2009-N-0484-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
Posted Date: 2010-01-19T05:00Z

[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2872-2874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-794]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance on Reagents 
for Detection of Specific Novel Influenza A Viruses

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
February 18, 2010.

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of

[[Page 2873]]

Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 
202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0584. Also 
include the FDA docket number found in brackets in the heading of the 
document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance on Reagents for Detection of Specific Novel Influenza A 
Viruses--(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 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.
    In the Federal Register of October 13, 2009 (74 FR 52493), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received, however it was not 
PRA related.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Annual Frequency        Total Annual
           Section of the Act              No. of  Respondents        per Response            Responses        Hours per  Response       Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
513(g)                                                        10                     2                    20                    15                   300
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 2874]]

    Due to a clerical error, capital costs and operating and 
maintenance costs that appeared in a notice published in the Federal 
Register of October 20, 2009 (74 FR 53749) were incorrect. There are 
actually no capital and maintenance costs; additionally, the hours per 
response which were reported as 10 are actually 15. Table 1 of this 
document contains the correct hour burden.

    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-794 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S