[Federal Register Volume 71, Number 217 (Thursday, November 9, 2006)]
[Notices]
[Pages 65828-65829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19045]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0183]


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.

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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 
December 11, 2006.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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--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 section 
513(a)(1)(B) of the act, 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'' (section 513(a)(1)(B) of the 
act). 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 control guidance document, ``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 for 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 considered comments expressed by the Centers for Disease 
Control and Prevention before the issuance of this guidance.
    FDA also published a notice in the Federal Register of May 22, 2006 
(71 FR 29342) soliciting comments on this information collection as 
required under 5 CFR 1320.8(d). In response, FDA received one comment 
concerning this information collection. The comment pointed out that 
the estimated hours per response should be closer to 15, rather than 
FDA's estimate of 10 hours, in order to comply with quality system 
regulation/document control for the new information collection. FDA 
agrees with this comment and as a result, the annual reporting burden 
hour estimate has been recalculated accordingly, i.e., the total annual 
reporting burden hour estimate is now 300 hours instead of 200.
    Respondents to this collection of information are manufacturers of 
in vitro diagnostic devices.
    FDA estimates the burden for this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden
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                                                                                                Total Operating
      No. of        Annual Frequency     Total Annual        Hours per         Total Hours      and  Maintenance
   Respondents        per Response        Responses           Response                               Costs
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10                                 2                 20                 15                300             $3,500
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[[Page 65829]]

    The FDA estimates that 10 respondents will be affected annually. 
Each respondent will collect this information twice per year, estimated 
to take 15 hours. This results in a total data collection burden of 300 
hours. (15 x 20 = 300). FDA estimates that cost of developing standard 
operating procedures for each data collection is $350 (10 hours of work 
at $35/hour). This results in a total cost to industry of $3,500 ($350 
x 10 respondents).

    Dated: November 6, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-19045 Filed 11-8-06; 8:45 am]
BILLING CODE 4160-01-S