[Federal Register Volume 84, Number 137 (Wednesday, July 17, 2019)]
[Notices]
[Pages 34190-34191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15160]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3662]


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 August 
16, 2019.

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: 202-395-7285, or emailed to [email protected]. 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 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

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 Part 866

OMB Control Number 0910-0584--Extension

    In accordance with section 513 of the Federal Food, Drug, and 
Cosmetic Act (FD&C 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 FD&C 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 
FD&C 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 March 22, 2006 (71 FR 14377), establishing the 
special controls necessary to provide reasonable assurance of the 
safety and effectiveness of that device and similar future devices. The 
new classification was codified in 21 CFR 866.3332, a regulation that 
describes the new classification for reagents for detection of specific 
novel influenza A viruses and sets forth the special controls that

[[Page 34191]]

help to provide a reasonable assurance of the safety and effectiveness 
of devices classified under that regulation. The regulation refers to 
the 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 
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 one respondent will be affected annually. The 
respondent will collect this information twice per year; each response 
is estimated to take 15 hours. This results in a total data collection 
burden of 30 hours.
    The guidance also refers to previously approved information 
collections found in FDA regulations. The collections of information in 
21 CFR part 801 have been approved under OMB control number 0910-0485; 
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 820 have been approved under OMB control 
number 0910-0073.
    In the Federal Register of March 5, 2019 (84 FR 7904), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                      Number of                        Average burden
                           Activity                                 Number of        records per      Total annual           per           Total hours
                                                                  recordkeepers     recordkeeper         records        recordkeeping
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Recordkeeping regarding reagents for detection of specific                    1                 2                 2                15                30
 novel influenza A viruses....................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Manufactures are increasingly adopting in silico methods 
(computational analysis) for the detection of specific novel Influenza 
A viruses over traditional laboratory techniques. Therefore, few 
manufactures are using reagents for detection of specific novel 
influenza A viruses. Based on these industry trends, we estimate a 
decrease in the number of total annual records and a corresponding 
decrease of 270 hours in the total burden since our last OMB approval.

    Dated: July 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15160 Filed 7-16-19; 8:45 am]
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