
[Federal Register Volume 84, Number 43 (Tuesday, March 5, 2019)]
[Notices]
[Pages 7904-7906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03899]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection associated with the 
guidance on reagents for detection of specific novel influenza A 
viruses.

DATES: Submit either electronic or written comments on the collection 
of information by May 6, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 6, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 6, 2019. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-3662 for ``Guidance on Reagents for Detection of Specific 
Novel Influenza A Viruses.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in

[[Page 7905]]

its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(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 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 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 7906]]



                                                   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 novel                  1                2                2               15               30
 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: February 27, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03899 Filed 3-4-19; 8:45 am]
 BILLING CODE 4164-01-P


