Document ID: FDA-2008-D-0610-0013
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an 
Influenza Pandemic
Posted Date: 2017-10-31T04:00Z

[Federal Register Volume 82, Number 209 (Tuesday, October 31, 2017)]
[Notices]
[Pages 50431-50433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23659]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2008-D-0610]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Guidance for Industry on Postmarketing Adverse Event 
Reporting for Medical Products and Dietary Supplements During an 
Influenza Pandemic

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the 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 the information collection in 
the guidance on ``Postmarketing Adverse Event Reporting for Medical 
Products and Dietary Supplements During an Influenza Pandemic.''

DATES: Submit either electronic or written comments on the collection 
of information by January 2, 2018.

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 January 2, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 2, 2018. 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

[[Page 50432]]

information submitted, marked and identified, as confidential, if 
submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2008-D-0610 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Guidance for Industry on 
Postmarketing Adverse Event Reporting for Medical Products and Dietary 
Supplements During an Influenza Pandemic.'' 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 
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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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 for Industry on Postmarketing Adverse Event Reporting for 
Medical Products and Dietary Supplements During an Influenza Pandemic

OMB Control Number 0910-0701--Extension

    This information collection supports the above captioned Agency 
guidance. The guidance includes recommendations for planning, 
notification, and documentation for firms that report postmarketing 
adverse events. The guidance recommends that each firm's pandemic 
influenza continuity of operations plan (COOP) include instructions for 
reporting adverse events, including a plan for the submission of stored 
reports that were not submitted within regulatory timeframes. The 
guidance explains that firms that are unable to fulfill normal adverse 
event reporting requirements during an influenza pandemic should: (1) 
Maintain documentation of the conditions that prevent them from meeting 
normal reporting requirements; (2) notify the appropriate FDA 
organizational unit responsible for adverse event reporting compliance 
when the conditions exist and when the reporting process is restored; 
and (3) maintain records to identify what reports have been stored.
    Based on the number of manufacturers that would be covered by the 
guidance, we estimate that approximately 5,000 firms will add the 
following to their COOP: (1) Instructions for reporting adverse events 
and (2) a plan for submitting stored reports that were not submitted 
within regulatory timeframes. We estimate that each firm will take 
approximately 50 hours to prepare the adverse event reporting plan for 
its COOP.
    We estimate that approximately 500 firms will be unable to fulfill 
normal adverse event reporting requirements because of conditions 
caused by an influenza pandemic and that these firms will notify the 
appropriate FDA organizational unit responsible for adverse event 
reporting compliance when the conditions exist. Although we do not 
anticipate such pandemic influenza conditions to occur every year, for 
purposes of the PRA, we estimate that each of these firms will notify 
FDA approximately once each year and that each notification will take 
approximately 8 hours to prepare and submit.
    Concerning the recommendation in the guidance that firms unable to 
fulfill normal adverse event reporting requirements maintain 
documentation of the conditions that prevent them from meeting these 
requirements and also maintain records to identify what adverse event 
reports have been stored and when the reporting process is restored, we 
estimate that approximately 500 firms will each need approximately 8 
hours to maintain the documentation and that approximately 500 firms 
will each need approximately 8 hours to maintain the records.
    We therefore estimate the burden of the collection of information 
as follows:

[[Page 50433]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                         Type of reporting                              Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Notify FDA when normal reporting is not feasible...................             500                1              500                8            4,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of
      Type of recordkeeping          Number of      records per    Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeper       records         record
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Add adverse event reporting plan           5,000               1           5,000              50         250,000
 to COOP........................
Maintain documentation of                    500               1             500               8           4,000
 influenza pandemic conditions
 and resultant high absenteeism.
Maintain records to identify                 500               1             500               8           4,000
 what reports have been stored
 and when the reporting process
 was restored...................
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    Total.......................  ..............  ..............  ..............  ..............         258,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on our experience with the information collection we have 
retained our current burden estimate of 258,000 hours annually.

    Dated: October 26, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-23659 Filed 10-30-17; 8:45 am]
 BILLING CODE 4164-01-P