83 FR 15153 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 68 (April 9, 2018)

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.

[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15153-15154]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0610]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 May 9, 
2018.

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 0910-0701. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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

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.
    In the Federal Register of October 31, 2017 (82 FR 50431) we 
published a notice inviting public comment of the proposed collection 
of information. Although one comment was received, it did not respond 
to any of the four information collection topics solicited in the 
notice under the PRA. We therefore made no changes to our estimate of 
the burden for the information collection, which remains as follows:

[[Page 15154]]



                                                     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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Add adverse event reporting                5,000               1           5,000              50         250,000
 plan 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..................
                                --------------------------------------------------------------------------------
    Total......................  ...............  ..............  ..............  ..............         258,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07154 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P