[Federal Register Volume 80, Number 3 (Tuesday, January 6, 2015)]
[Notices]
[Pages 508-509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30907]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1081]


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; Availability

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 (the PRA).

DATES: Fax written comments on the collection of information by 
February 5, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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; 
Availability (OMB Control Number 0910-0701)--Extension

    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, maintaining 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 approximately 500 firms will 
each need approximately 8 hours to maintain the records. Therefore, the 
total recordkeeping burden that would result from the guidance would be 
258,000 hours.
    The guidance also refers to previously approved collections of 
information found in FDA's adverse event reporting requirements in 21 
CFR 310.305, 314.80, 314.98, 600.80, 606.170, 640.73, 1271.350, and 
part 803. These regulations contain collections of information that are 
subject to review by OMB under the PRA (44 U.S.C. 3501-3520) and are 
approved under OMB control numbers 0910-0116, 0910-0291, 0910-0230, 
0910-0308, 0910-0437, and 0910-0543. In addition, the guidance also 
refers to adverse event reports for nonprescription human drug products 
marketed without an approved application and dietary supplements 
required under sections 760 and 761 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379aa and 379aa-1), which include collections 
of information approved under OMB control numbers 0910-0636 and 0910-
0635.
    In the Federal Register of August 11, 2014 (79 FR 46839), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. We received one comment. The comment said 
that during an influenza pandemic, FDA should not put forth a policy of 
reduced reporting, especially for newly approved drugs and vaccines. 
The comment recommended that FDA ask companies to modify their 
contingency plans by either leveraging the company's remote call center 
locations not affected by the pandemic or by outsourcing their safety 
reporting to such locations. The comment stated that at minimum, FDA 
should require weekly reporting or establish a threshold number of 
reports that a company must report to FDA. The comment added that FDA 
should specifically require reporting on newly approved drugs or 
vaccines for which there is little safety information.
    FDA response: The Guidance for Industry on Postmarketing Adverse 
Event Reporting for Medical Products and Dietary Supplements During an 
Influenza Pandemic does not describe an approach of reduced reporting 
during an influenza pandemic. Rather, the guidance states that ``normal 
adverse event reporting processes should be maintained to the maximum 
extent possible'' (see section III.C.1, page 3).

[[Page 509]]

FDA also provides recommendations on how to prioritize reporting when 
regulatory timelines cannot be met due to limited resources during a 
pandemic, so that FDA continues to receive critical safety information 
in a timely manner. For example, table 1 of the guidance outlines how 
companies should prioritize their submission of postmarketing safety 
reports during an influenza pandemic if normal processes of mandatory 
adverse event reporting are not feasible because of high employee 
absenteeism: Reports for pandemic influenza vaccines, drugs and 
biological products labeled for the treatment of influenza, drugs and 
biologics approved for less than three years, and products with special 
concerns as specified by FDA. The list includes reporting on newly 
approved products as the comment recommended. The guidance provides 
resources for companies establishing a COOP plan, but specifying the 
content of the COOP plans as suggested by the comment is beyond the 
scope of the guidance. Instead, the guidance provides the more general 
recommendation that ``each firm's pandemic influenza COOP plan should 
include instructions for reporting adverse events and the submission of 
any stored reports not submitted in the regulatory timeframes'' (see 
section III.B, page 2).
    FDA estimates the burden of this collection of information as 
follows:

                                                     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                    Average burden
      Type of recordkeeping          Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeper
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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.


    Dated: December 30, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30907 Filed 1-5-15; 8:45 am]
BILLING CODE 4164-01-P