[Federal Register Volume 79, Number 154 (Monday, August 11, 2014)]
[Notices]
[Pages 46839-46840]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 guidance which discusses 
FDA's approach to enforcement of adverse event reporting requirements 
during an influenza pandemic.

DATES: Submit either electronic or written comments on the collection 
of information by October 10, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA 
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: 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; 
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.

[[Page 46840]]

    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. 
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.
    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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                                  ..............  ..............  ..............  ..............         258,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: August 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-18944 Filed 8-8-14; 8:45 am]
BILLING CODE 4164-01-P