Document ID: FDA-2008-D-0610-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products, etc.
Posted Date: 2011-06-24T04:00Z

[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37124-37126]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15799]

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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of Management and Budget Review; Comment Request; Draft Guidance for 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.

DATES: Fax written comments on the collection of information by July 
25, 2011.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Draft Guidance for Industry on Postmarketing Adverse Event 
Reporting for Medical Products and Dietary Supplements During an 
Influenza Pandemic.'' Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

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review and clearance: Draft Guidance for Industry on Postmarketing 
Adverse Event Reporting for Medical Products and Dietary Supplements 
During an Influenza Pandemic; Availability--(OMB Control Number 0910-
New)

I. Background

    FDA is announcing the availability of a revised draft guidance for 
industry entitled ``Postmarketing Adverse Event Reporting for Medical 
Products and Dietary Supplements During an Influenza Pandemic.'' In the 
Federal Register of December 16, 2008 (73 FR 76364), FDA published 
notice of the availability of a draft guidance of the same title. FDA 
anticipates that during an influenza pandemic, industry and FDA 
workforces may be reduced while reporting of adverse events related to 
widespread use of medical products indicated for the treatment and 
prevention of influenza may increase, although the extent of these 
possible changes is unknown. The revised draft guidance discusses FDA's 
intended approach to enforcement of adverse event reporting 
requirements for drugs, biologics, medical devices, and dietary 
supplements during an influenza pandemic.

II. Revisions to the 2008 Draft Guidance

    FDA is issuing a revised draft guidance that includes 
recommendations for planning, notification, and documentation for firms 
that report postmarketing adverse events. The revised draft guidance 
recommends that each firm's pandemic influenza continuity of operations 
plan (COOP) include instructions for reporting adverse events and a 
plan for the submission of stored reports that were not submitted 
within regulatory timeframes. The revised draft guidance recommends 
that firms that are unable to fulfill normal adverse event reporting 
requirements during an influenza pandemic do the following:
     Document the conditions that prevent them from meeting 
normal reporting requirements,
     Notify the appropriate FDA organizational unit responsible 
for adverse event reporting compliance when these conditions exist and 
when the reporting process is restored, and
     Maintain records to identify what reports have been 
stored.
    These recommendations represent collections of information under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) 
discussed in section IV of this document. In issuing this revised draft 
guidance, FDA considered all comments that were submitted in response 
to the December 2008 draft guidance. Most comments requested that 
greater clarity be provided in certain sections; FDA has revised these 
sections accordingly.
    This draft guidance does not address monitoring and reporting of 
adverse events that might be imposed as a condition of authorization 
for products authorized for emergency use under section 564 of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb-
3). This draft guidance also does not address monitoring and reporting 
of adverse events as required by regulations establishing the 
conditions for investigational use of drugs, biologics, and devices. 
(See 21 CFR parts 312 and 812.)
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on 
postmarketing adverse event reporting for medical products and dietary 
supplements during pandemic influenza. It does not create or confer any 
rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Paperwork Reduction Act of 1995

    Under the PRA, Federal agencies must obtain approval from the 
Office of Management and Budget (OMB) for each collection of 
information that they

[[Page 37125]]

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 for each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing this notice of the 
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this 
draft guidance, FDA invites comments on the following topics: (1) 
Whether the proposed information collected is necessary for the proper 
performance of FDA's functions, including whether the information will 
have practical utility; (2) the accuracy of FDA's estimated burden of 
the proposed information collected, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information collected; and (4) ways to 
minimize the burden of information collected on the respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    The draft guidance explains FDA's approach to enforcement of 
adverse event reporting requirements for drugs, biologics, medical 
devices, and dietary supplements during an influenza pandemic, 
including an intent not to object to changes in the timing of 
submission of certain reports during some stages of the pandemic 
response. The Agency recommends that each firm's pandemic influenza 
COOP include instructions for reporting adverse events, including a 
plan for the submission of stored reports that were not submitted 
within regulatory timeframes. The draft 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 
draft 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 takem 
approximately 8 hours to prepare and submit.
    Concerning the recommendation in the draft 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 
draft guidance would be 258,000 hours.
    The draft 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 the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (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 draft 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 FD&C 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 January 7, 2011 (76 FR 1170), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

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

                                                       Table 2--Estimated Recordkeeping Burden \1\
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                                                                                           Annual
                                                                        Number of      frequency per     Total annual      Hours per       Total hours
                                                                      recordkeepers    recordkeeping       records           record
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Add adverse event reporting plan to COOP...........................           5,000                1            5,000               50          250,000
Maintain documentation of influenza pandemic conditions and                     500                1              500                8            4,000
 resultant high absenteeism........................................

[[Page 37126]]

 
Maintain records to identify what reports have been stored and when             500                1              500                8            4,000
 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 information collection.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/default.htm, 
or http://www.regulations.gov.

    Dated: June 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15799 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P