[Federal Register Volume 76, Number 5 (Friday, January 7, 2011)]
[Notices]
[Pages 1170-1173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-94]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0610]
Draft Guidance for Industry on Postmarketing Adverse Event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 the
availability of a draft guidance for industry entitled ``Postmarketing
Adverse Event Reporting for Medical Products and Dietary Supplements
During an Influenza Pandemic.'' The draft guidance discusses FDA's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. The agency makes
recommendations to industry for focusing limited resources on reports
[[Page 1171]]
related to products indicated for the prevention and treatment of
influenza and other specific types of reports indicated in the draft
guidance. This draft guidance is a revision of the draft guidance for
industry of the same title published on December 16, 2008.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by March 8, 2011. Submit written comments on the proposed collection of
information by March 8, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding pandemic influenza: Carmen Maher, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32, rm. 4146, Silver Spring, MD 20993-
0002, 301-796-8510.
Regarding human drug products: Solomon Iyasu, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4447, Silver Spring, MD 20993-0002, 301-
796-2370.
Regarding human biological products: Stephen Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
Regarding medical device products: Deborah Moore, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 3230, Silver Spring, MD 20993-0002,
301-796-6106.
Regarding dietary supplements: John Sheehan, Center for Food Safety
and Applied Nutrition (HFS-315), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 301-436-1488.
SUPPLEMENTARY INFORMATION:
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 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.
[[Page 1172]]
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 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 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1
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Number of
Number of responses per Total Hours 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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Total....................... .............. .............. .............. .............. 4,000
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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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Number of
Number of records per Total records Hours per Total hours
recordkeepers recordkeeping 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 information collection.
[[Page 1173]]
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: January 3, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-94 Filed 1-6-11; 8:45 am]
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