[Federal Register Volume 77, Number 37 (Friday, February 24, 2012)]
[Notices]
[Pages 11134-11135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4288]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 guidance for industry entitled ``Postmarketing 
Adverse Event Reporting for Medical Products and Dietary Supplements 
During an Influenza Pandemic.'' The 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 related to products indicated for 
the prevention and treatment of influenza and other specific types of 
reports indicated in the guidance.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this 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 
guidance document.
    Submit electronic comments on the 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: Toni Piazza-Hepp, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 4480, Silver Spring, MD 20993-0002, 301-
796-0520.
    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 guidance for industry 
entitled ``Postmarketing Adverse Event Reporting for Medical Products 
and Dietary Supplements During an Influenza Pandemic.'' 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 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 guidance provides 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 include instructions for reporting adverse events 
and a plan for the submission of stored reports that were not submitted 
within regulatory timeframes. The 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.
    This 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 
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 guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on postmarketing adverse event reporting for 
medical products and dietary supplements during pandemic influenza. It 
does not

[[Page 11135]]

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.

II. 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. 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.

III. The Paperwork Reduction Act of 1995

    This guidance contains information collection provisions 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). The 
collection of information in this guidance was approved under OMB 
control number 0910-0701.
    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 21 
CFR part 803. These regulations contain collections of information that 
are subject to review by 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 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.

IV. 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: February 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4288 Filed 2-23-12; 8:45 am]
BILLING CODE 4160-01-P