[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]


-----------------------------------------------------------------------

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 Draft Guidance for Industry on Postmarketing Adverse Event 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.

-----------------------------------------------------------------------

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availability of a draft guidance for industry entitled ``Postmarketing 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 The draft guidance discusses FDA's 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influenza and other specific types of reports indicated in the draft 
guidance. This draft guidance is a revision of the draft guidance for 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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:
    <bullet> Document the conditions that prevent them from meeting 
normal reporting requirements,
    <bullet> Notify the appropriate FDA organizational unit responsible 
for adverse event reporting compliance when these conditions exist and 
when the reporting process is restored, and
    <bullet> 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
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of     responses per       Total         Hours per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Notify FDA when normal reporting             500               1             500               8           4,000
 is not feasible................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           4,000
----------------------------------------------------------------------------------------------------------------
1 There are no capital costs or operating and maintenance costs associated with this information collection.


                                    Table 2--Estimated Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
                                     Number of      records per    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeping                      record
----------------------------------------------------------------------------------------------------------------
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...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         258,000
----------------------------------------------------------------------------------------------------------------
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]
BILLING CODE 4110-01-P