0701 SSA GFI AER for Flu Pandemic 2018 Ext

U.S. Food and Drug Administration
Guidance for Industry (GFI): Postmarketing Adverse Event Reporting for
Medical Products and Dietary Supplements During an Influenza Pandemic
OMB Control No. 0910-0701

SUPPORTING STATEMENT Part A: Justification

1. Circumstances Making the Collection of Information Necessary
This information collection supports the Food and Drug Administration (FDA, us or we)
guidance document entitled “Postmarketing Adverse Event Reporting for Medical Products and
Dietary Supplements During an Influenza Pandemic.” The guidance discusses FDA
recommendations on adverse event reporting requirements for drugs, biologics, medical devices,
and dietary supplements during an influenza pandemic. Because of the potential for high
employee absenteeism during an influenza pandemic, and because responsibility to report
adverse events during such a pandemic remains in effect, the guidance document is intended to
help firms meet adverse event reporting requirements under these circumstances.
Specifically the guidance provides recommendations to respondents on focusing limited
resources to certain types of reports. It 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.
We therefore request extension of OMB approval for the information collection provisions found
in the above-referenced guidance document.
2. Purpose and Use of the Information Collection
FDA believes the approach described in the guidance will make it possible for firms with
postmarketing adverse event reporting responsibilities to focus their limited resources on reports
related to critical products indicated for the treatment or prevention of influenza. FDA will
continue to receive reports on critical medical products. After pre-pandemic conditions are
restored, FDA will also have information to ensure that required reports are submitted as part of
our ongoing evaluation of postmarketing adverse events for safety problems.

3. Use of Improved Information Technology and Burden Reduction
Although not specifically addressed in the guidance, we assume that firms will rely on their
standard electronic information technology systems to develop and maintain the pandemic
influenza COOP recommended in the guidance. We also assume that firms will use standard
email technology to notify FDA when normal reporting is not feasible and when the normal
reporting processes have been restored.
4. Efforts to Identify Duplication and Use of Similar Information
Upon review of our inventory, as well as other agencies within the Department of Health and
Human Services that have public health protection responsibilities where similar information
collection might occur, we have found no duplication.
5. Impact on Small Businesses or Other Small Entities
The information collection provisions found in the guidance impose no undue burden on small
entities.
6. Consequences of Collecting the Information Less Frequently
The information collection recommended in the guidance reflects existing reporting requirements
found in current FDA regulations. We believe the recommendations discussed will help mitigate
disruptions in these reports that may occur as a result in high absenteeism during an influenza
pandemic.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
This information collection contains no inconsistency with the guidelines in 5 CFR 1320.5.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), we published a 60 day notice requesting public comment in
the Federal Register of October 31, 2017 (82 FR 50431). Although one comment from an
anonymous source was received, it addressed the efficacy of the influenza immunization
program rather than implementation of influenza pandemic preparedness, which is the subject of
the guidance and information collection. We did not adjust our burden estimate as a result of the
comment.
9. Explanation of Any Payment or Gift to Respondents
No gift or payment is provided to respondents to the information collection.

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10. Assurance of Confidentiality Provided to Respondents
Although we do not anticipate confidentiality issues resulting from the information collection,
our regulations provide for the confidentiality of information found in marketing applications
under 21 CFR 314.430 and 21 CFR Part 20. In addition, the unauthorized use or disclosure of
trade secrets required in applications is specifically prohibited under section 310(j) of the Federal
Food, Drug, and Cosmetic Act.
11. Justification for Sensitive Questions
The information collection contains no questions of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hourly Burden
FDA estimates the burden of this collection of information as follows:
Table 1-- Estimated Annual Reporting Burden1
Type of Reporting

Notify FDA when
normal reporting is not
feasible
1

No. of
Respondents

No. of
Responses
Per Respondent

Total
Annual
Responses

Average
Burden Per
Response

Total
Hours

500

1

500

8

4,000

There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2 -- Estimated Annual Recordkeeping Burden1
Type of Recordkeeping

Add adverse event report
planning to COOP
Maintain documentation of
influenza pandemic
conditions and resultant
high absenteeism
Maintain records to
identify what reports have
been stored and when the
reporting process was
restored
Total
1

No. of
Recordkeepers

No. of
Records
Per
Recordkeeper

Total
Annual
Records

Hours
Per
Record

Total
Hours

5,000

1

5,000

50

250,000

500

1

500

8

4,000

500

1

500

8

4,000

258,000

There are no capital costs or operating and maintenance costs associated with this collection of information.

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Based on the number of manufacturers that would be covered by the guidance, we estimate 5,000
firms will include the following in a COOP: (1) Instructions for reporting adverse events; and (2)
a plan for submitting stored reports that were not submitted within regulatory timeframes. We
estimate this activity will require 50 hours to prepare the adverse event reporting plan for its
COOP.
We estimate 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 expect or anticipate circumstances surrounding the
information collection to occur on an annual basis, we estimate that it would take 8 hours to
prepare a submission and use this figure as the basis for an annual estimate.
Concerning the recommendation that firms unable to fulfill normal adverse event reporting
requirements maintain documentation of the conditions that prevent them from meeting these
requirements; maintain records to identify what adverse event reports have been stored; and
when the reporting process is restored, we estimate 500 firms will spend 8 hours engaged in
these activities, respectively.
12b. Estimates of Costs
We consider there might be a one-time labor cost associated with preparing or revising a
COOP to cover adverse event reporting during an influenza pandemic. Assuming a loaded wage
rate of approximately $85 per hour (using wage data for clerical staff, upper- and middlemanagement, and including overhead costs) and multiply this figure by the number of annual
burden hours, we calculate this cost to be $21,930,000.
13. Estimates of Other Total Annual Cost Burden to Respondents and Recordkeepers
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
Assuming FDA would allocate approximately 30 minutes per each submission; multiplying this
figure by the number of annual responses; and using an average hourly wage-rate of $48, we
calculate the cost to the Federal Government would be $12,000.
15. Explanation for Program Changes or Adjustments
We retain the currently approved burden estimate for the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
We have no such plans for the information collection.

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17. Reason(s) Display of OMB Expiration Date is Inappropriate
Display of the OMB Expiration Date is appropriate and included in the guidance document.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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