Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

Forms and Documents

Document Name	Status
Pandemic SS 6 7 11.doc Supporting Statement A	2011-07-21

IC Document Collections

IC ID	Document Title	Status
198615	Maintain records to identify what reports have been stored and when the reporting process was restored Other-guidance document	New
198614	Maintain documentation of influenze pandemic conditions and resultant high absenteeism Other-guidance document	New
198613	One time - add adverse event reporting plan to COOP Other-guidance document	New
198612	Notify FDA when normal reporting is not feasible Other-guidance document	New

ICR Details

OMB Control No: 0910-0701	ICR Reference No: 201107-0910-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/06/2012
	Date Received in OIRA: 07/25/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved
Responses	6,500	0	0
Time Burden (Hours)	262,000	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The 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 guidance indicates which reports may generally be stored if necessary because of pandemic-related high employee absenteeism, without FDA objection. However, any delayed reports must be submitted after adverse event reporting processes have been restored to the pre-pandemic state. Firms should maintain records to identify what has been stored and when the processes were restored.

---

Authorizing Statute(s): US Code: 21 USC 379aa Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 1170	01/07/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 37124	06/24/2011
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Notify FDA when normal reporting is not feasible
One time - add adverse event reporting plan to COOP
Maintain documentation of influenze pandemic conditions and resultant high absenteeism
Maintain records to identify what reports have been stored and when the reporting process was restored

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	6,500	0	0	6,500	0	0
Annual Time Burden (Hours)	262,000	0	0	262,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of information.This guidance will explain to firms how to include certain information in their pandemic influenza COOP's, which will require more recordkeeping and reporting of that information to the FDA.

---

Annual Cost to Federal Government: $12,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/25/2011

---