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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT 0701 FINAL 12-24-14.doc Supporting Statement A	2014-12-24

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	Modified
198614	Maintain Documentation of Influenze Pandemic Conditions and Resultant High Absenteeism Other-Guidance	Modified
198613	Add Adverse Event Reporting Plan to COOP Other-Guidance	Modified
198612	Notify FDA When Normal Reporting is Not Feasible Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0701	ICR Reference No: 201412-0910-017
Status: Historical Active	Previous ICR Reference No: 201107-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/06/2015
	Date Received in OIRA: 01/08/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	36 Months From Approved	04/30/2015
Responses	6,500	0	6,500
Time Burden (Hours)	262,000	0	262,000
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 321, 331, 351-353, 355, 356 Name of Law: FD&C Act
   US Code: 21 USC 356a, 356b, 356c, 371,374,379e Name of Law: FD&C Act
  

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 46839	08/11/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 508	01/06/2015
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Notify FDA When Normal Reporting is Not Feasible
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

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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	6,500	0	0	0	0
Annual Time Burden (Hours)	262,000	262,000	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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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

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Common Form ICR:  No

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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: 01/08/2015

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