Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance

Forms and Documents

Document	Type	Status	Availability
0701 AER pandemic Non sub request June 2020.pdf	Justification for No Material/Nonsubstantive Change	Uploaded 2020-06-24	Available
0701 SSA GFI AER for Flu Pandemic 2018 Ext.pdf	Supporting Statement A	Uploaded 2018-04-05	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
198615	Maintain Records to Identify What Reports Have Been Stored and When the Reporting Process was Restored	Other-Agency Guidance	Modified
198614	Maintain Documentation of Influenze Pandemic Conditions and Resultant High Absenteeism	Other-Agency Guidance	Modified
198613	Add Adverse Event Reporting Plan to COOP	Other-Agency Guidance	Modified
198612	Notify FDA When Normal Reporting is Not Feasible	Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0701	ICR Reference No: 202006-0910-014
Status: Active	Previous ICR Reference No: 201804-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic: Agency Guidance
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/26/2020
	Date Received in OIRA: 06/24/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2021	05/31/2021	05/31/2021
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: This information collection supports agency guidance that includes FDA recommendations on adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The purpose of the information collection is to help support global preparedness in the event of such a pandemic and help offset associated threats and risks to the public health.

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Authorizing Statute(s): US Code: 21 USC 301 et. seq. 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:
	82 FR 50431	10/31/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 15153	04/09/2018
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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? Yes

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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: 06/24/2020

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