Postmarketing Adverse Drug Experienced Reporting - 21 CFR 310.305 and 314.80

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
5820	Postmarketing Adverse Drug Experienced Reporting - 21 CFR 310.305 and 314.80 Form	Migrated

ICR Details

OMB Control No: 0910-0230	ICR Reference No: 200207-0910-006
Status: Historical Active	Previous ICR Reference No: 199903-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Postmarketing Adverse Drug Experienced Reporting - 21 CFR 310.305 and 314.80
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 with change	Conclusion Date: 09/30/2002
	Date Received in OIRA: 07/31/2002
Terms of Clearance: Approved consistent with changes and clarifications in FDA memos of 9-23-02 and 9-27-02.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2005	09/30/2005	09/30/2002
Responses	10,959	0	18
Time Burden (Hours)	287,574	0	345,114
Cost Burden (Dollars)	1,416,000	0	0

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Abstract: Adverse Experience Reporting for Human Drug Products. All manufacturers of approved drug products are required to report to FDA all serious, unexpected adverse reactions. Manufacturers are also required to report all classes of foreign or domestic adverse reactions regardless of the source from which the manufacturer obtained the reaction information. This responsibility includes reporting adverse experiences described in scientific literature as well as adverse experiences from postmarketing epidemiological/surveillance studies.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Postmarketing Adverse Drug Experienced Reporting - 21 CFR 310.305 and 314.80	FDA-3500, FDA-3500A

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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	10,959	18	0	0	10,941	0
Annual Time Burden (Hours)	287,574	345,114	0	0	-57,540	0
Annual Cost Burden (Dollars)	1,416,000	0	0	1,416,000	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: $0

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 07/31/2002

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