Postmarketing Adverse Drug Experience Reporting

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0230 6-26-2015.doc Supporting Statement A	2015-06-29

IC Document Collections

IC ID	Document Title	Status
5821	Adverse Drug Experience Reporting -- 310.305(c)(5)	Modified
188678	Adverse Drug Event Recordkeeping -- 314.80(i)	Modified
188677	Adverse Event Recordkeeping -- 310.305(f)	Modified
188676	Adverse Event Reporting -- 314.80(c)(2)	Modified
188675	Adverse Event Reporting--314.80(c)(1)(iii)	Modified

ICR Details

OMB Control No: 0910-0230	ICR Reference No: 201506-0910-031
Status: Historical Active	Previous ICR Reference No: 201207-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Postmarketing Adverse Drug Experience Reporting
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: 12/09/2015
	Date Received in OIRA: 07/01/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2015
Responses	381,820	0	415,226
Time Burden (Hours)	6,724,780	0	7,312,076
Cost Burden (Dollars)	43,255	0	47,000

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Abstract: FDA regulations require the reporting to FDA of important adverse drug experience information associated with the use of unapproved-marketed prescription drug product. This information is used by FDA to determine at the earliest possible time whether to request a manufacturer, packer, or distributor to recall a product from the market or to recommend a seizure or injunction action to halt the marketing of the product and to remove it from the market. Such action, initiated promptly, may avert further adverse effects that may be associated with the use of the product. The primary purpose of FDA's adverse drug experience reporting system is to signal potentially serious safety problems, focusing especially on newly marketed drugs. Although premarket testing discloses a general safety profile of a new drug's comparatively common adverse effects, the larger and more diverse patient population exposed to the marketed drug provides, for the first time, the opportunity to collect information on rare, latent, and long-term effects. Signals are obtained from a variety of sources, including reports from patients, treating physicians, foreign regulatory agencies, and clinical investigators. Information derived from the adverse drug experience reporting system contributes directly to increased public health protection because such information enables FDA to make important changes to the product's labeling (such as adding a new warning) and, when necessary, to initiate removal of a new drug from the market.

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Authorizing Statute(s): US Code: 21 USC 310.305 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 314.80 Name of Law: Federal Food, Drug, and Cosmetic 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:
	80 FR 13009	03/12/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 35967	06/23/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Adverse Drug Experience Reporting -- 310.305(c)(5)
Adverse Event Reporting--314.80(c)(1)(iii)
Adverse Event Reporting -- 314.80(c)(2)
Adverse Event Recordkeeping -- 310.305(f)
Adverse Drug Event Recordkeeping -- 314.80(i)

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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	381,820	415,226	0	0	-33,406	0
Annual Time Burden (Hours)	6,724,780	7,312,076	0	0	-587,296	0
Annual Cost Burden (Dollars)	43,255	47,000	0	0	-3,745	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]? 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: 07/01/2015

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