Adverse Drug Experience Reporting

Forms and Documents

Document Name	Status
pra0230ss 2009 (7-8-2009).doc Supporting Statement A	2009-07-08

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)	New
188677	Adverse Event Recordkeeping -- 310.305(f)	New
188676	Adverse Event Reporting -- 314.80(c)(2)	New
188675	Adverse Event Reporting--314.80(c)(1)(iii)	New

ICR Details

OMB Control No: 0910-0230	ICR Reference No: 200904-0910-004
Status: Historical Active	Previous ICR Reference No: 200602-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: 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 with change	Conclusion Date: 07/23/2009
	Date Received in OIRA: 04/02/2009
Terms of Clearance: This ICR is approved consistent with revised supporting statement. FDA is reminded to accurately categorize the burdens (reporting, recordkeeping, or third-party disclosure) and the costs (capital costs).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2012	36 Months From Approved	07/31/2009
Responses	411,509	0	410,645
Time Burden (Hours)	7,089,086	0	7,037,246
Cost Burden (Dollars)	46,962	0	1,416,000

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Abstract: Sections 201, 502, 505, and 701 of the Federal Food, Drug, and Cosmetic Act require that marketed drugs be safe and effective. In order to know whether drugs that are not safe and effective are on the market, FDA must be promptly informed of adverse experiences occasioned by the use of marketed drugs. In order to help ensure this, FDA issued regulations at 21 CFR 310.305 and 314.80 to impose reporting and recordkeeping requirements on the drug industry that would enable FDA to take action necessary for protection of the public health from adverse drug experiences.

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Authorizing Statute(s): US Code: 21 USC 310 Name of Law: FFDCA
   US Code: 21 USC 314 Name of Law: FFDCA
  

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:
	73 FR 76358	12/16/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 10924	03/13/2009
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	411,509	410,645	0	0	864	0
Annual Time Burden (Hours)	7,089,086	7,037,246	0	0	51,840	0
Annual Cost Burden (Dollars)	46,962	1,416,000	0	0	-1,369,038	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: $121,075,000

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]? 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)? 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: 04/02/2009

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