Electronic Data Collection Using MedWatchPlus Portal and Rational Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350 and Part 803

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report	Form	New	Repair queued
Form FDA 1932 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report	Form and Instruction	New	Available
Form FDA 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report	Form	Modified	Available
Form FDA 1932a Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report	Form and Instruction	Modified	Available
Form FDA 1932 Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report	Form and Instruction	Modified	Available
0645 83-c.doc	Justification for No Material/Nonsubstantive Change	Uploaded 2010-03-12	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
192365	Early Warning Recall Voluntary	Other-system screenshot	New
192364	Reportable Food (human and animal) Voluntary View	Form	New	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
192364	Reportable Food (human and animal) Voluntary View	Other-system screenshot	New
192363	Reportable Food (human and animal) Mandatory View	Form and Instruction	New	Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
192363	Reportable Food (human and animal) Mandatory View	Other-system screenshot	New
192362	Mandatory View Using Direct Gateway-to-Gateway Transmission	Other-system screenshot	New
192361	Mandatory View Using MedWatch Plus Rational Questionnaire	Other-system screenshot	New
192360	Voluntary View	Other-system screenshot	New
189650	Early Warning Recall Voluntary View	Form	Modified	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
189649	Reportable Food (human and animal) Voluntary View	Form and Instruction	Modified	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
189649	Reportable Food (human and animal) Voluntary View	Other-guidance	Modified
189648	Reportable Food (human and animal) Mandatory View	Form and Instruction	Modified	Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
189648	Reportable Food (human and animal) Mandatory View	Other-screenshots	Modified
189647	Mandatory View Using Direct Gateway-to Gateway Transmission	Other-screenshots	Modified
189646	Mandatory View Using MedWatch Plus Rational Questionnaire	Other-screenshots	Modified
189645	Voluntary View	Other-screenshots	Modified

ICR Details

OMB Control No: 0910-0645	ICR Reference No: 201003-0910-004
Status: Historical Active	Previous ICR Reference No: 200906-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Electronic Data Collection Using MedWatchPlus Portal and Rational Questionnaire--21 CFR 310.305, 314.80, 314.98, 514.80, 600.80, 1271.350 and Part 803
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: 04/28/2010
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/29/2010
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	09/30/2012	09/30/2012
Responses	1,365,042	0	682,521
Time Burden (Hours)	462,318	0	1,444
Cost Burden (Dollars)	0	0	0

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Abstract: FDA is implementing electronic data collection to improve adverse event reporting across the agency. FDA's current processes and systems for adverse event reporting vary across its centers and are not optimal for the efficient collection of voluntary and mandatory adverse event reports, product problems/consumer complaints, or errors associated with the use of FDA-regulated products. Current FDA reporting forms (Forms FDA 3500, 3500A, 1932, and 1932a) are an outgrowth of a paper process era and frequently result in the submission of inconsistent and poor quality information. In addition, the agency is limited in its ability to modify its paper forms to keep pace with changes in the types of regulated products and the information necessary to meet evolving standards to ensure post market safety. Further, the existing supporting business processes are not able to efficiently manage the information being provided on the paper forms.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: FFDCA
   PL: Pub.L. 109 - 462 120 Name of Law: DSNDCPA
   PL: Pub.L. 110 - 85 1005 Name of Law: FDAAA
   US Code: 21 USC 355 Name of Law: FFDCA
   US Code: 21 USC 357 Name of Law: FFDCA
   US Code: 21 USC 360 Name of Law: FFDCA
   US Code: 21 USC 393 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 63153	10/23/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 23721	05/20/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

table that charts list of burden

IC Title	Form No.	Form Name
Early Warning Recall Voluntary
Early Warning Recall Voluntary View	FDA 1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Mandatory View Using Direct Gateway-to Gateway Transmission
Mandatory View Using Direct Gateway-to-Gateway Transmission
Mandatory View Using MedWatch Plus Rational Questionnaire
Mandatory View Using MedWatch Plus Rational Questionnaire
Reportable Food (human and animal) Mandatory View	FDA 1932	Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
Reportable Food (human and animal) Mandatory View	FDA 1932	Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report
Reportable Food (human and animal) Voluntary View	FDA 1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Reportable Food (human and animal) Voluntary View	FDA 1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Voluntary View
Voluntary View

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ICR Summary of Burden

table that charts list 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	1,365,042	682,521	0	682,521	0	0
Annual Time Burden (Hours)	462,318	1,444	0	460,874	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: FDA is implementing this new information collection in order to receive electronic data to improve adverse event reporting across the agency.

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Annual Cost to Federal Government: $12,967,899

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: 03/29/2010

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