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

Document Name	Status
Form 3800 Voluntary Adverse Event Report via the SRP Form	Modified
Form FDA 1932a Early Warning Recall Voluntary View Form	Removed
0645 SS 2013 .doc Supporting Statement A	2013-01-31

IC Document Collections

IC ID	Document Title	Status
192365	Early Warning Recall Voluntary Other-system screenshot	Removed
192364	Reportable Food (human and animal) Voluntary View Other-system screenshot	Removed
192363	Mandatory and Voluntary RFR Reports via the SRP Other-Screenshot	Modified
192362	Mandatory Adverse Event Report via the ESG	Modified
192361	Mandatory Adverse Event Report via the SRP Other-Screen Shot	Modified
192360	Voluntary Adverse Event Report via the SRP Form	Modified
189650	Early Warning Recall Voluntary View Form	Removed
189649	Reportable Food (human and animal) Voluntary View Other-guidance	Removed
189648	Reportable Food (human and animal) Mandatory View Other-screenshots	Removed
189647	Mandatory View Using Direct Gateway-to Gateway Transmission Other-screenshots	Removed
189646	Mandatory View Using MedWatch Plus Rational Questionnaire Other-screenshots	Removed
189645	Voluntary View Other-screenshots	Removed

ICR Details

OMB Control No: 0910-0645	ICR Reference No: 201301-0910-009
Status: Historical Inactive	Previous ICR Reference No: 201003-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: 18663
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 02/18/2013
	Date Received in OIRA: 01/31/2013
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB considers this ICR to be improperly submitted. The burden data entered into ROCIS does not match the data listed in Question 15 of the Supporting Statement. Please revise the ICR and resubmit it to OMB when ready. Please also consult the terms of clearance listed in the Supporting Statement and submit a memo responding to them on resubmission.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2013	36 Months From Approved	04/30/2013
Responses	1,365,042	0	1,365,042
Time Burden (Hours)	462,318	0	462,318
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 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
   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
  

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:
	77 FR 56847	09/14/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 3433	01/16/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Voluntary Adverse Event Report via the SRP	3800	Safety Reporting Portal
Mandatory Adverse Event Report via the SRP
Mandatory Adverse Event Report via the ESG
Mandatory and Voluntary RFR Reports via the SRP
Reportable Food (human and animal) Voluntary View	FDA 1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Early Warning Recall Voluntary
Voluntary View
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
Mandatory View Using Direct Gateway-to Gateway Transmission
Reportable Food (human and animal) Voluntary View	FDA 1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report
Early Warning Recall Voluntary View	FDA 1932a	Veterinary Adverse Drug Reaction, Lack of Effectiveness or Product Defect Report

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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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden estimate for the subject ICR was inadvertently over-reported in ICRAS/ROCIS in 2010, when the second and third rational questionnaires were approved as a non-material/non-substantive change. The over-reporting was caused by erroneously doubling the number of ICs from 6 to 12. This error was corrected by removing the 6 duplicative ICs. To further refine the reporting burden, 3 of the previous ICs that were segregated on the basis of mandatory versus voluntary reporting have been consolidated into one as appropriate. As submitted, the subject ICR now reflects a total of 4 information collections and also incorporates the burden reflected and approved under OMB Control No. 0910-0709. The latter ICR was initially obtained in May of last year to allow FDA to implement provisions of the Food Safety and Modernization Act. Accordingly, because of this consolidation, the Agency has submitted a discontinuation request for OMB Control No. 0910-0709 as it is now included in the instant ICR.

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Annual Cost to Federal Government: $28,401,010

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: 01/31/2013

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