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

ICR 201003-0910-004

OMB: 0910-0645

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Justification for No Material/Nonsubstantive Change
2010-03-12
ICR Details
0910-0645 201003-0910-004
Historical Active 200906-0910-003
HHS/FDA
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
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 04/28/2010
Retrieve Notice of Action (NOA) 03/29/2010
  Inventory as of this Action Requested Previously Approved
09/30/2012 09/30/2012 09/30/2012
1,365,042 0 682,521
462,318 0 1,444
0 0 0

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.

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
  
None

Not associated with rulemaking

  73 FR 63153 10/23/2008
74 FR 23721 05/20/2009
Yes

  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
Yes
Miscellaneous Actions
No
FDA is implementing this new information collection in order to receive electronic data to improve adverse event reporting across the agency.

$12,967,899
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
03/29/2010


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