MedWatch: The FDA Medical Products Reporting Program

ICR 201206-0910-012

OMB: 0910-0291

Federal Form Document

ICR Details
0910-0291 201206-0910-012
Historical Active 200810-0910-003
HHS/FDA
MedWatch: The FDA Medical Products Reporting Program
Revision of a currently approved collection   No
Regular
Approved with change 06/29/2012
Retrieve Notice of Action (NOA) 06/28/2012
  Inventory as of this Action Requested Previously Approved
06/30/2015 36 Months From Approved 06/30/2012
786,773 0 636,116
853,585 0 682,483
0 0 0

This information collection covers the reporting associated with the MedWatch program.

US Code: 21 USC 301 Name of Law: FFDCA
  
None

Not associated with rulemaking

  76 FR 55919 09/09/2011
76 FR 76417 12/07/2011
No

  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 786,773 636,116 0 11,500 139,157 0
Annual Time Burden (Hours) 853,585 682,483 0 4,792 166,310 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
The discretionary change is related to a new and more consumer-friendly version of the 3500 form; referred to as the 3500B.

$8,831,000
No
No
No
No
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.
06/27/2012


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