MedWatch: The FDA Medical Products Reporting Program

ICR 201112-0910-001

OMB: 0910-0291

Federal Form Document

ICR Details
0910-0291 201112-0910-001
Historical Inactive 200810-0910-003
HHS/FDA
MedWatch: The FDA Medical Products Reporting Program
Revision of a currently approved collection   No
Regular
Withdrawn and continue 06/27/2012
Retrieve Notice of Action (NOA) 12/08/2011
This submission is withdrawn to correct a technical error in the collection. The agency will resubmit within 1 business day.
  Inventory as of this Action Requested Previously Approved
12/31/2011 36 Months From Approved 06/30/2012
636,116 0 636,116
682,483 0 682,483
0 0 0

To ensure the safety, and identify any risks, harms, or other dangers to health, for all FDA-regulated human healthcare products, the Agency needs to be informed whenever an adverse event, product quality problem or product use error occurs. This risk identification process is the first necessary step that allows the agency to gather the information necessary to be able to evaluate the risk associated with the product, and take whatever action is necessary to mitigate or eliminate the public's exposure to the risk.

US Code: 42 USC 262 Name of Law: PHS Act
  
None

Not associated with rulemaking

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

Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
FDA is requesting a renewal with both a program change and minor adjustments in the existing Forms FDA 3500 and 3500A. The program change is a result of an Agency intention and goal of improving the number and quality of voluntary reports from consumers of serious adverse events and product quality problems by introducing a consumer-friendly version of the existing From FDA 3500. The Agency estimates that the hour burden with use of a consumer version of the existing voluntary reporting form can be reduced based on informal testing of the final, proposed version of the form, from the current 36 minutes per report to 25 minutes, a reduction of 30%. It is estimated that in CY2011, 35% of the 40,000 direct, voluntary reports submitted using the Form FDA 3500 will be from consumers/patients. The reduction in reporting burden hours for that population of voluntary consumer-reporters would be 14,000 reporters x 0.183 hours, or a total annual burden-hour reduction of 2,562 hours. The existing Forms FDA 3500 and 3500A have proposed minor changes to each form, with no additional questions added and several questions omitted as redundant information that is able to be addressed in other questions. Several fields have had the label or title modified in response to a change in law, rule or regulation or to clarify the type of information to be entered in a given field. The agency estimates that these changes will have no substantial impact on either reporting burden-hours or costs.

$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.
12/08/2011


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