MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)

ICR 202110-0910-001

OMB: 0910-0291

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0291 202110-0910-001
Received in OIRA 201807-0910-001
HHS/FDA CROSS CENTER
MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)
Extension without change of a currently approved collection   No
Regular 11/22/2021
  Requested Previously Approved
36 Months From Approved 11/30/2021
37,202 37,202
22,716 22,716
0 0

This information collection covers paper-based reporting under FDA's MedWatch safety reporting program. Respondents to the collection are those who submit event experience information to the agency regarding products regulated by FDA - both voluntarily and as prescribed in agency regulations.

US Code: 21 USC 301 et seq. Name of Law: FFDCA
  
None

Not associated with rulemaking
Other Documents for OIRA Review

  86 FR 34754 06/30/2021
86 FR 62184 11/09/2021
Yes

7
IC Title Form No. Form Name
All Centers - Form 3500B (Consumer Reporting) FDA 3500B, Form FDA 3500B MedWatch Voluntary Reporting - Spanish ,   MedWatch Consumer Reporting
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form FDA 3500 MedWatch
Center for Devices and Radiological Health - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) Form FDA 3500B, Form FDA 3500 MedWatch ,   MedWatch Voluntary Reporting - Spanish
Center for Food Safety and Applied Nutrition - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) FDA 3500, Form FDA 3500B MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors ,   MedWatch Voluntary Reporting - Spanish
Center for Food Safety and Applied Nutrition - Form 3500A (MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting) FDA 3500A MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Tobacco Products - Form 3500 (VOLUNTARY reporting of adverse events, product problems and product use errors) FDA 3500 MedWatch for VOLUNTARY reporting of adverse events, product problems and product use errors
Written Request for temporary waiver of mandatory electronic reporting

  Total Request 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 37,202 37,202 0 0 0 0
Annual Time Burden (Hours) 22,716 22,716 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$35,485,483
No
    Yes
    Yes
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  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.
11/22/2021


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