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

ICR 201807-0910-001

OMB: 0910-0291

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
233178
New
216812
Modified
216808
Modified
216806
Modified
216802
Modified
216801
Removed
216800
Modified
216799
Removed
216797
Removed
216796
Modified
ICR Details
0910-0291 201807-0910-001
Active 201505-0910-002
HHS/FDA CROSS CENTER
MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)
Revision of a currently approved collection   No
Regular
Approved with change 11/14/2018
Retrieve Notice of Action (NOA) 09/25/2018
Upon approval, FDA will discontinue (or revise to eliminate the relevant responses and burden hours already accounted for under this collection and related collection 0910-0645) OMB control numbers: 0910-0635, 0910-0636, and 0910-0800.
  Inventory as of this Action Requested Previously Approved
11/30/2021 36 Months From Approved 11/30/2018
37,202 0 769,995
22,716 0 909,395
0 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

  83 FR 11756 03/16/2018
83 FR 46166 09/12/2018
Yes

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

  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 37,202 769,995 0 1 -732,794 0
Annual Time Burden (Hours) 22,716 909,395 0 1 -886,680 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
Regulations implementing mandatory reporting electronically have become effective since last OMB review of the collection but provide for written requests for temporary waivers. We have therefore increased the estimated burden by one hour and one response annually for potential waiver requests. This is explained more fully in our supporting statement.

$0
No
    Yes
    Yes
No
No
No
Uncollected
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.
09/25/2018


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