MedWatch: The FDA Medical Products Reporting Program

ICR 201505-0910-002

OMB: 0910-0291

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Removed
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
New
Form and Instruction
Removed
Form and Instruction
Removed
Supporting Statement A
2015-06-08
IC Document Collections
IC ID
Document
Title
Status
5858 Removed
216812 New
216808 New
216806 New
216802 New
216801 New
216800 New
216799 New
216797 New
216796 New
202917 Removed
202916 Removed
ICR Details
0910-0291 201505-0910-002
Historical Active 201206-0910-012
HHS/FDA OC
MedWatch: The FDA Medical Products Reporting Program
Revision of a currently approved collection   No
Regular
Approved without change 09/30/2015
Retrieve Notice of Action (NOA) 06/11/2015
  Inventory as of this Action Requested Previously Approved
09/30/2018 36 Months From Approved 09/30/2015
769,995 0 786,773
909,395 0 853,585
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

  79 FR 73591 12/11/2014
80 FR 31042 06/01/2015
Yes

9
IC Title Form No. Form Name
Center for Biologics Evaluation and Research/Center for Drug Evaluation and Research - Form 3500A (Outsourcing Facilities) FDA 3500A MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Devices and Radiological Health - 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
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
MedWatch 3500B Consumer reporting FDA 3500b MedWatch Consumer Reporting
MedWatch 3500 for 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
MedWatch 3500a 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 Biologics Evaluation and Research/Center for Drug Evaluation and Research - 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
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 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 MedWatch (for use by user-facilities, importers, distributors, and manufacturers for MANDATORY reporting
Center for Devices and Radiological Health - 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 Food Safety and Applied Nutrition - 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
All Centers - Form 3500B (Consumer Reporting) FDA 3500B MedWatch Consumer Reporting

  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 769,995 786,773 0 -16,778 0 0
Annual Time Burden (Hours) 909,395 853,585 0 55,810 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
FDA is requesting a renewal with adjustments to the existing Forms FDA 3500, 3500A and 3500B.

$12,267,000
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
06/11/2015


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