MEDWATCH: FDA'S MEDICAL PRODUCT REPORTING PROGRAM

ICR 199410-0910-003

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
109997 Migrated
ICR Details
0910-0291 199410-0910-003
Historical Active 199304-0910-001
HHS/FDA
MEDWATCH: FDA'S MEDICAL PRODUCT REPORTING PROGRAM
Revision of a currently approved collection   No
Regular
Approved without change 01/20/1995
Retrieve Notice of Action (NOA) 10/27/1994
This information collection request is approved for one year. When FDA next submits a request for this collection, it should discuss all efforts underway to ensure coordination of coding structures with emerging industry consensus standards and efforts to harmonize with emerging international standards. As automated health records systems emerge, healthcare professionals should not have to use separate coding structures for this largely voluntary reporting system.
  Inventory as of this Action Requested Previously Approved
01/31/1996 01/31/1996 01/31/1995
318,339 0 270,525
296,719 0 257,182
0 0 0

THIS NEW FORM WILL BE USED FOR REPORTING ADVERSE EVENTS AND PRODUCT PROBLEMS WITH MEDICATIONS, DEVICES, AND OTHER PRODUCTS (SUCH AS DIETAR SUPPLEMENTS) THAT ARE REGULATED BY THE AGENCY.

None
None


No

1
IC Title Form No. Form Name
MEDWATCH: FDA'S MEDICAL PRODUCT REPORTING PROGRAM FDA 3500, 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 318,339 270,525 0 0 47,814 0
Annual Time Burden (Hours) 296,719 257,182 0 0 39,537 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
10/27/1994


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