ADVERSE DRUG EXPERIENCE REPORTING

ICR 199305-0910-005

OMB: 0910-0230

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
165498 Migrated
ICR Details
0910-0230 199305-0910-005
Historical Active 199302-0910-006
HHS/FDA
ADVERSE DRUG EXPERIENCE REPORTING
No material or nonsubstantive change to a currently approved collection   No
Emergency 05/25/1993
Approved with change 05/25/1993
Retrieve Notice of Action (NOA) 05/25/1993
  Inventory as of this Action Requested Previously Approved
05/31/1996 05/31/1996 05/31/1996
1,050 0 42,323
88 0 116,756
0 0 0

REQUIRES MANUFACTURERS OF APPROVED DRUGS TO REPORT ON ADVERSE REACTION TO THEIR DRUG PRODUCTS. THESE DATA ARE NEEDED FOR PURPOSES OF PUBLIC SAFETY.

None
None


No

1
IC Title Form No. Form Name
ADVERSE DRUG EXPERIENCE REPORTING FDA-1639

  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 1,050 42,323 0 0 -41,273 0
Annual Time Burden (Hours) 88 116,756 0 0 -116,668 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.
05/25/1993


© 2024 OMB.report | Privacy Policy