VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT -- 21 CFR PART 510

ICR 199310-0910-005

OMB: 0910-0012

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0012 199310-0910-005
Historical Active 199007-0910-003
HHS/FDA
VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT -- 21 CFR PART 510
Revision of a currently approved collection   No
Regular
Approved without change 01/07/1994
Retrieve Notice of Action (NOA) 10/13/1993
  Inventory as of this Action Requested Previously Approved
01/31/1997 01/31/1997 11/30/1993
1,100 0 1,100
1,250 0 1,250
0 0 0

INFORMATION IS GATHERED BY CVM FROM MANUFACTURERS OF ANIMAL DRUG PRODUCTS AND VETERINARIANS ON ADVERSE DRUG REACTIONS TO NEW ANIMAL DRUGS. THIS REGULATION REQUIRES THE SUBMISSION OF FULL REPORTS OF INFORMATION PERTINENT TO THE SAFETY AND EFFECTIVENSS OF THE NEW ANIMAL DRUG.

None
None


No

1
IC Title Form No. Form Name
VETERINARY ADVERSE DRUG REACTION, LACK OF EFFECTIVENESS, PRODUCT DEFECT REPORT -- 21 CFR PART 510 FDA 1932 &, 1932A

  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 1,100 1,100 0 0 0 0
Annual Time Burden (Hours) 1,250 1,250 0 0 0 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.
10/13/1993


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