Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report, and Transmittal of Periodic Reports and Promotional Material for New Animal Drugs. 21 CFR Part 510

ICR 200201-0910-002

OMB: 0910-0012

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0012 200201-0910-002
Historical Active 199810-0910-004
HHS/FDA
Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report, and Transmittal of Periodic Reports and Promotional Material for New Animal Drugs. 21 CFR Part 510
Extension without change of a currently approved collection   No
Regular
Approved without change 03/15/2002
Retrieve Notice of Action (NOA) 01/10/2002
Approved consistent with FDA memos attached. Approval is for one year because FDA has inadequately explained why, given the possibility of regulatory changes, a longer approval is needed. This will also allow FDA to report on electronic submission in its next approval request.
  Inventory as of this Action Requested Previously Approved
05/31/2003 05/31/2003 03/31/2002
6,750 0 6,750
54,225 0 45,137
0 0 0

Information is gathered by CVM from manufacturers of animal drug products and veterinarians on adverse drug reactions and product defects. Further, periodic reporting enables CVM to monitor use of the new animal drug or medicated animal feed after approval.

None
None


No

  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 6,750 6,750 0 0 0 0
Annual Time Burden (Hours) 54,225 45,137 0 0 9,088 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.
01/10/2002


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