Records and Reports Concerning Experience with Approved New Animal Drugs

ICR 200305-0910-001

OMB: 0910-0284

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0284 200305-0910-001
Historical Active 199307-0910-001
HHS/FDA
Records and Reports Concerning Experience with Approved New Animal Drugs
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 06/30/2003
Retrieve Notice of Action (NOA) 05/07/2003
  Inventory as of this Action Requested Previously Approved
06/30/2006 06/30/2006
45,528 0 0
69,493 0 0
0 0 0

Implementation of Section 512(1) of the Federal Food, Drug and Cosmetic Act and 21 CFR 514.80 (Attachment A) requires applicants of approved new animal drug applications and abbreviated new animal drug applications to submit product/manufacturing defects, initial and follow-up reports for adverse drug experiences and lack of effectiveness of new animal drugs, increased frequency 15-day alert reports, periodic drug experience reports (annually or semi-annually in a specific format), and other reports (special drug experience reports, advertisement and promotional material....

None
None


No

1
IC Title Form No. Form Name
Records and Reports Concerning Experience with Approved New Animal Drugs 1932, 1932A, 2301

  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 45,528 0 0 45,528 0 0
Annual Time Burden (Hours) 69,493 0 0 69,493 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
05/07/2003


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