Records and Reports Concerning Experience with Approved New Animal Drugs

ICR 200610-0910-004

OMB: 0910-0284

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supplementary Document
2006-10-02
Supporting Statement A
2006-10-03
IC Document Collections
ICR Details
0910-0284 200610-0910-004
Historical Active 200603-0910-013
HHS/FDA
Records and Reports Concerning Experience with Approved New Animal Drugs
Extension without change of a currently approved collection   No
Regular
Approved without change 01/04/2007
Retrieve Notice of Action (NOA) 10/17/2006
  Inventory as of this Action Requested Previously Approved
01/31/2010 36 Months From Approved 01/31/2007
43,518 0 45,528
83,555 0 138,114
0 0 0

To facilitate a determination as to whether there may be grounds for suspending or withdrawing approval of the new animal drug application or whether any applicable animal drug regulation should be amended or repealed.

None
None

Not associated with rulemaking

  71 FR 29157 05/19/2006
71 FR 55482 09/22/2006
Yes

  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 43,518 45,528 0 -2,010 0 0
Annual Time Burden (Hours) 83,555 138,114 0 -54,559 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
In response to comments received for the 60 day Federal register notice that published May 19,2006,( 71 FR 29157 ), FDA made an adjustment for its reporting and recordkeeping burden estimates. The reporting estimate increased from 34,827 hours to 40,957 hours and the recordkeeping burden estimate increased from 34,316 hours to 43,013 hours ( Refer to 30 day Federal Register notice; September 22,2006 ( 71 FR 55484)

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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.
10/04/2006


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