Animal Drug User Fee Cover Sheet

ICR 201404-0910-016

OMB: 0910-0539

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2014-04-24
IC Document Collections
IC ID
Document
Title
Status
6258 Modified
ICR Details
0910-0539 201404-0910-016
Historical Inactive 201102-0910-010
HHS/FDA CVM
Animal Drug User Fee Cover Sheet
Extension without change of a currently approved collection   No
Regular
Improperly submitted and continue 07/03/2014
Retrieve Notice of Action (NOA) 04/28/2014
In accordance with 5 CFR 1320, this ICR is improperly submitted. It lists a change due to agency discretion, precluding this from being an extension. Please correct this and resubmit.
  Inventory as of this Action Requested Previously Approved
04/30/2014 36 Months From Approved 08/31/2014
76 0 76
76 0 76
0 0 0

This request collects information regarding animal drug applications or supplemental animal drug applications to the Food and Drug Administration. Respondents are sponsors of animal drugs who are asked to provide information required by the Federal Food, Drug, and Cosmetic Act in support of their application. The information is used to initiate application review and to determine applicable user fees.

US Code: 21 USC 379h Name of Law: Authority to assess and use drug fees
  
None

Not associated with rulemaking

  79 FR 6199 02/03/2014
79 FR 22689 04/23/2014
No

1
IC Title Form No. Form Name
Animal Drug User Fee Cover Sheet 3546 Animal Drug User Fee Cover Sheet

No
Yes
Miscellaneous Actions
There is a decrease in the number of respondents since our last approval. This is due to a smaller number of applications in the past three years. Our previous estimate of an average of 76 submissions annually appears to have been incorrect, while we believe our current estimate more accurately reflects the current burden and may be attributed to the streamlining of agency tracking resources and improved database management.

$47,485
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
04/28/2014


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