New Animal Drugs for Investigational Use

ICR 201507-0910-004

OMB: 0910-0117

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-07-09
ICR Details
0910-0117 201507-0910-004
Historical Active 201207-0910-001
HHS/FDA CVM
New Animal Drugs for Investigational Use
Extension without change of a currently approved collection   No
Regular
Approved without change 08/14/2015
Retrieve Notice of Action (NOA) 07/14/2015
  Inventory as of this Action Requested Previously Approved
08/31/2018 36 Months From Approved 10/31/2015
6,226 0 5,528
13,805 0 12,328
607,376 0 0

This information collection request supports FDA's regulations regarding new animal drugs for investigational uses. Respondents to the collection are new animal drug sponsors.

US Code: 21 USC 512j Name of Law: null
  
None

Not associated with rulemaking

  80 FR 17758 04/02/2015
80 FR 35956 06/23/2015
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 6,226 5,528 0 698 0 0
Annual Time Burden (Hours) 13,805 12,328 0 1,477 0 0
Annual Cost Burden (Dollars) 607,376 0 0 607,376 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
This collection reflects an overall increase attributed to an increase in respondents. This is explained more fully in the agency's supporting statement at Q15. The agency also notes that the cost to industry for the information collection was not previously included in our last submission; however we have included that information in this request at Question 12b.

$640,782
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.
07/14/2015


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