Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

ICR 201707-0910-005

OMB: 0910-0620

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-07-26
IC Document Collections
IC ID
Document
Title
Status
197486
Removed
197485
Removed
197484
Removed
197483
Removed
197482
Removed
197481
Removed
197480
Removed
197479
Removed
197478
Removed
197477
Removed
197476
Removed
197475
Modified
183179
Modified
ICR Details
0910-0620 201707-0910-005
Historical Active 201406-0910-018
HHS/FDA CVM
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
Extension without change of a currently approved collection   No
Regular
Approved without change 08/28/2017
Retrieve Notice of Action (NOA) 07/27/2017
  Inventory as of this Action Requested Previously Approved
08/31/2020 36 Months From Approved 08/31/2017
293 0 293
4,922 0 4,922
0 0 0

This ICR collects information from respondents who wish to make a drug legally available to veterinarians and animal owners for the treatment of a minor animal species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). Respondents to the collection are sponsors of these products. FDA reviews the information collected to identify potential problems concerning the safety and effectiveness of the new animal drug.

US Code: 21 USC 369ccc-1 Name of Law: Minor Use and Minor Species Animal Health Act
  
None

Not associated with rulemaking

  81 FR 93689 12/21/2016
82 FR 33507 07/20/2017
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 293 293 0 0 0 0
Annual Time Burden (Hours) 4,922 4,922 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The burden for the information collection remains unchanged.

$139,851
No
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 [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.
07/27/2017


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