Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

ICR 201406-0910-018

OMB: 0910-0620

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-06-29
IC Document Collections
IC ID
Document
Title
Status
197486
Unchanged
197485
Unchanged
197484
Unchanged
197483
Unchanged
197482
Unchanged
197481
Unchanged
197480
Unchanged
197479
Unchanged
197478
Unchanged
197477
Unchanged
197476
Unchanged
197475
Unchanged
183179
Unchanged
ICR Details
0910-0620 201406-0910-018
Historical Active 201104-0910-009
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 08/27/2014
Retrieve Notice of Action (NOA) 06/30/2014
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved 08/31/2014
293 0 293
4,922 0 4,922
0 0 0

This information collection approval request is for a Food and Drug Administration (FDA) regulation that implements section 572 of the Minor Use and Minor Species (MUMS) Animal Health Act of 2004. The MUMS Act is made up of three sections (571, 572, and 573) and it establishes new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species as well as uncommon diseases in major animal species. Section 572 of the legislation provides for a public index listing of legally-marketed unapproved new animal drugs for minor species of animals. The drugs in this index are only indicated for use in non-food minor species or for use in early non-food life stages of food-producing minor species. Respondents to this collection are sponsors of pharmaceutical companies that sponsor new animal drugs.

US Code: 21 USC 360ccc Name of Law: null
   US Code: 21 USC 369ccc-1 Name of Law: null
   US Code: 21 USC 360ccc-2 Name of Law: null
  
None

Not associated with rulemaking

  79 FR 19094 04/07/2014
79 FR 35357 06/20/2014
No

13
IC Title Form No. Form Name
516.119
516.121
516.123
516.125
516.129
516.141
516.143
516.145
516.161
516.163
516.165
516.141 - Recordkeeping
516.165 - Recordkeeping

  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

$128,654
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  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.
06/30/2014


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