Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

ICR 201104-0910-009

OMB: 0910-0620

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2011-04-26
IC Document Collections
IC ID
Document
Title
Status
197486
New
197485
New
197484
New
197483
New
197482
New
197481
New
197480
New
197479
New
197478
New
197477
New
197476
New
197475
New
183179
Modified
ICR Details
0910-0620 201104-0910-009
Historical Active 200712-0910-014
HHS/FDA
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
Extension without change of a currently approved collection   No
Regular
Approved without change 06/27/2011
Retrieve Notice of Action (NOA) 04/27/2011
  Inventory as of this Action Requested Previously Approved
06/30/2014 36 Months From Approved 06/30/2011
293 0 358
4,922 0 4,923
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. This regulation, among other things, specifies the procedures for requesting eligibility and addition to the index as well as the annual reporting requirements for index holders.

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

  75 FR 75481 12/03/2010
76 FR 10605 02/25/2011
No

13
IC Title Form No. Form Name
516.121
516.123
516.125
516.141
516.143
516.145
516.161
516.129
516.119
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 293 358 0 0 -65 0
Annual Time Burden (Hours) 4,922 4,923 0 0 -1 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$128,654
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 [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.
04/27/2011


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