Index of Legally Marketed Unapproved New Animal Drugs for Minor Species - Final Rule

ICR 200712-0910-014

OMB: 0910-0620

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2007-12-12
IC Document Collections
ICR Details
0910-0620 200712-0910-014
Historical Active
HHS/FDA
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species - Final Rule
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/24/2008
Retrieve Notice of Action (NOA) 12/20/2007
  Inventory as of this Action Requested Previously Approved
03/31/2011 36 Months From Approved
358 0 0
4,923 0 0
0 0 0

This final rule implements Section 572 of the Minor Use Minor Species (MUMS) Animal Health Act of 2004. The MUMs Act is made up of three sections i.e., 571,572 and 573. 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 will only be indicated for use in non-food minor species or for use in early non-food life stages food producing minor species. This final rule, among other things, specifies the criteria and procedures for requesting eligibility and addition to the index as well as the annual reporting requirements for index holders.

US Code: 21 USC 360ccc-2 Name of Law: null
   US Code: 21 USC 360ccc Name of Law: null
   US Code: 21 USC 369ccc-1 Name of Law: null
  
US Code: 21 USC 360ccc Name of Law: null

0910-AF67 Final or interim final rulemaking 72 FR 69108 12/06/2007

  71 FR 48840 08/22/2006
72 FR 69108 12/06/2007
Yes

1
IC Title Form No. Form Name
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species- Final Rule

  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 358 0 358 0 0 0
Annual Time Burden (Hours) 4,923 0 4,923 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
New Collection

$69,000
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Denver Presley 3018271462

  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.
12/20/2007


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