Designation of New Animal Drugs for Minor Use or Minor Species (MUMS) - Final Rule

ICR 201312-0910-004

OMB: 0910-0605

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-12-11
IC Document Collections
ICR Details
0910-0605 201312-0910-004
Historical Active 201009-0910-009
HHS/FDA 21074
Designation of New Animal Drugs for Minor Use or Minor Species (MUMS) - Final Rule
Extension without change of a currently approved collection   No
Regular
Approved without change 02/07/2014
Retrieve Notice of Action (NOA) 12/11/2013
  Inventory as of this Action Requested Previously Approved
02/28/2017 36 Months From Approved 02/28/2014
157 0 157
1,362 0 1,362
0 0 0

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives designed to help pharmaceutical companies overcome the financial burdens they face in providing limited-demand animal drugs. These incentives are only available to sponsors whose drugs are designated "MUMS" by FDA. Respondents to this collection, therefore, are sponsors of animal drugs used for minor animal species as well as uncommon diseases in major animal species who wish to obtain a MUMS designation for their products. Participation in the MUMS program is optional, however respondents must report certain information to the agency to obtain benefits offered by the MUMS program.

US Code: 21 USC 301 Name of Law: null
  
None

Not associated with rulemaking

  78 FR 39734 07/02/2013
78 FR 71623 11/29/2013
No

1
IC Title Form No. Form Name
Designation of New Animal Drugs for Minor Use and MInor Species ( MUMS)

  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 157 157 0 0 0 0
Annual Time Burden (Hours) 1,362 1,362 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$30,375
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.
12/11/2013


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