Designation of New Animal Drugs for Minor Use or Minor Species

ICR 201912-0910-002

OMB: 0910-0605

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-01-03
IC Document Collections
ICR Details
0910-0605 201912-0910-002
Active 201701-0910-003
HHS/FDA CVM
Designation of New Animal Drugs for Minor Use or Minor Species
Extension without change of a currently approved collection   No
Regular
Approved without change 01/16/2020
Retrieve Notice of Action (NOA) 01/16/2020
  Inventory as of this Action Requested Previously Approved
01/31/2023 36 Months From Approved 02/29/2020
157 0 157
1,362 0 1,362
0 0 0

inor use drugs are drugs for use in major species (cattle, horses, swine, chickens, turkeys, dogs, and cats) that are needed for diseases that occur in only a small number of animals annually either because they occur infrequently or in limited geographic areas. Minor species are all animals other than humans that are not major species, for example, zoo animals, ornamental fish, parrots, ferrets, and guinea pigs. Some animals of agricultural importance are also minor species. These include animals such as sheep, goats, catfish, and honey bees. Participation in the MUMS program is completely optional for drug sponsors so the associated paperwork only applies to those sponsors who request and are subsequently granted ‘‘MUMS designation.’’ The rule specifies the criteria and procedures for requesting MUMS designation as well as the annual reporting requirements for MUMS designees.

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

Not associated with rulemaking

  84 FR 27333 06/12/2019
84 FR 67745 12/11/2019
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
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
01/16/2020


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