Designation of New Animal Drugs for Minor Use or Minor Species

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-0605SupportingStatement 1-05-23.docx	Supporting Statement A	Uploaded 2023-01-05	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
181664	Designation of New Animal Drugs for Minor Use and MInor Species ( MUMS)	Other-Electronic landing page	Modified

ICR Details

OMB Control No: 0910-0605	ICR Reference No: 202211-0910-011
Status: Historical Active	Previous ICR Reference No: 201912-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Designation of New Animal Drugs for Minor Use or Minor Species
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/17/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/09/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2026	36 Months From Approved	02/28/2023
Responses	69	0	157
Time Burden (Hours)	276	0	1,362
Cost Burden (Dollars)	0	0	0

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Abstract: Minor 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 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.

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Authorizing Statute(s): US Code: 21 USC 301 Name of Law: Federal Food, Drug and Cosmetic Act
   US Code: 21 USC 360 Name of Law: Federal Food, Drug and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 46961	08/01/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 1076	01/06/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

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

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ICR Summary of Burden

table that charts list of burden

	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	69	157	0	0	-88	0
Annual Time Burden (Hours)	276	1,362	0	0	-1,086	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The information collection reflects an overall adjustment decrease of 88 responses and 1,086 burden hours. The number of respondents for new designation requests decreased (from 15 to 5 respondents) due to changes in industry, while the number of respondents for annual reports increased (from 15 to 26 respondents), due to an increase in the number of sponsors holding active MUMS designations since the last renewal of this collection. We also decreased the number of responses per respondent for both the new designation request and the annual report (from 5 to 2), based on our experience over the last 3 years.

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Annual Cost to Federal Government: $64,090

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 01/09/2023

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