New Animal Drugs for Minor Use and Minor Species

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0910-0605 Supporting Statement 07-03-23.docx	Supporting Statement A	Uploaded 2023-07-03	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
259459	Recordkeeping; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species		New
259458	Reporting; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species	Other-Electronic landing page	New
259457	One-time Recordkeeping Burden; Designated New Animal Drugs for Minor Use and Minor Species (MUMS)		New
181664	Reporting; Designated 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: 202304-0910-001
Status: Active	Previous ICR Reference No: 202211-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: New Animal Drugs for Minor Use and Minor Species
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/07/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/05/2023
Terms of Clearance: Upon approval of this revision, FDA will discontinue the associated collection under 0910-0620.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved	02/28/2026
Responses	933	0	69
Time Burden (Hours)	5,905	0	276
Cost Burden (Dollars)	0	0	0

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Abstract: The respondents to this information collection are pharmaceutical companies that sponsor new animal drugs for Minor Use and Minor Species (MUMS) designation or requesters wishing to add a new animal drug to the index listing of legally marketed unapproved new animal drugs for minor species animals. MUMS drug designation makes the sponsor eligible for incentives to support the approval or conditional approval of the designated use and is completely optional for drug sponsors. The MUMS designation regulations specify the criteria and procedures for requesting MUMS designation as well as the annual reporting requirements for MUMS designees. Indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species. The indexing regulations specify the criteria and procedures for requesting eligibility for indexing and for requesting addition to the index, as well as the annual reporting requirements for holders of an index listing.

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Authorizing Statute(s): US Code: 21 USC 360 Name of Law: Federal Food, Drug and Cosmetic Act
   US Code: 21 USC 301 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 42080	06/29/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
One-time Recordkeeping Burden; Designated New Animal Drugs for Minor Use and Minor Species (MUMS)
Recordkeeping; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
Reporting; Designated New Animal Drugs for Minor Use and MInor Species (MUMS)
Reporting; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

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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	933	69	0	0	864	0
Annual Time Burden (Hours)	5,905	276	0	0	5,629	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: This revision request includes changes and adjustments to reflect an overall increase of 5,629 hours and a corresponding increase of 864 responses. For efficiency of Agency operations, we are consolidating the related information collection activities currently approved in OMB control numbers 0910-0605 and 0910-0620 into a single collection request. We also include burden that may be attributable to rulemaking (RIN 0910-A146), which became effective on December 14, 2022. In addition, upon review of the previous information collection submission related to indexing, we include burden associated with recordkeeping to address a data-entry error in the ROCIS system.

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Annual Cost to Federal Government: $232,457

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: 07/05/2023

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