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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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.
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
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.
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
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
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
Number of Information Collection (IC) in this ICR:
4
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
ICR Summary 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.
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
Agency Contact:
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov
Common Form ICR:
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:
(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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