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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:
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:
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
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.
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
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 1076
01/06/2023
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Designation of New Animal Drugs for Minor Use and MInor Species ( MUMS)
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
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.
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
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:
01/09/2023
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