View Information Collection Request (ICR) Package
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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:
0910-0337
ICR Reference No:
202409-0910-003
Status:
Active
Previous ICR Reference No:
202405-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Medicated Feed Mill License Application
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:
06/13/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/12/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2028
36 Months From Approved
06/30/2025
Responses
828
0
830
Time Burden (Hours)
39
0
36
Cost Burden (Dollars)
0
0
0
Abstract:
This collection of information supports implementation of requirements found in 21 CFR part 515. Manufacturers seeking a facility license submit a completed medicated feed mill license application using Form FDA 3448. We require the submission of a supplemental medicated feed mill license application for a change in facility ownership or a change in facility address. Respondents to the collection of information are those seeking a medicated feed mill license in accordance with FDA regulations.
Authorizing Statute(s):
US Code:
21 USC 360b
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:
89 FR 94740
11/29/2024
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 18679
05/01/2025
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
Medicated Feed Mill License - 21 CFR 515
FDA 3448
Medicated Feed Mill License Application
Maintenance of Records for Appoved Labeling fo Each "Type B" and "Type C" Labeling
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
828
830
0
0
-2
0
Annual Time Burden (Hours)
39
36
0
0
3
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:
We base our estimates on our recent experience with the existing medicated feed mill license application process. Our estimated burden for the information collection reflects an overall increase of 2.5 hours. We attribute this adjustment to a slight increase in the overall number of submissions we received over the last few years.
Annual Cost to Federal Government:
$1,711
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:
Domini Bean 301 796-5733 domini.bean@fda.hhs.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:
05/12/2025
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