Medicated Fee Mill License Application

ICR 201906-0910-006

OMB: 0910-0337

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-06-24
ICR Details
0910-0337 201906-0910-006
Historical Active 201606-0910-002
HHS/FDA CVM
Medicated Fee Mill License Application
Revision of a currently approved collection   No
Regular
Approved without change 09/10/2019
Retrieve Notice of Action (NOA) 08/16/2019
  Inventory as of this Action Requested Previously Approved
09/30/2022 36 Months From Approved 09/30/2019
935 0 991
54 0 56
0 0 0

This ICR collects information from feed manufactures that seek to manufacture feed using Category II, Type A medicated articles or manufacture certain liquid and free choice feed, using Category I, Type A medicated articles that must follow proprietary formulas or specifications are required to obtain a facility license. We require that a manufacturer 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.

None
None

Not associated with rulemaking

  83 FR 66280 12/26/2018
84 FR 34398 07/18/2019
No

  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 935 991 0 0 -56 0
Annual Time Burden (Hours) 54 56 0 0 -2 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Our estimated burden for the information collection reflects an overall decrease of 2 hours and a corresponding decrease of 56 responses/records. We attribute this adjustment to a net decrease in the number of submissions we received over the last few years.

$3,134
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
08/16/2019


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