Current Good Manufacturing Practice Regulations for Medicated Feed

ICR 202007-0910-009

OMB: 0910-0152

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-07-16
ICR Details
0910-0152 202007-0910-009
Active 201707-0910-001
HHS/FDA CVM
Current Good Manufacturing Practice Regulations for Medicated Feed
Extension without change of a currently approved collection   No
Regular
Approved with change 08/24/2020
Retrieve Notice of Action (NOA) 07/17/2020
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved 08/31/2020
15,661,942 0 15,757,633
2,173,254 0 2,238,520
0 0 0

This ICR concerns the recordkeeping requirements of FDA’s current good manufacturing practice (cGMP) regulations for medicated feeds. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and feed efficiency. A manufacturer is required to establish, maintain, and retain records for a medicated feed, including records to document procedures required during the manufacturing process to assure that proper quality control is maintained. Such records would, for example, contain information concerning receipt and inventory of drug components, batch production, laboratory assay results (i.e. batch and stability testing), labels, and product distribution. These records are subject to FDA review during an inspection. Medicated feeds that are not manufactured in accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

US Code: 21 USC 351 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  85 FR 12790 03/04/2020
85 FR 41594 07/10/2020
No

1
IC Title Form No. Form Name
Recordkeeping requirements for registered/licensed and non-registered/non-licensed commercial feed mills and mixer/feeders

  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 15,661,942 15,757,633 0 0 -95,691 0
Annual Time Burden (Hours) 2,173,254 2,238,520 0 0 -65,266 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
This information collection reflects a change due to the Agency estimate. Specifically, the number of recordkeepers has decreased from 877 to 825. This results in a decrease in the number of annual responses of 95,691 with a corresponding decrease in hours of 65,266.

$9,376
No
    No
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

  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.
07/17/2020


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