Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226

ICR 202007-0910-011

OMB: 0910-0154

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-07-22
ICR Details
0910-0154 202007-0910-011
Active 201707-0910-002
HHS/FDA CVM
Good Manufacturing Practice Regulations for Type A Medicated Articles, 21 CFR Part 226
Extension without change of a currently approved collection   No
Regular
Approved without change 08/24/2020
Retrieve Notice of Action (NOA) 07/22/2020
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved 08/31/2020
16,900 0 85,150
89,050 0 89,050
0 0 0

This ICR requests approval for recordkeeping requirements of FDA’s current good manufacturing practice (cGMP) regulations for Type A medicated articles. A Type A medicated article is a feed product containing a concentrated drug diluted with a feed carrier substance. A Type A medicated article is intended solely for use in the manufacture of another Type A medicated article or a Type B or Type C medicated feed. Medicated feeds are administered to animals for the prevention, cure, mitigation, or treatment of disease or for growth promotion and feed efficiency. Under part 226, a manufacturer is required to establish, maintain, and retain records for Type A medicated articles, including records to document procedures required under 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), and product distribution. These records are subject to FDA review during an inspection. Type A medicated articles which 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 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  85 FR 10170 02/21/2020
85 FR 41596 07/10/2020
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 16,900 85,150 0 -68,250 0 0
Annual Time Burden (Hours) 89,050 89,050 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
No adjustments or program changes are reported. The decrease in annual number of responses is due to the way the ICR was entered into ROCIS--five ICs were decreased to one.

$35,441
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.
07/22/2020


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