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

ICR 201707-0910-002

OMB: 0910-0154

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-07-27
ICR Details
0910-0154 201707-0910-002
Historical Active 201406-0910-017
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 08/28/2017
Retrieve Notice of Action (NOA) 07/27/2017
  Inventory as of this Action Requested Previously Approved
08/31/2020 36 Months From Approved 08/31/2017
85,150 0 85,150
89,050 0 89,050
0 0 0

This ICR concerns the recordkeeping requirements of FDA’s current good manufacturing practice (cGMP) regulations for Type A medicated articles in part 226 (21 CFR part 226). 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

  81 FR 71513 10/17/2016
82 FR 32834 07/18/2017
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 85,150 85,150 0 0 0 0
Annual Time Burden (Hours) 89,050 89,050 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$41,353
No
    No
    No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
07/27/2017


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