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
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.
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.