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
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.