Document ID: FDA-2010-N-0598-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Current Good Manufacturing Practice Regulations for Type A Medicated Articles
Posted Date: 2011-02-03T05:00Z

[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Pages 6142-6143]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2355]

[[Page 6142]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0598]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Current Good 
Manufacturing Practice Regulations for Type A Medicated Articles

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by March 
7, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0154. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Current Good Manufacturing Practice Regulations for Type A Medicated 
Articles--21 CFR Part 226 (OMB Control Number 0910-0154)--Extension

    Under section 501 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 351), FDA has the statutory authority to issue 
current good manufacturing practice (cGMP) regulations for drugs, 
including 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.
    Statutory requirements for cGMPs for type A medicated articles have 
been codified in part 226 (21 CFR part 226). Type A medicated articles 
which are not manufactured in accordance with these regulations are 
considered adulterated under section 501(a)(2)(B) of the FD&C Act. 
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.
    This information is needed so that FDA can monitor drug usage and 
possible misformulation of type A medicated articles. The information 
could also prove useful to FDA in investigating product defects when a 
drug is recalled. In addition, FDA will use the cGMP criteria in part 
226 to determine whether or not the systems used by manufacturers of 
type A medicated articles are adequate to assure that their medicated 
articles meet the requirements of the FD&C Act as to safety and also 
meet the article's claimed identity, strength, quality, and purity, as 
required by section 501(a)(2)(B) of the FD&C Act.
    The respondents for type A medicated articles are pharmaceutical 
firms that manufacture both human and veterinary drugs, those firms 
that produce only veterinary drugs, and commercial feed mills.
    In the Federal Register of November 26, 2010 (75 FR 72827), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                               Number of       Annual frequency     Total annual
                      21 CFR Section                         recordkeepers    per recordkeeping       records        Hours per record     Total hours
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226.42...................................................                115                260             29,900                .75             22,425
226.58...................................................                115                260             29,900               1.75             52,325
226.80...................................................                115                260             29,900                .75             22,425
226.102..................................................                115                260             29,900               1.75             52,325
226.110..................................................                115                260             29,900                .25              7,475
226.115..................................................                115                 10              1,150                .5                 575
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .................  .................  .................  .................            157,550
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 6143]]

    The estimate of the time required for record preparation and 
maintenance is based on Agency communications with industry. Other 
information needed to calculate the total burden hours (i.e., 
manufacturing sites, number of type A medicated articles being 
manufactured, etc.) are derived from Agency records and experience.

    Dated: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2355 Filed 2-2-11; 8:45 am]
BILLING CODE 4160-01-P