[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35360-35361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0389]


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 July 
21, 2014.

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 emailed to [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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), 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 (21 
U.S.C. 351(a)(2)(B). 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 April 7, 2014 (79 FR 19093), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                   Number of
        21 CFR Section             Number of      records per    Total annual    Average burden     Total hours
                                 recordkeepers   recordkeeper       records     per recordkeeper
----------------------------------------------------------------------------------------------------------------
226.42........................              65             260          16,900  0.75 (45                  12,675
                                                                                 minutes).
226.58........................              65             260          16,900  1.75............          29,575
226.80........................              65             260          16,900  0.75 (45                  12,675
                                                                                 minutes).

[[Page 35361]]

 
226.102.......................              65             260          16,900  1.75............          29,575
226.110.......................              65             260          16,900  0.25 (15                   4,225
                                                                                 minutes).
226.115.......................              65              10             650  0.5 (30 minutes)             325
                               ------------------------------------------------                  ---------------
        Total.................  ..............  ..............  ..............  ................          89,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.

    The estimate of time required for record preparation and 
maintenance is based on previous 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: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14471 Filed 6-19-14; 8:45 am]
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