[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Notices]
[Pages 19093-19094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and allow 60 days for public comment in response to the 
notice. This notice solicits comments on the recordkeeping requirements 
for manufacturers of Type A medicated articles.

DATES: Submit either electronic or written comments on the collection 
of information by June 6, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA, 44 U.S.C. 3501-3520, Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed reinstatement of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 19094]]

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.
    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 per recordkeeper     Total hours
                                                  recordkeepers     recordkeeper         records
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226.42........................................                65               260            16,900  0.75 (45 minutes)...............            12,675
226.58........................................                65               260            16,900  1.75 (1 hour, 45 minutes).......            29,575
226.80........................................                65               260            16,900  0.75 (45 minutes................            12,675
226.102.......................................                65               260            16,900  1.75 (1 hour, 45 minutes........            29,575
226.110.......................................                65               260            16,900  0.25 (15 minutes................             4,225
226.115.......................................                65                10               650  0.5 (30 minutes)................               325
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    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: March 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07647 Filed 4-4-14; 8:45 am]
BILLING CODE 4160-01-P