[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73101-73103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29928]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0601]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Current Good Manufacturing Practice Regulations for
Medicated Feeds
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
[[Page 73102]]
publish notice in the Federal Register concerning each proposed
collection of information, including each proposed extension of an
existing collection of information, and to allow 60 days for public
comment in response to the notice. This notice solicits comments on the
recordkeeping requirements for manufacturers of medicated animal feeds.
DATES: Submit either electronic or written comments on the collection
of information by January 28, 2011.
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: Johnny Vilela, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, 301-796-7651, [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 extension 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.
Current Good Manufacturing Practice Regulations for Medicated Feeds--21
CFR Part 225 (OMB Control Number 0910-0152)--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 medicated feeds. Medicated feeds are administered to animals
for the prevention, cure, mitigation, or treatment of disease, or
growth promotion and feed efficiency. Statutory requirements for cGMPs
have been codified under part 225 (21 CFR part 225). Medicated feeds
that are not manufactured in accordance with these regulations are
considered adulterated under section 501(a)(2)(B) of the FD&C Act.
Under part 225, a manufacturer is required to establish, maintain, and
retain records for a medicated feed, including records to document
procedures required during 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), labels, and product distribution.
This information is needed so that FDA can monitor drug usage and
possible misformulation of medicated feeds to investigate violative
drug residues in products from treated animals and to investigate
product defects when a drug is recalled. In addition, FDA will use the
cGMP criteria in part 225 to determine whether or not the systems and
procedures used by manufacturers of medicated feeds are adequate to
assure that their feeds meet the requirements of the FD&C Act as to
safety and also that they meet their claimed identity, strength,
quality, and purity, as required by section 501(a)(2)(B) of the FD&C
Act.
A license is required when the manufacture of a medicated feed
involves the use of a drug or drugs that FDA has determined requires
more control because of the need for a withdrawal period before
slaughter or because of carcinogenic concerns. Conversely, a license is
not required and the recordkeeping requirements are less demanding for
those medicated feeds for which FDA has determined that the drugs used
in their manufacture need less control. Respondents to this collection
of information are commercial feed mills and mixer-feeders.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills) \1\
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Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
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225.42(b)(5) through (b)(8)..... 1,004 260 261,040 1 261,040
225.58(c) and (d)............... 1,004 45 45,180 .5 22,590
225.80(b)(2).................... 1,004 1,600 1,606,400 .12 192,768
225.102(b)(1)................... 1,004 7,800 7,831,200 .08 626,496
225.110(b)(1) and (b)(2)........ 1,004 7,800 7,831,200 .015 117,468
225.115(b)(1) and (b)(2)........ 1,004 5 5,020 .12 602
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Total....................... .............. .............. .............. .............. 1,220,964
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 73103]]
Table 2--Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders) \1\
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Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
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225.42(b)(5) through (b)(8)..... 100 260 26,000 .15 3,900
225.58(c) and (d)............... 100 36 3,600 .5 1,800
225.80(b)(2).................... 100 48 4,800 .12 576
225.102(b)(1)................... 100 260 26,000 .4 10,400
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Total....................... .............. .............. .............. .............. 16,676
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Commercial Feed Mills) \1\
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Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
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225.142......................... 8,000 4 32,000 1 32,000
225.158......................... 8,000 1 8,000 4 32,000
225.180......................... 8,000 96 768,000 .12 92,160
225.202......................... 8,000 260 2,080,000 .65 1,352,000
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Total....................... .............. .............. .............. .............. 1,508,160
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 4--Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Mixer-Feeders) \1\
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Annual
21 CFR Section No. of frequency per Total annual Hours per Total hours
recordkeepers recordkeeping records record
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225.142......................... 45,000 4 180,000 1 180,000
225.158......................... 45,000 1 45,000 4 180,000
225.180......................... 45,000 32 1,440,000 .12 172,800
225.202......................... 45,000 260 11,700,000 .33 3,861,000
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Total....................... .............. .............. .............. .............. 4,393,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimate of the times required for record preparation and
maintenance is based on Agency communications with industry. Other
information needed to finally calculate the total burden hours (i.e.,
number of recordkeepers, number of medicated feeds being manufactured,
etc.) is derived from Agency records and experience.
Dated: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29928 Filed 11-26-10; 8:45 am]
BILLING CODE 4160-01-P