[Federal Register Volume 72, Number 222 (Monday, November 19, 2007)]
[Notices]
[Pages 65039-65041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-22587]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0305]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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
December 19, 2007.
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: 202-395-6974, or e-mailed to [email protected]. All comments
should be identified with the OMB control number 0910-0152. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Denver Presley Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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 Medicated Feeds--21
CFR Part 225 (OMB Control Number 0910-0152)--Extension
Under section 501 of the Federal Food, Drug, and Cosmetic Act (the
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 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,
[[Page 65040]]
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: (1) Monitor drug usage
and possible misformulation of medicated feeds, (2) investigate
violative drug residues in products from treated animals, and (3)
investigate product defects when a drug is recalled. In addition, FDA
will use the cGMP criteria under 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 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 act.
A license is required when the manufacturer 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.
In the Federal Register of August 16, 2007 (72 FR 46089), FDA
published a 60-day notice soliciting public comment on the proposed
collection of information provisions. In response to that notice, no
comments were received.
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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeper Records Recordkeeper Total Hours
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225.58(c) and (d) 1,060 45 47,700 .5 23,850
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225.80(b)(2) 1,060 1,600 1,696,000 .12 203,520
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225.102(b)(1) 1,060 7,800 8,268,000 .08 661,440
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225.110(b)(1) and (b)(2) 1,060 7,800 8,268,000 .015 124,020
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225.115(b)(1) and (b)(2) 1,060 5 5,300 .12 636
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Total 1,289,066
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\1\There are no capital or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders)\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
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225.42(b)(5) through (b)(8) 100 260 26,000 .15 3,900
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225.58(c) and (d) 100 36 3,600 .5 1,800
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225.80(b)(2) 100 48 4,800 .12 576
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225.102(b)(1) through (b)(5) 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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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
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225.142 8,000 4 32,000 1 32,000
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225.158 8,000 1 8,000 4 32,000
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225.180 8,000 96 768,000 .12 92,160
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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.
[[Page 65041]]
Table 4.--Estimated Annual Recordkeeping Burden (Nonregistered Unlicensed Mixer-Feeders)\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers per Recordkeeping Records Recordkeeper Total Hours
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225.142 45,000 4 180,000 1 180,000
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225.158 45,000 1 45,000 4 180,000
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225.180 45,000 32 1,440,000 .12 172,000
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225.202 45,000 260 11,700,000 .33 3,861,000
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Total 4,393,000
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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 13, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-22587 Filed 11-16-07; 8:45 am]
BILLING CODE 4160-01-S