[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             No. of         Annual Frequency       Total Annual         Hours per
                    21 CFR Section                       Recordkeepers      per Recordkeeping        Records          Recordkeeper        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             No. of         Annual Frequency       Total Annual         Hours per
                    21 CFR Section                       Recordkeepers      per Recordkeeping        Records          Recordkeeper        Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.142                                                           45,000                     4            180,000                1               180,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
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