[Federal Register Volume 72, Number 158 (Thursday, August 16, 2007)]
[Notices]
[Pages 46089-46090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-16088]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0305]


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 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 current good manufacturing practice (cGMP) regulations for 
medicated feeds.

DATES: Submit written or electronic comments on the collection of 
information by October 15, 2007.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments or 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: 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: 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 
act) (21 U.S.C. 351), FDA has the statutory authority to issue 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, 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 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.
    Respondents to this collection of information are commercial feed 
mills and mixer-feeders.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 46090]]



                             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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.


                               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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: August 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-16088 Filed 8-15-07; 8:45 am]
BILLING CODE 4160-01-S