
[Federal Register Volume 76, Number 25 (Monday, February 7, 2011)]
[Notices]
[Pages 6620-6621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2548]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0601]


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 March 
9, 2011.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, Juanmanuel.vilela@fda.hhs.gov.

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 
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.
    In the Federal Register of November, 29, 2010 (75 FR 73101), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received no comments.
    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              Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    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 6621]]


                                 Table 2--Estimated Annual Recordkeeping Burden
                                     [Registered licensed mixer-feeders] \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR section              Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR section              Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR section              Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    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: February 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2548 Filed 2-4-11; 8:45 am]
BILLING CODE 4160-01-P


