[Federal Register Volume 79, Number 119 (Friday, June 20, 2014)]
[Notices]
[Pages 35358-35360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-14472]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0193]


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 July 
21, 2014.

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 [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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

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 that they

[[Page 35359]]

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 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.
    In the Federal Register of April 7, 2014 (79 FR 19091), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four elements solicited in the notice and 
therefore will not be discussed in this document.
    FDA estimates the burden for this collection of information as 
follows:

                                 Table 1--Estimated Annual Recordkeeping Burden
                                 [Registered licensed commercial feed mills] \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR Section             Number of      records per    Total annual    Average burden     Total hours
                                 recordkeepers   recordkeeper       records     per recordkeeper
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)...             840             260         218,400  1...............         218,400
225.58(c) and (d).............             840              45          37,800  0.50 (30                  18,900
                                                                                 minutes).
225.80(b)(2)..................             840           1,600       1,344,000  0.12 (7 minutes)         161,280
225.102(b)(1).................             840           7,800       6,552,000  0.08 (5 minutes)         524,160
225.110(b)(1) and (b)(2)......             840           7,800       6,552,000  .015 (1 minute).          98,280
225.115(b)(1) and (b)(2)......             840               5           4,200  0.12 (7 minutes)             504
                               ------------------------------------------------                  ---------------
    Total.....................  ..............  ..............  ..............  ................       1,021,524
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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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR Section             Number of      records per    Total annual    Average burden     Total hours
                                 recordkeepers   recordkeeper       records     per recordkeeper
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)...             100             260          26,000  0.15 (9 minutes)           3,900
225.58(c) and (d).............             100              36           3,600  0.50 (30                   1,800
                                                                                 minutes).
225.80(b)(2)..................             100              48           4,800  0.12 (7 minutes)             576
225.102(b)(1) through (b)(5)..             100             260          26,000  0.40 (24                  10,400
                                                                                 minutes).
                               ------------------------------------------------                  ---------------
    Total.....................  ..............  ..............  ..............  ................          16,676
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR Section             Number of      records per    Total annual    Average burden     Total hours
                                 recordkeepers   recordkeeper       records     per recordkeeper
----------------------------------------------------------------------------------------------------------------
225.142.......................           4,186               4          16,744  1...............          16,744
225.158.......................           4,186               1           4,186  4...............          16,744
225.180.......................           4,186              96         401,856  0.12 (7 minutes)          48,223
225.202.......................           4,186             260       1,088,360  0.65 (39                 707,434
                                                                                 minutes).
                               ------------------------------------------------                  ---------------
    Total.....................  ..............  ..............  ..............  ................         789,145
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
        21 CFR Section             Number of      records per    Total annual    Average burden     Total hours
                                 recordkeepers   recordkeeper       records     per recordkeeper
----------------------------------------------------------------------------------------------------------------
225.142.......................           3,400               4          13,600  1...............          13,600
225.158.......................           3,400               1           3,400  4...............          13,600
225.180.......................           3,400              32         108,800  0.12 (7 minutes)          13,056
225.202.......................           3,400             260         884,000  0.33 (20                 291,720
                                                                                 minutes).
                               ------------------------------------------------                  ---------------

[[Page 35360]]

 
    Total.....................  ..............  ..............  ..............  ................         331,976
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimate of time 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: June 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14472 Filed 6-19-14; 8:45 am]
BILLING CODE 4160-01-P