[Federal Register Volume 66, Number 116 (Friday, June 15, 2001)]
[Notices]
[Pages 32629-32630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0046]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by July 
16, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (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 No. 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 for growth 
promotion and feed efficiency. Statutory requirements for CGMPs have 
been codified in 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 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 act as 
to safety and also 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, which FDA has determined requires 
more control because of the need for a withdrawal period before 
slaughter or carcinogenic concerns. Conversely, for those medicated 
feeds for which FDA has determined that the drugs used in their 
manufacture need less control, a license is not required and the 
recordkeeping requirements are less demanding. 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\
----------------------------------------------------------------------------------------------------------------
                                                               Annual        Total
              21 CFR Section                    No. of     Frequency per     Annual      Hours per   Total Hours
                                            Recordkeepers  Recordkeeping    Records    Recordkeeper
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)                       1,150            260       299,000             1      299,000
225.58 and (d)                         1,150             45        51,750            .5       25,875
225.80(b)(2)                                      1,150          1,600     1,840,000           .12      220,800
225.102(b)(1)                                     1,150          7,800     8,970,000           .08      717,600
225.110(b)(1) and (b)(2)                          1,150          7,800     8,970,000          0.15      134,550

[[Page 32630]]

 
225.115(b)(1) and (b)(2)                          1,150              5         5,750           .12          690
                                                                                                    ------------
  Total                                                                                               1,398,515
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                 Table 2.--Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders)\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Annual Frequency per                              Hours per
              21 CFR Section                No. of Recordkeepers      Recordkeeping     Total Annual Records      Recordkeeper           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8)                        100                   260                26,000                      .15              3,900
225.58 and (d)                          100                    36                 3,600                      .5               1,800
225.80(b)(2)                                       100                    48                 4,800                      .12                576
225.102(b)(1) through (b)(5)                       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 Frequency per                              Hours per
              21 CFR Section                No. of Recordkeepers      Recordkeeping     Total Annual Records      Recordkeeper           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                                                                                   ---------------------
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 Frequency per                              Hours per
              21 CFR Section                No. of Recordkeepers      Recordkeeping     Total Annual Records      Recordkeeper           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of the time required for record preparation and 
maintenance is based on agency communications with industry. Other 
information needed to 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 8, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15081 Filed 6-14-01; 8:45 am]
BILLING CODE 4160-01-S