[Federal Register Volume 66, Number 28 (Friday, February 9, 2001)]
[Notices]
[Pages 9707-9709]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3416]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0046]


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 manufacturers of medicated animal feeds.

DATES: Submit written or electronic comments on the collection of 
information by April 10, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (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, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1462.

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 reinstatement 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: (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.

[[Page 9708]]

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 growth 
promotion and feed efficiency. Statutory requirements for CGMP's have 
been codified under part 225 (21 CFR part 225). Medicated feeds which 
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.

               Table 1.--Estimated Annual Recordkeeping Burden (Registered License Holders) \1, 2\
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                                            Annual
   21 CFR Section          No. of        Frequency per     Total Annual        Hours per         Total Hours
                        Recordkeepers    Recordkeeping        Records        Recordkeeper
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through     1,150              260           299,000                 1            299,000
 (b)(8)
225.58(c) 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        1,150            7,800         8,970,000                  .015        134,550
 (b)(2)
225.115(b)(1) and        1,150                5             5,750                  .12             690
 (b)(2)
Total                                                                                       1,398,515
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Commercial feed mills.


               Table 2.--Estimated Annual Recordkeeping Burden (Registered License Holders) \1, 2\
----------------------------------------------------------------------------------------------------------------
                                            Annual
   21 CFR Section          No. of        Frequency per     Total Annual        Hours per         Total Hours
                        Recordkeepers    Recordkeeping        Records        Recordkeeper
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through       100              260            26,000                  .15           3,900
 (b)(8)
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
 through (b)(5)
Total                                                                                          16,676
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Licensed mixer-feeders.


                     Table 3.--Estimated Annual Recordkeeping Burden (Nonregistered) \1, 2\
----------------------------------------------------------------------------------------------------------------
                                            Annual
   21 CFR Section          No. of        Frequency per     Total Annual        Hours per         Total Hours
                        Recordkeepers    Recordkeeping        Records        Recordkeeper
----------------------------------------------------------------------------------------------------------------
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.
\2\ Unlicensed commercial feed mills.


[[Page 9709]]


                     Table 4.--Estimated Annual Recordkeeping Burden (Nonregistered) \1, 2\
----------------------------------------------------------------------------------------------------------------
                                          Annual
  21 CFR Section         No. of        Frequency per  Total Annual Records     Hours per         Total Hours
                      Recordkeepers    Recordkeeping                         Recordkeeper
----------------------------------------------------------------------------------------------------------------
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.
\2\ Unlicensed mixer-feeders.

    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 5, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-3416 Filed 2-8-01; 8:45 am]
BILLING CODE 4160-01-F