[Federal Register: June 14, 2004 (Volume 69, Number 113)]
[Notices]               
[Page 33040-33043]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn04-92]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0245]

 
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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[[Page 33041]]

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 August 13, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 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, Office of Management 
Programs (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 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 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 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:

         Table 1.--Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills)\1\
----------------------------------------------------------------------------------------------------------------
                        No. of        Annual Frequency     Total Annual         Hours per
 21 CFR Section     Recordkeepers     per Recordkeeper       Records          Recordkeeper        Total Hours
----------------------------------------------------------------------------------------------------------------
225.42(b)(5)                  1,150                260            299,000              1                 299,000
 through (b)(8)
----------------------------------------------------------------------------------------------------------------
225.58(c) and                 1,150                 45             51,750               .5                28,875
 (d)
----------------------------------------------------------------------------------------------------------------
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)                 1,150              7,800          8,970,000               .015             134,550
 and (b)(2)
----------------------------------------------------------------------------------------------------------------
225.115(b)(1)                 1,150                  5              5,750               .12                  690
 and (b)(2)
----------------------------------------------------------------------------------------------------------------

[[Page 33042]]


Total                                                                                                  1,397,825
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                      No. of         Annual Frequency      Total Annual         Hours per
21 CFR Section    Recordkeepers     per Recordkeeping        Records          Recordkeeper        Total Hours
----------------------------------------------------------------------------------------------------------------
225.42(b)(5)                  100                  260             26,000               .15                3,900
 through
 (b)(8)
----------------------------------------------------------------------------------------------------------------
225.58(c) and                 100                   36              3,600               .5                 1,800
 (d)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                      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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                      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
----------------------------------------------------------------------------------------------------------------
225.158                    45,000                    1             45,000              4                 180,000
----------------------------------------------------------------------------------------------------------------
225.180                    45,000                   32          1,440,000               .12              172,000
----------------------------------------------------------------------------------------------------------------
225.202                    45,000                  260         11,700,000               .33            3,861,000
----------------------------------------------------------------------------------------------------------------
TOTAL                                                                                                  4,393,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 33043]]

    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: June 4, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13215 Filed 6-10-04; 8:45 am]

BILLING CODE 4160-01-S