[Federal Register: February 9, 2001 (Volume 66, Number 28)]
[Notices]
[Page 9707-9709]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09fe01-53]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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
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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\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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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\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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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\
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Annual
21 CFR Section No. of Frequency per Total Annual Records Hours per Total Hours
Recordkeepers Recordkeeping Recordkeeper
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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.
\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