[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://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\
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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)
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225.58(c) and 1,150 45 51,750 .5 28,875
(d)
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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)
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225.115(b)(1) 1,150 5 5,750 .12 690
and (b)(2)
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[[Page 33042]]
Total 1,397,825
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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\
----------------------------------------------------------------------------------------------------------------
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)
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225.58(c) and 100 36 3,600 .5 1,800
(d)
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225.80(b)(2) 100 48 4,800 .12 576
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225.102(b)(1) 100 260 26,000 .4 10,400
through
(b)(5)
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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\
----------------------------------------------------------------------------------------------------------------
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
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225.158 8,000 1 8,000 4 32,000
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225.180 8,000 96 768,000 .12 92,160
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225.202 8,000 260 2,080,000 .65 1,352,000
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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\
----------------------------------------------------------------------------------------------------------------
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
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225.202 45,000 260 11,700,000 .33 3,861,000
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TOTAL 4,393,000
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\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