[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Notices]
[Pages 67076-67078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33487]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0510]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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 reinstatement of an existing collection of
information, and 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 comments on the collection of information by
February 23, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 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, 301-827-1472.
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
[[Page 67077]]
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 listed below.
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.
Current Good Manufacturing Practice Regulations for Medicated
Feeds--(21 CFR Part 225)--(OMB Control Number 0910-0152--
Reinstatement)
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 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 ensure that proper quality control
is maintained. Such records would, e.g., 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
ensure 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
(b)(8) 1,600 24 38,400 0.41 16,000
225.58(c) and (d) 1,600 24 38,400 0.25 9,600
225.80(b)(2) 1,600 24 38,400 0.16 6,400
225.102(b)(1)
through (b)(5) 1,600 24 38,400 1.0 38,400
225.110(b)(1) and
(b)(2) 1,600 24 38,400 0.25 9,600
225.115(b)(1) and
(b)(2) 1,600 24 38,400 0.25 9,600
Total 89,600
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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
(b)(8) 200 3 600 0.16 100
225.58(c) and (d) 200 3 600 0.16 100
225.80(b)(2) 200 3 600 0.083 50
225.102(b)(1)
through (b)(5) 200 3 600 0.5 300
225.110(b)(1) and
(b)(2) 3
225.115(b)(1) and
(b)(2) 3
Total 550
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Mixer-feeders.
\3\ There is no burden because medicated feeds are consumed on site (225.110 Distribution Records; 225.115--
Complaint files).
[[Page 67078]]
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 13,000 24 316,800 0.41 132,000
225.158 13,000 24 316,800 0.25 79,200
225.180 13,000 24 316,800 0.16 52,800
225.202 13,000 24 316,800 1.5 475,200
Total 739,200
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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 4.--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 45,000 3 135,000 0.16 22,500
225.158 45,000 3 135,000 0.16 22,500
225.180 45,000 3 135,000 0.083 11,250
225.202 45,000 3 135,800 0.5 67,500
Total 123,750
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ 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: December 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33487 Filed 12-22-97; 8:45 am]
BILLING CODE 4160-01-F