[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37396-37397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18398]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0510]
Agency Information Collection Activities; Submission for OMB
Review; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
proposed collection of information listed below has been submitted to
the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995 (the PRA).
DATES: Submit written comments on the collection of information by
August 10, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503,
Attention: Desk Officer for FDA.
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: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance.
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 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 ensure 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
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. The
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 burden hours 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) 200 3
225.115(b)(1) and (b)(2) 200 3
[[Page 37397]]
Total burden hours 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 (Sec. 225.110 Distribution records; Sec.
225.115 Complaint files).
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 burden hours 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 3 135,500 0.16 22,500
225.180 45,000 3 135,500 0.083 11,250
225.202 45,000 3 135,500 0.5 67,500
Total burden hours 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 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 30, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18398 Filed 7-9-98; 8:45 am]
BILLING CODE 4160-01-F