[Federal Register: November 3, 2004 (Volume 69, Number 212)]
[Notices]
[Page 64073-64074]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no04-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0245]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Current Good
Manufacturing Practice Regulations for Medicated Feeds
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 2, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie
Yokota, Desk Officer for FDA, FAX 202-395-6974.
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: In compliance with 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)--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 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.
In the Federal Register of June 14, 2004 (69 FR 33040), FDA
published a 60-day notice, soliciting comments on the collection of
information requirements for this clearance. In response, no comments
were received.
Respondents to this collection of information are commercial feed
mills and mixer-feeders.
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)
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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)
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225.115(b)(1) 1,150 5 5,750 .12 690
and (b)(2)
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Total 1,397,825
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\1\ There are no capital or operating and maintenance costs associated with this collection of information.
[[Page 64074]]
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
----------------------------------------------------------------------------------------------------------------
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.
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: October 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24448 Filed 11-2-04; 8:45 am]
BILLING CODE 4160-01-S