[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)
----------------------------------------------------------------------------------------------------------------
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)
----------------------------------------------------------------------------------------------------------------
225.115(b)(1)                 1,150                  5              5,750               .12                  690
 and (b)(2)
----------------------------------------------------------------------------------------------------------------
Total                                                                                                  1,397,825
----------------------------------------------------------------------------------------------------------------
\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)
----------------------------------------------------------------------------------------------------------------
225.58(c) and                 100                   36              3,600               .5                 1,800
 (d)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
----------------------------------------------------------------------------------------------------------------
225.202                    45,000                  260         11,700,000               .33            3,861,000
----------------------------------------------------------------------------------------------------------------
TOTAL                                                                                                  4,393,000
----------------------------------------------------------------------------------------------------------------
\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