
[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]               
[Page 73101-73103]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29no10-100]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0601]

 
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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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

[[Page 73102]]

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 either electronic or written comments on the collection 
of information by January 28, 2011.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: Johnny Vilela, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7651, juanmanuel.vilela@fda.hhs.gov.

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 
FD&C 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 FD&C 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 FD&C 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 FD&C 
Act.
    A license is required when the manufacture 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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                                                      Annual
         21 CFR Section               No. of       frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8).....           1,004             260         261,040           1             261,040
225.58(c) and (d)...............           1,004              45          45,180            .5            22,590
225.80(b)(2)....................           1,004           1,600       1,606,400            .12          192,768
225.102(b)(1)...................           1,004           7,800       7,831,200            .08          626,496
225.110(b)(1) and (b)(2)........           1,004           7,800       7,831,200            .015         117,468
225.115(b)(1) and (b)(2)........           1,004               5           5,020            .12              602
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       1,220,964
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 73103]]


             Table 2--Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders) \1\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
225.42(b)(5) through (b)(8).....             100             260          26,000             .15           3,900
225.58(c) and (d)...............             100              36           3,600             .5            1,800
225.80(b)(2)....................             100              48           4,800             .12             576
225.102(b)(1)...................             100             260          26,000             .4           10,400
                                 -------------------------------------------------------------------------------
    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\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
----------------------------------------------------------------------------------------------------------------
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         172,800
225.202.........................          45,000             260      11,700,000             .33       3,861,000
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............       4,393,800
----------------------------------------------------------------------------------------------------------------
\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: November 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29928 Filed 11-26-10; 8:45 am]
BILLING CODE 4160-01-P

