[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)<SUP>1 <SUP>2                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
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)<SUP>1 <SUP>2                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
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                                               <SUP>3                       
225.115(b)(1) and (b)(2)              200                                               <SUP>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)<SUP>1 <SUP>2                       
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
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       
----------------------------------------------------------------------------------------------------------------
\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)<SUP>1 <SUP>2                       
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
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       
----------------------------------------------------------------------------------------------------------------
\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