[Federal Register Volume 62, Number 246 (Tuesday, December 23, 1997)]
[Notices]
[Pages 67076-67078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33487]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97N-0510]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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 publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed reinstatement of an existing collection of 
information, and 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 written comments on the collection of information by 
February 23, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: 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

[[Page 67077]]

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 reinstatement 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 listed below.
    With respect to the following collection of information, FDA 
invites comments on: (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--
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 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 that proper quality control 
is maintained. Such records would, e.g., 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. 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                     
----------------------------------------------------------------------------------------------------------------
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                                                                                              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                
----------------------------------------------------------------------------------------------------------------
                                              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)                                                                             3                           
225.115(b)(1) and                                                                                               
 (b)(2)                                                                             3                           
Total                                                                                                 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 (225.110 Distribution Records; 225.115--    
  Complaint files).                                                                                             


[[Page 67078]]


                       Table 3.--Estimated Annual Recordkeeping Burden (Nonregistered)1 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                                                                                            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                       
----------------------------------------------------------------------------------------------------------------
                                              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             135,000               0.16           22,500       
225.180                    45,000               3             135,000               0.083          11,250       
225.202                    45,000               3             135,800               0.5            67,500       
Total                                                                                            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 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: December 16, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33487 Filed 12-22-97; 8:45 am]
BILLING CODE 4160-01-F