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 Department of Health and Human Services Food and Drug Administration [Docket No. 01N-0046]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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 July 16, 2001.
 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, Attn: Wendy Taylor,  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 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 No. 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 for growth promotion and feed efficiency.  Statutory requirements for CGMPs have been codified in 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 that 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. 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
21 CFR Section
No. of Recordkeepers
Annual Frequency ­per ­Recordkeeping
Total Annual Records
Hours ­per ­Recordkeeper
Total Hours225.42(b)(5) through (b)(8)
1,150
260
299,000
1
299,000225.58© and (d)
1,150
45
51,750
.5
25,875225.80(b)(2)
1,150
1,600
1,840,000
.12
220,800225.102(b)(1)
1,150
7,800
8,970,000
.08
717,600225.110(b)(1) and (b)(2)
1,150
7,800
8,970,000
0.15
134,550( print page 32630)225.115(b)(1) and (b)(2)
1,150
5
5,750
.12
690Total




1,398,5151
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 **Table**
                         2.—
                        **Estimated Annual Recordkeeping Burden (Registered Licensed Mixer-Feeders)**1
21 CFR Section
No. of Recordkeepers
Annual Frequency ­per ­­Recordkeeping
Total Annual Records
Hours ­per ­Recordkeeper
Total Hours225.42(b)(5) through (b)(8)
100
260
26,000
.15
3,900225.58© and (d)
100
36
3,600
.5
1,800225.80(b)(2)
100
48
4,800
.12
576225.102(b)(1) through (b)(5)
100
260
26,000
.4
10,400Total




16,6761
                         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
21 CFR Section
No. of Recordkeepers
Annual Frequency ­per ­Recordkeeping
Total ­Annual ­Records
Hours ­per ­Recordkeeper
Total Hours225.142
8,000
4
32,000
1
32,000225.158
8,000
1
8,000
4
32,000225.180
8,000
96
768,000
.12
92,160225.202
8,000
260
2,080,000
.65
1,352,000Total




1,508,1601
                         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
21 CFR Section
No. of Recordkeepers
Annual Frequency per ­Recordkeeping
Total Annual Records
Hours per Recordkeeper
Total Hours225.142
45,000
4
180,000
1
180,000225.158
45,000
1
45,000
4
180,000225.180
45,000
32
1,440,000
.12
172,800225.202
45,000
260
11,700,000
.33
3,861,000Total




4,393,8001
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 The estimate of the time 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 8, 2001. Margaret M. Dotzel, Associate Commissioner for Policy.


[FR Doc. 01-15081 Filed 6-14-01; 8:45 am] BILLING CODE 4160-01-S