Docket No. O1N - 0046 OMB 0910-0152

SUPPORTING STATEMENT

THE CURRENT GOOD MANUFACTURING PRACTICE FOR

MEDICATED FEEDS

A. JUSTIFICATION

1\. [Circumstances Making the Collection of Information
Necessary]{.underline}

The Federal Food, Drug, and Cosmetic Act (the act) under the Drug
Amendments of 1962 provides authorization to establish current good
manufacturing practice regulations (CGMPs) for drugs, including
medicated feeds. Medicated feeds which are not manufactured under
conforming methods or in conforming facilities are deemed to be
adulterated under section *5*01(a)(2)(B) of the act. Regulations
concerning current good manufacturing practices in the manufacture of
medicated feeds (21 CFR Part 225), were initially established May 11,
1965. The current regulations were published March 3, 1986.

The specific citations within 21 CFR Part 225 regarding recordkeeping
requirements for which

we request OMB approval are as follows:

Licensed Commercial Feed Mills:

21 CFR 225.42(b)(5) through (b)(8) - Recordkeeping - Specifies
recordkeeping requirements for procedures for the receipt , storage and
inventory control of medicated feeds.

21 CFR 225.588 (c) and (d) - Recordkeeping - Specifies recordkeeping
requirements for the results of periodic assays for medicated feeds that
are in accord with label specifications and also those medicated feeds
not within documented permissible assay limits.

21 CFR 225.80 (b)(2) - Recordkeeping - Requirement that verified
medicated feed label (s) be kept for one year.

21 CFR 225.102 (b)(1) - Recordkeeping - Specifies recordkeeping
requirements for master record files and production records for
medicated feeds.

21 CFR 225.110(b1) and (b)(2) - Recordkeeping - Specifies recordkeeping
requirements for maintenance of distribution records for medicated
feeds.

21 CFR 225.115 (b)(1) and (b)(2) - Recordkeeping - Specifies
recordkeeping requirements for maintenance of complaint files by the
medicated feed manufacturer.

Licensed Mixer - Feeders:

21 CFR 225.42(b)(5) through (b)(8) - Recordkeeping - Specifies
recordkeeping requirements for procedures for receipt, storage and
inventory control of medicated feeds.

21 CFR 225.58 8 (c) and (d) - Recordkeeping - Specifies recordkeeping
requirements for the results or periodic assays of medicated feeds that
are in accord with label specifications and also those medicated feeds
not within documented permissible assay limits.

21 CFR 225.80 (b)(2) - Recordkeeping - Requirement that verified
medicated feed label(s) be kept for one year.

21 CFR 225.102 (b)(1) through (b)(5) - Recordkeeping - Specifies
recordkeeping requirements for master record files and production
records for medicated feeds.

Licensed Commercial Feed Mills:

21 CFR 225.142 - Recordkeeping - Specifies recordkeeping requirements
for adequate recordkeeping procedures for identification , storage and
inventory control (receipt and use) of Type A medicated articles and
Type B medicated feeds.

21 CFR 225.158 - Recordkeeping - Specifies recordkeeping requirements
when the results of laboratory assays of drug components indicate that
the medicated feed is not in accord with the permissible assay limits.

21 CFR- 225.180 - Recordkeeping - Specifies recordkeeping requirements
for identification , storage and inventory control of labeling in a
manner that prevent label mixups and assures that correct labels are
used for medicated feeds.

21 CFR 225.202 - Recordkeeping - Specifies recordkeeping requirements
for retention of formula production and distribution records.

Unlicensed Mixer-Feeders:

21 CFR 225.142 - Recordkeeping - Specifies recordkeeping requirements
for adequate recordkeeping procedures for identification , storage and
inventory control (receipt and use), of

Type A medicated articles and Type B medicated feeds.

21 CFR 225.158 - Recordkeeping - Specifies recordkeeping requirements
when the results of laboratory assays of drug components indicate that
the medicated feed is not in accord with the permissible assay limits.

21 CFR- 225.180 - Recordkeeping - Specifies recordkeeping requirements
for identification , storage and inventory control of labeling in a
manner that prevent label mixups and assures that correct labels are
used for medicated feeds.

21 CFR 225.202 - Recordkeeping - Specifies recordkeeping requirements
for retention of formula production and distribution records.

2\. [Purpose and Use of the Information]{.underline}

Medicated animal feeds are produced using Type A medicated articles and
various feed ingredients such as ground corn. These feeds contain animal
drugs intended for prevention, cure, mitigation, or treatment of disease
(therapeutic use), or intended to affect the structure or function of
the animal (growth promotion and feed efficiency). Compliance with
cGMP\`s provides some assurance that medicated feeds will be safe and
effective for their labeled conditions of use and that edible products
from treated animals will be free of unsafe drug residues. The
recordkeeping and retention requirements are intended as a drug
accountability system consisting of records of receipt, batch
production, daily drug inventory, distribution, and compliant files.

Facilities manufacturing certain medicated feeds using Type A medicated
articles are required to register as drug manufacturers under section
510 of the act; as such, these firms are subject to FDA inspection every
two years. Recordkeeping and retention requirements provide documented
evidence of compliance with current good manufacturing practices. The
remaining medicated feed manufacturers, while not required to register
with FDA, are required to be in compliance with a less stringent set of
current good manufacturing practice requirements. These facilities are
subject to occasional inspection by FDA, generally for cause.

The kind of records required by 21 CFR Part 225 are those normally
maintained by an efficient feed manufacturing facility to monitor its
own functions and drug accountability. Drug inventory control is
necessary so that the firms and Agency investigators can monitor drug
usage and possible over-or-under formulation of medicated feeds. In
addition, such information is reviewed by the Agency in the course of
follow-up investigations of drug residues in edible products of treated
animals.

3\. [Use of Information Technology and Burden Reduction]{.underline}

The industry is increasingly turning to the use of automated production
facilities. The use of

computer generated records is acceptable for the purposes of
recordkeeping for FDA inspections.

4\. [Efforts to Identify Duplication and Use of Similar
Information]{.underline}

Each manufacturer is responsible for the labeling and recordkeeping for
the products they manufacture. No duplication would, therefore, occur.
There are no similar records that could substitute for those required by
these regulations.

5\. [Impact on Small Business or Other Small Entities]{.underline}

The same information is requested from large and small firms and is the
minimal amount needed. Headquarters and field personnel provide direct
assistance and advice to small businesses in dealing with the
requirements through the FDA Office of Small Manufacturers Assistance.

6\. [Consequences of Collecting the Information Less
Frequently]{.underline}

If this information was not reported, FDA would not have access to
information necessary for determining risk to the public health, of a
potential contamination problem concerning medicated feeds.

7\. [Special Circumstances Relating to the Guidelines of 5 CFR
1320.5]{.underline}

None of the collection requirements are inconsistent with 5 CFR 1320.5.

8\. [Comments in Response to the Federal Register Notice and Efforts to
Consult Outside]{.underline} [Agencies]{.underline}.

No comments were received in response to the Federal Register Notice (FR
/Vol. 66. Feb. 0,2001/ pp9707).

9\. [Explanation of Any Payment or Gift to Respondents]{.underline}

This information collection does not provide for payment or gifts to
respondents.

10\. [Assurance of Confidentiality Provided to Respondent]{.underline}

All confidential information will be kept confidential in accordance
with 18 U.S.C. 1905 and 21 U.S.C.331(j), as well as section 301(j) of
the Act.

11\. [Justification for Sensitive Questions]{.underline}

These regulations do not contain questions pertaining to sex behavior,
attitude, religious beliefs, or any other matters that are commonly
considered private or sensitive in nature.

12\. [Estimates of Hour Burden Including Annualized Hourly
Costs]{.underline}

The burden hours for this collection of information were derived as
follows:

There are approximately 54,250 feed manufacturers that must comply with
current good, manufacturing practice (cGMP\'s) regulations for medicated
feeds when manufacturing medicated animal feed. Licensed manufacturers,
those manufacturing a medicated feeds using a drug which FDA has
determined requires more control because of the need for a withdrawal
period before slaughter or carcinogenic concerns, are required to comply
with the more stringent cGMP\'s. Those firms not required to be licensed
must comply with the less demanding cGMPs. Of the 54,250 manufacturers,
it is estimated that 1,250 are license holders (1,150 are commercial
feed mills and 100 are mixer‑feeders or on‑farm operations). The
remainder of the 54,250 (i.e., 53,000) consists of non‑license holders
(8,000 are commercial feed mills and 45,000 are mixer‑feeder
operations).

Thus, a breakout of the recordkeeping requirements for each class of
facility are as follows:

Table 1.- Estimated Annual Recordkeeping Burden (Registered License
Commercial Feed Mill) 1

+-----------+-----------+-----------+-----------+-----------+-----------+
| 21 CFR    | No. of    | Annual    | Total     | Hours per | Total     |
| Section   | Reco      | Frequency | Annual    | Rec       | Hours     |
|           | rdkeepers | per       | Records   | ordkeeper |           |
|           |           | Reco      |           |           |           |
|           |           | rdkeeping |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225.42    | 1150      | 260       | 299,000   | 1         | 299,000   |
| (b)(5)    |           |           |           |           |           |
| through   |           |           |           |           |           |
| (b)(8)    |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225.58    | 1150      | 45        | 51,750    | .5        | 25,875    |
|           |           |           |           |           |           |
| ( c) and  |           |           |           |           |           |
| (d)       |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225       | 1150      | 1600      | 1,840,000 | .12       | 220,800   |
| .80(b)(2) |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225.      | 1150      | 7800      | 8,970,000 | .08       | 717,600   |
| 102(b)(1) |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225.      | 1150      | 7800      | 8,970,000 | .015      | 134,550   |
| 110(b)(1) |           |           |           |           |           |
| and       |           |           |           |           |           |
| (b)(2)    |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225.      | 1150      | 5         | 5750      | .12       | 690       |
| 115(b)(1) |           |           |           |           |           |
| and       |           |           |           |           |           |
| (b)(2)    |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| TOTAL     |           |           |           |           | 1,398,515 |
+-----------+-----------+-----------+-----------+-----------+-----------+

1 There are no capital costs or operating and maintenance costs
associated with this collection of infor

^Table\ 2\ -Estimated\ Annual\ Recordkeeping\ Burden\ (Registered\ License\ Mixer\ Feeders)\ 1^

+-----------+-----------+-----------+-----------+-----------+-----------+
| 21 CFR    | No. of    | Annual    | Total     | Hours per | Total     |
| Section   | Reco      | Frequency | Annual    | Rec       | Hours     |
|           | rdkeepers | per       | Records   | ordkeeper |           |
|           |           | Reco      |           |           |           |
|           |           | rdkeeping |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225       | 100       | 260       | 26,000    | .15       | 3,900     |
| .42(b)(5) |           |           |           |           |           |
| through   |           |           |           |           |           |
| (b)(8)    |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225.58(c) | 100       | 36        | 3600      | .5        | 1800      |
| and       |           |           |           |           |           |
|           |           |           |           |           |           |
| (d))      |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225       | 100       | 48        | 4800      | .12       | 576       |
| .80(b)(2) |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| 225.      | 100       | 260       | 26,000    | .4        | 10,400    |
| 102(b)(1) |           |           |           |           |           |
| through   |           |           |           |           |           |
| (b)(5)    |           |           |           |           |           |
+-----------+-----------+-----------+-----------+-----------+-----------+
| TOTAL     |           |           |           |           | 16,676    |
+-----------+-----------+-----------+-----------+-----------+-----------+

1 There are no capital costs or operating and maintenance costs
associated with this collection of information

> Commercial feed mills will, on average, manufacture about 400
> different medicated feeds requiring recordkeeping. The recordkeeping
> burden for each feed mill is 3.04 hours per product x 400 products =
> 1,215.5 hours per year. Therefore, the total annual burden in hours
> for 1,150 commercials feed mills is 1,150 x 1,215.5 = 1,397,825.
>
> Mixer-feeders on average manufacture 12 different medicated feeds
> requiring recordkeeping. The recordkeeping burden for each
> mixer-feeder is 13.90 hours per product x 12 products = 166.76 hours
> per year. Therefore, the total annual burden in hours for the 100
> mixers-feeders is 100 x 166.76 = 16,676.

Table 3- Estimated Recordkeeping Burden ( Nonregistered Unlicensed
Commercial Feed Mills) 1

  ----------- --------------- --------------- ----------- -------------- -----------
  21 CFR      No. of          Annual          Total       Hours per      Total Hours
  Section     Recordkeepers   Frequency per   Annual      Recordkeeper   
                              Recordkeeping   Records                    

  225.142     8000            4               32,000      1              32,000

  225.158     8000            1               8000        4              32,000

  225.180     8000            96              768,000     .12            92,160

  225.202     8000            260             2,080,000   .65            1,352,000

  TOTAL                                                                  1,508,160
  ----------- --------------- --------------- ----------- -------------- -----------

1 There are no capital costs or opersating and maintenance costs
associated with this collection of information

Table 4 - Estimated Annual Recordkeping Burden (Non Registered
Unlicensed Mixer Feeders 1

  ----------- --------------- --------------- ------------ -------------- -----------
  21 CFR      No. of          Annual          Total Annual Hours per      Total Hours
  Section     Recordkeepers   Frequency per   Records      Recordkeeper   
                              Recordkeeping                               

  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 associated
with this collection of information,

Commercial feed mills will, on average, manufacture about 24 different
medicated feeds requiring recordkeeping. The recordkeeping burden for
each feed mill is 7.85 hours per products x 24 products = 188.52 hours
per year. Therefore, the total annual burden in hours for 8,000
commercial feed mills is 8,000 x 188.52 = 1,508,160.

Mixer-feeders on average manufacture 8 different medicated feeds
requiring recordkeeping. The recordkeeping burden for each mixer-feeder
is 12.20 hours per product x 8 products = 97.62 hours per year.
Therefore, the total annual burden in hours for the 45,000 mixer-feeders
is 45,000 x 97.62 = 4,393,000.

Costs to Respondents

The costs to the respondents is calculated as a function of the time
required for compliance with these requirements. The total annual cost
to the respondents is estimated to be \$73,156,610. The costs estimate
is based on an aggregate average hourly wage of \$10.00, and an annual
burden of 7,315,661 hours (\$10.00 x 7,315,661 = \$73,156,610).

14\. [Annualized Costs to the Federal Government]{.underline}

It has been estimated that an FDA inspector spends approximately 8 hours
conducting the inspection and writing the report. Five hundred
thirty-seven inspections were conducted by FDA personnel in 2000. These
inspections, conducted by a GS 12-05 earning approximately 28.96 an hour
resulted in an estimated annual cost of 8 hours x 537 inspections x
28.96 per hour = \$124,412.16.

15\. [Explanation of Program Change or Adjustments:]{.underline}

Prior publications announcing opportunity for public comment on
estimated burden have not generated comments. Recent discussions with
industry representatives finds previous burdens exceedingly low. We have
adjusted the numbers of feeds manufactured and the times required to
comply with the regulation, resulting in an increase from 946,852 hours
in 1998 to the current estimate of 7,315,661 hours.

16\. [Plans for Tabulation and Publication and Project Time
Schedule]{.underline}

There is no intent on the part of the Federal Government to publish this
data, nor is any

general statistical analysis by the Federal Government anticipated