**[OMB 0910-0337]{.underline}**

[SUPPORTING STATEMENT]{.underline}

A. JUSTIFICATION

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

The Animal Drug Availability Act (ADAA) of October 9, 1996, amended
section 512 of the FD&C Act to replace the system for the approval of
specific medicated feed with a general licensing system for feed mills.

Before passage of the ADAA, medicated feed manufacturers were required
to obtain approved Medicated Feed Applications (MFAs) in order to
manufacture certain types of medicated feeds. An individual approved MFA
was required for each and every applicable medicated feed. The ADAA
streamlined the paperwork process for gaining approval to manufacture
medicated feeds by replacing the MFA system with a facility license for
each medicated feed manufacturing facility. Implementing regulations are
at 21 CFR Part 515.

We are requesting OMB approval for information collection under the
following citations:

**21 CFR 515.10(b) Reporting**

Specifies requirements for submitting a completed medicated feed mill
license application using Form FDA 3448.

**21 CFR 515.11(b) Reporting**

Specifies requirements for supplemental medicated feed mill license
applications for a change in ownership and/or a change in address for
the facility using Form FDA 3448

**21 CFR 515.23 Reporting**

Sets forth written requirements for for voluntary revocation of a
medicated feed mill license by the sponsor of that facility on the
grounds that the facility is no longer manufacturing medicated animal
feed.

**21 CFR 515.30(c) Reporting**

Details requirements for filing a request for a hearing by a sponsor to
give reasons why a medicated feed mill license should not be refused or
revoked.

**21 CFR 515.305(b) Recordkeeping**

Requires maintenance of approved labeling for each Type B and Type C
medicated animal feed being manufactured.

We are also requesting approval of FDA Form 3448 ( attached).

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

We will use the information required from the medicated feed
manufacturing facility, in accordance with 21 CFR 515.10(b), to
determine if a medicated feed mill license application will be approved
or denied. Form FDA 3448 will be used to certify the information.

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

We have assembled the list of licensees in a computerized data base
available on the CVM Home Page on the Internet. The Home Page also
contains information on licensing and a license application, Form FDA
3448.

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

Each medicated feed manufacturing facility is requested to submit data
to obtain a license. Data collected is site specific, so there is no
duplication of efforts.

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

The proposed collection of information carries the same burden for small
or large firms. The data collection is minimal.

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

Medicated feed manufacturing facilities will not be allowed to enter the
market if the information is not submitted. This is a one time
submission.

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

All of the reporting requirements are consistent with 5 CFR 1320.5

8\. [Efforts to Obtain Comments on the Information Collection Before
Submission to OMB]{.underline}.

In the Federal Register of May 23, 2003, \[68FR26237\], FDA published a
60 day notice requesting comment on the collection of information. In
response to that collection, FDA received no coments. In addition, the
American Feed Industry Association, an industry association of feed
mills, and the Animal Health Institute fully support the new licensing
system, as indicated by their support of the legislative initiative and
the passage of the ADAA.

.

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

There are no payments or gifts to respondents.

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

Information will be kept confidential in accordance with FDAs public
information regulations in 21 CFR Part 20.

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

The information collection does not involve any questions of a sensitive
nature.

12\. [Estimates of Hour Burden to Respondents]{.underline}

Estimated annual reporting burden on industry is 36.6 hours as shown in
the table below. Industry estimates it takes about 1/4 hour to submit
the application. We estimate 132 original and supplement applications,
and voluntary revocations for a total of 33 hours (132 submissions x 1/4
hour). An additional 3 hours is added for the rare notice of opportunity
for a hearing to not approve or revoke an application. Finally, we
estimate 36 hours for maintaining and retrieving labels as required by
21 CFR 510.305. We estimated .03 hours for each of approximately 1,160
licensees. Total burden for reporting and recordkeeping would be 71.0
hours.

Table 1 - Estimated Annual Reporting Burden

+----------+------------+----------+-----------+-----------+----------+
| 21 CFR   | No. of     | Annual   | Total     | Hours per | Total    |
|          | R          | F        | Annual    | Response  | Hours    |
|          | espondents | requency | Responses |           |          |
|          |            | per      |           |           |          |
|          |            | Response |           |           |          |
+----------+------------+----------+-----------+-----------+----------+
| 5        | 7          | 1        | 7         | 0.25      | 1.75     |
| 15.10(b) |            |          |           |           |          |
|          | 100        | 1        | 100       | 0.25      | 25       |
| 5        |            |          |           |           |          |
| 15.11(b) | 25         | 1        | 25        | 0.25      | 6.25     |
|          |            |          |           |           |          |
| 515.23   | 0.15       | 1        | 0.15      | 24        | 3.6      |
|          |            |          |           |           |          |
| 5        |            |          |           |           |          |
| 15.30(c) |            |          |           |           |          |
+----------+------------+----------+-----------+-----------+----------+
| Total    |            |          |           |           | 36.6     |
| Burden   |            |          |           |           |          |
|          |            |          |           |           |          |
| Hours    |            |          |           |           |          |
+----------+------------+----------+-----------+-----------+----------+

Table 2 - Estimated Annual Recordkeeping Burden

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

  510.305   1,160           1               1,160       0.03           34.80
  --------- --------------- --------------- ----------- -------------- -----------

13\. [Estimate of Other Total Cost Burden to Respondents and
Recordkeepers]{.underline}

Total annual cost burden is included in the preceding paragraph. There
are no additional costs to respondents.

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

We estimate that it will take us 40 minutes to process each of the

approximately132original applications, supplemental applications and
voluntary

revocations in a years. This would result in approximately 88 hours (2/3
hour x

132 applications).

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

The increase in burden is due to an increase in the number of
recordkeepers

.

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

. Information is not to be published for statistical use. However, the
list of licensees

is available on the CVM Home Page on the Internet.