Docket No. O1N - 0048 OMB 0910-0154

SUPPORTING STATEMENT

CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES - 21
CFR PART 226

A. JUSTIFICATION

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

The Federal Food, Drug, and Cosmetic Act ( the act), authorizes
establishment by FDA of current good manufacturing practice regulations
(CGMPs), for drugs, including Type A medicated articles which are
intended for use in the manufacture of medicated complete animal feeds.
Type A medicated articles are feed products containing a concentrated
drug diluted with a feed carrier substance(s). Current good
manufacturing practices regulations in the manufacture of medicated
premixes were established November 1, 1967. The Title \"Medicated
Premix\", was changed to \'Type A Medicated Article as of March 1, 1986.
Type A medicated articles which are not manufactured in accordance with
CGMPs are deemed to be adulterated under section 501 (a)(2)(B) of the
Act.

The collection of information requirements within 21 CFR Part 226 for
which OMB approval is being requested are summarized below:

21 CFR 226.42 - Recordkeeping - Requirement that records be prepared and
maintained for two years with respect to components (drug and nondrug),
used in the manufacture of the medicated premixes.

21 CFR 226.58 - Recordkeeping- Specifies recordkeeping requirements for
establishment of laboratory controls to ensure that adequate
specifications and test procedures for the drug components and Type A
Medicated Article(s) conform to appropriate standards of identity,
strength, quality and purity.

21 CFR 226.80 Recordkeeping- Requires maintenance of records for
packaging and labeling of Type A Medicated Article(s).

21 CFR 226-102- Recordkeeping - Requirement for maintenance of
master-formula and batch production records for Type A Medicated
Article(s).

21 CFR 226.110 Recordkeeping - Requirement for maintenance of
distribution records ( 2 years), for each shipment of Type A Medicated
Article(s) for recall purposes.

21 CFR 226.115 Recordkeeping - Requirement for maintenance of complaint
files for Type A medicated article for two years.

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

Records retention required by 21 CFR Part 226 are those normally
maintained by an efficient drug manufacturing facility to monitor its
own functions and drug accountability. Drug inventory control is
necessary to monitor drug usage and possible under-or-over-formulation
of Type A medicated articles. Production and distribution records are
essential in the investigation of product defects, particularly when a
drug recall is indicated.

3[.]{.underline} [Use of Information Technology]{.underline}

The kind of information required by these regulations may be met by the
type of records normally on hand and those introduced by the use of
computer technology. Computers have been introduced to maintain control
over the total manufacturing process, Many firms now use computerized
forms to maintain procedures and provide analytical information. With
computer assisted equipment, many areas of recordkeeping are handled
routinely and without error. The FDA has developed guides to assure that
computerized operations are validated and properly run.

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

Data collected is site specific, so there is no duplication of efforts.
There are no other regulations that require collection of the same data.

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 Manufacture Assistance.

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

The information required under these regulations must be developed for
each batch of Type A medicated article manufactured. There is no time
schedule for information collection. The frequency is set by the
manufacturers production schedule.

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 the Agenc]{.underline}y

This regulation was subject to public comment under the Administrative
Procedures Act and public comments were addressed as part of the public
rulemaking process. No changes have been made in the regulatory
requirements and no comments were submitted in response to the 60 day
Federal Register notice of February 9, 2001, (66 FR 9706). Additionally,
there is continuous communication with two organizations representing
the industry i.e., the Animal Health Institute, Alexandria, VA and the
American Feed Industry Association, Arlington, VA.

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

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

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

Confidentiality of information will be safeguarded within the provisions
of FDA\'s public information regulations in 21 CFR Part 20.

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

This information collection does not involve questions pertaining to sex
behavior, attitude, religious beliefs, or any other matters that are
commonly considered private or sensitive in nature.

12\. [Estimate of Hour Burden Including Annualized Hourly
Cost]{.underline}

Under the act, all manufacturers of Type A medicated articles are
required to register. Because these firms may also be registered as
manufacturers of animal drugs (pharmaceutical dosage forms) or animal
feeds, an accurate complete count is difficult. Our best estimate is
that approximately 115 firms are involved in the manufacture of Type A
medicated articles. All manufacturers are required to keep records to
document procedures required under the manufacturing process to assure
that proper quality control is maintained. Time spent on records under
the regulations related to the manufacturing operation are estimated as
follows:

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

  226.42      115             260             29,900      0.75           22,425

  226.58      115             260             29,900      1.75           52,325

  226.80      115             260             29,900      0.75           52,325

  226.102     115             260             29,900      1.75           52,325

  226.110     115             260             29,900      0.25           7475

  226.115     115             10              1150        0.5            575

  TOTAL                                                                  187,450
  ----------- --------------- --------------- ----------- -------------- -----------

13\. [Estimate of Other Total Annual Cost Burden to Respondent or
Recordkeeper]{.underline}

There are no additional annual cost burdens to respondents.

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

The cost to the Federal Government reflects the time an investigator
spends reviewing the various type of records to ensure proper adherence
to the cGMPs. During an inspection, a review of the records amounts to
approximately 15 minutes per record as an average. Depending on the type
of record and data, the time can range from 5 minutes to 30 minutes. FDA
professional staff spends approximately 36 hours per inspection in the
observation of facilities, operations and records. Based upon 21
inspections per year, the cost to the government is \$21,987 (21x
\$1047), per inspection. The hourly rate was computed on the basis of a
GS 12-05 investigator making 60,242 per annum or 28.96 per hour, and the
hourly rate of a GS 5-05 clerk typist making 33,068 per annum or 15.90
per hour.

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

There has been a significant decrease in the number of firms
manufacturing Type A

medicated articles since last approval of this collection of information
i.e., from 200 firm to 115 firms. However, total production has remained
about the same with the lesser number of manufacturers producing more
per firm. As a result, the hourly burden has increased (adjustment),
over the the previous approval from 150,000 to 187,450 burden hours.

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

This section is not applicable since the information collected is site
dependent and

not sent to a central point for compilation for statistical purposes.