0154 ss 7-15-2020

United States Food and Drug Administration
Current Good Manufacturing Practice Regulations for Type A Medicated Articles
OMB Control No. 0910-0154
SUPPORTING STATEMENT
Part A: Justification:
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, Agency, us or we)
regulations. Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act),
FDA has the statutory authority to issue current good manufacturing practice (CGMP)
regulations for drugs, including Type A medicated articles. A Type A medicated article is a feed
product containing a concentrated drug diluted with a feed carrier substance. A Type A
medicated article is intended solely for use in the manufacture of another Type A medicated
article or a Type B or Type C medicated feed. 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 for Type A medicated articles have been codified
in part 226 (21 CFR part 226). Type A medicated articles which are not manufactured in
accordance with these regulations are considered adulterated under section 501(a)(2)(B) of the
FD&C Act (21 U.S.C. 351(a)(2)(B). Under part 226, a manufacturer is required to establish,
maintain, and retain records for Type A medicated articles, including records to document
procedures required under the manufacturing process to ensure 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), and product distribution.
We therefore request OMB extension of OMB approval of 0910-0154 found in 21 CFR part 226;
Current Good Manufacturing Practice Regulations for Type A Medicated Articles, as discussed
in this supporting statement.
2. Purpose and Use of the Information Collection
The required records are used by both the respondents and the FDA. The records are used by
manufacturers of Type A medicated articles to verify that appropriate control measures have
been maintained, or that appropriate corrective actions were taken if the control measures were
not maintained. Such verification activities are essential to ensure that the CGMP system is
working as planned. We review the records during the conduct of periodic plant inspections.
This information is needed so that we can monitor drug usage and possible misformulation of
Type A medicated articles. The information could also prove useful to us in investigating
product defects when a drug is recalled. In addition, we will use the CGMP criteria in part 226
to determine whether or not the systems used by manufacturers of Type A medicated articles are
adequate to ensure that their medicated articles meet the requirements of the FD&C Act as to
safety and also meet the article’s claimed identity, strength, quality, and purity, as required by
section 501(a)(2)(B) of the FD&C Act.

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3. Use of Improved Information Technology and Burden Reduction
The regulation does not specifically prescribe the use of automated, electronic, mechanical, or
other technological techniques or other forms of information technology as necessary for use by
firms. Companies are free to use whatever forms of information technology may best assist them
in retaining the appropriate records and making them available to regulatory officials. We
estimate that about ninety percent (90%) of respondents will keep some of the required records
electronically in the next 3 years.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. There is no duplication of effort in this
area. Data collected by each manufacturer is site specific. In addition, no duplication of Federal
regulations concerning medicated feed manufacturing is likely because of the clear
Congressional authorization in section 501(a)(2)(B) of the FD&C Act that FDA promulgate
regulations for drugs, including Type A medicated articles, as opposed to the U.S. Department of
Agriculture.
5. Impact on Small Businesses or Other Small Entities
Our best estimate is that approximately 65 firms are involved in the manufacturing of Type A
medicated articles. We estimate that 75 percent of these 65 firms, or 49 respondents, are small
businesses, and we have kept their particular needs in mind during the development of these
regulations. The recordkeeping is no more burdensome for small businesses than for large. The
requirements are the minimum requirements for CGMPs. We aid small businesses in complying
with our requirements through our Regional Small Business Representatives and through the
scientific and administrative staffs within the agency. We have provided a Small Business Guide
on our website at https://www.fda.gov/animal-veterinary/resources-you/industry.
6. Consequences of Collecting the Information Less Frequently
Under a CGMP system, the frequency of data collection by each manufacturer would occur
periodically during Type A medicated article manufacturing operations, but that frequency of
observation and recording would vary considerably for different manufacturers and different
Type A medicated articles. Less frequent recordkeeping would reduce or nullify the
effectiveness of the regulation to provide assurance to both the Type A medicated article
manufacturer and FDA that the Type A medicated article meets standards for safety and meets
the claimed identity, strength, quality, and purity standards. We do not collect CGMP records as
a routine matter. Records remain on file at each Type A medicated article manufacturing
facility. We would examine the records during a periodic inspection or during an investigation.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with this collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
FDA published a 60-day notice for public comment in the Federal Register of February 21, 2020
(85 FR 10170). No comments were received.
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9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, we consulted with our Privacy Office to ensure
appropriate handling of information collected.
This information collection request (ICR) collects personally identifiable information (PII). PII is
collected in the context of the individuals’ professional capacity. The PII collected as part of
inspections includes name, address, email address, phone number and fax number.
FDA further determined that although PII is collected the collection is not subject to the Privacy
Act of 1974 and the particular notice and other requirements of the Act do not apply.
Specifically, FDA does not use name or any other personal identifier to retrieve records from the
information collected. FDA also minimized the PII to be collected to protect the privacy of the
individuals.
Company records describing manufacturing procedures, which may be consulted during a
facility inspection, and CGMP records that we may copy or take possession of often contain
trade secret and confidential commercial information. Confidential commercial information is
protected from disclosure under the Freedom of Information Act (FOIA) under sections 552(a)
and (b) (5 U.S.C. 552(a) and (b)), by section 301(j) of the FD&C Act, and by part 20 of our
regulations (21 CFR part 20).
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection as follows:
Table 1. --Estimated Annual Reporting Burden
21 CFR Section

No. of
Recordkeepers

226.42; requires records be
prepared and maintained for
two years with respect to
components (drug and nondrug), used in the manufacture
of the medicated premixes.

65

No. of
Total
Records per
Annual
Recordkeeper Records
260
16,000

226.58; requires recordkeeping
for establishment of laboratory
controls to ensure that

65

260

3

16,000

Average
Total
Burden per
Hours
Recordkeeping
.75 (45 12,675
minutes)

1.75 (1 hour,
45 minutes)

29,575

adequate specifications and
test procedures for the drug
components and Type A
medicated articles conform to
appropriate standards of
identity, strength, quality and
purity.
226.80; requires maintenance
of records for packaging and
labeling of Type A medicated
articles.
226.102; requires maintenance
of master-formula and batchproduction records for Type A
medicated articles.
226.110; requires maintenance
of distribution records (2
years), for each shipment of
Type A medicated articles for
recall purposes.
226.115; requires maintenance
of complaint files for Type A
medicated articles for two
years.
Total

65

260

16,900

.75 (45 12,675
minutes)

65

260

16,900

1.75 (1 hour, 29,575
45 minutes)

65

260

16,900

.025 (15
minutes)

4,225

65

10

650

.5 (30
minutes)

325

89,050

12b. Annualized Cost Burden Estimate
21 CFR Part
Form No.
Activity
Type of Respondent
Records clerk1

Total Burden
Hours

89,050

Hourly Wage
Rate

$25.86

Total Respondent
Costs

$2,302,833

1May

2019 National Industry-Specific Occupational Employment and Wage Estimates, Bureau of Labor Statistics
and including 30% for benefits (https://www.bls.gov/oes/current/oes434199.htm)

13. Estimates of Other Total Annual Costs to Respondents/Recordkeepers or Capital Costs
There are no capital, start-up, operating or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government
We estimate the cost to the Federal government to be $35,441.28. This estimate is based on the
salary of an FTE at the GS-12/Step 5 level in the locality pay area of Washington-BaltimoreArlington in 2020 ($46.88/hour x 36 hours per inspection x 21 inspections = $35,441.28).

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15. Explanation for Program Changes or Adjustments
No adjustments or program changes are reported. The decrease in annual number of responses is
due to the way the ICR was entered into ROCIS--five ICs were decreased to one.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collected will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration date will be displayed.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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