0154 ss 7-27-2017

FOOD AND DRUG ADMINISTRATION
Current Good Manufacturing Practice Regulations for Type A Medicated Articles,
21 CFR Part 226
OMB Control No. 0910-0154
SUPPORTING STATEMENT
Terms of Clearance: None.
A. Justification
1. Circumstances Making the Collection of Information Necessary
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 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), and product distribution.
We request extension of OMB approval of the information collection provisions in the
following citations:
21 CFR 226.42 - Recordkeeping - Requirement that records be prepared and maintained
for two years with respect to components (drug and non-drug), 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 articles conform to
appropriate standards of identity, strength, quality and purity.

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21 CFR 226.80 - Recordkeeping- Requires maintenance of records for packaging and
labeling of Type A medicated articles.
21 CFR 226-102- Recordkeeping - Requirement for maintenance of master-formula and
batch production records for Type A medicated articles.
21 CFR 226.110 - Recordkeeping - Requirement for maintenance of distribution records
(2 years), for each shipment of Type A medicated articles for recall purposes.
21 CFR 226.115 - Recordkeeping - Requirement for maintenance of complaint files for
Type A medicated articles for two years.
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 assure 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.
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 three years.
4. Efforts to Identify Duplication and Use of Similar Information
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.

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5. Impact on Small Businesses or Other Small Entities
Our best estimate is that approximately 65 firms are involved in the manufacture of Type
A medicated articles. We estimate that 75% 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
http://www.fda.gov/oc/industry/.
6. Consequences of Collecting the Information Less Frequently
Data collection occurs occasionally. 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
In accordance with 5 CFR 1320.8(d), on October 17, 2016, FDA published in the Federal
Register (81 FR 71513) a 60-day notice soliciting public comment. No comments were
received.
Additionally, there is ongoing communication with two organizations representing the
industry: the Animal Health Institute, Alexandria, VA and the American Feed Industry
Association, Arlington, VA.
9. Explanation of Any Payment or Gift to Respondents
This collection of information does not provide for payment or gifts to respondents.

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10. Assurance of Confidentiality Provided to Respondents
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
This information collection does not involve questions that are of a personally sensitive
nature.
12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection as follows:

21 CFR Section

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

Table 1.--Estimated Annual Reporting Burden
No. of
No. of Records Total Annual
Recordkeepers
per
Records
Recordkeeper

Average Burden per
Recordkeeping

65

260

16,900

.75 (45 minutes)

12,675

65

260

16,900

1.75 (1 hour, 45
minutes)

29,575

65

260

16,900

.75 (45 minutes)

12,675

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Total
Hours

21 CFR Section

Table 1.--Estimated Annual Reporting Burden
No. of
No. of Records Total Annual
Recordkeepers
per
Records
Recordkeeper

226.102; requires
maintenance of masterformula and batch production
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

Average Burden per
Recordkeeping

Total
Hours

65

260

16,900

1.75 (1 hour, 45
minutes)

29,575

65

260

16,900

.025 (15 minutes)

4,225

65

10

650

.5 (30 minutes)

325

89,050

We based our estimate of the time required for record preparation and maintenance on our
communications with industry. We derived additional information needed to calculate the
total burden hours (i.e., manufacturing sites, number of Type A medicated articles being
manufactured, etc.) from our records and experience.

12 b. Annualized Cost Burden Estimate
Type of Respondent
Records Clerk

Total Burden Hourly Wage
Hours
Rate1
89,050
$18.64

Total Respondent
Costs
$1,659,892

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May 2015 National Industry-Specific Occupational Employment and Wage Estimates, US Department of Labor,
Bureau of Labor Statistics, Information and Record Clerks 43-4199(https://www.bls.gov/oes/current/oes434199.htm)

13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/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 that the average hourly wage for respondents is equivalent to a GS-12-5
level in the locality pay area of Washington-Baltimore in 2016, approximately
$42.08/hour. Increasing this wage by 30% to account for overhead costs ($12.62), FDA
estimates the average hourly cost to respondents to be $54.70/hour. Based upon 21
inspections per year and 36 hours per inspection, the cost to the Federal Government is
$41,353.20 (21 inspections x 36 hours/inspection x $54.70 = $41,353.20).

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15. Explanation for Program Changes or Adjustments
The burden has not changed from the burden shown in the current inventory.
16. Plans for Tabulation and Publication and Project Time Schedule
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.
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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