0152 ss 7-26-2017-1

FOOD AND DRUG ADMINISTRATION
Current Good Manufacturing Practice Regulations for Medicated Feeds--21 CFR Part 225
OMB Control No. 0910-0152
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) (21 U.S.C.
351), FDA has the statutory authority to issue current good manufacturing practice (cGMP)
regulations for drugs, including medicated feeds. Medicated feeds are administered to
animals for the prevention, cure, mitigation, or treatment of disease, or growth promotion and
feed efficiency. Statutory requirements for cGMPs have been codified under part 225 (21
CFR part 225). Medicated feeds that are not manufactured in accordance with these
regulations are considered adulterated under section 501(a)(2)(B) of the FD&C Act.
Under part 225, a manufacturer is required to establish, maintain, and retain records for a
medicated feed, including records to document procedures required during 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), labels, and product distribution.
This information is needed so that FDA can monitor drug usage and possible misformulation
of medicated feeds to investigate violative drug residues in products from treated animals and
to investigate product defects when a drug is recalled. In addition, FDA will use the cGMP
criteria in part 225 to determine whether or not the systems and procedures used by
manufacturers of medicated feeds are adequate to assure that their feeds meet the
requirements of the FD&C Act as to safety, and also that they meet their claimed identity,
strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.
A license is required when the manufacturer of a medicated feed involves the use of a drug or
drugs that FDA has determined requires more control because of the need for a withdrawal
period before slaughter or because of carcinogenic concerns. Conversely, a license is not
required and the recordkeeping requirements are less demanding for those medicated feeds
for which FDA has determined that the drugs used in their manufacture need less control.
We request extension of OMB approval of the information collection provisions in the
following citations:

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Registered 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 225.58(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) through (b)(5) - Recordkeeping - Specifies recordkeeping
requirements for master record files and production records for medicated feeds.
21 CFR 225.110(b)(1) 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.
Registered 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(c) and (d) - Recordkeeping - Specifies recordkeeping requirements for the
results of 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...
Nonregistered Unlicensed 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 for investigation
and corrective action when the results of laboratory assays of drug components indicate that
the medicated feed is not in accord with the permissible assay limits.
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21 CFR 225.180 - Recordkeeping - Specifies recordkeeping requirements for identification,
storage and inventory control of labeling in a manner that prevents label mix-ups and assures
that correct labels are used for medicated feeds.
21 CFR 225.202 - Recordkeeping - Specifies recordkeeping requirements for formulation,
production, and distribution of medicated feeds.
Nonregistered 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 mix-ups and assures
that correct labels are used for medicated feeds.
21 CFR 225.202 - Recordkeeping - Specifies recordkeeping requirements for formulation,
production, and distribution of medicated feeds.
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 medicated feeds 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 permits us to determine whether the medicated feed products have been consistently
processed in conformance with appropriate cGMP controls. We use the records required in
part 225 to determine whether or not the systems and procedures used by manufacturers of
medicated feeds are adequate to assure that their feeds meet the requirements of the FD&C
Act as to safety, and also that they meet their claimed identity, strength, quality, and purity,
as required by section 501(a)(2)(B) of the FD&C Act. We also review the records during the
conduct of follow-up investigations of drug residues in edible products of treated animals.

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
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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. Each manufacturer is responsible for the
labeling and recordkeeping for the products they manufacture. There are no similar records
that could substitute for those required by these regulations. 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 medicated feeds, as opposed to the U.S. Department of
Agriculture.
5. Impact on Small Businesses or Other Small Entities
By feed mill size, most respondents (to the USDA study referenced below) had feed mills
that produced from 1,000 to 9,999 tons per year. Only 56 feed mills had production of over
100,000 tons per year, yet they produced 53 percent of the total.1 Based on this, we estimate
that 75% of the 8,563 medicated feed manufacturers (reported in tables 1 through 4), or 6,422
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 processor would occur periodically during medicated feed manufacturing operations,
but that frequency of observation and recording would vary considerably for different
manufacturers and different medicated feed products. Less frequent recordkeeping would
reduce or nullify the effectiveness of the regulation to provide assurance to both the
medicated feed manufacturer and FDA that the medicated feed 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 medicated feed
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.

1 “Feed Mill Operations of Agricultural Cooperatives,” U.S. Department of Agriculture Research Report #207, September 2005

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8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment in
the Federal Register of October 17, 2016 (81 FR 71508). FDA received one letter in
response to the notice, which contained multiple comments. One comment was generally
supportive of the recordkeeping provisions of part 225. Another comment suggested that we
should collect data from manufacturers of medicated feed, and described several benefits of
having this information. Our regulations in part 225 require recordkeeping to document
procedures required during the manufacturing process to assure that proper quality control is
maintained. The regulations do not require manufacturers to submit this information to us on
a routine basis but, rather, to make the information available to us upon inspection. To the
extent that the comments recommend changes to our cGMP regulations for medicated feed,
which can only be accomplished by rulemaking, the comments were outside the scope of the
four collection of information topics on which the notice requested comments and will not be
discussed in this document.
9. Explanation of Any Payment or Gift to Respondents
This information collection does not provide for payment or gifts to respondents.
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 the regulations (21 CFR part 20).
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a personally sensitive
nature.

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12. Estimates of Annualized Burden Hours and Costs
12 a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Recordkeeping Burden [Registered Licensed Commercial Feed Mills]1
21 CFR Section
No. of
No. of Records per
Total Annual
Average Burden per
Recordkeepers
Recordkeeper
Records
Recordkeeper
225.42(b)(5) through
877
260
228,020
1
(b)(8), requires
records of receipt,
storage and
inventory control of
medicated feeds.
225.58(c) and (d),
877
45
39,465
.50
requires records of
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.
225.80(b)(2),
877
1,600
1,403,200
.12
requires that verified
medicated feed
label(s) be kept for
one year.
225.102(b)(1)
877
7,800
6,840,600
.08
through (b)(5),
requires records of
master record files
and production
records for
medicated feeds.
225.110(b)(1) and
877
7,800
6,840,600
.02
(b)(2), requires
maintenance of
distribution records
for medicated feeds.
225.115(b)(1) and
877
5
4,385
.12
(b)(2), requires
maintenance of
complaint files by
the medicated feed
manufacturer.
Total

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Total Hours
228,020

19,732.50

168,384

547,248

136,812

526.20

1,100,722.70

Table 2.--Estimated Annual Recordkeeping Burden [Registered Licensed Mixer-Feeders]1

21 CFR Section

No. of
Recordkeepers

No. of Records
per Recordkeeper

Total
Annual
Records

Average Burden
per
Recordkeeper

Total
Hours

225.42(b)(5) through
(b)(8), requires
records of receipt,
storage and inventory
control of medicated
feeds.
225.58(c) and (d),
requires records of
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.
225.80(b)(2), requires
that verified
medicated feed
label(s) be kept for
one year.
225.102(b)(1)
through (b)(5),
requires records of
master record files
and production
records for medicated
feeds.
Total

100

260

26,000

.15

3,900

100

36

3,600

.50

1,800

100

48

4,800

.12

576

100

260

26,000

.40

10,400

16,676

Table 3.--Estimated Annual Recordkeeping Burden [Nonregistered Unlicensed Commercial Feed Mills]1

21 CFR Section

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Average Burden
per
Recordkeeper

Total
Hours

225.142, requires
procedures for
identification, storage
and inventory control
(receipt and use) of Type
A medicated articles and
Type B medicated feeds.

4,186

4

16,744

1

16,744

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21 CFR Section

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Average Burden
per
Recordkeeper

Total
Hours

225.158, requires records
of investigation and
corrective action when
the results of laboratory
assays of drug
components indicate that
the medicated feed is not
in accord with the
permissible assay limits.
225.180, requires
identification, storage
and inventory control of
labeling in a manner that
prevents label mix-ups
and assures that correct
labels are used for
medicated feeds.
225.202, requires records
of formulation,
production, and
distribution of medicated
feeds.
Total

4,186

1

4,186

4

16,744

4,186

96

401,856

.12

48,223

4,186

260

1,088,360

.65

707,434

789,145

Table 4.--Estimated Annual Recordkeeping Burden [Nonregistered Unlicensed Mixer-Feeders]1

21 CFR Section

225.142, requires
procedures for
identification, storage
and inventory control
(receipt and use) of Type
A medicated articles and
Type B medicated feeds.
225.158, requires records
of investigation and
corrective action when
the results of laboratory
assays of drug
components indicate that
the medicated feed is not
in accord with the
permissible assay limits.

No. of
Recordkeepers

No. of
Records per
Recordkeeper

Total
Annual
Records

Average Burden
per
Recordkeeper

Total
Hours

3,400

4

13,600

1

13,600

3,400

1

3,400

4

13,600

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21 CFR Section

No. of
Recordkeepers

225.180, requires
identification, storage
and inventory control of
labeling in a manner that
prevents label mix-ups
and assures that correct
labels are used for
medicated feeds.
225.202, requires records
of formulation,
production, and
distribution of medicated
feeds.
Total

No. of
Records per
Recordkeeper

Total
Annual
Records

Average Burden
per
Recordkeeper

Total
Hours

3,400

32

108,800

.12

13,056

3,400

260

884,000

.33

291,720

331,976

We based our estimate of 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., number of recordkeepers, number of medicated feeds being
manufactured, etc.) from our records and experience.
12b. Annualized Cost Burden Estimate
Type of
Respondent
Feed Mill Worker

Total Burden
Hours
2,159,321

Hourly Wage Rate Total Respondent Costs
$15.412

$33,275,136.61

2

Bureau of Labor Statistics, National Industry-Specific Occupation Employment and Wage Estimates for Records Clerks, May
2015

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 collection.
14. Annualized Cost to the Federal Government
Our review of the records would generally occur as part of our inspection activities. We
estimate that our review of the records would take one hour per inspection. We estimate the
hourly cost for the review to be $34.06 per hour, the GS-12/Step-5 rate for the year 2017.
Thus, we estimate the cost to the Federal Government for the review of records to be $34.06
per review ($34.06 /hour x 1 hour). Assuming we review records for 680 inspections per
year, we estimate that the total annual cost to the Federal Government would be $23,160.80
($34.06 x 680 inspections).

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15. Explanation for Program Changes or Adjustments
This information collection reflects a change due to the agency estimate. Specifically, the
number of recordkeepers has increased from 840 to 877. This results in an increase in the
number of annual responses of 68,088, with a corresponding increase in hours of 79,199.
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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