0152 ss 7-16-2020

United States Food and Drug Administration
Current Good Manufacturing Practice Regulations for Medicated Feeds
OMB Control No. 0910-0152
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 (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 ensure 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. Respondents to this
collection of information are commercial feed mills and mixer/feeders.
We therefore request OMB extension of OMB approval of 0910-0152 found in 21 CFR part 225;
Current Good Manufacturing Practice Regulations for Medicated Feed 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 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
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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 the systems and procedures used by manufacturers of
medicated feeds are adequate to ensure 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 would examine the records during a
periodic inspection or during an investigation.
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.
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 percent 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
https://www.fda.gov/animal-veterinary/resources-you/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
1
“Feed Mill Operations of Agricultural Cooperatives,” U.S. Department of Agriculture Research Report #207,
September 2005

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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 March 4, 2020 (85
FR 12790). No comments were received.
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 the regulations (21 CFR part 20).
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.

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12. Estimates of Annualized Burden Hours and Cost
12a. Annualized Hour Burden Estimate
Table 1. – Estimated Annual Recordkeeping Burden (Registered Licensed Commercial Feed Mills)1
21 CFR Section
No. of
No. of Records
Total
Average
Total Hours
Recordkeepers
per
Annual
Burden per
Recordkeeper
Records
Recordkeeping
225.42(b)(5) through (8)
825
260
214,500
1
214,500
requires records of receipt,
storage, and inventory control
of medicated feeds.
225.58(c) and (d) requires
825
45
37,125
0.50 (30
18,562.50
records of the results of
minutes)
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
825
1,600
1,320,000
0.12 (7
158,400
verified medicated feed
minutes)
label(s) be kept for 1 year.
225.102(b)(1) through (5),
825
7,800
6,435,000
0.08 (5
514,800
requires records of master
minutes)
record files and production
records for medicated feeds.
225.110(b)(1) and (2) requires
825
7,800
6,435,000 0.02 (1 minute)
128,700
maintenance of distribution
records for medicated feeds.
225.115(b)(1) and (2) requires
825
5
4,125
0.12 (7
495
maintenance of complaint files
minutes)
by the medicated feed
manufacturer.
Total
1,035,457.50
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2. – Estimated Annual Recordkeeping Burden (Registered Licensed Mixer/Feeders)1
21 CFR Section
No. of
No. of Records
Total
Average Burden
Total Hours
Recordkeepers
per
Annual
per
Recordkeeper
Records
Recordkeeping
225.42(b)(5) through (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 1 year.

100

260

26,000

0.15 (9 minutes)

3,900

100

36

3,600

0.50 (30
minutes)

1,800

100

48

4,800

0.12 (7 minutes)

576

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225.102(b)(1) through (5)
requires records of master
record files and production
records for medicated
feeds.
Total
1

100

260

26,000

0.40 (24
minutes)

10,400

16,676

There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3. – Estimated Annual Recordkeeping Burden (Nonregistered Non-licensed Commercial Feed Mills)1
21 CFR Section
No. of
No. of
Total Annual
Average
Total Hours
Recordkeepers
Records per
Records
Burden per
Recordkeeper
Recordkeeping

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.
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
1

4,186

4

16,744

1

16,744

4,186

1

4,186

4

16,744

4,186

96

401,856

0.12 (7
minutes)

48,223

4,186

260

1,088,360

0.65 (39
minutes)

707,434

789,145

There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 4. – Estimated Annual Recordkeeping Burden (Nonregistered Non-licensed Mixer/Feeders)1
21 CFR Section
No. of
No. of
Total Annual
Average
Total Hours
Recordkeepers Records per
Records
Burden per
Recordkeeper
Recordkeeper
225.142 requires procedures for
3,400
4
13,600
1
13,600
identification, storage, and
inventory control (receipt and
use) of Type A medicated articles
and Type B medicated feeds.
225.158 requires records of
3,400
1
3,400
4
13,600
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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225.180 requires identification,
3,400
32
108,800
0.12 (7
13,056
storage, and inventory control of
minutes)
labeling in a manner that
prevents label mix-ups and
assures that correct labels are
used for medicated feeds.
225.202 requires records of
3,400
260
884,000
0.33 (20
291,720
formulation, production, and
minutes)
distribution of medicated feeds.
Total
331,976
1
There are no capital costs or operating and maintenance costs associated with this collection of information.

12b. Annualized Cost Burden Estimate
Type of Respondent
Feed Mill Worker1

Total Burden
Hours
2,173,254.50

Hourly Wage
Rate
26.51

Total Respondent
Costs
$57,612,976.80

1

May 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 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 $46.88 per hour, based on the GS-12/Step-5 rate in the pay area of
Washington-Baltimore-Arlington, DC-MD-VA-WV-PA for the year 2020. Thus, we estimate the
cost to the Federal Government for the review of records to be $46.88 per review ($46.88 /hour x
1 hour). Assuming we review records for 200 inspections per year, we estimate that the total
annual cost to the Federal Government would be $9,376.00 ($46.88 x 200 inspections).
15. Explanation for Program Changes or Adjustments
This information collection reflects a change due to the Agency estimate. Specifically, the
number of recordkeepers has decreased from 877 to 825. This results in a decrease in the
number of annual responses of 95,691 with a corresponding decrease in hours of 65,266.
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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