0627 ss final 4-4-2018

U.S. Food and Drug Administration
Substances Prohibited from Use in Animal Food or Feed
OMB Control No. 0910-0627
SUPPORTING STATEMENT
Part A: Justification
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA, us or we)
regulations regarding substances prohibited from use in animal food or feed. Bovine
spongiform encephalopathy (BSE) is a progressive and fatal neurological disorder of cattle that
results from an unconventional transmissible agent and presents particular risks to the public
health. BSE belongs to the family of diseases known as transmissible spongiform
encephalopathies (TSEs). All TSEs affect the central nervous system of infected animals. To
implement certain public health protection provisions of the Federal Food, Drug, and Cosmetic
Act, as amended, we have codified regulations at 21 CFR Part 589 (Substances prohibited from
use in animal food or feed) to further strengthen existing safeguards against the transmission
and spread of BSE in the United States through animal feed.
Specifically, requirements under 21 CFR 589.2001: Cattle materials prohibited in animal food
or feed to prevent the transmission of bovine spongiform encephalopathy prohibit the use of
certain cattle origin materials in the food or feed of all animals. These materials are referred to
as “cattle materials prohibited in animal feed” or CMPAF. To demonstrate compliance with
the regulatory requirements respondents must maintain certain records. Also under 21 CFR
589.2001, FDA may designate a country as not subject to the requirements. A country seeking
such a designation must submit a written request that includes specific information about BSE
case history, risk factors, measures to prevent the introduction and transmission of BSE, as well
as any other relevant information.
We therefore request extension of the approval for the information collection requirements
found under 21 CFR 589.2001.
2. Purpose and Use of the Information Collection
The information collection is used to implement public health protection provisions of the act
designed to prevent the transmission and spread of BSE. We use the recordkeeping
information to determine industry compliance with the regulatory requirements. Information
reported to FDA is used in determining whether a country may be designated as not subject to
the regulation in accordance with specific requirements.
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 to fulfill the
information collection requirements. Respondents may utilize information technology as
desired and we estimate fifty percent (50%) will use electronic means to keep the required
records.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. However, a review of our inventory
suggests that the information collection may be combined with OMB Control No. 0910-0339:
Substances Prohibited from Use in Animal Food or Feed, which accounts for the burden
associated with information collection under 21 CFR Part 589.2000 (Animal proteins
prohibited in ruminant feed). This related collection expires October 31, 2019, before which
time FDA will evaluate both collections to see whether consolidation is appropriate.
5. Impact on Small Businesses or Other Small Entities
We believe approximately thirty to fifty percent (30-50%) of respondents are small businesses;
however we believe the information collection poses no undue burden on small entities. At the
same time, FDA aids small businesses in complying with its requirements through our Regional
Small Business Representatives and through the scientific and administrative staffs within the
agency. We also provide a Small Business Guide on our website at:
http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm.
6. Consequences of Collecting the Information Less Frequently
The information collection schedule is consistent with statutory requirements and applicable
regulations.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for 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), FDA published a 60-day notice in the Federal Register of
November 3, 2017 (82 FR 51279). Four comments were received in response to the notice but
were not discussed in our 30 day notice of February 26, 2018 (83 FR 8287). We regret this
oversight. None of the comments suggested we revise our estimate of the burden associated
with the information collection and all comments supported enforcement of the underlying
regulation. Finally, one comment provided us with reference to a confirmed case of BSE and
underscored the importance of the information collection. We appreciate these comments and,
regarding the feedback as positive, have retained our current estimate as discussed more fully
below at Question 12 of this Supporting Statement.

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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
Confidentiality of information is safeguarded within the provisions of FDA’s public
information regulations in 21 CFR Part 20.
11. Justification for Sensitive Questions
This information collection does not involve questions that are of a sensitive nature.
12. Estimates of Annualized Burden Hours and Costs
We estimate the burden of this collection of information as follows:
12 a. Annualized Hour Burden Estimate
Table 1.--Estimated Annual Recordkeeping Burden1
21 CFR Part 589.2001;
Activity
589.2001(c)(2)(ii); maintain
written procedures
589.2001(c)(2)(vi) and
(c)(3)(i); maintain records
589.2001(c)(3)(i)(A) and (B);
certification or documentation
from the supplier
Total
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No. of
No. of
Total
Average
Total
Recordkeepers Records per
Annual
Burden per
Hours
Recordkeeper Records
Recordkeeping
50
1
50
20 1,000
175

1

175

20

3,500

175

1

175

26

4,550

9,050

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

Our estimate of the recordkeeping burden associated with the information collection is based
on our experience since implementation of the regulatory requirements set forth in our final
rule of April 25, 2008 (73 FR 22720 at 22753). Although somewhat dated, we find no basis on
which to revise our estimate at this time.
Table 2.--Estimated Annual Reporting Burden1
21 CFR Section; Activity

589.2001(f); request for
designation
589.2001(f); response to
request for review by FDA

No. of
Respondents

No. of
Responses per
Respondent

Total
Average
Annual
Burden per
Responses Response

Total
Hours

1

1

1

80

80

1

1

1

26

26

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Table 2.--Estimated Annual Reporting Burden1
21 CFR Section; Activity

No. of
Respondents

No. of
Responses per
Respondent

Total
Average
Annual
Burden per
Responses Response

Total
Hours

Total
1

106

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

Similarly, our estimate of the reporting burden for designation under § 589.2001(f) is based on
estimates found in our final rule. Since the rule’s effective date in 2009, only two requests for
designation have been received; however we retain our current estimate of 1 to permit such
requests for designation by respondents.
12 b. Annualized Cost Burden Estimate
Type of Respondent

Total Burden Hours

Hourly Wage
Total Respondent
Rate
Costs
106
$43.90
$4,653.40

Compliance Officer1
1

2016 National Industry-Specific Occupational Employment and Wage Estimates, US Department of Labor,
Bureau of Labor Statistics (https://www.bls.gov/oes/current/oes131041.htm) $33.77 hourly wage plus 30%
adjusted for benefits.

As reflected above, the regulation allows a country to submit an application requesting a
designation as not being subject to the restrictions on the use of CMPAF. Using the total
number of hours for annual reporting (106 hours) multiplied by an hourly wage for an industry
compliance officer ($43.90), the estimated cost to respondents is $4,653.40.
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
Costs to the Federal Government were calculated by using 2018 OPM wage rates for a GS-13Step 4 employee in the Washington-Baltimore area ($51.11/hour) and multiplying this figure
by the number of FTE hours FDA might expend on the review of designation requests under
the regulation. Total estimated costs are therefore $3424.37.
15. Explanation for Program Changes or Adjustments
We have retained the currently approved burden for the information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
We have no plans to tabulate and publish information from this information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
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There are no reasons why display of the expiration date for OMB approval of the information
collection would be inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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