0884 ss 9-23-2020

UNITED STATES FOOD & DRUG ADMINISTRATION
Manufacturers/Processors of Feed Additives, Premixes, Compound Feed,
Distillers’ Dried Grains, and Distillers’ Dried Grains with Solubles for Use with Animals
with Interest in Exporting to The People’s Republic of China
OMB Control No. 0910-0884

SUPPORTING STATEMENT – Part A: Justification
1. Circumstances Making the Collection of Information Necessary
Food and Drug Administration (FDA, the agency, us or we) general enforcement regulations in
21 CFR part 1 govern the export of FDA-regulated products. In accordance with the regulations,
“[p]ersons exporting an article under section 801(e)(1) of the act or an article otherwise subject
to section 801(e)(1) of the act shall maintain records ... demonstrating that the product meets the
requirements of section 801(e)(1) of the act,” and that such records, “must contain sufficient
information to match the foreign purchaser's specifications to a particular export.” (See 21 CFR
1.101(b); information collection associated with 21 CFR 1.101(d) in conjunction with drugs,
biological products, and devices exported under section 802 of the act is covered under OMB
control no. 0910-0482.) In addition, regulations in part 1, subpart H (21 CFR §§ 1.225-1.245)
provide that anyone engaged in the manufacturing/processing, packing, or holding of food for
consumption in the United States, including animal food, must register with FDA unless a waiver
has been granted. Information collection provisions applicable to 21 CFR part 1, subpart H are
currently approved under OMB control no. 0910-0502. Consistent with 21 CFR 1.232,
registration data provided to FDA by respondents includes contact information, facility
information, and various pieces of product information depending on requirements applicable to
the product.
In this request we are seeking approval for information collection associated with the
establishment and maintenance of a list of manufactures of feed additives, premixes, compound
feed, distillers’ dried grains, and distillers’ dried grains with solubles (hereinafter,
“manufacturers/processors” of “covered products”) registered with FDA who wish to export
covered products to The People’s Republic of China. On January 15, 2020, the United States
and China entered into an Economic and Trade Agreement (the Agreement) which, among other
things, is intended to streamline the procedures for, and improve the efficiencies of, exporting
covered products to China. Inclusion on the list is also intended to facilitate trade of the covered
products by allowing more expeditious identification of relevant data. In this way we can help
better meet the demand for U.S. animal feed products in China and promote the development
animal husbandry. Because we expect that the relevant data to be included on the list is already
retained by respondents in satisfying domestic requirements as well as business operational
needs, we believe minimum burden will be incurred.

Accordingly we request OMB approval of the information collection provisions associated with
establishing a list of manufacturers of covered products who have interest in trading with China,
as discussed in this supporting statement.
2. Purpose and Use of the Information Collection
We use respondent requests to be placed on the list to verify that respondents want to be [or want
facility information to be] included and to ensure the accuracy of data to be disclosed. By
requesting to be placed on the list, respondents agree to disclose relevant data elements, as
agreed upon by the U.S. government and China, that demonstrate a covered product meets
acceptable foreign entry criteria.
3. Use of Improved Information Technology and Burden Reduction
At this time, the information collection is completed by email. As resources enable us to
enhance and integrate existing agency information systems to accommodate the new information
collection, we will consider ways to more efficiently produce and maintain the list.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection. We have a related information collection
approved under OMB control no. 0910-0509 regarding the establishment and maintenance of a
similar list for human foods. Upon further evaluation of the program we will consider whether
combining the information collections is appropriate.
5. Impact on Small Businesses or Other Small Entities
We do not believe the information collection poses undue burden on small entities. At the same
time, we provide assistance to small businesses through resources on our website at
www.fda.gov, including small entity compliance guidance on food facility registration.
6. Consequences of Collecting the Information Less Frequently
We intend to provide quarterly updates to China in accordance with the terms of the Trade
Agreement.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances associated with the collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
We published a 60-day notice for public comment in the Federal Register of April 16, 2020 (85
FR 21242). Although no comments were received, in our 30-day notice of August 6, 2020 (85
FR 47796) we revised our table to better clarify the nature of the information collection.

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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. Information collected includes firm name, facility
name, and address and we have determined that a Privacy Statement is not required under The
Privacy Act of 1974.
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Cost
We estimate the burden of the information collection as follows:
12a. Annualized Hour Burden Estimate:
21 CFR; IC Activity

No. of
Respondents

§ 1.101(b)(1); Request for list
placement to export to China--data
elements demonstrating that
product meets the foreign
purchaser’s specifications.
1

450

No. of
Responses
per
Respondent

Total
Annual
Responses

Average
Burden
per
Response

Total
Hours

450

.083
(5 mins.)

38

1

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

Based on the number of annual facility registrations there is a potential for several hundred
respondents to the information collection. Since establishing the collection, we have received
requests for 197 facilities to be placed on the list. We assume it takes 5 minutes (.0833 hour) to
compose and submit the requisite e-mail. Based on this experience and our experience with
similar information collection, we estimate 450 annual requests and 38 burden hours.
12b. Annualized Cost Burden Estimate:
Type of Respondent
1

Executive Secretary

Burden Hours

38

1

Hourly Wage Rate

Total Respondent Costs

39.32

$1,494.16

May 2019 National Industry-Specific Occupational Employment and Wage Estimates, US Department of Labor,
Bureau of Labor Statistics, Executive Secretaries 43-601. (https://www.bls.gov/oes/current/oes436011.htm) $30.25
hourly wage plus 30% adjusted for benefits.

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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
Assuming we allocate one FTE to review and validate submissions, factor a wage rate of $41.37
(current GS-12/1 wage rate in the Washington DC Metropolitan Area based on current data
available at www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2020/generalschedule/) by the annual hourly reporting burden, our estimate of the annual cost to the Federal
government for the information collection is $9,308.25 (450 x .50 x $41.37 = $9,308.25).
15. Explanation for Program Changes or Adjustments*
This is a new information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
FDA has no such plans for the information collection.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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