Establish & Maintain List of US Mfr/Processors of Feed Additives, Premixes, Compound Feed, Distillers' Dried Grains, & Dried Grains w/ Solubles for Use w/ Animals; Interest in Exporting to China

Forms and Documents

Document Name	Status
Signed Request for Emergency Clearance_Trade Agreement_02_10_2020.pdf Supplementary Document	2020-02-19
China Trade Agreement List ss 2-19-2020.pdf Supporting Statement A	2020-02-19

IC Document Collections

IC ID	Document Title	Status
240002	U.S. Manufacturers/processors of covered products Other-email template	New

ICR Details

OMB Control No: 0910-0884	ICR Reference No: 202002-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Establish & Maintain List of US Mfr/Processors of Feed Additives, Premixes, Compound Feed, Distillers' Dried Grains, & Dried Grains w/ Solubles for Use w/ Animals; Interest in Exporting to China
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 02/19/2020
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/19/2020
	Date Received in OIRA: 02/19/2020
Terms of Clearance: The agency must follow the standard notice and comment process in order to continue data collection beyond this emergency 6-month expiration.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	6 Months From Approved
Responses	450	0	0
Time Burden (Hours)	37	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: U.S. manufacturers and processors of feed additives, premixes, compound feed, distillers' dried grains, and distillers' dried grains with solubles for use with animals who wish to export their products to the People's Republic of China must send a request to FDA to be included on a facility list.

Emergency Justfication: The Food and Drug Administration (FDA or we) is requesting emergency processing under 5 CFR § 1320.13 of a new information collection request (ICR). This ICR supports an agency program by which respondents may be included on a list of U.S. manufacturers and processors of feed additives, premixes, compound feed, distillers’ dried grains, and distillers dried grains with solubles for use with animals (hereinafter, “manufacturers/processors” of “covered products”) that wish to export their products to the People’s Republic of China (China). On January 15, 2020, the United States and China entered into an Economic and Trade Agreement (the Agreement) which, among other things, will streamline the procedures for, and improve the efficiencies of, the exportation of U.S. covered products to China. These provisions of the Agreement are intended to facilitate trade between the two countries to better meet the demand for U.S. animal feed products in China and to promote the development of animal husbandry in China.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
U.S. Manufacturers/processors of covered products

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	450	0	0	450	0	0
Annual Time Burden (Hours)	37	0	0	37	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $1,950

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/19/2020

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