List of US Manufacturers of Specific CVM-Regulated Products with Interest in Exporting Covered Products to China

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0884 CVM China List SSA Aug 2020.docx	Supporting Statement A	Uploaded 2020-08-21	Available
Signed Request for Emergency Clearance_Trade Agreement_02_10_2020.pdf	Supplementary Document	Uploaded 2020-02-19	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
240002	U.S. Manufacturers/processors of covered products	Other-email template	Unchanged

ICR Details

OMB Control No: 0910-0884	ICR Reference No: 202007-0910-012
Status: Historical Inactive	Previous ICR Reference No: 202002-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: List of US Manufacturers of Specific CVM-Regulated Products with Interest in Exporting Covered Products to China
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 09/23/2020
	Date Received in OIRA: 08/24/2020
Terms of Clearance: to be resubmitted as an extension without change.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2020	36 Months From Approved	09/30/2020
Responses	450	0	450
Time Burden (Hours)	37	0	37
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.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 21242	04/16/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 47796	08/05/2020
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $9,308

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? No

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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: 08/24/2020

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