Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood,Infant Formula, and Formula for Young Children Manufacturers/Processorswith Interest in Exporting to China

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
227012	FDA Guidance Reporting Provisions for Specified List of Exports to China	New

ICR Details

OMB Control No: 0910-0839	ICR Reference No: 201705-0910-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Establishing and Maintaining a List of U.S. Milk and Milk Product, Seafood,Infant Formula, and Formula for Young Children Manufacturers/Processorswith 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: 06/19/2017
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/27/2017
	Date Received in OIRA: 05/26/2017
Terms of Clearance: If the collection is expected to continue beyond the 6 months approved, the agency will need to follow the standard notice and comment procedures (60- and 30-days).

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2017	6 Months From Approved
Responses	1,950	0	0
Time Burden (Hours)	20,400	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request supports agency guidance for manufacturers of specified products with interest in exporting to China. The guidance includes recommendations for respondents that we believe will help facilitate trade in this regard.

Emergency Justfication: The United States and China have been in negotiations to enter into a Memorandum of Understanding (“China MOU”) under which China would permit the manufacturers/processors to export from the United States to China covered products in a manner consistent with Chinese law. As the competent authority recognized by China with respect to FDA-regulated foods, FDA helps facilitate international trade of such products. With respect to the collection of information at issue, we intend to facilitate trade by establishing and maintaining a list of exporters of covered products that meet certain criteria requested by China under the China MOU. Specifically, under the China MOU, FDA intends to include on the export list those manufacturers/processors over which FDA has regulatory oversight; that FDA has determined to be in good regulatory standing; and that have provided FDA with a certification of the manufacturer’s/processor’s compliance with Chinese standards, laws, and regulations from a third-party certification body recognized by China. The collection is thus essential to the mission of the agency under § 1320.13(a)(1)(ii)).

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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
	Other Documents for OIRA Review

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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
FDA Guidance Reporting Provisions for Specified List of Exports to China

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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	1,950	0	0	1,950	0	0
Annual Time Burden (Hours)	20,400	0	0	20,400	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 in support of agency guidance established to permit exporting by manufacturers of specified products to China.

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Annual Cost to Federal Government: $181,344

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 05/26/2017

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