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

ICR 201705-0910-007

OMB: 0910-0839

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0839 201705-0910-007
Historical Active
HHS/FDA CFSAN
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
New collection (Request for a new OMB Control Number)   No
Emergency 06/19/2017
Approved without change 06/27/2017
Retrieve Notice of Action (NOA) 05/26/2017
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
12/31/2017 6 Months From Approved
1,950 0 0
20,400 0 0
0 0 0

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.
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)).

None
None

Not associated with rulemaking
Other Documents for OIRA Review

No

1
IC Title Form No. Form Name
FDA Guidance Reporting Provisions for Specified List of Exports to China

  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
Yes
Miscellaneous Actions
No
This is a new information collection in support of agency guidance established to permit exporting by manufacturers of specified products to China.

$181,344
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
05/26/2017


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