Request for Information from U.S. Processors that Export to the European Community

Forms and Documents

Document	Type	Status	Availability
0320 EU Dairy List Federal Register Notice.doc	Supplementary Document	Uploaded 2007-08-30	Available
0320 21 USC 393d2.doc	Supplementary Document	Uploaded 2007-08-30	Available
0320 ss 8-30-2007.doc	Supporting Statement A	Uploaded 2007-08-30	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5895	Request for Information from U.S. Processors that Export to the European Community	Other-Consolidated List of Exporters to EC	Modified
182184	Request for Information from U.S. Processors that Export to the European Community	Other-Consolidated List of Exporters to EC	New
182183	Request for Information from U.S. Processors that Export to the European Community	Other-Consolidated List of Exporters to EC	New
182182	Request for Information from U.S. Processors that Export to the European Community	Other-Consolidated List of Exporters to EC	New
182181	Request for Information from U.S. Processors that Export to the European Community	Other-Consolidated List of Exporters to EC	New
182180	Request for Information from U.S. Processors that Export to the European Community	Other-Consolidated List of Exporters to EC	New

ICR Details

OMB Control No: 0910-0320	ICR Reference No: 200709-0910-007
Status: Historical Active	Previous ICR Reference No: 200705-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Request for Information from U.S. Processors that Export to the European Community
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/13/2007
	Date Received in OIRA: 09/28/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2010	36 Months From Approved	11/30/2007
Responses	146	0	211
Time Burden (Hours)	37	0	558
Cost Burden (Dollars)	0	0	0

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Abstract: The European Community (EC) is a group of 27 European countries that have agreed to harmonize their commodity requirements to facilitate commerce among member States. EC legislation for intra-EC trade has been extended to trade with non-EC countries, including the United States. For certain food products (e.g., shell eggs, dairy products, game meat, game meat products, animal casings, and gelatin), EC legislation requires assurances from the responsible authority of the country of origin that the processor of the food is in compliance with applicable regulatory requirements. FDA uses a list process to meet this requirement. FDA requests information from processors that export certain animal-derived products (e.g., shell eggs, dairy products, game meat, game meat products, animal casings, and gelatin) to the EC. FDA uses the information to maintain lists of processors that have demonstrated current compliance with U.S. requirements and provides the lists to the EC quarterly. Inclusion on the list is voluntary. EC member countries refer to the lists at ports of entry to verify that products offered for importation to the EC from the United States are from processors that meet U.S. regulatory requirements. Products processed by firms not on the lists are subject to detention and possible refusal at the port. Through this process, FDA is implementing the general policy-making authority granted the Commissioner under 21 U.S.C. 393(d)(2).

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Authorizing Statute(s): US Code: 21 USC 393(d)(2) Name of Law: FFDCA
  

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:
	72 FR 34256	06/21/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 52140	09/12/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Request for Information from U.S. Processors that Export to the European Community
Request for Information from U.S. Processors that Export to the European Community
Request for Information from U.S. Processors that Export to the European Community
Request for Information from U.S. Processors that Export to the European Community
Request for Information from U.S. Processors that Export to the European Community
Request for Information from U.S. Processors that Export to the European Community

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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	146	211	0	0	-65	0
Annual Time Burden (Hours)	37	558	0	0	-521	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: $21,234

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 09/28/2007

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