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

Forms and Documents

Document Name	Status
0320 83-c explanation 5-30-2007.doc Justification for No Material/Nonsubstantive Change	2007-05-30

IC Document Collections

IC ID	Document Title	Status
5895	Request for Information from U.S. Processors that Export to the European Community Other-83-C explanation	Modified

ICR Details

OMB Control No: 0910-0320	ICR Reference No: 200705-0910-006
Status: Historical Active	Previous ICR Reference No: 200407-0910-008
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/05/2007
	Date Received in OIRA: 05/30/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2007	09/30/2007	09/30/2007
Responses	211	0	191
Time Burden (Hours)	558	0	553
Cost Burden (Dollars)	0	0	0

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Abstract: The European Community directives for intra-Community trade in animal products require lists of processing establishments. FDA maintains and updates the lists of processors/firms trading in shell eggs, dairy products, animal casings, gelatin, game meat and game meat products.

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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
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	211	191	0	20	0	0
Annual Time Burden (Hours)	558	553	0	5	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: FDA/CFSAN wishes to expand the types of dairy products for which U.S. firms/processors may request inclusion on the list of U.S. firms/processors eligible to export dairy products to the European Community (EC). The current dairy products list includes only U.S. firms/processors handling heat-treated (pasteurized) products. In response to requests to expand the list, FDA will evaluate U.S. firms/processors wishing to export to the EC raw milk cheeses (unpasteurized milk made into cheese) that may be lawfully shipped in interstate commerce and include them on the list, provided that they are in compliance with U.S. laws and regulations and have provided FDA with the requested information. Adding the firms/processors of raw milk cheeses represents approximately 20 additional respondents and 5 burden hours.

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Annual Cost to Federal Government: $0

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: 05/30/2007

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