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

Forms and Documents

Document Name	Status
0320 Supporting Statement Final 3-27-2017.docx Supporting Statement A	2017-03-27

IC Document Collections

IC ID	Document Title	Status
5895	Shell Eggs, Game Meat and Game Meat Products, Gelatin, and Collagen Other-List of Exporters	Modified
182184	Reporting: Request for Information from U.S. Processors that Export to the European Community - Collagen Other-Consolidated List of Exporters to EC	Removed
182183	Reporting: Request for Information from U.S. Processors that Export to the European Community - Gelatin Other-Consolidated List of Exporters to EC	Removed
182182	Reporting: Request for Information from U.S. Processors that Export to the European Community - Animal Casings Other-Consolidated List of Exporters to EC	Removed
182181	Reporting: Request for Information from U.S. Processors that Export to the European Community - Game Meat & Game Meat Products Other-Consolidated List of Exporters to EC	Removed
182180	Reporting: Request for Information from U.S. Processors that Export to the European Community - Dairy Other-Consolidated List of Exporters to EC	Removed

ICR Details

OMB Control No: 0910-0320	ICR Reference No: 201703-0910-015
Status: Historical Active	Previous ICR Reference No: 201402-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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: 05/25/2017
	Date Received in OIRA: 04/25/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2020	36 Months From Approved	05/31/2017
Responses	40	0	146
Time Burden (Hours)	10	0	37
Cost Burden (Dollars)	0	0	0

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Abstract: The European Council (EC) directive 2003/863/EC requires that shipments of raw, bulk collagen and gelatin products be accompanied by certification stating that the product, derived from ruminant bones, bovine hides and pigskins has been produced in compliance with this directive. The directive contains the requirements for sourcing, manufacture, transport and storage of raw materials and manufacture of finished products. Article 23 of Chapter III of the directive requires a list identifying the non-EC firms and processors that meet EC requirements and has appropriate animal and public health certificates.

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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:
	81 FR 68424	10/04/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 18915	04/24/2017
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Reporting: Request for Information from U.S. Processors that Export to the European Community - Gelatin
Reporting: Request for Information from U.S. Processors that Export to the European Community - Dairy
Reporting: Request for Information from U.S. Processors that Export to the European Community - Game Meat & Game Meat Products
Reporting: Request for Information from U.S. Processors that Export to the European Community - Animal Casings
Shell Eggs, Game Meat and Game Meat Products, Gelatin, and Collagen
Reporting: Request for Information from U.S. Processors that Export to the European Community - Collagen

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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	40	146	0	0	-106	0
Annual Time Burden (Hours)	10	37	0	0	-27	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: The burden for this ICR has been reduced (an adjustment) from the currently approved burden. The number of responses from has decreased from 146 to 40, and the total burden decreased from 37 to 10. These changes are the result of: • Transferring response and hourly burden for previously maintained lists of eligible exporters of dairy products to Europe from this collection to OMB Collection Number 0910-0509 (120 responses, 30 hours), • Consolidation of animal casings burden (5 responses and 1 hour) with collagen burden, and • Additional gelatin and collagen responses (4 responses and 1 burden hour for gelatin and 15 responses and 4 burden hours for collagen). Therefore, the total change in burden for this collection is a reduction of 106 responses (146 – 120 – 5 + 4 +15) and 27 burden hours (37 -30 – 0.5 + 0.25 + 3.5) for a new total of 40 responses and 10 burden hours. The previously approved ICR submitted to OMB included six ICs entered in ROCIS and which were stated in the table in Item 12. Upon this submission, we consolidated the six ICs in Item 12 of the supporting statement to four ICs, and consolidated all six ICs into on IC in ROCIS. Therefore, for this submission of extension, this ICR now has one IC in ROCIS. The information collection activities and the burden associated with each IC, however, remain broken down into four ICs in this supporting statement's table in Item 12.

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Annual Cost to Federal Government: $8,237

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: 04/25/2017

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