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

Forms and Documents

Document	Type	Status	Availability
SS-0910-0320[1].rev. 02-08-2011.doc	Supporting Statement A	Uploaded 2011-02-08	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5895	Reporting - Request for Information from U.S. Processors that Export to the European Community - Shell Eggs	Other-Consolidated List of Exporters to EC	Modified
182184	Reporting: Request for Information from U.S. Processors that Export to the European Community - Collagen	Other-Consolidated List of Exporters to EC	Modified
182183	Reporting: Request for Information from U.S. Processors that Export to the European Community - Gelatin	Other-Consolidated List of Exporters to EC	Modified
182182	Reporting: Request for Information from U.S. Processors that Export to the European Community - Animal Casings	Other-Consolidated List of Exporters to EC	Modified
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	Modified
182180	Reporting: Request for Information from U.S. Processors that Export to the European Community - Dairy	Other-Consolidated List of Exporters to EC	Modified

ICR Details

OMB Control No: 0910-0320	ICR Reference No: 201011-0910-004
Status: Historical Active	Previous ICR Reference No: 200709-0910-007
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/27/2011
	Date Received in OIRA: 11/29/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2014	36 Months From Approved	02/28/2011
Responses	146	0	146
Time Burden (Hours)	37	0	37
Cost Burden (Dollars)	0	0	0

---

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.

---

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

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 51077	08/18/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 71444	11/23/2010
Did the Agency receive public comments on this ICR? No

---

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

IC Title	Form No.	Form Name
Reporting: Request for Information from U.S. Processors that Export to the European Community - Animal Casings
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 - Collagen
Reporting - Request for Information from U.S. Processors that Export to the European Community - Shell Eggs
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

---

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	146	0	0	0	0
Annual Time Burden (Hours)	37	37	0	0	0	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:

---

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]? 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

---

Common Form ICR:  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:

(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: 11/29/2010

---