Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle

Forms and Documents

Document Name	Status
SS-0910-0597.doc Supporting Statement A	2010-01-29

IC Document Collections

IC ID	Document Title	Status
45778	Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle	Removed
45777	Reporting Requirements for Importers of Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle	Modified
45776	Foreign Facilities Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle	Modified
45775	Domestic Facilities Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle	Modified

ICR Details

OMB Control No: 0910-0597	ICR Reference No: 201001-0910-009
Status: Historical Inactive	Previous ICR Reference No: 200610-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 03/29/2010
	Date Received in OIRA: 01/29/2010
Terms of Clearance: This collection has been improperly submitted under the terms of 5 CFR 1320. The collection is listed as an extension but contains discretionary changes that impact the burden. Please resumbit this collection as a revision.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2010	36 Months From Approved	03/31/2010
Responses	37,707	0	37,707
Time Burden (Hours)	43,039	0	43,039
Cost Burden (Dollars)	0	0	0

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Abstract: To address the potential risk of bovine spongiform encephalopathy (BSE), in human food, including dietary supplements, and cosmetics, the BSE Recordkeeping final rule requires that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records that document the absence of prohibited cattle materials in such products and require that such records be made available to FDA for inspection and copying.

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Authorizing Statute(s): US Code: 21 USC 371 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 342 Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	74 FR 54827	11/23/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 4977	01/26/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle
Domestic Facilities Recordkeeping Requirements for Human Food and Cosmetics Manufactured from, Processed With, or Otherwise Containing, Material from Cattle
Foreign Facilities Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle
Reporting Requirements for Importers of Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material from Cattle

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: The recordkeeping burden hours have decreased primaily because the one-time record design burden hours associated with the new rule in 2006 are no longer included in the burden estimate. In addition the reporting burden hours have increased from zero hours to 1809 hours because the reporting hours were erroneously included in the recodkeeping burden table in the 2006 estimate.

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Annual Cost to Federal Government: $297,340

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)? 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: 01/29/2010

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