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 #2 -Rev. 04-14-2011..doc Supporting Statement A	2011-11-10

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	Recordkeeping: Foreign facilities-- Requirement for Maintainence of Records Regarding Shipment of Cattle Material That Is To Be Used In Human Food and Cosmetics	Modified
45776	Recordkeeping - Domestic Facilities: Requirement for Maintainence of Records Regarding Shipment of Cattle Material That Is to Be Used In Human Food and Cosmetics	Modified
45775	Reporting: Affirmation By Importer of Record That the Human Food or Cosmetic Was Manufactured in Accordance With the Applicable Requirements of 21 CFR 189.5 ( c ) ( 6 ) & 21 CFR 700.27 ( c ) ( 6 )	Modified

ICR Details

OMB Control No: 0910-0597	ICR Reference No: 201111-0910-005
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: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Withdrawn	Conclusion Date: 03/21/2012
	Date Received in OIRA: 11/14/2011
Terms of Clearance: In accordance with 5 CFR 1320, this ICR has been withdrawn at the request of the agency.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
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 342 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 371 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	10/23/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 4077	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
Reporting: Affirmation By Importer of Record That the Human Food or Cosmetic Was Manufactured in Accordance With the Applicable Requirements of 21 CFR 189.5 ( c ) ( 6 ) & 21 CFR 700.27 ( c ) ( 6 )
Recordkeeping - Domestic Facilities: Requirement for Maintainence of Records Regarding Shipment of Cattle Material That Is to Be Used In Human Food and Cosmetics
Recordkeeping: Foreign facilities-- Requirement for Maintainence of Records Regarding Shipment of Cattle Material That Is To Be Used In Human Food and Cosmetics
Recordkeeping Requirements for 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: No

Burden Increase Due to:

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: There were no program changes. Please refer to Item #15 of the supporting statement for the adjustment explanation. Also this ICR was inadvertantly withdrawn by OMB and is being resubmitted for reinstatement again. As per discussion with the OMB Desk Officer, Drew Perraut, republication of another 30 day notice is waived.

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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]? 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: 11/14/2011

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