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

Forms and Documents

Document	Type	Status	Availability
0623 Supporting Statement Part A 2017.pdf	Supporting Statement A	Uploaded 2017-11-22	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
213145	Recordkeeping requirements foreign facilities		Unchanged
213144	Recordkeeping Requirements Domestic Facilities		Unchanged
213143	Affirmation by importer of record		Unchanged
184590	Response to Request for Review by FDA		Unchanged
184589	Request for Designation		Unchanged

ICR Details

OMB Control No: 0910-0623	ICR Reference No: 201711-0910-005
Status: Active	Previous ICR Reference No: 201409-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Reporting and 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: Approved without change	Conclusion Date: 01/02/2018
	Date Received in OIRA: 11/29/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2021	36 Months From Approved	01/31/2018
Responses	138,703	0	138,703
Time Burden (Hours)	22,884	0	22,884
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports FDA regulations regarding food and cosmetics containing material from cattle. The regulations are intended to protect against the transmission of bovine spongiform encephalopathy (BSE). Respondents to the collection are manufacturers and/or distributors of food and cosmetic products who must comply with applicable reporting and recordkeeping.requirements.

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Authorizing Statute(s): US Code: 21 USC 301 et. seq. 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:
	82 FR 27501	06/15/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	82 FR 56615	11/29/2017
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Request for Designation
Response to Request for Review by FDA
Recordkeeping Requirements Domestic Facilities
Recordkeeping requirements foreign facilities
Affirmation by importer of record

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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	138,703	138,703	0	0	0	0
Annual Time Burden (Hours)	22,884	22,884	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:

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Annual Cost to Federal Government: $316,577

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 11/29/2017

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