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

Forms and Documents

Document Name	Status
0623 Supporting Statement Part A 2014.pdf Supporting Statement A	2014-09-29

IC Document Collections

IC ID	Document Title	Status
213145	Recordkeeping requirements foreign facilities	New
213144	Recordkeeping Requirements Domestic Facilities	New
213143	Affirmation by importer of record	New
184590	Response to Request for Review by FDA	Modified
184589	Request for Designation	Modified

ICR Details

OMB Control No: 0910-0623	ICR Reference No: 201409-0910-006
Status: Historical Active	Previous ICR Reference No: 201106-0910-008
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/26/2014
	Date Received in OIRA: 09/30/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2017	36 Months From Approved	11/30/2014
Responses	138,703	0	2
Time Burden (Hours)	22,884	0	106
Cost Burden (Dollars)	0	0	0

---

Abstract: Section 801(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 381(a)) provides requirements with regard to imported food and cosmetics and provides for refusal of admission into the United States of human food and cosmetics that appear to be adulterated. Section 701(b) of the FD&C Act (21 U.S.C. 371(b)) authorizes the Secretaries of Treasury and Health and Human Services to jointly prescribe regulations for the efficient enforcement of section 801 of the FD&C Act. To address the potential risk of bovine spongiform encephalopathy (BSE) in human food and cosmetics, FDA regulations in 189.5 and 700.27 (21 CFR 189.5 and 700.27) designate certain materials from cattle as "prohibited cattle materials," including specified risk materials, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, and mechanically separated (MS) (Beef). Under the regulations no human food or cosmetic may be manufactured from, processed with, or otherwise contain prohibited cattle materials. However, the Agency may designate a country from which cattle materials inspected and passed for human consumption are not considered prohibited cattle materials and their use does not render a human food or cosmetic adulterated. Sections 189.5(e) and 700.27(e) provide that a country seeking to be so designated must send a written request to the Director, Center for Food Safety and Applied Nutrition (CFSAN). Sections 189.5 and 700.27 further state that countries that have been designated under 189.5(e) and 700.27(e) will be subject to future review by FDA to determine whether designation remains appropriate.

---

Authorizing Statute(s): US Code: 21 USC 801(a) 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:
	79 FR 44785	08/01/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 57937	09/26/2014
Did the Agency receive public comments on this ICR? No

---

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

---

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	2	0	138,701	0	0
Annual Time Burden (Hours)	22,884	106	0	22,778	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Burden increase reflects incorporation of collection elements previously included under 0910-0597. This is explained more fully at Q.15 of the supporting statement.

---

Annual Cost to Federal Government: $300,337

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: 09/30/2014

---