2011-15142. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From,...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by July 20, 2011.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0623. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Request for Designation as Country Not Subject to the Restrictions Applicable to Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle—(OMB Control Number 0910-0623)—Extension

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). The information the country is required to submit includes information about a country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and other information relevant to determining whether specified risk materials, the small intestine of cattle not otherwise excluded from being a prohibited cattle material, material from nonambulatory disabled cattle, or MS(Beef) from the country seeking designation should be considered prohibited cattle materials. FDA uses the information to determine whether to grant a request for designation, and whether to impose conditions if a request is granted.

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. As part of this process, FDA may ask designated countries to confirm that their BSE situation and the information submitted by them in support of their original application remain unchanged. FDA may revoke a country's designation if FDA determines that it is no longer appropriate. Therefore, designated countries may respond to periodic requests by FDA by submitting information to confirm that their designation remains appropriate. FDA uses the information to ensure that their designation remains appropriate.

This estimate is based on FDA's experience and the average number of requests for designation under 189.5 and 700.27 received in the past 3 years. FDA received 1 request for designation in 2009 and 1 in 2010. Based on this experience, FDA estimates the annual number of new requests for designation will be one. FDA estimates that preparing the information required by 189.5 and 700.27 and submitting it to the Agency in the form of a written request to the Director, CFSAN will require a burden of approximately 80 hours per request. Thus, the annual burden for new requests for designation is estimated to be 80 hours, as shown in table 1, row 1 of this document. Under 189.5(e) and 700.27(e), designated countries are subject to future review by FDA and may respond to periodic requests by FDA by submitting information to confirm that their designation remains appropriate. In the last 3 years, FDA has not requested any reviews. Thus, the Agency estimates that one or fewer will occur annually in the future. We estimate that the designated country undergoing a review in the future will need one third the time it took preparing its request for designation to respond to FDA's request for review, or 26 hours (80 hours × 0.33 = 26.4 hours, rounded to 26). The annual burden for reviews is estimated to be 26 hours, as shown in table 1, row 2 of this document. The total annual burden for this information collection is estimated to be 106 hours.

In the Federal Register of April 15, 2011 (76 FR 21378), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section	No. of respondents	No. of responses per respondent	Total annual responses	Average burden per response	Total hours
189.5 and 700.27—request for designation	1	1	1	80	80
189.5(e) and 700.27(e)—response to request for review by FDA	1	1	1	26	26
Total					106
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: June 14, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.