Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Proposed Rules 9527 

Agency’s determination in the proposed 

rule, dietary supplements containing the 

free form of phytosterols would have to 

be relabeled or reformulated by 

February 21, 2011. The comments that 

the Agency received from industry 

stated that 75 days is not enough time 

to reformulate or relabel dietary 

supplements containing free 

phytosterols and requested that FDA 

consider extending its enforcement 

discretion for the use of the health claim 

in a consistent manner with the 2003 

letter. 

The Agency also understands that 

there are many conventional foods 

currently available in the marketplace 

that contain phytosterols at a level of 

0.4 g free phytosterol equivalents per 

RACC. These foods contain phytosterol 

ingredients that have not been the 

subject of a generally recognized as safe 

(GRAS) notification letter to which the 

Agency had no further questions at a 

level greater than 0.4 g free sterol 

equivalents per RACC. A level of 0.4 g 

free sterol equivalents per RACC is less 

than the new proposed requirement of 

0.5 g of phytosterols per RACC, based 

on the nonesterified weight of 

phytosterols. Products with 0.4 g free 

sterol equivalents per RACC would also 

have to be reformulated or relabeled 

beginning on February 21, 2011. 

Based on these concerns about 

reformulation and relabeling during a 

75-day period, FDA considers it 

appropriate to extend the period of time 

that it intends to exercise enforcement 

discretion based on the 2003 letter. FDA 

intends to exercise enforcement 

discretion until February 21, 2012, with 

regard to the use of a claim about 

reduced risk of CHD in the labeling of 

a phytosterol-containing food, including 

foods other than those specified in 

§ 101.83(c)(2)(iii)(A), based on the 

factors set forth in the 2003 letter for the 

use of such claim in the labeling of food. 

Information submitted by industry and 

trade associations about the amount of 

time necessary to reformulate, relabel, 

and to submit a GRAS notification in 

addition to the Agency’s experience 

with the economic impact of labeling 

and reformulation changes on industry 

have served as the basis for the Agency’s 

extension of the period during which it 

intends to exercise enforcement 

discretion to February 21, 2012, based 

on the 2003 letter. This document does 

not change how FDA intends to 

consider exercising its enforcement 

discretion when claims are made 

consistent with the proposed 

requirements in the proposed rule. 

Rather, this document only relates to 

FDA’s enforcement discretion based on 

the 2003 letter, and FDA will determine 

what, if any, further action is necessary, 

pending its review of the Cargill and 

Pharmachem petitions. Food bearing the 

health claim would be required to 

comply with any revised requirements 

established in the final rule when the 

final rule becomes effective. 

References 

1. Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration. Letter of Enforcement 

Discretion from FDA to Cargill Health & 

Food Technologies. Docket No. FDA– 

2000–P–0102, document ID DRAFT– 

0059 (formerly 2000P–1275/LET3) and 

Docket No. FDA–2000–P–0133, 

document ID DRAFT–0127 (formerly 

2000P–1276/LET4). February 14, 2003. 

Dated: February 14, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–3678 Filed 2–17–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF DEFENSE 

Defense Acquisition Regulations 

System 

48 CFR Parts 211, 212, and 252 

Defense Federal Acquisition 

Regulation Supplement; Reporting of 

Government-Furnished Property 

(DFARS Case 2009–D043) 

AGENCY: Defense Acquisition 

Regulations System; Department of 

Defense (DoD). 

ACTION: Proposed rule; extension of 

comment period. 

SUMMARY: DoD is proposing to amend 

the Defense Federal Acquisition 

Regulation Supplement (DFARS) to 

revise and expand reporting 

requirements for Government-furnished 

property to include items uniquely and 

non-uniquely identified, and to clarify 

policy for contractor access to 

Government supply sources. 

DATES: Comments on the proposed rule 

should be submitted in writing to the 

address shown below on or before April 

8, 2011, to be considered in the 

formation of the final rule. 

ADDRESSES: You may submit comments, 

identified by DFARS Case 2009–D043, 

using any of the following methods: 

Regulations.gov: http:// 

www.regulations.gov. 

Submit comments via the Federal 

eRulemaking portal by inputting 

‘‘DFARS Case 2009–D043’’ under the 

heading ‘‘Enter keyword or ID’’ and 

selecting ‘‘Search.’’ Select the link 

‘‘Submit a Comment’’ that corresponds 

with ‘‘DFARS Case 2009–D043.’’ Follow 

the instructions provided at the ‘‘Submit 

a Comment’’ screen. Please include your 

name, company name (if any), and 

‘‘DFARS Case 2009–D043’’ on your 

attached document. 

E-mail: dfars@osd.mil. Include 

DFARS Case 2009–D043 in the subject 

line of the message. 

Fax: 703–602–0350. 

Mail: Defense Acquisition Regulations 

System, Attn: Ms. Clare Zebrowski, 

OUSD (AT&L) DPAP/DARS, 3060 

Defense Pentagon, Room 3B855, 

Washington, DC 20301–3060. 

Comments received generally will be 

posted without change to http:// 

www.regulations.gov, including any 

personal information provided. To 

confirm receipt of your comment(s), 

please check http://www.regulations.gov 

approximately two to three days after 

submission to verify posting (except 

allow 30 days for posting of comments 

submitted by mail). 

FOR FURTHER INFORMATION CONTACT: Ms. 

Clare Zebrowski, Telephone 703–602– 

0289; facsimile 703–602–0350. Please 

cite DFARS Case 2009–D043. 

SUPPLEMENTARY INFORMATION: 

A. Background 

DoD published a proposed rule in the 

Federal Register on December 22, 2010 

(75 FR 80426), with a request for 

comment by February 22, 2011. DoD is 

extending the comment period for 45 

days to provide additional time for 

interested parties to review the 

proposed DFARS changes. DoD is 

planning a public meeting and detailed 

information on the meeting will be 

published in the Federal Register at a 

later date. 

Ynette R. Shelkin, 

Editor, Defense Acquisition Regulations 

System. 

[FR Doc. 2011–3727 Filed 2–17–11; 8:45 am] 

BILLING CODE 5001–08–P 

DEPARTMENT OF TRANSPORTATION 

Surface Transportation Board 

49 CFR Part 1002 

[EP 542 (Sub-No. 18)] 

Regulations Governing Fees for 

Services 

AGENCY: Surface Transportation Board, 

DOT. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The Board proposes to amend 

the regulations governing user fees for 

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