Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Proposed Rules 9525 

of this section who are employed after 

exiting an employment service delivery 

system compared to the total number of 

those participants who exited. The 

method of calculation will be 

established through policy guidance 

issued by the Department. 

(c) The national EER for veterans and 

eligible persons is the EER achieved by 

the national State employment service 

delivery system for those veterans and 

eligible persons who are participants in 

all of the State employment service 

delivery systems for the program year 

under review. The national EER 

resulting from this calculation is 

expressed as a percentage that is 

rounded to the nearest tenth of a 

percent. 

(d) A State’s program year EER is the 

EER for veterans and eligible persons (as 

calculated in paragraph (b) of this 

section) achieved by a single State’s 

employment service delivery system for 

those veterans and eligible persons who 

are included in the EER measure for that 

State’s employment service delivery 

system for the program year under 

review. The program year EER resulting 

from this calculation is expressed as a 

percentage that is rounded to the nearest 

tenth of a percent. 

§ 1001.164 What is the uniform national 

threshold EER, and how will it be 

calculated? 

(a) The uniform national threshold 

EER for a program year is equal to 90% 

of the national EER for veterans and 

eligible persons (as defined in 

§ 1001.163(c)). 

(b) The uniform national threshold 

EER resulting from this calculation is 

expressed as a percentage that is 

rounded to the nearest tenth of a 

percent. 

§ 1001.165 When will the uniform national 

threshold EER be published? 

When practicable, the Veterans’ 

Employment and Training Service 

(VETS) will publish the uniform 

national threshold EER for a given 

program year by the end of December of 

the calendar year in which that program 

year ends. 

§ 1001.166 How will the uniform national 

threshold EER be used to evaluate whether 

a State will be required to submit a 

corrective action plan (CAP)? 

(a) Comparison. Each State’s program 

year EER will be compared to the 

uniform national threshold EER for that 

program year. State agencies that do not 

achieve a program year EER that equals 

or exceeds the national threshold EER 

(90% of the national EER) for the year 

under review will be subject to a review 

by VETS to determine whether the 

program year EER is deficient. 

(b) Review. For each State whose 

program year EER is subject to review to 

determine deficiency, the review will 

consider the degree of difference 

between the State’s program year EER 

and the uniform national threshold EER 

for that program year, as well as the 

annual unemployment data for the State 

as compiled by the Bureau of Labor 

Statistics. 

(1) The review also may consider 

other relevant measures of prevailing 

economic conditions and regional 

economic conditions, as well as other 

measures of the performance of 

workforce programs and/or any 

information the State may submit. 

(2) The review will include 

consultation with VETS field staff about 

findings from their on-site reviews and 

desk audits of State agency 

implementation of policies and 

procedures for services to veterans, and 

also may include consultation with staff 

affiliated with other agencies of the 

Department, as appropriate. 

(c) Requirement of a CAP. A State 

whose program year EER is determined 

to be deficient will be required to 

submit a CAP to improve the State’s 

performance in assisting veterans to 

meet their employment needs as a 

condition of receiving its next-due 

JVSG. 

(1) Any State whose program year 

EER has been determined to be deficient 

will be notified by March 31 of the year 

following the calendar year in which the 

program year under review ended. 

(2) For any State that is required to 

submit a CAP, VETS will provide 

technical assistance (TA) regarding the 

development of the CAP. The CAP must 

be submitted to the Grant Officer’s 

Technical Representative by June 30 of 

the year following the calendar year in 

which the program year under review 

ended. 

(3) VETS will review the CAP 

submitted by the State and determine 

whether to approve it or to provide 

additional TA to the State. 

(i) If VETS approves the CAP, the 

State must expeditiously implement it. 

(ii) If VETS does not approve the CAP, 

it will take such steps as are necessary 

to implement corrective actions to 

improve the State’s EER for veterans and 

eligible persons. 

(4) If a State fails to cooperate with 

the actions imposed by the Department 

under paragraph (c)(3)(ii) of this section, 

the Assistant Secretary for Veterans’ 

Employment and Training may take any 

actions available to remedy noncompliance under 20 CFR 1001.130(a) 

(referring to the compliance measures 

discussed in 20 CFR part 658, subpart 

H). 

§ 1001.167 In addition to the procedures 

specified in these regulations, will the 

Department be conducting any other 

monitoring of compliance regarding 

services to veterans? 

Yes. VETS will continue to monitor 

compliance with the regulations related 

to veterans’ priority of service at 20 CFR 

1010.240(b) jointly with the 

Employment and Training 

Administration. If a State’s program year 

EER is determined to be deficient for a 

given program year, that deficiency 

would constitute information to be 

considered in monitoring priority of 

service, since failure to fully implement 

priority of service could be one of the 

contributors to a deficient program year 

EER. 

[FR Doc. 2011–3536 Filed 2–17–11; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2000–P–0102, FDA–2000– 

P–0133, and FDA–2006–P–0033] 

Health Claim; Phytosterols and Risk of 

Coronary Heart Disease 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Extension of enforcement 

discretion. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending the 

period of time that it intends to exercise 

enforcement discretion, concerning the 

use of the health claim for phytosterols 

and risk of coronary heart disease 

(CHD), in a manner that is consistent 

with FDA’s February 14, 2003, letter of 

enforcement discretion to Cargill Health 

and Food Technologies. In the proposed 

rule for this health claim that published 

on December 8, 2010 (75 FR 76526), the 

Agency provided a period of 75 days 

from the date of publication of the 

proposed rule during which FDA 

intended to exercise its enforcement 

discretion for the use of such claim 

consistent with the 2003 letter. FDA is 

extending this period during which the 

Agency intends to exercise enforcement 

discretion to February 21, 2012. 

DATES: Submit either electronic or 

written comments by April 19, 2011. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS

9526 Federal Register / Vol. 76, No. 34 / Friday, February 18, 2011 / Proposed Rules 

1The agency received two letters from trade 

associations representing dietary supplement 

manufacturers and distributors. One was submitted 

by the Council for Responsible Nutrition on 

December 22, 2010, seeking an extension of the 

Agency’s enforcement discretion based on the 2003 

letter and one was submitted by the Consumer 

Healthcare Products Association on January 31, 

2011, requesting that FDA permit manufacturers of 

dietary supplement products with claims regarding 

free phytosterols and heart disease that were 

marketed prior to December 8, 2010 (the date of 

issuance of the proposed rule), to continue 

marketing of such products until a final rule is 

published. In addition, the Agency received two 

petitions for an administrative stay of action, one 

from Cargill, Inc., dated January 7, 2011 (‘‘Cargill 

petition’’), and another from Pharmachem 

Laboratories, Inc., dated January 28, 2011 

(‘‘Pharmachem petition’’) (Docket Nos. FDA–2000– 

P–0102, FDA–2000–P–0133, and FDA–2006–P– 

0033). The Agency is currently considering these 

petitions. This document does not represent a 

decision on the petitions, in whole or in part. We 

note that Cargill, Inc., and Pharmchem Laboratories, 

Inc., both requested in their petitions that FDA stay 

rescission of enforcement discretion under the 2003 

letter pending issuance of the final rule. FDA’s 

decision set forth in this document to extend 

consideration of enforcement discretion based on 

the 2003 letter until February 21, 2012, is consistent 

with Cargill and Pharmachem’s requests except for 

the duration of the Agency’s enforcement 

discretion. 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Blakeley Fitzpatrick, Center for Food 

Safety and Applied Nutrition (HFS– 

830), 5100 Paint Branch Pkwy., College 

Park, MD 20740, 301–436–2176. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of September 8, 2000 

(65 FR 54686), FDA issued an interim 

final rule (IFR) authorizing a health 

claim for plant sterol/stanol esters and 

CHD. Among other requirements, the 

Agency established in the IFR that 

spreads and dressings for salads must 

contain at least 0.65 grams (g) of plant 

sterol esters per reference amount 

customarily consumed (RACC) to be 

eligible to bear the health claim and that 

spreads, dressings for salad, snack bars, 

and dietary supplements in soft gel form 

must contain at least 1.7 g of plant 

stanol esters per RACC to be eligible to 

bear the health claim. 

The Agency received a letter, dated 

January 6, 2003, from Cargill Health and 

Food Technologies requesting that FDA 

issue a letter stating its intention not to 

enforce certain requirements in the IFR 

(Ref. 1). The letter cited new scientific 

evidence and comments submitted to 

FDA in the plant sterol/stanol esters 

health claim rulemaking in support of 

extending the authorized health claim to 

all forms and sources of phytosterols, 

and product forms that may effectively 

reduce blood cholesterol levels. In 

response to the letter submitted by 

Cargill and other comments received to 

the IFR, the Agency issued a letter of 

enforcement discretion on February 14, 

2003 (the 2003 letter). In such letter, the 

Agency explained that it would 

consider exercising enforcement 

discretion, pending publication of the 

final rule, with respect to certain 

requirements of the health claim. 

Specifically, the Agency stated it would 

consider such discretion with regard to 

the use of the claim in the labeling of 

a phytosterol-containing food, including 

foods other than those specified in 

§ 101.83(c)(2)(iii)(A) (21 CFR 

101.83(c)(2)(iii)(A)), if: (1) The food 

contains at least 400 milligrams (mg) per 

RACC of phytosterols; (2) mixtures of 

phytosterol substances (i.e., mixtures of 

sterols and stanols) contain at least 80 

percent beta-sitosterol, campesterol, 

stigmasterol, sitostanol, and 

campestanol (combined weight); (3) the 

food meets the requirements of 

§ 101.83(c)(2)(iii)(B) through 

(c)(2)(iii)(D); (4) products containing 

phytosterols, including mixtures of 

sterols and stanols in free forms, use a 

collective term in lieu of the terms 

required by § 101.83(c)(2)(i)(D) in the 

health claim to describe the substance 

(e.g., ‘‘plant sterols’’ or ‘‘phytosterol’’); (5) 

the claim specifies that the daily dietary 

intake of phytosterols that may reduce 

the risk of CHD is 800 mg or more per 

day, expressed as the weight of free 

phytosterol; (6) vegetable oils for home 

use that exceed the total fat 

disqualifying level can bear the health 

claim along with a disclosure statement 

that complies with 21 CFR 101.13; and 

(7) the use of the claim otherwise 

complies with § 101.83. Thus, the 2003 

letter described intended enforcement 

discretion with respect to (1) different 

forms and mixtures of phytosterols in a 

wider variety of products and (2) the use 

of the claim on foods containing lower 

levels of phytosterols than set forth in 

the IFR. 

In the Federal Register of December 8, 

2010 (75 FR 76526), the Agency issued 

a proposed rule that, if finalized, would 

amend § 101.83. The proposed rule, in 

part, responds to a petition received on 

May 5, 2006, and it also includes the 

evaluation of new scientific data that 

was not available when the IFR was 

published. 

The Agency stated in the proposed 

rule for the phytosterols and risk of CHD 

health claim that, pending issuance of a 

final rule, FDA intends to consider the 

exercise of its enforcement discretion on 

a case-by-case basis when a health claim 

regarding phytosterols and CHD is made 

in a manner that is consistent with the 

proposed rule (75 FR 76526 at 76546). 

The proposed rule also states that, 

beginning 75 days after the date of 

publication of the proposed rule 

(February 21, 2011), FDA does not 

intend to exercise its enforcement 

discretion based on the 2003 letter. 

Therefore, starting on February 21, 

2011, all products bearing the health 

claim must be in compliance with 

§ 101.83, or if the health claim is made 

in a manner that is consistent with the 

proposed rule, the Agency may exercise 

enforcement discretion. 

In the proposed rule, the Agency 

proposed to make several changes to the 

requirements for the nature of the food 

eligible to bear the claim that differ from 

the requirements in current § 101.83 and 

from the basis for enforcement 

discretion in the 2003 letter. Among 

other changes, FDA proposed to 

increase the amount of phytosterols that 

must be present in the food product 

from 0.4 to 0.5 g of phytosterols per 

RACC and to only allow the use of the 

claim in dietary supplements containing 

the esterified form of phytosterols. 

Since publication of the proposed 

rule, the Agency has received requests 

from industry to extend the 75-day 

period from the date of publication of 

the proposed rule for the exercise of 

FDA enforcement discretion based on 

the 2003 letter.1 In particular, many of 

the comments stated that 75 days was 

not enough time for industry to come 

into compliance with § 101.83 or to 

make the claim consistent with the 

proposed requirements in the proposed 

rule. FDA understands almost all 

dietary supplement products in the 

marketplace contain the free form of 

phytosterols, specifically in solid tablet 

dosage forms. One reason that the free 

form is used more frequently in the 

production of dietary supplements is 

because it has less bulk, and therefore, 

manufacturers can produce smaller pills 

that are easier for consumers to 

swallow. Based on the totality of 

publicly available scientific evidence for 

the cholesterol-lowering effects of 

nonesterified phytosterols in dietary 

supplements at the time that the 

proposed rule was published, the 

Agency determined that the evidence 

was inconsistent and tentatively 

concluded that the scientific evidence 

for the relationship between dietary 

supplements containing nonesterified 

phytosterols and CHD did not meet the 

significant scientific agreement 

standard. The Agency, therefore, 

proposed to amend § 101.83(c)(2)(iii)(B) 

to make the use of the health claim 

available only to phytosterol estercontaining dietary supplements that 

meet all of the specific requirements in 

§ 101.83. Therefore, based on the 

WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS

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 

WReier-Aviles on DSKGBLS3C1PROD with PROPOSALS