9844 Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Rules and Regulations 

2FDA received a petition for an administrative 

stay of action with an embedded citizen petition 

from Pharmavite LLC (‘‘Pharmavite petition’’) dated 

February 24, 2011, and a petition for an 

administrative stay from Botanical Laboratories, 

Inc. (‘‘Botanical petition’’), dated March 18, 2011 

(Docket Nos. FDA–2000–P–0102, FDA–2000–P– 

0133, and FDA–2006–P–0033). Specifically, 

Pharmavite LLC requests FDA to stay its February 

18, 2011, decision to discontinue enforcement 

discretion for dietary supplements containing free 

phytosterols that have been shown, through an 

adequate and well-controlled clinical trial, to 

reduce low density lipoprotein (LDL) and total 

cholesterol, pending publication of a final rule for 

the health claim. In a citizen petition embedded in 

the petition for an administrative stay, Pharmavite 

LLC also asked us to agree that: (1) A dietary 

supplement produced by Pharmavite LLC has been 

shown to effectively reduce LDL and total 

cholesterol; (2) FDA will continue to exercise 

enforcement discretion to permit this dietary 

supplement to bear an appropriately worded claim 

pursuant to the 2010 proposed regulation, pending 

publication of a final rule addressing the health 

claim; and (3) the final rule will allow those dietary 

supplements containing free phytosterols that have 

been shown through an adequate and wellcontrolled clinical trial to effectively reduce LDL 

and total cholesterol to bear the claim. Botanical 

Laboratories, Inc., requested that FDA stay its 

February 18, 2011, decision to discontinue 

enforcement discretion for dietary supplements 

containing phytosterols in liquid form until the 

issuance of a final rule for the health claim. We are 

currently considering these petitions. This 

document does not represent a decision on these 

petitions, in whole or in part. 

additional petitions; one requesting an 

administrative stay of action with an 

embedded citizen petition and the other 

requesting an administrative stay of 

action. Each of the requests for an 

administrative stay of action concern 

FDA’s use of enforcement discretion 

related to labeling of dietary 

supplements, pending the publication of 

a final rule.2 In addition, FDA received 

numerous comments on the 2010 

proposed rule requesting that FDA 

extend the period of enforcement 

discretion based on the 2003 letter until 

publication of a final rule. FDA has 

received new scientific data and 

information, through comments to the 

2010 proposed rule, or submitted with 

petitions, relating to several of the 

factors we set forth in the 2003 letter, 

e.g., the possible health benefit of free 

phytosterols in dietary supplements and 

the minimum daily consumption 

amount of phytosterols necessary to 

achieve the claimed effect. We are 

reviewing the comments and 

information we received and do not 

intend to make a determination as to the 

daily phytosterols consumption amount 

needed to achieve the claimed effect or 

the eligibility of dietary supplements 

containing free phytosterols to bear the 

authorized health claim until the 

publication of the final rule. 

Based on the new data and 

information currently under our review 

that may be important, to our 

consideration in deciding what 

requirements to include in the final 

rule, and the need to focus FDA’s 

resources on other public health 

priorities, we find it appropriate to 

continue to extend our consideration of 

the exercise of enforcement discretion 

for the labeling of foods, including 

dietary supplements, bearing a health 

claim regarding phytosterols and risk of 

CHD consistent with the 2003 letter, 

until publication of the final rule. 

Therefore, FDA is extending the 

period during which it intends to 

exercise enforcement discretion, 

consistent with the factors set forth in 

the 2003 letter, until publication of a 

final rule for the phytosterols and risk 

of CHD health claim. 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. 

Food, including dietary supplements, 

bearing the health claim would be 

required to comply with any revised 

requirements established in the final 

rule when the final rule becomes 

effective. 

III. Reference 

The following reference has been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m. Monday 

through Friday. 

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 15, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3940 Filed 2–17–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9571] 

RIN 1545–BJ84 

Allocation and Apportionment of 

Interest Expense; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document contains 

corrections to the final regulations (TD 

9571), which were published in the 

Federal Register on January 17, 2012 

(77 FR 2225) that provide guidance 

regarding the allocation and 

apportionment of interest expense. 

DATES: This correction is effective on 

February 21, 2012, and is applicable on 

January 17, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey L. Parry, (202) 622–3850 (not a 

toll-free call). 

SUPPLEMENTARY INFORMATION: 

Background 

The temporary regulations (TD 9571) 

that are the subject of these corrections 

are under section 864 of the Internal 

Revenue Code. 

Need for Correction 

As published, the temporary 

regulations contain errors that may 

prove to be misleading and are in need 

of clarification. 

List of Subjects 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Correction of Publication 

Accordingly, 26 CFR part 1 is 

corrected by making the following 

correcting amendments: 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

§ 1.861–9T [Corrected] 

■ Par. 2. Section 1.861–9T is amended 

by revising paragraph (l) to read as 

follows: 

§ 1.861–9T Allocation and apportionment 

of interest expense (temporary). 

* * * * * 

(l) Expiration date. The applicability 

date of paragraphs (e)(2), (e)(3), and 

(h)(4) expires on January 13, 2015. 

§ 1.861–11T [Corrected] 

■ Par. 3. Section 1.861–11T is amended 

by revising paragraph (i) to read as 

follows: 

§ 1.861–11T Special rules for allocating 

and apportioning interest expense of an 

affiliated group of corporations (temporary). 

* * * * * 

mstockstill on DSK4VPTVN1PROD with RULES

Federal Register / Vol. 77, No. 34 / Tuesday, February 21, 2012 / Rules and Regulations 9845 

(i) Expiration date. The applicability 

date of paragraph (d)(6)(ii) expires on 

January 13, 2015. 

Robin R. Jones, 

Federal Register Liaison Officer, Publications 

and Regulations Branch, Legal Processing 

Division, Associate Chief Counsel, Procedure 

and Administration. 

[FR Doc. 2012–3855 Filed 2–17–12; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9567] 

RIN 1545–BK17 

Reporting of Specified Foreign 

Financial Assets; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correcting amendment. 

SUMMARY: This document contains 

corrections to final regulations (TD 

9567), which were published in the 

Federal Register on Monday, December 

19, 2011, relating to the reporting of 

specified foreign financial assets. 

DATES: Effective date: This correction is 

effective February 21, 2012, and is 

applicable beginning December 19, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Joseph S. Henderson, (202) 622–3880 

(not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations that are the 

subject of these corrections are under 

section 6038 of the Internal Revenue 

Code. 

Need for Correction 

As published on December 19, 2011 

(76 FR 78561), final regulation (TD 

9567), contains errors which may prove 

to be misleading and are in need of 

clarification. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Accordingly, 26 CFR part 1 is 

corrected by making the following 

correcting amendments. 

PART 1—INCOME TAXES 

■ Paragraph 1. The authority citation 

for part 1 continues to read in part as 

follows: 

Authority: 26 U.S.C. 7805 * * * 

PART 1—[CORRECTED] 

■ Par. 2. Section 1.6038D–2T is 

amended by: 

■ 1. Revising the last sentence of 

paragraph (b)(3). 

■ 2. Revising, in paragraph (d), the 

subject heading and fifth sentence of 

paragraph (2)(i) in the Example. 

The revisions read as follows: 

§ 1.6038D–2T Requirement to report 

specified foreign financial assets 

(temporary). 

* * * * * 

(b) * * * 

(3) * * * See § 1.6038D–5T(f) for 

rules to determine the maximum value 

of an interest in a foreign trust or estate. 

* * * * * 

(d) * * * 

Example. * * * 

(2) * * * 

(i) Married specified individuals filing 

separate annual returns. * * * See 

§ 1.6038D–5T(b) regarding the 

maximum value of a jointly owned and 

specified foreign financial asset to be 

reported by a specified person, 

including a married specified 

individual, that is a joint owner of an 

asset. * * * 

* * * * * 

■ Par. 3. Section 1.6038D–4T is 

amended by revising paragraph (a)(9) to 

read as follows: 

§ 1.6038D–4T Information required to be 

reported (temporary). 

(a) * * * 

(9) The foreign currency exchange rate 

and, if the source of such rate is other 

than as described in § 1.6038D–5T(c)(1), 

the source of the rate used to determine 

the specified foreign financial asset’s 

U.S. dollar value, including maximum 

value; and 

* * * * * 

■ Par. 4. Section 1.6038D–5T is 

amended by revising paragraph (c)(1). 

§ 1.6038D–5T Valuation guidelines 

(temporary). 

* * * * * 

(c) * * * 

(1) In general. Except as provided in 

paragraph (c)(2) of this section, the U.S. 

Treasury Department’s Financial 

Management Service foreign currency 

exchange rate is to be used to convert 

the value of a specified foreign financial 

asset into U.S. dollars for purposes of 

determining the aggregate value of 

specified foreign financial assets in 

which a specified person has an interest 

and determining the maximum value of 

a specified foreign financial asset. 

* * * * * 

■ Par. 5. Section 1.6038D–7T is 

amended by revising paragraphs 

(a)(1)(i)(C) and (b) introductory text to 

read as follows: 

§ 1.6038D–7T Exceptions from the 

reporting of certain assets under section 

6038D (temporary). 

(a) * * * 

(1) * * * 

(i) * * * 

(C) Form 8621, ‘‘Return by a 

Shareholder of a Passive Foreign 

Investment Company or Qualified 

Electing Fund’’; 

* * * * * 

(b) Owner of certain trusts. A 

specified person that is treated as an 

owner of any portion of a domestic trust 

under sections 671 through 678 is not 

required to file Form 8938 to report any 

specified foreign financial asset held by 

the trust if the trust is— 

* * * * * 

Guy R. Traynor, 

Federal Register Liaison, Legal Processing 

Division, Publication and Regulations Br., 

Procedure & Administration. 

[FR Doc. 2012–3935 Filed 2–17–12; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9567] 

RIN 1545–BK17 

Reporting of Specified Foreign 

Financial Assets; Correction 

AGENCY: Internal Revenue Service (IRS). 

ACTION: Final rule; correction. 

SUMMARY: This document contains 

corrections to final regulations (TD 

9567), which were published in the 

Federal Register on Monday, December 

19, 2011, relating to reporting of 

specified foreign financial assets. 

DATES: Effective Date: This correction is 

effective February 21, 2012, and is 

applicable beginning December 19, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Joseph S. Henderson, (202) 622–3880 

(not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The final regulations that are the 

subject of these corrections are under 

section 6038 of the Internal Revenue 

Code. 

mstockstill on DSK4VPTVN1PROD with RULES