Federal Register / Vol. 74, No. 42 / Thursday, March 5, 2009 / Proposed Rules 9577 

reorganization described in section 

368(a)(1)(E).’’. 

36. On page 3522, column 3, § 1.358– 

2(i) Example 5.(ii), line 10, the language 

‘‘is not dividend equivalent, such 

terms’’ is corrected to read ‘‘does not 

have the effect of a dividend, such 

terms’’. 

37. On page 3523, column 1, § 1.358– 

2(i) Example 6.(i), line 8, the language 

‘‘reorganization under section 

368(a)(1)(A).’’ is corrected to read 

‘‘reorganization described in section 

368(a)(1)(A).’’. 

38. On page 3523, column 1, § 1.358– 

2(i) Example 7.(i), line 6, the language 

‘‘of Corporation X in a reorganization 

under’’ is corrected to read ‘‘of 

Corporation X in a reorganization 

described in’’. 

39. On page 3523, column 2, § 1.358– 

2(i) Example 8.(ii), line 5, the language 

‘‘liability of J, the rules of paragraph (g) 

this’’ is corrected to read ‘‘liability of J, 

the rules of paragraph (g) of this’’. 

40. On page 3523, column 2, § 1.358– 

2(i) Example 9.(i), lines 9 through 11, 

the language ‘‘Corporation X in a 

reorganization under section 

368(a)(1)(D). Pursuant to the terms of 

the plan of reorganization, J surrenders 

J’s’’ is corrected to read ‘‘Corporation X 

in a reorganization described in section 

368(a)(1)(D). Pursuant to the terms of 

the plan of reorganization, J 

surrenders’’. 

41. On page 3523, column 2, § 1.358– 

2(i) Example 9.(ii), line 5 from the 

bottom of the column, the language 

‘‘recapitalized in a reorganization 

under’’ is corrected to read 

‘‘recapitalized in a reorganization 

described in’’. 

42. On page 3523, column 3, § 1.358– 

2(i) Example 10.(i), lines 12 thru 14, the 

language ‘‘Corporation X in a 

reorganization under section 

368(a)(1)(D). Pursuant to the terms of 

the plan of reorganization, J surrenders 

J’s’’ is corrected to read ‘‘Corporation X 

in a reorganization described in section 

368(a)(1)(D). Pursuant to the terms of 

the plan of reorganization, J 

surrenders’’. 

43. On page 3523, column 3, § 1.358– 

2(i) Example 10.(ii), line 10 from the 

bottom of the column, the language ‘‘be 

recapitalized in a reorganization under’’ 

is corrected to read ‘‘be recapitalized in 

a reorganization described in’’. 

44. On page 3524, column 2, § 1.358– 

2(i) Example 13.(i), line 9, the language 

‘‘reorganization under section 

368(a)(1)(A).’’ is corrected to read 

‘‘reorganization described in section 

368(a)(1)(A).’’. 

45. On page 3524, column 3, § 1.358– 

2(i) Example 14.(i), line 9, the language 

‘‘reorganization under section 

368(a)(1)(A),’’ is corrected to read 

‘‘reorganization described in section 

368(a)(1)(A),’’. 

46. On page 3525, column 1, § 1.358– 

2(i) Example 15.(ii), line 3 from the 

bottom of the paragraph, the language 

‘‘each has a basis of $6 and is treated as 

having’’ is corrected to read ‘‘each has 

a basis of $5 and is treated as having’’. 

47. On page 3525, column 1, § 1.358– 

2(i) Example 16.(i), line 4, the language 

‘‘Shares of Corporation Y in an 

exchange to’’ is corrected to read 

‘‘Shares of Corporation Y stock in an 

exchange to’’. 

48. On page 3525, column 1, § 1.358– 

2(i) Example 17.(i), line 2, the language 

‘‘Facts. The facts are the same as 

Example 1,’’ is corrected to read ‘‘Facts. 

The facts are the same as Example 16,’’. 

§ 1.358–6 [Corrected] 

49. On page 3525, column 2, § 1.358– 

6(f)(3), line 4 from the bottom of the 

paragraph, the language ‘‘1 revised April 

1, 2008 for the year’’ is corrected to read 

‘‘1 revised April 1 for the year’’. 

§ 1.861–12 [Corrected] 

50. On page 3525, column 3, § 1.861– 

12(c)(2)(vi), lines 1 through 3, the 

language ‘‘Adjustments in respect of 

redeemed stock for taxpayers using the 

tax book value method. Solely for’’ is 

corrected to read ‘‘Adjustments in 

respect of redeemed stock for taxpayers 

using the tax book value method. Solely 

for’’. 

51. On page 3525, column 3, § 1.861– 

12(c)(2)(vi), lines 13 through 15, the 

language ‘‘taken into account under 

§ 1.302–5(a)(3) as of the close of the 

redeemed shareholder’s taxable year 

(unrecovered’’ is corrected to read 

‘‘taken into account under § 1.302–5 as 

of the close of the redeemed 

shareholder’s taxable year (deferred’’. 

52. On page 3525, column 3, § 1.861– 

12(c)(2)(vi), line 4 from the bottom of 

the column, the language ‘‘unrecovered 

loss (and allocated among’’ is corrected 

to read ‘‘deferred loss (and allocated 

among’’. 

§ 1.1001–6 [Corrected] 

53. On page 3526, column 2, 

§ 1.1001–6(c), line 10 from the top of the 

column, the language ‘‘still 

unliquidated. Solely for purposes of’’ is 

corrected to read ‘‘still unliquidated 

investment. Solely for purposes of’’. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel, (Procedure and Administration). 

[FR Doc. E9–4657 Filed 3–4–09; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–144615–02] 

RIN 1545–BI47 

Section 482: Methods To Determine 

Taxable Income in Connection With a 

Cost Sharing Arrangement; Correction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Correction to notice of proposed 

rulemaking by cross-reference to 

temporary regulations. 

SUMMARY: This document contains 

corrections to a notice of proposed 

rulemaking by cross-reference to 

temporary regulations (REG–144615–02) 

that was published in the Federal 

Register on Monday, January 5, 2009 

providing further guidance and 

clarification regarding methods under 

section 482 to determine taxable income 

in connection with a cost sharing 

arrangement in order to address issues 

that have arisen in administering the 

current regulations. These temporary 

regulations potentially affect controlled 

taxpayers within the meaning of section 

482 that enter into cost sharing 

arrangements as defined therein. 

FOR FURTHER INFORMATION CONTACT: 

Kenneth P. Christman, (202) 435–5265 

(not a toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background 

The correction notice that is the 

subject of this document is under 

section 482 of the Internal Revenue 

Code. 

Need for Correction 

As published, the notice of proposed 

rulemaking by cross-reference to 

temporary regulations (REG–144615–02) 

published January 5, 2009 (74 FR 236), 

contains errors that may prove to be 

misleading and are in need of 

clarification. 

Correction of Publication 

Accordingly, the publication of the 

notice of proposed rulemaking by crossreference to temporary regulations 

(REG–144615–02), which was the 

subject of FR Doc. E8–30712, is 

corrected as follows: 

1. On page 236, in the document 

headings, under the caption ACTION:, the 

language ‘‘Notice of proposed 

rulemaking by cross-reference to 

temporary regulations, notice of 

proposed rulemaking, and notice of 


dwashington3 on PROD1PC60 with PROPOSALS
9578 Federal Register / Vol. 74, No. 42 / Thursday, March 5, 2009 / Proposed Rules 

public hearing.’’ is corrected to read 

‘‘Notice of proposed rulemaking by 

cross-reference to temporary regulations 

and notice of public hearing.’’. 

2. On page 236, column 3, in the 

preamble, under the paragraph heading 

‘‘Special Analyses’’, last line of the 

column, the language ‘‘sharing 

agreements. Few small entities’’ is 

corrected to read ‘‘sharing arrangements. 

Few small entities’’. 

3. On page 237, column 1, in the 

preamble, under the paragraph heading 

‘‘Special Analyses’’, first paragraph of 

the column, line 2, the language 

‘‘agreements, as defined by these’’ is 

corrected to read ‘‘arrangements, as 

defined by these’’. 

4. On page 237, column 1, in the 

preamble, under the paragraph heading 

‘‘Comments and Public Hearing’’, third 

paragraph, line 1, the language ‘‘The 

rules of 26 CFR 601.601(a)(93)’’ is 

corrected to read ‘‘The rules of 26 CFR 

601.601(a)(3)’’. 

§ 1.482–2 [Corrected] 

5. On page 237, column 3, § 1.482– 

2(f)(2), the language ‘‘Election to apply 

paragraph (b) of this section to earlier 

taxable years.’’ is corrected to read 

‘‘Election to apply paragraph (b) to 

earlier taxable years.’’. 

LaNita Van Dyke, 

Chief, Publications and Regulations Branch, 

Legal Processing Division, Associate Chief 

Counsel (Procedure and Administration). 

[FR Doc. E9–4687 Filed 3–4–09; 8:45 am] 

BILLING CODE 4830–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

45 CFR Part 46 

Office for Human Research 

Protections; Institutional Review 

Boards 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of Public Health and Science, 

Office for Human Research Protections. 

ACTION: Advanced notice of proposed 

rulemaking; request for comments. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

Public Health and Science is seeking 

information and comments on whether 

OHRP should pursue a notice of 

proposed rulemaking (NPRM) to enable 

OHRP to hold institutional review 

boards (IRB) and the institutions or 

organizations operating the IRBs, 

hereafter referred to as the IRB 

organizations (IORG), directly 

accountable for meeting certain 

regulatory requirements of the 

Department of Health and Human 

Services (HHS) regulations for the 

protection of human subjects. OHRP is 

contemplating this regulatory change to 

encourage institutions to rely on IRBs 

that are operated by another institution 

or organization, when appropriate. 

Historically, OHRP has only enforced 

compliance with 45 CFR part 46 

through the institutions that were 

engaged in human subjects research. 

This has been the case even in 

circumstances when a regulatory 

violation was directly related to the 

responsibilities of an external IRB that 

was designated on the engaged 

institution’s assurance of compliance 

with OHRP. OHRP is considering 

whether to pursue a regulatory change 

that would enable the Department to 

hold IRBs and IORGs directly 

accountable for compliance with the 

provisions of 45 CFR part 46 that relate 

to an IRB’s or IORG’s responsibilities. 

OHRP believes that such a regulatory 

change in its enforcement authority may 

address one of the main disincentives 

institutions have cited as inhibiting 

them from exercising the regulatory 

flexibility that currently permits 

institutions to implement a variety of 

cooperative review arrangements and to 

rely on the review of an IRB operated by 

another institution or organization. If 

institutions become more willing to rely 

on cooperative review arrangements and 

on review of IRBs operated by other 

institutions or organizations, OHRP 

believes that this will reduce 

administrative burdens such as the time 

associated with IRB review for multisite studies, the time devoted by IRB 

staff and investigators to duplicative IRB 

review, and the time and personnel 

costs associated with operating an IRB 

for those institutions that choose not to 

establish an internal IRB—without 

diminishing human subject protections. 

This request for information and 

comments stems from interest in this 

issue from the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) and others, as 

well as two meetings on alternative IRB 

models that OHRP co-sponsored in 

November 2005 and November 2006 

along with the National Institutes of 

Health (NIH), the Association of 

American Medical Colleges (AAMC), 

and the American Society of Clinical 

Oncology (ASCO). 

DATES: Submit written or electronic 

information and comments by June 3, 

2009. 

ADDRESSES: You may submit comments 

by any of the following methods: 

• E-mail: IRBaccountability@hhs.gov. 

Include ‘‘IRB Accountability RFI’’ in the 

subject line. 

• Fax: 301–402–2071. 

• Mail/Hand Delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Julie Kaneshiro, OHRP, 1101 Wootton 

Parkway, Suite 200, Rockville, MD 

20852. 

Comments received within the 

comment period, including any 

personal information provided, will be 

made available to the public upon 

request. 

FOR FURTHER INFORMATION CONTACT: Julie 

Kaneshiro, OHRP, 1101 Wootton 

Parkway, Suite 200, Rockville, MD 

20852; 240–453–6900; e-mail 

julie.kaneshiro@hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

HHS, through OHRP, regulates 

research involving human subjects 

conducted or supported by HHS in 

regulations codified at 45 CFR part 46. 

The HHS regulations at 45 CFR part 46 

identify requirements that pertain to 

several different entities, including the 

IRB and the institution engaged in nonexempt human subjects research. The 

IRB is an administrative body that takes 

the form of a board, committee, or 

group, and is responsible for conducting 

initial and continuing review of 

research involving human subjects. The 

IRB must have authority to approve, 

require modification in (in order to 

secure approval), or disapprove all 

research activities covered by the HHS 

regulations (45 CFR 46.109(a)). An IRB’s 

primary purpose in reviewing research 

is to ensure the protection of the rights 

and welfare of human research subjects. 

Requirements for an Assurance of 

Compliance 

The HHS regulations for the 

protection of human subjects require 

that each institution engaged in nonexempt human subjects research 

conducted or supported by HHS provide 

a written assurance satisfactory to the 

Secretary of Health and Human Services 

that it will comply with the 

requirements of the HHS regulations (45 

CFR 46.103(a)). OHRP reviews and 

approves such assurances on behalf of 

HHS. The Federalwide Assurance 

(FWA) is now the only type of assurance 

accepted and approved by OHRP. An 

FWA commits the entire institution 

(including institutional officials, IRBs 

designated in the assurance, research 

investigators, and all other employees or 

agents) to compliance with the HHS 

regulations whenever the institution is 

engaged in HHS-conducted or 


dwashington3 on PROD1PC60 with PROPOSALS