52804 Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Proposed Rules 

agency, including whether the 

information will have practical utility; 

(b) the accuracy of the burden estimate; 

(c) ways to enhance the quality, utility, 

and clarity of the information collected; 

and (d) ways to minimize the burden of 

the collection of information on the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

Written comments regarding the 

burden-hour estimates or other aspects 

of the collection of information 

requirements contained in the proposed 

rule should be sent to both BEA and 

OMB following the instructions given in 

the ADDRESSES section above. 

Regulatory Flexibility Act 

The Chief Counsel for Regulation, 

Department of Commerce, has certified 

to the Chief Counsel for Advocacy, 

Small Business Administration, under 

the provisions of the Regulatory 

Flexibility Act (5 U.S.C. 605(b)), that 

this proposed rulemaking, if adopted, 

will not have a significant economic 

impact on a substantial number of small 

entities. Few small U.S. businesses are 

subject to the reporting requirements of 

this survey. U.S. companies that have 

direct investments abroad tend to be 

quite large, thereby excluding them 

from the definition of small entity. The 

proposed changes to the BE–11 annual 

survey would not increase the burden 

on small businesses. The exemption 

level for the BE–11 survey is set in 

terms of the size of a U.S. company’s 

foreign affiliates (foreign companies 

owned 10 percent or more by the U.S. 

company); if a foreign affiliate has total 

assets, sales, or net income (loss) greater 

than the exemption level, it must be 

reported on Form BE–11B(LF), BE–

11B(SF), BE–11B(FN), BE–11B(EZ), or 

BE–11C. With the increase in the 

exemption level for the BE–11 survey 

for nonbank affiliates of nonbank U.S. 

Reporters from $40 million to $60 

million, the burden on small businesses 

would not increase and is likely to 

decrease since the U.S. parent company 

required to file the report is typically 

many times larger than its largest 

foreign affiliate. BEA estimates that 

about 1,700 majority-owned nonbank 

foreign affiliates will shift from being 

reported on the long form to the short 

form under the $225 million exemption 

level. About 3,000 nonbank foreign 

affiliates will no longer be required to be 

reported under the $60 million 

exemption level; almost 4,000 foreign 

affiliates were added to the sample due 

to growth in the universe since the 2004 

BE–10 benchmark survey. About 200 

U.S. Reporters will no longer be 

required to report the annual survey 

because all of their affiliates would be 

exempt. 

Because few small businesses are 

impacted by this rule, and because those 

small businesses that are impacted are 

subject to only minimal recordkeeping 

burdens, the Chief Counsel for 

Regulation certifies that this proposed 

rule will not have a significant 

economic impact on a substantial 

number of small entities. 

List of Subjects in 15 CFR Part 806 

Economic statistics, Multinational 

corporations, Penalties, Reporting and 

recordkeeping requirements, U.S. 

investment abroad. 

Dated: August 20, 2008. 

Rosemary Marcuss, 

Acting Director, Bureau of Economic 

Analysis. 

For the reasons set forth in the 

preamble, BEA proposes to amend 15 

CFR part 806 as follows: 

PART 806—DIRECT INVESTMENT 

SURVEYS 

1. The authority citation for 15 CFR 

part 806 continues to read as follows: 

Authority: 5 U.S.C. 301; 22 U.S.C. 3101–

3108; E.O. 11961 (3 CFR, 1977 Comp., p. 86), 

as amended by E.O. 12318 (3 CFR, 1981 

Comp., p. 173) and E.O. 12518 (3 CFR, 1985 

Comp., p. 348). 

2. Sections 806.14(f)(3)(ii) 

introductory text, (f)(3)(ii)(A) and (B), 

(f)(3)(iv), (f)(3)(v) introductory text, and 

(f)(3)(v)(A) are revised to read as 

follows: 

§ 806.14 U.S. Direct Investment Abroad. 

* * * * * 

(f) * * * 

(3) * * * 

(ii) Forms BE–11B(LF), (SF), and (EZ) 

(Report for Majority-owned Nonbank 

Foreign Affiliate of Nonbank U.S. 

Reporter). 

(A) A BE–11B(LF) (Long Form) must 

be filed for each majority-owned 

nonbank foreign affiliate of a nonbank 

U.S. Reporter for which any one of the 

three items—total assets, sales or gross 

operating revenues excluding sales 

taxes, or net income after provision for 

foreign income taxes—was greater than 

$225 million (positive or negative) at the 

end of, or for, the affiliate’s fiscal year, 

unless the nonbank foreign affiliate is 

selected to be reported on Form BE–

11B(EZ). 

(B) A BE–11B(SF) (Short Form) must 

be filed for each majority-owned 

nonbank foreign affiliate of a nonbank 

U.S. Reporter for which any one of the 

three items listed in paragraph 

(f)(3)(ii)(A) of this section was greater 

than $60 million (positive or negative), 

but for which no one of these items was 

greater than $225 million (positive or 

negative), at the end of, or for, the 

affiliate’s fiscal year, unless the nonbank 

foreign affiliate is selected to be 

reported on Form BE–11B(EZ). 

* * * * * 

(iv) Form BE–11C (Report for 

Minority-owned Nonbank Foreign 

Affiliate of Nonbank U.S. Reporter) 

must be filed for each minority-owned 

nonbank foreign affiliate of a nonbank 

U.S. Reporter that is owned at least 20 

percent, but not more than 50 percent, 

directly and/or indirectly, by all U.S. 

Reporters of the affiliate combined, and 

for which any one of the three items 

listed in paragraph (f)(3)(ii)(A) of this 

section was greater than $60 million 

(positive or negative) at the end of, or 

for, the affiliate’s fiscal year. 

(v) Based on the preceding, an affiliate 

is exempt from being reported if it meets 

any one of the following criteria: 

(A) For nonbank affiliates of nonbank 

U.S. Reporters, none of the three items 

listed in paragraph (f)(3)(ii)(A) of this 

section exceeds $60 million (positive or 

negative). However, affiliates that were 

established or acquired during the year 

and for which at least one of these items 

was greater than $10 million but not 

over $60 million must be listed, and key 

data items reported, on a supplement 

schedule on Form BE–11A. 

* * * * * 

[FR Doc. E8–21311 Filed 9–10–08; 8:45 am] 

BILLING CODE 3510–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR 878 

[Docket No. FDA–2006–N–0178] (formerly 

Docket No. 2006N–0362) 

General and Plastic Surgery Devices; 

Reclassification of the Absorbable 

Hemostatic Device; Reopening of 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

October 14, 2008, the comment period 

for a proposed rule published in the 

Federal Register of October 31, 2006 (71 

FR 63728) to reclassify the absorbable 

hemostatic device from class III 

(premarket approval) into class II 

(special controls). FDA is reopening the 


rmajette on PRODPC74 with PROPOSALS
Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Proposed Rules 52805 

comment period to update comments 

and to receive any new information. 

Elsewhere in this issue of the Federal 

Register, FDA is also reopening the 

comment period on a notice of 

availability of a draft guidance 

document that would serve as the 

special control if FDA reclassifies this 

device. 

DATES: Submit written or electronic 

comments on the proposed rule by 

October 14, 2008. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

David Krause, Center for Devices and 

Radiological Health (HFZ–410), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

240–276–3638. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 31, 

2006 (71 FR 63728), FDA published a 

proposed rule to reclassify the 

absorbable hemostatic device intended 

to produce hemostasis from class III 

(premarket approval) to class II (special 

controls). FDA invited interested 

persons to comment on the proposed 

rule by January 29, 2007. In the Federal 

Register of May, 8, 2007 (72 FR 26011), 

FDA reopened the comment period for 

30 days in response to two requests for 

additional time for preparation of 

comments. 

On July 2, 2007, FDA received a 

petition under 21 CFR 10.30 and 10.35 

requesting that the agency refrain from 

issuing a final regulation for the 

proposed reclassification and the draft 

special controls guidance for the 

absorbable hemostatic device until an 

updated and complete administrative 

record is made available to the public. 

The petitioner also requested that FDA 

reopen the rulemaking for the proposed 

reclassification to allow submission of 

comments based on the administrative 

record. FDA has updated the 

administrative record in the Division of 

Dockets Management (see ADDRESSES). 

FDA is also reopening the comment 

period for 30 days. Although you can 

comment on any guidance at any time 

(see 21 CFR 10.115(g)(5)), elsewhere in 

this issue of the Federal Register, FDA 

is reopening the comment period on a 

notice of availability of a draft guidance 

document that would serve as the 

special control if the device is 

reclassified. 

II. How to Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments to http://www.regulations.gov 

or two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA through FDMS only. 

Dated: September 4, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21200 Filed 9–10–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 301 

[REG–160868–04] 

RIN 1545–BF61 

Section 6707A and the Failure To 

Include on Any Return or Statement 

Any Information Required To Be 

Disclosed Under Section 6011 With 

Respect to a Reportable Transaction 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

by cross-reference to temporary 

regulations. 

SUMMARY: In the Rules and Regulations 

section of this issue of the Federal 

Register, the IRS is issuing temporary 

regulations under section 6707A of the 

Internal Revenue Code (Code), which 

provide the rules relating to the 

assessment of penalties under section 

6707A for the failure to include on any 

return or statement any information 

required to be disclosed under section 

6011 with respect to a reportable 

transaction. The text of those temporary 

regulations also serves as the text of 

these proposed regulations. 

DATES: Written or electronic comments 

and requests for a public hearing must 

be received by December 10, 2008. 

ADDRESSES: Send submission to: 

CC:PA:LPD:PR (REG–160868–04), room 

5203, Internal Revenue Service, P.O. 

Box 7604, Ben Franklin Station, 

Washington, DC 20044. Submissions 

may be hand delivered Monday through 

Friday between the hours of 8 a.m. and 

4 p.m. to: CC:PA:LPD:PR (REG–160868–

04), Courier’s Desk, Internal Revenue 

Service, 1111 Constitution Avenue, 

NW., Washington, DC, or sent 

electronically via the Federal 

eRulemaking Portal at http:// 

www.regulations.gov (IRS REG–160868–

04). 

FOR FURTHER INFORMATION CONTACT: 

Concerning the proposed regulations, 

Matthew Cooper (202) 622–4940; 

concerning submissions of comments 

and requests for a public hearing, 

Richard Hurst (202) 622–2949 (TDD 

telephone) (not toll-free numbers) and 

his e-mail address is 

Richard.A.Hurst@irscounsel.treas.gov. 

SUPPLEMENTARY INFORMATION: 

Background and Explanation of 

Provisions 

Temporary regulations in the Rules 

and Regulations section of this issue of 

the Federal Register amend the 

Procedure and Administration 

Regulations (26 CFR part 301) relating to 

section 6707A. Section 811 of the 

American Jobs Creation Act of 2004, 

Public Law 108–357 (118 Stat. 1418) 

added section 6707A to the Code to 

provide a monetary penalty for the 

failure to include on any return or 

statement any information required to 

be disclosed under section 6011 with 

respect to a reportable transaction. The 

temporary regulations set forth the rules 

relating to the assessment of the penalty 

as well as the factors that the 

Commissioner (or the Commissioner’s 

delegate) will consider in deciding 

whether the penalty should be 

rescinded based on promoting 

compliance with the Code and effective 

tax administration. The text of those 

temporary regulations also serves as the 

text of these proposed regulations. The 

preamble to the temporary regulations 

explains the amendments. 

Special Analyses 

It has been determined that this notice 

of proposed rulemaking is not a 

significant regulatory action as defined 

in Executive Order 12866. Therefore, a 

regulatory assessment is not required. It 

also has been determined that section 

553(b) of the Administrative Procedure 

Act (5 U.S.C. chapter 5) does not apply 


rmajette on PRODPC74 with PROPOSALS