52802 Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Proposed Rules 

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. Under the proposed 

regulations, foreign-owned U.S. 

businesses would be required to report 

on the BE–15 survey if they have total 

assets, sales or gross operating revenues, 

or net income that exceed $40 million. 

According the Small Business 

Administration’s Table of Small 

Business Size Standards, in most 

industries, businesses with $40 million 

of assets are not considered small 

businesses. The only industry for which 

the reporting requirements for the BE–

15 survey would affect small businesses, 

would be for certain types of banking 

and finance companies, where the 

threshold for being considered a small 

business is $175 million. BEA estimates 

that about 60 banking and finance 

affiliates would be considered small 

businesses and would have to report on 

the BE–15. About 20 of these small 

businesses would be required to file on 

the BE–15B, and about 40 (half in 

alternate years) would be required to file 

on the BE–15(EZ). Based on average 

burden hours per response of 3.5 hours 

for the BE–15B and 1.5 hours for the 

BE–15(EZ) in alternate years, BEA 

estimates the total respondent burden of 

the BE–15 on small companies to be 100 

hours out of a total estimated 

respondent burden on all companies of 

68,000 hours. 

Because few small businesses are 

subject to the reporting requirements 

and because those small businesses that 

are subject to reporting are subject to 

minimal recordkeeping burdens, the 

Chief Counsel for Regulation certifies 

that this proposed rule will not have a 

significant impact on a substantial 

number of small entities. 

List of Subjects in 15 CFR Part 806 

Economic statistics, Foreign 

investment in the United States, 

International transactions, Penalties, 

Reporting and recordkeeping 

requirements. 

Dated: July 30, 2008. 

J. Steven Landefeld, 

Director, Bureau of Economic Analysis. 

For 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. Section 806.15(i) is revised to read 

as follows: 

§ 806.15 Foreign direct investment in the 

United States. 

* * * * * 

(i) Annual report form. BE–15—

Annual Survey of Foreign Direct 

Investment in the United States: One 

report is required for each consolidated 

U.S. affiliate exceeding an exemption 

level of $40 million. Form BE–15A must 

be filed by each majority-owned U.S. 

affiliate (a ‘‘majority-owned’’ U.S. 

affiliate is one in which the combined 

direct and indirect ownership interests 

of all foreign parents of the U.S. affiliate 

exceed 50 percent) for which at least 

one of the three items—total assets, 

sales or gross operating revenues 

excluding sales taxes, or net income 

after provision for U.S. income taxes—

exceeds $275 million (positive or 

negative). Form BE–15B must be filed 

by each majority-owned U.S. affiliate for 

which at least one of the three items—

total assets, sales or gross operating 

revenues excluding sales taxes, or net 

income after provision for U.S. income 

taxes—exceeds $120 million (positive or 

negative) but no one item exceeds $275 

million (positive or negative), and by 

each minority-owned U.S. affiliate (a 

‘‘minority-owned’’ U.S. affiliate is one 

in which the combined direct and 

indirect ownership interest of all foreign 

parents of the U.S. affiliate is 50 percent 

or less) for which at least one of the 

three items—total assets, sales or gross 

operating revenues excluding sales 

taxes, or net income after provision for 

U.S. income taxes—exceeds $120 

million (positive or negative). Form BE–

15(EZ) must be filed every other year by 

each U.S. affiliate for which at least one 

of the three items—total assets, sales or 

gross operating revenues excluding sales 

taxes, or net income after provision for 

U.S. income taxes—exceeds $40 million 

(positive or negative) but no one item 

exceeds $120 million (positive or 

negative). U.S. affiliates will be mailed 

Form BE–15(EZ) in years when they are 

required to file; in alternate years, these 

U.S. affiliates will be mailed a letter 

confirming that they are not required to 

file and asking them to update their 

contact information with BEA. A BE–15 

Claim for Exemption must be filed by 

each U.S. affiliate to claim exemption 

from filing a BE–15A, BE–15B, or BE–

15(EZ). Following an initial filing, the 

BE–15 Claim for Exemption is not 

required annually from those U.S. 

affiliates that meet the stated exemption 

criteria from year to year. 

* * * * * 

[FR Doc. E8–21070 Filed 9–10–08; 8:45 am] 

BILLING CODE 3510–06–P 

DEPARTMENT OF COMMERCE 

Bureau of Economic Analysis 

15 CFR Part 806 

[Docket No. 080731960–81014–01] 

RIN 0691–AA66 

Direct Investment Surveys: BE–11, 

Annual Survey of U.S. Direct 

Investment Abroad 

AGENCY: Bureau of Economic Analysis, 

Commerce. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This proposed rule amends 

regulations of the Bureau of Economic 

Analysis, Department of Commerce 

(BEA) to amend the reporting 

requirements for the BE–11, Annual 

Survey of U.S. Direct Investment 

Abroad. The BE–11 survey is conducted 

annually and is a sample survey that 

obtains financial and operating data 

covering U.S. parent companies and 

their foreign affiliates. BEA proposes 

changes in the reporting criteria that 

will raise the thresholds for reporting. 

DATES: Comments on this proposed rule 

will receive consideration if submitted 

in writing on or before 5 p.m. November 

10, 2008. 

ADDRESSES: You may submit comments, 

identified by RIN 0691–AA66, and 

referencing the agency name (Bureau of 

Economic Analysis), by any of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

For agency, select ‘‘Commerce 

Department—all.’’

• E-mail: David.Galler@bea.gov. 

• Fax: Office of the Chief, Direct 

Investment Division, (202) 606–5318. 

• Mail: Office of the Chief, Direct 

Investment Division, U.S. Department of 


rmajette on PRODPC74 with PROPOSALS
Federal Register / Vol. 73, No. 177 / Thursday, September 11, 2008 / Proposed Rules 52803 

Commerce, Bureau of Economic 

Analysis, BE–50, Washington, DC 

20230. 

• Hand Delivery/Courier: Office of the 

Chief, Direct Investment Division, U.S. 

Department of Commerce, Bureau of 

Economic Analysis, BE–50, Shipping 

and Receiving, Section M100, 1441 L 

Street, NW., Washington, DC 20005. 

Written comments regarding the 

burden-hour estimates or other aspects 

of the information-of-collection 

requirements contained in the proposed 

rule should be sent to both BEA through 

any of the methods above and to the 

Office of Management and Budget 

(OMB), O.I.R.A., Paperwork Reduction 

Project 0608–0053, Attention PRA Desk 

Officer for BEA, via e-mail at 

pbugg@omb.eop.gov, or by FAX at 202–

395–7245. 

Public Inspection: All comments 

received are a part of the public record 

and will generally be posted to http:// 

www.regulations.gov without change. 

All personal identifying information (for 

example, name, address, etc.) 

voluntarily submitted by the 

commentator may be publicly 

accessible. Do not submit confidential 

business information or otherwise 

sensitive or protected information. BEA 

will accept anonymous comments. 

FOR FURTHER INFORMATION CONTACT: 

David H. Galler, Chief, Direct 

Investment Division (BE–50), Bureau of 

Economic Analysis, U.S. Department of 

Commerce, Washington, DC 20230; 

phone (202) 606–9835. 

SUPPLEMENTARY INFORMATION: This 

proposed rule would amend 15 CFR 

part 806.14 to set forth the reporting 

requirements for the BE–11, Annual 

Survey of U.S. Direct Investment 

Abroad. The Department of Commerce, 

as part of its continuing effort to reduce 

paperwork and respondent burden, 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections, as required by the 

Paperwork Reduction Act of 1995. 

Description of Changes 

The BE–11 survey is a mandatory 

survey and is conducted annually by 

BEA under the International Investment 

and Trade in Services Survey Act (22 

U.S.C. 3101–3108), hereinafter, ‘‘the 

Act.’’ BEA will send the survey to 

potential respondents in March of each 

year; responses will be due by May 31. 

In order to align BEA’s survey 

program with available resources, which 

have declined as a result of a recent 

reduction in BEA’s budget, BEA 

proposes changes in the reporting 

criteria: (a) An increase in the threshold 

for reporting on the BE–11B(SF) short 

form and BE–11C form from $40 million 

to $60 million; and (b) an increase in the 

threshold for reporting on the BE–

11B(LF) long form from $150 million to 

$225 million. Majority-owned nonbank 

affiliates with assets, sales or gross 

operating revenues, or net income (loss) 

over $60 million but less than or equal 

to $225 million would be filed on a 

short form; majority-owned nonbank 

affiliates with assets, sales or gross 

operating revenues, or net income (loss) 

over $225 million would be filed on a 

long form. Minority-owned nonbank 

affiliates with assets, sales or gross 

operating revenues, or net income (loss) 

over $60 million would be filed on a C 

form. Two reporting thresholds remain 

unchanged—the threshold for reporting 

on Form BE–11B(FN) remains at $250 

million and the threshold for reporting 

only selected items on Form BE–11A 

remains at $150 million. 

Survey Background 

The Bureau of Economic Analysis 

(BEA), U.S. Department of Commerce, 

conducts the BE–11 survey under the 

authority of the International 

Investment and Trade in Services 

Survey Act (22 U.S.C. 3101–3108), 

hereinafter, ‘‘the Act.’’ Section 4(a) of 

the Act requires that the President shall, 

to the extent he deems necessary and 

feasible, conduct a regular data 

collection program to secure current 

information on international financial 

flows and other information related to 

international investment and trade in 

services, including (but not limited to) 

such information as may be necessary 

for computing and analyzing the United 

States balance of payments, the 

employment and taxes of United States 

parents and affiliates, and the 

international investment and trade in 

services position of the United States. 

In Section 3 of Executive Order 

11961, as amended by Executive Orders 

12318 and 12518, the President 

delegated the responsibility for 

performing functions under the Act 

concerning direct investment to the 

Secretary of Commerce, who has 

redelegated it to BEA. The annual 

survey of U.S. direct investment abroad 

is a sample survey that collects 

information on a variety of measures of 

the overall operations of U.S. parent 

companies and their foreign affiliates, 

including total assets, sales, net income, 

employment and employee 

compensation, research and 

development expenditures, and exports 

and imports of goods. The sample data 

are used to derive universe estimates in 

nonbenchmark years from similar data 

reported in the BE–10, Benchmark 

Survey of U.S. Direct Investment 

Abroad, which is taken every five years. 

The data are needed to measure the size 

and economic significance of direct 

investment abroad, measure changes in 

such investment, and assess its impact 

on the U.S. and foreign economies. The 

data are disaggregated by country and 

industry of the foreign affiliate and by 

industry of the U.S. parent. 

Executive Order 12866 

This proposed rule has been 

determined to be not significant for 

purposes of E.O. 12866. 

Executive Order 13132 

This proposed rule does not contain 

policies with Federalism implications as 

that term is defined in E.O. 13132. 

Paperwork Reduction Act 

This proposed rule contains a 

collection-of-information requirement 

subject to review and approval by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act (PRA). The requirement will be 

submitted to the OMB for approval as a 

revision to a collection currently 

approved under OMB control number 

0608–0053. 

Notwithstanding any other provisions 

of the law, no person is required to 

respond to, nor shall any person be 

subject to a penalty for failure to comply 

with, a collection-of-information subject 

to the requirements of the Paperwork 

Reduction Act unless that collection 

displays a currently valid OMB control 

number. 

The BE–11 survey, as proposed, is 

expected to result in the filing of reports 

from approximately 1,550 respondents. 

The respondent burden for this 

collection of information will vary from 

one company to another, but is 

estimated to average 99.3 hours per 

response, including time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

Thus the total respondent burden of the 

survey is estimated at 153,850 hours 

(1,550 respondents times 99.3 hours 

average burden). Although the proposed 

amendments to the reporting rules 

lower respondent burden, this estimate 

is somewhat above the burden of 

122,900 hours currently carried for this 

survey in the OMB inventory, due to 

growth in the number and size of U.S. 

parent companies and foreign affiliates 

since the survey was last cleared. 

Comments are requested concerning: 

(a) Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 


rmajette on PRODPC74 with PROPOSALS
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