Federal Register / Vol. 87, No. 123 / Tuesday, June 28, 2022 / Proposed Rules 38311 

Airspace Designations and Reporting 

Points, dated August 10, 2021, and 

effective September 15, 2021, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

ANM OR E Christmas Valley, OR [New] 

Christmas Valley Airport, OR 

(Lat. 43°14′11′′ N, long. 120°39′53′′ W) 

That airspace extending upward from 700 

feet above the surface within a 14-mile radius 

of the Christmas Valley Airport. 

Issued in Des Moines, Washington, on June 

21, 2022. 

B.G. Chew, 

Acting Group Manager, Operations Support 

Group, Western Service Center. 

[FR Doc. 2022–13614 Filed 6–27–22; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Economic Analysis 

15 CFR Part 801 

[Docket No. 220616–0135] 

RIN 0691–AA92 

Direct Investment Surveys: BE–13, 

Survey of New Foreign Direct 

Investment in the United States 

AGENCY: Bureau of Economic Analysis, 

Commerce. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: This proposed rule would 

amend regulations of the Department of 

Commerce’s Bureau of Economic 

Analysis (BEA) to set forth the reporting 

requirements for the BE–13, Survey of 

New Foreign Direct Investment in the 

United States (‘‘BE–13 survey’’). The 

BE–13 survey collects information on 

the acquisition or establishment of U.S. 

business enterprises by foreign 

investors, and information on 

expansions by existing U.S. affiliates of 

foreign companies. The data collected 

through the survey are used to measure 

the amount of new foreign direct 

investment in the United States and 

ensure complete coverage of BEA’s 

other foreign direct investment 

statistics. BEA proposes one change to 

the reporting requirements of the survey 

that will reduce respondent burden, 

simplify reporting, and increase the 

efficiency of the data collection. This 

mandatory BE–13 survey is required 

from persons subject to the reporting 

requirements, whether or not they are 

contacted by BEA. 

DATES: Comments on this proposed rule 

will receive consideration if submitted 

in writing on or before August 29, 2022. 

ADDRESSES: You may submit comments, 

identified by RIN 0691–AA92, and 

referencing the agency name (Bureau of 

Economic Analysis), by any of the 

following methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

For Keyword or ID, enter ‘‘EAB–2022– 

0001.’’ 

• Email: Ricardo.Limes@bea.gov. 

• Mail: Direct Transactions and 

Positions Branch, U.S. Department of 

Commerce, Bureau of Economic 

Analysis, BE–49NI, Washington, DC 

20233. 

• Hand Delivery/Courier: Direct 

Transactions and Positions Branch, U.S. 

Department of Commerce, Bureau of 

Economic Analysis, BE–49NI, 4600 

Silver Hill Road, Suitland, MD 20746. 

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 BEA through any 

of the methods above and also to the 

Office of Management and Budget 

(OMB) by submitting comments at 

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review’’ or by using the search function 

and entering the title of the collection. 

Public Inspection: All comments 

received are a part of the public record 

and will generally be posted to https:// 

www.regulations.gov without change. 

Personal identifying information 

voluntarily submitted by the commenter 

may be publicly accessible. Do not 

submit confidential business 

information or otherwise sensitive or 

protected information. BEA will accept 

anonymous comments (enter N/A in 

required fields if you wish to remain 

anonymous). 

FOR FURTHER INFORMATION CONTACT: 

Ricardo Limes, Chief, Direct 

Transactions and Positions Branch (BE– 

49NI), Bureau of Economic Analysis, 

U.S. Department of Commerce, 4600 

Silver Hill Road, Washington, DC 

20233; email Ricardo.limes@bea.gov or 

301–278–9659. 

SUPPLEMENTARY INFORMATION: The BE– 

13, Survey of New Foreign Direct 

Investment in the United States, is a 

mandatory survey conducted by BEA 

under the authority of the International 

Investment and Trade in Services 

Survey Act (22 U.S.C. 3101–3108). 

The purpose of the BE–13 survey is to 

collect data on the acquisition or 

establishment of U.S. business 

enterprises by foreign investors and the 

expansion of existing U.S. affiliates of 

foreign companies to establish a new 

facility where business is conducted. 

The data collected on the survey are 

used to measure the amount and 

economic significance of new foreign 

direct investment in the United States 

and assess its impact on the U.S. 

economy. Foreign direct investment in 

the United States is defined as the 

ownership or control, directly or 

indirectly, by one foreign person 

(foreign parent) of 10 percent or more of 

the voting securities of an incorporated 

U.S. business enterprise, or an 

equivalent interest of an unincorporated 

U.S. business enterprise, including a 

branch. 

This proposed rule would amend 15 

CFR 801.7 to set forth the reporting 

requirements for the BE–13, Survey of 

New Foreign Direct Investment in the 

United States. Under this proposed rule, 

persons subject to the reporting 

requirements of the BE–13, Survey of 

New Foreign Direct Investment in the 

United States, would be required to 

respond, whether or not they are 

contacted by BEA. 

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, 44 

U.S.C. 3501–3520 (PRA). 

Description of Changes 

The proposed change amends the 

regulations for the BE–13 survey. 

Specifically, BEA proposes to change 

the reporting requirements of form BE– 

13E, Fiscal Year End Cost Update for 

Projects Originally Reported on Forms 

BE–13B and BE–13D. The form collects 

updated cost information for greenfield 

investments—i.e., establishments or 

expansions of U.S. businesses by foreign 

investors filed on BE–13B or BE–13D 

forms, respectively—and is required to 

be filed annually until the establishment 

or expansion of the U.S. business 

enterprise is complete. 

BEA proposes to limit the filing 

requirement of the BE–13E form to three 

years after the year the investment is 

initiated. BEA has found that this 

timeframe would be sufficient to collect 

the vast majority of the changes to total 

planned expenditures of greenfield 

investments and provide data users with 

insightful statistics on the ultimate cost 

of these investments. The proposed 

change would reduce respondent 

burden and the BEA resources needed 

to continue to collect and process these 


khammond on DSKJM1Z7X2PROD with PROPOSALS
38312 Federal Register / Vol. 87, No. 123 / Tuesday, June 28, 2022 / Proposed Rules 

updates, allowing BEA to focus 

resources on the featured statistics for 

more recent periods. 

BEA will describe any proposed 

changes to the information collected 

through the survey (including the 

addition, deletion, and/or modification 

of existing questions and definitions) in 

a public notice and will solicit 

comments as part of the requirements of 

the Paperwork Reduction Act (PRA). 

Any changes to reporting requirements 

or significant expansions in scope of the 

surveys would be conducted by 

rulemaking. 

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 

sufficient to warrant preparation of a 

Federalism assessment under E.O. 

13132. 

Paperwork Reduction Act 

This proposed rule contains a 

collection-of-information requirement 

subject to review and approval by OMB 

under the PRA. The requirement will be 

submitted to OMB for approval as a 

reinstatement, with change, of a 

previously approved collection under 

OMB control number 0608–0035. 

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 PRA unless 

that collection displays a currently valid 

OMB control number. 

The BE–13 survey, as proposed, is 

expected to result in the filing of 

approximately 3,027 reports from U.S. 

affiliates each year. The respondent 

burden for this collection of information 

is expected to vary because of 

differences in company structure, size, 

and complexity, but is estimated to 

average 1.1 hours per response. The 

burden includes 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 for 

this survey is estimated at 3,027 hours, 

compared to 2,547 hours for the 

previous BE–13 survey estimate. The 

increase in burden hours is due to the 

increase in the overall number of 

respondents expected to file, partially 

offset by a reduction in the number of 

BE–13E forms expected to be filed. 

We are soliciting public comments to 

permit the Department of Commerce/ 

Bureau of Economic Analysis to: (a) 

Evaluate whether the proposed 

information collection is necessary for 

the proper functions of the Department, 

including whether the information will 

have practical utility; (b) Evaluate the 

accuracy of our estimate of the time and 

cost burden for this proposed collection, 

including the validity of the 

methodology and assumptions used; (c) 

Evaluate ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (d) Minimize the 

reporting burden on those who are to 

respond, 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 (RFA), 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. 

Most of the U.S. business enterprises 

that are required to file the survey are 

units of multinational enterprises. For 

the few small businesses that are 

foreign-owned, BEA has attempted to 

keep burden to a minimum by asking 

only those questions that are considered 

essential and for which answers are 

likely to be readily available from the 

existing records of the business. The 

amount of information required to be 

reported by each U.S. business 

enterprise is determined by the type and 

cost of the transaction. When the cost of 

the acquisition, establishment, or 

expansion is less than $3 million, the 

U.S. business enterprise will only be 

required to report selected items on the 

BE–13 Claim for Exemption. The burden 

for this form is an average of 15 

minutes. 

Because relatively few small 

businesses are required to file the 

survey and because those that are 

impacted are subject to only a minimal 

recordkeeping burden, 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 801 

Economic statistics, Foreign 

investment in the United States, 

International transactions, Penalties, 

Reporting and record keeping 

requirements. 

Paul W. Farello, 

Associate Director of International 

Economics, Bureau of Economic Analysis. 

For reasons set forth in the preamble, 

BEA proposes to amend 15 CFR part 801 

as follows: 

PART 801—SURVEY OF 

INTERNATIONAL TRADE IN SERVICES 

BETWEEN U.S. AND FOREIGN 

PERSONS AND SURVEYS OF DIRECT 

INVESTMENT 

■ 1. The authority citation for 15 CFR 

part 801 continues to read as follows: 

Authority: 5 U.S.C. 301; 15 U.S.C. 4908; 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. Revise § 801.7 to read as follows: 

§ 801.7 Rules and regulations for the BE– 

13, Survey of New Foreign Direct 

Investment in the United States. 

The BE–13, Survey of New Foreign 

Direct Investment in the United States, 

is conducted to collect data on the 

acquisition or establishment of U.S. 

business enterprises by foreign investors 

and the expansion of existing U.S. 

affiliates of foreign companies to 

establish new facilities where business 

is conducted. Foreign direct investment 

is defined as the ownership or control 

by one foreign person (foreign parent) of 

10 percent or more of the voting 

securities of an incorporated U.S. 

business enterprise, or an equivalent 

interest of an unincorporated U.S. 

business enterprise, including a branch. 

BEA will describe the proposed 

information collection in a public notice 

and will solicit comments according to 

the requirements of the Paperwork 

Reduction Act (44 U.S.C. 3501–3520). 

All legal authorities, provisions, 

definitions, and requirements contained 

in §§ 801.1 through 801.2 and §§ 801.4 

through 801.6 are applicable to this 

survey. Specific additional rules and 

regulations for the BE–13 survey are 

given in paragraphs (a) through (d) of 

this section. More detailed instructions 

are given on the report forms and 

instructions. 

(a) Response required. A response is 

required from persons subject to the 

reporting requirements of the BE–13, 

Survey of New Foreign Direct 

Investment in the United States, 

contained herein, whether or not they 


khammond on DSKJM1Z7X2PROD with PROPOSALS
Federal Register / Vol. 87, No. 123 / Tuesday, June 28, 2022 / Proposed Rules 38313 

are contacted by BEA. Also, a person, or 

their agent, who is contacted by BEA 

about reporting in this survey, either by 

sending them a report form or by 

written inquiry, must respond in writing 

pursuant to this section. This may be 

accomplished by filing the properly 

completed BE–13 report (BE–13A, BE– 

13B, BE–13D, BE–13E, or BE–13 Claim 

for Exemption). 

(b) Who must report. A BE–13 report 

is required of any U.S. business 

enterprise, except certain private funds, 

see exception in item (b.4.), in which: 

(1) A foreign direct investment in the 

United States relationship is created; 

(2) An existing U.S. affiliate of a 

foreign parent establishes a new U.S. 

business enterprise, expands its U.S. 

operations, or acquires a U.S. business 

enterprise, or; 

(3) BEA requests a cost update (Form 

BE–13E) for a U.S. business enterprise 

that previously filed Form BE–13B or 

BE–13D. 

(4) Certain private funds are exempt 

from reporting on the BE–13 survey. If 

a U.S. business enterprise is a private 

fund and does not own, directly or 

indirectly, 10 percent or more of another 

business enterprise that is not also a 

private fund or a holding company, it is 

not required to file any BE–13 report 

except to indicate exemption from the 

survey if contacted by BEA. 

(c) Forms to be filed. Depending on 

the type of investment transaction, U.S. 

affiliates would report their information 

on one of five forms—BE–13A, BE–13B, 

BE–13D, BE–13E, or BE–13 Claim for 

Exemption. 

(1) Form BE–13A—Report for a U.S. 

business enterprise when a foreign 

entity acquires a voting interest 

(directly, or indirectly through an 

existing U.S. affiliate) in that U.S. 

business enterprise including segments, 

operating units, or real estate; and 

(i) The total cost of the acquisition is 

greater than $3 million; and 

(ii) By this acquisition, the foreign 

entity now owns at least 10 percent of 

the voting interest (directly, or 

indirectly through an existing U.S. 

affiliate) in the acquired U.S. business 

enterprise. 

(2) Form BE–13B—Report for a U.S. 

business enterprise when it is 

established by a foreign entity or by an 

existing U.S. affiliate of a foreign parent; 

and 

(i) The expected total cost to establish 

the new U.S. business enterprise is 

greater than $3 million; and 

(ii) The foreign entity owns at least 10 

percent of the voting interest (directly, 

or indirectly through an existing U.S. 

affiliate) in the new U.S. business 

enterprise. 

(3) Form BE–13D—Report for an 

existing U.S. affiliate of a foreign parent 

when it expands its operations to 

include a new facility where business is 

conducted and the expected total cost of 

the expansion is greater than $3 million. 

(4) Form BE–13E—Report for a U.S. 

business enterprise that previously filed 

Form BE–13B or BE–13D. Form BE–13E 

collects updated cost information and 

will be collected annually for three 

years after the year of the establishment 

or expansion of the U.S. business 

enterprise. 

(5) Form BE–13 Claim for 

Exemption—Report for a U.S. business 

enterprise that: 

(i) was contacted by BEA but does not 

meet the requirements for filing Forms 

BE–13A, BE–13B, or BE–13D; or 

(ii) whether or not contacted by BEA, 

met all requirements for filing Forms 

BE–13A, BE–13B, or BE–13D except the 

$3 million reporting threshold. 

(d) Due date. The BE–13 forms are 

due no later than 45 calendar days after 

the acquisition is completed, the new 

U.S. business enterprise is established, 

the expansion is begun, the cost update 

is requested, or a notification letter is 

received from BEA by a U.S. business 

enterprise that does not meet the filing 

requirements for the survey. 

[FR Doc. 2022–13713 Filed 6–27–22; 8:45 am] 

BILLING CODE 3510–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 201 and 314 

[Docket No. FDA–2021–N–0862] 

RIN 0910–AH62 

Nonprescription Drug Product With an 

Additional Condition for 

Nonprescription Use 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is proposing to establish 

requirements for a nonprescription drug 

product with an additional condition for 

nonprescription use (ACNU). The 

proposed rule, if finalized, would 

establish requirements for a 

nonprescription drug product that has 

an ACNU that an applicant must 

implement to ensure appropriate selfselection or appropriate actual use, or 

both, by consumers without the 

supervision of a healthcare practitioner. 

The proposed rule is intended to 

increase options for applicants to 

develop and market safe and effective 

nonprescription drug products, which 

could improve public health by 

broadening the types of nonprescription 

drug products available to consumers. 

DATES: Either electronic or written 

comments on the proposed rule must be 

submitted by October 26, 2022. Submit 

comments (including recommendations) 

on information collection issues under 

the Paperwork Reduction Act of 1995 by 

July 28, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

October 26, 2022. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 


khammond on DSKJM1Z7X2PROD with PROPOSALS