Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Rules and Regulations 49939 

(3) The exporter has paid, or 

committed to pay, all export charges 

due in accordance with the volume, 

export price, and export charge rate or 

rates, if any, as calculated under an 

international agreement entered into by 

the country of export and the United 

States and consistent with the export 

charge determinations published by the 

Under Secretary for International Trade 

of the Department of Commerce. 

(iv) Any substantiating 

documentation that supports an 

importer’s softwood lumber declaration 

is subject to the recordkeeping 

provisions set forth in part 163 of title 

19 to the CFR. 

(d) Entry requirements for home 

packages and kits—(1) Declaration and 

required documentation. Home 

packages and kits as described in 

section 804(c)(7)(A)(i) through (iv) of the 

Title VIII of the Tariff Act of 1930, as 

amended (19 U.S.C. 1202 et seq.) are not 

subject to the entry requirements set 

forth in paragraph (c) of this section. 

However, the importer is required to 

make a declaration pursuant to section 

804(c)(7)(B) and is required to retain 

and produce upon demand by CBP, the 

following documentation: 

(i) A copy of the appropriate home 

design, plan, or blueprint matching the 

customs entry in the United States. 

(ii) A purchase contract from a retailer 

of home kits or packages signed by a 

customer not affiliated with the 

importer. 

(iii) A listing of all parts in the 

package or kit being entered into the 

United States that conforms to the home 

design, plan, or blueprint for which 

such parts are being imported. 

(iv) If a single contract involved 

multiple entries, an identification of all 

the items required to be listed under 

paragraph (d)(1)(iii) of this section that 

are included in each individual 

shipment. 

(2) Records and retention. There is no 

requirement to present physical copies 

of the softwood lumber home packages 

and kits documentation to CBP at the 

time of filing the entry summary; 

however copies must be maintained in 

accordance with the applicable 

recordkeeping provisions set forth in 

part 163 of title 19 to the CFR. 

(e) Other softwood lumber entry 

requirements. Other entry requirements 

may be applicable to certain imports of 

softwood lumber or softwood lumber 

from Canada. Importers are advised to 

refer to § 12.140 (19 CFR 12.140) of this 

chapter for information regarding 

applicability and entry requirements. 

PART 163—RECORDKEEPING 

■ 4. The authority citation for part 163 

continues to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 

1484, 1508, 1509, 1510, 1624. 

■ 5. The Appendix to part 163 is 

amended by adding, in numerical order, 

a listing for § 12.142 under section IV to 

read as follows: 

Appendix to Part 163—Interim (a)(1)(A) 

List 

* * * * * 

IV. * * * 

§ 12.142 Softwood Lumber Importer 

Declaration Supporting Documentation, 

Softwood Lumber Home Packages and Kits 

Documentation. 

* * * * * 

W. Ralph Basham, 

Commissioner, U.S. Customs and Border 

Protection. 

Approved: August 20, 2008. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. E8–19641 Filed 8–22–08; 8:45 am] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Customs and Border 

Protection 

DEPARTMENT OF THE TREASURY 

19 CFR Part 141 

[Docket No. USCBP–2008–0062] 

RIN 1505–AB96; CBP Dec. 08–31 

First Sale Declaration Requirement 

AGENCIES: Customs and Border 

Protection, Department of Homeland 

Security; Department of the Treasury. 

ACTION: Interim rule; solicitation of 

comments. 

SUMMARY: This document establishes an 

importer declaration requirement 

pursuant to section 15422(a) of the 

Food, Conservation, and Energy Act of 

2008 to assist Customs and Border 

Protection (CBP) in gathering 

information for all goods entered for 

consumption or withdrawn from 

warehouse for consumption on the 

transaction valuation of goods imported 

into the United States. Effective for a 

one-year period beginning August 20, 

2008, all importers will be required to 

provide a declaration to CBP at the time 

of filing a consumption entry when, in 

a series of sequential sales, the 

transaction value of the imported 

merchandise is determined on the basis 

of the ‘‘first or earlier sale’’ of goods—

the first sale in which the goods are 

‘‘sold for exportation to the United 

States’’ or any other sale earlier than the 

last sale prior to the introduction of the 

merchandise into the United States. CBP 

will then report the frequency of the use 

of the ‘‘first sale’’ rule and other 

associated data to the International 

Trade Commission (ITC) on a monthly 

basis. 

DATES: This interim rule is effective on 

August 20, 2008. Comments must be 

received on or before October 24, 2008. 

ADDRESSES: You may submit comments, 

identified by docket number, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments 

via docket number USCBP–2008–0062. 

• Mail: Trade and Commercial 

Regulations Branch, U.S. Customs and 

Border Protection, 1300 Pennsylvania 

Avenue, NW., (Mint Annex), 

Washington, DC 20229. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

comments received will be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. Submitted 

comments may also be inspected on 

regular business days between the hours 

of 9 a.m. and 4:30 p.m. at the Trade and 

Commercial Regulations Branch, Office 

of International Trade, Regulations and 

Rulings, Customs and Border Protection, 

799 9th Street, NW. (5th Floor), 

Washington, DC. Arrangements to 

inspect submitted comments should be 

made in advance by calling Mr. Joseph 

Clark at (202) 572–8768. 

FOR FURTHER INFORMATION CONTACT: 

Monika Brenner, Valuation and Special 

Programs Branch, Regulations and 

Rulings, Office of International Trade, 

(202) 572–8835. 

SUPPLEMENTARY INFORMATION: 

Public Participation 

Interested persons are invited to 

participate in this rulemaking by 

submitting written data, views, or 

arguments on all aspects of the interim 

rule. Customs and Border Protection 


ebenthall on PRODPC60 with RULES
49940 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Rules and Regulations 

(CBP) also invites comments that relate 

to the economic, environmental, or 

federalism effects that might result from 

this interim rule. Comments that will 

provide the most assistance will 

reference a specific portion of the 

interim rule, explain the reason for any 

recommended change, and include data, 

information, or authority that support 

such recommended change. 

Background 

The value of merchandise imported 

into the United States is determined 

primarily under transaction value which 

the U.S. value law, set forth in 19 U.S.C. 

1401a, defines as ‘‘the price actually 

paid or payable for the merchandise 

when sold for exportation to the United 

States’’ plus specified additions to that 

amount. 19 U.S.C. 1401a(b)(1). The 

phrase ‘‘sold for exportation to the 

United States’’ is not defined in 19 

U.S.C. 1401a, nor in the implementing 

regulations set forth in part 152 of title 

19 of the Code of Federal Regulations 

(19 CFR part 152). 

Notice of Proposed Interpretation 

On January 24, 2008, CBP published 

in the Federal Register (73 FR 4254) a 

notice informing interested parties that 

CBP proposed a new interpretation of 

the expression ‘‘sold for exportation to 

the United States’’ for purposes of 

applying the transaction value method 

of valuation in a series of sales 

importation scenario. Under this 

proposed new interpretation in a 

transaction involving a series of sales, 

the price paid in the last sale occurring 

prior to the introduction of the goods 

into the United States, instead of an 

earlier sale, would be considered the 

price actually paid or payable for the 

imported goods when sold for 

exportation to the United States. CBP is 

withdrawing the notice of proposed 

interpretation. 

Food, Conservation, and Energy Act of 

2008 

On May 22, 2008, Congress passed the 

Food, Conservation, and Energy Act of 

2008 (the ‘‘Act’’), Public Law 110–234, 

122 Stat. 1547 (19 U.S.C. 1484 note). 

Section 15422 of the Act, in pertinent 

part, requires: 

• CBP must collect a declaration as to 

whether the transaction value of the 

imported merchandise is determined on 

the basis of the price paid in the first or 

earlier sale occurring prior to the 

introduction of the merchandise into the 

United States. 

• CBP must provide the collected 

information to the ITC on a monthly 

basis. 

• ITC must submit a report to the 

House Ways and Means Committee and 

the Senate Finance Committee within 

90 days of receipt of CBP’s final 

monthly report. 

• A ‘‘sense of Congress’’ provision 

advises that CBP not amend its 

interpretation of ‘‘sold for exportation to 

the United States’’ for purposes of 

applying the transaction value of the 

imported merchandise in a series of 

sales before January 1, 2011. Beginning 

on January 1, 2011, CBP may propose to 

change its interpretation only if CBP: (1) 

Consults with and provides notice to the 

committees noted above not less than 

180 days prior to proposing a change 

and not less than 90 days prior to 

publishing a change; (2) consults with, 

provides notice to, and takes into 

consideration views expressed by the 

Commercial Operations Advisory 

Committee not less than 120 days prior 

to proposing a change and not less than 

60 days prior to publishing a change; 

and (3) receives the explicit approval of 

the Secretary of the Treasury prior to 

publishing a change. CBP should also 

take into consideration the ITC report 

before publishing any change to the 

expression ‘‘sold for exportation to the 

United States.’’

Required Information on Entry 

Summary (CBP Form 7501) 

In addition to the entry and entry 

summary information otherwise 

required for importation into the United 

States, as per section 484 of the Tariff 

Act of 1930, as amended (19 U.S.C. 

1484), the Act obligates CBP to require 

that a U.S. importer of merchandise 

provide a declaration at the time of 

entry of the merchandise on the entry 

summary form, CBP Form 7501, as to 

whether the value of the imported 

merchandise was determined on the 

basis of the price paid by the buyer in 

the ‘‘first or earlier sale.’’

On June 10, 2008, CBP participated in 

a teleconference call with members of 

the Trade Support Network (TSN), a 

group of private-sector trade 

representatives that provides CBP with 

input on the development of Customs 

Modernization projects. Participants in 

the call discussed various ways to 

indicate when customs value is based 

on the ‘‘first sale’’ on CBP Form 7501. 

Initially, CBP had considered requiring 

importers to provide three data elements 

on CBP Form 7501. During the 

teleconference, CBP agreed with TSN 

members that requiring importers to 

provide as few data elements as possible 

would be the most efficient and least 

burdensome manner in which to 

implement the declaration requirement. 

CBP has concluded, based upon its 

consultation with the TSN, that it will 

require importers to provide one data 

element. 

In order to implement the above 

requirement of the Act, importers will 

be required to insert a single code on 

CBP Form 7501 at the line-item level, 

indicating when first sale was used to 

determine the value of the imported 

merchandise. An importer will be 

required to enter an ‘‘F’’ next to the 

declared value if the value of the 

merchandise is based on transaction 

value, and the transaction value of the 

merchandise is based on the price paid 

by the buyer in the ‘‘first or earlier sale.’’

This special indicator code will enable 

CBP to fulfill its information collection 

obligation under the Act. 

Inapplicability of Notice and Delayed 

Effective Date Requirements 

Pursuant to 5 U.S.C. 553(b)(B) and 

(d)(3), CBP has determined that it would 

be impracticable and contrary to the 

public interest to delay publication of 

this rule in final form pending an 

opportunity for public comment and 

that there is good cause for this interim 

rule to become effective immediately 

upon publication. These interim 

amendments to 19 CFR 141.61(g) 

conform the regulations to the 

information collection requirements set 

forth in section 15422(a) of the Food, 

Conservation, and Energy Act of 2008, 

Public Law 110–234, 122 Stat. 1547 (19 

U.S.C. 1484 note), which is effective 

August 20, 2008. These interim 

amendments inform the public of the 

procedures necessary to comply with 

the statutory requirements. For these 

reasons, pursuant to the provisions of 5 

U.S.C. 553(d)(3), CBP finds that there is 

good cause for dispensing with a 

delayed effective date. 

Regulatory Flexibility Act and 

Executive Order 12866 

Because no notice of proposed 

rulemaking is required for this interim 

rule, the provisions of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) do 

not apply. Further, these interim 

amendments do not meet the criteria for 

a ‘‘significant regulatory action’’ as 

specified in E.O. 12866. 

Paperwork Reduction Act 

The collections of information in this 

document are contained in § 141.61(g) 

(19 CFR 141.61(g)). This information is 

used by CBP to fulfill its information 

collection obligations under section 

15422(a) of the Food, Conservation, and 

Energy Act of 2008, Public Law 110–

234, 122 Stat. 1547 (19 U.S.C. 1484 

note), which mandates that CBP require 

a U.S. importer of merchandise to 


ebenthall on PRODPC60 with RULES
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Rules and Regulations 49941 

provide information at the time of entry 

of the merchandise on the entry 

summary form, CBP Form 7501, as to 

whether the value of the imported 

merchandise was determined on the 

basis of the price paid by the buyer in 

the ‘‘first or earlier sale.’’ The likely 

respondents are business organizations 

including importers and brokers. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a valid control number 

assigned by OMB. This collection of 

information falls under the previously 

approved collection 1651–0022 for the 

Entry Summary, CBP Form 7501. 

Signing Authority 

This document is being issued in 

accordance with § 0.1(a)(1) of title 19 of 

the Code of Federal Regulations (19 CFR 

0.1(a)(1)) pertaining to the authority of 

the Secretary of the Treasury (or his/her 

delegate) to approve regulations related 

to certain customs revenue functions. 

List of Subjects in 19 CFR Part 141 

Customs duties and inspection, Entry 

of merchandise, Reporting and 

recordkeeping requirements. 

Amendments to the Regulations 

■ For the reasons stated above, part 141 

of title 19 of the Code of Federal 

Regulations (19 CFR part 141) is 

amended as set forth below. 

PART 141—ENTRY OF MERCHANDISE 

■ 1. The general authority citation for 

part 141 continues to read, and the 

specific authority for § 141.16 is added, 

to read as follows: 

Authority: 19 U.S.C. 66, 1448, 1484, 1624. 

* * * * * 

Section 141.61 also issued under sec. 

15422(a), Pub. L. 110–234, 122 Stat. 1547 (19 

U.S.C. 1484 note) and 19 U.S.C. 1401a. 

* * * * * 

■ 2. Section 141.61 is amended by 

adding a new paragraph (g) to read as 

follows: 

§ 141.61 Completion of entry and entry 

summary documentation. 

* * * * * 

(g) Declaration of value. Pursuant to 

section 15422(a) of the Food, 

Conservation, and Energy Act of 2008 

(Pub. L. 110–234), for all goods entered 

for consumption or withdrawn from 

warehouse for consumption from 

August 20, 2008 through August 19, 

2009, an importer of merchandise must 

enter an ‘‘F’’ next to the declared value 

on CBP Form 7501, or the electronic 

filing equivalent, when the declared 

transaction value of the imported 

merchandise is determined on the basis 

of the price paid by the buyer in a sale 

occurring earlier than the last sale prior 

to the introduction of the merchandise 

into the United States. 

W. Ralph Basham, 

Commissioner, U.S. Customs and Border 

Protection. 

Approved: August 20, 2008. 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. E8–19640 Filed 8–20–08; 4:15 pm] 

BILLING CODE 9111–14–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 16, 610, 640, 812, 814, 

822, and 860 

[Docket No. FDA–2008–N–0423] 

FDA Regulations; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending a 

regulatory hearing process regulation to 

correct an inaccurate citation, and 

regulations pertaining to biological 

products to correct two typographical 

errors. FDA is also amending certain 

medical device regulations to include 

references to and mailing address 

information for the Center for Biologics 

Evaluation and Research (CBER), Center 

for Drug Evaluation and Research 

(CDER), and Center for Devices and 

Radiological Health (CDRH). This action 

is being taken to ensure the accuracy of 

FDA’s regulations. 

DATES: This rule is effective August 25, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Denise Sa ́nchez, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is amending 21 CFR 16.1 to 

correct an inaccurate citation and is 

amending 21 CFR 610.51 and 21 CFR 

640.53 to correct typographical errors. 

FDA is also amending its medical 

device regulations in 21 CFR 812, 814, 

and 860 to include references to and 

mailing addresses for CBER and CDER, 

and 21 CFR 822.8 to correct an 

inadvertent omission of the mailing 

address for CDRH. Submissions 

regarding a medical device must be sent 

to the address of the appropriate center 

that has regulatory responsibility for the 

medical device. Therefore, FDA is 

updating these regulations to include 

address information for all appropriate 

centers. 

Publication of this document 

constitutes final action under the 

Administrative Procedures Act (5 U.S.C. 

553). FDA has determined that notice 

and public comment are unnecessary 

because this amendment to the 

regulations provides only technical 

changes to correct an inaccurate citation 

and typographical errors, and to update 

mailing addresses and other 

information, and is nonsubstantive. 

List of Subjects 

21 CFR Part 16 

Administrative practice and 

procedure. 

21 CFR Part 610 

Biologics, Labeling, Reporting and 

recordkeeping requirements. 

21 CFR Part 640 

Blood, Labeling, Reporting and 

recordkeeping requirements. 

21 CFR Part 812 

Health records, Medical devices, 

Medical research, Reporting and 

recordkeeping requirements. 

21 CFR Part 814 

Administrative practice and 

procedure, Confidential business 

information, Medical devices, Medical 

research, Reporting and recordkeeping 

requirements. 

21 CFR Part 822 

Medical devices, Reporting and 

recordkeeping requirements. 

21 CFR Part 860 

Administrative practice and 

procedure, Medical devices. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act, and Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food 

and Drugs, 21 CFR parts 16, 610, 640, 

812, 814, 822, and 860 are amended as 

follows: 

PART 16—REGULATORY HEARING 

BEFORE THE FOOD AND DRUG 

ADMINISTRATION 

■ 1. The authority citation for 21 CFR 

part 16 continues to read as follows: 


ebenthall on PRODPC60 with RULES