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for consumption or withdrawn from 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
49942 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Rules and Regulations 

Authority: 15 U.S.C. 1451–1461; 21 U.S.C. 

141–149, 321–394, 467f, 679, 821, 1034; 28 

U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364. 

§ 16.1 [Amended] 

■ 2. Section 16.1 is amended in 

paragraph (b)(2), by removing 

‘‘§ 1270.15(e)’’ and adding in its place 

‘‘§ 1270.43(e)’’. 

PART 610—GENERAL BIOLOGICAL 

PRODUCTS STANDARDS 

■ 3. The authority citation for 21 CFR 

part 610 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360, 360c, 360d, 360h, 360i, 371, 

372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 

264. 

§ 610.53 [Amended] 

■ 4. Section 610.53 is amended in 

paragraph (c) in the table, under column 

A, by removing the words 

‘‘Cryoprecipitated AFH’’ and adding in 

their place ‘‘Cryoprecipitated AHF.’’

PART 640—ADDITIONAL STANDARDS 

FOR HUMAN BLOOD AND BLOOD 

PRODUCTS 

■ 5. The authority citation for 21 CFR 

part 640 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 353, 

355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 

264. 

§ 640.51 [Amended] 

■ 6. Section 640.51 is amended in 

paragraph (b) by removing the word 

‘‘Plasmaphersis’’ and adding in its place 

‘‘Plasmapheresis.’’

PART 812—INVESTIGATIONAL 

DEVICE EXEMPTIONS 

■ 7. The authority citation for 21 CFR 

part 812 continues to read as follows: 

Authority: 21 U.S.C. 331, 351, 352, 353, 

355, 360, 360c–360f, 360h–360j, 371, 372, 

374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 

262, 263b–263n. 

■ 8. Section 812.20 is amended by 

revising paragraph (d) to read as 

follows: 

§ 812.20 Application. 

* * * * * 

(d) Information previously submitted. 

Information previously submitted to the 

Center for Devices and Radiological 

Health, the Center for Biologics 

Evaluation and Research, or the Center 

for Drug Evaluation and Research, as 

applicable, in accordance with this 

chapter ordinarily need not be 

resubmitted, but may be incorporated by 

reference. 

PART 814—PREMARKET APPROVAL 

OF MEDICAL DEVICES 

■ 9. The authority citation for 21 CFR 

part 814 continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 353, 360, 

360c–360j, 371, 372, 373, 374, 375, 379, 379e, 

381. 

■ 10. Section 814.42 is amended by 

revising the fourth sentence of 

paragraph (d)(2) to read as follows: 

§ 814.42 Filing a PMA. 

* * * * * 

(d) * * * 

(2) * * * If FDA does not reverse its 

decision not to file the PMA, the 

applicant may request reconsideration 

of the decision from the Director of the 

Center for Devices and Radiological 

Health, the Director of the Center for 

Biologics Evaluation and Research, or 

the Director of the Center for Drug 

Evaluation and Research, as applicable. 

* * * 

* * * * * 

■ 11. Section 814.100 is amended by 

revising paragraph (c)(2) to read as 

follows: 

§ 814.100 Purpose and scope. 

* * * * * 

(c) * * * 

(2) Submitting an HDE to the Office of 

Device Evaluation (ODE), Center for 

Devices and Radiological Health 

(CDRH), the Center for Biologics 

Evaluation and Research (CBER), or the 

Center for Drug Evaluation and Research 

(CDER), as applicable. 

* * * * * 

■ 12. Section 814.104 is amended by 

revising paragraph (d) to read as 

follows: 

§ 814.104 Original applications. 

* * * * * 

(d) Address for submissions and 

correspondence. Copies of all original 

HDEs amendments and supplements, as 

well as any correspondence relating to 

an HDE, must be sent or delivered to the 

following: 

(1) For devices regulated by the 

Center for Devices and Radiological 

Health, send this information to the 

Document Mail Center (HFZ–401), 

Office of Device Evaluation, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850. 

(2) For devices regulated by the 

Center for Biologics Evaluation and 

Research, send this information to the 

Document Control Center (HFM–99), 

Center for Biologics Evaluation and 

Research, Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

(3) For devices regulated by the 

Center for Drug Evaluation and 

Research, send this information to the 

Central Document Control Room, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 5901–B 

Ammendale Rd., Beltsville, MD 20705–

1266. 

PART 822—POSTMARKET 

SURVEILLANCE 

■ 13. The authority citation for 21 CFR 

part 822 continues to read as follows: 

Authority: 21 U.S.C. 331, 352, 360i, 360l, 

371, 374. 

■ 14. Section 822.8 is amended by 

adding a sentence after the first sentence 

to read as follows: 

§ 822.8 When, where, and how must I 

submit my postmarket surveillance plan? 

* * * For devices regulated by the 

Center for Devices and Radiological 

Health, send three copies of your 

submission to the Postmarket 

Surveillance Document Center (HFZ–

541), Epidemiology Branch, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850–

3229. * * * 

PART 860—MEDICAL DEVICE 

CLASSIFICATION PROCEDURES 

■ 15. The authority citation for 21 CFR 

part 860 continues to read as follows: 

Authority: 21 U.S.C. 360c, 360d, 360e, 

360i, 360j, 371, 374. 

■ 16. Section 860.7 is amended by 

revising paragraph (g)(4) to read as 

follows: 

§ 860.7 Determination of safety and 

effectiveness. 

* * * * * 

(g) * * * 

(4) Required information that has 

been submitted previously to the Center 

for Devices and Radiological Health, the 

Center for Biologics Evaluation and 

Research, or the Center for Drug 

Evaluation and Research, as applicable, 

need not be resubmitted, but may be 

incorporated by reference. 

■ 17. Section 860.123 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 860.123 Reclassification petition: 

Content and form. 

* * * * * 

(b) * * * 

(1) For devices regulated by the 

Center for Devices and Radiological 

Health, addressed to the Food and Drug 

Administration, Center for Devices and 

Radiological Health, Regulations Staff 


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Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Rules and Regulations 49943 

(HFZ–215), 1350 Piccard Dr., Rockville, 

MD 20857; for devices regulated by the 

Center for Biologics Evaluation and 

Research, addressed to the Document 

Control Center (HFM–99), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448; for devices regulated 

by the Center for Drug Evaluation and 

Research, addressed to the Central 

Document Control Room, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 5901–B 

Ammendale Rd., Beltsville, MD 20705–

1266, as applicable. 

* * * * * 

Dated: August 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19654 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

PEACE CORPS 

22 CFR Part 304 

RIN 0420–AA23 

Claims Against the Government Under 

the Federal Tort Claims Act 

AGENCY: Peace Corps. 

ACTION: Final rule. 

SUMMARY: The Peace Corps is revising 

its regulation concerning claims filed 

under the Federal Tort Claims Act, to 

make the regulation internally 

consistent with another provision 

stating that the Chief Financial Officer 

has authority to approve claims for 

amounts under $5000. 

DATES: The final rule is effective 

September 24, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Nancy G. Miller, Associate General 

Counsel, Office of the General Counsel, 

202–692–2150. 

SUPPLEMENTARY INFORMATION: The Peace 

Corps published a proposed rule on July 

9, 2008, for public review and comment. 

See 73 FR 39270, (July 9, 2008). The 

Peace Corps received no public 

comments and the Agency has made no 

further revisions. Therefore, this rule is 

final and will be effective on the date 

stated above. 

On March 16, 2007, Peace Corps 

revised 22 CFR 304.7 to provide that the 

Chief Financial Officer ‘‘has the 

authority to adjust, determine, 

compromise, and settle claims for less 

than $5,000.’’ This final rule will rectify 

an omission in sec. 304.10 which did 

not refer to the Chief Financial Officer’s 

authority for deciding claims worth less 

than $5,000. 

This rule amends section 304.10(b) to 

provide that the Chief Financial Officer 

will make final determinations for 

claims worth less than $5,000. 

Executive Order 12866 

This regulation has been determined 

to be non-significant within the 

meaning of Executive Order 12866. 

Regulatory Flexibility Act of 1980 (5 

U.S.C. 605(b)) 

This regulatory action will not have a 

significant adverse impact on a 

substantial number of small entities. 

Unfunded Mandates Act of 1995 (Sec. 

202, Pub. L. 104–4) 

This regulatory action does not 

contain a Federal mandate that will 

result in the expenditure by state, local, 

and tribal governments, in aggregate, or 

by the private sector of $100 million or 

more in any one year. 

Paperwork Reduction Act of 1995 (44 

U.S.C., Chapter 35) 

This regulatory action will not impose 

any additional reporting or 

recordkeeping requirements under the 

Paperwork Reduction Act. 

Federalism (Executive Order 13132) 

This regulatory action does not have 

Federalism implications, as set forth in 

Executive Order 13132. It will not have 

substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

List of Subjects in 22 CFR Part 304 

Claims. 

■ Accordingly, Peace Corps amends 22 

CFR part 304 as follows: 

PART 304—CLAIMS AGAINST THE 

GOVERNMENT UNDER THE FEDERAL 

TORT CLAIMS ACT 

■ 1. The authority citation for part 304 

continues to read as follows: 

Authority: 28 U.S.C. 2672; 22 U.S.C. 

2503(b); E.O. 12137, as amended. 

■ 2. Amend § 304.10 by revising 

paragraph (b) to read as follows: 

§ 304.10 Review of claim. 

* * * * * 

(b) After legal review and 

recommendation by the General 

Counsel, the Director of the Peace Corps 

will make a written determination on 

the claim, unless the claim is worth less 

than $5,000, in which case the Chief 

Financial Officer will make the written 

determination. 

Dated: August 18, 2008. 

Tyler Posey, 

General Counsel. 

[FR Doc. E8–19642 Filed 8–22–08; 8:45 am] 

BILLING CODE 6015–01–P 

DEPARTMENT OF THE INTERIOR 

Minerals Management Service 

30 CFR Parts 203, 250, 251, 256, 280, 

281, and 290 

[Docket ID: MMS–2007–OMM–0065] 

RIN 1010–AD43 

Electronic Payment of Fees for Outer 

Continental Shelf Activities 

AGENCY: Minerals Management Service 

(MMS), Interior. 

ACTION: Final rule. 

SUMMARY: This final rule requires that 

all lessees, operators, permittees, and 

right-of-way holders pay all fees for 

processing plans, applications, and 

permits electronically. This rule will aid 

industry in payment processing and 

reduce payment processing errors. This 

rule will improve MMS processing 

efficiency and facilitate the correction of 

industry payment errors. The MMS will 

not accept checks, money orders, or 

cashier’s checks for payment of fees 

after the effective date of this final rule. 

The final rule also adjusts certain cost 

recovery fees for inflation. 

DATES: Effective Date: This rule becomes 

effective on September 24, 2008. 

FOR FURTHER INFORMATION CONTACT: Kirk 

Malstrom, Office of Offshore Regulatory 

Programs, Regulations and Standards 

Branch, (703) 787–1751. 

SUPPLEMENTARY INFORMATION: 

Background 

The MMS published a proposed rule 

on December 21, 2007 (72 FR 72648), 

that would require all lessees, operators, 

pipeline right-of-way (ROW) holders, 

and permittees to submit payments for 

cost recovery service fees electronically. 

The comment period for the proposed 

rule closed February 19, 2008, and 

Chevron submitted the one and only 

comment on the proposed rule. The 

commenter supports the concept of 

submitting fees electronically through 

Pay.gov. The commenter stated 

concerns about only using Pay.gov and 

provided rule language to allow 

alternatives for a different payment 

portal if so needed. The MMS believes 

Pay.gov to be the best option for paying 


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