Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Rules and Regulations 13111 

organization has yet to implement a 

hedge for marginal losses. Accordingly, 

we decline to order hedging of marginal 

losses at this time. Nevertheless, we 

recognize that a marginal loss hedge 

could provide benefits to certain market 

participants. The Commission supports 

development of a marginal loss hedging 

product if its design progresses beyond 

the theoretical level and it can be 

developed cost-effectively. 

47. The Commission also denies 

SMUD’s request to exempt long-term 

firm transmission customers from 

marginal losses and charge them actual 

or estimated system average losses. This 

raises a market design issue that has 

implications beyond the design of longterm firm transmission rights and is 

more appropriately resolved by each 

transmission organization on a case-bycase basis. Moreover, since we find that 

EPAct 2005 does not address marginal 

losses, this request is beyond the scope 

of this rulemaking proceeding. 

By the Commission. 

Kimberly D. Bose, 

Secretary. 

[FR Doc. E9–6698 Filed 3–25–09; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 1, 26, 201, 203, 206, 310, 

312, 314, 320, and 600 

[Docket No. FDA–2009–N–0133] 

Change of Addresses and Names; 

Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

regulations to reflect a change of address 

for the Center for Drug Evaluation and 

Research’s (CDER’s) Central Document 

Room in Beltsville, MD; the relocation 

of certain CDER offices to the White Oak 

campus in Silver Spring, MD; and 

changes of the names of certain CDER 

organizational units. This action is 

editorial in nature and is intended to 

ensure the accuracy and clarity of the 

agency’s regulations. 

DATES: This rule is effective March 26, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Wendy Aaronson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 1128, 

Silver Spring, MD 20993–0002, 301– 

796–0410. 

SUPPLEMENTARY INFORMATION: FDA is 

amending its regulations in parts 1, 26, 

201, 203, 206, 310, 312, 314, 320, and 

600 (21 CFR parts 1, 26, 201, 203, 206, 

310, 312, 314, 320, and 600) to reflect 

the following changes: (1) Names of 

certain CDER organizational units; (2) a 

change of address for CDER’s Central 

Document Room in Beltsville, MD; and 

(3) the relocation of certain CDER offices 

to the White Oak campus in Silver 

Spring, MD. The addresses are locations 

to which applicants must submit 

information related to marketing 

applications or products regulated by 

CDER or from which the public can 

request information. Where appropriate, 

Internet addresses for obtaining 

information and forms are added and 

outdated addresses are removed. 

The technical amendments made by 

this document are largely related to 

paper submissions; however, FDA is 

committed to adapting its business 

practices to evolving technology, 

including using the significant 

advancements in Web-based, electronic 

systems. We anticipate that, in future 

rulemakings, Web-based filing of most 

submissions will eventually be required. 

We anticipate that when a change to an 

electronic submission system is 

implemented, we will provide guidance 

to address any technical questions 

related to such submissions. 

The technical amendments, reflected 

in the regulatory text of this final rule, 

are as follows: 

• In § 1.101(d)(2)(ii), the address to 

submit notifications for products 

regulated by CDER exported under 

section 802 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 382) is 

changed to the White Oak campus. 

• In Appendix E to subpart A of part 

26, the contact information for CDER’s 

Office of Compliance is updated to the 

White Oak campus. 

• In § 201.58, the address to submit 

requests for waivers of labeling 

requirements is updated to the Beltsville 

Central Document Room. 

• In § 203.12, the CDER address for 

notification of an appeal from an 

adverse decision regarding 

reimportation of an insulin-containing 

or prescription drug by a district office 

is changed to the White Oak campus. 

• In § 203.37(e), the address to submit 

information regarding falsification of 

drug sample records or loss or theft of 

samples for prescription drugs and 

biological products regulated by CDER 

is changed to the White Oak campus. 

• In § 203.70(b)(1), the address to 

apply for a reward for providing 

information leading to a criminal 

proceeding or conviction related to the 

sale, purchase, or trade of a drug sample 

is changed to the White Oak campus. 

• In § 206.7(b)(1)(i), the address to 

request exemptions from imprinting 

requirements for solid oral dosage form 

drugs is updated to the Beltsville 

Central Document Room. 

• In § 310.6(e), the address for 

interested parties to submit the names of 

drug products, and of their 

manufacturers or distributors, that 

should be subject to the same 

purchasing and regulatory policies as 

those reviewed by the Drug Efficacy 

Study Group is changed to the White 

Oak campus. 

• In §§ 310.305(c) and 314.98(b), the 

address to submit postmarketing safety 

reports is updated to the Beltsville 

Central Document Room. (Note that 

applicants and any person other than 

the applicant whose name appears on 

the label of an approved drug product 

as a manufacturer, packer, or distributor 

may also elect to submit postmarketing 

safety reports in electronic format.) 

• In §§ 310.305(d)(4) and 314.80(f)(4), 

the address to obtain reporting forms is 

updated to reflect Internet availability. 

• In §§ 310.501(e) and 310.515(d), the 

name and address to request labeling 

guidance for estrogen drug products are 

updated to the Division of Reproductive 

and Urologic Products and the White 

Oak campus. 

• In § 312.140(b), mailing instructions 

are updated to ensure submissions are 

addressed properly. 

• In §§ 312.145(b) and 314.445(b), the 

CDER unit from which to request a list 

of CDER guidances is updated to the 

Division of Drug Information. The 

address is updated to the White Oak 

campus, and an Internet address is 

added to reflect the availability of the 

list on the Internet. 

• In § 314.80(d)(2) and (f)(3)(ii), the 

CDER unit to contact regarding 

alternative reporting formats is updated 

to the Office of Surveillance and 

Epidemiology. 

• In § 314.81(b)(3)(i), the address to 

obtain Form FDA–2253 (Transmittal of 

Advertisements and Promotional 

Labeling for Drugs for Human Use) is 

updated to reflect Internet availability. 

• In § 314.200(a)(3), the address to 

request opinions of the applicability of 

a notice of opportunity for a hearing 

published in the Federal Register to a 

specific product that may be identical, 

related, or similar to a product listed in 

the notice is changed to the White Oak 

campus. 

• In § 314.440(a), an outdated address 

to submit applications, abbreviated 

applications, and related 

13112 Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Rules and Regulations 

correspondence is removed and in 

§ 314.440(a)(1), mailing instructions are 

updated to ensure submissions are 

addressed properly and the address to 

obtain folders for binding applications 

is updated to reflect information 

available at an Internet address. 

• In § 320.30(c)(1), the name and 

address to submit general inquiries 

related to bioavailability requirements 

and methodology are updated to the 

Office of Clinical Pharmacology and the 

White Oak campus. 

• In § 600.2(b)(1), the address for 

submitting biological product deviation 

reports for biological products regulated 

by CDER is changed to the White Oak 

campus. 

• In § 600.2(b)(3), the address for 

submitting advertising and promotional 

labeling supplements required under 

§ 600.12(f) is updated to the Beltsville 

Central Document Room. 

Publication of this document 

constitutes final action on these changes 

under the Administrative Procedure 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 update names and addresses 

of CDER organizational units. 

List of Subjects 

21 CFR Part 1 

Cosmetics, Drugs, Exports, Food 

labeling, Imports, Labeling, Reporting 

and recordkeeping requirements. 

21 CFR Part 26 

Animal drugs, Biologics, Drugs, 

Exports, Imports. 

21 CFR Part 201 

Drugs, Labeling, Reporting and 

recordkeeping requirements. 

21 CFR Part 203 

Labeling, Prescription drugs, 

Reporting and recordkeeping 

requirements, Warehouses. 

21 CFR Part 206 

Drugs. 

21 CFR Part 310 

Administrative practice and 

procedure, Drugs, Labeling, Medical 

devices, Reporting and recordkeeping 

requirements. 

21 CFR Part 312 

Drugs, Exports, Imports, 

Investigations, Labeling, Medical 

research, Reporting and recordkeeping 

requirements, Safety. 

21 CFR Part 314 

Administrative practice and 

procedure, Confidential business 

information, Drugs, Reporting and 

recordkeeping requirements. 

21 CFR Part 320 

Drugs, Reporting and recordkeeping 

requirements. 

21 CFR Part 600 

Biologics, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 1, 26, 

201, 203, 206, 310, 312, 314, 320, and 

600 are amended as follows: 

PART 1—GENERAL ENFORCEMENT 

REGULATIONS 

■ 1. The authority citation for 21 CFR 

part 1 continues to read as follows: 

Authority: 15 U.S.C. 1453, 1454, 1455; 19 

U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 333, 

334, 335a, 343, 350c, 350d, 352, 355, 360b, 

362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 

241, 243, 262, 264. 

§ 1.101 [Amended] 

■ 2. Section 1.101 is amended in 

paragraph (d)(2)(ii) by removing ‘‘(HFD– 

310)’’; and by removing ‘‘5600 Fishers 

Lane, Rockville, MD 20857’’ and adding 

in its place ‘‘10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002’’. 

PART 26—MUTUAL RECOGNITION OF 

PHARMACEUTICAL GOOD 

MANUFACTURING PRACTICE 

REPORTS, MEDICAL DEVICE QUALITY 

SYSTEM AUDIT REPORTS, AND 

CERTAIN MEDICAL DEVICE PRODUCT 

EVALUATION REPORTS: UNITED 

STATES AND THE EUROPEAN 

COMMUNITY 

■ 3. The authority citation for 21 CFR 

part 26 continues to read as follows: 

Authority: 5 U.S.C. 552; 15 U.S.C. 1453, 

1454, 1455; 18 U.S.C. 1905; 21 U.S.C. 321, 

331, 351, 352, 355, 360, 360b, 360c, 360d, 

360e, 360f, 360g, 360h, 360i, 360j, 360l, 

360m, 371, 374, 381, 382, 383, 393; 42 U.S.C. 

216, 241, 242l, 262, 264, 265. 

■ 4. Appendix E to subpart A of part 26 

is amended under the heading ‘‘B. 

Forthe United States:’’ in the entry for 

‘‘Human Drugs’’ by removing ‘‘(HFD– 

300), 5600 Fishers Lane, Rockville, MD 

20857, phone: 301–827–8910, fax: 301– 

827–8901’’ and by adding in its place 

‘‘10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, phone: 301– 

796–3100, fax: 301–847–8747’’. 

PART 201—LABELING 

■ 5. The authority citation for 21 CFR 

part 201 continues to read as follows: 

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

353, 355, 358, 360, 360b, 360gg–360ss, 371, 

374, 379e; 42 U.S.C. 216, 241, 262, 264. 

§ 201.58 [Amended] 

■ 6. Section 201.58 is amended in the 

second sentence by removing ‘‘5600 

Fishers Lane, Rockville, MD 20857’’ and 

by adding in its place ‘‘Central 

Document Room, 5901–B Ammendale 

Rd., Beltsville, MD 20705–1266’’. 

PART 203—PRESCRIPTION DRUG 

MARKETING 

■ 7. The authority citation for 21 CFR 

part 203 continues to read as follows: 

Authority: 21 U.S.C. 331, 333, 351, 352, 

353, 360, 371, 374, 381. 

§ 203.12 [Amended] 

■ 8. Section 203.12 is amended by 

removing ‘‘(HFD–300)’’ both times it 

appears; and by removing ‘‘5600 Fishers 

Lane, Rockville, MD 20857’’ both times 

it appears and adding in its place 

‘‘10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002’’. 

§ 203.37 [Amended] 

■ 9. Section 203.37 is amended in the 

first sentence of paragraph (e) by 

removing ‘‘(HFD–330)’’; and by 

removing ‘‘5600 Fishers Lane, Rockville, 

MD 20857’’ and adding in its place 

‘‘10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002’’. 

§ 203.70 [Amended] 

■ 10. Section 203.70 is amended in 

paragraph (b)(1) by removing ‘‘(HFD– 

300)’’; and by removing ‘‘5600 Fishers 

Lane, Rockville, MD 20857’’ and adding 

in its place ‘‘10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002’’. 

PART 206—IMPRINTING OF SOLID 

ORAL DOSAGE FORM DRUG 

PRODUCTS FOR HUMAN USE 

■ 11. The authority citation for 21 CFR 

part 206 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 355, 

371; 42 U.S.C. 262. 

§ 206.7 [Amended] 

■ 12. Section 206.7 is amended in 

paragraph (b)(1)(i) by removing ‘‘5600 

Fishers Lane, Rockville, MD 20857’’ and 

by adding in its place ‘‘5901–B 

Ammendale Rd., Beltsville, MD 20705– 

1266’’. 

PART 310—NEW DRUGS 

■ 13. The authority citation for 21 CFR 

part 310 continues to read as follows: 

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

353, 355, 360b–360f, 360j, 361(a), 371, 374, 

Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Rules and Regulations 13113 

375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 

263b–263n. 

§ 310.6 [Amended] 

■ 14. Section 310.6 is amended in the 

first sentence of paragraph (e) by 

removing ‘‘HFD–300, 5600 Fishers Lane, 

Rockville, MD 20857’’ and by adding in 

its place ‘‘10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002’’. 

■ 15. Section 310.305 is amended in 

paragraph (c) by removing ‘‘Division of 

Pharmacovigilance and Epidemiology 

(HFD–730)’’ and by adding in its place 

‘‘Central Document Room’’; by removing 

‘‘5600 Fishers Lane, Rockville, MD 

20857’’ and by adding in its place 

‘‘5901–B Ammendale Rd., Beltsville, 

MD 20705–1266’’; and by revising 

paragraph (d)(4) to read as follows: 

§ 310.305 Records and reports concerning 

adverse drug experiences on marketed 

prescription drugs for human use without 

approved new drug applications. 

* * * * * 

(d) * * * 

(4) FDA Form 3500A and instructions 

for completing the form are available on 

the Internet at http://www.fda.gov/ 

medwatch/index.html. 

* * * * * 

§ 310.501 [Amended] 

■ 16. Section 310.501 is amended in 

paragraph (e) by removing ‘‘Metabolism 

and Endocrine Drug Products (HFD– 

510)’’ and by adding in its place 

‘‘Reproductive and Urologic Products’’ 

and by removing ‘‘5600 Fishers Lane, 

Rockville, MD 20857’’ and by adding in 

its place ‘‘10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002’’. 

§ 310.515 [Amended] 

■ 17. Section 310.515 is amended in the 

second sentence of paragraph (d) by 

removing ‘‘Metabolism and Endocrine 

Drug Products (HFD–510)’’ and by 

adding in its place ‘‘Reproductive and 

Urologic Products’’ and by removing 

‘‘5600 Fishers Lane, Rockville, MD 

20857’’ and by adding in its place 

‘‘10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002’’. 

PART 312—INVESTIGATIONAL NEW 

DRUG APPLICATION 

■ 18. The authority citation for 21 CFR 

part 312 continues to read as follows: 

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

353, 355, 356, 371, 381, 383, 393; 42 U.S.C. 

262. 

§ 312.140 [Amended] 

■ 19. Section 312.140 is amended in the 

second sentence of paragraph (b) by 

removing ‘‘directed to the appropriate 

Center and division’’ and by adding in 

its place ‘‘sent to the appropriate center 

at the address indicated in this section 

and marked to the attention of the 

responsible division’’. 

§ 312.145 [Amended] 

■ 20. Section 312.145 is amended in the 

third sentence of paragraph (b) by 

removing ‘‘Division of Communications 

Management, Drug Information Branch 

(HFD–210)’’ and by adding in its place 

‘‘Division of Drug Information’’ and by 

removing ‘‘5600 Fishers Lane, Rockville, 

MD 20857’’ and by adding in its place 

‘‘10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002’’. 

PART 314—APPLICATIONS FOR FDA 

APPROVAL TO MARKET A NEW DRUG 

■ 21. The authority citation for 21 CFR 

part 314 continues to read as follows: 

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

353, 355, 356, 356a, 356b, 356c, 371, 374, 

379e. 

■ 22. Section 314.80 is amended as 

follows: 

■ a. In the second sentence of paragraph 

(d)(2), by removing ‘‘Division of 

Pharmacovigilance and Epidemiology’’ 

and by adding in its place ‘‘Office of 

Surveillance and Epidemiology’’; and 

■ b. By revising paragraphs (f)(3)(ii) and 

(f)(4) to read as follows: 

The revisions read as follows: 

§ 314.80 Postmarketing reporting of 

adverse drug experiences. 

* * * * * 

(f) * * * 

(3) * * * (ii) The format is agreed to 

in advance by the Office of Surveillance 

and Epidemiology. 

(4) FDA Form 3500A and instructions 

for completing the form are available on 

the Internet at http://www.fda.gov/ 

medwatch/index.html. 

* * * * * 

■ 23. Section 314.81 is amended by 

revising the last sentence of paragraph 

(b)(3)(i) to read as follows: 

§ 314.81 Other postmarketing reports. 

* * * * * 

(b) * * * 

(3) * * * 

(i) * * *Form FDA–2253 is available 

on the Internet at http://www.fda.gov/ 

opacom/morechoices/fdaforms/ 

cder.html. 

* * * * * 

§ 314.98 [Amended] 

■ 24. Section 314.98 is amended in 

paragraph (b) by removing ‘‘Division of 

Epidemiology and Surveillance (HFD– 

730)’’ and by adding in its place 

‘‘Central Document Room’’ and by 

removing ‘‘5600 Fishers Lane, Rockville, 

MD 20857’’ and by adding in its place 

‘‘5901–B Ammendale Rd., Beltsville, 

MD 20705–1266’’. 

§ 314.200 [Amended] 

■ 25. Section 314.200 is amended in the 

second sentence of paragraph (a)(3) by 

removing ‘‘(HFD–310)’’; and by 

removing ‘‘5600 Fishers Lane, Rockville, 

MD 20857’’ and adding in its place 

‘‘10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002’’. 

■ 26. Section 314.440 is amended by 

revising paragraph (a) introductory text, 

and paragraph (a)(1) to read as follows: 

§ 314.440 Addresses for applications and 

abbreviated applications. 

(a) Applicants shall send applications, 

abbreviated applications, and other 

correspondence relating to matters 

covered by this part, except for products 

listed in paragraph (b) of this section, to 

the appropriate office identified below: 

(1) Except as provided in paragraph 

(a)(4) of this section, an application 

under § 314.50 or § 314.54 submitted for 

filing should be directed to the Central 

Document Room, 5901–B Ammendale 

Rd., Beltsville, MD 20705–1266. 

Applicants may obtain information 

about folders for binding applications 

on the Internet at http://www.fda.gov/ 

cder/ddms/binders.htm. After FDA has 

filed the application, the agency will 

inform the applicant which division is 

responsible for the application. 

Amendments, supplements, 

resubmissions, requests for waivers, and 

other correspondence about an 

application that has been filed should 

be addressed to 5901–B Ammendale 

Rd., Beltsville, MD 20705–1266, to the 

attention of the appropriate division. 

* * * * * 

§ 314.445 [Amended] 

■ 27. Section 314.445 is amended in the 

third sentence of paragraph (b) by 

removing ‘‘Division of Communications 

Management, Drug Information Branch 

(HFD–210)’’ and by adding in its place 

‘‘Division of Drug Information’’ and by 

removing ‘‘5600 Fishers Lane, Rockville, 

MD 20857’’ and by adding in its place 

‘‘10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002’’. 

PART 320—BIOAVAILABILITY AND 

BIOEQUIVALENCE REQUIREMENTS 

■ 28. The authority citation for 21 CFR 

part 320 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 355, 

371. 

13114 Federal Register / Vol. 74, No. 57 / Thursday, March 26, 2009 / Rules and Regulations 

§ 320.30 [Amended] 

■ 29. Section 320.30 is amended in 

paragraph (c)(1) by removing ‘‘and 

Biopharmaceutics (HFD–850), 5600 

Fishers Lane, Rockville, MD 20857’’ and 

by adding in its place ‘‘, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002’’. 

PART 600—BIOLOGICAL PRODUCTS: 

GENERAL 

■ 30. The authority citation for 21 CFR 

part 600 continues to read as follows: 

Authority: 21 U.S.C. 321, 351, 352, 355, 

360, 360i, 371, 374; 42 U.S.C. 216, 262, 263, 

263a, 264, 300aa–25. 

§ 600.2 [Amended] 

■ 31. Section 600.2 is amended as 

follows: 

a. In paragraph (b)(1) by removing 

‘‘(HFD–330)’’; and by removing ‘‘5600 

Fishers Lane, Rockville, MD 20857’’ and 

adding in its place ‘‘10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002’’; and 

b. In paragraph (b)(3) by removing 

‘‘(HFD–42)’’; and by removing ‘‘5600 

Fishers Lane, rm. 8B45, Rockville, MD 

20857’’ and adding in its place ‘‘5901– 

B Ammendale Rd., Beltsville, MD 

20705–1266’’. 

Dated: March 20, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–6795 Filed 3–25–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 558 

New Animal Drugs for Use in Animal 

Feeds 

CFR Correction 

In title 21 of the Code of Federal 

Regulations, part 558, revised as of 

April 1, 2008, on page 410, in § 558.58 

(e)(1)(iii), the entry for Bambermycins 1 

to 3, in the column under ‘‘Limitations’’ 

remove ‘‘057926’’ and in its place add 

‘‘016592’’; in the column under 

‘‘Sponsors’’, add ‘‘016592’’. 

[FR Doc. E9–6810 Filed 3–25–09; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 101 

[Docket Nos. TSA–2006–24191; USCG– 

2006–24196] 

RIN 1652–AA41 

Transportation Worker Identification 

Credential (TWIC) Implementation in 

the Maritime Sector; Hazardous 

Materials Endorsement for a 

Commercial Driver’s License 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Department of Homeland 

Security (DHS) through the United 

States Coast Guard (Coast Guard) issues 

this final rule to amend one provision 

of its previously issued final rule. 

Specifically, the Coast Guard is 

amending its definition of secure area to 

take into account facilities in American 

Samoa, whose workers are not required 

to be authorized to work in the United 

States under U.S. immigration law when 

working in American Samoa. 

DATES: This final rule is effective March 

26, 2009. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of dockets TSA–2006–24191 and 

USCG–2006–24196, and are available 

for inspection or copying at the Docket 

Management Facility (M–30), U.S. 

Department of Transportation, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find this docket on the Internet by going 

to http://www.regulations.gov, selecting 

the Advanced Docket Search option on 

the right side of the screen, inserting 

TSA–2006–24191 or USCG–2006–24196 

in the Docket ID box, pressing Enter, 

and then clicking on the item in the 

Docket ID column. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call 

LCDR Jonathan Maiorine, Coast Guard; 

telephone 1–877–687–2243. If you have 

questions on viewing the docket, call 

Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

I. Regulatory History 

On May 22, 2006, the Department of 

Homeland Security (DHS), through the 

United States Coast Guard (Coast Guard) 

and the Transportation Security 

Administration (TSA), published a joint 

notice of proposed rulemaking entitled 

‘‘Transportation Worker Identification 

Credential (TWIC) Implementation in 

the Maritime Sector; Hazardous 

Materials Endorsement for a 

Commercial Driver’s License’’ in the 

Federal Register (71 FR 29396). This 

was followed by a 45-day comment 

period and four public meetings. The 

Coast Guard and TSA issued a joint 

final rule, under the same title, on 

January 25, 2007 (72 FR 3492) 

(hereinafter referred to as the original 

TWIC final rule). The preamble to that 

final rule contains a discussion of the 

provisions found in the original TWIC 

final rule, which became effective on 

March 26, 2007. 

On September 28, 2007, the Coast 

Guard and TSA issued a joint final rule 

(72 FR 55043) that, among other things, 

revised the definition for ‘‘secure area’’ 

to account for facilities in the 

Commonwealth of the Northern Mariana 

Islands (the CNMI), as non-citizen 

workers at those facilities are not 

required to have authorization to work 

in the United States under U.S. 

immigration law before being allowed to 

work. 

On May 7, 2008, the Coast Guard and 

TSA issued a joint final rule to realign 

the compliance date for implementation 

of the original TWIC final rule (see 73 

FR 25562). The date by which mariners 

need to obtain a TWIC, and by which 

owners and operators of vessels and 

outer continental shelf facilities must 

implement access control procedures 

using TWIC, is April 15, 2009. Owners 

and operators of facilities that must 

comply with 33 CFR part 105 are subject 

to earlier, rolling compliance dates, as 

set forth in 33 CFR 105.115(e). The 

Coast Guard announced these rolling 

compliance dates via notices published 

in the Federal Register. The final 

compliance date for all COTP Zones is 

not later than April 15, 2009. 

On September 30, 2008, the Coast 

Guard announced the compliance date 

for COTP Zone Honolulu would be 

February 12, 2009 (73 FR 56730). On 

February 12, 2009, the Coast Guard 

announced the extension of that 

compliance date, for the territory of 

American Samoa only, to April 14, 

2009, due to the fact that a large 

percentage of the maritime workforce is 

not native to the island, and does not 

need to be authorized to work in the 

United States under U.S. immigration 

law before being allowed to work in 

American Samoa. In that notice, the 

Coast Guard stated that the extension 

was being granted in order to allow time