64964 Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 

In the preamble to the final rule, FDA 

stated that it intended to publish a 

guidance on applying this rule. In a 

notice published in the Federal Register

on February 22, 2001 (66 FR 11172), 

FDA invited public comments on the 

topics that should be included in such 

a guidance. FDA agrees with the 

comments that were submitted stating 

that the preamble to the structure/

function rule and the numerous 

courtesy letters that the agency has 

issued since the enactment of section 

403(r)(6) provide considerable guidance 

to dietary supplement manufacturers 

about the types of claims that the agency 

considers to be disease claims. 

Therefore, FDA has decided not to issue 

such a guidance at this time. FDA will 

continue to monitor dietary supplement 

manufacturers’ compliance with section 

403(r)(6) of the act and § 101.93, take 

enforcement action where appropriate, 

and reconsider the possibility of issuing 

guidance if future developments 

warrant.

IV. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the substantiation 

draft guidance document. (FDA is not 

specifically seeking comment on its 

decision not to publish additional 

guidance on the structure/function 

rule.) Two copies of mailed comments 

are to be submitted, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. The draft 

guidance and received comments are 

available for public examination in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday.

V. Electronic Access

Persons with access to the Internet 

may obtain the document at http://

www.cfsan.fda.gov or http://

www.fda.gov/dockets/ecomments. Once 

on this site, select 2004D–0466 

‘‘Guidance for Industry: Substantiation 

for Dietary Supplement Claims Made 

Under Section 403(r)(6) of the Federal 

Food, Drug, and Cosmetic Act’’ and 

follow the directions. Copies of this 

draft guidance may be obtained on the 

Internet from the CFSAN homepage at 

http://www.cfsan.fda.gov.

Dated: October 25, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24871 Filed 11–4–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Border and Transportation Security; 

Notice to Aliens Included in the United 

States Visitor and Immigrant Status 

Indicator Technology System (US–

VISIT)

AGENCY: Border and Transportation 

Security Directorate, DHS.

ACTION: Notice.

SUMMARY: The Department of Homeland 

Security (Department or DHS) has 

established the United States Visitor 

and Immigrant Status Indicator 

Technology Program (US–VISIT), an 

integrated, automated entry-exit system 

that records the arrival and departure of 

aliens; verifies aliens’ identities; and 

authenticates aliens’ travel documents 

through comparison of biometric 

identifiers. On August 31, 2004, DHS 

implemented the second phase of US–

VISIT by publishing an interim final 

rule in the Federal Register at 69 FR 

53318 authorizing DHS to require 

certain aliens to provide fingerprints, 

photographs or other biometric 

identifiers upon arrival in the United 

States at the 50 most trafficked land 

ports of entry. The interim rule also 

authorized DHS to identify the specific 

land border ports in a separate notice 

published in the Federal Register. 

This notice identifies the 50 most 

trafficked land ports of entry where US–

VISIT will be implemented. The notice 

further provides an estimated date when 

each port will begin enrolling aliens in 

US–VISIT at the secondary inspection 

area. Pursuant to the August 31, 2004 

interim rule, all 50 ports of entry will 

begin enrolling aliens in US–VISIT no 

later than December 31, 2004. 

In addition, as stated in the August 

31, 2004 interim rule, this notice 

identifies only land ports of entry in 

which aliens will be enrolled in US–

VISIT upon entry into the United States. 

DHS will announce, through a future 

notice in the Federal Register, the 

piloting of a biometric data collection 

program at a limited number of sites as 

part of US–VISIT processing upon 

departure from the United States.

FOR FURTHER INFORMATION, CONTACT:

Michael Hardin, Senior Policy Advisor, 

US–VISIT, Border and Transportation 

Security, Department of Homeland 

Security, 1616 N. Fort Myer Drive, 18th 

Floor, Arlington, Virginia 22209, (202) 

298–5200. 

The 50 Land Border Ports of Entry 

(POEs) that will begin biometric data 

collection as part of US–VISIT 

processing no later than December 31, 

2004 are as follows: 

Estimated start date of November 15, 

2004 (6):

Port Huron POE, Blue Water Bridge, 

Highway 69 and International Border, 

Port Huron, Michigan 

Douglas POE, Rte 191 and International 

Border, Douglas, AZ 

Lincoln-Juarez Bridge POE, Laredo, TX 

Gateway to the Americas International 

Bridge POE, Laredo, TX 

Columbia Solidarity Bridge POE, 

Laredo, TX 

World Trade Bridge POE, Laredo, TX 

Estimated start date of December 6, 

2004 (11):

Niagara Falls POE (to include LewistonQueenstown, Whirlpool, and Rainbow 

Bridges), Niagara Falls, NY 

Peace Bridge POE, Moore Drive and 

International Border, Buffalo, NY 

Detroit Ambassador Bridge POE, Detroit, 

MI 

Detroit-Windsor Tunnel POE, Detroit, 

MI 

Lukeville POE, Highway 85 & 

International Border, Lukeville, AZ 

Nogales East (Deconcini POE), Nogales, 

AZ 

Nogales West (Mariposa POE), Nogales, 

AZ 

San Luis POE, Highway 95 & 

International Border, San Luis, AZ 

Andrade POE, Andrade, CA 

Calexico East-Imperial Valley POE, Rte 

111 and International Border, 

Calexico, CA 

Calexico West POE, Rte 111 and 

International Border, Calexico, CA

Estimated start date of December 13, 

2004 (11):

Fabens POE 18051, Island Guadalupe, 

Fabens, TX 

Presidio POE, Border Station Highway 

67, Presidio, TX 79845 

Santa Teresa POE, Santa Teresa, NM 

Otay Mesa POE, 9777 Via De La 

Amistad, San Diego, CA 

San Ysidro POE, Highway 5 and 

International Border, San Diego, CA 

Tecate POE, Hwy 188 and International 

Border, Tecate, CA 

Blaine-Pacific Highway POE, Rte. 543 

and International Border, Blaine, WA 

Blaine-Peace Arch POE, Interstate 5 and 

International Border, Blaine, WA 

Lynden POE, Rte. 539 and International 

Border, Lynden, WA 

Point Roberts POE, Tyee Drive and 

Roosevelt Way, Point Roberts, WA 

Sumas POE, Cherry Street and 

International Avenue, Sumas, WA 

Estimated start date of December 20, 

2004 (10):

Champlain POE, Highway 87 and 

International Border, Champlain, NY 

Massena POE, Rte. 45 and International 

Border, Rooseveltown, NY 

Thousand Islands POE, Highway 81 and 

International Border, Alexandria Bay, 

NY 

Federal Register / Vol. 69, No. 216 / Tuesday, November 9, 2004 / Notices 64965

Sault Ste. Marie POE, The International 

Bridge, Highway 75 and International 

Border, Sault Ste. Marie, MI 

Bridge of the Americas POE, El Paso, TX 

Paso del Norte Bridge POE, El Paso, TX 

Ysleta POE, Ysleta-Zaragoza Bridge, El 

Paso, TX 

Derby Line POE, Highway 91 and 

International Border, Derby Line, VT 

Calais—Ferry Point POE, Main Street 

and International Border, Calais, ME 

International Falls POE, Rte 53 and 

International Border, International 

Falls, MN

Estimated start date of December 27, 

2004 (12):

Gateway International Bridge POE, 

Brownsville, TX 

Brownsville/Matamoros Bridge POE, 

Brownsville, TX 

Hidalgo POE, McAllen-Hidalgo-Reynosa 

International Bridge, McAllen, TX 

Los Indios POE, Free Trade Bridge at 

Los Indios, Los Indios, TX 

Los Tomates/Veterans International 

Bridge POE, Brownsville, TX 

Pharr POE, Pharr-Reynosa International 

Bridge, Pharr, TX 

Progreso POE, Progreso/Nuevo Progreso 

International Bridge, Progreso, TX 

Rio Grande City POE, Starr-Camargo 

Bridge, Rio Grande City, TX 

Roma POE, Roma-Ciudad Miguel 

Alema ́n Bridge, Highway 83 and 

International Border, Roma, TX 

Del Rio POE, Del Rio/Cuidad Acuna 

International Bridge, Garfield Avenue 

and International Border, Del Rio, TX 

Eagle Pass Bridge I POE, Eagle Pass/

Piedras Negras Bridge, Highway 57 

and International Border, Eagle Pass, 

TX 

Eagle Pass Bridge II POE, Camino Real 

International Bridge, Highway 57 and 

International Border, Eagle Pass, TX 

DHS has included these dates as 

estimates only. Should changes occur 

following the publication of this notice, 

revised estimated dates can be found on 

the US–VISIT Web site at http://

www.dhs.gov/us-visit. All of these listed 

ports of entry, however, will begin US–

VISIT implementation by December 31, 

2004.

Dated: October 11, 2004. 

Tom Ridge, 

Secretary of Homeland Security.

[FR Doc. 04–24966 Filed 11–8–04; 8:45 am] 

BILLING CODE 4410–10–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service 

DEPARTMENT OF DEFENSE 

Army Corps of Engineers 

Notice of Intent To Prepare an 

Environmental Impact Statement/

Environmental Impact Report for the 

South Bay Salt Ponds Restoration 

Project and the South San Francisco 

Bay Shoreline Study

AGENCIES: U.S. Fish and Wildlife 

Service, Interior; U.S. Army Corps of 

Engineers, Defense.

ACTION: Notice of intent.

SUMMARY: Pursuant to the National 

Environmental Policy Act of 1969, as 

amended (NEPA), the U.S. Fish and 

Wildlife Service (USFWS) and the U.S. 

Army Corps of Engineers (Corps) intend 

to prepare a joint programmatic 

Environmental Impact Statement/

Environmental Impact Report (EIS/EIR) 

to address the potential impacts of the 

South Bay Salt Ponds Restoration 

Project and the South San Francisco Bay 

Shoreline Study, San Francisco Bay, 

California. The two projects are closely 

interrelated and proposed planning and 

actions would be done in coordination 

with each other. The California 

Department of Fish and Game (CDFG) 

will be the lead agency under the 

California Environmental Quality Act 

(CEQA). 

Federal Lead Agencies Proposed and 

Connected Actions 

The Federal Joint Lead Agencies are 

proposing to undertake two closely 

related actions that would help prevent 

flooding and provide for the restoration 

of the South Bay Salt Ponds. USFWS 

proposes to prepare a long-term 

restoration plan for the South Bay Salt 

Ponds, which includes managed pond 

and tidal marsh habitat, as well as flood 

management and recreation 

components. The proposed action 

would provide for implementation of 

the first phase (Phase 1) of the South 

Bay Salt Ponds restoration plan. The 

area of the FWS proposed project falls 

within the larger scope of the actions 

the Corps is proposing along South San 

Francisco Bay shoreline. The Corps is 

proposing to implement a series of 

activities for tidal and fluvial flood 

damage reduction, environmental 

restoration, and related purposes along 

the South San Francisco Bay shoreline. 

The Corps’ feasibility study may include 

most of the components of the South 

Bay Salt Pond Restoration Project. Thus 

these interconnected actions are 

deserving of one cohesive EIS/EIR 

analysis. 

Two public scoping meetings will be 

held to solicit comments on the 

environmental effects of the range of 

potential projects and the appropriate 

scope of the EIS/EIR. The public is 

invited to comment on environmental 

issues to be addressed in the EIS/EIR 

during these meetings.

DATES: Written comments from all 

interested parties are encouraged and 

must be received on or before December 

9, 2004. The first of two public scoping 

meetings will be held on Tuesday, 

November 16, 2004, from 7 p.m. to 9 

p.m. at the NASA Research Center, 

Building 943, Moffett Field, California. 

A second scoping meeting will be held 

on Wednesday, November 17, 2004, 

from 7 p.m. to 9 p.m. at Centennial Hall, 

22292 Foothill Boulevard, Room 4, in 

Hayward, California. Persons needing 

reasonable accommodations in order to 

attend and participate in the public 

scoping meetings should contact Tim 

Corrigan at (510) 286–0325 sufficiently 

in advance of the meeting to allow time 

to process the request.

ADDRESSES: Written comments and 

requests for information should be sent 

to Margaret Kolar, Refuge Manager, U.S. 

Fish and Wildlife Service, San 

Francisco Bay NWR Complex. PO Box 

524, Newark, California 94560, or 

Yvonne LeTellier, Project Manager, U.S. 

Army Corps of Engineers, 333 Market 

Street 8th Floor, San Francisco, 

California 94105–2197. Written 

comments may also be sent by facsimile 

to (510) 792–5828, or via e-mail through 

the public comments link on the South 

Bay Salt Ponds Restoration Project Web 

site, at www.southbayrestoration.org/

QuestionlComment.html. All 

comments received, including names 

and addresses, will become part of the 

administrative record and available to 

the public.

FOR FURTHER INFORMATION CONTACT:

Margaret Kolar, Refuge Manager, U.S. 

Fish and Wildlife Service, San 

Francisco Bay NWR Complex, (510) 

792–0222, or Yvonne LeTellier, Project 

Manager, U.S. Army corps of Engineers, 

(415) 977–8466. For questions 

concerning the CEQA process, contact 

Carl Wilcox, Habitat Conservation 

Manager, California Department of fish 

and Game, Region 3 Headquarters, PO 

Box 47, Yountville, California, 94559, 

telephone: (707) 944–5525.

SUPPLEMENTARY INFORMATION: The joint 

programmatic EIS/EIR will address both 

the proposed South Bay Salt Ponds 

Restoration Project and the South San 

Francisco Bay Shoreline Study. USFWS 

and the Corps propose to integrate the