Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 64315

applicant may not amend or supplement 

an [ANDA] to seek approval of a drug 

referring to a different listed drug from 

the listed drug identified in the 

application as submitted to the 

Secretary’’ (MMA, Title XI, section 

1101(a)(1)(B)). In part, the draft 

guidance clarifies the definition of 

‘‘listed drug’’ in the context of ANDAs 

as directed by the MMA. Portions of the 

guidance addressing ‘‘listed drug’’ are 

expected to be of use to sponsors who 

are contemplating submitting an 

amendment or supplement to an 

existing ANDA rather than submitting a 

new application. The draft guidance 

should aid these sponsors in 

determining when to reference a 

different listed drug and, thus, when to 

submit a new application rather than an 

amendment or supplement. A situation 

that is not considered in this guidance 

is that where a pending ANDA was 

submitted referencing a petition 

approved under section 505(j)(2)(C) of 

the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 355(j)(2)(C)), and 

another application is approved for the 

product described in the petition before 

the pending ANDA is approved. FDA 

has not completed its analysis of this 

situation, and therefore the draft 

guidance does not cover it.

In addition to the definition of ‘‘listed 

drug,’’ the draft guidance clarifies 

certain other significant changes made 

by the MMA to provisions of the act that 

were originally added by the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) (Hatch-Waxman). These include 

changes made by the MMA with respect 

to the availability and termination of 30-

month stays of approval on ANDAs and 

505(b)(2) applications under section 

505(j)(5)(B)(iii) and 505(c)(3)(C) of the 

act, respectively, and to requirements 

for notice of patent certifications 

described by section 505(b)(2)(A)(iv) 

and 505(j)(2)(A)(vii)(IV) of the act 

(paragraph IV certifications). The draft 

guidance also clarifies the applicability 

of certain changes made by the MMA 

regarding the period described by 

section 505(j)(5)(B)(iv) of the act during 

which ANDAs with paragraph IV 

certifications that were not the first to be 

submitted cannot be approved (180-day 

exclusivity). Finally, this guidance 

explains the effective dates that apply to 

the MMA’s amendments. FDA is aware 

that these changes are complex and 

include significant departures from 

previous law. The agency therefore 

wishes to provide guidance to industry 

to clarify these amendments.

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on the definition of ‘‘listed drug’’ for 

amendments and supplements to 

ANDAs, and on 30-month stays and 

certain other matters related to the 

approval of ANDAs and 505(b)(2) 

applications. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations.

II. Comments

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the draft guidance. Two 

copies of mailed comments are to be 

submitted, except that individuals may 

submit one 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.

III. Electronic Access

Persons with access to the Internet 

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: October 18, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24675 Filed 11–3–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

DEPARTMENT OF TRANSPORTATION 

Maritime Administration 

[USCG–2004–16860] 

Gulf Landing, LLC Deepwater Port 

License Application

AGENCY: Coast Guard, DHS, and 

Maritime Administration, DOT.

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The U.S. Coast Guard (USCG) 

and the U.S. Maritime Administration 

(MARAD) will hold a public hearing to 

receive information relevant to the 

issuance or denial of the requisite 

federal license for the proposed Gulf 

Landing, LLC (Gulf Landing) Deepwater 

Port project. The proposed Gulf Landing 

Deepwater Port would be located in 

West Cameron Lease Block Number 213, 

approximately 38 miles south of 

Cameron, Louisiana. We encourage 

interested individuals and organizations 

to attend the public hearing and submit 

comments. We also seek comments from 

anyone unable to attend the public 

hearing. In conjunction with the public 

hearing, the USCG and MARAD will 

also hold an informational open house 

regarding the proposed Gulf Landing 

Deepwater Port project.

DATES: The public hearing will be held 

on Thursday, November 18, 2004, from 

5 to 7 p.m., in New Orleans, Louisiana. 

The informational open house will be 

held on Thursday, November 18, 2004, 

from 3 to 4:30 p.m., at the same location 

in New Orleans, Louisiana. The public 

hearing will continue beyond 7 p.m. if 

necessary to ensure all individuals 

present at that time who wish to 

comment have an opportunity to do so. 

Comments intended for inclusion in 

the public docket [USCG–2004–16860] 

must reach the Docket Management 

Facility on or before January 3, 2005.

ADDRESSES: The public hearing and 

informational open house will be held 

at the following location: Hyatt Regency 

New Orleans Hotel, Poydras at Loyola 

Avenue, New Orleans, Louisiana 70113, 

telephone 504–561–1234. 

You may submit comments identified 

by Coast Guard docket number USCG–

2004–16860 to the Docket Management 

Facility at the U.S. Department of 

Transportation. To avoid duplication, 

please use only one of the following 

methods: 

(1) Web Site: http://dms.dot.gov.

(2) Mail: Docket Management Facility, 

U.S. Department of Transportation, 400 

Seventh Street, SW., Washington, DC 

20590–0001. 

(3) Fax: 202–493–2251. 

(4) Delivery: Room PL–401 on the 

Plaza level of the Nassif Building, 400 

Seventh Street, SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The telephone number is 202–366–

9329. 

(5) Federal eRulemaking Portal:

http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: For 

further information concerning this 

notice, the Gulf Landing Deepwater Port 

license application, or the public 

hearing or informational open house, 

contact LCDR Derek Dostie, U.S. Coast 

Guard at (202) 267–0662 or 

ddostie@comdt.uscg.mil. If you have 

questions on viewing or submitting 

material to the docket, call Andrea M. 

64316 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 

Jenkins, Program Manager, Docket 

Operations, telephone 202–366–0271.

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

Whether or not you attend the public 

hearing or informational open house, we 

encourage you to submit written 

comments and related materials. All 

comments received will be posted, 

without change, to http://dms.dot.gov

and will include any personal 

information you have provided. We 

have an agreement with the Department 

of Transportation (DOT) to use the 

Docket Management Facility. Please see 

DOT’s ‘‘Privacy Act’’ paragraph below. 

Submitting comments: If you submit a 

comment, please include your name and 

address, identify the docket number 

[USCG–2004–16860], indicate your 

specific concern, and give the reason for 

each comment. You may submit your 

comments and material by electronic 

means, mail, fax, or delivery to the 

Docket Management Facility at the 

address under ADDRESSES; but please 

submit your comments and material by 

only one means. If you submit them by 

mail or delivery, submit them in an 

unbound format, no larger than 81⁄2 by 

11 inches, suitable for copying and 

electronic filing. If you submit them by 

mail and would like to know that they 

reached the Facility, please enclose a 

stamped, self-addressed postcard or 

envelope. We will consider all 

comments and material received during 

the comment period. 

Viewing comments and documents:

To view comments, as well as 

documents mentioned in this preamble 

as being available in the docket, go to 

http://dms.dot.gov at any time and 

conduct a simple search using the 

docket number USCG–2004–16860. You 

may also visit the Docket Management 

Facility in room PL–401 on the Plaza 

level of the Nassif Building, 400 

Seventh Street, SW., Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

Privacy Act: Anyone can search the 

electronic form of all comments 

received into any of our dockets by the 

name of the individual submitting the 

comment (or signing the comment, if 

submitted on behalf of an association, 

business, labor union, etc.). You may 

review the Department of 

Transportation’s Privacy Act Statement 

in the Federal Register published on 

April 11, 2000 (65 FR 19477), or you 

may visit http://dms.dot.gov.

Public Hearing/Informational Open 

House 

The Coast Guard and the Maritime 

Administration will hold a public 

hearing on Thursday, November 18, 

2004 from 5 to 7 p.m., at the Hyatt 

Regency New Orleans Hotel, Poydras at 

Loyola Avenue, New Orleans, Louisiana 

70113, telephone 504–561–1234. The 

informational open house will be held 

on Thursday, November 18, 2004 from 

3 p.m. to 4:30 p.m., at the same location 

in New Orleans, Louisiana. We invite 

the public and representatives of 

interested agencies to attend and 

provide comments on the proposed 

license application. If you plan to attend 

the public hearing or informational 

open house and need special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

contact the U.S. Coast Guard as 

indicated in FOR FURTHER INFORMATION

CONTACT. We ask that you make such 

requests at least three (3) business days 

before the scheduled meeting. Include a 

contact person’s name and telephone 

number, your specific need, and (for 

persons with hearing impairments) a 

TDD number. 

Proposed Deepwater Port Background 

Information 

The application plan calls for 

construction of a deepwater port and 

associated anchorages in an area 

situated in the Gulf of Mexico, 

approximately 38 miles south of 

Cameron, Louisiana in West Cameron 

Lease Block Number 213, in water depth 

of approximately 55 feet, and adjacent 

to an existing shipping fairway servicing 

the Calcasieu River and area ports. 

Gulf Landing’s terminal would be 

capable of storing up to 200,000 cubic 

meters of LNG. On average, Gulf 

Landing expects the terminal would 

vaporize and deliver 1 billion cubic feet 

per day (Bcfd) of natural gas to the 

pipelines; with a peak daily send-out 

rate of 1.2 Bcfd. Gulf Landing proposes 

to construct, own, and operate up to 5 

offshore pipelines, ranging from 16 to 36 

inches in diameter that would traverse 

a combined 65.7 nautical miles. The 

pipelines would interconnect with 

existing natural gas pipelines located in 

the Gulf of Mexico. Gas would then be 

delivered to the onshore national 

pipeline grid for delivery to any 

consumption market east of the Rocky 

Mountains. 

The project would consist of two 

concrete gravity base structures (GBSs) 

housing the LNG containment facilities, 

along with topside unloading and 

vaporization equipment, living quarters, 

and a ship berthing system. 

The terminal would be able to receive 

LNG carriers with cargo capacities 

between 125,000 and 200,000 cubic 

meters and unload up to 135 LNG 

carriers per year. All marine systems, 

communication, navigation aids and 

equipment necessary to conduct safe 

LNG carrier operations and receiving of 

cargo during specified atmospheric and 

sea states would be provided at the port. 

The regasification process would 

consist of lifting the LNG from storage 

tanks, pumping the cold liquid to 

pipeline pressure, subsequent 

vaporization of the LNG across heat 

exchanging equipment, and send-out 

through custody transfer metering to the 

gas pipeline network. No gas 

conditioning is required for the terminal 

since the incoming LNG would be 

pipeline quality. 

License Application Background 

Information 

The Gulf Landing Deepwater Port 

license application was submitted to the 

Secretary of Transportation on 

November 3, 2003. The license 

application calls for construction of the 

Gulf Landing Deepwater Port to be 

located in West Cameron Lease Block 

Number 213 approximately 38 miles 

south of Cameron, Louisiana. 

Additional information concerning the 

contents of the application can be found 

online at http://dms.dot.gov under 

docket number USCG–2004–16860, or 

in the notice of application published in 

the Federal Register at 69 FR 14 (Jan. 

22, 2004), pages 3165–3167. This public 

hearing is being held pursuant to 33 

U.S.C. 1504(g) to receive information 

relevant to the issuance or denial of the 

requisite federal license for the 

proposed Gulf Landing, LLC Deepwater 

Port project. 

Procedural 

The public meeting will be structured 

to provide interested members of the 

public with an opportunity to present 

comments regarding the license 

application. Speakers at the public 

meeting will be recognized in the 

following order: elected officials, public 

agencies, individuals or groups in the 

sign-up order, and anyone else who 

wishes to speak. Speakers may be asked 

to limit their oral comments to five (5) 

minutes in order to afford everyone an 

opportunity to speak. Any person who 

wishes may appear and speak or present 

evidence at this public hearing. Persons 

planning to speak at the hearing should 

contact the U.S. Coast Guard as 

indicated in FOR FURTHER INFORMATION

CONTACT, any time prior to the hearing. 

Written statements and exhibits may be 

submitted in place of or in addition to 

Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 64317

oral statements and will be made a part 

of the hearing record. Written 

statements and exhibits may be 

delivered before or during the hearing, 

or they may be submitted for up to 45 

days following the date of the hearing to 

the Docket Management Facility listed 

under ADDRESSES.

Dated: October 29, 2004. 

Joseph J. Angelo, 

Director of Standards, Marine Safety, 

Security, and Environmental Protection, U.S. 

Coast Guard. 

Richard Lolich, 

Acting Director, Office of Ports and Domestic 

Shipping, U.S. Maritime Administration.

[FR Doc. 04–24642 Filed 11–3–04; 8:45 am] 

BILLING CODE 4910–15–P

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service 

Draft Revised Recovery Plan for the 

Laysan Duck (Anas laysensis)

AGENCY: Fish and Wildlife Service, 

Interior.

ACTION: Notice of document availability 

for review and comment. 

SUMMARY: The U.S. Fish and Wildlife 

Service (we) announces the availability 

of the Draft Revised Recovery Plan for 

the Laysan Duck (Anas laysanensis) for 

public review and comment.

DATES: Comments on the draft revised 

recovery plan must be received on or 

before January 3, 2005.

ADDRESSES: Copies of the draft revised 

recovery plan are available for 

inspection, by appointment, during 

normal business hours at the following 

location: U.S. Fish and Wildlife Service, 

Pacific Islands Fish and Wildlife Office, 

300 Ala Moana Boulevard, Room 3–122, 

Honolulu, Hawaii 96850 (telephone: 

(808) 792–9400). Requests for copies of 

the draft revised recovery plan and 

written comments and materials 

regarding this plan should be addressed 

to the Field Supervisor, Ecological 

Services, at the above Honolulu address. 

An electronic copy of the draft revised 

recovery plan is also available at http:/

/endangered.fws.gov/recovery/

index.html#plans.

FOR FURTHER INFORMATION CONTACT:

Holly Freifeld, Fish and Wildlife 

Biologist, at the above Honolulu 

address.

SUPPLEMENTARY INFORMATION: 

Background 

Recovery of endangered or threatened 

animals and plants is a primary goal of 

the Endangered Species Act (Act) (16 

U.S.C. 1531 et seq.) and our endangered 

species program. Recovery means 

improvement of the status of listed 

species to the point at which listing is 

no longer required under the criteria set 

out in section 4(a)(1) of the Act. 

Recovery plans describe actions 

considered necessary for the 

conservation of the species, establish 

criteria for downlisting or delisting 

listed species, and estimate time and 

cost for implementing the measures 

needed for recovery.

The Act requires the development of 

recovery plans for endangered or 

threatened species unless such a plan 

would not promote the conservation of 

the species. Section 4(f) of the Act 

requires that public notice, and an 

opportunity for public review and 

comment, be provided during recovery 

plan development. We will consider all 

information presented during the public 

comment period on each new or revised 

recovery plan. Substantive technical 

comments may result in changes to a 

recovery plan. Substantive comments 

regarding recovery plan implementation 

may not necessarily result in changes to 

the recovery plans, but will be 

forwarded to appropriate Federal agency 

or other entities so that they can take 

these comments into account during the 

course of implementing recovery 

actions. Individual responses to 

comments will not be provided. 

The Laysan duck is federally listed as 

endangered and is also listed as 

endangered by the State of Hawaii. This 

species currently is found only on the 

small island of Laysan in the 

Northwestern Hawaiian Islands, but it 

was also known historically from the 

island of Lisianski, and bones or fossils 

have been found in the Main Hawaiian 

Islands on Hawaii, Maui, Molokai, 

Oahu, and Kauai, indicating it 

previously had a much wider 

distribution. The Main Hawaiian Island 

populations of this species likely were 

extirpated by nonnative mammalian 

predators around the time of human 

settlement. The Laysan duck’s current 

population is estimated to be 459 birds, 

but its numbers on Laysan have 

fluctuated from 7 to 688 adult birds 

during the past century. This species 

uses all available habitats on Laysan, 

including coastal areas, a hypersaline 

lagoon, mudflats, and densely vegetated 

upland areas. It eats a variety of 

arthropods, sometimes seeds, leaves, 

and algae, and at certain seasons 

consumes large quantities of aquatic 

midge larvae. The primary threats to 

this species are its small population size 

and restricted range, stochastic 

fluctuations in food availability that 

cause its numbers to vary, potential 

inbreeding depression and disease 

susceptibility, and storms that could 

cause direct mortality and destroy the 

duck’s habitat on the single low-lying 

island to which it is currently restricted. 

The recovery goals are to conserve 

and recover the Laysan duck to the 

point where it can be downlisted 

(reclassified from endangered to 

threatened status) and eventually to 

delist the species (remove it from the 

List of Endangered and Threatened 

Wildlife and Plants). The objectives by 

which these goals will be met are to 

protect the existing population on 

Laysan and reestablish additional viable 

populations of the duck in areas that are 

managed to be free of predators. To 

accomplish these objectives, this 

recovery plan outlines high priority 

tasks that fall generally into four 

categories. First, the duck population on 

Laysan must be monitored and its 

habitat restored and protected. Second, 

wild juvenile ducks must be 

translocated to appropriate predator-free 

Northwestern Hawaiian Islands and 

eventually to sites in the Main Hawaiian 

Islands where predators are effectively 

controlled. Translocated populations 

must be closely monitored and managed 

to enhance population growth. Third, a 

captive propagation program must be 

initiated, with the aim of producing 

Laysan ducks for release primarily at 

predator-controlled Main Hawaiian 

Island sites. Fourth, further research 

must be undertaken on the life history, 

demography, disease susceptibility, and 

genetics of the Laysan duck to refine the 

recovery criteria and management 

techniques for this species. 

Public Comments Solicited 

We solicit written comments on the 

draft revised recovery plan described. 

All comments received by the date 

specified above will be considered prior 

to approval of this plan.

Authority: The authority for this action is 

section 4(f) of the Endangered Species Act, 

16 U.S.C. 1533(f).

Dated: August 12, 2004. 

David J. Wesley, 

Acting Regional Director, Region 1, U.S. Fish 

and Wildlife Service.

[FR Doc. 04–24619 Filed 11–3–04; 8:45 am] 

BILLING CODE 4310–55–P