Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Notices 63547

announces the following Federal 

advisory committee meeting.

NAME: National Task Force on Fetal 

Alcohol Syndrome and Fetal Alcohol 

Effect (NTFFASFAE).

TIMES AND DATES: 9 a.m.–4:30 p.m., 

December 6, 2004; 9 a.m.–12 noon, 

December 7, 2004.

PLACE: Westin Buckhead Atlanta Hotel, 

3391 Peachtree Road, NE., 30326, 

telephone (404) 365–0065, fax (404) 

365–8787.

STATUS: Open to the public, limited only 

by the space available. The meeting 

room accommodates approximately 65 

people.

PURPOSE: The Secretary is authorized by 

the Public Health Service Act, Section 

399G, (42 U.S.C. S 280f, as added by 

Public Law 105–392) to establish a 

National Task Force on Fetal Alcohol 

Syndrome and Fetal Alcohol Effect to: 

(1) Foster coordination among all 

governmental agencies, academic bodies 

and community groups that conduct or 

support Fetal Alcohol Syndrome (FAS) 

and Fetal Alcohol Effect (FAE) research, 

programs and surveillance; and(2) to 

otherwise meet the general needs of 

populations actually or potentially 

impacted by FAS and FAE.

MATTERS TO BE DISCUSSED: Agenda items 

include: An overview of effective 

strategies to reduce the risk of problem 

drinking and alcohol-exposed 

pregnancies; what is needed to 

implement effective programs in the 

service delivery system; alcohol 

advertising and adolescent girls; and a 

discussion of issues presented. 

Additional agenda items include: 

Prevention and Post-Exposure working 

group sessions; updates from Task Force 

members on current initiatives; an 

update on activities from the 

Interagency Coordinating Committee on 

Fetal Alcohol Syndrome, the CDC and 

other Federal agencies; future topics, 

and scheduling the next meeting. 

Agenda items are subject to change as 

priorities dictate.

FOR FURTHER INFORMATION CONTACT: R. 

Louise Floyd,DSN, RN, Designated 

Federal Official, National Center on 

Birth Defects and Developmental 

Disabilities, CDC, 1600Clifton Road, 

NE., (E–86), Atlanta, Georgia 30333, 

telephone (404) 498–3923, fax (404) 

498–3550. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register

notices pertaining to announcements of 

meetings and other committee 

management activities for both the CDC 

and ATSDR.

Dated: October 27, 2004. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–24391 Filed 11–1–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

The Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) and the 

National Center for Environmental 

Health/Agency for Toxic Substances 

Disease Registry (ATSDR) announce the 

following committee meeting:

Name: Board of Scientific Counselors 

(BSC), National Center for Environmental 

Health/Agency for Toxic Substances 

andDisease Registry (NCEH/ATSDR). 

Time and Dates: 8:30 a.m.–5 p.m., 

November 18, 2004, 8:30 a.m.–12:30 p.m., 

November 19, 2004. 

Place: CDC Headquarters facility, 1600 

Clifton Road, Atlanta, GA 30333. 

Status: Open to the public for observation, 

limited only by the space available. The 

meeting room accommodates approximately 

100 people. 

Purpose: The Secretary, and by delegation, 

the Director of the Centers for Disease 

Control and Prevention and the 

Administrator of the National Center for 

Environmental Health/Agency for Toxic 

Substances and Disease Registry, are 

authorized under section 301 (42 U.S.C. 241) 

and section 311 (42 U.S.C. 243) of the Public 

Health Service Act, as amended, to (1) 

conduct, encourage, cooperate with, and 

assist other appropriate public authorities, 

scientific institutions, and scientists in the 

conduct of research, investigations, 

experiments, demonstrations, and studies 

relating to the causes, diagnosis, treatment, 

control, and prevention of physical and 

mental diseases and other impairments; (2) 

assist States and their political subdivisions 

in the prevention of infectious diseases and 

other preventable conditions and in the 

promotion of health and well-being; and (3) 

train State and local personnel in health 

work. The Board of Scientific Counselors, 

NCEH/ATSDR provides advice and guidance 

to the Secretary, HHS; the Director, CDC and 

Administrator, ATSDR; and the Director, 

NCEH/ATSDR, regarding program goals, 

objectives, strategies, and priorities in 

fulfillment of the agencies’ mission to protect 

and promote people’s health. The Board 

provides advice and guidance that will assist 

NCEH/ATSDR in ensuring scientific quality, 

timeliness, utility, and dissemination of 

results. The Board also provides guidance to 

help NCEH/ATSDR work more efficiently 

and effectively with its various constituents 

and to fulfill its mission in protecting 

America’s health. 

Matters To Be Discussed: The agenda items 

for the meeting on November 18–19, 2004, 

will include but are not limited to an update 

on future initiatives; update on NCEH/

ATSDR consolidation and accomplishments; 

reports on the Program Peer Review and the 

Community and Tribal subcommittees and 

the Health Department Workgroup; update 

on NCEH/ATSDR strategic priorities; report 

on social/behavioral sciences at NCEH/

ATSDR; a review of the ATSDR Draft Dioxin 

Soil Policy Guidelines; and a presentation on 

the Emergency Preparedness and Response 

activities at NCEH/ATSDR. 

Agenda items are tentative and subject to 

change. 

For Further Information Contact:

Individuals interested in attending the 

meeting, please contact Sandra Malcom, 

Committee Management Specialist, NCEH/

ATSDR, 1600 Clifton Road, Mail Stop E–28, 

Atlanta, GA 30303; telephone 404/498–0003, 

fax 404/498–0059; e-mail: smalcom@cdc.gov.

The deadline for notification of attendance is 

November 12, 2004. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both CDC and the National Center for 

Environmental Health/Agency for 

ToxicSubstances and Disease Registry.

Dated: October 27, 2004. 

B. Kathy Skipper, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention.

[FR Doc. 04–24389 Filed 11–1–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002E–0340]

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; GANIRELIX ACETATE 

INJECTION (Formerly ANTAGON)

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

GANIRELIX ACETATE INJECTION and 

is publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

63548 Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Notices 

extension of a patent that claims that 

human drug product.

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT:

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6699.

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive.

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted, as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B).

FDA recently approved for marketing 

the human drug product GANIRELIX 

ACETATE INJECTION (ganirelix 

acetate). GANIRELIX ACETATE 

INJECTION is indicated for the 

inhibition of premature LH surges in 

women undergoing controlled ovarian 

hyperstimulation. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for GANIRELIX ACETATE 

INJECTION (U.S. Patent No. 4,801,577) 

from Syntex, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated December 30, 2002, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of GANIRELIX 

ACETATE INJECTION represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period.

FDA has determined that the 

applicable regulatory review period for 

GANIRELIX ACETATE INJECTION is 

3,558 days. Of this time, 3,376 days 

occurred during the testing phase of the 

regulatory review period, while 182 

days occurred during the approval 

phase. These periods of time were 

derived from the following dates:

1. The date an exemption under 

section 505 of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355) became effective: November 2, 

1989. The applicant claims October 3, 

1989, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was November 2, 

1989, which was 30 days after FDA 

receipt of the IND.

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the act: January 29, 1999. The 

applicant claims January 28, 1999, as 

the date the new drug application 

(NDA) for GANIRELIX ACETATE 

INJECTION (NDA 21–057) was initially 

submitted. However, FDA records 

indicate that NDA 21–057 was 

submitted on January 29, 1999.

3. The date the application was 

approved: July 29, 1999. FDA has 

verified the applicant’s claim that NDA 

21–057 was approved on July 29, 1999.

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 5 years of patent 

term extension.

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by January 3, 2005. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

May 2, 2005. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30.

Comments and petitions should be 

submitted to the Division of Dockets 

Management (see ADDRESSES). Three 

copies of any mailed information 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. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday.

Dated: October 15, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–24378 Filed 11–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG 2004–19483] 

Review and Approval of Classification 

Societies

AGENCY: Coast Guard, DHS.

ACTION: Notice of policy; request for 

comments. 

SUMMARY: This notice contains 

procedures the Coast Guard will use to 

review classification societies seeking 

Coast Guard approval to perform certain 

functions for vessels. Under the 2004 

Coast Guard and Maritime 

Transportation Authorization Act, after 

January 1, 2005, classification societies 

may not perform those certain functions 

for vessels unless they are either 

approved by the Coast Guard or are full 

members of the International 

Association of Classification Societies. 

Class societies seeking Coast Guard 

approval should submit a package in 

accordance with the procedures in this 

notice. The Coast Guard also seeks 

public comment on the procedures 

described herein for reviewing and 

approving classification societies.

DATES: This notice of policy is effective 

November 2, 2004. Comments and 

related material must reach the Docket 

Management Facility on or before 

January 3, 2005.

ADDRESSES: