Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices 20501

ANDA No. Drug Applicant

88–067 ........................ Orphenadrine Citrate S. R. Tablets, 100 mg ...................... Do.

88–117 ........................ Triprolidine Hydrochloride Tablets, 2.5 mg

Pseudoephedrine Hydrochloride Tablets, 60 mg.

West-Ward Pharmaceutical Corp.

88–199 ........................ Folic Acid Tablets, 1 mg ...................................................... Unit Dose Laboratories.

88–256 ........................ Meclizine Hydrochloride Tablets, 12.5 mg .......................... Do.

88–257 ........................ Meclizine Hydrochloride Tablets, 25 mg ............................. Do.

88–288 ........................ Bethanechol Chloride Tablets, 10 mg ................................. Ascot Hospital Pharmaceuticals, Inc.

88–289 ........................ Bethanechol Chloride Tablets, 25 mg ................................. Do.

88–307 ........................ Thioridazine Hydrochloride Oral Concentrate, 30 mg/milliliters (mL).Geneva Pharmaceuticals, Inc., 2555 West Midway Blvd.,

Broomfield, CO 80038–0446.

88–308 ........................ Thioridazine Hydrochloride Oral Concentrate, 100 mg/mL . Do.

88–318 ........................ Triprolidine Hydrochloride Tablets, 2.5 mg

Pseudoephedrine Hydrochloride Tablets, 60 mg.

Circa Pharmaceuticals.

88–332 ........................ Thioridazine Hydrochloride Tablets, 10 mg ........................ Mylan Pharmaceuticals, Inc.

88–333 ........................ Thioridazine Hydrochloride Tablets, 25 mg ........................ Do.

88–334 ........................ Thioridazine Hydrochloride Tablets, 50 mg ........................ Do.

88–335 ........................ Thioridazine Hydrochloride Tablets, 100 mg ...................... Do.

88–582 ........................ Quinidine Gluconate Sustained Release Tablets, 324 mg . Ascot Hospital Pharmaceuticals, Inc.

88–646 ........................ Methocarbamol Tablets, 500 mg ......................................... Roxane Laboratories, Inc.

89–079 ........................ Nitroglycerin Controlled Release Capsules, 9 mg .............. Ascot Hospital Pharmaceuticals, Inc.

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the ANDA’s listed

above, and all amendments and

supplements thereto, is hereby

withdrawn, effective on May 26, 1995.

Dated: April 10, 1995.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 95–10272 Filed 4–25–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Advisory Commission on Childhood

Vaccines; Request for Nominations for

Voting Members

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice.

SUMMARY: The Health Resources and

Services Administration (HRSA) is

requesting nominations to fill three

vacancies on the Advisory Commission

on Childhood Vaccines (ACCV). The

ACCV was established by title XXI of

the Public Health Service Act (the Act),

as enacted by Public Law (Pub. L.) 99–

660 and as subsequently amended, and

advises the Secretary of Health and

Human Services (the Secretary) on

issues related to implementation of the

National Vaccine Injury Compensation

Program (VICP).

FOR FURTHER INFORMATION CONTACT: Mr.

Jerry Anderson, Principal Staff Liaison,

Policy and Commission Branch,

Division of Vaccine Injury

Compensation, at (301) 443–1533.

DATES: Nominations are to be submitted

by May 26, 1995.

ADDRESSES: All nominations are to be

submitted to the Director, Division of

Vaccine Injury Compensation, Bureau of

Health Professions, HRSA, Parklawn

Building, Room 8A–35, 5600 Fishers

Lane, Rockville, Maryland 20857.

SUPPLEMENTARY INFORMATION: Under the

authorities that established the ACCV,

viz., the Federal Advisory Committee

Act of October 6, 1972 (P.L. 92–463) and

section 2119 of the Act, 42 U.S.C.

300aa–19, as added by P.L. 99–660 and

amended, HRSA is requesting

nominations for three voting members

of the ACCV.

The ACCV advises the Secretary on

the implementation of the VICP; on its

own initiative or as the result of the

filing of a petition, recommends changes

in the Vaccine Injury Table; advises the

Secretary in implementing the

Secretary’s responsibilities under

section 2127 regarding the need for

childhood vaccination products that

result in fewer or no significant adverse

reactions; surveys Federal, State, and

local programs and activities relating to

the gathering of information on injuries

associated with the administration of

childhood vaccines, including the

adverse reaction reporting requirements

of section 2125(b); advises the Secretary

on means to obtain, compile, publish,

and use credible data related to the

frequency and severity of adverse

reactions associated with childhood

vaccines; and recommends to the

Director, National Vaccine Program,

Office of the Assistant Secretary for

Health, research related to vaccine

injuries which should be conducted to

carry out the VICP.

The ACCV consists of nine members

appointed by the Secretary as follows:

Three health professionals, of whom at

least two are pediatricians, who are not

employees of the United States, who

have expertise in the health care of

children, the epidemiology, etiology and

prevention of childhood diseases, and

the adverse reactions associated with

vaccines; three members from the

general public, of whom at least two are

legal representatives of children who

have suffered a vaccine-related injury or

death; and three attorneys, of whom at

least one shall be an attorney whose

specialty includes representation of

persons who have suffered a vaccinerelated injury or death and one shall be

an attorney whose specialty includes

representation of vaccine

manufacturers. In addition, the Director

of the National Institutes of Health, the

Assistant Secretary for Health, the

Director of the Centers for Disease

Control and Prevention, and the

Commissioner of the Food and Drug

Administration (or the designees of such

officials) serve as nonvoting ex officio

members.

Specifically, HRSA is requesting

nominations for three voting members

of the ACCV representing: (1) A health

professional with special experience in

childhood diseases; (2) a member from

the general public who is a legal

representative of a child who has

suffered a vaccine-related injury or

death; and (3) an attorney whose

specialty includes representation of

persons who have suffered a vaccinerelated injury or death. Nominees will

be invited to serve 3-year terms

beginning January 1, 1996, and ending

December 31, 1998.

Interested persons may nominate one

or more qualified persons for
20502 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices

membership on the ACCV. Nominations

shall state that the nominee is willing to

serve as a member of the ACCV and

appears to have no conflict of interest

that would preclude the ACCV

membership. Potential candidates will

be asked to provide detailed information

concerning such matters as financial

holdings, consultancies, and research

grants or contracts to permit evaluation

of possible sources of conflicts of

interest. A curriculum vitae should be

submitted with the nomination.

The Department of Health and Human

Services has special interest in assuring

that women, minority groups, and the

physically handicapped are adequately

represented on advisory committees and

therefore extends particular

encouragement to nominations for

appropriately qualified female,

minority, or physically handicapped

candidates.

Dated: April 19, 1995.

Ciro V. Sumaya,

Administrator.

[FR Doc. 95–10175 Filed 4–25–95; 8:45 am]

BILLING CODE 4160–15–P

Substance Abuse and Mental Health

Services Administration

Office for Women’s Services; Meeting

Pursuant to Pub. L. 92–463, notice is

hereby given of a teleconference

meeting of the Advisory Committee for

Women’s Services in May 1995.

The meeting will be held by

telephone conference call. The meeting

agenda of the Advisory Committee for

Women’s Services will include a

discussion of women’s substance abuse

and mental health service needs within

the context of the SAMHSA Strategic

Plan, the proposed SAMHSA

Performance Partnership grants, and

proposed Policy Demonstration grants.

A summary of this meeting and/or a

roster of committee members may be

obtained from: Jennifer B. Fiedelholtz,

Executive Secretary, Advisory

Committee for Women’s Services, Office

for Women’s Services, Substance Abuse

and Mental Health Services

Administration, Parklawn Building,

Room 13–99, 5600 Fishers Lane,

Rockville, Maryland 20857, Telephone:

(301) 443–5184.

Substantive information may be

obtained from the contact whose name

and telephone number is listed below.

Committee Name: Advisory Committee for

Women’s Services.

Meeting Date: May 22, 1995.

Place: Room 12–94, Parklawn Building,

5600 Fishers Lane, Rockville, Maryland

20857.

Open: 2:00 p.m. to adjournment.

Contact: Jennifer B. Fiedelholtz, Room 13–

99, Parklawn Building, Telephone (301) 443–

5184.

Dated: April 20, 1995.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 95–10204 Filed 4–25–95; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

Draft Environmental Impact Statement

(DEIS) for the Yellowstone Pipeline

Rights-of-Way Renewal Across Trust

and Allotted Lands of the Flathead

Indian Reservation, Montana

AGENCY: Bureau of Indian Affairs,

Interior.

ACTION: Notice of availability of DEIS

and public hearing dates.

SUMMARY: The Draft Environmental

Impact Statement (DEIS) is for the

proposed renewal of rights-of-way for an

existing petroleum products pipeline.

Constructed in 1954, this pipeline

transports gasoline, diesel fuel, and jet

fuel from refineries in Billings,

Montana, 588 miles west to Spokane

and Moses Lake, Washington. A portion

of the pipeline crosses both tribal and

allotted trust lands on the Flathead

Indian Reservation in northwestern

Montana.

The Yellowstone Pipe Line Company

(YPL) and the Confederated Salish and

Kootenai Tribes of the Flathead Nation

(CSKT) executed a lease agreement for

these trust lands for the period April 21,

1975, through April 21, 1995. It was

approved by the Bureau of Indian

Affairs (BIA), which serves as the

federal trustee for the lands. The YPL

requested a renewal of its lease from the

CSKT in order to continue operating the

pipeline through the year 2016.

A third party consultant, L.W. Reed

Consultants, Inc. of Fort Collins,

Colorado, is preparing the EIS for the

BIA. They signed vouchers saying that

they have no interest in the final

decision of the BIA and have no conflict

of interests involving YPL. The BIA

required that YPL fund the EIS.

This notice is published pursuant to

Sec. 1503.1 of the Council on

Environmental Quality Regulations (40

CFR, Parts 1500 through 1508)

implementing the procedural

requirements of the National

Environmental Policy Act of 1969, as

amended (42 U.S.C. 4321 et seq.),

Department of Interior Manual (516 DM

1–6) and is in the exercise of authority

delegated to the Assistant Secretary—

Indian Affairs by 209 DM 8.

DATES: Public hearings on the DEIS will

be held on the following dates:

Thursday, May 11; Monday, May 15;

Tuesday, May 16; Wednesday, May 17;

and Thursday, May 18. Written

comments must arrive on or before June

26, 1995, at the address given below. We

will consider all comments received

during this period in preparing the Final

EIS.

ADDRESSES: Written comments may be

submitted at the public meetings, or

sent to: Mr. Ernest Moran,

Superintendent, Flathead Agency, Box

A, Pablo, MT 59855.

Public hearings on the DEIS will be

held at the following locations and

times: Cavanaugh’s River Inn, Spokane,

WA, Thursday May 11, 7 p.m.; Ruby’s

Reserve Street Inn, Missoula, MT,

Monday May 15, 7 p.m.; St. Ignatius

Community Center, St. Ignatius, MT,

Tuesday May 16, 4 p.m.; CSKT Tribal

Complex, Pablo, MT, Wednesday May

17, 11 a.m.; Tribal Senior Citizens

Center, Hot Springs, MT, Thursday May

18, 4 p.m.

If you would like a copy of this DEIS,

please contact Mr. Lanny Reed, Lanny

Reed Consultants Inc., 516 Spring

Canyon Court, Fort Collins, Colorado

80525, or call toll-free at (800) 695–

9305. We have sent copies of the DEIS

to all agencies and individuals who

previously requested them.

FOR FURTHER INFORMATION CONTACT: Mr.

Jim Beyer, Flathead Agency Box A,

Pablo, Montana 59855, telephone (406)

675–7200 ext. 260, or you may call tollfree at (800) 695–9305.

SUPPLEMENTARY INFORMATION: The

Department of the Interior classifies the

renewal of an existing right-of-way

‘‘where there would be essentially no

change in use and continuation would

not lead to environmental degradation’’

as a Categorical Exclusion under NEPA.

In this case, two large spills and five

smaller ones on the Reservation during

the life of the pipeline indicated that

continuation might lead to significant

environmental degradation. Therefore,

the Superintendent of the Flathead

Agency, BIA, in consultation with the

CSKT, decided that an EIS would be

required prior to any federal decision

concerning lease renewal.

The Proposed Action consists of the

YPL’s request to renew existing rightsof-way across trust lands, with added

pipeline safety improvements. The

action is needed in order to continue:

(1) Operation of the pipeline to serve the

needs of the public; (2) transportation of