38658 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices

3. On page 34903, in the first column,

under the ‘‘Procedure’’ portion, in the

ninth line, ‘‘July 28 and 29’’ is corrected

to read ‘‘July 29’’.

Dated: July 10, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–19031 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Nucleic Acid Testing for Hepatitis C

Virus (HCV) and Other Viruses in

Blood Donors; Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is announcing the following

public workshop: Nucleic Acid Testing

for Hepatitis C Virus (HCV) and Other

Viruses in Blood Donors. The topic to be

discussed is the exploration of the

current state of technology and

implementation of nucleic acid testing

for screening blood donors.

Date and Time: The workshop will be

held on Wednesday, September 16,

1998, 8:30 a.m. to 5 p.m.

Location: The workshop will be held

at the Parklawn Bldg., 3d floor,

conference rooms D and E, 5600 Fishers

Lane, Rockville, MD 20857.

Contact: Joseph Wilczek, Center for

Biologics Evaluation and Research

(HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

6129, FAX 301–827–2843.

Registration: Mail or fax registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by

Friday, September 4, 1998. Registration

at the site will done on a space available

basis on the day of the workshop,

beginning at 7:30 a.m. There is no

registration fee for the workshop. Space

is limited, therefore interested parties

are encouraged to register early.

If you need special accommodations

due to a disability, please contact Joseph

Wilczek at least 7 days in advance.

Agenda: The public workshop is

intended to discuss nucleic acid testing

that currently is the most sensitive

method available to further reduce

disease transmission by blood

transfusion in the early window phase

of infection. Nucleic acid testing is

being implemented for blood donor

screening by testing plasma pools, and

pool testing may be useful by serving as

an interim measure until screening of

individual blood donations is

technologically feasible.

Regulatory and scientific topics to be

discussed at the workshop include

donor testing issues, pooling strategies,

and test validation and reference

materials for standardization of various

nucleic acid technologies.

Transcripts: Transcripts of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting at a cost of 10 cents per page.

Dated: July 9, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19110 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Oncologic Drugs Advisory Committee;

Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Oncologic Drugs

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 1, 1998, 8:30 a.m. to

5:30 p.m., and September 2 and 3, 1998,

8 a.m. to 5:30 p.m.

Location: Holiday Inn, Versailles

Ballroom, 8120 Wisconsin Ave.,

Bethesda, MD.

Contact Person: Karen M. TempletonSomers, Center for Drug Evaluation and

Research (HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7001, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12542. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On September 1, 1998, the

committee will discuss: (1) New drug

application (NDA) 20–893 MetaretTM

(suramin hexasodium for injection),

Parke-Davis Pharmaceutical Research,

indicated for the treatment of patients

with hormone refractory prostate

cancer; and (2) NDA 20–892 ValstarTM

(valrubicin 40 milligrams/milliliter),

Anthra Pharmaceuticals, Inc., indicated

for intravesical use in the treatment of

patients with biopsy-proven carcinoma

in situ of the urinary bladder who are

refractory to bacille Calmette-Gu ̃ erin

(BCG) immunotherapy and for whom

cystectomy is contraindicated. On

September 2, 1998, the committee will

discuss: (1) NDA supplement 17–970/S–

040 Nolvadex (tamoxifen citrate),

Zeneca Pharmaceuticals, indicated for

the prevention of breast cancer in

women at high risk; and (2) biologics

license application (BLA) 98–0369

HerceptinTM (trastuzumab), Genentech,

Inc., indicated for the treatment of

patients with metastatic breast cancer

who have tumors which overexpress

HER2. On September 3, 1998, the

committee will discuss: (1) NDA

supplement 20–571/S–08 CamptosarTM

(irinotecan hydrochloride injection),

Pharmacia & Upjohn, indicated for the

treatment of patients with metastatic

carcinoma of the colon or rectum whose

disease has recurred or progressed

following a 5-FU-based therapy; and (2)

NDA supplement 20–451/S–003

Photofrin (porfimer sodium) for

injection, QLT PhotoTherapeutics, Inc.,

indicated for the reduction of

obstruction and palliation of symptoms

in patients with completely or partially

obstructing endobronchial nonsmall cell

lung cancer.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by August 14, 1998. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:15 a.m., on September 1,

1998, and between approximately 8:15

a.m. and 8:45 a.m., on September 2 and

3, 1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before August 14, 1998, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).
Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 / Notices 38659

Dated: July 9, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–19030 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0393]

National Shellfish Sanitation Program

Guide for the Control of Molluscan

Shellfish; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guide entitled ‘‘National

Shellfish Sanitation Program (NSSP)

Guide for the Control of Molluscan

Shellfish.’’ The guide was developed

cooperatively by FDA and the Interstate

Shellfish Sanitation Conference (ISSC)

with the intent of replacing the existing

NSSP Manuals of Operation, Parts I and

II. The guide contains a Model

Ordinance for ensuring that only safe

and sanitary shellfish are offered for sale

in interstate commerce. Language

contained in the Model Ordinance has

been codified for easy adoption into law

or regulation by State regulatory

agencies. The guide also includes

documentation supportive of the

codified language of the Model

Ordinance, including: The NSSP’s

history, public health reasons and

explanations specific to the guidelines

contained in the Model Ordinance,

NSSP guidance documents, suggested

NSSP forms, shellfish policy setting

documents, pertinent Federal

regulations, and references to the public

health reasons and explanations. These

supportive materials aid in ensuring

consistent and uniform implementation

of a national shellfish safety program.

DATES: Comments on the guide may be

submitted at any time.

ADDRESSES: Submit written comments

on the guide to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Submit

written requests for single copies of the

guide entitled ‘‘National Shellfish

Sanitation Program Guide for the

Control of Molluscan Shellfish’’ to the

contact person in the nearest regional

office listed in the SUPPLEMENTARY

INFORMATION section of this

document. Send two self-addressed

adhesive labels to assist in processing

your requests. An electronic version of

the guide is available on the World

Wide Web at (http/www.issc.org).

FOR FURTHER INFORMATION CONTACT: Paul

W. DiStefano, Office of Seafood, Center

for Food Safety and Applied Nutrition

(HFS–417), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3150,

FAX: 202–418–3198, e-mail:

‘‘pdistefa@bangate.fda.gov’’, or the

contact person in the nearest regional

office as listed in the

SUPPLEMENTARY INFORMATION

section of this document.

SUPPLEMENTARY INFORMATION: Copies of

the guide entitled ‘‘National Shellfish

Sanitation Program Guide for the

Control of Molluscan Shellfish’’ can be

obtained from the nearest regional office

as follows:

FDA Addresses Contact Person

Stoneham District Office, State Programs Branch, One Montvale Ave.,

Stoneham, MA 02180

David G. Field

New York Regional Office, 850 Third Ave., Brooklyn, NY 11232–1593 Jerry H. Mulnick

Baltimore District Office, Investigations Branch, 900 Madison Ave., Baltimore, MD 21201Al A. Ondis

Atlanta Regional Office, State Cooperative Programs, 60 Eighth St.

NE., Atlanta, GA 30309

James A. Casey

Charleston Resident Post, 334 Meeting St., rm. 505, P.O. Box 21077,

Charleston, SC 29413

Donald Hesselman

Tallahassee Resident Post, Hobbs Federal Bldg., 227 North Bronough

St., suite 4150, Tallahassee, FL 32301

Marc B. Glatzer

Baton Rouge Resident Post, 5353 Essen Lane, suite 220, Baton

Rouge, LA 70809

John E. Veazey

Detroit District Resident Post, 1560 East Jefferson Ave., Detroit, MI

48207

Nicholas L. Majerus

Dallas Regional Office, 7920 Elmbrook Dr., suite 102, Dallas, TX 75247 David A. Blevins

Seattle District Office, 100 Second Ave., suite 2400, Seattle, WA 98104 Tim E. Sample

Shellfish Safety Team (HFS–628), 200 C St. SW., Washington, DC

20204

Stanley D. Ratcliffe

FDA is the Federal agency responsible

for administration of the NSSP. The

NSSP is a voluntary program in which

State shellfish control agencies, the

shellfish industry, FDA, and other

Federal agencies participate. The NSSP,

which has been in existence since 1925,

addresses the sanitary control of fresh

and frozen molluscan shellfish (oysters,

clams, mussels, and scallops) offered for

sale in interstate commerce. To promote

uniform administrative and technical

controls, the NSSP has developed and

maintained recommended shellfish

control practices for adoption by

member States. These control practices,

which were initially published as the

NSSP Manuals of Operation, Parts I and

II, are contained in the guide ‘‘NSSP

Guide for the Control of Molluscan

Shellfish.’’

In 1982, interested State officials and

members of the shellfish industry

formed the ISSC to provide a structure

wherein State regulatory authorities

could meet on a regular basis to discuss

ways to improve shellfish sanitation and

safety. FDA and the ISSC entered into

a memorandum of understanding

(MOU) that was published in the

Federal Register of March 30, 1984 (49

FR 12751), agreeing, among other

things, that FDA would provide

technical assistance to the ISSC. The

ISSC in turn would help FDA develop

or revise program criteria and guidelines

in the NSSP Manuals of Operation.

Based on the MOU, and in cooperation

with the ISSC, FDA periodically

publishes revisions of the NSSP