Federal Register / Vol. 65, No. 26 / Tuesday, February 8, 2000 / Notices 6213

Pursuant to Public Law 92–463,

notice is hereby given of a meeting of

the Secretary’s Advisory Committee on

Genetic Testing (SACGT), U.S. Public

Health Service. The meeting will be

held at the International Trade Center,

Polaris Ballroom, 1300 Pennsylvania

Avenue, NW, Washington, DC 20004,

starting on February 24, 2000, at

approximately 9:00 a.m. and will recess

at approximately 5:30 p.m. The meeting

will reconvene on February 25, 2000, at

approximately 8:00 a.m. and will

adjourn at approximately 5:00 p.m. The

meeting will be open to the public.

Attendance by the public will be limited

by the space available. The committee

will review public comments received

in response to A Public Consultation on

Oversight of Genetic Tests published in

the Federal Register on December 1,

1999 (64 FR 67273), and work toward

the development of final

recommendations on the oversight of

genetic testing. A limited period of time

will be provided for public comment,

and individuals interested in

participating in the public comment

period should contact Ms. Sarah Carr,

SACGT Executive Secretary, as shown

below.

Under authority of 42 U.S.C. 217a,

Section 222 of the Public Health Service

Act, as amended, the Department of

Health and Human Services (DHHS)

established the SACGT to advise and

make recommendations to the Secretary

through the Assistant Secretary for

Health on all aspects of the

development and use of genetic tests.

The SACGT is directed to: (1)

Recommend policies and procedures for

the safe and effective incorporation of

genetic technologies into health care; (2)

assess the effectiveness of existing and

future measures for oversight of genetic

tests; (3) and identify research needs

related to the Committee’s purview.

Further information about the SACGT

is available at the following web site:

http://www4.od.nih.gov/oba/sacgt.htm.

If you wish to attend, please register

through the web site. A draft meeting

agenda will be posted to the web site

prior to the meeting. Individuals who

wish to provide public comments

should notify Ms. Carr, by telephone at

301–496–9838 or E-mail at

sc112c@nih.gov as soon as possible and

provide a copy of their remarks to Ms.

Carr by February 15, 2000. Those who

plan to attend the meeting and need

special assistance, such as sign language

interpretation or other reasonable

accommodations, should notify Ms. Carr

at 301–496–9838. The SACGT office is

located at 6000 Executive Boulevard,

Suite 302, Bethesda, Maryland 20892.

Dated: February 3, 2000.

Sarah Carr,

Executive Secretary, SACGT.

[FR Doc. 00–2906 Filed 2–7–00; 8:45 am]

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Notice of Meeting

Office of the Director, Centers for

Disease Control and Prevention (CDC),

announces the following meeting:

Name: Guide to Community Preventive

Services (GCPS) Task Force Meeting.

Times and Dates: 9 a.m.-5:30 p.m.,

February 9, 2000; 8 a.m.–3:30 p.m., February

10, 2000.

Place: The Renaissance Waverly Hotel,

2450 Galleria Parkway, Atlanta, Georgia

30339, telephone (770) 953–4500.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 40 people.

Purpose: The mission of the Task Force is

to develop and publish a Guide to

Community Preventive Services, which is

based on the best available scientific

evidence and current expertise regarding

essential public health services and what

works in the delivery of those services.

Matters to be Discussed: Agenda items

include: a briefing of administrative activities

in the Community Guide Branch,

recommendation approvals for the Oral

Health and Tobacco Chapters, updates for the

following chapters: Diabetes, Cancer, Motor

Vehicle Occupant Injuries, Mental Health,

Physical Activity, Nutrition, Sexual

Behavioral, Alcohol, Violence Prevention

and Sociocultural Environment, an update on

the Economic Evaluation and a discussion of

actions items for the next quarter.

Agenda items are subject to change as

priorities dictate.

Contact Person for Additional Information:

Stephanie Zaza, M.D., M.P.H., Chief, CPS

Guide Development Activity, Division of

Prevention Research and Analytic Methods,

Epidemiology Program Office, CDC, 4770

Buford Highway, M/S K–73, Atlanta, Georgia

30341, telephone 770/488–8189.

Persons interested in reserving a space for

this meeting should call 770/488–8189 by

close of business on February 7, 2000.

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 Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention.

[FR Doc. 00–2899 Filed 2–7–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–0671]

Bestblood, Ltd.; Revocation of U.S.

License No. 1116

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revocation of the establishment license

(U.S. License No. 1116) and product

licenses (the licenses) issued to

Bestblood, Ltd., doing business as

Optimum Healthcare, Inc., for the

manufacture of Whole Blood, Red Blood

Cells, Red Blood Cells Frozen, Whole

Blood CPD, Red Blood Cells

Deglycerolized, and Whole Blood

CPDA–1. Bestblood, Ltd., did not

respond to a notice of opportunity for a

hearing on a proposal to revoke its

licenses.

DATES: The revocation of the

establishment license (U.S. License No.

1116) and product licenses is effective

February 8, 2000.

FOR FURTHER INFORMATION CONTACT:

Joseph L. Okrasinski, Jr., Center for

Biologics Evaluation and Research

(HFM–17), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD. 20852–1448, 301–827–

6210.

SUPPLEMENTARY INFORMATION: FDA is

revoking the establishment license (U.S.

License No. 1116) and product licenses

issued to Bestblood, Ltd., doing

business as Optimum Healthcare, Inc.,

239 Randall St., San Francisco, CA

94131, for the manufacture of Whole

Blood, Red Blood Cells, Red Blood Cells

Frozen, Whole Blood CPD, Red Blood

Cells Deglycerolized, and Whole Blood

CPDA–1. Proceedings to revoke the

licenses were initiated because an

attempted inspection of the facility by

FDA, as required under 21 CFR 600.21,

revealed that the firm was no longer in

operation.

In a certified, return-receipt letter

dated June 16, 1997, FDA notified the

firm that the attempt to conduct an

inspection at Bestblood, Ltd., 239

Randall St., San Francisco, CA 94131

was unsuccessful because the facility

was apparently no longer in operation

and requested that the firm notify FDA

in writing of the firm’s status. This letter

was sent to 239 Randall St., San

Francisco, CA 94131, and also to P.O.

Box 843, Cupertino, CA 95054–0843,

6214 Federal Register / Vol. 65, No. 26 / Tuesday, February 8, 2000 / Notices

and each was returned to the agency as

undeliverable.

In a certified, return-receipt letter sent

to Bestblood, Ltd., dated March 4, 1998,

at both addresses mentioned previously

and returned as undeliverable, FDA

indicated that an attempt to conduct an

inspection at the facility was

unsuccessful. The letter advised the

firm that, under 21 CFR 601.5(b)(1) and

(b)(2), when FDA finds that authorized

employees have been unable to gain

access to an establishment for the

purpose of carrying out an inspection

required under § 600.21, or the

manufacturing of products or of a

product has been discontinued to an

extent that a meaningful inspection

cannot be made, proceedings for license

revocation may be instituted. FDA also

indicated that a meaningful inspection

could not be made at the establishment

and issued to the firm a notice of FDA’s

intent to revoke U.S. License No. 1116

and announced its intent to offer an

opportunity for a hearing.

Under 21 CFR 12.21(b), FDA

published in the Federal Register of

April 15, 1999 (64 FR 18623), a notice

of opportunity for a hearing on a

proposal to revoke the licenses of

Bestblood, Ltd. In the notice, FDA

explained that the proposed license

revocation was based on the inability of

authorized FDA employees to conduct a

meaningful inspection of the facility

because it was no longer in operation,

and noted that documentation in

support of license revocation had been

placed on file with the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5600 Fishers

Lane, rm. 1061 Rockville, MD 20852.

The notice provided the firm 30 days to

submit a written request for a hearing

and 60 days to submit any data and

information justifying a hearing. The

notice provided other interested persons

with 60 days to submit written

comments on the proposed revocation.

The firm did not respond within the 30-

day time period with a written request

for a hearing. The 30-day time period

prescribed in the notice of opportunity

for a hearing and in the regulations, may

not be extended. No other comments

were received.

Accordingly, under 21 CFR 12.38,

section 351 of the Public Health Service

Act (42 U.S.C. 262), and under the

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Director, Center for

Biologics Evaluation and Research (21

CFR 5.68) the establishment license

(U.S. License No. 1116) and the product

licenses issued to Bestblood, Ltd., are

revoked, effective February 8, 2000.

Dated: January 13, 2000.

Mark Elengold,

Deputy Director for Operations, Center for

Biologics Evaluation and Research.

[FR Doc. 00–2768 Filed 2–7–00; 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’s regulatory issues.

Date and Time: The meeting will be

held on March 16, 2000, from 8:30 a.m.

to 5:30 p.m., and March 17, 2000, from

8 a.m. to 1 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 March 16, 2000, the

committee will discuss: (1) New drug

application (NDA) 21–063, Eloxatin

(oxaliplatin), Sanofi Pharmaceuticals,

Inc., indicated for the first-line

treatment of patients with advanced

colorectal cancer in combination with

5–U based chemotherapy; and (2) NDA

20–571/SE1–009, Camptosar Injection

(irinotecan hydrochloride injection),

Pharmacia and Upjohn Co., indicated as

a component of first-line therapy for

patients with metastatic carcinoma of

the colon or rectum. On March 17, 2000,

the committee will discuss NDA 21–

174, gemtuzumab zogamicin, WyethAyerst Laboratories, indicated for the

treatment of patients with CD33 positive

acute myeloid leukemia in relapse.

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 March 8, 2000. Oral

presentations from the public will be

scheduled between approximately 8:45

a.m. and 9:15 a.m., and 1:30 p.m. and

1:45 p.m. on March 16, 2000, and

between approximately 8:15 a.m. and

8:45 a.m. on March 17, 2000. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before March 8, 2000,

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. After the scientific

presentations, a 30-minute open public

session may be conducted for interested

persons who have submitted their

request to speak by March 8, 2000, to

address issues specific to the

submission or topic before the

committee.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 28, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–2770 Filed 2–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–2912]

Review of Supplemental Applications

for Approved New Animal Drugs;

Center Responsibility and Standards

for Prompt Review; Availability of Draft

Guidance

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: As required by the Food and

Drug Administration Modernization Act

of 1997 (FDAMA), the Food and Drug

Administration’s (FDA) Center for

Veterinary Medicine (CVM) is making

available information regarding the

approval of supplemental applications

for approved new animal drugs. CVM is

publishing standards for the prompt

review of supplemental applications

and referencing an existing guidance

that describes how supplemental

applications may qualify for priority

review. CVM is also designating an