69776 Federal Register / Vol. 65, No. 224 / Monday, November 20, 2000 / Notices

Status: Open to the public, limited

only by the space available.

Purpose: The Committee advises and

makes recommendations to the

Secretary, the Assistant Secretary for

Health, the Director, CDC, and Director,

National Center for Injury Prevention

and Control (NCIPC) regarding feasible

goals for the prevention and control of

injury. The Committee makes

recommendations regarding policies,

strategies, objectives, and priorities, and

reviews progress toward injury

prevention and control. The Committee

provides advice on the appropriate

balance of intramural and extramural

research, and also provides guidance on

the needs, structure, progress and

performance of intramural programs,

and on extramural scientific program

matters. The Committee provides

second-level scientific and

programmatic review for applications

for research grants, cooperative

agreements, and training grants related

to injury control and violence

prevention, and recommends approval

of projects that merit further

consideration for funding support. The

Committee also recommends areas of

research to be supported by contracts

and cooperative agreements and

provides concept review of program

proposals and announcements.

Matters to be Discussed: Following

the Acting Director’s update, which will

include an introduction of the new

NCIPC Director, NCIPC’s Division of

Violence Prevention will give an

overview of violence against women

programs. The Committee will also

discuss reports from the November 28,

2000, meetings of the Subcommittee on

Family and Intimate Violence

Prevention and Subcommittee on

Science and Program Review.

This notice is published less than 15

days prior to the meeting due to

administrative delay.

Contact Person for More Information:

Mr. Thomas E. Blakeney, Acting

Executive Secretary, ACIPC, NCIPC,

CDC, 4770 Buford Highway, NE, M/S

K61, Atlanta, Georgia 30341–3724,

telephone 770/488–1481.

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.

Dated: November 15, 2000.

Carolyn J. Russell,

Management Analysis and Services Office,

Centers for Disease Control and Prevention.

[FR Doc. 00–29720 Filed 11–16–00; 12:15

pm]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for Voting

Members on Public Advisory

Committees

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

The Food and Drug Administration

(FDA) is requesting nominations for

voting members to serve on the

Allergenic Products Advisory

Committee, Biological Response

Modifiers Advisory Committee, Blood

Products Advisory Committee,

Transmissible Spongiform

Encephalopathies Advisory Committee,

and the Vaccines and Related Biological

Products Advisory Committee in the

Center for Biologics Evaluation and

Research (CBER). Nominations will be

accepted for vacancies that will or may

occur through January 31, 2002.

FDA has a special interest in ensuring

that women, minority groups, and

individuals with disabilities are

adequately represented on advisory

committees and, therefore, encourages

nominations of qualified candidates

from these groups.

DATES: Because scheduled vacancies

occur on various dates throughout each

year, no cutoff date is established for the

receipt of nominations. However, when

possible, nominations should be

received at least 6 months before the

date of scheduled vacancies for each

year, as indicated in this notice.

ADDRESSES: All nominations and

curricula vitae should be sent to the

addresses below.

FOR FURTHER INFORMATION CONTACT:

Regarding nominations, except for

consumer representatives: Nancy T.

Cherry, Scientific Advisors and

Consultants Staff, Center for Biologics

Evaluation and Research (HFM–71),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–0314.

Regarding nominations for consumer

representatives: Maureen A. Hess, Office

of Consumer Affairs (HFE–50), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4421.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations of voting

members with appropriate expertise for

vacancies listed below.

1. Allergenic Products Advisory

Committee: Three vacancies occurring

August 31, 2001; immunology,

pediatrics, internal medicine,

biochemistry, statistics, and related

scientific fields.

2. Biological Response Modifiers

Advisory Committee: Five vacancies

occurring March 31, 2001; biological

response modifiers, immunology,

virology, molecular biology, rDNA

technology, infectious diseases, viral

oncology, statistics, and cellular

kinetics.

3. Blood Products Advisory

Committee: Nine vacancies occurring

September 30, 2001; clinical and

administrative medicine, hematology,

immunology, blood banking, surgery,

internal medicine, biochemistry,

engineering, statistics, biological and

physical sciences, and other related

scientific fields.

4. Transmissible Spongiform

Encephalopathies Advisory Committee:

Three vacancies occurring January 31,

2002; clinical administrative medicine,

hematology, virology, neurology,

infectious diseases, immunology, blood

banking, surgery, internal medicine,

biochemistry, biostatistics,

epidemiology, biological and physical

sciences, sociology/ethics, and other

related professions.

5. Vaccines and Related Biological

Products Advisory Committee: Three

vacancies occurring January 31, 2002;

immunology, molecular biology, rDNA,

virology, bacteriology, epidemiology,

biostatistics, allergy, preventive

medicine, infectious diseases,

pediatrics, microbiology, and

biochemistry.

Functions

Allergenic Products Advisory Committee

Reviews and evaluates available data

concerning the safety, effectiveness, and

adequacy of labeling of marketed and

investigational allergenic biological

products or materials that are

administered to humans for the

diagnosis, prevention, or treatment of

allergies and allergic diseases.

Biological Response Modifiers Advisory

Committee

Reviews and evaluates available data

relating to the safety, effectiveness, and

appropriate use of biological response

modifiers which are intended for use in

Federal Register / Vol. 65, No. 224 / Monday, November 20, 2000 / Notices 69777

the prevention and treatment of a broad

spectrum of human diseases.

Blood Products Advisory Committee

Reviews and evaluates available data

concerning the safety, effectiveness, and

appropriate use of blood and products

derived from blood and serum or

biotechnology which are intended for

use in the diagnosis, prevention, or

treatment of human diseases.

Transmissible Spongiform

Encephalopathies Advisory Committee

Reviews and evaluates available

scientific data concerning the safety of

products which may be at risk for

transmission of spongiform

encephalopathies having an impact on

the public health.

Vaccines and Related Biological

Products Advisory Committee

Reviews and evaluates data

concerning the safety, effectiveness, and

appropriate use of vaccines and related

biological products which are intended

for use in the prevention, treatment, or

diagnosis of human diseases.

Qualifications

Persons nominated for membership

on the committees shall have adequately

diversified experience appropriate to

the work of the committee in such fields

as clinical and administrative medicine,

engineering, biological and physical

sciences, statistics, and other related

professions. The nature of specialized

training and experience necessary to

qualify the nominee as an expert

suitable for appointment may include

experience in medical practice,

teaching, and/or research relevant to the

field of activity of the committee. The

particular needs at this time for each

committee are shown above. The term of

office is up to 4 years, depending on the

appointment date.

Nomination Procedures

Any interested person may nominate

one or more qualified persons for

membership on one or more of the

advisory committees. Self-nominations

are also accepted. Nominations shall

include the name of the committee, a

complete curriculum vitae of each

nominee, current business address and

telephone number, and shall state that

the nominee is aware of the nomination,

is willing to serve as a member (name

of committee(s) must be specified), and

appears to have no conflict of interest

that would preclude membership. FDA

will ask the potential candidates to

provide detailed information concerning

such matters as financial holdings,

employment, and research grants and/or

contracts to permit evaluation of

possible sources of conflict of interest.

Consumer Representatives

Any interested person may nominate

one or more qualified persons for

membership on one or more of the

advisory committees to represent

consumer interests. Self-nominations

are also accepted. To be eligible for

selection, the applicant’s experience

and/or education will be evaluated

against Federal civil service criteria for

the position to which the person will be

appointed.

Selection of members representing

consumer interests is conducted

through procedures that include use of

a consortium of consumer organizations

that has the responsibility for

recommending candidates for the

agency’s selection. Candidates should

possess appropriate qualifications to

understand and contribute to the

committee’s work.

Nominations shall include a complete

curriculum vitae of each nominee,

current address and telephone numbers,

and shall state that the nominee is

aware of the nomination, is willing to

serve as a member, and appears to have

no conflict of interest that would

preclude membership. FDA will ask the

potential candidates to provide detailed

information concerning such matters as

financial holdings, employment, and

research grants and/or contracts to

permit evaluation of possible sources of

conflict of interest. The nomination

should state whether the nominee is

interested only in a particular advisory

committee or in any advisory

committee. The term of office is up to

4 years, depending on the appointment

date.

This notice is issued under the

Federal Advisory Committee Act (5

U.S.C. app. 2) and 21 CFR part 14

relating to advisory committees.

Dated: November 7, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–29536 Filed 11–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–0218]

Guidance for Reviewers: Potency

Limits for Standardized Dust Mite and

Grass Allergen Vaccines: A Revised

Protocol; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance document

entitled ‘‘Guidance for Reviewers:

Potency Limits for Standardized Dust

Mite and Grass Allergen Vaccines: A

Revised Protocol’’ dated October 2000.

The guidance document provides

information on the revised release limits

to be used by the Center for Biologics

Evaluation and Research (CBER) for its

evaluation of standardized dust mite

and grass allergen vaccines submitted to

CBER for lot release. The establishment

of suitable potency limits for

standardized allergen vaccines

submitted to CBER for lot release is

necessary to help ensure the safety,

purity, and potency of these products.

The guidance document announced in

this notice finalizes the draft guidance

entitled ‘‘Guidance for Reviewers:

Potency Limits for Standardized Dust

Mite and Grass Allergen Vaccines: A

Revised Protocol’’ that was announced

in the Federal Register on February 15,

2000.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for

Reviewers: Potency Limits for

Standardized Dust Mite and Grass

Allergen Vaccines: A Revised Protocol’’

dated November 2000 to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

The document may also be obtained by

mail by calling the CBER Voice

Information System at 1–800–835–4709

or 301–827–1800, or by fax by calling

the FAX Information System at 1–888–

CBER–FAX or 301–827–3844. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance

document.

Submit written comments on the

document to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Joseph L. Okrasinski, Center for

Biologics Evaluation and Research

(HFM–17), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

6210.

SUPPLEMENTARY INFORMATION: