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:

69778 Federal Register / Vol. 65, No. 224 / Monday, November 20, 2000 / Notices

I. Background

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’’ November July 2000. The

guidance document provides

information to FDA reviewers regarding

broader relative potency limits for CBER

evaluation of standardized dust mite

and grass allergen vaccines submitted to

CBER for lot release. Issues addressed in

the guidance document include, but are

not limited to, the following: (1)

Diagnostic equivalence, (2) theraputic

equivalence, (3) safety equivalence, (4)

lot-to-lot variation in allergen vaccine

potency, and (5) current and broadened

CBER release limits for standardized

dust mite and grass allergen vaccines

submitted to CBER for lot release. 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 (65 FR 7557).

This guidance document represents

the agency’s current thinking with

regard to the potency limits for

standardized dust mite and grass

allergen vaccines. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statutes

and regulations. As with other guidance

documents, FDA does not intend this

document to be all-inclusive and

cautions that not all information may be

applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

guidance document. Two copies of any

comments are to be submitted, except

individuals may submit one copy.

Comments should be identified with the

docket number found in the brackets in

the heading of this document. A copy of

the document and received comments

are available for public examination in

the Dockets Management Branch

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

through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cber/guidelines.htm.

Dated: October 13, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–29537 Filed 11–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–3010]

‘‘Guidance for Industry: Testing Limits

in Stability Protocols for Standardized

Grass Pollen Extracts’’; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a document entitled

‘‘Guidance for Industry: Testing Limits

in Stability Protocols for Standardized

Grass Pollen Extracts’’ dated November

2000. The guidance document provides

information on developing stability

protocols for standardized grass pollen

extracts. The development of suitable

stability studies is necessary to

determine the shelf life of standardized

grass pollen extracts 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

Industry on Testing Limits in Stability

Protocols for Standardized Grass Pollen

Extracts’’ that was announced in the

Federal Register of August 25, 1997.

DATES: Submit written comments at any

time.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Guidance for Industry: Testing Limits

in Stability Protocols for Standardized

Grass Pollen Extracts’’ 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

guidance 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:

I. Background

FDA is announcing the availability of

a document entitled ‘‘Guidance for

Industry: Testing Limits in Stability

Protocols for Standardized Grass Pollen

Extracts’’ dated November 2000. The

guidance document is intended to

provide information to manufacturers

regarding stability studies on grass

pollen extracts. Such stability studies

are used to determine the shelf life of

the product. This guidance document

does not, however, change lot release

criteria for these products. Issues

addressed in the guidance document

include, but are not limited to: (1)

Current lot release criteria, (2) lot

release versus stability protocol, (3)

modified stability protocol, (4) retesting,

(5) dealing with test failure, and (6)

extension of dating. The guidance

document announced in this notice

finalizes the draft guidance entitled

‘‘Guidance for Industry on Testing

Limits in Stability Protocols for

Standardized Grass Pollen Extracts’’ that

was announced in the Federal Register

of August 25, 1997 (62 FR 44975).

This guidance document represents

the agency’s current thinking with

regard to the testing limits in stability

protocols for standardized grass pollen

extract. It does not create or confer any

rights for or on any person and does not

operate to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the requirement

of the applicable statutes and

regulations. As with other guidance

documents, FDA does not intend this

document to be all-inclusive and

cautions that not all information may be

applicable to all situations. The

document is intended to provide

information and does not set forth

requirements.

II. Comments

Interested persons may, at any time,

submit written comments to the Dockets

Management Branch (address above)

regarding this guidance document. Two