9338 Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Notices

Dated: February 14, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–4194 Filed 2–16–95; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETINGS: The following advisory

committee meetings are announced:

Allergenic Products Advisory

Committee

Date, time, and place. March 10,

1995, 9 a.m., Woodmont Office Complex

I, conference room 400–N, 1401

Rockville Pike, Rockville, MD.

Type of meeting and contact person.

This meeting will be held by a

telephone conference call. A speaker

telephone will be provided in the

conference room to allow public

participation in the meeting. Open

committee discussion on review of

research, 9 a.m. to 10 a.m.; closed

committee deliberations, 10 a.m. to

11:05 a.m.; open public hearing, 11:05

a.m. to 12:05 p.m., unless public

participation does not last that long;

Jack Gertzog or Sandy Salins, Center for

Biologics Evaluation and Research

(HFM–21), Food and Drug

Administration, 1401 Rockville Pike,

Bethesda, MD 20852, 301–827–0314, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Allergenic Products Advisory

Committee, code 12388.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

allergenic biological products intended

for use in the diagnosis, prevention, or

treatment of human disease.

Agenda—Open public hearing.

Interested persons requesting to present

data, information, or views, orally or in

writing, on issues pending before the

committee, should communicate with

the contact person.

Open committee discussion. The

committee will discuss the intramural

scientific program of the Laboratory of

Immunobiochemistry and the clinical

research programs of individuals in the

Division of Allergenic Products and

Parasitology.

Closed committee deliberations. The

committee will discuss the intramural

scientific program. This portion of the

meeting will be closed to prevent

disclosure of personal information

concerning individuals associated with

the research program, disclosure of

which would constitute a clearly

unwarranted invasion of personal

privacy (5 U.S.C. 552b(c)(6)).

Arthritis Advisory Committee

Date, time, and place. March 27,

1995, 8:30 a.m., Holiday Inn—Silver

Spring, Plaza Ballroom, 8777 Georgia

Ave., Silver Spring, MD. Elsewhere in

this issue of the Federal Register, FDA

is publishing a notice announcing a

joint meeting on March 28, 1995, with

the Nonprescription Drugs Advisory

Committee.

Type of meeting and contact person.

Open public hearing, 8:30 a.m. to 9:30

a.m., unless public participation does

not last that long; open committee

discussion, 9:30 a.m. to 12:30 p.m.;

closed committee deliberations, 12:30

p.m. to 5:30 p.m.; Isaac F. Roubein,

Center for Drug Evaluation and Research

(HFD–9), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Arthritis Advisory Committee, code

12532.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in arthritic conditions.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before March 16, 1995,

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 required to make their

comments.

Open committee discussion. The

committee will discuss the new drug

application (NDA) 18–922, Lodine

(etodolac) Wyeth-Ayerst Laboratories,

which is proposed for the treatment of

rheumatoid arthritis.

Closed committee deliberations. The

committee will review trade secret and/

or confidential commercial information

relevant to pending investigational new

drugs. This portion of the meeting will

be closed to permit discussion of this

information (5 U.S.C. 552b(c)(4)).

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes
Federal Register / Vol. 60, No. 33 / Friday, February 17, 1995 / Notices 9339

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: February 14, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–4195 Filed 2–16–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

Technology Assessment Conference

on Gaucher Disease: Current Issues in

Diagnosis and Treatment

Notice is hereby given of the NIH

Technology Assessment Conference on

‘‘Gaucher Disease: Current Issues in

Diagnosis and Treatment,’’ which will

be held February 27–March 1, 1995, in

the Masur Auditorium of the National

Institutes of Health, 9000 Rockville

Pike, Bethesda, Maryland 20892. The

conference begins at 8:30 a.m. on

February 27 and 28 and at 9 a.m. on

March 1.

Gaucher disease, the inherited

deficiency of the enzyme

glucocerebrosidase, is the most common

lysosomal storage disease and the most

frequently inherited disorder in the

Ashkenazic Jewish population. In the

past decade there has been much

progress both in our understanding of

the molecular biology of the disease and

the ability to treat Gaucher patients.

However, many issues regarding

diagnosis, population screening, and

therapy for Gaucher patients do not

have clear consensus. Gaucher disease

is characterized by a remarkable degree

of clinical heterogeneity, ranging from

severely affected infants to totally

asymptomatic adults. Patients with

Gaucher disease have been classified

into three major types on the basis of

clinical signs and symptoms: Type 1—

non-neuropathic; type 2—acute

neuropathic; and type 3—subacute

neuropathic.

All types of Gaucher disease result

from the deficiency of the same enzyme,

glucocerebrosidase, and the diagnosis

can be made by measurement of enzyme

activity obtained from a tube of blood.

The most striking difference between

the types is the presence of neurologic

manifestations and the rate of

progression. Even within the different

types there is not a unique clinical

presentation. Some patients with type 1

Gaucher disease, which is by far the

most common type, may display

anemia, low platelets, massively

enlarged livers and spleens, and

extensive skeletal disease, while others

have no symptoms and have been

recognized only during screening or

evaluation for other diseases.

The gene for glucocerebrosidase on

chromosome 1q21 has been

characterized and sequenced. Multiple

mutations have been identified in the

glucocerebrosidase gene in patients’

DNA, several of which are encountered

frequently. While some patients with

similar clinical courses share the same

genotype, there are other examples

where patients with the same DNA

mutations have very different clinical

manifestations. It is still not clear to

what extent a person’s phenotype or

prognosis can be accurately predicted

on the basis of current DNA mutation

analysis. Furthermore, while the

availability of molecular techniques has

made possible early prenatal diagnosis,

heterozygote detection and population

screening for Gaucher disease, the

advisability and usefulness of these

techniques remains unsolved.

Gaucher disease has been

traditionally managed by supportive

therapy including total and partial

splenectomy, transfusions, and