Federal Register / Vol. 65, No. 27 / Wednesday, February 9, 2000 / Notices 6377

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Psychopharmacologic Drugs Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

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.

ACTION: Notice.

Name of Committee:

Psychopharmacologic 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 9, 2000, 8 a.m. to 4:30

p.m.

Location: Holiday Inn, The Ballroom,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Sandra L. Titus or

LaNise S. Giles, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane (for express delivery, 5630

Fishers Lane, rm. 1093), Rockville, MD

20857, 301–827–7001, or e-mail:

Tituss@cder.fda.gov, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area) code 12544.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss

the best way to develop drugs for the

treatment of the various psychiatric and

behavioral disturbances that are

frequently associated with Alzheimer’s

disease and other dementias. In

particular, the presentations and

discussions will focus on the problem of

how to identify, define, and name the

clinical entities that fall under this

broad category of disorders. This is a

major regulatory issue because the

failure to adequately define specific

disorders in this area could lead to

misleading labeling. As background

information for this meeting, FDA has

provided an issues paper at http://

www.fda.gov/ohrms/dockets/dockets/

00n–0088/00n–0088.htm) that describes

in detail the regulatory issues and

concerns and proposes how this

question might be addressed. This paper

is intended to serve as a stimulus for

others in the community of clinicians,

academicians, and pharmaceutical

sponsors to articulate and submit

alternative positions in response to this

question. Interested persons may submit

written statements by February 17,

2000. Written statements submitted by

the above date will be made available on

FDA’s website identified above. In

addition to submitting written

statements, interested persons are

invited to make presentations of up to

10 minutes in an expanded open public

session at the March 9, 2000, meeting.

Those persons interested in making a

presentation should follow the

procedures given in the ‘‘Procedure’’

section below.

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

Dockets Management Branch, Food and

Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

These submissions should contain

Docket No. 00N–0088, and should be

received by February 17, 2000. Oral

presentations from the public will be

scheduled between approximately 10

a.m. and 12:30 p.m. Additional time

may be allocated for oral presentations.

Time allotted for each presentation may

be limited to 10 minutes. Those desiring

to make formal oral presentations

should notify the contact person before

February 17, 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.

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. 00–2861 Filed 2–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D–0084]

Draft Guidance for Industry on Special

Protocol Assessment; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Special Protocol

Assessment.’’ This draft guidance is

intended to provide guidance for

industry on procedures that will be

adopted by the Center for Drug

Evaluation and Research (CDER) and the

Center for Biologics Evaluation and

Research (CBER) to evaluate issues

related to the adequacy (e.g., design,

conduct, analysis) of certain proposed

studies.

DATES: Submit written comments on the

draft guidance and the collection of

information provisions by April 10,

2000. General comments on agency

guidance documents are welcome at any

time.

ADDRESSES: Copies of this draft

guidance for industry are available on

the Internet at http://www.fda.gov/cder/

guidance/index.htm or http://

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

Submit written requests for single

copies of the draft guidance to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857; or the Office

of Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3844, FAX: 888–CBERFAX. Send two

self-addressed adhesive labels to assist

the office in processing your requests.

Submit written comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Requests and comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Murray M. Lumpkin, Center for Drug

Evaluation and Research (HFD–2), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

5400; or Robert A. Yetter, Center for

Biologics Evaluation and Research

(HFM–10), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

0373.

SUPPLEMENTARY INFORMATION:

I. Description of the Guidance

FDA is announcing the availability of

a draft guidance for industry entitled

‘‘Special Protocol Assessment.’’ The

draft guidance is intended to provide

guidance for industry on procedures

that will be adopted by CDER and CBER

to evaluate issues related to the

adequacy (e.g., design, conduct,

analysis) of certain proposed studies.

This draft guidance describes

procedures for sponsors to request