3906 Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–4090, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12529. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will hear

presentations and discuss the

occurrence of spinal/epidural

hematomas with the concurrent use of

approved low molecular weight

heparins or heparinoids and spinal/

epidural anesthesia or spinal puncture.

The committee will also consider

labeling for low molecular weight

heparins and heparinoids concerning

these adverse events. The approved

drug products under discussion and

their sponsors are: (1) Lovenox

(enoxeparin sodium) Injection, RhonePoulenc Rorer Pharmaceuticals, Inc.; (2)

Fragmin (dalteparin sodium) Injection,

Pharmacia & Upjohn; (3) Orgaran

(danaparioid sodium) Injection,

Organon, Inc.; and (4) NormifloTM

(ardeparin sodium) Injection, Wyeth

Laboratories, Inc.

Procedure: On February 5, 1998, from

8 a.m. to 3:45 p.m., the meeting is open

to the public. 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 January 29, 1998. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before January 29, 1998, 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.

Closed Committee Deliberations: On

February 5, 1998, from 3:45 p.m. to 5:30

p.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). The investigational

new drug and Phase I and II drug

products in process will be presented

and recent action on selected new drug

applications will be discussed.

FDA regrets that it was unable to

publish this notice 15 days prior to the

February 5, 1998, Anesthetic and Life

Support Drugs Advisory Committee

meeting. Because the agency believes

there is some urgency to bring these

issues to public discussion and

qualified members of the Anesthetic and

Life Support Drugs Advisory Committee

were available at this time, the

Commissioner concluded that it was in

the public interest to hold this meeting

even if there was not sufficient time for

the customary 15-day public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 22, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–2024 Filed 1–23–98; 11:47 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Food 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: Food Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on February 11, 12, and 13, 1998,

8:30 a.m. to 5 p.m.

Location: DoubleTree Hotel, Pentagon

City, 300 Army Navy Dr., Arlington, VA.

Contact Person: Catherine M.

DeRoever, Center for Food Safety and

Applied Nutrition (HFS–22), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4251,

FAX 202–205–4970, E-mail

CDEROEVE@BANGATE.FDA.GOV, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

10564. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On February 11, 12, and 13,

1998, the committee will undertake

discussions on dietary supplements.

Issues raised in the report of the White

House Commission on Dietary

Supplement Labeling relating to

postmarket surveillance and consumer

research will be discussed. Also, two

aspects relating to good manufacturing

practices (GMP’s) for dietary

supplements will be addressed. The

agency is interested in

recommendations for ensuring the

identity for different types of dietary

ingredients and on recordkeeping

requirements. On February 13, 1998,

two committee working groups will

continue discussing assignments

stemming from the Keystone report on

health claims.

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 February 9, 1998. Oral

presentations from the public will be

scheduled between approximately 4

p.m. and 5 p.m. on February 11 and 12,

1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before February 9, 1998, 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 22, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–2023 Filed 1–23–98; 11:47 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Open Meeting For Representatives of

Health Professional Organizations

AGENCY: Food and Drug Administration

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting with representatives of

health professional organizations. The

meeting will be chaired by Sharon

Smith Holston, Deputy Commissioner

for External Affairs. The agenda will

include presentations and discussions

on the topics of the FDA Modernization

Act of 1997, and the role of FDA in the

regulation of products used in

complementary and alternative

medicine. There will also be a brief

update on tobacco.

DATES: The meeting will be held on

Monday, February 9, 1998, from 1:30

p.m. to 3 p.m.

ADDRESSES: The meeting will be held at

the Bethesda Hyatt, One Metro Center,

Bethesda, MD.
Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices 3907

REGISTRATION: There is no registration

fee, however, space is limited. Persons

will be registered in the order in which

calls are received. Please call Betty B.

Palsgrove at 301–827–6618 to register.

Registrations also may be transmitted by

fax to 1–800–344–3332 or 301–443–

2446. Please include the name and title

of the person attending and the name of

the organization.

FOR FURTHER INFORMATION CONTACT:

Peter H. Rheinstein, M.D., J.D., Office of

Health Affairs (HFY–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6630.

SUPPLEMENTARY INFORMATION:

The purpose of the meeting is to

provide an opportunity for

representatives of health professional

organizations and other interested

persons to be briefed by senior FDA

staff. It will also provide an opportunity

for informal discussion on these topics

of particular interest to health

professional organizations.

This public meeting is free of charge;

however, space is limited. Registration

for the meeting will be accepted in the

order received and should be sent to the

contact person. Registration should

include the name and title of the person

attending and the name of the

organization being represented, if any.

Dated: January 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1850 Filed 1–26–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Medical Imaging 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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Medical Imaging

Drugs Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on February 9, 1998, 8 a.m. to 5

p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Leander B. Madoo,

Center for Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–80–741–8138 (301–443–0572 in

the Washington, DC area), code 12540.

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

Agenda: The committee will discuss

the safety and efficacy of new drug

application (NDA) 20–887 AcuTectTM,

Diatide, Inc., a radiopharmaceutical

agent for the detection and localization

of acute venous thrombosis.

Procedure: On February 9, 1998, from

8 a.m. to 1 p.m. and from 2 p.m. to 5

p.m. the meeting is open to the public.

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 February

2, 1998. Oral presentations from the

public will be scheduled between

approximately 8:30 a.m. and 9:30 a.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before February 2,

1998, 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.

Closed Committee Deliberations: On

February 9, 1998, from 1 p.m. to 2 p.m.,

the meeting will be closed to permit

discussion and review of trade secret

and/or confidential information relating

to NDA 20–887 AcuTectTM (5 U.S.C.

552b(c)(4)).

FDA regrets that it was unable to

publish this notice 15 days prior to the

February 9, 1998, Medical Imaging

Drugs Advisory Committee meeting.

Because the agency believes there is

some urgency to bring this issue to

public discussion and qualified

members of the Medical Imaging Drugs

Advisory Committee were available at

this time, the Commissioner concluded

that it was in the public interest to hold

this meeting even if there was not

sufficient time for the customary 15-day

public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: January 22, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–2022 Filed 1–23–98; 11:47 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0017]

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH);

Draft Guidance on Validation of

Analytical Procedures: Definition and

Terminology (#63), and Validation of

Analytical Procedures: Methodolgy

(#64); Availability; Request for

Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; request for comments.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability for comment of two draft

guidance for industry (GFI) documents

entitled ‘‘Validation of Analytical

Procedures: Definition and

Terminology’’ (number 63) and

‘‘Validation of Analytical Procedures:

Methodology’’ (number 64). These

related draft GFI documents have been

adapted for veterinary use by the

International Cooperation on

Harmonisation of Technical

Requirements for Registration of

Veterinary Medicinal Products (VICH)

from two guidelines, Q2A and Q2B, that

were adopted by the International

Conference on Harmonisation (ICH) of

Technical Requirements for Registration

of Pharmaceuticals for Human Use. The

draft guidance is intended to provide

guidance on characteristics that should

be considered during the validation of

analytical procedures included as part

of registration applications for approval

of veterinary medicinal products

submitted to the European Union,

Japan, and the United States.

DATES: Submit written comments on

these draft GFI documents by March 30,

1998.

ADDRESSES: Submit written comments

on the two draft GFI documents to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm 1–23, Rockville,

MD 20857. Comments should be

identified with the full title of the draft

GFI document and the docket number

found in the heading of this document.