Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Notices 40127

Institutes of Health, 9000 Rockville

Pike, Bethesda, MD 20892.

Contact: Joseph Wilczek, Center for

Biologics Evaluation and Research

(HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

6129, FAX 301–827–2843.

Registration and Request for Oral

Presentations: Mail or fax registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by

August 28, 1998. Registration at the site

will be done on a space available basis

on the day of the workshop beginning

at 7:30 a.m. There is no registration fee

for the workshop. Requests for oral

presentations should be sent to Jaroslav

G. Vostal, Division of Hematology

(HFM–335), Center for Biologics

Evaluation and Research, Food and

Drug Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448, 301–

496–2577, FAX 301–402–2780, e-mail

‘‘VOSTAL@A1.CBER.FDA.GOV’’. Space

is limited, therefore interested parties

are encouraged to register early.

If you need special accommodations

due to disability, please contact Joseph

Wilczek at least 7 days in advance.

Agenda: The goals of the workshop

include the following: (1) Review

current methodology for measuring

platelet clinical efficacy; (2) define the

clinical efficacy of a platelet transfusion;

(3) discuss similarities and differences

between intact platelets and platelet

substitutes; (4) present animal models

used for measuring platelet substitute

efficacy; and (5) discuss design of

clinical trials to establish clinical

efficacy for platelets and platelet

substitutes. The information obtained

from these presentations will assist FDA

in developing standards to evaluate

novel platelet products and to assure the

safety and effectiveness of these

products.I11Transcripts: Transcripts of

the workshop may be requested in

writing from the Freedom of

Information Office (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, rm. 12A–16, Rockville, MD 20857,

approximately 15 days after the

workshop at a cost of 10 cents per page.

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19896 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0497]

Hematopoietic Stem/Progenitor Cell

Products: Discussion of Unrelated

Allogeneic Placental/Umbilical Cord

Blood and Peripheral Blood Cell

Banking and Transplantation; Notice of

Public Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

The Food and Drug Administration

(FDA) is announcing the following

public workshop: Hematopoietic Stem/

Progenitor Cell Products: Discussion of

Unrelated Allogeneic Placental/

Umbilical Cord Blood and Peripheral

Blood Cell Banking and

Transplantation. This workshop, which

is cosponsored by FDA and the National

Institutes of Health, will include a

discussion of the current status of

clinical and nonclinical laboratory data

to support the development of standards

for unrelated allogeneic peripheral and

placental/umbilical cord blood

hematopoietic stem/progenitor cell

products; studies to obtain data for

product safety and effectiveness; and

the notice and request for comments

entitled ‘‘Request for Proposed

Standards for Unrelated Allogeneic

Peripheral and Placental/Umbilical

Cord Blood Hematopoietic Stem/

Progenitor Cell Products; Request for

Comments’’ that published in the

Federal Register of January 20, 1998 (63

FR 2985).

Date and Time: The public workshop

will be held on Thursday, September

10, 1998, 8 a.m. to 5 p.m.

Location: The public workshop will

be held at the Jack Masur Auditorium,

Bldg. 10, National Institutes of Health,

9000 Rockville Pike, Bethesda, MD.

Contact Person: Joseph Wilczek, Food

and Drug Administration, Center for

Biologics Evaluation and Research

(HFM–350), 1401 Rockville Pike,

Rockville, MD 20852, 301–827–6129,

FAX 301–827–2843.

SUPPLEMENTARY INFORMATION: The goals

of this workshop are to: (1) Discuss the

current status of related and unrelated

allogeneic peripheral blood

hematopoietic stem/progenitor cell

collection; (2) discuss the current status

of unrelated allogeneic placental/

umbilical cord blood banking and

transplantation; (3) discuss issues

regarding the administration of

cytokines to normal donors for the

mobilization of peripheral blood

hematopoietic stem/progenitor cells and

transplantation; and (4) address

questions the public may have regarding

the notice and request for comments

published in the Federal Register of

January 20, 1998 (63 FR 2985). The

information obtained from these

presentations will assist FDA and the

interested public in developing

standards for unrelated allogeneic

peripheral blood and placental/

umbilical cord blood hematopoietic

stem/progenitor cell products.

Registration and Requests for Oral

Presentations: Send or fax registration

information (including name, title, firm

name, address, telephone, and fax

number), written material, and requests

to make oral presentations, to the

contact person by Tuesday, August 11,

1998. Registration at the site will be

done on a space available basis on the

day of the workshop beginning at 7:30

a.m. There is no registration fee for this

workshop.

If you need special accommodations

due to a disability, please contact Joseph

Wilczek at least 7 days in advance.

Transcripts: Transcripts of the

workshop may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

workshop at a cost of 10 cents per page.

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19892 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0049]

Guidance for Industry on

Environmental Assessment of Human

Drug and Biologics Applications;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Environmental Assessment of

Human Drug and Biologics

Applications.’’ This guidance is

intended to provide information on

when an environmental assessment (EA)

should be submitted in support of a

human drug or biologics application