Licensure of Apheresis Blood Products; Public Workshop, 33509 [E7-11615]
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Federal Register / Vol. 72, No. 116 / Monday, June 18, 2007 / Notices
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/cber/
minutes/workshop-min.htm.
Dated: June 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11613 Filed 6–15–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0217]
Licensure of Apheresis Blood
Products; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
jlentini on PROD1PC65 with NOTICES
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled: Licensure of Apheresis Blood
Products. The purpose of the public
workshop is to educate industry on the
licensure requirements and license
application procedures for Platelets,
Pheresis; Red Blood Cells; and Plasma
collected by automated blood cell
separator devices.
Date and Time: The public workshop
will be held on August 15, 2007, from
8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Lister Hill Center
Auditorium, Bldg. 38A, National
Institutes of Health, 8800 Rockville
Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson,
Center for Biologics Evaluation and
Research(HFM–302), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6129, FAX: 301–827–2843, email: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
contact person by July 31, 2007. There
is no registration fee for the public
workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space available basis beginning at 7:30
a.m.
VerDate Aug<31>2005
18:19 Jun 15, 2007
Jkt 211001
If you need special accommodations
due to a disability, please contact
Rhonda Dawson at least 7 days in
advance.
The
public workshop will feature
presentations by experts from
government and industry. The
workshop will include presentations by
FDA on: (1) Requirements for licensure,
and applicable regulations and
guidances, for Platelets, Pheresis; Red
Blood Cells; and Plasma (intended for
transfusion) collected by apheresis
instruments; (2) the FDA managed
review process; and (3) failure
investigations of apheresis products.
Device manufacturers will present an
overview of their devices and review
validation procedures and quality
control processes. Representatives from
blood establishments will present case
studies of licensing applications. FDA
will lead a question and answer session
with workshop participants.
Comments: All individuals wishing to
submit questions to be addressed at the
public workshop should submit written
or electronic comments by July 31,
2007, to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Transcripts: Transcripts of the public
workshop may be requested in writing
from the Freedom of Information Office
(HFI–35), Food and Drug
Administration, 5600 Fishers Lane,
rm.6–30, Rockville, MD 20857,
approximately 15 working days after the
public workshop at a cost of 10 cents
per page. A transcript of the public
workshop will be available on the
Internet at https://www.fda.gov/cber/
minutes/workshop-min.htm.
33509
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
SUPPLEMENTARY INFORMATION:
Dated: June 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–11615 Filed 6–15–07; 8:45 am]
BILLING CODE 4160–01–S
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice and request for
comments.
AGENCY:
SUMMARY: The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public and other
Federal agencies to take this
opportunity to comment on a proposed
revised information collection. In
accordance with the Paperwork
Reduction Act of 1995, this notice seeks
comments concerning FEMA’s National
Emergency Training Center (NETC) to
approve and coordinate the use of the
NETC facility for extracurricular
training activities.
SUPPLEMENTARY INFORMATION: The
National Emergency Training Center
(NETC) is a FEMA facility that houses
the Emergency Management Institute
(EMI) and the National Fire Academy
(NFA). NETC provides training and
educational programs for Federal, State,
and local personnel in hazard
mitigation, emergency response and
preparedness, fire prevention and
control, disaster response, and longterm disaster recovery. Special groups
sponsored by EMI, NFA or other FEMA
organizations may use NETC facilities to
conduct activities closely related to and
in direct support of their activities. Such
groups include other Federal
departments and agencies, groups
charted by Congress such as the
American Red Cross, State and local
governments, volunteer groups, and
national and international associations
representing State and local
governments.
Collection of Information
Title: Approval and Coordination of
requirements to use NETC for
Extracurricular Training Activities.
Type of Information Collection:
Revision of an existing collection.
OMB Number: 1660–0029.
Form Numbers: FEMA Form 75–10,
Request for Housing Accommodations,
and FEMA Form 75–11, Request for Use
of NETC Facility.
Abstract: Data will be obtained from
special groups that request to use NETC
facilities for extracurricular training
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[Federal Register Volume 72, Number 116 (Monday, June 18, 2007)]
[Notices]
[Page 33509]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-11615]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0217]
Licensure of Apheresis Blood Products; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing a public
workshop entitled: Licensure of Apheresis Blood Products. The purpose
of the public workshop is to educate industry on the licensure
requirements and license application procedures for Platelets,
Pheresis; Red Blood Cells; and Plasma collected by automated blood cell
separator devices.
Date and Time: The public workshop will be held on August 15, 2007,
from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Lister Hill
Center Auditorium, Bldg. 38A, National Institutes of Health, 8800
Rockville Pike, Bethesda, MD 20894.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research(HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843,
e-mail: rhonda.dawson@fda.hhs.gov.
Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone and fax numbers)
to the contact person by July 31, 2007. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited. Registration on the day of the public workshop will
be provided on a space available basis beginning at 7:30 a.m.
If you need special accommodations due to a disability, please
contact Rhonda Dawson at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The public workshop will feature
presentations by experts from government and industry. The workshop
will include presentations by FDA on: (1) Requirements for licensure,
and applicable regulations and guidances, for Platelets, Pheresis; Red
Blood Cells; and Plasma (intended for transfusion) collected by
apheresis instruments; (2) the FDA managed review process; and (3)
failure investigations of apheresis products. Device manufacturers will
present an overview of their devices and review validation procedures
and quality control processes. Representatives from blood
establishments will present case studies of licensing applications. FDA
will lead a question and answer session with workshop participants.
Comments: All individuals wishing to submit questions to be
addressed at the public workshop should submit written or electronic
comments by July 31, 2007, to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to https://www.fda.gov/
dockets/ecomments. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm.6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at https://www.fda.gov/cber/minutes/workshop-min.htm.
Dated: June 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11615 Filed 6-15-07; 8:45 am]
BILLING CODE 4160-01-S
