In Vitro Analysis of Cell/Scaffold Medical Products; Public Workshop, 58102 [E7-20191]
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58102
Federal Register / Vol. 72, No. 197 / Friday, October 12, 2007 / Notices
Once you obtain your account ID and
password, you will enter them and log
into FURLS. From the FURLS/FDA
Industry Systems menu, there will be a
button that you will click to go to the
Device Registration and Listing Module
(DRLM) of FURLS. New establishments
will register their establishment and
existing establishments will re-register
their establishments using choices on
the DRLM menu. Once you make your
selection—either Register a Facility or
Annual Re-registration—the system will
prompt you through the entry of
information about your establishment
and your devices.
If you have any problems with this
process you may call 240–276–0111 for
assistance. (Note: This phone number is
for assistance with establishment
registration and establishment fee
payment only, and not for any other
aspects of medical device user fees.)
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B. Step Two—Determine Whether an
Annual Registration Fee is Required and
Get Your Invoice if a Fee is Due
After you enter your establishment
registration information into the system,
you will be informed whether or not the
payment of an annual registration fee is
required to complete your registration
(these fees are only required for device
manufacturers, single-use re-processors,
and specification developers as stated in
section I of this document). If your
establishment is subject to a fee, you
will be given a summary sheet that: (1)
Tells you what your payment options
are and (2) leads you to a link for your
specific invoice, which will be available
on-line as a portable document format
(PDF) file that you should print copies
of; one to submit with your payment (if
not submitted electronically) and the
other to keep for your records.
C. Step Three—Pay Your Invoice, if
Required
Make the payment, if required, in U.S.
currency. The summary page will
include payment information that may
permit you the option of paying
electronically. If that option is provided,
you may follow the instructions
provided to make payment
electronically. If that option is not
provided, or you choose not to make
your payment electronically, you may
pay by check.
Your check, made in U.S. dollars and
drawn on a U.S. bank, can be mailed to:
Food and Drug Administration, P.O.
Box 70961, Charlotte, NC 28272–0961.
(Please note that this is different than
the address for payments of application
and annual report fees and is to be used
only for payment of annual
establishment registration fees.)
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16:35 Oct 11, 2007
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If checks are to be sent by a courier
that requests a street address, the
courier can deliver the checks to:
Wachovia Bank, Attn: Food and Drug
Administration—Lockbox 70961, rm.
NC0810, 1525 West WT Harris Blvd.,
Charlotte, NC 28262. (Note: This
Wachovia Bank address is for courier
delivery only; do not send mail to this
address.)
Please make sure that the FDA post
office box number (P.O. Box 70961) is
written on the check, along with the
invoice number printed on your invoice.
A copy of your printed invoice should
also be mailed in the same envelope
with your check. FDA’s tax
identification number is 53–0196965.
Wire transfers may also be used to pay
annual establishment fees. The routing
and transit number is 021030004 and
the account number is 75060099. The
invoice number should also be included
with any wire transfer information, to
assure that the invoice is properly
credited.
FDA is in the process of
implementing alternate Web-based
payment methods, and the option of
electronic payment may not be
immediately available for FY 2008
payments. For more information on
these payment options and when they
will be available, please visit FDA’s
Web site at https://www.fda.gov, select
the appropriate user fee type, and click
on ‘‘User Fee Cover Sheet.’’
Dated: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. 07–5051 Filed 10–9–07; 12:06 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
In Vitro Analysis of Cell/Scaffold
Medical Products; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Biologics Evaluation
and Research and Center for Devices
and Radiological Health, and the
National Institute of Standards and
Technology are announcing a public
workshop entitled: In Vitro Analysis of
Cell/Scaffold Medical Products. The
purpose of the public workshop is to
discuss issues that should be considered
when evaluating cell/scaffold medical
products and to determine which test
methods are currently available and
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
which new analytical procedures
should be further researched for the
evaluation of cell/scaffold medical
products.
Date and Time: The public workshop
will be held on December 6 and 7, 2007,
from 8:30 a.m. to 4 p.m.
Location: The public workshop will
be held at the National Transportation
and Safety Board, 490 L’Enfant Plaza
East, SW., Washington, DC 20594.
Contact Person: Bernadette Kawaley,
Center for Biologics Evaluation and
Research (HFM–43), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–2000, FAX: 301–827–3079, email: CBERTraining@fda.hhs.gov
(Subject line: Tissue Engineering
Workshop).
Registration: Mail or fax your
registration information (including
name, title, firm name, address,
telephone and fax numbers) to the
contact person by November 15, 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 8 a.m.
If you need special accommodations
due to a disability, please contact
Bernadette Kawaley (see Contact
Person) at least 7 days in advance.
The
public workshop will feature
presentations by experts from the
medical field and the government. The
first day of the workshop will include
discussions on in vitro assays of product
performance. The second day of the
workshop will include discussions on
tools for quantifying the response of
cells and tissues.
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 athttps://www.fda.gov/cber/
minutes/workshop-min.htm.
SUPPLEMENTARY INFORMATION:
Dated: October 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–20191 Filed 10–11–07; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\12OCN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 197 (Friday, October 12, 2007)]
[Notices]
[Page 58102]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-20191]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
In Vitro Analysis of Cell/Scaffold Medical Products; Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), Center for Biologics
Evaluation and Research and Center for Devices and Radiological Health,
and the National Institute of Standards and Technology are announcing a
public workshop entitled: In Vitro Analysis of Cell/Scaffold Medical
Products. The purpose of the public workshop is to discuss issues that
should be considered when evaluating cell/scaffold medical products and
to determine which test methods are currently available and which new
analytical procedures should be further researched for the evaluation
of cell/scaffold medical products.
Date and Time: The public workshop will be held on December 6 and
7, 2007, from 8:30 a.m. to 4 p.m.
Location: The public workshop will be held at the National
Transportation and Safety Board, 490 L'Enfant Plaza East, SW.,
Washington, DC 20594.
Contact Person: Bernadette Kawaley, Center for Biologics Evaluation
and Research (HFM-43), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448, 301-827-2000, FAX: 301-827-
3079, e-mail: CBERTraining@fda.hhs.gov (Subject line: Tissue
Engineering Workshop).
Registration: Mail or fax your registration information (including
name, title, firm name, address, telephone and fax numbers) to the
contact person by November 15, 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 8 a.m.
If you need special accommodations due to a disability, please
contact Bernadette Kawaley (see Contact Person) at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: The public workshop will feature
presentations by experts from the medical field and the government. The
first day of the workshop will include discussions on in vitro assays
of product performance. The second day of the workshop will include
discussions on tools for quantifying the response of cells and tissues.
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 athttps://www.fda.gov/cber/minutes/workshop-min.htm.
Dated: October 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-20191 Filed 10-11-07; 8:45 am]
BILLING CODE 4160-01-S
