Medical Devices 101: An Educational Forum; Public Workshop, 968 [07-92]
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Federal Register / Vol. 72, No. 5 / Tuesday, January 9, 2007 / Notices
receives on the docket (Docket Number
2006D–0347). Suggestions,
recommendations, and materials may be
seen at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
V. Transcripts
Following the meeting, transcripts
will be available for review at https://
www.fda.gov/cdrh/oivd/
presentations.html#r, and the Division
of Dockets Management (see ADDRESSES)
between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: January 3, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–93 Filed 1–8–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Medical Devices 101: An Educational
Forum; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ycherry on PROD1PC63 with NOTICES
ACTION:
Notice of public workshop.
SUMMARY: The Food and Drug
Administration (FDA), Office of
Regulatory Affairs (ORA), Southwest
Regional Office (SWRO), in
cosponsorship with the FDA Medical
Device Industry Coalition (FMDIC) and
the Risk Management Small Business
Development Center (RMSBDC), is
announcing a public workshop entitled
‘‘Medical Devices 101: An Educational
Forum.’’ This public workshop is
intended to provide an overview on
FDA’s medical device requirements to
entrepreneurs, startup companies, and
small businesses.
Date and Time: The public workshop
will be held on February 9, 2007, from
8 a.m. to 5 p.m.
Location: The public workshop will
be held at the Hoblitzelle Auditorium at
the Bill Priest Campus of El Centro
College, 1402 Corinth St. in Dallas, TX.
Contact Person: David Arvelo, Food
and Drug Administration, 4040 North
Central Expressway, suite 900, Dallas,
TX 75204, 214–253–4952, FAX: 214–
253–4970, e-mail:
oraswrsbr@fda.hhs.gov.
Registration: Registration by January
26, 2007, is strongly encouraged. The
RMSBDC has a $75 early registration fee
to cover the cost of facilities, materials,
and refreshments. Please submit your
registration as soon as possible.
Registration at the site may be possible
VerDate Aug<31>2005
13:55 Jan 08, 2007
Jkt 211001
on a space available basis on the day of
the public workshop beginning at 8 a.m.
The cost of registration after January 26,
2007, is $99 payable to RMSBDC. If you
need special accommodations due to a
disability, please contact David Arvelo
(see Contact Person) at least 7 days in
advance.
Registration Form Instructions: To
register, please complete the RMSBDC
registration form and submit along with
payment to RMSBDC, Attn: Saira
Roberts, 1402 Corinth St., Dallas, TX
75215. You may fax the completed
registration form to RMSBDC at 214–
860–5867. To obtain a copy of the
registration form, please call RMSBDC
at 214–860–5887 or 214–860–5849. The
registration form is also available online
at https://www.ntsbdc.org/.
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts 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.
SUPPLEMENTARY INFORMATION: The
workshop is being held in response to
the interest in the topics discussed from
small medical device entrepreneurs and
startup manufacturers in the Dallas
District area. FDA presents this
workshop in cosponsorship with FMDIC
and RMSBDC to help achieve objectives
set forth in section 406 of the Food and
Drug Administration Modernization Act
of 1997 (21 U.S.C. 393), which include
working closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. This is also consistent with the
purposes of FDA’s Regional Small
Business Program, which are in part to
respond to industry inquiries, develop
educational materials, sponsor
workshops and conferences to provide
firms, particularly small businesses,
with firsthand working knowledge of
FDA’s requirements and compliance
policies. This workshop is also
consistent with the Small Business
Regulatory Enforcement Fairness Act of
1996 (Public Law 104–121), as an
outreach activity by Government
agencies to small businesses.
The goal of the workshop is to present
information that will enable
manufacturers and regulated industry to
better comply with the Medical Device
QSR. The following topics will be
broadly covered at the workshop: (1)
Medical device classification, (2)
establishment registration, (3) device
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
listing, (4) premarket notification, (5)
premarket approval, (6) Quality System
Regulation, (7) labeling, and (8)
postmarket surveillance.
Dated: January 3, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07–92 Filed 1–8–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Vaccines and Related Biological
Products 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: Vaccines and
Related Biological Products 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 January 25, 2007, from 8 a.m.
to 5 p.m.
Location: Doubletree Hotel, 8120
Wisconsin Ave., Bethesda, MD 20814.
Contact Person: Christine Walsh or
Denise Royster, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512391. Please call the Information
Line for up-to-date information on this
meeting.
Agenda: In Session I, the committee
will hear presentations and make
recommendations on the safety and
immunogenicity of PENTACEL
(Diphtheria and Tetanus Toxoids and
Acellular Pertussis Adsorbed,
Inactivated Poliovirus and Haemophilus
b Conjugate (Tetanus Toxoid Conjugate)
Vaccine Combined (DTaP-IPV/Hib)),
manufactured by Sanofi Pasteur, Ltd. In
Session II, the committee will hear an
overview of the research programs in
the Office of Vaccines Research and
Review, Center for Biologics Evaluation
and Research (CBER). In the closed
session, the committee will discuss the
E:\FR\FM\09JAN1.SGM
09JAN1
]]>Agencies
[Federal Register Volume 72, Number 5 (Tuesday, January 9, 2007)]
[Notices]
[Page 968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 07-92]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Medical Devices 101: An Educational Forum; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with
the FDA Medical Device Industry Coalition (FMDIC) and the Risk
Management Small Business Development Center (RMSBDC), is announcing a
public workshop entitled ``Medical Devices 101: An Educational Forum.''
This public workshop is intended to provide an overview on FDA's
medical device requirements to entrepreneurs, startup companies, and
small businesses.
Date and Time: The public workshop will be held on February 9,
2007, from 8 a.m. to 5 p.m.
Location: The public workshop will be held at the Hoblitzelle
Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth
St. in Dallas, TX.
Contact Person: David Arvelo, Food and Drug Administration, 4040
North Central Expressway, suite 900, Dallas, TX 75204, 214-253-4952,
FAX: 214-253-4970, e-mail: oraswrsbr@fda.hhs.gov.
Registration: Registration by January 26, 2007, is strongly
encouraged. The RMSBDC has a $75 early registration fee to cover the
cost of facilities, materials, and refreshments. Please submit your
registration as soon as possible. Registration at the site may be
possible on a space available basis on the day of the public workshop
beginning at 8 a.m. The cost of registration after January 26, 2007, is
$99 payable to RMSBDC. If you need special accommodations due to a
disability, please contact David Arvelo (see Contact Person) at least 7
days in advance.
Registration Form Instructions: To register, please complete the
RMSBDC registration form and submit along with payment to RMSBDC, Attn:
Saira Roberts, 1402 Corinth St., Dallas, TX 75215. You may fax the
completed registration form to RMSBDC at 214-860-5867. To obtain a copy
of the registration form, please call RMSBDC at 214-860-5887 or 214-
860-5849. The registration form is also available online at https://
www.ntsbdc.org/.
Transcripts: Transcripts of the public workshop will not be
available due to the format of this workshop. Course handouts 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.
SUPPLEMENTARY INFORMATION: The workshop is being held in response to
the interest in the topics discussed from small medical device
entrepreneurs and startup manufacturers in the Dallas District area.
FDA presents this workshop in cosponsorship with FMDIC and RMSBDC to
help achieve objectives set forth in section 406 of the Food and Drug
Administration Modernization Act of 1997 (21 U.S.C. 393), which include
working closely with stakeholders and maximizing the availability and
clarity of information to stakeholders and the public. This is also
consistent with the purposes of FDA's Regional Small Business Program,
which are in part to respond to industry inquiries, develop educational
materials, sponsor workshops and conferences to provide firms,
particularly small businesses, with firsthand working knowledge of
FDA's requirements and compliance policies. This workshop is also
consistent with the Small Business Regulatory Enforcement Fairness Act
of 1996 (Public Law 104-121), as an outreach activity by Government
agencies to small businesses.
The goal of the workshop is to present information that will enable
manufacturers and regulated industry to better comply with the Medical
Device QSR. The following topics will be broadly covered at the
workshop: (1) Medical device classification, (2) establishment
registration, (3) device listing, (4) premarket notification, (5)
premarket approval, (6) Quality System Regulation, (7) labeling, and
(8) postmarket surveillance.
Dated: January 3, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-92 Filed 1-8-07; 8:45 am]
BILLING CODE 4160-01-S
