Medical Device Interoperability; Public Workshop, 69125-69126 [E9-30871]
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Federal Register / Vol. 74, No. 249 / Wednesday, December 30, 2009 / Notices
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government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Meeting
mstockstill on DSKH9S0YB1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Arthritis and Musculoskeletal
and Skin Diseases Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Arthritis and
Musculoskeletal and Skin Diseases Advisory
Council.
Date: February 2, 2010.
Open: 8:30 a.m. to 2 p.m.
Agenda: To discuss administrative details
relating to the Council’s business and special
reports.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6, Bethesda, MD 20892.
Closed: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6, Bethesda, MD 20892.
Contact Person: Susana Serrate-Sztein, MD,
Director, Division of Skin and Rheumatic
Diseases, NIAMS/NIH, 6701 Democracy
Blvd, Suite 800, Bethesda, MD 20892–4872.
(301) 594–5032. szteins@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
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instituted stringent procedures for entrance
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will be inspected before being allowed on
campus. Visitors will be asked to show one
VerDate Nov<24>2008
19:01 Dec 29, 2009
Jkt 220001
Dated: December 18, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–30889 Filed 12–29–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Medical Device Interoperability; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Devices and
Radiological Health, in co-sponsorship
with Continua Health Alliance and the
Center for Integration of Medicine &
Innovative Technology (CIMIT) is
announcing a public workshop entitled
‘‘Medical Device Interoperability.’’ The
purpose of the workshop is to facilitate
discussion among FDA, industry,
academia, professional societies,
clinical investigators and other
interested parties on issues related to
safe and effective interoperable medical
devices.
Dates and Times: The public
workshop will be held on January 25
and 26, 2010, from 9 a.m. to 5 p.m. and
on January 27, 2010, from 9 a.m. to 12
noon. Participants are encouraged to
arrive early to ensure time for parking
and security screening before the
meeting. Security screening will begin
at 8 a.m. and registration will begin at
8:30 a.m.
Location: The public workshop will
be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Silver
Spring, MD 20993.
Contact Persons: Sandy Weininger,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave., WO62/rm.
4212, Silver Spring, MD 20993, 301–
796–2582, sandy.weininger@fda.hhs.
gov; or John Murray, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., WO66/rm. 2634, Silver Spring,
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
69125
MD 20993, 301–796–5543,
john.murray@fda.hhs.gov.
Registration: To register for the public
workshop, please visit the following
Web site: https://mdpnp.org/
FDA_Interop_Workshop.php. There is a
registration fee of $500 to attend the
public workshop to cover the expenses
and attendees must register in advance.
The registration process will be handled
by Continua Health Alliance. In person,
attendance is limited to 200
participants.
Registration may be limited to achieve
balanced participation. Upon
registering, you will receive a notice
indicating that your registration has
been received and is pending
confirmation. You will receive an
additional email within 1 week
notifying you if your registration was
accepted or declined. You may also
register to attend the public workshop
via Web cast for a reduced fee.
Non-U.S. citizens are subject to
additional security screening, and they
should register as soon as possible. If
you need special accommodations
because of a disability, please contact
Susana Rosales
(Susana.Rosales@fda.hhs.gov) at least 7
days before the public workshop.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public
Workshop?
The purpose of the public workshop
is to facilitate discussion among FDA
and other interested parties regarding
the safety and effectiveness of
interoperable medical devices.
II. What Are the Topics We Intend to
Address at the Public Workshop?
We hope to discuss a large number of
issues at the public workshop,
including, but not limited to the
following:
• What are the types of clinical
scenarios that would make use of
medical device interoperability?
• What are the issues associated with
premarket and postmarket studies for
interoperable medical devices?
• What tools (e.g., standards,
guidances) are in place or need to be
developed to assure safety and
effectiveness of interoperable medical
device systems? What issues should
they address?
• What are the risks associated with
medical device interoperability and
‘‘system of systems’’ composing medical
devices?
• What are other issues relevant to
assuring the safety and effectiveness of
interoperable medical devices?
E:\FR\FM\30DEN1.SGM
30DEN1
69126
Federal Register / Vol. 74, No. 249 / Wednesday, December 30, 2009 / Notices
III. Where Can I Find Out More About
This Public Workshop?
Background information on the public
workshop, registration information, the
agenda, information about lodging, and
other relevant information will be
posted, as it becomes available, on the
Internet at https://www.fda.gov/cdrh/
meetings.html and at https://mdpnp.org/
FDA_Interop_Workshop.php.
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.regulations.gov.
Dated: December 18, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and
Radiological Health.
[FR Doc. E9–30871 Filed 12–29–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meetings
mstockstill on DSKH9S0YB1PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, ‘‘Ancillary Studies in
Immunomodulation Clinical Trials.’’
Date: January 19, 2010.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817.
(Telephone Conference Call.)
Contact Person: Paul A. Amstad, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
VerDate Nov<24>2008
19:01 Dec 29, 2009
Jkt 220001
MSC 7616, Bethesda, MD 20892–7616. 301–
402–7098. pamstad@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, ‘‘Immunobiology of
Mesenchymal Stem Cells.’’
Date: January 26, 2010.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817.
(Telephone Conference Call.)
Contact Person: Maryam Feili-Hariri, PhD,
Scientific Review Officer, Immunology
Review Branch, Scientific Review Program,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892–7616. 301–
402–5658. haririmf@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Atopic Dermatitis Research
Network (ADRN).
Date: February 2, 2010.
Time: 8 a.m. to 12 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Marriott Renaissance M Street Hotel,
1143 New Hampshire Avenue, NW.,
Washington, DC 20037.
Contact Person: Paul A. Amstad, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892–7616. 301–
402–7098. pamstad@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Atopic Dermatitis Research
Network: Statistical and Clinical
Coordinating Center (ADRN SACCC).
Date: February 2, 2010.
Time: 12 p.m. to 6 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Marriott Renaissance M Street Hotel,
1143 New Hampshire Avenue, NW., Potomac
Room, Washington, DC 20037.
Contact Person: Paul A. Amstad, PhD,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892–7616. 301–
402–7098. pamstad@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Highly Innovative Tactics to
Interrupt Transmission of HIV (HIT–IT).
Date: February 4–5, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Waterford Suite, Bethesda, MD
20814.
Contact Person: Betty Poon, PhD, Scientific
Review Officer, Scientific Review Program,
Division of Extramural Activities, NIAID/
NIH/DHHS, 6700B Rockledge Drive, MSC
7616, Bethesda, MD 20892–7616. 301–402–
6891. poonb@mail.nih.ogv.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 22, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–30868 Filed 12–29–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Customs and Border Protection
Accreditation and Approval of SGS
North America, Inc., as a Commercial
Gauger and Laboratory
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of accreditation and
approval of SGS North America, Inc., as
a commercial gauger and laboratory.
SUMMARY: Notice is hereby given that,
pursuant to 19 CFR 151.12 and 19 CFR
151.13, SGS North America, Inc., 1084
West Lathrop Ave., Savannah, GA
31402, has been approved to gauge and
accredited to test petroleum and
petroleum products for customs
purposes, in accordance with the
provisions of 19 CFR 151.12 and 19 CFR
151.13. Anyone wishing to employ this
entity to conduct laboratory analyses
and gauger services should request and
receive written assurances from the
entity that it is accredited or approved
by the U.S. Customs and Border
Protection to conduct the specific test or
gauger service requested. Alternatively,
inquires regarding the specific test or
gauger service this entity is accredited
or approved to perform may be directed
to the U.S. Customs and Border
Protection by calling (202) 344–1060.
The inquiry may also be sent to
cbp.labhq@dhs.gov. Please reference the
website listed below for a complete
listing of CBP approved gaugers and
accredited laboratories.
https://cbp.gov/xp/cgov/import/
operations_support/labs_scientific_svcs/
commercial_gaugers/.
DATES: The accreditation and approval
of SGS North America, Inc., as
commercial gauger and laboratory
became effective on September 16, 2009.
The next triennial inspection date will
be scheduled for September 2012.
FOR FURTHER INFORMATION CONTACT:
Anthony Malana, Laboratories and
Scientific Services, U.S. Customs and
Border Protection, 1300 Pennsylvania
Avenue, NW., Suite 1500N,
Washington, DC 20229, 202–344–1060.
E:\FR\FM\30DEN1.SGM
30DEN1
]]>Agencies
[Federal Register Volume 74, Number 249 (Wednesday, December 30, 2009)]
[Notices]
[Pages 69125-69126]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-30871]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Medical Device Interoperability; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), Center for Devices and
Radiological Health, in co-sponsorship with Continua Health Alliance
and the Center for Integration of Medicine & Innovative Technology
(CIMIT) is announcing a public workshop entitled ``Medical Device
Interoperability.'' The purpose of the workshop is to facilitate
discussion among FDA, industry, academia, professional societies,
clinical investigators and other interested parties on issues related
to safe and effective interoperable medical devices.
Dates and Times: The public workshop will be held on January 25 and
26, 2010, from 9 a.m. to 5 p.m. and on January 27, 2010, from 9 a.m. to
12 noon. Participants are encouraged to arrive early to ensure time for
parking and security screening before the meeting. Security screening
will begin at 8 a.m. and registration will begin at 8:30 a.m.
Location: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Contact Persons: Sandy Weininger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., WO62/rm. 4212, Silver Spring, MD 20993, 301-796-2582,
sandy.weininger@fda.hhs.gov; or John Murray, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., WO66/rm. 2634, Silver Spring, MD 20993, 301-796-5543,
john.murray@fda.hhs.gov.
Registration: To register for the public workshop, please visit the
following Web site: https://mdpnp.org/FDA_Interop_Workshop.php. There
is a registration fee of $500 to attend the public workshop to cover
the expenses and attendees must register in advance. The registration
process will be handled by Continua Health Alliance. In person,
attendance is limited to 200 participants.
Registration may be limited to achieve balanced participation. Upon
registering, you will receive a notice indicating that your
registration has been received and is pending confirmation. You will
receive an additional email within 1 week notifying you if your
registration was accepted or declined. You may also register to attend
the public workshop via Web cast for a reduced fee.
Non-U.S. citizens are subject to additional security screening, and
they should register as soon as possible. If you need special
accommodations because of a disability, please contact Susana Rosales
(Susana.Rosales@fda.hhs.gov) at least 7 days before the public
workshop.
SUPPLEMENTARY INFORMATION:
I. Why Are We Holding This Public Workshop?
The purpose of the public workshop is to facilitate discussion
among FDA and other interested parties regarding the safety and
effectiveness of interoperable medical devices.
II. What Are the Topics We Intend to Address at the Public Workshop?
We hope to discuss a large number of issues at the public workshop,
including, but not limited to the following:
What are the types of clinical scenarios that would make
use of medical device interoperability?
What are the issues associated with premarket and
postmarket studies for interoperable medical devices?
What tools (e.g., standards, guidances) are in place or
need to be developed to assure safety and effectiveness of
interoperable medical device systems? What issues should they address?
What are the risks associated with medical device
interoperability and ``system of systems'' composing medical devices?
What are other issues relevant to assuring the safety and
effectiveness of interoperable medical devices?
[[Page 69126]]
III. Where Can I Find Out More About This Public Workshop?
Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
https://www.fda.gov/cdrh/meetings.html and at https://mdpnp.org/FDA_Interop_Workshop.php.
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.regulations.gov.
Dated: December 18, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-30871 Filed 12-29-09; 8:45 am]
BILLING CODE 4160-01-S
