2013 Medical Countermeasures Initiative Regulatory Science Symposium, 20664 [2013-07893]
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Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
the report of the intramural research
programs and make recommendations
regarding personnel staffing decisions.
Persons attending FDA’s advisory
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meetings and will make every effort to
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: April 2, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2013–07961 Filed 4–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
2013 Medical Countermeasures
Initiative Regulatory Science
Symposium
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
ACTION:
Notice of meeting.
The Food and Drug Administration
(FDA) is announcing the following
meeting: 2013 Medical Countermeasures
initiative (MCMi) Regulatory Science
Symposium. The symposium is
intended to provide a forum for the
exchange of ideas for medical
countermeasure development, highlight
work on regulatory science as it applies
to the development and advancement of
medical countermeasures, facilitate
innovative directions, and inform
stakeholders on medical
countermeasure-related scientific
progress and accomplishments.
Dates and Times: The symposium
will be held on May 29 and May 30,
2013, from 9 a.m. to 5 p.m., and on May
31, 2013, from 9 a.m. to 12 noon.
Persons interested in attending the
VerDate Mar<15>2010
17:14 Apr 04, 2013
Jkt 229001
symposium in person or viewing via
Webcast must register by May 24, 2013,
at 5 p.m. EST.
Location: The symposium will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Entrance for the symposium
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
Contact: Rakesh Raghuwanshi, Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 4283, Silver Spring, MD 20993,
301–796–4769, Fax: 301–847–8615,
email: AskMCMi@fda.hhs.gov.
Registration: If you wish to attend the
symposium or view via Webcast, you
must register at https://www.fda.gov/
medicalcountermeasures by May 24,
2013, at 5 p.m. EST. When registering,
you must provide the following
information: (1) Your name, (2) title, (3)
company or organization (if applicable),
(4) mailing address, (5) phone number,
and (6) email address.
There is no fee to register for the
symposium and registration will be on
a first-come, first-served basis. Early
registration is recommended because
seating is limited.
If you need special accommodations
due to a disability, please enter
pertinent information in the ‘‘Notes’’
section of the electronic registration
form when you register.
Date: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07893 Filed 4–4–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Society of Clinical Research
Associates-Food and Drug
Administration: Food and Drug
Administration Clinical Trial
Requirements, Regulations,
Compliance, and Good Clinical
Practice
Food and Drug Administration,
HHS.
PO 00000
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Notice of conference.
The Food and Drug
Administration (FDA) is announcing an
educational conference co-sponsored
with the Society of Clinical Research
Associates (SOCRA). The conference on
FDA’s clinical trial requirements is
designed to aid the clinical research
professional’s understanding of the
mission, responsibilities, and authority
of FDA and to facilitate interaction with
FDA representatives. The program will
focus on the relationships among FDA
and clinical trial staff, investigators, and
institutional review boards (IRBs).
Individual FDA representatives will
discuss the informed consent process
and informed consent documents, and
regulations relating to drugs, devices,
and biologics, as well as inspections of
clinical investigators, IRBs, and research
sponsors.
DATES: Date and Time: The conference
will be held on May 15 and 16, 2013,
from 8 a.m. to 5 p.m.
Location: The conference will be held
at the Renaissance Seattle Hotel, 515
Madison St., Seattle, WA 98104.
Contact Person: Jane Kreis, Food and
Drug Administration, 1301 Clay St.,
Suite 1180N, Oakland, CA 94612, 510–
287–2708, FAX: 510–287–2739; or
Society of Clinical Research Associates
(SOCRA), 530 West Butler Ave., Suite
109, Chalfont, PA 18914, 800–762–7292,
FAX: 215–822–8633, email:
SoCRAmail@aol.com, Web site:
www.socra.org.
Registration and Meeting Information:
See SOCRA Web site, www.SoCRA.org.
https://www.socra.org/html/
FDA_Conference.htm. Registrations fees
are as follows: $575.00 for SOCRA
members; $650.00 for nonmembers
(includes membership); $450.00 for
Federal Government members; $525.00
for Federal Government nonmembers;
FDA employee rate is fee-waived. The
registration fee will cover actual
expenses including refreshments, lunch,
materials, and speaker expenses. If you
need special accommodations due to a
disability, please contact Jane Kreis (see
Contact Person) at least 10 days in
advance.
SUMMARY:
The
public workshop helps fulfill the
Department of Health and Human
Services’ and FDA’s important mission
to protect the public health. The
workshop will provide those engaged in
FDA-regulated (human) clinical trials
with information on a number of topics
concerning FDA requirements related to
informed consent, clinical investigation
requirements, institutional review board
inspections, electronic record
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2013–N–0001]
AGENCY:
ACTION:
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Page 20664]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07893]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
2013 Medical Countermeasures Initiative Regulatory Science
Symposium
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
meeting: 2013 Medical Countermeasures initiative (MCMi) Regulatory
Science Symposium. The symposium is intended to provide a forum for the
exchange of ideas for medical countermeasure development, highlight
work on regulatory science as it applies to the development and
advancement of medical countermeasures, facilitate innovative
directions, and inform stakeholders on medical countermeasure-related
scientific progress and accomplishments.
Dates and Times: The symposium will be held on May 29 and May 30,
2013, from 9 a.m. to 5 p.m., and on May 31, 2013, from 9 a.m. to 12
noon. Persons interested in attending the symposium in person or
viewing via Webcast must register by May 24, 2013, at 5 p.m. EST.
Location: The symposium will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the symposium
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Contact: Rakesh Raghuwanshi, Office of Counterterrorism and
Emerging Threats, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 4283, Silver Spring, MD 20993, 301-796-4769, Fax:
301-847-8615, email: AskMCMi@fda.hhs.gov.
Registration: If you wish to attend the symposium or view via
Webcast, you must register at https://www.fda.gov/medicalcountermeasures
by May 24, 2013, at 5 p.m. EST. When registering, you must provide the
following information: (1) Your name, (2) title, (3) company or
organization (if applicable), (4) mailing address, (5) phone number,
and (6) email address.
There is no fee to register for the symposium and registration will
be on a first-come, first-served basis. Early registration is
recommended because seating is limited.
If you need special accommodations due to a disability, please
enter pertinent information in the ``Notes'' section of the electronic
registration form when you register.
Date: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07893 Filed 4-4-13; 8:45 am]
BILLING CODE 4160-01-P
