Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 20663-20664 [2013-07961]
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mstockstill on DSK4VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 66 / Friday, April 5, 2013 / Notices
Transcripts: As soon as a transcript is
available, it will be accessible at https://
www.regulations.gov. It also may be
viewed at the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. You
should send written requests for a
hardcopy or CD–ROM transcript to the
Division of Freedom of Information,
(ELEM–1029), Food and Drug
Administration, 12420 Parklawn Dr.,
Element Bldg., Rockville, MD 20857.
The purpose of the multilateral
framework on the ICCR is to pave the
way for the removal of regulatory
obstacles to international trade while
maintaining global consumer protection.
ICCR is a voluntary international
group of cosmetics regulatory
authorities from the United States,
Japan, the European Union, and Canada.
These regulatory authority members
will enter into constructive dialogue
with their relevant cosmetics industry
trade associations and public advocacy
groups. Currently, the ICCR members
are: Health Canada; the European
Directorate General for Health and
Consumers; the Ministry of Health,
Labor and Welfare of Japan; and the U.S.
Food and Drug Administration. All
decisions made by consensus will be
compatible with the laws, policies,
rules, regulations, and directives of the
respective administrations and
governments. Members will implement
and/or promote actions or documents
within their own jurisdictions and seek
convergence of regulatory policies and
practices. Successful implementation
will need input from stakeholders.
You may present data, information, or
views orally or in writing on issues
pending at the public meeting. Time
allotted for oral presentations may be
limited to 10 minutes or less for each
presenter. If you wish to make an oral
presentation, you should notify the
contact person by April 22, 2013, and
submit a brief statement of the general
nature of the evidence or arguments that
you wish to present, your name,
address, telephone number, fax number,
and email address, and indicate the
approximate time you need to make
your presentation. If you need special
accommodations due to a disability,
please contact Maria Rossana
(Rosemary) Cook (see Contact Person)
by May 1, 2013.
We will make the agenda for the
public meeting available on the Internet
at: https://www.fda.gov/Cosmetics/
InternationalActivities/Conferences
MeetingsWorkshops/International
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CooperationonCosmeticsRegulations
ICCR/default.htm. We may use the
information that you provide to us
during the public meeting to help us
prepare for the July 8 to 10, 2013 ICCR–
7 meeting.
Dated: April 1, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2013–07949 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]
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 May 8, 2013, from 1 p.m. to
approximately 4 p.m.
Location: Rockwall II, Conference
Room 1033, 5515 Security Lane,
Rockville, MD 20852. The public is
welcome to attend the meeting at the
specified location where a
speakerphone will be provided. Public
participation in the meeting is limited to
the use of the speakerphone in the
conference room.
Contact Person: Donald W. Jehn 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). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
PO 00000
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20663
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On May 8, 2013, the
committee will meet in open session to
hear updates of the research programs in
the Laboratory of DNA Viruses, Division
of Viral Products, Office of Vaccines
Research and Review, Center for
Biologics Evaluation and Research,
FDA.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: On May 8, 2013, from 1
p.m. to approximately 3:20 p.m., the
meeting is open to the public. Interested
persons may present data, information,
or views, orally or in writing, on issues
pending before the committee. Written
submissions may be made to the contact
person on or before May 1, 2013. Oral
presentations from the public will be
scheduled between approximately 2:20
p.m. and 3:20 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before April 23,
2013. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 24, 2013.
Closed Committee Deliberations: On
May 8, 2013, from approximately 3:20
p.m. to approximately 4 p.m., the
meeting will be closed to permit
discussion where disclosure would
constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C.
552b(c)(6)). The committee will discuss
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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
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Donald W.
Jehn or Denise Royster at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
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
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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
Frm 00053
Fmt 4703
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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:
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]]>Agencies
[Federal Register Volume 78, Number 66 (Friday, April 5, 2013)]
[Notices]
[Pages 20663-20664]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07961]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
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 May 8, 2013, from 1 p.m.
to approximately 4 p.m.
Location: Rockwall II, Conference Room 1033, 5515 Security Lane,
Rockville, MD 20852. The public is welcome to attend the meeting at the
specified location where a speakerphone will be provided. Public
participation in the meeting is limited to the use of the speakerphone
in the conference room.
Contact Person: Donald W. Jehn 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). A notice in the Federal Register
about last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough to
provide timely notice. Therefore, you should always check the Agency's
Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory committee meeting link, or call
the advisory committee information line to learn about possible
modifications before coming to the meeting.
Agenda: On May 8, 2013, the committee will meet in open session to
hear updates of the research programs in the Laboratory of DNA Viruses,
Division of Viral Products, Office of Vaccines Research and Review,
Center for Biologics Evaluation and Research, FDA.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: On May 8, 2013, from 1 p.m. to approximately 3:20 p.m.,
the meeting is open to the public. Interested persons may present data,
information, or views, orally or in writing, on issues pending before
the committee. Written submissions may be made to the contact person on
or before May 1, 2013. Oral presentations from the public will be
scheduled between approximately 2:20 p.m. and 3:20 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
April 23, 2013. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by April 24, 2013.
Closed Committee Deliberations: On May 8, 2013, from approximately
3:20 p.m. to approximately 4 p.m., the meeting will be closed to permit
discussion where disclosure would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will
discuss
[[Page 20664]]
the report of the intramural research programs and make recommendations
regarding personnel staffing decisions.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Donald W. Jehn or
Denise Royster at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
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
