Request for Notification From Industry Organizations Interested in Participating in the Selection Process and Request for Nominations for a Nonvoting Industry Representative on the Vaccines and Biological Products Advisory Committee, 60506-60507 [2011-25120]
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60506
Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
4952, FAX: 214–253–4970, e-mail:
david.arvelo@fda.hhs.gov.
For information on accommodation
options, contact conference coordinator
Karen Smith or Andrea Graves at the
Robert M. Kerr Food & Agricultural
Products Center, Oklahoma State
University, 148 FAPC, Stillwater, OK
74078–6055, 405–744–6071, FAX: 405–
744–6313, or e-mail:
karenl.smith@okstate.edu or
andrea.graves@okstate.edu. More
information is also available online at
https://www.fapc.biz/fooddefense.html.
(FDA has verified the Web site address,
but FDA is not responsible for any
subsequent changes to the Web site after
this document publishes in the Federal
Register.)
Registration: You are encouraged to
register by October 21, 2011. The
workshop has a $150 registration fee to
cover the cost of facilities, materials,
speakers, and breaks. Seats are limited;
please submit your registration as soon
as possible. The workshop will be filled
in order of receipt of registration. Those
accepted into the workshop will receive
confirmation. Registration will close
after the workshop is filled. Registration
at the site is not guaranteed but may be
possible on a space available basis on
the day of the public workshop
beginning at 8 a.m. The cost of
registration at the site is $200 payable to
FAPC. There is no registration fee for
FDA employees.
If you need special accommodations
due to a disability, please contact Karen
Smith (see Contact) at least 7 days in
advance.
Registration Form Instructions: To
register, please complete the online
registration form at https://www.fapc.biz/
fooddefense.html.
Transcripts: Transcripts of the public
workshop will not be available due to
the format of this workshop. Course
handouts may be requested after the
date of the public workshop through the
contact persons (see Contact) at cost
plus shipping.
SUPPLEMENTARY INFORMATION: This
public workshop is being held in
response to the large volume of food
defense inquiries from food
manufacturers originating from the area
covered by the FDA Dallas District
Office. The SWRO presents this
workshop 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 consistent with the
purposes of the Southwest Regional
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Small Business Representative Program,
which are in part to respond to industry
inquiries, develop educational
materials, and sponsor workshops and
conferences to provide firms,
particularly small businesses, with
firsthand working knowledge of FDA’s
regulations and compliance policies.
This workshop is also consistent with
the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub.
L. 104–121), as outreach activities by
government agencies to small
businesses.
The goal of this public workshop is to
present information that will enable
regulated industry to better comply with
the regulations authorized by the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(the Bioterrorism Act) and to better
understand FDA’s food defense
guidance documents, especially in light
of growing concerns about food
protection. Information that FDA
presents will be based on Agency
position as articulated through
regulation, guidance, and information
previously made available to the public.
Topics to be discussed at the workshop
(both by FDA and non-FDA speakers)
include: (1) Food defense awareness and
definitions, (2) FDA food defense tools
such as ALERT and Employees FIRST,
(3) regulations issued under the
Bioterrorism Act, (4) food defense
guidance documents, (5) investigating
food-related incidents effectively, (6)
physical plant security, (7) crisis
management, and other related topics.
For more information, please visit
https://www.fapc.biz/fooddefense.html.
FDA expects that participation in this
public workshop will provide regulated
industry with greater understanding of
the Agency’s regulatory and policy
perspectives on food protection,
increase compliance with FDA
regulations, and heighten food defense
awareness.
Dated: September 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–25114 Filed 9–28–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
and Request for Nominations for a
Nonvoting Industry Representative on
the Vaccines and Biological Products
Advisory Committee
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Vaccines and Related
Biological Products Advisory
Committee for the Center for Biologics
Evaluation and Research (CBER) notify
FDA in writing. FDA is also requesting
nominations for a nonvoting industry
representative to serve the Vaccines and
Related Biological Products Advisory
Committee. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nomination
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
the FDA by October 31, 2011, for the
vacancy listed in this document.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA by October 31, 2011.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Donald Jehn (see FOR FURTHER
INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Donald Jehn, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852–
1448, 301–827–0314, FAX: 301–827–
0294, e-mail: donald.jehn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative on the CBER
Advisory Committee.
SUMMARY:
I. Vaccines and Related Biological
Products Advisory Committee
The Vaccines and Related Biological
Products Advisory Committee (the
Committee) advises the Commissioner
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Federal Register / Vol. 76, No. 189 / Thursday, September 29, 2011 / Notices
of Food and Drugs (the Commissioner)
or designee in discharging
responsibilities as they relate to the
regulation of vaccines and related
biological products. Members are asked
to provide their expert scientific and
technical advice to FDA to help make
sound decisions on the safety,
effectiveness, and appropriate use, of
vaccines and related biological
products.
tkelley on DSKG8SOYB1PROD with NOTICES
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT and DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the Committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative (for the roles
specified in this document).
Nominations must include a current
resume or curriculum vitae of the
nominee including current business
address and/or home address, telephone
number, email address if available, and
the role for which the individual is
being nominated. FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process).
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages nominations
for appropriately qualified candidates
from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
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60507
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: September 23, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
National Institutes of Health
[FR Doc. 2011–25120 Filed 9–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases Notice
of Closed Meeting
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 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 Institute of Diabetes and Digestive
and Kidney Diseases Special Emphasis Panel;
Digestive Diseases Core Centers.
Date: December 2, 2011.
Time: 8 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person:
Maria E. Davila-Bloom, PhD, Scientific
Review Officer, Review Branch, DEA,
NIDDK, National Institutes Of Health, Room
758, 6707 Democracy Boulevard, Bethesda,
MD 20892–5452, (301) 594–7637, davilabloomm@extra.niddk.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: September 23, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–25095 Filed 9–28–11; 8:45 am]
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Center for Scientific Review; Notice of
Closed Meetings
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: Center for Scientific
Review Special Emphasis Panel, Surgical
Sciences and Bioengineering.
Date: October 20, 2011.
Time: 12 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Malgorzata Klosek, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4188,
MSC 7849, Bethesda, MD 20892, (301) 435–
2211, klosekm@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: Diabetes, Obesity and Reproductive
Sciences.
Date: October 25–26, 2011.
Time: 11:30 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Krish Krishnan, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, (301) 435–
1041, krishnak@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Fellowship:
Genes, Genomes, and Genetics.
Date: October 26, 2011.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Allen Barlow Richon,
PhD., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184,
MSC 7892, Bethesda, MD 20892, 301–435–
1024, allen.richon@nih.hhs.gov.
E:\FR\FM\29SEN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 189 (Thursday, September 29, 2011)]
[Notices]
[Pages 60506-60507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25120]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process and Request for Nominations
for a Nonvoting Industry Representative on the Vaccines and Biological
Products Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
a nonvoting industry representative to serve on the Vaccines and
Related Biological Products Advisory Committee for the Center for
Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is
also requesting nominations for a nonvoting industry representative to
serve the Vaccines and Related Biological Products Advisory Committee.
A nominee may either be self-nominated or nominated by an organization
to serve as a nonvoting industry representative. Nomination will be
accepted for current vacancies effective with this notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to the FDA by
October 31, 2011, for the vacancy listed in this document.
Concurrently, nomination materials for prospective candidates should be
sent to FDA by October 31, 2011.
ADDRESSES: All letters of interest and nominations should be submitted
in writing to Donald Jehn (see FOR FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT: Donald Jehn, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401
Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, FAX: 301-827-
0294, e-mail: donald.jehn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative on the CBER Advisory Committee.
I. Vaccines and Related Biological Products Advisory Committee
The Vaccines and Related Biological Products Advisory Committee
(the Committee) advises the Commissioner
[[Page 60507]]
of Food and Drugs (the Commissioner) or designee in discharging
responsibilities as they relate to the regulation of vaccines and
related biological products. Members are asked to provide their expert
scientific and technical advice to FDA to help make sound decisions on
the safety, effectiveness, and appropriate use, of vaccines and related
biological products.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT and DATES). Within the subsequent
30 days, FDA will send a letter to each organization that has expressed
an interest, attaching a complete list of all such organizations; and a
list of all nominees along with their current resumes. The letter will
also state that it is the responsibility of the interested
organizations to confer with one another and to select a candidate,
within 60 days after the receipt of the FDA letter, to serve as the
nonvoting member to represent industry interests for the Committee. The
interested organizations are not bound by the list of nominees in
selecting a candidate. However, if no individual is selected within 60
days, the Commissioner will select the nonvoting member to represent
industry interests.
III. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry representative
(for the roles specified in this document). Nominations must include a
current resume or curriculum vitae of the nominee including current
business address and/or home address, telephone number, email address
if available, and the role for which the individual is being nominated.
FDA will forward all nominations to the organizations expressing
interest in participating in the selection process for the committee.
(Persons who nominate themselves as nonvoting industry representatives
will not participate in the selection process).
FDA has a special interest in ensuring that women, minority groups,
individuals with physical disabilities, and small businesses are
adequately represented on its advisory committees, and therefore,
encourages nominations for appropriately qualified candidates from
these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: September 23, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-25120 Filed 9-28-11; 8:45 am]
BILLING CODE 4160-01-P
