Thirteenth International Paul-Ehrlich-Seminar: Allergen Products for Diagnosis and Therapy: Regulation and Science; Public Workshop, 44015-44016 [2011-18534]
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Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices
meeting format will include a
presentation by FDA and presentations
by stakeholders and members of the
public who have registered in advance
to present at the meeting. The amount
of time available for presentations will
be determined by the number of people
who register to make a presentation. We
will also provide an opportunity for
organizations and individuals to submit
either electronic or written comments to
the docket after the meeting (see
Comments). FDA policy issues are
beyond the scope of this initiative.
Accordingly, the presentations should
focus on process and funding issues,
and not focus on policy.
Dated: July 19, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–18591 Filed 7–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Thirteenth International Paul-EhrlichSeminar: Allergen Products for
Diagnosis and Therapy: Regulation
and Science; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA), Center for Biologics Evaluation
and Research (CBER), in cosponsorship
with the Paul-Ehrlich-Institut (PEI), and
the Drug Information Association (DIA),
is announcing a public workshop
entitled: ‘‘13th International PaulEhrlich-Seminar: Allergen Products for
Diagnosis and Therapy: Regulation and
44015
Science.’’ The purpose of the public
workshop is to bring together scientists,
clinicians, and regulators from
throughout the world to discuss the
regulation of allergenic products with
respect to their use for the diagnosis and
treatment of allergenic diseases and
asthma. The public workshop will
provide a forum for scientists,
clinicians, and regulators to discuss
natural and modified allergens as they
relate to the pathogenesis, diagnosis,
and treatment of allergic diseases.
Dates and Times: See the following
table 1.
TABLE 1—WORKSHOP SCHEDULE
Dates
mstockstill on DSK4VPTVN1PROD with NOTICES
September
September
September
September
14,
15,
16,
17,
2011
2011
2011
2011
Registration times
...........................................
...........................................
...........................................
...........................................
Location: The public workshop will
be held at the Hyatt Regency
Washington on Capitol Hill, 400 New
Jersey Ave., NW., Washington, DC
20001. Overnight accommodations can
be booked at the Hyatt Regency
Washington on Capitol Hill, under
group code ‘‘DIA event’’. Reduced rates
are available until August 24, 2011. For
the public workshop rate, call 1–800–
243–2546 or go to the Web site at
https://washingtonregency.hyatt.com/
hyatt/hotels/. (FDA has verified the Web
site addresses throughout this
document, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Contact Person: Sandra Menzies,
Center for Biologics Evaluation and
Research (HFM–422), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–3181, FAX: 301–402–2776;
e-mail: Sandra.menzies@fda.hhs.gov (in
the subject line, type ‘‘13th IPES’’.)
Registration: Registration will be
handled directly by DIA. Registration
fees apply to all attendees. Registration
will be accepted by mail, fax, or online.
Register online at https://
www.diahome.org. For mailing or faxing
registration information, see the Web
site at: https://www.diahome.org/
VerDate Mar<15>2010
17:59 Jul 21, 2011
Jkt 223001
Public workshop hours
3 p.m. to 6 p.m ...................................................
7 a.m. to 8:30 a.m ..............................................
None ...................................................................
None ...................................................................
DIAHome/Education/FindEducational
Offering.aspx?productID=25839&event
Type=Meeting. Early registration is
recommended because seating is
limited. Registration at the public
workshop will be provided on a spaceavailable basis.
If you need special accommodations
due to a disability, please contact DIA
at least 15 days prior to the start of the
public workshop at 215–293–5800;
FAX: 215–442–6199; or e-mail
Constance.Burnett@diahome.org or
JoAnn.Boileau@diahome.org.
Continuing Education: This activity
has been planned and implemented in
accordance with the essential areas and
policies of the Accreditation Council for
Continuing Medical Education
(ACCME) through the joint sponsorship
of Postgraduate Institute for Medicine
(PIM) and the DIA. PIM is accredited by
the ACCME to provide continuing
medical education for physicians. PIM
designates this educational activity for a
maximum of 17.75 American Medical
Association Physician’s Recognition
Ward (AMA PRA) Category 1
Credit(s).TM Physicians should only
claim credit commensurate with the
extent of their participation in the
activity. DIA has been approved as an
Authorized Provider by the
International Association for Continuing
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
7:30
8:30
8:30
8:45
p.m.
a.m.
a.m.
a.m.
to
to
to
to
9 p.m. (keynote session).
5 p.m.
6 p.m.
12:30 p.m.
Education and Training (IACET), 8405
Greensboro Dr., suite 800, McLean, VA
22102; 703–506–3275. DIA is authorized
by IACET to offer 1.8 continuing
education units for this program.
For about
30 years, the International Paul-EhrlichSeminar has been a forum for regulators,
scientists, and industry to discuss issues
related to standardization and
regulation of diagnostic and therapeutic
allergenic products. The public
workshop will consist of a series of
seminars and discussions focused on
standardization of allergens, including
biochemical characterization, their
mechanism of action as therapeutics,
and ongoing and recently completed
clinical trials as to safety and efficacy of
a number of allergenic products as
therapeutics.
FDA protects and advances the public
health by approving biological products
that it determines meets the
requirements for safety, purity, and
potency for the conditions for which the
applicant is seeking approval, based on
factors that include a review of data
and, in some cases, taking into account
recommendations and input from
independent experts (e.g., advisory
committees), input from interested
parties, and public comments.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22JYN1.SGM
22JYN1
mstockstill on DSK4VPTVN1PROD with NOTICES
44016
Federal Register / Vol. 76, No. 141 / Friday, July 22, 2011 / Notices
PEI is an institution of the Federal
Republic of Germany. PEI reports to the
¨
Bundesministerium fur Gesundheit
(Federal Ministry of Health). Most of its
activities relate to provisions in German
and European medicinal product
legislation, such as the approval of
clinical trials and the marketing
authorization of particular groups of
medicinal products. Since its
foundation more than 100 years ago, PEI
has concentrated on many biological
medicinal products, including vaccines
for humans and animals, medicinal
products containing antibodies,
allergens for therapy and diagnostics,
blood and blood products, and more
recently, tissue and medicinal products
for gene therapy, somatic cell therapy,
and xenogenic cell therapy.
DIA is a nonprofit, multidisciplinary,
member-driven scientific association
with a membership of over 22,000.
These members are primarily from the
regulatory Agencies, academia, contract
service organizations, pharmaceutical,
biological and device industry, and from
other health care organizations. DIA
provides a neutral global forum for the
exchange and dissemination of
knowledge on the discovery,
development, evaluation, and
utilization of medicines and related
health care technologies. Through these
activities, DIA provides development
opportunities for its members.
The public workshop will feature
presentations by FDA and regulators
from Canada, China, Europe, and
Mexico. The public workshop will begin
with a keynote address by Harold S.
Nelson and end with a closing address
by N. Franklin Adkinson, Jr. During the
public workshop, the following topics
will be discussed:
• Standardization and
characterization of natural allergenic
products;
• Methods in product and study
design of effective allergenic products
for therapy;
• Standardization and
characterization of modified and
recombinant allergenic products;
• Immunological mechanisms of
allergy immunotherapy;
• Immunotherapy with purified
allergen components;
• Extrinsic adjuvants in the use of
allergen immunotherapy;
• Immunomodulatory properties of
allergens; and
• State-of-the-art of immunotherapy
in different allergic diseases.
DIA will provide all seminar
attendees with a Web link no later than
4 weeks post-seminar. The Web link
will provide access to approved Portable
Document Format (PDF) presentations.
VerDate Mar<15>2010
17:59 Jul 21, 2011
Jkt 223001
The Web link will be available for
approximately 6 months postseminar.
Dated: July 19, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2011–18534 Filed 7–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
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 September 20, 2011, from 8 a.m.
to approximately 5:15 p.m.
Location: Hilton Hotel, Washington
DC North/Gaithersburg, 620 Perry
Pkwy., Gaithersburg, MD 20977, 301–
977–8900. For those unable to attend in
person, the meeting will also be Web
cast. The link for the Web cast is
available at https://fda.yorkcast.com/
webcast/Viewer/?peid=
84f95996804743439bcc5be
69d1908051d.
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), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
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 and
call the appropriate advisory committee
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: On September 20, 2011, the
committee will meet in open session to
hear an overview of the research
program in the Laboratory of Enteric
and Sexually Transmitted Diseases,
Division of Bacterial, Parasitic and
Allergenic Products, Office of Vaccines
Research and Review, Center for
Biologics Evaluation and Research,
FDA. The committee will then discuss
and make recommendations on the
safety and immunogenicity (surrogate
endpoint) of Pneumococcal 13-valent
conjugate vaccine (Diphtheria CRM197
Protein) in adults aged 50 years and
older using an accelerated approval
regulatory pathway.
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 link.
Procedure: On September 20, 2011,
between approximately 8 a.m. and
10 a.m., and between approximately
10:45 a.m. and 5:15 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 September 13, 2011.
Oral presentations from the public will
be scheduled between approximately
9:30 a.m. and 10 a.m. and between
approximately 3:45 p.m. and 4:15 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 September 1, 2011. 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
E:\FR\FM\22JYN1.SGM
22JYN1
]]>Agencies
[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44015-44016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18534]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Thirteenth International Paul-Ehrlich-Seminar: Allergen Products
for Diagnosis and Therapy: Regulation and Science; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA), Center for Biologics
Evaluation and Research (CBER), in cosponsorship with the Paul-Ehrlich-
Institut (PEI), and the Drug Information Association (DIA), is
announcing a public workshop entitled: ``13th International Paul-
Ehrlich-Seminar: Allergen Products for Diagnosis and Therapy:
Regulation and Science.'' The purpose of the public workshop is to
bring together scientists, clinicians, and regulators from throughout
the world to discuss the regulation of allergenic products with respect
to their use for the diagnosis and treatment of allergenic diseases and
asthma. The public workshop will provide a forum for scientists,
clinicians, and regulators to discuss natural and modified allergens as
they relate to the pathogenesis, diagnosis, and treatment of allergic
diseases.
Dates and Times: See the following table 1.
Table 1--Workshop Schedule
----------------------------------------------------------------------------------------------------------------
Dates Registration times Public workshop hours
----------------------------------------------------------------------------------------------------------------
September 14, 2011.............. 3 p.m. to 6 p.m.... 7:30 p.m. to 9 p.m. (keynote session).
September 15, 2011.............. 7 a.m. to 8:30 a.m. 8:30 a.m. to 5 p.m.
September 16, 2011.............. None............... 8:30 a.m. to 6 p.m.
September 17, 2011.............. None............... 8:45 a.m. to 12:30 p.m.
----------------------------------------------------------------------------------------------------------------
Location: The public workshop will be held at the Hyatt Regency
Washington on Capitol Hill, 400 New Jersey Ave., NW., Washington, DC
20001. Overnight accommodations can be booked at the Hyatt Regency
Washington on Capitol Hill, under group code ``DIA event''. Reduced
rates are available until August 24, 2011. For the public workshop
rate, call 1-800-243-2546 or go to the Web site at https://washingtonregency.hyatt.com/hyatt/hotels/. (FDA has verified the Web
site addresses throughout this document, but FDA is not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.)
Contact Person: Sandra Menzies, Center for Biologics Evaluation and
Research (HFM-422), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-3181, FAX: 301-402-2776;
e-mail: Sandra.menzies@fda.hhs.gov (in the subject line, type ``13th
IPES''.)
Registration: Registration will be handled directly by DIA.
Registration fees apply to all attendees. Registration will be accepted
by mail, fax, or online. Register online at https://www.diahome.org. For
mailing or faxing registration information, see the Web site at: https://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=25839&eventType=Meeting. Early
registration is recommended because seating is limited. Registration at
the public workshop will be provided on a space-available basis.
If you need special accommodations due to a disability, please
contact DIA at least 15 days prior to the start of the public workshop
at 215-293-5800; FAX: 215-442-6199; or e-mail
Constance.Burnett@diahome.org or JoAnn.Boileau@diahome.org.
Continuing Education: This activity has been planned and
implemented in accordance with the essential areas and policies of the
Accreditation Council for Continuing Medical Education (ACCME) through
the joint sponsorship of Postgraduate Institute for Medicine (PIM) and
the DIA. PIM is accredited by the ACCME to provide continuing medical
education for physicians. PIM designates this educational activity for
a maximum of 17.75 American Medical Association Physician's Recognition
Ward (AMA PRA) Category 1 Credit(s).\TM\ Physicians should only claim
credit commensurate with the extent of their participation in the
activity. DIA has been approved as an Authorized Provider by the
International Association for Continuing Education and Training
(IACET), 8405 Greensboro Dr., suite 800, McLean, VA 22102; 703-506-
3275. DIA is authorized by IACET to offer 1.8 continuing education
units for this program.
SUPPLEMENTARY INFORMATION: For about 30 years, the International Paul-
Ehrlich-Seminar has been a forum for regulators, scientists, and
industry to discuss issues related to standardization and regulation of
diagnostic and therapeutic allergenic products. The public workshop
will consist of a series of seminars and discussions focused on
standardization of allergens, including biochemical characterization,
their mechanism of action as therapeutics, and ongoing and recently
completed clinical trials as to safety and efficacy of a number of
allergenic products as therapeutics.
FDA protects and advances the public health by approving biological
products that it determines meets the requirements for safety, purity,
and potency for the conditions for which the applicant is seeking
approval, based on factors that include a review of data and, in some
cases, taking into account recommendations and input from independent
experts (e.g., advisory committees), input from interested parties, and
public comments.
[[Page 44016]]
PEI is an institution of the Federal Republic of Germany. PEI
reports to the Bundesministerium f[uuml]r Gesundheit (Federal Ministry
of Health). Most of its activities relate to provisions in German and
European medicinal product legislation, such as the approval of
clinical trials and the marketing authorization of particular groups of
medicinal products. Since its foundation more than 100 years ago, PEI
has concentrated on many biological medicinal products, including
vaccines for humans and animals, medicinal products containing
antibodies, allergens for therapy and diagnostics, blood and blood
products, and more recently, tissue and medicinal products for gene
therapy, somatic cell therapy, and xenogenic cell therapy.
DIA is a nonprofit, multidisciplinary, member-driven scientific
association with a membership of over 22,000. These members are
primarily from the regulatory Agencies, academia, contract service
organizations, pharmaceutical, biological and device industry, and from
other health care organizations. DIA provides a neutral global forum
for the exchange and dissemination of knowledge on the discovery,
development, evaluation, and utilization of medicines and related
health care technologies. Through these activities, DIA provides
development opportunities for its members.
The public workshop will feature presentations by FDA and
regulators from Canada, China, Europe, and Mexico. The public workshop
will begin with a keynote address by Harold S. Nelson and end with a
closing address by N. Franklin Adkinson, Jr. During the public
workshop, the following topics will be discussed:
Standardization and characterization of natural allergenic
products;
Methods in product and study design of effective
allergenic products for therapy;
Standardization and characterization of modified and
recombinant allergenic products;
Immunological mechanisms of allergy immunotherapy;
Immunotherapy with purified allergen components;
Extrinsic adjuvants in the use of allergen immunotherapy;
Immunomodulatory properties of allergens; and
State-of-the-art of immunotherapy in different allergic
diseases.
DIA will provide all seminar attendees with a Web link no later
than 4 weeks post-seminar. The Web link will provide access to approved
Portable Document Format (PDF) presentations. The Web link will be
available for approximately 6 months postseminar.
Dated: July 19, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-18534 Filed 7-21-11; 8:45 am]
BILLING CODE 4160-01-P
