[Federal Register Volume 76, Number 141 (Friday, July 22, 2011)]
[Notices]
[Pages 44015-44016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-18534]
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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.
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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
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Dates Registration times Public workshop hours
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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.
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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 http://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: [email protected] (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 http://www.diahome.org. For
mailing or faxing registration information, see the Web site at: http://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
[email protected] or [email protected].
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]
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