Immune Responses to Enzyme Replacement Therapies: Role of Immune Tolerance Induction; Public Workshop, 27313 [2014-10933]
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Federal Register / Vol. 79, No. 92 / Tuesday, May 13, 2014 / Notices
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designs.
Dated: May 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
III. Significance of Guidance
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
This guidance, developed under the
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VerDate Mar<15>2010
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[FR Doc. 2014–10952 Filed 5–12–14; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Immune Responses to Enzyme
Replacement Therapies: Role of
Immune Tolerance Induction; Public
Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration’s (FDA) Center for Drug
Evaluation and Research, in
cosponsorship with the National
Organization for Rare Disorders (NORD),
is announcing a 1-day public workshop
entitled ‘‘Immune Responses to Enzyme
Replacement Therapies: Role of Immune
Tolerance Induction.’’ Partners and
stakeholders planning the workshop
also include representatives from
academia, industry, and patients. The
purpose of this workshop is to provide
a forum to discuss the role of immune
tolerance induction in patients receiving
replacement biological products.
DATES: The public workshop will be
held on June 9, 2014, from 8 a.m. to 5
p.m.
ADDRESSES: The public workshop will
be held at 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 public workshop
participants (non-FDA employees) is
through Bldg. 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.
FOR FURTHER INFORMATION CONTACT:
Maureen Dewey, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–0845, FAX: 301–
796–9905, Maureen.Dewey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA’s
Center for Drug Evaluation and
Research, in co-sponsorship with
NORD, is announcing a 1-day public
workshop entitled ‘‘Immune Responses
to Enzyme Replacement Therapies: Role
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 9990
27313
of Immune Tolerance Induction.’’ The
cosponsored workshop will facilitate an
ongoing dialogue among relevant parties
on issues related to the role of immune
tolerance induction in enzyme
replacement therapies. The workshop
will discuss the impact of anti-drug and
neutralizing antibodies on efficacy and
safety of enzyme replacement therapies
intended to treat patients with
lysosomal storage diseases and the risks
and benefits of implementing
prophylactic immune tolerance
regimens to preclude generation of these
antibodies. Stakeholders, including
patients and patient organizations,
industry sponsors, academia, and FDA,
will discuss challenging issues related
to immune tolerance induction in
enzyme replacement therapies.
Registration: There is no fee to attend
the public workshop, but advanced
online registration is requested. Space is
limited, and registration will be on a
first-come, first-served basis. To register
online, please visit https://events.
rarediseases.org/?page_id=4&ee=13.
Onsite registration the day of the
workshop will be available, but
advanced registration is preferred.
If you need special accommodations
due to a disability, please contact
Maureen Dewey (see FOR FURTHER
INFORMATION CONTACT) at least 7 days in
advance.
Transcripts: Transcripts of the
workshop will be available for review at
the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and at
https://www.regulations.gov
approximately 30 days after the
workshop. A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. Send written
requests to the Division of Freedom of
Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
Dr., Element Bldg., Rockville, MD
20857. Send faxed requests to 301–827–
9267.
Dated: May 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–10933 Filed 5–12–14; 8:45 am]
BILLING CODE 4160–01–P
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[Federal Register Volume 79, Number 92 (Tuesday, May 13, 2014)]
[Notices]
[Page 27313]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-10933]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
Immune Responses to Enzyme Replacement Therapies: Role of Immune
Tolerance Induction; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research, in cosponsorship with the National
Organization for Rare Disorders (NORD), is announcing a 1-day public
workshop entitled ``Immune Responses to Enzyme Replacement Therapies:
Role of Immune Tolerance Induction.'' Partners and stakeholders
planning the workshop also include representatives from academia,
industry, and patients. The purpose of this workshop is to provide a
forum to discuss the role of immune tolerance induction in patients
receiving replacement biological products.
DATES: The public workshop will be held on June 9, 2014, from 8 a.m. to
5 p.m.
ADDRESSES: The public workshop will be held at 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 public
workshop participants (non-FDA employees) is through Bldg. 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.
FOR FURTHER INFORMATION CONTACT: Maureen Dewey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-0845, FAX: 301-
796-9905, Maureen.Dewey@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA's Center for Drug Evaluation and
Research, in co-sponsorship with NORD, is announcing a 1-day public
workshop entitled ``Immune Responses to Enzyme Replacement Therapies:
Role of Immune Tolerance Induction.'' The cosponsored workshop will
facilitate an ongoing dialogue among relevant parties on issues related
to the role of immune tolerance induction in enzyme replacement
therapies. The workshop will discuss the impact of anti-drug and
neutralizing antibodies on efficacy and safety of enzyme replacement
therapies intended to treat patients with lysosomal storage diseases
and the risks and benefits of implementing prophylactic immune
tolerance regimens to preclude generation of these antibodies.
Stakeholders, including patients and patient organizations, industry
sponsors, academia, and FDA, will discuss challenging issues related to
immune tolerance induction in enzyme replacement therapies.
Registration: There is no fee to attend the public workshop, but
advanced online registration is requested. Space is limited, and
registration will be on a first-come, first-served basis. To register
online, please visit https://events.rarediseases.org/?page_id=4&ee=13.
Onsite registration the day of the workshop will be available, but
advanced registration is preferred.
If you need special accommodations due to a disability, please
contact Maureen Dewey (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.
Transcripts: Transcripts of the workshop will be available for
review at the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and
at https://www.regulations.gov approximately 30 days after the workshop.
A transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Send written
requests to the Division of Freedom of Information (ELEM-1029), Food
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville,
MD 20857. Send faxed requests to 301-827-9267.
Dated: May 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10933 Filed 5-12-14; 8:45 am]
BILLING CODE 4160-01-P
