First Annual Neonatal Scientific Workshop-Roadmap for Applying Regulatory Science to Neonates; Notice of Public Workshop, 56590-56591 [2014-22460]
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Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Notices
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 AnnMarie
Williams, at 301–796–5966.
Annmarie.williams@fda.hhs.gov 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: September 16, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2014–22444 Filed 9–19–14; 8:45 am]
BILLING CODE 4164–01–P
from 8 a.m. to 5 p.m. Section II provides
attendance and registration information.
ADDRESSES: The public scientific
workshop will be held at the FDA White
Oak Campus, 10903 New Hampshire
Ave., Building 31 Conference Center,
the Great Room (Rm. 1503A), Silver
Spring, MD 20993–0002. Entrance for
the public scientific workshop
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/
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Indira Hills, Food and Drug
Administration, Center for Drug
Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4508,
Silver Spring, MD 20993, 301–796–
9686, FAX: 301–796–9907, indira.hills@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
First Annual Neonatal Scientific
Workshop—Roadmap for Applying
Regulatory Science to Neonates;
Notice of Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public scientific workshop to discuss
the roadmap for applying regulatory
science to neonates. This public
scientific workshop is being cosponsored with the FDA, the Critical
Path Institute (C-Path) and the
Burroughs Welcome Fund (BWF).
The purpose of the public scientific
workshop is to initiate constructive
discussion among regulators,
researchers, health care providers,
representatives from the pharmaceutical
industry and health care organizations,
and the general public to determine
whether there is sufficient interest on
the part of stakeholders to develop a
neonatal consortium and to discuss
potential working groups dedicated to
the regulatory science required to
develop neonatal therapeutics.
DATES: The public scientific workshop
will be held on October 28 and 29, 2014,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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17:07 Sep 19, 2014
Jkt 232001
C-Path and BWF, in cooperation with
FDA and various stakeholders,
including industry, academia,
professional organizations, patient
advocacy groups, and other government
Agencies, are proposing to establish the
Neonatal Consortium in order to
leverage resources and expertise toward
mutually beneficial goals and in the
interest of public health. Some of the
potential priorities of the Neonatal
Consortium to be discussed at the
public scientific workshop would be the
following:
1. Developing and qualifying
biomarkers, clinical outcome
assessments, and other drug
development tools. Valid and reliable
endpoints are presently lacking in
neonatal clinical trials.
2. Developing physiologically-based
pharmacokinetic modeling and
simulation to predict on and off target
responses to drugs.
3. Optimizing clinical trial designs for
the neonatal population. One aspect of
clinical trial design in neonates is the
need for long-term studies to properly
evaluate the effects of an intervention.
There is also interest in examining
bioethical questions related to neonatal
care and their solutions.
4. Maximizing the use of registry data.
Such registries may be useful in longterm studies.
5. Developing Clinical Data
Interchange Standards Consortium data
standards for registry data, electronic
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health record information, and clinical
trial data.
6. Building a neonatal database in
which standardized data pooled from
industry and academic neonatal trials
could reside. Such a database would be
an invaluable resource for the neonatal
community.
II. Attendance and Registration
The FDA Conference Center at the
White Oak location is a Federal facility
with security procedures and limited
seating. Individuals who wish to
participate in the public scientific
workshop (in person or via web) must
register on or before October 20, 2014,
by visiting https://www.cvent.com/d/
34qr03 and contacting Indira Hills (see
FOR FURTHER INFORMATION CONTACT) or
Kerrie Bennymadho, Project
Coordinator, Critical Path Institute, 520–
382–1377, Cell: 760–636–3046,
kbennymadho@c-path.org regarding
registration. Early registration is
recommended. Registration is free and
will be on a first-come, first-served
basis. However, FDA may limit the
number of participants from each
organization based on space limitations.
Onsite registration on the day of the
public scientific workshop will be based
on space availability. The registration
deadline is October 20, 2014.
FDA will provide additional
background information at the time the
Federal Register notice is published and
an agenda approximately 2 weeks before
the public scientific workshop at FDA
Meeting Information page, which is
available online at https://www.fda.gov/
Drugs/NewsEvents/ucm410863.htm.
If you need special accommodations
because of disability, please contact
Indira Hills (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the public scientific workshop.
A live Webcast of this public
scientific workshop will be viewable at
Adobe Connect Link: https://
collaboration.fda.gov/nsw2014/ on the
day of the public scientific workshop. A
video record of the public scientific
workshop will be available at the same
Web address for 1 year.
III. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305). A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. Written requests
are to be sent to the Division of Freedom
of Information (ELEM–1029), Food and
Drug Administration, 12420 Parklawn
E:\FR\FM\22SEN1.SGM
22SEN1
Federal Register / Vol. 79, No. 183 / Monday, September 22, 2014 / Notices
Dr., Element Bldg., Rockville, MD
20857.
Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22460 Filed 9–19–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive
License: Direct Impact Corona
Ionization Mass Spectrometry
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
This is notice, in accordance
with 35 U.S.C. 209 and 37 CFR part 404,
that the Food and Drug Administration,
an agency within the Department of
Health and Human Services, through
the National Institutes of Health Office
of Technology Transfer is contemplating
the grant of an exclusive worldwide
license to practice the inventions
embodied in HHS Ref. No. E–258–2011/
0, ‘‘Direct Impact Corona Ionization
(DICI) Mass Spectrometry;’’ U.S. Patent
8,704,169, to Vivione Biosciences, Inc.,
a corporation incorporated under the
laws of the State of Arkansas, having a
principle place of business at 515 W.
Matthews Ave., Jonesboro, AR 72401.
The United States of America is the
assignee of the patent rights pertaining
to this invention.
The exclusivity period of the
contemplated license may be granted for
no more than seven (7) years, may be
territorially limited to the United States
and may be limited to a field of use
directed to direct impact corona
ionization mass spectrometry pattern
recognition devices and systems for
detection of small molecules and
microbiological agents.
DATES: Only written comments and/or
applications for a license that are
received by the NIH Office of
Technology Transfer on or before
October 22, 2014 will be considered.
ADDRESSES: Requests for a copy of the
patent application, inquiries, comments
and other materials relating to the
contemplated license should be directed
to: Michael Shmilovich, Esq, CLP,
Senior Licensing and Patent Manager,
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
5019; Facsimile: (301) 402–0220; Email:
shmilovm@mail.nih.gov. A signed
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SUMMARY:
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confidential disclosure agreement may
be required to receive copies of the
patent application assuming it has not
already been published under the
publication rules of either the U.S.
Patent and Trademark Office or the
World Intellectual Property
Organization.
SUPPLEMENTARY INFORMATION: E–258–
2011/0 (U.S. Patent 8,704,169)—The
invention relates to the uses of an
AccuTOF DART (time-of-flight mass
spectrometer coupled to direct analysis
in real time) mass spectrometer for
qualitatively analyzing samples
(originally designed for microbes) based
on the serendipitous discovery that
glowing direct impact corona ionization
greatly enhances sensitivity of
identification. This direct impact corona
ionization occurred while repositioning
the stainless steel pin too close to the
grid of the ion source gun. Examination
revealed that not only did the peak
intensity increase by 490 fold but the
spectral information was well beyond
anything seen before with only the
normal ionization mode on the same
instrument. Initially, pyrolysis was
considered necessary for vaporizing low
volatility components of microbiological
analytes, a prerequisite for ionizing and
introducing samples into the mass
spectrometer. However, pyrolysis
introduced particles from burned
electrical wiring insulation because of
the high current necessary. As an
alternative, the inventors replaced the
pyrolysis device with a power generator
used for direct corona ionizing
microbiological analytes in a controlled
fashion. Furthermore, a small custommade glass cylinder with two
juxtaposing holes on each side was set
up within the sample introduction
chamber to exclude oxygen thus
preventing oxidation of microbiological
analytes. Additionally, the insulation
provided by this cylinder kept out
ambient moisture thus ensuring proton
transfer from water molecules would
not contribute to irreproducible
ionization of the analyte.
The prospective exclusive license will
be royalty-bearing and comply with the
terms and conditions of 35 U.S.C. 209
and 37 CFR part 404. The prospective
exclusive license may be granted unless,
within thirty (30) days from the date of
this published notice, the National
Institutes of Health Office of Technology
Transfer receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.
Properly filed competing applications
for a license filed in response to this
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56591
notice will be treated as objections to
the contemplated license. Comments
and objections submitted in response to
this notice will not be made available
for public inspection, and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: September 18, 2014.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2014–22454 Filed 9–19–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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, Clinical and
Translational Imaging Applications.
Date: October 15, 2014.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Eileen W Bradley, DSC,
Chief, SBIB IRG, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5100, MSC 7854, Bethesda, MD
20892, (301) 435–1179, bradleye@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Vascular Biology of Diabetes and
Atherosclerosis.
Date: October 15, 2014.
Time: 12:00 p.m. to 2:00 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: Anshumali Chaudhari,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4124,
E:\FR\FM\22SEN1.SGM
22SEN1
]]>Agencies
[Federal Register Volume 79, Number 183 (Monday, September 22, 2014)]
[Notices]
[Pages 56590-56591]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22460]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0001]
First Annual Neonatal Scientific Workshop--Roadmap for Applying
Regulatory Science to Neonates; Notice of Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
scientific workshop to discuss the roadmap for applying regulatory
science to neonates. This public scientific workshop is being co-
sponsored with the FDA, the Critical Path Institute (C-Path) and the
Burroughs Welcome Fund (BWF).
The purpose of the public scientific workshop is to initiate
constructive discussion among regulators, researchers, health care
providers, representatives from the pharmaceutical industry and health
care organizations, and the general public to determine whether there
is sufficient interest on the part of stakeholders to develop a
neonatal consortium and to discuss potential working groups dedicated
to the regulatory science required to develop neonatal therapeutics.
DATES: The public scientific workshop will be held on October 28 and
29, 2014, from 8 a.m. to 5 p.m. Section II provides attendance and
registration information.
ADDRESSES: The public scientific workshop will be held at the FDA White
Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center,
the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for
the public scientific workshop 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/WhiteOakCampusInformation/ucm241740.htm.
FOR FURTHER INFORMATION CONTACT: Indira Hills, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 21, Rm. 4508, Silver Spring, MD 20993, 301-796-
9686, FAX: 301-796-9907, indira.hills@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
C-Path and BWF, in cooperation with FDA and various stakeholders,
including industry, academia, professional organizations, patient
advocacy groups, and other government Agencies, are proposing to
establish the Neonatal Consortium in order to leverage resources and
expertise toward mutually beneficial goals and in the interest of
public health. Some of the potential priorities of the Neonatal
Consortium to be discussed at the public scientific workshop would be
the following:
1. Developing and qualifying biomarkers, clinical outcome
assessments, and other drug development tools. Valid and reliable
endpoints are presently lacking in neonatal clinical trials.
2. Developing physiologically-based pharmacokinetic modeling and
simulation to predict on and off target responses to drugs.
3. Optimizing clinical trial designs for the neonatal population.
One aspect of clinical trial design in neonates is the need for long-
term studies to properly evaluate the effects of an intervention. There
is also interest in examining bioethical questions related to neonatal
care and their solutions.
4. Maximizing the use of registry data. Such registries may be
useful in long-term studies.
5. Developing Clinical Data Interchange Standards Consortium data
standards for registry data, electronic health record information, and
clinical trial data.
6. Building a neonatal database in which standardized data pooled
from industry and academic neonatal trials could reside. Such a
database would be an invaluable resource for the neonatal community.
II. Attendance and Registration
The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Individuals who
wish to participate in the public scientific workshop (in person or via
web) must register on or before October 20, 2014, by visiting https://www.cvent.com/d/34qr03 and contacting Indira Hills (see FOR FURTHER
INFORMATION CONTACT) or Kerrie Bennymadho, Project Coordinator,
Critical Path Institute, 520-382-1377, Cell: 760-636-3046,
path.org">kbennymadho@c-path.org regarding registration. Early registration is
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from
each organization based on space limitations. Onsite registration on
the day of the public scientific workshop will be based on space
availability. The registration deadline is October 20, 2014.
FDA will provide additional background information at the time the
Federal Register notice is published and an agenda approximately 2
weeks before the public scientific workshop at FDA Meeting Information
page, which is available online at https://www.fda.gov/Drugs/NewsEvents/ucm410863.htm.
If you need special accommodations because of disability, please
contact Indira Hills (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the public scientific workshop.
A live Webcast of this public scientific workshop will be viewable
at Adobe Connect Link: https://collaboration.fda.gov/nsw2014/ on the
day of the public scientific workshop. A video record of the public
scientific workshop will be available at the same Web address for 1
year.
III. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management (HFA-305). A transcript will also be
available in either hardcopy or on CD-ROM, after submission of a
Freedom of Information request. Written requests are to be sent to the
Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn
[[Page 56591]]
Dr., Element Bldg., Rockville, MD 20857.
Dated: September 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22460 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P
