Cooperative Research and Development Agreement (CRADA) Opportunity for Development of an Assay To Detect Genetic Markers Related to Elevated Serum Tryptase in Familial Tryptasemia and Mast Cell Activation Disorders, 20658-20659 [2016-08100]
Download as PDF
<![CDATA[
20658
Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-up
Exclusive License: Therapeutics and
PMA-Approved Diagnostics for
Alzheimer’s Disease (intranasal
delivery), Parkinson’s Disease,
Neuropathy,Neuropathic Pain,
Peripheral Neuropathy, Diabetic
Neuropathy, Neurapraxia,
Axonotmesis and Neurotmesis
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 National Institute of
Neurological Disorders and Stroke
(NINDS), National Institutes of Health
(NIH), Department of Health and Human
Services, is contemplating the grant of a
start-up exclusive license to AestasRx
Inc., which is located in North Carolina,
to practice the inventions embodied in
the following patents: U.S. Patent
8,597,660, issued December 3, 2013
(HHS reference E–144–2010/0–US–02).
The patent rights in these inventions
have been assigned to the United States
of America. The prospective start-up
exclusive license territory may be
worldwide and the field of use may be
limited to therapeutics (including smallmolecule TFP5 mimetics) and PMAapproved diagnostics for Alzheimer’s
disease (intranasal delivery only),
Parkinson’s Disease, neuropathy,
neuropathic pain, peripheral
neuropathy, diabetic neuropathy,
neurapraxia, axonotmesis and
neurotmesis.
SUMMARY:
Only written comments and/or
applications for a license which are
received by NINDS Technology Transfer
on or before April 25, 2016 will be
considered.
DATES:
Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated start-up exclusive license
should be directed to: Susan Ano, Ph.D.,
NINDS Technology Transfer, 31 Center
Drive, Suite 8A52, MSC2540, Bethesda,
MD 20892; Telephone: (301) 435–5515;
Email: anos@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
invention discloses treating
neurodegenerative diseases by
administering cyclin dependent kinase
5 (Cdk5) inhibitory peptides derived
from P35, the activator of Cdk5.
Abnormally hyperactive Cdk5 has been
shown to be associated with a variety of
mstockstill on DSK4VPTVN1PROD with NOTICES
ADDRESSES:
VerDate Sep<11>2014
17:48 Apr 07, 2016
Jkt 238001
neurodegenerative disorders. This
invention describes isolated peptide
fragments, pharmaceutical compositions
and methods for use of such for treating
subjects with a neurodegenerative
disease, such as Alzheimer’s disease
(AD), Amyotrophic Lateral Sclerosis
(ALS) and Parkinson’s disease (PD). An
inhibitory fragment, TFP5, disclosed in
this invention, has been shown to
ameliorate symptoms of AD in disease
animal models without any evidence of
toxicity. In particular, TFP5 treatment of
rat cortical neurons reduced
hyperactivation of Cdk5 upon neuronal
stress and insults. Following
intraperitoneal (ip) injection, TFP5 was
capable of crossing the blood-brain
barrier and localizing within the brain
where it was found to rescue memory
deficits and pathology in a double
transgenic mouse (APP/PS1) AD model.
The prospective start-up exclusive
license may be granted unless within
fifteen (15) days from the date of this
published notice, the NIH 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.
Complete applications for a license in
the field of use filed in response to this
notice will be treated as objections to
the grant of the contemplated start-up
exclusive license. Comments and
objections submitted 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: April 4, 2016.
Susan Ano,
Technology Development Coordinator,
NINDS Technology Transfer, National
Institutes of Health.
[FR Doc. 2016–08097 Filed 4–7–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Cooperative Research and
Development Agreement (CRADA)
Opportunity for Development of an
Assay To Detect Genetic Markers
Related to Elevated Serum Tryptase in
Familial Tryptasemia and Mast Cell
Activation Disorders
ACTION:
Notice.
The National Institute of
Allergy and Infectious Diseases (NIAID),
a component of the National Institutes
SUMMARY:
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
of Health (NIH), Department of Health
and Human Services (HHS) seeks to
enter into a CRADA with a commercial
partner to collaborate on the
development and commercialization of
an assay to detect a genetic variation
related to mast cell activation disorders.
DATES: Interested CRADA collaborators
must submit a confidential proposal
summary to the NIAID (attention Amy
F. Petrik at the address below) on or
before 8 June 2016 for consideration.
Guidelines for preparing full CRADA
proposals will be communicated shortly
thereafter to all respondents with whom
initial confidential discussions will
have established sufficient mutual
interest. CRADA proposals submitted
thereafter may be considered if a
suitable CRADA collaborator has not
been selected.
ADDRESSES: Questions should be
addressed to Amy F. Petrik, Ph.D.,
Technology Transfer and Intellectual
Property Office, National Institute of
Allergy and Infectious Diseases, 5601
Fishers Lane, Suite 6D, Rockville, MD
20892–9804, Tel: (240) 627–3721 or
email: petrika@niaid.nih.gov.
SUPPLEMENTARY INFORMATION:
Approximately 4–6% of the general
Western population exhibit elevated
basal levels of serum tryptase. As a mast
cell mediator, tryptase is expected to be
transiently elevated following allergic
stimuli. Sustained elevation of serum
tryptase levels can be associated with
symptoms of mast cell mediator release
(such as flushing, itching and swelling),
neuropsychiatric symptoms (such as
chronic pain, anxiety and
dysautonomia) and gastrointestinal (GI)
symptoms (including functional GI
disorders like irritable bowel syndrome
as well as eosinophilic GI disease) as
well as an increased risk for systemic
anaphylaxis.
The NIAID Investigators have recently
reported that these symptomatic
tryptase elevations can be inherited in
an autosomal dominant fashion and are
associated with the phenotype
described above (Lyons, J.J., et al. J
Allergy Clin Immunol, 133 (2014), pp.
1471–1474). Through next generation
sequencing and linkage analysis the
NIAID Investigators identified a
structural variant cosegregating with
disease. They then developed an assay,
based on digital droplet PCR, to identify
individuals with this variant, and
estimate that 5–8% of Caucasians may
have it, and be at risk for being
symptomatic.
Under the CRADA, the assay will be
developed toward licensure. Due to the
relatively high prevalence of serum
tryptase elevation, NIAID Investigators
E:\FR\FM\08APN1.SGM
08APN1
Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
anticipate receiving a large number of
samples for analysis which would
exceed their capacity. A collaborator
with the expertise and capacity for
implementing a CLIA or FDA approved
test for this genetic variant is sought.
A Cooperative Research and
Development Agreement (CRADA) is
the anticipated collaborative agreement
to be entered into with NIAID pursuant
to the Federal Technology Transfer Act
of 1986, codified as 15 U.S.C. 3710a,
and Executive Order 12591 of April 10,
1987, as amended. A CRADA is an
agreement designed to enable certain
collaborations between Government
laboratories and non-Government
laboratories. A CRADA is not a grant,
and it is not a contract for the
procurement of goods/services. The
NIAID is prohibited from transferring
funds to a CRADA collaborator. Under
a CRADA, NIAID can contribute
facilities, staff, materials, and expertise.
The CRADA collaborator can contribute
facilities, staff, materials, expertise, and
funds. The CRADA collaborator will
also have an option to negotiate the
terms of an exclusive or non-exclusive
commercialization license to subject
inventions arising under the CRADA.
The goals of the CRADA include the
rapid publication of research results and
timely commercialization of products,
diagnostics, and treatments that result
from the research.
The expected duration of the CRADA
with be two (2) to three (3) years.
Dated: April 2, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and
Intellectual Property Office, National Institute
of Allergy and Infectious Diseases.
[FR Doc. 2016–08100 Filed 4–7–16; 8:45 am]
BILLING CODE 4140–01–P
mstockstill on DSK4VPTVN1PROD with NOTICES
National Institute of Environmental
Health Sciences; 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
Jkt 238001
Dated: April 5, 2016.
Carolyn Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–08094 Filed 4–7–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on 12/31/2015,
pages 81830–81832. No comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Heart, Lung and
Blood Institute (NHLBI), National
Institutes of Health, may not conduct or
sponsor, and the respondent is not
required to respond to, an information
collection that has been extended,
revised, or implemented on or after
SUMMARY:
National Institutes of Health
17:48 Apr 07, 2016
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; NIH Loan Repayment
Program (Clinical and Pediatric Researchers).
Date: April 22, 2016.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
Place: NIEHS/National Institutes of Health,
Keystone Building, 530 Davis Drive, Research
Triangle Park, NC 27709 (Virtual Meeting).
Contact Person: Rose Anne M. McGee,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30,
Research Triangle Park, NC 27709, (919) 541–
0752, mcgee1@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
Submission for OMB Review; 30-Day
Comment Request; The Framingham
Heart Study (NHLBI)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
20659
October 1, 1995, unless it displays a
currently valid OMB control number.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, OIRA_submission@
omb.eop.gov or by fax to 202–395–6974,
Attention: NIH Desk Officer.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Ms. Deshiree Belis, National
Heart, Lung, and Blood Institute,
National Institutes of Health, 6705
Rockledge Dr., Suite 6185A, Bethesda,
MD 20892, or call non-toll-free number
301–435–1032, or Email your request,
including your address to
deshiree.belis@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Proposed Collection: The Framingham
Heart Study, 0925–0216, Revision,
National Heart, Lung, and Blood
Institute (NHLBI), the National
Institutes of Health (NIH).
Need and Use of Information
Collection: This proposal is to extend
the Framingham Study to examine the
Generation Three Cohort, New Offspring
Spouses and Omni Group 2 Cohort, as
well as to continue to monitor the
morbidity and mortality which occurs
in all Framingham Cohorts. The
contractor, with the collaborative
assistance of NHLBI Intramural staff,
will invite study participants, schedule
appointments, administer examinations
and testing, enter information into
computer databases for editing, and
prepare scientific reports of the
information for publication in
appropriate scientific journals. All
participants have been examined
previously and thus the study deals
with a stable, carefully described group.
Data are collected in the form of an
observational health examination
involving such components as blood
pressure measurements, venipuncture,
electrocardiography and a health
interview, including questions about
lifestyles and daily living situations.
The National Heart, Lung, and Blood
Institute uses the results of the
Framingham Study to: (1) Characterize
risk factors for cardiovascular and lung
E:\FR\FM\08APN1.SGM
08APN1
]]>Agencies
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)]
[Notices]
[Pages 20658-20659]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08100]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Cooperative Research and Development Agreement (CRADA)
Opportunity for Development of an Assay To Detect Genetic Markers
Related to Elevated Serum Tryptase in Familial Tryptasemia and Mast
Cell Activation Disorders
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Institute of Allergy and Infectious Diseases
(NIAID), a component of the National Institutes of Health (NIH),
Department of Health and Human Services (HHS) seeks to enter into a
CRADA with a commercial partner to collaborate on the development and
commercialization of an assay to detect a genetic variation related to
mast cell activation disorders.
DATES: Interested CRADA collaborators must submit a confidential
proposal summary to the NIAID (attention Amy F. Petrik at the address
below) on or before 8 June 2016 for consideration. Guidelines for
preparing full CRADA proposals will be communicated shortly thereafter
to all respondents with whom initial confidential discussions will have
established sufficient mutual interest. CRADA proposals submitted
thereafter may be considered if a suitable CRADA collaborator has not
been selected.
ADDRESSES: Questions should be addressed to Amy F. Petrik, Ph.D.,
Technology Transfer and Intellectual Property Office, National
Institute of Allergy and Infectious Diseases, 5601 Fishers Lane, Suite
6D, Rockville, MD 20892-9804, Tel: (240) 627-3721 or email:
petrika@niaid.nih.gov.
SUPPLEMENTARY INFORMATION: Approximately 4-6% of the general Western
population exhibit elevated basal levels of serum tryptase. As a mast
cell mediator, tryptase is expected to be transiently elevated
following allergic stimuli. Sustained elevation of serum tryptase
levels can be associated with symptoms of mast cell mediator release
(such as flushing, itching and swelling), neuropsychiatric symptoms
(such as chronic pain, anxiety and dysautonomia) and gastrointestinal
(GI) symptoms (including functional GI disorders like irritable bowel
syndrome as well as eosinophilic GI disease) as well as an increased
risk for systemic anaphylaxis.
The NIAID Investigators have recently reported that these
symptomatic tryptase elevations can be inherited in an autosomal
dominant fashion and are associated with the phenotype described above
(Lyons, J.J., et al. J Allergy Clin Immunol, 133 (2014), pp. 1471-
1474). Through next generation sequencing and linkage analysis the
NIAID Investigators identified a structural variant cosegregating with
disease. They then developed an assay, based on digital droplet PCR, to
identify individuals with this variant, and estimate that 5-8% of
Caucasians may have it, and be at risk for being symptomatic.
Under the CRADA, the assay will be developed toward licensure. Due
to the relatively high prevalence of serum tryptase elevation, NIAID
Investigators
[[Page 20659]]
anticipate receiving a large number of samples for analysis which would
exceed their capacity. A collaborator with the expertise and capacity
for implementing a CLIA or FDA approved test for this genetic variant
is sought.
A Cooperative Research and Development Agreement (CRADA) is the
anticipated collaborative agreement to be entered into with NIAID
pursuant to the Federal Technology Transfer Act of 1986, codified as 15
U.S.C. 3710a, and Executive Order 12591 of April 10, 1987, as amended.
A CRADA is an agreement designed to enable certain collaborations
between Government laboratories and non-Government laboratories. A
CRADA is not a grant, and it is not a contract for the procurement of
goods/services. The NIAID is prohibited from transferring funds to a
CRADA collaborator. Under a CRADA, NIAID can contribute facilities,
staff, materials, and expertise. The CRADA collaborator can contribute
facilities, staff, materials, expertise, and funds. The CRADA
collaborator will also have an option to negotiate the terms of an
exclusive or non-exclusive commercialization license to subject
inventions arising under the CRADA. The goals of the CRADA include the
rapid publication of research results and timely commercialization of
products, diagnostics, and treatments that result from the research.
The expected duration of the CRADA with be two (2) to three (3)
years.
Dated: April 2, 2016.
Suzanne Frisbie,
Deputy Director, Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases.
[FR Doc. 2016-08100 Filed 4-7-16; 8:45 am]
BILLING CODE 4140-01-P
