81 FR 20658 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 68 (April 8, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 68 (April 8, 2016)
| Page Range | 20658-20659 | |
| FR Document | 2016-08100 |
[Federal Register Volume 81, Number 68 (Friday, April 8, 2016)] [Notices] [Pages 20658-20659] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
![20658 Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices
DEPARTMENT OF HEALTH AND neurodegenerative disorders. This of Health (NIH), Department of Health
HUMAN SERVICES invention describes isolated peptide and Human Services (HHS) seeks to
fragments, pharmaceutical compositions enter into a CRADA with a commercial
National Institutes of Health and methods for use of such for treating partner to collaborate on the
subjects with a neurodegenerative development and commercialization of
Prospective Grant of Start-up disease, such as Alzheimer’s disease an assay to detect a genetic variation
Exclusive License: Therapeutics and (AD), Amyotrophic Lateral Sclerosis related to mast cell activation disorders.
PMA-Approved Diagnostics for (ALS) and Parkinson’s disease (PD). An DATES: Interested CRADA collaborators
Alzheimer’s Disease (intranasal inhibitory fragment, TFP5, disclosed in must submit a confidential proposal
delivery), Parkinson’s Disease, this invention, has been shown to summary to the NIAID (attention Amy
Neuropathy,Neuropathic Pain, ameliorate symptoms of AD in disease F. Petrik at the address below) on or
Peripheral Neuropathy, Diabetic animal models without any evidence of before 8 June 2016 for consideration.
Neuropathy, Neurapraxia, toxicity. In particular, TFP5 treatment of Guidelines for preparing full CRADA
Axonotmesis and Neurotmesis rat cortical neurons reduced proposals will be communicated shortly
AGENCY: National Institutes of Health, hyperactivation of Cdk5 upon neuronal thereafter to all respondents with whom
HHS. stress and insults. Following initial confidential discussions will
intraperitoneal (ip) injection, TFP5 was have established sufficient mutual
ACTION: Notice.
capable of crossing the blood-brain interest. CRADA proposals submitted
SUMMARY: This is notice, in accordance barrier and localizing within the brain thereafter may be considered if a
with 35 U.S.C. 209 and 37 CFR part 404, where it was found to rescue memory suitable CRADA collaborator has not
that the National Institute of deficits and pathology in a double been selected.
Neurological Disorders and Stroke transgenic mouse (APP/PS1) AD model. ADDRESSES: Questions should be
(NINDS), National Institutes of Health The prospective start-up exclusive addressed to Amy F. Petrik, Ph.D.,
(NIH), Department of Health and Human license may be granted unless within Technology Transfer and Intellectual
Services, is contemplating the grant of a fifteen (15) days from the date of this Property Office, National Institute of
start-up exclusive license to AestasRx published notice, the NIH receives Allergy and Infectious Diseases, 5601
Inc., which is located in North Carolina, written evidence and argument that Fishers Lane, Suite 6D, Rockville, MD
to practice the inventions embodied in establishes that the grant of the license 20892–9804, Tel: (240) 627–3721 or
the following patents: U.S. Patent would not be consistent with the email: petrika@niaid.nih.gov.
8,597,660, issued December 3, 2013 requirements of 35 U.S.C. 209 and 37 SUPPLEMENTARY INFORMATION:
(HHS reference E–144–2010/0–US–02). CFR part 404. Approximately 4–6% of the general
The patent rights in these inventions Complete applications for a license in
Western population exhibit elevated
have been assigned to the United States the field of use filed in response to this
basal levels of serum tryptase. As a mast
of America. The prospective start-up notice will be treated as objections to
cell mediator, tryptase is expected to be
exclusive license territory may be the grant of the contemplated start-up
transiently elevated following allergic
worldwide and the field of use may be exclusive license. Comments and
stimuli. Sustained elevation of serum
limited to therapeutics (including small- objections submitted to this notice will
tryptase levels can be associated with
molecule TFP5 mimetics) and PMA- not be made available for public
symptoms of mast cell mediator release
approved diagnostics for Alzheimer’s inspection and, to the extent permitted
(such as flushing, itching and swelling),
disease (intranasal delivery only), by law, will not be released under the
neuropsychiatric symptoms (such as
Parkinson’s Disease, neuropathy, Freedom of Information Act, 5 U.S.C.
chronic pain, anxiety and
neuropathic pain, peripheral 552.
dysautonomia) and gastrointestinal (GI)
neuropathy, diabetic neuropathy, Dated: April 4, 2016. symptoms (including functional GI
neurapraxia, axonotmesis and Susan Ano, disorders like irritable bowel syndrome
neurotmesis. Technology Development Coordinator, as well as eosinophilic GI disease) as
DATES: Only written comments and/or NINDS Technology Transfer, National well as an increased risk for systemic
Institutes of Health. anaphylaxis.
applications for a license which are
received by NINDS Technology Transfer [FR Doc. 2016–08097 Filed 4–7–16; 8:45 am] The NIAID Investigators have recently
on or before April 25, 2016 will be BILLING CODE 4140–01–P reported that these symptomatic
considered. tryptase elevations can be inherited in
an autosomal dominant fashion and are
ADDRESSES: Requests for copies of the DEPARTMENT OF HEALTH AND associated with the phenotype
patent application, inquiries, comments, HUMAN SERVICES described above (Lyons, J.J., et al. J
and other materials relating to the Allergy Clin Immunol, 133 (2014), pp.
contemplated start-up exclusive license National Institutes of Health 1471–1474). Through next generation
should be directed to: Susan Ano, Ph.D., sequencing and linkage analysis the
NINDS Technology Transfer, 31 Center Cooperative Research and
NIAID Investigators identified a
Drive, Suite 8A52, MSC2540, Bethesda, Development Agreement (CRADA)
structural variant cosegregating with
MD 20892; Telephone: (301) 435–5515; Opportunity for Development of an
disease. They then developed an assay,
Email: anos@mail.nih.gov. Assay To Detect Genetic Markers
based on digital droplet PCR, to identify
Related to Elevated Serum Tryptase in
mstockstill on DSK4VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION: This individuals with this variant, and
invention discloses treating Familial Tryptasemia and Mast Cell
estimate that 5–8% of Caucasians may
neurodegenerative diseases by Activation Disorders
have it, and be at risk for being
administering cyclin dependent kinase ACTION: Notice. symptomatic.
5 (Cdk5) inhibitory peptides derived Under the CRADA, the assay will be
from P35, the activator of Cdk5. SUMMARY: The National Institute of developed toward licensure. Due to the
Abnormally hyperactive Cdk5 has been Allergy and Infectious Diseases (NIAID), relatively high prevalence of serum
shown to be associated with a variety of a component of the National Institutes tryptase elevation, NIAID Investigators
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![Federal Register / Vol. 81, No. 68 / Friday, April 8, 2016 / Notices 20659
anticipate receiving a large number of individuals associated with the contract October 1, 1995, unless it displays a
samples for analysis which would proposals, the disclosure of which currently valid OMB control number.
exceed their capacity. A collaborator would constitute a clearly unwarranted Direct Comments to OMB: Written
with the expertise and capacity for invasion of personal privacy. comments and/or suggestions regarding
implementing a CLIA or FDA approved Name of Committee: National Institute of the item(s) contained in this notice,
test for this genetic variant is sought. Environmental Health Sciences Special especially regarding the estimated
A Cooperative Research and Emphasis Panel; NIH Loan Repayment public burden and associated response
Development Agreement (CRADA) is Program (Clinical and Pediatric Researchers). time, should be directed to the: Office
the anticipated collaborative agreement Date: April 22, 2016. of Management and Budget, Office of
to be entered into with NIAID pursuant Time: 8:00 a.m. to 5:00 p.m. Regulatory Affairs, OIRA_submission@
to the Federal Technology Transfer Act Agenda: To review and evaluate contract
proposals.
omb.eop.gov or by fax to 202–395–6974,
of 1986, codified as 15 U.S.C. 3710a, Place: NIEHS/National Institutes of Health, Attention: NIH Desk Officer.
and Executive Order 12591 of April 10, Keystone Building, 530 Davis Drive, Research Comment Due Date: Comments
1987, as amended. A CRADA is an Triangle Park, NC 27709 (Virtual Meeting). regarding this information collection are
agreement designed to enable certain Contact Person: Rose Anne M. McGee, best assured of having their full effect if
collaborations between Government Scientific Review Officer, Scientific Review received within 30-days of the date of
laboratories and non-Government Branch, Division of Extramural Research and this publication.
laboratories. A CRADA is not a grant, Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30, FOR FURTHER INFORMATION CONTACT: To
and it is not a contract for the Research Triangle Park, NC 27709, (919) 541– obtain a copy of the data collection
procurement of goods/services. The 0752, mcgee1@niehs.nih.gov. plans and instruments, submit
NIAID is prohibited from transferring (Catalogue of Federal Domestic Assistance comments in writing, or request more
funds to a CRADA collaborator. Under Program Nos. 93.115, Biometry and Risk information on the proposed project,
a CRADA, NIAID can contribute Estimation—Health Risks from contact: Ms. Deshiree Belis, National
facilities, staff, materials, and expertise. Environmental Exposures; 93.142, NIEHS Heart, Lung, and Blood Institute,
The CRADA collaborator can contribute Hazardous Waste Worker Health and Safety National Institutes of Health, 6705
facilities, staff, materials, expertise, and Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and Rockledge Dr., Suite 6185A, Bethesda,
funds. The CRADA collaborator will MD 20892, or call non-toll-free number
Education; 93.894, Resources and Manpower
also have an option to negotiate the Development in the Environmental Health 301–435–1032, or Email your request,
terms of an exclusive or non-exclusive Sciences; 93.113, Biological Response to including your address to
commercialization license to subject Environmental Health Hazards; 93.114, deshiree.belis@nih.gov. Formal requests
inventions arising under the CRADA. Applied Toxicological Research and Testing, for additional plans and instruments
The goals of the CRADA include the National Institutes of Health, HHS) must be requested in writing.
rapid publication of research results and Dated: April 5, 2016. Proposed Collection: The Framingham
timely commercialization of products, Carolyn Baum, Heart Study, 0925–0216, Revision,
diagnostics, and treatments that result Program Analyst, Office of Federal Advisory National Heart, Lung, and Blood
from the research. Committee Policy. Institute (NHLBI), the National
The expected duration of the CRADA [FR Doc. 2016–08094 Filed 4–7–16; 8:45 am] Institutes of Health (NIH).
with be two (2) to three (3) years. Need and Use of Information
BILLING CODE 4140–01–P
Dated: April 2, 2016. Collection: This proposal is to extend
Suzanne Frisbie, the Framingham Study to examine the
Deputy Director, Technology Transfer and DEPARTMENT OF HEALTH AND Generation Three Cohort, New Offspring
Intellectual Property Office, National Institute HUMAN SERVICES Spouses and Omni Group 2 Cohort, as
of Allergy and Infectious Diseases. well as to continue to monitor the
[FR Doc. 2016–08100 Filed 4–7–16; 8:45 am] National Institutes of Health morbidity and mortality which occurs
BILLING CODE 4140–01–P in all Framingham Cohorts. The
Submission for OMB Review; 30-Day
contractor, with the collaborative
Comment Request; The Framingham
assistance of NHLBI Intramural staff,
Heart Study (NHLBI)
DEPARTMENT OF HEALTH AND will invite study participants, schedule
HUMAN SERVICES SUMMARY: Under the provisions of appointments, administer examinations
Section 3507(a)(1)(D) of the Paperwork and testing, enter information into
National Institutes of Health Reduction Act of 1995, the National computer databases for editing, and
Institutes of Health (NIH) has submitted prepare scientific reports of the
National Institute of Environmental to the Office of Management and Budget information for publication in
Health Sciences; Notice of Closed (OMB) a request for review and appropriate scientific journals. All
Meeting approval of the information collection participants have been examined
Pursuant to section 10(d) of the listed below. This proposed information previously and thus the study deals
Federal Advisory Committee Act, as collection was previously published in with a stable, carefully described group.
amended (5 U.S.C. App.), notice is the Federal Register on 12/31/2015, Data are collected in the form of an
hereby given of the following meeting. pages 81830–81832. No comments were observational health examination
The meeting will be closed to the received. The purpose of this notice is involving such components as blood
mstockstill on DSK4VPTVN1PROD with NOTICES
public in accordance with the to allow an additional 30 days for public pressure measurements, venipuncture,
provisions set forth in sections comment. The National Heart, Lung and electrocardiography and a health
552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Blood Institute (NHLBI), National interview, including questions about
as amended. The contract proposals and Institutes of Health, may not conduct or lifestyles and daily living situations.
the discussions could disclose sponsor, and the respondent is not The National Heart, Lung, and Blood
confidential trade secrets or commercial required to respond to, an information Institute uses the results of the
property such as patentable material, collection that has been extended, Framingham Study to: (1) Characterize
and personal information concerning revised, or implemented on or after risk factors for cardiovascular and lung
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Document Created: 2018-02-07 13:49:51
Document Modified: 2018-02-07 13:49:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Interested CRADA collaborators must submit a confidential | |
| FR Citation | 81 FR 20658 |
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