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)

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.

[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]


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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.

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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