SOLICITATION NOTICE
A -- Novel Technologies in Newborn Screening
- Notice Date
- 8/6/2009
- Notice Type
- Presolicitation
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-CDBPM-10-14
- Archive Date
- 10/6/2009
- Point of Contact
- Seena Mathews, Phone: 301-435-4965, Ross Kelley, Phone: 301-435-6960
- E-Mail Address
-
mathewss@mail.nih.gov, rk17a@nih.gov
(mathewss@mail.nih.gov, rk17a@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Branch, Office of Acquisitions intends to negotiate a 12 month extension to the contract with Health Research Incorporated (HRI) of Rensselaer, NY to continue operations of the Novel Technologies in Newborn Screening. The planned extension will permit HRI and collaborators to provide evidence and feasibility of technologies related to Severe Combined Immunodeficiency (SCID) in the environment of newborn screening. The extension in time is needed to provide ample time for HRI to coordinate the evaluation of a sample of significant power to provide evidence of efficacy. The objective of the contract is to specifically: (1) develop and refine Luminex universal DNA array assays to detect mutations associated with the following disorders: galactosemia, biotinidase deficiency, medium-chain-acyl-CoA dehydrogenase (MCAD) deficiency, hearing loss due to connexion-26 mutations or cytomegalovirus; (2) develop xMAP assays by applying multiplex immunoassay techniques to test for the following conditions: congenital hypothyroidism, congenital adrenal hyperplasia, cystic fibrosis, Krabbe disease and other leukodystrophies; combine and multiplex to a single assay; (3) evaluate and validate each protocol using de-identified samples from the New York State Newborn Screening Program and the CDC National Newborn Screening Quality Assurance Program; (4) evaluate and validate each protocol using fully characterized newborn samples tied to complete 10-year medical histories from the Newborn Screening Program of the States Serum Institute; (5) provide quality control and performance control standards for the operation of each new protocol developed through interaction with the CDC; and, (6) integrate statistical data and results from the xMAP system into the PerkinElmer Specimen Gate Laboratory Information Management System (LIMS), which is compatible with other enterprise-level databases. Statutory authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(a)(2)(ii), only one responsible source and no other supplies or services will satisfy agency requirements. The contractor is uniquely qualified by virtue of its continued performance over this period of time and is the only source that can provide the oversight of evidence and feasibility analyses for the following reasons: there is infrastructure in place which would allow for a short start-up time for new projects, the program has a collaboration in place with the CDC, and the laboratory is prepared to coordinate statistical date and results immediately. In addition, given the rapid pace of progress in the field and development of new candidate disorders for newborn screening, HRI has the necessary scientific expertise to allow integration of newly developed testing algorithms into its current platform. However, if there are sources who feel they are able to perform the requirement, they must respond by submitting information (5 page limit) required in Numbered Note 22 within 45 days of publication of this synopsis. To be deemed capable of providing laboratory oversight for a multistate pilot study of SCID the offeror must submit a written capability statement that clearly demonstrates: 1) The technical expertise and large-scale capacity to test for SCID in identified newborn dried blood spots, using appropriate screening technology either immediately or with a short set up period (less than 3 months). 2) The ability to provide immediate confirmatory testing procedures for presumed positive results. 3) The capacity and resources needed for tracking positive cases and arranging for appropriate follouw up care and referral of identified newborns with presumed SCID in a timely manner 4) An administrative structure that is conducive to prospective, rather than retrospective, pilot testing (including documentation of ability to obtain human subjects approval in a timely manner). 5) Adequate quality assurance and quality control procedures in place for accurate assessment of findings. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. The capability statement will be considered solely for the purpose of determining whether to conduct a competitive procurement. Overnight deliveries should be mailed to the National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Boulevard, Suite 7A07, Bethesda, Maryland 20852. No collect calls or facsimile transmissions will be accepted. Respondents may submit their capability statements via email in addition to 2 hard copies
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-CDBPM-10-14/listing.html)
- Record
- SN01902352-W 20090808/090807000921-75ffbaea8984bcc9fe9c84d90e83a895 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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