SOURCES SOUGHT
A -- Newborn Screening Translational Research Network
- Notice Date
- 2/20/2013
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in 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-2013-11
- Archive Date
- 3/23/2013
- Point of Contact
- Katharine Minker, Phone: 301-402-7571, David Fitton, Phone: 301-443-5239
- E-Mail Address
-
km571h@nih.gov, fittond@mail.nih.gov
(km571h@nih.gov, fittond@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Newborn Screening Translational Research Network Description Background: Newborn screening programs currently screen more than 4 million U.S. infants per year The intent of newborn screening is to detect potentially fatal or disabling conditions in newborns, thereby providing a window of opportunity for early treatment, often while the child is still asymptomatic. This public health program has saved countless lives through the identification of infants who are at risk for congenital disorders for which early interventions and treatments have the potential to reduce morbidity and mortality. In 2006 the American College of Medical Genetics (ACMG) developed newborn screening guidelines that recommend that all newborn infants be screened for 29 "core conditions" and that 25 secondary conditions identified during the core evaluations are to be reported. These recommendations have been accepted by the HHS Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) (authorized by the Children's Health Act of 2000), and the Secretary of HHS. Most states now use this or very similar panels for newborn screening. There has been broad acceptance of these screening guidelines by state screening laboratories, and interest in adding new tests that have been appropriately vetted to the recommended panel. In addition, under the Newborn Screening Saves Lives Act of 2007, the Hunter Kelly Newborn Screening Research Program within NICHD is authorized to carry out, coordinate, and expand research in newborn screening. Currently, policies related to newborn screening are determined through analysis of the severity and incidence of each condition under consideration, the specificity and sensitivity of the screening test, the natural history of the disorder, and the efficacy, safety, and effectiveness of treatments available for the disorder. To date, there are thousands of rare disorders that have been identified and hundreds that could potentially benefit from newborn screening. However, research in this arena, where many of the disorders are rare diseases and states have varying rules and regulations related to newborn screening, has been challenging for investigators. To address this problem in the NBSTRN was established to provide infrastructure support to scientist working to: a) Identify, develop and test promising new screening technologies; b) Increase the specificity of newborn screening; c) Expand the number of conditions for which screening tests are available or; d) Develop experimental treatments and disease management strategies for additional newborn conditions, and other genetic, metabolic, hormonal and or functional conditions that can be detected through newborn screening for which treatment is not yet available. The purpose of this solicitation is to hold an open competition to maintain and enhance the infrastructure resources within the NBSTRN. Objective: Maintain, administer and enhance the Newborn Screening Translational Research Network (NBSTRN) and the provision of technical, regulatory, statistical, and administrative support to carry out the tasks specified below, and other tasks as directed by the Project Officer: 1) Address the needs of biomedical investigators the country to effectively share and have access to dried bloodspots and other samples including possibly enrolled patients in a site-independent manner for research. 2) Facilitate evaluating the predictive value of biomarkers through early phase clinical/epidemiological studies. 3) Encourage collaboration and rapid dissemination of information to ensure progress and avoid fragmentation of effort. 4) Facilitate research on the development of new methods and technologies. 5) Facilitate research on screened and treated patients to define effectiveness of treatments and long-term outcomes. Requirements: To be deemed capable of developing and maintaining the NBSTRN, the offeror must submit a written capability statement that clearly demonstrates their experience and ability to: 1. Maintain and administer an efficient and reliable virtual repository of residual dried bloodspots. 2. Maintain, administer and enhance a laboratory performance database 3. Maintain and enhance a network of centralized and institutionally-enabled infrastructure to support the capture and managed storage of longitudinal clinical data from individuals following newborn screening. 4. Maintain a data repository that securely houses long term follow-up genomic data, materials metadata and key phenotypic data for subjects followed within the long term follow-up dataset. 5. Establish, Maintain and Administer a web based interactive resource related to the ethical, legal and social issues relevant to Newborn Screening for investigators. 6. Facilitate, through collaborations with other Federal entities (e.g., National Library of Medicine, Centers for Disease Control, Health Resources and Services Administration, relevant National Institutes of Health of Health Institutes) and interested stake holders, the development and use of common data elements and standardized language for newborn screening disorders and disorders that may benefit in the future from newborn screening. 7. Facilitate the timely dissemination of research findings. 8. Establish a twelve member Steering Committee, recommended by ACMG and consented by NICHD that will serve in an advisory capacity. It will be comprised of research scientists with expertise in disorders relevant to newborn screening. AT THIS TIME THE NICHD IS REQUESTING CAPABILITY STATEMENTS FROM ALL QUALIFIED BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSAL. The applicable North American Industry Classification System (NAICS) code for this requirement would be 541711. All qualified businesses, who believe that they have the capabilities described above are encouraged to submit two copies of written Capability Statement to attention of Katharine Minker, Contracting Officer, at the address provided by 3:00 PM Local Time on March 8, 2013. The address where capability statements should be mailed to is: NIH, NICHD Office of Acquisitions, 6100 Executive Blvd., Room 7A-07 MSC 7540, Bethesda, Maryland 20892-7510.The Capability Statement should be limited to no more than 15 pages and it should clearly address each of the competencies stated above. NO COLLECT CALL WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL SEE NUMBERED NOTE 25.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-CDBPM-2013-11/listing.html)
- Record
- SN02991305-W 20130222/130220234443-c08295e2d540bac338b60a063f95e141 (fbodaily.com)
- Source
-
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