MODIFICATION
A -- Newborn Screening Translational Research Network
- Notice Date
- 2/28/2013
- Notice Type
- Modification/Amendment
- 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
- 3/30/2013
- Point of Contact
- Katharine Minker, Phone: 301-402-7571, Ross Kelley, Phone: 301-435-6960
- E-Mail Address
-
km571h@nih.gov, rk17a@nih.gov
(km571h@nih.gov, rk17a@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Newborn Screening Translational Research Network Description is revised to read as follows: The Intellectual and Developmental Disabilities Branch (IDD) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is interested in identifying any concerns with the requisite capabilities to establish and maintain a Newborn Screening Translational Research Network (NBSTRN). 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 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. In order to execute this type of research responsibly and successfully, a comprehensive research infrastructure is needed therefore, the NICHD proposes to establish and maintain a research infrastructure for a Newborn Screening Translational Research Network (NBSTRN). Objective: The primary purposes of the NBSTRN are to provide an infrastructure for research that facilitates the development of new screening methods, clinical trials for new therapeutic interventions and support longitudinal research to study the long-term health of children identified through newborn screening. The NBSTRN shall support the following goals: Requirements: To be deemed capable of establishing and maintaining the NBSTRN, the offeror must submit a written capability statement that clearly demonstrates their experience and ability in each of the following areas to: 1) Establish, maintain and administer a virtual repository of dried blood spots. 2) Establish, maintain and administer a laboratory performance database. 3) Establish, maintain and administer a system of long term clinical follow-up of individuals identified via newborn screening. 4) Establish, maintain and administer - Ethical and Legal support resource for investigators 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 is 541711. All qualified businesses who believe that they have the capabilities described above are encouraged to submit two copies of a written Capability Statement to attention of Katharine Minker, Contracting Officer, at the address provided by 3:00 PM Local Time on March 15, 2013. The address where capability statements should be mailed to is: National Institutes of Health, NICHD Office of Acquisitions, 6100 Executive Blvd., Room 7A-07, MSC 7510, 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 CALLS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL to km571h@nih.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-CDBPM-2013-11/listing.html)
- Record
- SN02998618-W 20130302/130228234829-23b9ad90d8e9f4157d58350651a1220c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |