Federal contract opportunity NIH-NICHD-IDD-2014-12 for research and development in biotechnology at National Institutes of Health National Institute of Child Health and Human Development, response was due Mar 15, 2014.
Pilot Newborn Screening Studies of Novel Technologies in a High Throughput Environment
The goal 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. Such early detection and treatment can have a profound impact on the clinical severity of the condition in the affected child. If left undiagnosed and untreated, the consequences of the targeted disorders can be dire, many causing irreversible neurological damage, intellectual, developmental and physical disabilities, and even death. 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 by the Secretary of HHS. Most states now use this or very similar panels for newborn screening. Currently, there are thousands of rare disorders that have been identified and hundreds that could potentially benefit from newborn screening.
Sec. 116 of the Newborn Screening Saves Lives Act of 2007 encourages the NIH to "continue carrying out, coordinating, and expanding research in newborn screening --- including identifying, developing, and testing the most promising new screening technologies, in order to improve already existing screening tests, increasing the specificity of newborn screening, and expanding the number of conditions for which screening tests are available."
It has become evident that a major impediment to adding new conditions to the RUSP (recommended uniform screening panel) are the challenges related to implementing new technologies in high throughput newborn screening laboratories. The ability to provide evidence of the feasibility of the assay, both scientifically and logistically, in a timely manner is difficult. This is especially apparent when screening for rare diseases where the likelihood of detecting a single case during standard newborn screening in a single laboratory can take years. Collaborative efforts, implemented across multiple states or newborn screening laboratories, are necessary for the successful development and implementation of new assays.
The purpose of this contract is to support the development of novel technologies in newborn screening. This will be accomplished by conducting pilot studies of screening tools for new and promising conditions in a high throughput newborn screening environment.
It is the intent of this initiative to encourage collaboration with other Federal agencies with each agency focusing on their areas of expertise in the field. The project will also leverage resources that are part of NICHD's Newborn Screening Translational Research Network (NBSTRN) including access to the Laboratory Performance Program developed to collect, aggregate and analyze de-identified screening data.
To be deemed capable of performing this requirement, the offeror must submit a written capability statement that clearly demonstrates their experience and ability to provide the following capabilities:
• Technical expertise and high throughput capacity to test for disorders using newborn dried blood spots with appropriate screening technology either immediately or with a short set up period (less than 3 months).
• Ability to provide efficient confirmatory testing procedures for presumed positive results.
• The capacity and resources needed for tracking positive cases.
• The ability to arrange appropriate follow up care and referral of identified newborns in a time frame comparable to other currently used newborn screening assays.
• An administrative structure that is conducive to prospective, rather than retrospective, pilot testing (including documentation of ability to obtain human subjects approval within 6 months of being presented with an NICHD nominated condition).
• Documented quality assurance and quality control procedures in place for accurate assessment of findings.
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 a written capability statement. The Capability Statement should be limited to no more than 15 pages and it should clearly address each of the competencies stated above.
The written capability statement may be sent by regular U.S. Mail OR via email to the attention of Katharine Minker, Contracting Officer, by 3:00 PM local time on March 14, 2014.
If sending by U.S. Mail: Provide two hard copies and mail to: NIH, NICHD Office of Acquisitions, 6100 Executive Blvd., Room 7A-07 MSC 7510, Bethesda, Maryland 20892-7510.
If sending via email: The email address where capability statements should be emailed is email@example.com.