Newborn Screening Pilot Studies

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This synopsis has been updated to correct the synopsis title to, "Newborn Screening Pilot Studies." The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources? (2) whether they are small businesses? service disabled veteran owned small businesses? 8(a) small businesses, veteran owned small businesses? HUBZone small businesses? woman owned small businesses? or small disadvantaged businesses and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This requirement is assigned a code of 541715 in the NAICS, and the small business size standard for such requirements is 1,000 employees or less. Background: 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 recommended that all newborn infants be screened for 29 "core conditions" and that 25 secondary conditions identified during the core evaluations be reported. These recommendations were 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. This panel now includes 35 core conditions and 26 secondary conditions that form the Recommended Uniform Screening Panel (RUSP). Currently, there are thousands of rare disorders that have been identified and hundreds that could potentially benefit from newborn screening. Sec. 113 of the Newborn Screening Saves Lives Act of 2014 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." In addition, the Newborn Screening Saves Lives Act Reauthorization of 2014 states: - The Secretary, in conjunction with the Director of the National Institutes of Health and taking into consideration the recommendations of the Advisory Committee, may continue carrying out, coordinating, and expanding research in newborn screening (to be known as "Hunter Kelly Newborn Screening Research Program") including conducting pilot studies on conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementation. It has become evident that a major impediment to adding new conditions to the RUSP is the challenges related to implementing new technologies in high throughput newborn screening laboratories. The ability to provide evidence of the feasibility of the assay and confirmatory testing for the condition, 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 often necessary for the successful development and implementation of new assays. The purpose of this requirement is to support the development of the evidence base for new conditions to be added to the RUSP and the feasibility of implementing new screening paradigms in a newborn screening setting. This will be accomplished by conducting pilot studies for new and promising conditions with high potential to be nominated to the RUSP, or those recently nominated (or in some cases, recently approved) for addition to the RUSP, in a high throughput newborn screening environment. This contract will compete a pool of high throughput newborn screening laboratories (state or private) with the capacity to screen many newborns in relatively short periods of time that are representative of various regions of the United States. 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 the Longitudinal Pediatric Data Resource, common data elements, laboratory performance resources, and others. Use of algorithms such as the Collaborative Laboratory Integrated Reports (CLIR) tool to collect, aggregate, and analyze screening data and establish reference cutoff values is encouraged. Requirements: To be deemed capable of performing this requirement, the potential offerors must submit a capability statement that clearly demonstrates their experience and ability to provide the following capabilities: Technical expertise and high throughput capacity to test a large number of samples (at least 100,000 over a two-year period) for disorders using newborn dried blood spots with appropriate screening technology either immediately or with a short set-up period. 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 the selected condition) and adhere to state or program requirements for informed consent. Documented quality assurance and quality control procedures in place for accurate assessment of findings. The capacity to screen for more than one new condition during a 5-year period under this contract when additional conditions are selected for pilot testing (generally one new condition every 1-2 years) Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Confidentiality: Any proprietary information included must be marked as such. Responses: Small businesses that believe they possess the capabilities necessary to undertake this project should send an electronic copy of their capability statement addressing the areas listed above. Please state clearly in the subject line of the email that it is in response to NIH NICHD-IDD-SBSS-2021-7. Please limit responses to 15 pages or less, exclusive of resumes. Electronic capability statements should be received by the Contracting Officer no later than 2:00 PM Eastern time on February 12, 2021. Capability statements must identify the small business status of their organization. No phone calls will be accepted. Respondents must submit their capability statement via electronic submission only. Information submitted must be pertinent and specific in the technical areas under consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in house research and development effort? (2) Personnel: Name, professional qualifications and specific experience of scientist, and technical personnel who may be assigned as principal investigator and/or project officer? (3) Facilities: Availability and description of facilities required to perform the work. Any other specific and pertinent information as it pertains to this area of procurement that would enhance our consideration and evaluation of the information submitted. The designated NAICS code for this effort is 541715 and the size standard is 1,000 employees or less. Please send your capability statement to the attention of Angela Wish at angela.wish@nih.gov and Alice Pagan at alice.pagan@nih.gov.