Newborn Screening Translational Research Network

Small Business Sources Sought (SBSS) Notice Number: NIH-NICHD-SBSS-2018-17 Agency/Office: National Institutes of Health Location: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Key Dates: Release Date: January 12, 2018 Response Date: January 29, 2017 Purpose of this Announcement: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. 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; (a) small businesses, veteran-owned 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 541711 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1000 employees or less. Background and Project Requirements: 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) (originally authorized by the Children's Health Act of 2000), and the Secretary of HHS. This panel now includes 34 core conditions and 26 secondary conditions that form the Recommended Uniform Screening Panel (RUSP). 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 and reaffirmed under the Newborn Screening Saves Lives Reauthorization Act of 2014, 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, the Newborn Screening Translational Research Network (NBSTRN) was established to provide infrastructure support and scientific guidance to researchers 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; and/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 NBSTRN and provide technical, regulatory, statistical, scientific, and administrative support to carry out the tasks specified below: 1) Address the needs of biomedical investigators throughout 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. Anticipated Period of Performance: The anticipated period of performance is five years, from September 2018 - September 2023. Capability Statement/Information: The NICHD is seeking Small Businesses capable of meeting the criteria listed below. Small Business organizations must submit Capability Statements in response to this notice. 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 (ELSI) relevant to Newborn Screening for investigators. 6. Facilitate, through collaborations with other Federal entities and interested stakeholders, 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. Support active and future newborn screening research projects, including pilot studies for conditions with the potential to be added to the RUSP. 8. Facilitate the timely dissemination of research findings in the form of written publications, web-based materials, and presentations at newborn screening-related in-person or virtual meetings, such as the annual ACMG meeting and the Association of Public Health Laboratories newborn screening symposium to a variety of stakeholders. 9. Establish working groups composed of scientific experts in the NBS field to provide input on topics relevant to NBSTRN functions, such as: - integration of data into clinical practice - common data elements - long-term follow up - bioethics and legal issues - IT security and data governance 11. Establish a twelve-member Steering Committee, whose members will be recommended by ACMG and consented by NICHD, that will serve in an advisory capacity. It will convene at least twice a year and be comprised of: a) Research scientists with expertise in disorders relevant to newborn screening b) Clinicians c) Ethicists d) Bioinformatics experts e) Laboratory experts f) Public health professionals 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 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. Responses to this notice will not be considered adequate responses to a solicitation. CONFIDENTIALITY: No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Interested Small Business organizations that believe they possess the capabilities necessary to perform this project should submit electronic copies to Katharine Minker, Contracting Officer (E-mail to katharine.minker@nih.gov) Please limit responses to 20 pages or less. These pages exclude resumes. Electronic capability statements should be received by the Contracting Officer by January 29, 2018, 4:00 pm EST. Capability statements must identify the business status of the organization, NAICS code along with DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZONE). Inquiries should be directed to: Katharine Minker, Contracting Officer, DHHS/NIH/NICHD/CMB, km571h@nih.gov telephone 301-402-7571, OR, Secondary point of contact Lola St. John, Contracting Officer, DHHS/NIH/NICHD/CMB, Email: lk202p@nih.gov