Newborn Screening Pilot Studies   6

THIS IS A REQUEST FOR PROPOSAL (RFP). THE PROPOSAL SUBMISSION DUE DATE HAS BEEN EXTENDED TO JULY 1, 2021.

The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institue of Child Health and Human Development (NICHD), Intellectual and Developmental Disabilities (IDD) Branch is planning to issue an RFP for multiple Indefinite/Delivery, Indefinite/Quantity (IDIQ) type contracts for an ordering period of six (6) years for the Newborn Screening Pilot Studies.

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.

Public Law 113-240 Sec 1116 of the Newborn Screening Saves Lives Reauthorization 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." Specifically, 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; and other activities that would improve newborn screening, as identified by the Director.

It has become evident, however, that a major impediment to implementing new technologies in high throughput newborn screening laboratories is the ability to provide evidence of the feasibility of the assay, both scientifically and logistically, in a timely manner. A majority of disorders considered for newborn screening are rare diseases where the likelihood of detecting cases during standard newborn screening in a single laboratory is very low. For this reason, collaborative efforts, implemented across multiple states or newborn screening laboratories, are necessary for the successful development and implementation of new assays and the addition of new conditions to the Recommended Uniform Screening Panel (RUSP). The RUSP panel now includes 35 core conditions and 26 secondary conditions as recommended by the ACHDNC.

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 acquisition will recompete a pool of high throughput newborn screening laboratories (state or private) with the capacity to screen many newborns (at least 100,000 over a two-year period) in relatively short periods of time that are representative of various regions of the United States.

It is the intent of this initiative that the selected contractors collaborate with other Federal agencies focusing on their areas of expertise in the field. The contractors will also leverage infrastructure resources that are part of NICHD's Newborn Screening Translational Research Network (NBSTRN; nbstrn.org), including the Longitudinal Pediatric Data Resource, common data elements, laboratory performance resources, and others. Use of algorithms such as the Collaborative Laboratory Integrated Reports tool to collect, aggregate, and analyze screening data and establish reference cutoff values is encouraged.

Overall, the contractor(s) will be required, in a State or private newborn screening laboratory, to 1) provide validation of testing strategies for new conditions designated by NICHD in a high throughput newborn screening environment; 2) perform confirmatory testing with sensitive and specific diagnostic tests; 3) refer infants who screen positive to an appropriate health care provider and/or specialty clinic for treatment and provide follow-up.

Testing will be implemented across the population for all newborns with no randomization and testing platforms will be chosen by the Contractor.

This is an RFP. This announcement does not commit the Government to award a contract(s). The following tentative schedule of events is anticipated for this acquisition:

The RFP and any amendments to the RFP will be available only electronically and can be accessed through the beta.Sam.Gov website at: https://beta.sam.gov/. It is anticipated that performance will begin on or about September 28, 2021.

OFFERORS ARE RESPONSIBLE FOR ROUTINELY CHECKING THE BETA.SAM.GOV CONTRACT OPPORTUNITIES WEBSITE FOR ANY POSSIBLE SOLICITATION AMENDMENTS THAT MAY BE ISSUED.

This acquisition is a full and open competition under the North American Industry Classification System (NAICS) code 541715. Any questions concerning this RFP must be submitted electronically to: Angela Wish at angela.wish@nih.gov, Contract Specialist and Alice Pagan at alice.pagan@nih.gov, Contracting Officer. The reference number to be used for this announcement is RFP-NIH-NICHD-IDD-2021-7. All electronic questions sent must include this reference number in the subject line of the email to both Ms. Wish and Ms. Pagan concurrently.