Newborn Screening Translational Research Network (NBSTRN)

Added: May 17, 2018 7:33 am Pre-Solicitation Notice Information

Introduction

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), of the Department of Health and Human Services (HHS) supports research related to newborn screening. The NICHD, Intellectual and Developmental Disabilities Branch, has a requirement to maintain and enhance the infrastructure resources within the Newborn Screening Translational Research Network (NBSTRN).

Description

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.

NICHD intends to solicit proposals for this effort through full and open competitive procedures under NAICS 541715.

Selection of an Offeror for contract award will be based on an evaluation of proposals against three factors. The factors in order of importance are: (1) technical, (2) cost/price, and (3) past performance. Technical factors are significantly more important than cost/price.

It is anticipated that a single cost reimbursement, completion type contract will be awarded for a 5-year period of performance consisting of a base and four option periods. Performance will begin on or about September 26, 2018, with an anticipated effort of approximately 6,566 FTEs per year.

Any responsible offeror may submit a proposal which will be considered by the Agency.
This RFP will be available electronically on or about June 4, 2018, and may be accessed through the FedBizOpps website at http://FedBizOpps.gov. All responsible sources may submit a proposal which will be considered by the agency. This notice does not commit the Government to award a contract.

No collect calls will be accepted. No facsimile or email transmissions will be accepted.