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Delivery Order HHSN275201500001I-HHSN27500002
Award Date
9/15/16
Potential Completion Date
6/30/18
Potential Value
$630K
Overview
🤔 AI Insights
Buyer Personas
Industry Personas
Buyer Personas In this Market
Activity
2
Transactions
3
Subawards
Opportunity Stack
1
Federal Agency
National Institute of Child Health and Human Development
Awardee
Emory University
Ultimate Awardee
Not listed
NAICS Category
541712 - Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
PSC Category
AN12 - Health R&D Services; Health Care Services; Applied Research
Federal Contract Vehicle
Newborn Screening Pilot Studies
Set-Aside Type
No Set-Aside Used
Extent Competed
Full and Open Competition
Major Defense Program
Not listed
Pricing Type
Cost No Fee
Place of Performance
Atlanta, GA 30322, USA
Solicitation Procedures
Multiple Award, Fair Opportunity
Number Of Offers Received
3
Legislative Mandate
Economy Act
National Interest Action
Not listed
Research Type
Not listed
Primary Consortia Member
Not listed
Newborn Screening Pilot Studies
Master IDIQ
HHSN275201500001I
Indefinite Delivery Contract
HHSN275201500001I-HHSN27500002
Delivery Order
Description
Update #1
- R & D- MEDICAL: BIOMEDICAL (APPLIED RESEARCH/EXPLORATORY DEVELOPMENT)
Posted 9/15/16, 12:00 AM
Name
Description
Solicitation Number
Federal Agency
Type
Posted Date
(Click to sort descending)
Newborn Screening Pilot Studies
Added: May 01, 2015 1:25 pm THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT MAY 18, 2015. THE ANTICIPATED DUE DATE FOR SUBMISSION OF PROPOSALS IN RESPONSE TO THE RFP IS ON OR ABOUT JULY 2, 2015.The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Intellectual and Developmental Disabilities (IDD) is planning to issue an RFP for multiple Indefinite/Delivery, Indefinite/Quantity (IDIQ) task order contracts for a period of five (5) years for the Newborn Screening Pilot Studies.The purpose of this acquisition is to create a pool of high throughput newborn screening laboratories with the capacity to screen a large number of newborns in relatively short periods of time that are representative of various regions of the United States. The selected Contractors will operate under an IDIQ Task Order contract to rapidly develop protocols and initiate testing shortly after the addition of a new condition to the Recommended Uniform Screening Panel (RUSP).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 31"core conditions" and that 26 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 116 of the Newborn Screening Saves Lives Reauthorization Act of 2014 encourages the NIH to “conduct pilot studies on conditions recommended by the Advisory Committee to ensure that screenings are ready for nationwide implementation.”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 implementation of assays and the addition of new conditions to the RUSP.The requirements of the contract will not extend beyond the scope of what a state or entity would do to add any new condition to the state newborn screening panel and does not include what would be considered "research" under the HHS protection of human subjects regulations, 45 CFR Part 46. The Contractors shall collaborate with other Federal agencies focusing on their areas of expertise in the field. The Contractors shall also leverage infrastructure resources that are part of NICHD’s NBSTRN.The Contractors shall, in a State Newborn Screening environment, 1) provide validation of technologies amenable to newborn screening; 2) perform confirmatory testing with sensitive and specific diagnostic tests; 3) refer children who screen positive for treatment and provide follow-up. Testing will be implemented state-wide for all newborns with no randomization and testing platforms will be chosen by the state.The Contractor shall perform testing on a variety of newborn screening appropriate disorders recommended by the RUSP.This is not an RFP and this announcement does not commit the Government to award a contract. The RFP is subject to the availability of funds. The RFP will be available electronically on or about May 18, 2015 and may be accessed through the FedBizOpps website at http://www.FedBizOpps.gov. The due date for submission of proposals in response to the RFP is anticipated on or about July 2, 2015. Performance will begin on or about September 29, 2015. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement.This acquisition has been designated as a full and open competition under the North American Industry Classification System (NAICS) code 541712. Any questions concerning this announcement must be submitted electronically to Megan Gnall at megan.gnall@nih.gov, Contracting Officer AND Alice Pagán at alice.pagan@nih.gov, Contracting Officer. The reference number to be used for this announcement is RFP-NIH-NICHD-IDD-2015-3. All electronic questions sent must include this reference number in the subject line of the email to both Ms. Gnall and Ms. Pagán concurrently.
NIH-NICHD-IDD-2015-3
Department of Health and Human Services National Institutes of Health
Award Notice 1/1
5/1/15, 1:25 PM
Mod #
Description
Reason For Modification
Federal Obligation
(Click to sort descending)
Date
(Click to sort ascending)
P00002
NEWBORN SCREENINGS FOR PILOT STUDY FOR ADRENOLEUKODYSTROPHY (ALD)
Close Out
($34k)
8/28/19
1
Other Administrative Action
$0
3/6/18
Not listed
- R & D- MEDICAL: BIOMEDICAL (APPLIED RESEARCH/EXPLORATORY DEVELOPMENT)
Not listed
$663.9k
9/15/16