SOLICITATION NOTICE
A -- Newborn Screening Pompe Pilot Study
- Notice Date
- 4/10/2014
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-IDD-2014-12
- Point of Contact
- Katharine Minker, Phone: 301-402-7571, Alice L Pagan, Phone: 301-435-6959
- E-Mail Address
-
km571h@nih.gov, ap425k@nih.gov
(km571h@nih.gov, ap425k@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Pre-Solicitation Notice. This is not a request for technical or cost proposals. No solicitation is available at this time and requests for solicitation packages will not receive a response. The goal of public health newborn screening programs 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 27 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. Sec. 116 of the Newborn Screening Saves Lives Act of 2007 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." It has become evident 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 example Michigan has 114,159 annual births and Severe Combined Immune Deficiency has a reported prevalence of 1:100,000. 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). Pompe disease is one of at least 40 different types of Lysosmal Storage Disorders (LSDs). Pompe disease leads to a deficiency of the enzyme acid α-glucosidase (GAA), resulting in the accumulation of lysosomal glycogen ultimately leading to to tissue damage. All individuals with Pompe disease share the underlying GAA enzyme deficiency however, variability in enzyme activity leads to a broad spectrum of illness. Pompe disease is generally classified into two broad categories, infantile and late-onset disease. Infantile-onset Pompe disease is the most severe form of the disease It can be further divided into the classic form, with profound and progressive hypotonia and cardiomyopathy, and death in the first year of life. The nonclassic infantile form is not associated with cardiomyopathy and survival may be longer. Individuals with late-onset disease may not develop clinically significant weakness until later in childhood or as adults. This form of Pompe disease is associated with progressive weakness. Premature death can occur in middle age or older ages due to respiratory failure. Late-onset Pompe disease varies in age of onset and degree of illness. Late-onset Pompe disease can also be associated with specific types of cardiac involvement. It must be noted that at the time of diagnosis and through the first year of life, it may be difficult to classify cases, which can make the description of ongoing prospective case-finding activities challenging to describe. The purpose of this contract is to support the development, implementation and proof of concept in newborn screening for Pompe disease. NICHD intends to solicit proposals for this effort through full and open competitive procedures under NAICS 541711. It is anticipated that multiple (up to three) cost reimbursement, completion type contracts will be awarded for an 18-month period of performance. Performance will begin on or about September 26, 2014. This RFP will be available electronically on or about May 1, 2014, and may be accessed through the FedBizOpps website at http://www.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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NICHD-IDD-2014-12/listing.html)
- Record
- SN03336051-W 20140412/140410235552-a30fe6f0d498f28c9df09bf1f5166d3e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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