Lewy Body Dementia Brain and DNA Tissue Samples from the National Centralized Repository for Alzheimer's Disease and Related Dementias

THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD ON A SOLE SOURCE BASIS. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. The purpose of this procurement is to provide the National Institute of Neurological Disorders and Stroke (NINDS), Neurodegenerative Research Unit (NDRU) Laboratory with 835 Lewy body dementia DNA samples (5 ?g of DNA per patient in 50 ng/?l dilutions) and 34 Lewy body dementia brain tissue samples (100 mg/case) from the National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD) (Biospecimens). The contractor shall provide the above-described Biospecimens to the NDRU Laboratory within thirty to sixty days after receipt of the Government's purchase order. REGULATORY AUTHORITY: The resultant purchase order will include all applicable provisions and clauses of the Federal acquisition Regulation (FAR) in effect through Federal Acquisition Circular (FAC) 2023-02 published February 14, 2023. STATEMENT OF NEED AND PURPOSE: The Neurodegenerative Diseases Research Unit (NDRU) Laboratory, a part of the National Institute of Neurological Disorders and Stroke (NINDS), has undertaken a project aimed at identifying genetic risk factors in patients suffering from Lewy body dementia (LBD), a fatal form of dementia affecting about 1.4 million Americans. Toward this end, the NDRU Laboratory requires 869 brain and DNA tissue samples collected from Lewy body dementia patients. These unique tissue samples are stHored at the National Centralized Repository for Alzheimer's Disease and Related Dementias (NCRAD), a NIH-funded, national repository where clinical information and biological materials such as DNA, plasma, serum, RNA, CSF, cell lines and brain tissue can be stored and requested by dementia researchers. The NDRU Laboratory will use the tissue samples for whole-genome sequencing, to apply modern gene discovery techniques to this understudied form of dementia, and to generate a genomic resource for the dementia research community. Obtaining these tissue samples is critical for the continuation of NDRU Laboratory's research efforts in studying the molecular genetic underpinnings of LBD. The unique, 869, Lewy body dementia brain and DNA tissue samples are available only from the NCRAD. Direct substitutes of these tissue samples cannot be obtained from any other source. BACKGROUND INFORMATION AND OBJECTIVE: Age-related neurodegenerative conditions place a growing and substantial socioeconomic burden on people residing in the United States. Although a lot of progress has been made in defining the genetic risk factors for Alzheimer's disease, there is an unmet need to understand the genetic determinants in Lewy body dementia (LBD), a fatal neurodegenerative disease affecting about 1.4 million Americans. The NDRU Lab will perform whole-genome-sequencing of DNA samples from patients diagnosed with LBD, apply modern gene discovery tools, and expand the LBD genomic resource (https://amp-pd.org/unified-cohorts/lbd) for the research community. Increasing the number of cases with LBD for genomic investigations will allow the NDRU Lab to identify novel risk factors and accelerate the pace of therapeutic discovery in this understudied disease. This project is central to the NDRU's mission to understand the genetic causes of neurodegenerative diseases that are plaguing millions of Americans. SALIENT CHARACTERISTICS: These unique Biospecimens and associated data are stored at the NCRAD. The Biospecimens are part of the only and largest collection of tissue samples from Lewy body dementia patients. QUANTITY: Eight hundred thirty-five (835) Lewy body dementia DNA samples (5 ?g of DNA per patient in 50 ng/?l dilutions) and thirty-four (34) Lewy body dementia brain tissue samples (100 mg/case) DELIVERY REQUIREMENTS: The above-described Biospecimens shall be delivered 30 to 60 days after receipt of the Government's purchase order, to the Neurodegenerative Disease Research Unit, Neurogenetics Branch, NINDS, 35 Convent Dr., Room 1B-205, Bethesda, MD 20892-3707, ATTN: Dr. Sonja Scholz. SINGLE-SOLE SOURCE DETERMINATION This is a non-competitive procurement conducted under the authority of 41 U.S.C. 253(c) under provisions of statutory authority of FAR Subpart 6.302-1 - only one responsible source and no other supplies or services will satisfy agency requirements. The salient characteristics of the Biospecimens that limit the availability to a single source are NCRAD maintains the largest collection of LBD tissue samples and associated data in the world, no other biospecimen repository possesses and can provide these Biospecimens, and no direct substitutes for these Biospecimens exist. As there is no reasonably available alternative for obtaining these Biospecimens, and since only the NCRAD can provide the Biospecimens, the Government intends to issue a purchase order on a sole-source basis to the following vendor: Trustees of Indiana University 980 Indiana Ave., Room 2232 Indianapolis, IN 46202-5130 ATTN: Kaci Lacy, Project Manager. National Centralized Repository for Alzheimer's Disease and Related Dementias Contract Type: A firm-fixed-price contract is planned for this acquisition. CLOSING STATEMENT THIS NOTICE OF INTENT TO AWARD ON A SOLE-SOURCE BASIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability in response to this notice. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this Notice shall contain sufficient information to establish the interested party's bona-fide capability to fulfill the requirement and shall include unit price, list price, shipping and handling costs, the delivery period after contract award, prompt payment discount terms, the F.O.B. Point (Destination or Origin), the organization's Unique Entity ID (UEI) and Taxpayer Identification Number (TIN), and the organization's certification of business size for the applicable NAICS code. All offerors must have an active registration in the System for Award Management (SAM) (www.sam.gov) at the time of response submission. All responses must provide evidence of the offeror's ability to provide the items that meets all the requirements in this announcement. All responses must be received by the closing date and time of this announcement and reference Notice ID 75N95023Q00142. Responses must be submitted electronically to Marlene Milgram, Contract Specialist, NINDS Section, Office of Acquisitions, National Institute on Drug Abuse at contact@example.gov. Responses submitted by U.S. Mail or fax will NOT be accepted.