Sources Sought This notice shall not be construed as a RFP or as any commitment or obligation on the part of the Government to issue a solicitation. The Government does not intend to award a contract on the basis of this request, so proposals will not be considered. No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow-up information requests. As permitted by FAR Part 10, this is a market research tool being utilized for informational and planning purposes. Your responses will assist the Government in the development of its acquisition strategy for a possible Request for Proposal (RFP), to be issued at a later date, and in determining whether any type of small business set-aside is possible for this procurement or whether full and open competitive procedures should be utilized. This is strictly market research and the Government will not entertain any questions. Background The ALS Registry Act (H.R. 2295) was passed on October 16, 2008. The ALS Registry Act amends the Public Health Service Act to require the Secretary of DHHS, acting through the Director of CDC/ATSDR, to (1) develop a system to collect data on amyotrophic lateral sclerosis (ALS); and (2) establish a national registry for the collection and storage of ALS data. In October, 2010, ATSDR officially launched the National ALS Registry. The purpose of the ALS Registry is to better describe the incidence and prevalence of ALS in the United States; examine factors, such as environmental and occupational, that might be associated with the disease; better outline key demographic factors (such as age, race or ethnicity, gender, and family history of individuals who are diagnosed with the disease) associated with the disease; and facilitate examination of the connection between ALS and other motor neuron disorders that can be confused with ALS, misdiagnosed as ALS, and in some cases progress to ALS. Because little is known about the role genetics plays in ALS, ATSDR conducted a pilot study to determine the feasibility of establishing a biorepository of samples from persons with ALS. The findings of that pilot study indeed support the creation of a biorepository. Current samples from the National ALS Biorepository are approximately 1400 patients have been collected, including blood, urine, hair, and nails samples, as well as post-mortem specimens from up to 48 patients, such as whole brains, spinal cords, and cerebrospinal fluid. Objective and Scope Objective The purpose of this contract is to maintain and continue a national biorepository of specimens from persons with ALS enrolled in the National ALS Registry. The National ALS Biorepository will consist of two components. The first component is the pre-mortem consisting of samples such as blood, urine, saliva, hair, and nails. The second is the post-mortem component which consists of samples such as bone, muscle, skin, teeth, whole brains, spinal cords, and cerebrospinal fluid (CSF). Note, these specimens are subject to change as required by the Government. Previously collected samples may be used for the purpose of creating cell lines as well as other derivatives for the purpose of advancing research in the areas of biomarkers, genetics, disease progression, and environmental exposures. Scope This technical approach involves nine primary tasks, in which the contractor will provide support services for the operation, collection, transport, maintenance, cataloging, dissemination, logistics, and ongoing analyses as directed by ATSDR of sample supply and demand of an existing biorepository of specimens from persons with ALS enrolled in the National ALS Registry. In performing this contract, the contractor shall: Task 1: IRB & OMB Support Support the National ALS Registry with relevant IRB and OMB-PRA package materials. The contractor shall prepare, deliver, be familiar with, and have knowledge of all necessary internal/external clearances documents (e-Clearance, IRB, OMB). Task 2: Participation Recruitment Select and recruit participants enrollees, with input from Registry staff, in the National ALS Registry. The contractor shall use an appropriate sampling scheme for choosing enrollees, so that samples are as nationally representative as possible. This is subject to change at the direction of ATSDR. Task 3: Consent and Scheduling Collection Conduct informed consent in accordance with an established ALS protocols and schedule collections. Task 4: Conduct Collection and Logistics Conduct collections and facilitate the logistics for enrollees to be sampled according to a geographical representative sampling scheme. The contractor shall provide all materials needed for the collections. Task 5: Process and Store Specimens Process and store specimens (according to existing protocol). Ensure all samples are stored properly and in an approved facility. Current inventory levels can be found here: https://www.cdc.gov/als/BiorepositoryStudies.html Task 6 : Specimen Request Process Support ATSDR in the ALS Specimen Request Process by implementing and existing approved plan for releasing specimens to qualified scientists/researchers. This includes facilitating data review to ensure scientific merit, recovering costs for specimen request, and managing distribution. The Government anticipates up to 10 requests per year. Task 7: Marketing Plan and Specimen Supply/Demand The contractor shall develop and implement an approved plan to market availability of specimens in the National ALS Biorepository to scientists/researchers, domestically and internationally. The contractor shall also conduct an analysis of the types of specimens that may be requested and collected as well as documentation of specimens distributed throughout the year. Task 8: Development of Publications Support development of publications related to the National ALS Registry/Biorepository. Should scientific publications be developed based on the work, the contractor shall comply with ATSDR and CDC requirements for pre-submission review, co-authorship, and clearance of scientific documents. Task 9: Collection of biospecimens from existing biorepositories Work with existing ALS research organizations that have ALS specimens for research that can be added to sample reserves of the National ALS Biorepository. This is subject to change at the direction of ATSDR. Submission Instructions: Responses via electronic mail (email) are due on or before January 15, 2021 at 2pm Eastern Time to Mr. Eric A. Uhls, email address:
[email protected] and must include the information requested below. Please include the notice ID (678-001) in the subject line of all correspondence. Only emailed responses will be accepted. Responses greater than 15 pages double-sided pages (including all attachments) will not be considered. Late responses will not be accepted. The North American Industry Classification System (NAICS) Code for this Sources Sought Notice is 541715 – Size Standards in number of employees: 1,000. Qualified firms shall submit a statement of interest on company letterhead demonstrating the firm’s qualifications to perform the defined work. Responses must be complete and sufficiently detailed to address the specific information. The documentation shall address, at a minimum, the following: Company Profile to include: Company name and address; Two points of contact (names, titles, phone numbers and email addresses); DUNS number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.betaSam.gov/: Business designation/status (must correlate with SAM registration): _____ Small business _____ HUBZone _____ WOSB _____ 8(a) _____ VOSB _____ SDVOSB _____ Small Disadvantaged Business ______Large business Documentation, in detail, of the company’s capability: Staff expertise, including availability, experience, and formal and other training; Completed projects in the last 5 years of similar size and scope; Corporate experience and management capability; Examples of prior completed Government contracts, reference, and other related information; Staff expertise, including availability, experience, and training; Comments or opinions pertaining to the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and/or approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; Proposed NAICS code: Recommendations for a different NAICS code. If so, please explain? This notice shall not be construed as a RFP or as any commitment or obligation on the part of the Government to issue a solicitation. The Government does not intend to award a contract on the basis of this request, so proposals will not be considered. No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow-up information requests. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications and capabilities to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality – No proprietary, classified, confidential, or sensitive information should be included in the response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Response is strictly voluntary - it is not mandatory to submit a response to this notice to participate in any formal RFP process that may take place in the future. However, it should be noted that information gathered through this notice may significantly influence our acquisition strategy. All interested parties will be required to respond separately to any solicitations posted as a result of this sources sought notice. We appreciate your interest and thank you in advance for responding to the Sources Sought.