Biological Specimens’ Receipt, Storage, Management and Distribution
This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regar... This is a Research and Development (R & D) Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential R & D requirement. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: The National Institute on Aging (NIA) at the National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS), conducts and funds various longitudinal and clinical studies on aging that generate or have generated collections of biological specimens (biospecimens), related phenotypic and clinical data, imaging data, and other resources pertaining to these research activities. The NIA’s Division of Geriatrics and Clinical Gerontology established the Aging Research Biobank (Biobank) and officially announced it in January 2019 (https://agingresearchbiobank.nia.nih.gov/). The main goal is to provide a state-of-the-art inventory system for the receipt, storage, maintenance, and distribution of biospecimens, related phenotypic and clinical data, imaging data, and other resources in support of future research initiatives. Receiving, storing, managing, and allowing subsequent use of biological materials and associated data collected in clinical studies is one way for the NIA to meet its responsibility to maximize the value of these studies and comply with NIH Data Sharing Policy (https://sharing.nih.gov/data-management-and-sharing-policy). Scientists not involved in the original studies are then enabled to test new hypotheses without new data or biospecimen collection and potentially pool data across several studies to increase the power of statistical analyses. Further, the collection of patient and control biospecimens from many different studies in a single repository is extremely valuable because researchers can more rapidly access them through the Aging Research Biobank to validate clinical hypotheses and algorithms for clinical decision making. These collections considerably contribute to a better understanding of the aging process by advancing the development of prognostics, markers, and therapeutics for conditions related to aging. Purpose and Objectives: Biospecimens are generally received as bulk relocations at the end of a study, but partial relocations or intermittent shipping from ongoing studies also occur. This requirement involves, receipt, storage, maintenance, and distribution of: A) Collections already in house (10 study collections, with a total of 2,476,086 samples (as of June 2022) including the following various types: adipose tissue; buffy coat, cell pellets (including buccal cell pellets; dry cell pellets); cryopreserved cells; DNA, EVB B-cells; EBV B-Cell pellets; muscle tissue; packed cells; PAXgene; PBMC; plasma (including plasma citrate; plasma EDTA); serum; urine (including 24-hour urine; spot urine); whole blood. B) Optional tasks that target the expansion of the Aging Research Biobank program through inclusion of new collections of biospecimens and related phenotypic and clinical data, imaging data and other resources on an ongoing base for the duration of the contract periods. Once included in the Aging Research Biobank, these new collections estimated in 500,000 new biospecimens will undergo the same required services outlined here for receipt, storage, maintenance, and distribution. The biospecimens currently stored or to be stored in the Aging Research Biobank were or are being collected over many years from studies that carefully selected subjects and are available in a finite quantity. Each biospecimen is unique and cannot be replaced if lost, damaged, or contaminated. Therefore, it is critical that these biospecimens are stored under optimal conditions according to type of biospecimen, following standard operating procedures (SOPs) and best biorepository practices. The Contractors responsible for the Aging Research Biobank Biological Specimens Receipt, Storage, Maintenance and Distribution (Biospecimens Contract) and for the Aging Research Biobank Data Coordination and Systems Management (Data Contract) shall collaborate closely to develop tools to facilitate management and usage of the Aging Research Biobank resources. Project requirements: The main purpose of this requirement is to give continuity to research and development services already in place for existing resources, improve these services, and expand the Aging Research Biobank collection by bringing additional new biospecimens from ongoing or new studies or from collections already stored in the Aging Research Biobank. This Biological Specimens Receipt, Storage, Management, and Distribution component of the Aging Research Biobank is aimed to accomplish the following in a highly efficient, rapid, secure, and cost-effective manner as summarized: A. Planning and logistics to ensure provision of a scientific, technical, and administrative infrastructure that supports efficient planning, initiation, implementation, and management of the Aging Research Biobank activities. B. Securing, receiving, cataloging, processing, storing, and disbursing human biological specimens from NIA-sponsored studies or studies approved to have their biospecimens and related phenotypic and clinical data and other resources included in the Aging Research Biobank. C. Providing adequate cold storage facilities and equipment (freezers are to be acquired with Federal funds under this requirement) that will help secure, catalogue, process, store, and disburse biospecimens following Biospecimen Repository Best Practices as defined by the International Society of Biological and Experimental Repositories-ISBER (http://www.isber.org) or by the National Cancer Institute (NCI) available at https://biospecimens.cancer.gov/bestpractices/. D. Providing a secure back-up system and a plan for disaster recovery. E. Developing, performing, and maintaining Quality Assurance Surveillance Program (QASP) for the facility, operations, stored specimens, shipping materials, and personnel in accordance with all applicable Federal, State, and local regulations. F. Providing a web-based computerized inventory/tracking database for the biospecimens management to support the Aging Research Biobank operations. G. Developing and implementing a transition plan that includes budget to ensure proper documentation of stored biospecimens at the conclusion of the performance period or upon request by the NIA Contracting Officer’s Representative (COR). Anticipated period of performance: Base Period: July 30, 2023 – July 29, 2024, plus four option years. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in an outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contract Specialist and Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Karen Mahon, Contracting Officer, at e-mail address Karen.Mahon@nih.gov. The response must be received on or before September 8, 2022, 10:00 am, Eastern Time. “Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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 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 presolicitation synopsis and solicitation may be published in www.sam.gov. 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 your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”
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