NIH Brain and Tissue Repository

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) the classification/ type of small business (e.g., whether they are small businesses, 8(a) small businesses, HubZone small businesses, service-disabled veteran-owned small businesses, veteran-owned small business, economically disadvantaged women-owned small business (EDWOSB) or women-owned small business (WOSB)) and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. Teaming and partnering arrangements among small businesses is encouraged. A. Background The National Institute of Mental Health (NIMH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health, seek to establish mechanisms to make human brain tissue and biospecimen samples more widely available for research on neurological, psychiatric, and neurodevelopmental disorders. In order to do so, the NIH intends to establish multiple contract collection sites (i.e., the "Neurobiobank") to provide services that will actively acquire, receive, store, catalog, preserve, and distribute specimens (including fetal tissues) to qualified investigators. These services were previously provided through grants which have expired and/or will be expiring in the coming years. The NIH will now continue these services through competitively awarded contracts. B. Purpose and Objectives The purpose of this acquisition is to provide services which make human tissue (including fetal) more widely available for research. The NIH intends to establish multiple awardees/collection sites in order to provide sufficient critical resources for research on neurological, psychiatric, and neurodevelopmental disorders. The objective is to award to sites that can acquire at least 100 donors per year (but at a minimum, at least 300 unique human donors by the end of the five-year contract period). C. Project requirements Qualified sources will be required to acquire specimens, document and maintain a current inventory by entering data on the donors and tissue samples into to a third party interactive web site (508c compliant) herein referred to as the NIH Neurobiobank Portal and participate in the sharing of tissue(s) and associated data under the guidelines set forth in the Statement of Work. The NIH Neurobiobank Portal will serve the critical purpose of requesting access to tissues and coordinating the distribution from the various brain banks to qualified scientific investigators who are dedicated to the improved understanding, care and treatment of these disorders (see http://www.nimh.nih.gov/; http://www.ninds.nih.gov/; and http://www.nichd.nih.gov/ for areas of disease focus). Various types of deliverables will be required including a collection of brain tissue and biospecimines, data, and reports. The anticipated contracts will include Standard Operating Procedures (SOPs) and protocols to ensure uniformity among sites when possible, and Quality Assurance/Quality Control requirements for prospective evaluation of short and long term specimen integrity, viability and function. Qualified sources should have the ability to provide: 1. An infrastructure to actively acquire, receive, store, catalog, preserve, and distribute brain tissue and biospecimines to qualified investigators. Tissue shall be collected in accordance with all applicable state and local laws and Federal regulations. Tissue acquired will be focused on the postmortem brain, other nervous system tissues from individuals with neurodevelopmental disorders, neurological disorders, and neuropsychiatric disorders and controls. Other tissues, pre-mortem biopsies, and prenatal material will also be a valuable component and will be collected on an ad hoc basis. 2. Data collection utilizing standard forms (with web-based entry and searchable data collation) and compatible computerized databases, the Contractor shall report data and an accurate index of their Brain Bank inventory to the NIH Neurobiobank Portal, a third party interactive web site (508c compliant), on a quarterly basis. 3. Sufficient capacity to store and maintain biologic specimens derived from 300-500 unique human donors by the end of the five-year contract period (multiple specimens may come from any given individual). This includes sufficient ultra- freezers and additional storage and processing capacity should be available for non-frozen material including fixed tissues. Provide a climate-controlled facility with the capacity to maintain room temperatures such that freezers can function normally when all equipment is operating, with sufficient back up power to maintain normal operation in a power failure. Provide enough back-up freezer space to accommodate the failure of at least one freezer. Complete transfer of the contents of a freezer shall occur within 2 hours of an initial freezer failure. Provide adequate, on-site back-up power to handle complete electrical power failure. 4. Established mechanisms for registering potential donors for the Neurobiobank and outreach to appropriate disease advocacy organizations. 5. Option The Government intends to include options for additional services which may include: Option 1: Enhancement of tissue processing for highly sought tissues: Neuropathological examination of all specimens to characterize the status of the donated tissue using industry standard methods and techniques. D. Other important considerations. 1. Protocols and standards at a minimum should meet those set forth in the NCI Best Practices for Biospecimen Resources (http://biospecimens.cancer.gov/global/pdfs/NCI_Best_Practices_060507.pdf) established by the Office of Biorepository and Biospecimen Research. 2. 508 compliance is applicable for all systems housing data 3. Compliance with NIH/OHRP guidelines and 45CFR Part 46, to ensure that the Bank has undergone annual review by an Institutional Review Board (IRB) 4. Information Technology (IT) Security that is compliant with the Federal Information Security Management Act of 2002 (FISMA) to ensure security of all data generated over the life of the contract. 5. Appropriate shipping licenses and permits from local, State, Federal and International authorities for the safe import, storage and distribution of biological specimens, according to current regulatory guidelines, will be required, as applicable. 6. Procedures and protocols for safe handling of potentially hazardous and infectious materials will be required. E. Anticipated period of performance. June 2013 - May 2015 (with yearly options to extend term of the contract through May 2023) F. Capability statement /information sought. Capability statements should clearly state/describe your ability, experience, and resources to design and carry out the services listed above, including: 1. Staff expertise that would be working on this project, including their availability, experience, and formal and other training 2. Infrastructure currently available to perform this project 3. Prior completed projects of similar nature 4. Your business size (number of employees and gross annual revenue), your eligibility under 8(a) or other set-aside programs, as applicable (note: the applicable NAICS code for this requirement is 541711, 500 employees); and 5. Your management structure, history of your organization (e.g., number of years in business and DUNS #) G. Disclaimer and Important Notes. Please note that in order to qualify as an eligible small business for purposes of a small business set-aside, at least 50% of the direct labor cost must be in-house. Specifically, FAR 52.219-14 - Limitations on Subcontracting, states that at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern. 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. Responses will be held in a confidential manner. 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 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. If the Government decides to issue a solicitation, a Request for Proposal (RFP) will be available solely via the FEDBIZOPPS web page at http://www.fedbizopps.gov/. It will be the Offeror's responsibility to monitor the FEDBIZOPPS web page for the release of any solicitation and amendments, and to download the RFP and all attachments. Responses to this notice should be received no later than the posted due date, and can be sent either by mail, fax, or e-mail (jacobsonmj@mail.nih.gov) to the point of contact listed. If using the U.S. Postal Service or commercial overnight services, please send an original plus five (5) copies of your response. Note: for commercial overnight services, use the Rockville, MD. 20852 address. H. 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).