A--NIH NeuroBioBank Brain and Tissue Repository

National Institutes of Health (NIH) plan to solicit proposals under full and open competition procedures from offerors having the capability to provide services that will increase the availability of post-mortem human brain tissue for research. The NIH intends to support multiple awardees/collection sites in order to provide sufficient critical resources for research on neurological, psychiatric, and neurodevelopmental disorders. The objective is to make awards to offerors that can acquire at least 70 donors per year (with the possibility of up to 150 unique human donors per year for a range of 350 � 1,000 by the end of the five-year contract period, if all option periods are exercised. Qualified offerors will be required to acquire brains from deceased donors with diverse neurodevelopmental, neurological, and neuropsychiatric disorders, as well as individuals with no known brain disorders. Donors should be aged across the life span, and of diverse race and ethnicity. Offerors shall document and maintain a current inventory by entering data on the donors and tissue samples into a third-party interactive website (Section 508 compliant) herein referred to as the NIH NeuroBioBank Portal,and participate in the sharing of tissue(s) and associated data under the NIH NeuroBioBank guidelines. The NIH NeuroBioBank Portal will facilitate tissue requests and coordinate the distribution from the various brain banks to qualified scientific investigators who are dedicated to the improved understanding, treatment, and prevention of these disorders; (see NIMH, NINDS, NICHD, and NIA for areas of disease focus). Various types of deliverables will be required including a collection of brain tissue and biospecimens, data, and progress 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 offerors should have the ability to: 1. Provide an infrastructure to actively acquire, receive, characterize, preserve, store, catalog, and distribute brain tissue and other biospecimens 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, neurological, and neuropsychiatric disorders and unaffected controls. Other tissues including pre-mortem biopsies and surgical resections are also considered valuable resources for research and will be collected on an ad hoc basis. 2. Acquire autopsy reports, medical records, and other clinical data from the next of kin of acquired donors. Using these information sources as well as other validated methods including a comprehensive neuropathological evaluation and post-mortem interviews (when appropriate), determine to a high-level of confidence, the clinical brain diagnoses of the donor at the time of death. 3. Utilize standard forms for data collection (with web-based entry and searchable data collection) and compatible computerized databases. The Contractor shall report data and an accurate index of their brain and tissue inventory to the NIH NeuroBioBank Portal, a third-party interactive website (Section 508 compliant), on a quarterly basis. 4. Provide sufficient capacity to store and maintain biologic specimens derived from 350 � 1,000 unique human donors by the end of the five-year contract period, if all options are exercised for non-frozen material including fixed tissues will be considered when evaluation capacity to perform these services. The Contractor should 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. The Contractor shall also provide enough back-up freezer space to accommodate the failure of at least two freezers. Complete transfer of the contents of a freezer shall occur within two (2) hours of an initial freezer failure. Adequate on-site back-up power to handle complete electrical power failure must be provided. 5. Establish mechanisms for registering potential donors for the NIH NeuroBioBank and engage in outreach for brain donation to appropriate disease advocacy organizations. 6. Participate in bi-monthly NIH NeuroBioBank Directors conference calls and an annual in-person meeting designed to provide updates and feedback on ways to improve efficiency, quality, and usability. Other Important Considerations: 1. Protocols and standards at a minimum should meet those set forth in the NCI Best Practices for Biospecimen Resources established by the Office of Biorepository and Biospecimen Research. 2. Section 508 compliance is applicable for all systems housing data. 3. Compliance with the NIH/Office for Human Research Protections (OHRP) guidelines and 45 CFR Part 46, to ensure that the Bank has undergone annual review by the Institutional Review Board (IRB). 4. Information Technology (IT) Security that is compliant with the Federal Information Security Modernization Act of 2014 (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. 7. Each successful offeror must have a Federal Wide Assurance (FWA) currently accepted and approved by the Department of Health and Human Services� (HHS) Office for Human Research Protections (OHRP) or demonstrate that it has submitted to OHRP for issuance of an Assurance. Each successful offeror must comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR 46. 8. NIMH anticipates one or more award(s) of a single, cost reimbursement, level of effort type contract for one 12-month base period and four 12-month option periods. This award is a competitive renewal of Contract Nos. 75N95019C00045, 75N95019C00046, 75N95019C00047, 75N95019C00048, 75N95019C00049, and 75N95019C00050 titled �The NIH NeuroBioBank.� 9. The Government does not intend to use policies contained in FAR Part 12, Acquisition of Commercial Items, in its solicitation for these services. However, interested parties may identify to the Contracting Officer their interest and capability to satisfy the Government�s requirements with a commercial item within fifteen (15) days of this notice. 10. In accordance with FAR 5.203, the solicitation is expected to be released after at least fifteen (15) days of this posting and will be available electronically at beta.sam.gov. All information required for submission of a proposal will be contained in or accessible through the solicitation. The solicitation will also provide instructions for submission of any questions. 11. Responses to the solicitation will be due, at a minimum, thirty (30) days from the release date. All responsible sources may submit a proposal whi