The NIH neurobiobank brain and tissue repository

Amendment 1 to RFP 75N95019R00006 has been posted. All offerors must review and acknowledge receipt of this Amendment in its offer uploaded to eCPS. .

RFP 75N95019R00006. NIMH is soliciting contractors for the The NIH NeuroBioBank Brain and Tissue Repository. Please submit any questions and proposal intents (Attachment 2) to jeffrey.brown@nih.gov by no later than 12 pm Eastern on February 20, 2019. Questions will be answered through a formal amendment to the RFP. Proposals are due in the
NIH electronic Contract
Proposal Submission (eCPS) Website
by 3pm Eastern on March 22, 2019. Late proposals will not be accepted.
IMPORTANT INFO: All contractors are now required to be registered and active in SAM.GOV at the time they submit a proposal. If a contractor is not registered or has an expired account status when they submit a proposal that proposal will be excluded from consideration..

Presolicitation/Synopsis

Description

The National Institute of Mental Health (NIMH) plans 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 50 donors per year (with the possibility of up to 200 unique human donors per year for a range of 250 - 1,000 by the end of the five-year contract period, if all option periods are exercised).

Qualified offerors will be required to acquire specimens, 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, NIDA and NIA for areas of disease focus). Various types of deliverables will be required including a collection of brain tissue and biospecimens, 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 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 primarily focused on the postmortem brain, but other nervous system tissues from individuals with neurodevelopmental, neurological, and neuropsychiatric disorders and unaffected controls shall also be sought. 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 250 - 1,000 unique human donors by the end of the five-year contract period, if all option periods are exercised. Sufficient freezer space as well as additional storage and processing capacity for non-frozen material including fixed tissues will be considered when evaluating 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 one freezer. Complete transfer of the contents of a freezer shall occur within 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. http://biospecimens.cancer.gov/bestpractices/2016-NCIBestPractices.pdf

2. Section 508 compliance is applicable for all systems housing data.

3. Compliance with 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.

The 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. The successful offeror must comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR 46.

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. HHSN271201300028C, HHSN271201300029C, HHSN271201300030C, HHSN271201300031C, HHSN271201300032C, and HHSN271201400045C titled "NIMH, NICHD, and NINDS Brain and Tissue Repository (NBTR)."
RFP No. 75N95019R00006 will be available electronically on or about 15 days from the date of this posting. You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 45 days from the release date. NIMH anticipates an August 2019 award date. NIMH will consider proposals submitted by any responsible offeror. This advertisement does not commit the Government to award a contract.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons or organizations may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.

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