This is a 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 this potential Research & Development (R&D) requirement. Small Businesses are encouraged to respond. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

Background
The National Institute of Mental Health (NIMH), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Neurological Diseases and Stroke (NINDS), the National Institute on Aging (NIA) and the Blueprint for Neuroscience (https://neuroscienceblueprint.nih.gov/), National Institutes of Health (NIH) seek to continue to make human brain tissue and related biospecimen samples widely available for research on neurological, psychiatric, and neurodevelopmental disorders through multiple contract collection sites (i.e., the "NeuroBioBank") providing services that will actively acquire, receive, store, characterize, catalog, preserve, and distribute specimens to qualified investigators.

Purpose and Objectives
The purpose of this acquisition is to provide services that will increase the availability of human 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).

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 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 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 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:

1. Provide an infrastructure to actively acquire, receive, store, catalog, characterize, preserve, and distribute brain tissue and 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 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.

Capability Statement/Information Sought
THIS IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. Interested organizations submitting a capability statement must provide the following: (1) information regarding the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information; (2) respondent's DUNS number, organization name, address, point of contact, and size and type of business (e.g. 8(a), HUBZone, etc.) pursuant to the applicable NAICS code; and (3) any other information that may be helpful in developing or finalizing the acquisition requirement.

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.

Submission Instructions
Respondents should provide responses accordingly: (1) submit one (1) copy of the response electronically. No telephone or facsimile responses will be accepted; (2) format capability statements using Microsoft Word or Adobe PDF including attachments, resumes, charts, etc., and using 11-point or 12-point font, 8.5" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing; (3) organize material in such a manner that clearly identifies and addresses capability requirements and provide an executive summary; (4) capability statement should not exceed ten (10) single sided pages including references; (5) responses should be received no later than November 9, 2018 at 3:00 PM Local Time; (6) include respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and email addresses; and (7) send responses to this notice via email to [email protected] and [email protected].

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).

Bid Protests Not Available