SOURCES SOUGHT NOTICE

1. Solicitation Number: 75N95024R00010

1. Title:  NIH NeuroBioBank Brain and Tissue Repository

1. Classification Code:  A – Research & Development

1. NAICS Code:  541714 Research and Development in Biotechnology (except      Nanobiotechnology)

1. Size Standard:  1,000 Employees

1. Description: 

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 to perform this potential Research & Development (R&D) requirement; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Small Businesses are encouraged to respond.

For equipment/supply requirements, responses must include the place of manufacturing (i.e., address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e., address Non-Manufacturer Rule).

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.

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 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 post-mortem brain tissue and related biospecimen samples widely available for research on neurological, psychiatric, and neurodevelopment disorders through multiple contract collection sites (i.e., the “NIH NeuroBioBank”) providing services that will actively acquire, receive, store, characterize, catalog, preserve, and distribute human brain specimens to qualified investigators.

Purpose and Objectives:

The purpose of this acquisition is to provide services that will increase the availability of 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.

Project requirements:

Qualified sources 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 shalldocument 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 sources should have the ability to:

1.  Provide an infrastructure to actively acquire, receive, process, store, catalog, characterize, preserve, and distribute human postmortem 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.

1.  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.

1. 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.

1. 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.

1. Establish mechanisms for registering potential donor for the NIH NeuroBioBank and engage in outreach for brain donation to appropriate disease advocacy organizations.

1. 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.

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

1. 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).

1. 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.

1. 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.

1. Procedures and protocols for safe handling of potentially hazardous and infectious materials will be required.

Anticipated period of performance:

The anticipated period of performance for this requirement is one (1) 12-month base period and four (4) 12-month option periods.

Capability statement /information sought:

Companies that believe they possess the capabilities to provide the required products or 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.

Submission Instructions:

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 and 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 Contracting Officer.  Facsimile responses are NOT accepted.

The response must be submitted to Robin Knightly, Contracting Officer, at e-mail address [email protected].

The response must be received on or before November 15, 2023, at 5:00 p.m. Eastern Standard 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).”