NOTE: This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.
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) 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; 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.
The National Institute of Mental Health (NIMH) is the lead federal agency for research on mental disorders with a mission to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure. NIMH also has a substantial investment in supporting HIV research; an investment that is guided by the NIH Strategic Plan for HIV and HIV-Related Research and coordinated through the NIH Office of AIDS Research. In 1998 the National NeuroAIDS Tissue Consortium was established to support researchers around the world who wish to further NIMH’s understanding of HIV-associated central nervous system dysfunction – including cognitive, neurologic and mental health outcomes. Through core funding from NIMH and The National Institute of Neurological Disorders and Stroke (NINDS) and supplemental funding from The National Institute on Drug Abuse (NIDA) this consortium provides clinical data and biological specimens to investigators interested in HIV-induced neuropathogenesis in the context of anti-retroviral therapy, as well as investigators who are advancing efforts toward a cure for HIV. Two operational areas fall under the umbrella of the National NeuroAIDS Tissue Consortium. One area consists of clinical sites that collect, store, and distribute high quality and well characterized biospecimens, as well as prospective neuromedical, neuropsychological, and psychiatric clinical data that have been collected from people living with HIV and HIV-negative volunteers. Another area is the data coordinating center which works with each clinical site to manage data and brain banking operations, serves as a data repository, provides biostatistical expertise, and expands coordination and distribution capability. The data coordinating center also manages data resources for the CNS HIV Antiretroviral Therapy Effects Research (CHARTER) cohort (established in 200)2), whose study aims are to determine how central and peripheral nervous system complications of HIV are affected by different histories and regimens of antiretroviral therapy (ART).
In an effort to better align with NIH strategic plans, policies and scientific priorities NIMH, along with NINDS, NIDA and The National Institute on Aging (NIA) is seeking to continue, as well as enhance efforts to support neuroHIV biospecimen banking, using a contract mechanism henceforth known as the “NIH National NeuroHIV Tissue Consortium (NNTC) Clinical Sites.” The objectives of the NNTC Clinical Sites are to provide access to post-mortem brains, related biospecimens and relevant clinical data from donors with HIV and control brains. NNTC Clincal Sites will provide services to actively acquire, process, store, curate, preserve, and distribute central nervous system and related biological specimens to qualified investigators, while adhering to the highest ethical standards regarding specimen procurement, data sharing, consent, protection of human subjects, and donor anonymity. The NNTC Clinical Sites will also be expected to maintain biospecimens under high quality conditions and distribute them in an equitable and ethical manner. Each site is required to coordinate with a separately contracted NNTC Data Coordinating Center.
To maintain and enhance the NIH NNTC Clinical Site Operations, the NIMH NNTC contractor shall demonstrate scientific expertise related to NIH’s HIV-related research priorities and biospecimen collection. This expertise should inform the contractor’s work in conducting the following tasks, but are not limited to:
- Recruiting and acquiring donors from diverse backgrounds, diverse geographic catchment areas and/or those that represent current HIV epidemiology
- Establishing and meeting milestones for biospecimen collection
- Collecting CNS tissue that at a minimum includes brain and spinal cord, and may also contain other PNS tissue including peripheral nerve, muscle, thymus (if available) lymph node, and spleen as directed, acquiring biospecimens that may change focus of disease co-infection/disorders that align with ongoing and future NIH initiative
- Collecting and providing detailed antemortem clinical data from participants and/or informants
- Data should include longitudinal medical, neurological, neuroimaging, medication related, domain-based neuropsychological assessments data, and substance use history through administration of required assessments including standardized questionnaires and medical records.
- Collecting and providing detailed assessments after death, including but not limited to:
- Neuropathological evaluation – Brain and Spinal Cord
- Organ HIV-related Pathology
- Organ Pathology – non-HIV related
- Collection of fluids may occur during scheduled study visits or, if necessary, upon a participant’s demise
- Cause and manner of death
- Medications at the time of death (ATOD)
- If unavailable during antemortem assessment and/or if contacted after an individual’s death
- Contributing to existing NeuroHIV collections
- Existing specimens with evidence of high-quality, well-characterized tissue, including quality metrics such as RIN, 260/280 ratio, tissue pH etc., and supporting antemortem neuropathological, genetic, clinical, and other phenotypic data
Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below to support the NIH NNTC Clinical Site’s mission. Specifically, the Contractor shall: Provide a secure environment and the necessary biorepository infrastructure and provide personnel with the scientific and technical expertise in biorepository science, program management, data management and informatics to maintain, enhance, and expand the NIH NNTC Clinical Sites. The NIH NNTC contractor will be provided government owned equipment, materials, and inventory database necessary to maintain the current biospecimen inventory that support the NIH NNTC Clinical Sites operations. Additional resources, such as mechanical freezers, cryogenic storage units, and biospecimens, may be added to the program over the period of the contract and will be considered government owned. The contractor shall provide the facilities necessary to optimize support of current inventory and facilitate continued expansion.
The contractor shall maintain general Quality Management Plan with appropriate Quality Control and Quality Assurance operating procedures, critical to the successful operation of the program, and comply with all necessary regulatory and statutory obligations including but not limited to College of American Pathologist (CAP)- Biorepository Accreditation Program, International Organization for Standardization (ISO) certification, Good Practices compliant for clinical, laboratory, and manufacturing practices applicable to industry biorepositories, and adhere to ISBER Best Practices for Biospecimen Repositories.
The contractor shall maitain provide detailed plans describing data security, back-up, and disaster recovery measures and incorporate the details into the Information System Security Plan. The plan shall include a daily backup of all changes to the electronic resources to protect against accidental loss. A back-up copy of the electronic resources shall be stored in a remote, secure location and shall be updated at least weekly. Plans shall also include a system for archiving records not needed for daily activities but that need to be retained as records and need to be accessible for audits and inspections.
The contractor shall ensure that equipment, including mechanical freezers, liquid nitrogen or cryogenic units, and refrigerators in primary and backup facilities are maintained and monitored by trained qualified staff. All equipment is to be operated, maintained, calibrated, and serviced according to manufacturer’s instructions and the contractor’s institution established schedules for preventive maintenance, and as specified in the technical requirements for this contract.
The contractor shall not use the biospecimens, data, and documentation acquired, modified, or developed through the process of this contract for any purpose other than that specified in this contract, without prior written approval of the Contracting Officer (CO) and Contracting Officer Representative (COR).
The contractor shall comply with NIMH IT security policies and procedures for contracts including but not limited to IT Security Plan (IT-SP), IT Risk Assessment (IT-RA), FIPS199 Assessment, vulnerability scanning, and Section 508 accessibility. The contractor shall ensure that computer hardware and software procedures comply with all Federal and State regulations related to storage and distribution of inventory data and biospecimens. The contractor shall meet any applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and all other relevant Federal and State regulations governing the protection of health information from human subjects.
The contractor shall ensure that computer programs, databases and other resources, including but not limited to guidance documents and instructions developed through this contract are compliant with terminology and data standards established by NIMH.
Anticipated Period of Performance/Contract Mechanism:
- Award anticipated in February 2023 (FY23)
- Base period (12-months) & Four option periods (12-months for each option)
- Contract type TBD
Other Important Considerations:
If you or your firm/business has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541715 size standard of 1,000 employees. All respondents are requested to identify their firm's size and type of business.
Interested firms responding to this Small Business Sources Sought Notice should adhere to the following:
1. Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities and at a minimum address the below:
- Respondents’ opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition.
- Information regarding 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.
- Respondents’ DUNS number, cage code, orgainzation name and address.
- Respondents' Socio-economic Status (e.g., 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).
- Business size (e.g., small or large) pursuant to the applicable NAICS code.
- GSA or other Government Contract Number.
- Clear and convincing documentation of your capability and ability to provide the services.
- Examples of prior completed contracts and other related information.
- Any other information that may be helpful in developing or finalizing the requirement.
2. The capability statement should not exceed 15 pages using a font size 10 or larger and shall include:
- respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and the name, address, telephone number, and e-mail address of the Contract Specialist or Contracting Officer to whom the information should be sent.
3. All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Kristina.Jenkins@nih.gov and Valerie.Whipple@nih.gov in MS Word or Adobe Portable Document Format (PDF) by the closing date and time of this announcement. Facsimile responses will not be accepted, and all responses must reference the Notice ID.
“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 pre-solicitation synopsis and solicitation may be published on SAM.gov Contract Opportunities. 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).”