Loren Data's SAM Daily™

fbodaily.com
Home Today's SAM Search Archives Numbered Notes CBD Archives Subscribe
SAMDAILY.US - ISSUE OF NOVEMBER 18, 2021 SAM #7292
SOURCES SOUGHT

99 -- National NeuroHIV Tissue Consortium (NNTC) Data Coordinating Center

Notice Date
11/16/2021 2:45:13 PM
 
Notice Type
Sources Sought
 
NAICS
541715 — Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
 
Contracting Office
NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
 
ZIP Code
20892
 
Solicitation Number
NIMH-23000002
 
Response Due
12/3/2021 12:00:00 PM
 
Archive Date
12/18/2021
 
Point of Contact
Kristina Jenkins, Valerie Whipple
 
E-Mail Address
kristina.jenkins@nih.gov, valerie.whipple@nih.gov
(kristina.jenkins@nih.gov, valerie.whipple@nih.gov)
 
Description
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. Background: 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 2002), 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 management, using a contract mechanism henceforth known as the �NIH National NeuroHIV Tissue Consortium (NNTC) Data Coordinating Center (DCC).� The objectives of the NNTC DCC �are to work with the separately contracted NNTC Clinical Sites and CHARTER R24 grantees, to serve as the data repository for the NNTC Clinical Sites and the CHARTER Cohort; to provide management and database capabilities that ensure effective clinical and brain banking operations; to provide scientific expertise in biostatistics, data analytics and HIV-1 epidemiology that enable broad analysis of an NNTC database; and to expand capability to coordinate the distribution of specimens and data stored at other clinical sites to ensure neuroHIV investigators have access to CNS and PNS specimens that are difficult to obtain from HIV-1 infected individuals across the lifespan. Project Requirements: To maintain and enhance the NIH NNTC DCC operations, the NIH NNTC DCC contractor shall demonstrate scientific expertise related to NIH�s HIV-related research priorities and biospecimen management. This expertise should inform the contractor�s work in conducting the following tasks, but are not limited to: Serve as the interface and coordinator for investigators seeking to use the NNTC Clinical Sites and CHARTER cohort specimens and data Provide oversight and quality control for data for acquisition from the NNTC Clinical Sites as well as from investigators using NNTC Clinical Sites specimens Provide expansion capability based on data within the NNTC Clinical Sites and investigators Integrate NNTC Clinical Sites and CHARTER cohort related data and share datasets with the research community Design and implement means to link and integrate all antemortem and postmortem data on NNTC Clinical Sites and CHARTER cohort subjects with research data obtained by investigators on NNTC Clinical Sites specimens Structure, curate and integrate large datasets based on established knowledge of neuroHIV with the aim of allowing it to be successfully used by investigators Develop methods to ensure clinical sites and data coordination center function synergistically and communicate effectively Establish mechanism for expansion of the NNTC Clinical Sites and CHARTER cohort database and its functionalities � especially as it serves to help develop new relationships and linkages with other brain banks, biorepositories and the neuroHIV research community Store and provide analyses of detailed antemortem clinical data from participants and/or informants that includes longitudinal medical, neurological, neuroimaging, medication, domain-based neuropsychological assessments data, and substance use history, by administration of required assessments including standardized questionnaires and medical records Store and provide analyses of detailed postmortem data from participants and/or informants that includes organ pathology data Establish mechanism for working with NIH staff to determine how specimens will be distributed to the scientific community. While decisions should be made in partnership with NIH staff, the contractor will be expected to play a significant role in the process so as to limit NIH staff burden 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 DCC�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 DCC. The NIH NNTC DCC contractor will be provided government owned equipment, materials, and inventory database necessary to maintain the current biospecimen inventory that support the NIH NNTC DCC 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 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: N/A Special Instructions: 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,�� 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, organization 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. 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).�
 
Web Link
SAM.gov Permalink
(https://beta.sam.gov/opp/6e6b79ca987143cebbe3520f4db44603/view)
 
Record
SN06178615-F 20211118/211116230127 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

FSG Index  |  This Issue's Index  |  Today's SAM Daily Index Page |
ECGrid: EDI VAN Interconnect ECGridOS: EDI Web Services Interconnect API Government Data Publications CBDDisk Subscribers
 Privacy Policy  Jenny in Wanderland!  © 1994-2024, Loren Data Corp.