Clinical Research Support Services - CRSS

THIS IS A REQUEST FOR INFORMATION (RFI) ONLYIn accordance with FAR 15.201(e), this is a Request for Information (RFI). This is NOT a solicitation for proposals, proposal abstracts, or quotations. This RFI is issued for the purpose of obtaining knowledge and information for project planning purposes.BACKGROUNDThe National Institute on Aging (NIA), one of the 27 Institutes and Centers of National Institutes of Health (NIH), leads the federal government in conducting and supporting research on aging and the health and well-being of older people. The Institute seeks to understand the nature of aging and the aging process, and diseases and conditions associated with growing older, in order to extend the healthy, active years of life.In 1974, Congress granted authority to form NIA to provide leadership in aging research, training, health information dissemination, and other programs relevant to aging and older people. Subsequent amendments to this legislation designated NIA as the primary

Federal agency on Alzheimer’s disease research.The Institute's mission is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and clinician scientists in aging; provide research resources; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences.NIA’s research initiative has substantially increased in recognition of growing public interest and urgency surrounding research on aging, including Alzheimer's Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD).Through NIA’s extramural research program, the Institute oversees a clinical research portfolio, that includes four divisions (Aging Biology, Behavioral and Social Research, Geriatrics and Clinical Gerontology, and Neuroscience) and multiple disease areas. Following the enactment of the National Alzheimer’s Project Act (NAPA) in 2011, NIA’s AD/ADRD clinical research portfolio has grown substantially. The NIA portfolio now spans pharmacological, behavioral, and social interventions. In addition, it includes care, caregiving, AD/ADRD prevention.The Government is issuing this RFI to ensure four (4) goals:(1) facilitate early (pre-Request for Proposal [RFP]) engagement with industry, in accordance with FAR 15.201(e).(2) improve NIDA’s understanding of market capabilities and current vendor offerings for provision of the services as outlined in the Draft Statement of Work (See Attachment 1).(3)  collect input and build knowledge on the vendors’ capabilities to provide the services outlined in the Statement of Work.(4) Provide the specifications and set expectations with industry to support NIH’s commitment to fair competition, in accordance with FAR 5.401.REQUESTED INFORMATIONRespondents are encouraged to submit feedback and questions in order to identify any gaps in the SOW including areas requiring clarification, missing or ambiguous requirements, staffing considerations and any other general comments or concerns. Vendors may also provide specific comments and suggestions for refining the SOW to reflect clear guidance to industry and industry best practices, as well as provide additional information that they think is relevant for developing the acquisition strategy for this requirement.Interested vendors should furnish the following information to NIDA:I. Comments on the Draft Statement of Work (Attachment 2)II. RFI Questions (Attachment 3)Note: Responses to the questions in Attachment 3 are welcome but not required. The questions are intended to provide the government with feedback about the feasibility of the requirement and broaden the knowledge of vendor capabilities. III. Vendor Business Information (Attachment 4)DISCLAIMER AND IMPORTANT NOTESThis RFI is issued solely for information and planning purposes to facilitate the acquisition planning process. It does not constitute a Request for Proposal (RFP)/Request for Quotation (RFQ) or a promise to issue an RFP/RFQ in the future, nor does it restrict the Government as to the ultimate acquisition approach. This notice does NOT obligate the Government to award a contract or otherwise pay for the information provided in response. Further, NIDA is not seeking proposals through this RFI and will not accept unsolicited proposals. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Any contract that might be awarded based on information received or derived from this RFI will be the outcome of a competitive process. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback with respect to any information submitted. Potential respondents should continue to monitor NIDA announcements for additional information pertaining to this RFI. Please note that NIDA will not respond to questions about the policy issues raised in this RFI. NIDA may or may not choose to contact individual commenters. Such communications would only serve to further clarify written responses.SUBMISSION INSTRUCTIONS Responses should be submitted electronically to: iris.merscher@nih.gov. Responses are requested by 5:00 p.m., December 9, 2022. Responses received after the due date may not be included in the development of the acquisition strategy.The Government reserves the right to determine whether to respond to questions and may consolidate responses to similar questions. If NIDA decides to publish questions and responses, they will be posted for visibility to the public on sam.gov.TELEPHONE RESPONSES WILL NOT BE ACCEPTED.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). All submissions become Government property and will not be returned.Attachments:1 – Draft Statement of Work (SOW), 7 pages2 – Comments on the Draft Statement of Work, 1 page3 – RFI Questions, 1 page4 – Business Information, 1 page