National Institute on Aging Clinical Research Support Services - CRSS

PRE-SOLICITATION NOTICE

The National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA), on behalf of the National Institute on Aging (NIA), is seeking qualified sources to perform a potential requirement to support Research and Development (R&D). NIDA anticipates the issuance of a request for proposals (75N95023R00013) on or about February 15, 2023, titled National Institute on Aging Clinical Research Support Services - CRSS.

Background:

The National Institute on Aging, one of the 27 Institutes and Centers of National Institutes of Health, leads the federal government in conducting and supporting research on aging and the health and well-being of older people. NIA provides leadership in aging research, training, health information dissemination, and other programs relevant to aging, including Alzheimer's Disease (AD) and Alzheimer’s Disease-Related Dementias (ADRD).

Following the enactment of the National Alzheimer’s Project Act, NIA’s AD/ADRD clinical research portfolio includes pharmacological, behavioral, and social interventions.

Contract Objectives:

Given the clinical research portfolio, including AD/ADRD research, NIA requires centralized support for clinical research management across the institute. The contract will provide support in the areas of Data Safety and Monitoring Boards (DSMB), regulatory compliance, biostatistics, recruitment support, and training as needed. The contract will also assist with producing centralized procedures for tracking clinical research regulatory compliance and quality assurance/quality control activities.  The overarching goal of the contract is to provide centralized, flexible, as-needed, easy-to-access support for clinical research management and respond to staff needs across domains critical to clinical research management.

The aim of the contract is to provide centralized and integrated administrative, regulatory, logistic, and statistical support for clinical research management across NIA. Support service areas include project management and implementation, regulatory expertise, quality assurance/quality control, promoting participant recruitment, statistical consultation, developing tools, templates, and trainings, and managing the administration of Data Safety and Monitoring Boards.

Project Requirements:

A copy of the DRAFT Statement of Work (SOW) is attached to this notice for reference. The draft SOW describes the activities and requirements of the prospective contract and should be used for informational purposes only. 

OTHER IMPORTANT CONSIDERATIONS

Contract Type and Contractor’s Accounting System

The Government anticipates awarding one Indefinite Delivery/Indefinite Quantity (ID/IQ) contract for this requirement with cost reimbursement Task Orders. Therefore, to be considered for an award under the resultant solicitation, the offeror’s accounting system and practices must be adequate and suitable for accumulating costs under government contracts.  Offerors will be required to provide evidence of the accounting system being adequate and the proposal shall include a certification that its systems meet all the specifications outlined in the solicitation for an adequate accounting system, in accordance with FAR 16.301-3, 16.403-1, and in compliance with FAR Part 31.

NOTICE TO OFFERORS

As noted above, it is anticipated that the resultant contract will be a single award ID/IQ contract with cost reimbursement Task Orders to an offeror capable of performing all aspects of the work described in the SOW. The anticipated award date is December 2023.The proposed contract will be issued using full and open competition. The North American Industry Classification System (NAICS) code for this procurement is 541715 with a corresponding size standard of 1000 employees. The Government intends to make an award using the procedures for competitive negotiated acquisitions as authorized in FAR Part 15.

The proposed acquisition was previously publicized under Small Business Sources Sought notice 75N95023R00013-SBSS and Request For Information notice 75N95023R00013-RFI.

This is a pre-solicitation notice. This is NOT a solicitation. A solicitation may or not be issued. The estimated issue date of the solicitation is 15 days from the date of this notice but no later than February 20, 2023. Proposals will be due on or about 45 days after the solicitation release date. The solicitation will be posted on the SAM.gov website. Proposals must be submitted through the NIH electronic Contract Proposal Submission (eCPS) system. Detailed submission instructions will be provided upon issuance of the solicitation. All questions regarding this acquisition shall be submitted in writing via email to: iris.merscher@nih.gov. Please reference the solicitation number 75N95023R00013 and project title on your written request. TELEPHONE INQUIRIES WILL NOT BE ACCEPTED.