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This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. This notice seeks to obtain information regarding the availability and capability of qualified small business to perform a potential Research and Development (R & D) requirement.

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; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition method including whether a set-aside is possible.

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 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. 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 now spans pharmacological, behavioral, and social interventions.

Purpose and 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 draft copy of the draft Statement of Work (SOW) is attached to this notice for review. The draft SOW describes the core activities and requirements of the prospective contract. Interested organizations are to use the draft SOW to prepare capability statements in response to this notice.

Contract Award:

The Government anticipates awarding one Indefinite Delivery/Indefinite Quantity (ID/IQ) contract for this requirement. The expected award date will be December 2023.

Other important considerations:

Contract Type and Contractor's Accounting System

It is anticipated that the resultant contract will be a single award ID/IQ type contract 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. The offeror must further certify that the accounting system is currently in full operation at the time of award.

CAPABILITY STATEMENT / INFORMATION SOUGHT.

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

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 Contract Specialist. Facsimile responses are NOT accepted.

The response must be submitted electronically to Iris Merscher, Contract Specialist, at iris.merscher@nih.gov.

The response must be received on or before December 28, 2022, by 5:00 p.m., Eastern 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 pre-solicitation 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).

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