Contract Research Organization for the National Institute on Alcohol Abuse and

This notice is issued by the NICHD Office of Acquisitions on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

This is a Small Business Sources Sought (SBSS) notice issued for market research purposes only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time and no award will be made on the basis of responses received to this Small Business Sources Sought notice.

The purpose of this notice is to obtain information regarding: (1) the availability and capability of all 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 according 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 exclusively for small business concerns 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 applicable NAICS code for this requirement is 541715, ¿Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology¿ with a small business size standard of 1,000 employees or less.

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is seeking capability statements from small business organizations (NAICS 541715; small business size standard is 1,000 employees) with experience in providing support for medications development.

Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol problems. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone.

Thus, the search for new molecular targets and more efficacious medications is critical. The creation of the NIAAA's Medications Development program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7-8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct clinical trials of promising compounds to treat alcohol problems.

The planned acquisition is a follow-on requirement to active indefinite delivery/indefinite quantity contract 75N94019D00001, ¿, awarded to Fast-Track Drugs & Biologics, LLC with a task order ordering period of 2/1/2019 through 1/31/2026.

An indefinite delivery/indefinite quantity (IDIQ) contract with an ordering period of seven years (commencing 2/1/2026) is being contemplated to continue the CRO support services currently provided under the active CRO contract for the NIAAA Medications Development Clinical Trials Network. Individual task orders for assigned clinical trials will be issued as needs arise on a cost plus fixed fee basis. (The clinical sites for each assigned task order/clinical study will be under separate contracts directly with the NIAAA).

The Contractor shall serve as the CRO for the NIAAA Clinical Trials Network to support all aspects of multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder (AUD). The CRO contractor shall support development, coordination and operation of each task order-assigned clinical trial including but not limited to clinical trial coordination support, clinical site oversight and management support, preparation of study documents, electronic data capture of clinical data from all participating clinical sites, Good Clinical Practice (GCP) monitoring services, acquisition and facilitation of study medication and packaging, shipping and coordination of study medication, logistical and meeting services, regulatory support and services, statistical and data analysis, and final clinical study report preparation and submission and manuscript preparation. It is anticipated that 4-6 trials will be ordered via individual task orders during the seven-year ordering period of the indefinite delivery/indefinite quantity (IDIQ) contract.

See the attachment to this announcement entitled SMALL BUSINESS SOURCES SOUGHT 75N94025R00008 for instructions on how to respond to this announcement.