SMALL_BUSINESS_SOURCES_SOUGHT_75N94025R00008_1.pdf

SMALL BUSINESS SOURCES SOUGHT 75N94025R00008

“Clinical Research Organization for the National Institute on Alcohol and Alcohol Abuse (NIAAA) Medications Development Clinical Trials Network”

Description:

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.

Per FAR 19.001, a small business concern means any business entity organized for profit (even if its ownership is in the hands of a nonprofit entity) with a place of business in the United States or its outlying areas and that makes a significant contribution to the U.S. economy through payment of taxes and/or use of American products , material and/or labor etc.

Please note that in order to qualify as an eligible small business for purposes of a small business set-aside (where large businesses, universities and non-profits would be excluded from competing for part of or the entire requirement), per FAR 52.219-14, “Limitations on Subcontracting” at least 50% of the cost of contract performance must be performed by the small business (inclusive of any small business subcontractors).

Background:

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).

This Small Business Sources Sought announcement is for a Contract Research Organization (CRO) for the NIAAA Medications Development Branch Extramural Clinical Program. The Contractor shall serve as the CRO to support all aspects of multiple, multi-center, pharmacotherapy clinical trials for the treatment of Alcohol Use Disorder (AUD). The CRO contractor shall supp ort 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.

Conduct of the trials will be monitored by an independent Data and Safety Monitoring Board (DSMB) chosen by and reporting to the NIAAA. The CRO will consult regularly with the NIAAA Program team staff to establish research priorities and provide on-going updates on the status of the trial(s). Studies conducted in association with this program are expected to emphasize treatment of Alcohol Use Disorder (AUD) with novel or repurposed compounds.

Project Requirements Include:

1. Clinical trial study coordination and management

2. Preparation of the study protocol, informed consent forms, and statistical analysis plan

3. Preparation and maintenance of electronic data capture at clinical sites and a compatible, validated clinical data management system.

4. Preparation of case report forms, manual of operations and other study related documents

5. Data coordination, data quality assurance and data quality control

6. GCP clinical monitoring and reporting to NIAAA

7. Procurement, packaging, shipping and coordination of study medication

8. Logistical and meeting services

9. Regulatory support to include preparation of Investigation New Drug (IND) applications, annual reports, and other necessary IND submissions

10. Adverse event and Serious adverse event reporting

11. Statistical support and data analysis

12. Final clinical study report preparation

13. Study manuscript preparation

Information Requested:

1. Experience: An outline of previous work specific to the requirements and tasks listed above;

2. Personnel: Name, professional qualifications and specific experience of scientist and/or technical personnel who may be assigned as principal investigator and other key positions;

3. Facilities: Availability and description of facilities and equipment required to conduct the analyses; and

4. Other: Any other specific and relevant information that would improve the Government’s consideration and evaluation of the information presented is desirable.

The Capability Statement Must Demonstrate the Ability to:

Small business concerns that possess the capabilities necessary to undertake the efforts described should submit complete documentation of their capabilities to the Contracting Officer. This capability statement should include: 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as they relate to the requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, and 4) any other specific and relevant information that would improve the Government's consideration and evaluation of the information presented.

Further, Past Performance documentation, which should include, but not be limited to, a minimum of two (2) contracts performed for either Government or commercial organizations shall be provided.

References shall include for each contract: names, titles, contract number, total price or cost, telephone numbers of government Contracting Officer Representative and Contracting Officers.

Information Submission Instructions:

The offeror shall provide an electronic version only of their response to this notice. Responses shall include the organization's name, address, point of contact, size of business pursuant according to the North American Industrial Classification Code (NAICS) and must address all the technical information requested.

The page limit is 15 pages using a font size 10 or larger. Responses will assist the Government in selecting the appropriate acquisition mechanism.

Additionally, the response must provide answers to the following questions:

1. Is your organization a small business under NAICS code 541715 (1,000 employees or less)?

2. Does your firm qualify as a small disadvantaged small business?

3. If disadvantaged, is your firm certified under section 8(a) of the Small Business Act?

4. Are you a certified HUB Zone firm?

5. Are you a woman-owned or operated business?

6. Are you a certified Service-Disabled Veteran Owned or Veteran Owned business?

This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. This is not a Request for Proposals. The Government DOES NOT intend to award a contract based on responses under this announcement. Interested parties shall not be reimbursed for costs associated with preparation of their responses. Any proprietary information should be so marked. Interested organizations presenting a Capability Statement in response to this Small Business Sources Sought a n n o u n c e m e n t must identify their size status.

AII capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Point of Contact below in MS Word or Adobe Portable

Document Format (PDF). The subject line must specify Small Business Sources Sought 75N94025R00008. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 5:00 PM (Eastern Daylight Time) on June 20, 2025. CAPABILITY

STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED.

Please send responses to this Small Business Sources Sought announcement via e-mail to:

Jason Williams, Contracting Officer NICHD Office of Acquisitions, ARB, NIAAA Team E-MAIL: jason.williams2@nih.gov

Primary Point of Contact:

Jason Williams Contracting Officer NICHD Office of Acquisitions, ARB, NIAAA Team mailto:jason.williams2@nih.gov jason.williams2@nih.gov

PH: 301-443-3877

Secondary Point of Contact:

Lisa Schaupp Section Chief NICHD Office of Acquisitions, ARB, NIAAA Team lisa.schaupp@nih.gov

PH: 301-827-8135

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 to 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).

mailto:jason.williams2@nih.gov mailto:lisa.schaupp@nih.gov