OTSB_SSN - 75N95025R00038 - Clinical Services and Resources.pdf

Document Type: Sources Sought Notice

Solicitation No. 75N95025R00038

Project Title: Clinical Services and Resources for the National Institute on Drug Abuse, Intramural Research Program (NIDA, IRP)

NAICS Code: 622110 - General Medical and Surgical Hospitals

Contracting Office Address:

NIDA Section, Contracts Management Branch Red C/O NIH Mail Center

NIDA 3WFN MSC 6023

16071 Industrial Drive Gaithersburg, MD 20877 (20892 for USPS)

Description

The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), seeks Capability Statements from Other Than Small Business (OTSB) organizations for the preparation and distribution of research drug products.

This is an OTHER THAN SMALL BUSINESS SOURCES SOUGHT NOTICE. This is NOT a solicitation, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified business sources; and (2) their size classification relative 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 is possible.

Background Information:

The mission of the NIDA IRP is to conduct state-of-the-art research on basic mechanisms that underlie drug use and addiction and to develop new methods for treatment. Research is supported at the molecular, cellular, and clinical levels and is conceptually integrated, highly innovative, and focused on major problems in the field of addiction.

NIDA IRP attempts to elucidate the nature of substance use disorders; to determine the potential effectiveness of new therapies for addiction, both pharmacological and psychosocial; and to decipher the long-term consequences of drugs on the development, maturation, function, and structure of the human brain and other organ systems.

Using human volunteers, the IRP clinical program conducts multidisciplinary research involving residential and nonresidential clinical addiction studies interrelating with pre-clinical laboratory investigations. In general, these studies evaluate the nature of drug use and addiction by assessing the abuse potential of drugs, investigating their underlying mechanisms, and assessing treatment modalities for substance use disorders.

Purpose and Objectives for the Procurement:

The purpose of this potential requirement is to provide the NIDA IRP with clinical care support services and resources necessary to maintain the research operation of the NIDA IRP Clinical Research Program.

Project Requirements:

1. Management of Personnel and Contract Administration It is the responsibility of the Contractor to ensure adequate staffing and supervision of staff as applicable. The Contractor shall ensure that the clinical staff working on this contract maintain professional licensure, including but not limited to Basic Life Support (BLS) and Advanced Life Support (ALS) training. The Contractor must maintain any other professional responsibilities and abide by a professional code of conduct. The Government may provide specialized training for contractor staff on a case-by-case basis. Contract administration staff shall oversee the performance of the contract in terms of customer satisfaction.

The Contractor shall review budgeted hours and costs versus actual expenditures, and report any or all issues to the Contracting Officer's Representative (COR). The Contractor will handle all contract financials and will provide data to the COR. This includes monitoring of hours, billing, and reconciliations. In addition, the Contractor will coordinate the timely submission of contract deliverables to the COR. The Contractor shall provide management of personnel and contract administration services from the Contractor's site.

2. Medical Consultation

Approximately 500 participants are involved in one or more research protocols per year at the NIDA IRP.

The Contractor shall provide the equipment, supplies, and ancillary services necessary to conduct medical consultations and rare emergency medical care. Specifically, the Contractor shall provide 1) Urgent or non-routine medical consultation services for participants who are identified with a medical condition upon screening, and 2) On-call cardiology consultation.

3. Diagnostic Laboratory and Other Testing Services The Contractor shall provide necessary diagnostic laboratory and radiology services as requested for the clinical research program. The Contractor shall provide all equipment as well as software to allow electronic transfer of laboratory data (ordering and results) between the Contractor and the NIDA IRP. In addition, the Contractor must provide all supplies and ancillary services necessary to conduct the radiology, neuroradiology, and laboratory tests.

4. Supplies and Pharmacy Support The Contractor will provide a mechanism to obtain necessary medical equipment, supplies and services for the clinical research program in the BRC. This includes, but is not limited to, medication, phlebotomy supplies, laboratory specimen supplies (test tubes, urinalysis supplies), IV maintenance supplies to support approximately five clinical study sessions/day that require these supplies. In addition, there may be special procedures supplies that would be pre-specified between the Contractor and the Office of the Clinical Director.

5. Domiciliary Oversight and Care Domiciliary Oversight and Care- This service will be acquired on a Fixed Fee/month basis.

The Contractor shall provide overnight stay capability in a facility that can accommodate NIDA participants. NIDA anticipates approximately 12 overnight stays per month; however, this can fluctuate depending on the clinical protocols currently running.

6. Nursing Services The facility should include technicians and nursing staff who will be required to complete the NIDA IRP training to use HuRIS and enter the system monthly to maintain access. At times, the Contractor may be required to provide specialized nursing services for those individuals participating in protocols that require consecutive night’s accommodations. Specialized nursing services will include:

1. Administration of research drugs and/or medications as dictated by NIDA-approved study procedures.

2. Collection, processing and storage of biological specimens. Proper storage container will be provided by NIDA.

3. Collection of neuropsychological and other forms of behavioral assessments as defined by the research study design. These assessments will be performed directly into a NIDA-provided computer terminal equipped with NIDA Clinical Data Warehouse (CDW) software. NIDA will provide Clinical Research Unit (CRU) staff with training in the use of this software and assure VPN authorization by end users. Contractors must login and use the system every month to retain clinical access. Nurses must maintain login credentials.

4. Any vital signs required by the protocol will also be recorded directly into CDW software on the NIDA computer.

7. Transition Services

The Contractor shall perform transition services necessary to ensure an effective transition-in and transition-out of contractor support and continued operations, as well as an orderly transition period without any interruption or loss of proficiency of services.

If you are interested in responding to this notice, you must demonstrate and document in any capability statement you submit extensive experience with and the ability to perform the above tasks.

Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but is not limited to, current or past contracts with the Government and/or commercial organizations, references, (i.e., names, titles, telephone numbers), and any other information serving to document the organization's capability (e.g., awards, commendations, etc.).

The information you send should be relevant and specific in the technical area under consideration, on each of the following qualifications:

(1) Experience: An outline of previous projects;

(2) Personnel: Name, professional qualifications and specific experience of scientists and technical personnel who may be assigned as principal investigator and/or project director;

(3) Facilities: Availability and description of facilities to perform the tasks mentioned above; and

(4) Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented.

THIS IS NOT A REQUEST FOR PROPOSALS: This notice is for informational and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement or otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. All capability statements should provide the following: 1) company name and address; 2) point of contact;

3) phone/fax/email; 4) NAICS Code(s); 5) business size and status; 6) capability information in response to the requirements and qualifications identified in this notice; and 7) type(s) of business, if any (e.g., 8(a), Veteran-owned, service-disabled Veteran-owned, HUBZone, SDB, women-owned, or other small business).

Electronic capability statements must be submitted to Scott Duernberger and Josh Lazarus, whose contact information is included, NO LATER THAN March 30, 2025.

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).

POINTS OF CONTACT:

Primary POC:

NAME: Scott Duernberger TITLE: Contract Specialist, NIDA EMAIL: ADDRESS: scott.duernberger@nih.gov

Secondary POC:

NAME: Josh Lazarus TITLE: Contracting Officer, NIDA EMAIL ADDRESS: josh.lazarus@nih.gov