INTRODUCTION: The Center for Disease Control and Prevention (CDC) is issuing this source sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support the requirement for Tuberculosis (TB) Clinical Trial Drug Management Support. The intention is to procure this requirement on a competitive basis. BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES (IN FULL OR IN PART) OR PROCURED THROUGH FULL AND OPEN COMPETITION MAY be made. All Small Business Set-Aside categories will be considered. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. PLACE OF PERFORMANCE: Location % On-Site Government - 0% % Off-Site Contractor - 100% Contractor Offsite Facility with delivery to several clinical research locations DISCLAIMER “THIS SOURCES SOUGHT IS FOR INFORMATIONAL PURPOSES ONLY. THIS IS NOT A “REQUEST FOR PROPOSAL (RFP)” TO BE SUBMITTED. IT DOES NOT CONSTITUTE A SOLICITATION AND SHALL NOT BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. RESPONSES IN ANY FORM ARE NOT OFFERS AND THE GOVERNMENT IS UNDER NO OBLIGATION TO AWARD A CONTRACT AS A RESULT OF THIS ANNOUNCEMENT. NO FUNDS ARE AVAILABLE TO PAY FOR PREPARATION OF RESPONSES TO THIS ANNOUNCEMENT. ANY INFORMATION SUBMITTED BY RESPONDENTS TO THIS TECHNICAL DESCRIPTION IS STRICTLY VOLUNTARY. RESPPONSES WILL NOT BE RETURNED TO THE RESPONDER. NOT RESPONDING TO THIS NOTICE DOES NOT PRECLUDE PARTICIPATION IN ANY FUTURE REQUEST FOR QUOTE (RFQ) OR INVITATION FOR BID (IFB) OR RFP, IF ANY ISSUED. IF A SOLICITATION IS RELEASED, IT WILL BE SYNOPSIZED ON THE GOVERNMENT-WIDE POINT OF ENTRY (GPE). IT IS THE RESPONSIBILITY OF POTENTIAL OFFERORS TO MONITOR THE GPE FOR ADDITIONAL INFORMMATION PERTAINING TO THIS REQUIREMENT.” PROGRAM BACKGROUND: The TB Clinical Trial Drug Management Support , CDC is designated as the large Phase 2 and long-term Phase 3 clinical trials to evaluate new TB drugs, drug regiments, and preventive interventions. In accordance with the tasks outlined in the Statement of Work (SOW)/ Performance Work Statement (PWS) the Contractor shall provide all labor, materials, and equipment to provide clinical drug trial management. REQUIRED CAPABILITIES: The Contractor shall provide all labor, materials, and equipment to provide clinical trial drug management services in support of the areas specified in the Program Background (above). Further detail is provided in the draft SOW/PWS attached to this announcement (Attachment 1). The vendor shall be familiar with the CDC’s program. The vendor shall be established in the field of drug management for clinical trials. The vendors shall expertise in: Management of investigational products (study drugs) used for clinical research Temperature controlled storage and shipment of study drugs Management of international drug shipment Drug Destruction processes If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated to deliver technical capability, organizations should address the administrative and management structure of such arrangements. The Government will evaluate market information to ascertain potential market capacity to: 1) provide services consistent, in scope and scale, with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with tight program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation; and 4) provide services under a performance based service acquisition contract. SPECIAL REQUIREMENTS : Section 508 compliance EO 14005 compliance EO 13556 compliance ELIGIBILITY: The applicable NAICS code for this requirement is 493190- Other Warehousing and Storage with a Small Business Size Standard of $36.5M. The Product Service Code is S215- Housekeeping- Warehousing/ Storage. Businesses of all sizes are encouraged to respond; however, each respondent must clearly identify their business size in their capabilities statement. ADDITIONAL INFORMATION AND SUBMISSION DETAILS (CAPABILITIES STATEMENT): A draft SOW/ PWS statement is attached for review (Attachment 1). Interested parties are requested to submit a capabilities statement of no more than ten (10) pages in length in Times New Roman font of not less than 10 pitch. The deadline for response to this request is no later than 3 pm, EST, 10 March 2024. All responses under this Sources Sought Notice must be e-mailed to Elizabeth C. Wheeler,
[email protected] Your response must address at a minimum the following items: 1.) What type of work has your company performed in the past in support of the same or similar requirement? 2.) Can or has your company managed a task of this nature? If so, please provide details. 3.) Can or has your company managed a team of subcontractors before? If so, provide details. 4.) What specific technical skills does your company possess which ensure capability to perform the tasks? 5.) The contract type is anticipated to be Firm- Fixed- Price (FFP). If you believe this contract type may not be feasible, please provide an alternative contract type along a justification for your recommendation. 6.) If you have a suggested optimal CLIN structure for the contract, that you consider suitable, kindly provide it along with your reasoning in your response to this notice. 7.) Please note that under a Small-Business Set-Aside, in accordance with FAR 52.219-14, the small business prime must perform at least 50% of the work themselves in terms of the cost of performance. Provide an explanation of your company’s ability to perform at least 50% of the tasking described in this PBSOW for the base period as well as the option periods. 8.) Provide a statement including current small/large business status and company profile to include number of employees, annual revenue history, office locations, DUNs number, etc. 9.) Respondents to this notice also must indicate whether they qualify as a Small, Small Disadvantaged, Women-Owned, HUBZone, or Service-Disabled Veteran-Owned Small Business Concern. 10.) Include in your response your ability to meet the requirements in the Facility and Safeguarding requirements. The estimated period of performance consists of five years, i.e., base year plus 4 option periods, etc.) with performance commencing in September 2024. Specifics regarding the number of option periods are in the PWS and will be provided in the solicitation. The proposed contract is anticipated to include tasking that would be accomplished by labor categories that are subject to the Service Contract Act or a collective bargaining agreement. Upon evaluation of the capability statements, if it is determined that this requirement will be an unrestricted competition, the Government intends to evaluate the Small-Business responses and conduct further market research to identify a subcontracting goal. Your response to this Sources Sought, including any capabilities statement, shall be electronically submitted to the Contract Specialist, Elizabeth C. Wheeler in either Microsoft Word or Portable Document Format (PDF), via email at
[email protected] . All data received in response to this Sources Sought that is marked or designated as corporate or proprietary will be fully protected from any release outside the Government . No phone calls will be accepted. All questions must be submitted to the Contract Specialist identified above. The Government is not committed nor obligated to pay for the information provided, and no basis for claims against the Government shall arise because of a response to this Sources Sought.