Clinical Materials Services
Project History: Re-competition (Contract No.: HHSN272201700085C) Current Contractor: Fisher BioServices 20439 Seneca Meadows Parkway Germantown, MD 20876 Project Description: Research supported and c... Project History: Re-competition (Contract No.: HHSN272201700085C) Current Contractor: Fisher BioServices 20439 Seneca Meadows Parkway Germantown, MD 20876 Project Description: Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which is funded through a variety of research grants , cooperative agreements, and contracts. The evaluation of new and improved vaccine, therapeutic, diagnostic and device candidates in clinical trials and clinical studies is an essential element of DMID’s efforts. Through an extensive network of grants, cooperative agreements and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase 1, Phase 2, and Phase 4 (and occasionally Phase 3) clinical trials for the evaluation of bacterial, viral and parasitic vaccines, other biologics, drugs, diagnostics and devices as preventive, therapeutic, diagnostic and device measures against infectious diseases in people of all ages and risk categories. Much of this clinical research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases, including SARS-CoV-2, avian influenza and anti-microbial resistance, and those supporting the evaluation of safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens In 2017, NIAID awarded a contract to Fisher BioServices Corporation (HHSN272201700085C) to provide for the operation of a Clinical Materials Services (CMS) facility that adheres to current Good Manufacturing Practice (cGMP), for the acquisition, receipt, storage and shipping of clinical agents and clinical specimens in support of DMID- sponsored clinical trials and research programs in the U.S. and abroad and ensures that all work performed is done in compliance with federal and/or local clinical trial related regulations. This solicitation is intended to recompete and continue these services. Clinical agents include investigational study products (drugs, vaccines, therapeutics, diagnostics and devices), commercial products, placebos, syringes, and other protocol/Manual of Procedures (MOP)-mandated supplies to be used in DMID-sponsored clinical trials. Clinical specimens include sera or other protocol-mandated specimens obtained from DMID-approved clinical research sites, to be distributed or tested at DMID- approved testing laboratories. Any awardee resulting from this solicitation will be transferred samples and data as part of initial transition activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractor(s). It is anticipated that one (1) Cost-Reimbursement, Level-of-Effort type contract will be awarded for a one-year Base Period and six (6) Term Options and quantity options with the period of performance beginning on or about June 2022. It is estimated that 10 Full-Time equivalents (FTEs), based upon a work year of 20,325 hours including subcontractor and consultant personnel, will be required. If the Offeror’s work year is less than the 20,325 hours, the Offeror must understand that the requirement is for the Contractor to provide the exact number of hours required per year for its proposal to be considered responsive. This information is furnished to Offerors for information purposes only and is not to be considered restrictive for proposal purposes. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about June 22, 2021, and may be accessed through beta.SAM.gov. Beta.SAM.gov connects to the NIAID electronic Contract Proposal Submission (eCPS) website (ALL R&D solicitations MUST be in eCPS). For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.
Data sourced from SAM.gov.
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Clinical Materials Services
This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the avai... This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. 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; and (3) 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. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. BACKGROUND Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, diagnostics and devices, which is funded through a variety of research grants and contracts. The evaluation of new and improved vaccine, therapeutic, diagnostic and device candidates in clinical trials and clinical studies is an essential element of DMID’s efforts. Through an extensive network of grant and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase 1, Phase 2, and Phase 4 (and occasionally Phase 3) clinical trials for the evaluation of bacterial, viral and parasitic vaccines, other biologics, drugs, diagnostics and devices as preventive, therapeutic, and diagnostic measures against infectious diseases in people of all ages and risk categories. Much of this clinical research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases, including avian influenza and antimicrobial resistance, and those supporting the evaluation of safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm), PURPOSE AND OBJECTIVES The purpose of this Small Business Sources Sought Notice (SBSS) is to identify qualified small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted. In September 13, 2017, NIAID awarded a 5-year contract to Fisher BioServices Corporation (HHSN272201700085C) to provide for the operation of a Clinical Materials Services facility (CMS) that adheres to current Good Manufacturing Practice (cGMP), for the acquisition, receipt, storage and shipping of clinical agents and clinical specimens in support of DMID-sponsored clinical trials and research programs in the U.S. and abroad and ensures that all work performed is done in compliance with federal and/or local clinical trial related regulations. This sources sought notice is intended to recompete and continue these services. PROJECT REQUIREMENTS The anticipated solicitation will be for the management and operation of a cGMP-compliant clinical materials services facility including receipt, aliquoting, labeling, packaging, repackaging, shipping, acquiring, testing and disposing of clinical agents and clinical specimens. All work performed under the anticipated contract must be done in compliance with federal and/or local clinical trial related regulations. Clinical agents include investigational study products (drugs, vaccines, therapeutics, diagnostics and devices), commercial products, placebos, syringes, and other protocol/Manual of Procedures (MOP)-mandated supplies to be used in DMID-sponsored clinical trials. Clinical specimens include sera or other protocol-mandated specimens obtained from DMID-approved clinical research sites, to be distributed or tested at DMID-approved testing laboratories. Any awardee resulting from the anticipated solicitation will be transferred samples and data as part of initial transition activities. NIAID recognizes that a single organization or institution may not have the expertise and facilities required to perform all of the activities set forth in the Statement of Work and, consequently, that the Contractor may need to be supported to a certain extent by the expertise and resources of subcontractors to perform some of the tasks required. The Contractor shall be responsible for ALL work performed under the anticipated contract including that performed by any subcontractor(s). ANTICIPATED PERIOD OF PERFORMANCE The Government anticipates making one award. It is anticipated that the duration of the level-of-effort contract will be a one year contract with options for six (6) additional years. CAPABILITY STATEMENT/INFORMATION SOUGHT Capability statements submitted by potential sources as a result of this announcement should demonstrate the respondent’s qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to: Technical Approach: adequacy, appropriateness and feasibility of approaches to providing the proposed clinical agent and clinical specimen repository services, including: 1. Receipt, appropriate storage, monitoring, distribution and disposition of clinical agents from product suppliers in support of DMID-sponsored clinical research 2. Labeling, packaging and repacking of clinical agents for distribution to DMID-approved clinical research sites and DMID approved testing laboratories 3. Receipt of all required shipping documents 4. Validation of packaging and shipping procedures for the shipment of clinical agents under correct temperature conditions 5. Monitoring of product inventories and expiration dates 6. Acquisition of clinical agents and non-clinical testing 7. Receipt, storage, monitoring, distribution, and disposition of clinical specimens in support of DMID sponsored clinical research 8. Aliquoting, labeling, of clinical specimens for distribution and testing at DMID approved testing laboratories 9. Maintenance and operation of an electronic system for requesting services and tracking agents and specimens. Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Facilities, Equipment, and Safety: adequacy, appropriateness, and availability of safe facilities of the respondent and all proposed subcontractors to carry out clinical agent and clinical specimen repository activities. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. Assume that: 1. On the effective date of the contract, 1,000,000 vials of specimen and 500,000 vials of product will need to be transferred. 2. Shipments will be made to clinical trials in both domestic and foreign locales, for up to 100 trials. In addition, potential sources must be able to provide a total level of effort of 20,325 total hours per year for a period of performance of seven years (Base period plus six, one-year Options). In any year of the contract, the selected Contractor will also be able to respond to requests to expend increased effort based on the exercise of Options for 10,163 additional hours for two additional quantity options, with the same hours cited in the option, within a contract year. HOW TO SUBMIT A RESPONSE PAGE LIMITATIONS: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed seven (7) pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. REQUIRED BUSINESS INFORMATION • DUNS. • Company Name. • Company Address. • Company Point of Contact, Phone and Email address • Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. • Do you have a Government approved accounting system? If so, please identify the agency that approved the system. • Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at www.sam.gov. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address). NUMBER OF COPIES AND DELIVERY POINT Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Harun Ali, Contract Specialist, at harun.ali@nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify NIHAI75N93021R00011. Facsimile responses will not be accepted.
Data sourced from SAM.gov.
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