Inactive

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MS... Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892-9821 Sources Sought Notice Information Introduction 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 The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), mission is to conduct and support basic and applied research to better understand, treat and ultimately prevent infectious, immunologic and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID advances the understanding, diagnosis, and treatment of many of the world’s most intractable and widespread diseases. NIAID has a duel mandate: to conduct and support research in the areas listed above and to respond rapidly to newly-emerging or re-emerging infectious diseases that pose a threat to domestic or global public health. Toward this end, NIAID manages a complex and diverse research portfolio that aims to expand the breadth and depth of knowledge in all areas of infectious, immunologic, and allergic diseases and develop flexible domestic and international research capacities to respond appropriately to emerging and re-emerging disease threats at home and abroad. When emerging diseases create a need for rapid response, NIAID does not currently have a contract mechanism comprehensive enough to cover all the requirements of the response. For example, NIAID may be researching vaccines or treatments for a particular disease at the time an outbreak of that disease occurs somewhere in the world. NIAID would quickly need to develop a research infrastructure to support or facilitate the science in that location, which may include the conduct of clinical trials. This type of work can be particularly challenging considering the remote locations, culture of the surrounding communities and lack of access to basic care, supplies, and facilities. Capacity building and maintaining assets in resource poor settings to leverage in the case of a new health emergency represents a bona fide government need. Although external assets (human and otherwise) may be appropriate to begin clinical research tasks due to urgency issues, a transition to using local assets is critical to long-term success. Building local capacity meets obligations outlined in clinical research ethical principles, improves community collaboration and satisfaction, and improves clinical research participant recruitment abilities. This requirement will provide the much-needed mechanism for emergency preparedness and rapid response NIAID-wide. This contract focuses primarily on NIAID’ s Intramural research efforts, conducted through comprehensive research programs. The three intramural divisions are the Division of Clinical Research (DCR), the Division of Intramural Research (DIR), and the Vaccine Research Center (VRC). This requirement is written with the needs of all intramural divisions in mind and will allow cross-division collaboration where the opportunity to do so exists and is desired. The Division of Clinical Research (DCR) plays an integral role in facilitating the efficient and effective performance of NIAID research programs on both the domestic and the international level. DCR’s vision is to facilitate high quality, state-of-the-art NIAID clinical research in the areas of allergic, immunologic, and infectious diseases. DCR is also responsible for Special Projects as designated by the NIAID Director, providing an effective rapid response of clinical research activities in support of priorities for emerging and re-emerging diseases, as set forth by the Department of Health and Human Services (HHS) or other government agencies. The Division of Intramural Research’s (DIR) purpose is to make scientific discoveries that promote the development of new treatments, vaccines, diagnostics, and therapeutics that improve human health. DIR research goals are to expand knowledge of normal immune system components and functions, define mechanisms responsible for abnormal immune function (immunodeficiency, allergy, and autoimmunity), understand the biology of infection (etiology and pathology of infection, identification and biology of infectious agents, and the host response), and develop strategies to prevent and treat immunologic, allergic, and infectious diseases. The mission of the Vaccine Research Center (VRC) is to conduct research that facilitates the development of effective vaccines for human disease. With the ability to award task orders under the following activity areas, NIAID will have the ability to respond quickly to outbreaks and emergencies, foreign and domestic. Clinical Trials and Human Subject Research Chemistry Manufacturing and Controls (CMC) Activities Non-Clinical Research: Animal Studies Analytics, Bioinformatics, Computational Biology and Biostatistical Support Storage and Repository Regulatory and Quality Assurance Support Basic and Mechanistic Studies and Specialized Support Services NIAID anticipates awarding multiple Indefinite Delivery, Indefinite Quantity (IDIQ) contracts to organizations that have the capabilities required to fulfill the technical requirements of the Task Areas. Respondence must submit separate capability statements for each Task Area where they are capable to best meet the overall qualifications needed to fulfill the technical requirements of that Task Area. Respondence will be considered only in the Task Area(s) included in their proposal(s). Purpose and Objectives Responses from this notification shall provide the capacity and capability for a broad range of services necessary to support and conduct biomedical research in support of the NIAID mission and the management of activities specified under the Task Areas. Services include expanding the breadth and depth of knowledge in all areas of infectious, immunologic, and allergic diseases and developing flexible domestic and international research capacities to respond appropriately to emerging and re-emerging disease threats both domestic and foreign. In addition, the capability to streamline and ramp up rapid response due to a public health emergency. This Indefinite Delivery Indefinite Quantity (IDIQ) contract shall be administered and used primarily to support NIAID’s Division of Clinical Research, Division of Intramural Research, and Vaccine Research Center. Project requirements The requirements include seven Task Areas and a general description of the Task Area as follows: TASK AREA A: Clinical Trials and Human Subject Research – Under this Task Area the Contractor shall provide support services for, data analysis of, and design, development, implementation, and conduct of clinical studies and trials. Support will facilitate rapid response activities to address public health threats and or emergencies. Clinical studies can be interventional or observational, include clinical trials Phase 0-IV, natural history studies, and other human subjects research. In addition, community engagement and social mobilization activities particularly at foreign and resource limited sites will be supported. TASK AREA B: Chemistry Manufacturing and Controls (CMC) Activities – Under this Task Area, the Contractor shall provide support for a broad range of services required for design, development, manufacture, and release of product as Clinical Trial Materials, including precursors, preliminary states, and all required testing. Ancillary products (examples are placebos, diluents, adjuvants, master banks, testing standards, reference materials) and other materials manufactured or purchased to support clinical trials or CMC activities may also be required. In addition to actual cGMP production, activities within scope include all activities preliminary to manufacturing (e.g. formulation studies, process development, and development or engineering lots) and Task Orders for these activities can be required without an associated cGMP task. Also, within scope are all activities required to maintain material in a usable state including storage, shipping, testing (in process, release, stability, and quality actions), and preparation of documents to support regulatory submissions. TASK AREA C: Non-Clinical Research: Animal Studies – Under this Task Area, the Contractor shall provide a broad and flexible range of animal services and model capabilities in support of research on infectious, immunologic and allergic diseases. Studies will utilize various species such as non-human primate, small and large mammals, and non-traditional animal models and various containment levels, ABSL 1 - 4. TASK AREA D: Analytics, Bioinformatics, Computational Biology, and Biostatistical Support – Under this Task Area, the Contractor shall provide bioinformatics and biostatistical support resources and services for the infectious disease community. This includes development and application of data collection, data-analytical and theoretical methods, mathematical modeling and computational simulation techniques. TASK AREA E: Storage and Repository: Under this Task Area, the Contractor shall provide a quality-assured central repository for the acquisition, authentication, storage, inventory, and distribution of a broad range of NIAID materials. Materials may include (1) unique, irreplaceable research specimens from pre-clinical or clinical studies; (2) Clinical Trial Materials, including cGMP inventory, or other reagents, and / or (3) other materials generated by or required for NIAID research. Storage conditions may include room temperature, refrigerated, frozen, ultracold frozen, or liquid nitrogen (liquid or vapor). Materials may be infectious and require handling conditions suitable for BSL-2. Ability to manage BSL-3 or BSL-4 materials might also be needed. TASK AREA F: Regulatory and Quality Assurance – Under this Task Area, the Contractor shall provide for Regulatory and Quality Assurance support including collection of data, documents and information required for preparation and prepare documents, review for content and format, submit for regulatory filing with the US Food and Drug Administration (e.g. pre-Investigational New Drug (IND), IND) or other international regulatory Agencies according to federal and international regulatory authorities’ regulations. Contractors might also be involved in Quality Management System activities including development, audit, and management support. TASK AREA G: Basic and Mechanistic Studies and Specialized Services – Under this Task Area, the Contractor shall conduct and analyze basic, early phase clinical, and mechanistic studies to generate new ideas; test or further existing ideas, principles, and theories; to provide for development, implementation and advancement of technologies; and to provide specialized services to support the activities of the NIAID. Anticipated period of performance The anticipated ordering period is for seven years beginning February 1, 2021 through January 31, 2028. Other important considerations As appropriate, offerors should be capable of maintaining full and continuous accreditation of animal facilities by AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care) [http://www.aaalac.org/accreditation/index.cfm], Office of Laboratory Animal Welfare (OLAW) Assurance [http://grants.nih.gov/grants/olaw/olaw.htm], and compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, including environmental enrichment [http://grants.nih.gov/grants/olaw/references/phspol.htm]. Facilities requirements are to provide and maintain state-of-the art facilities, equipment, space, and other resources and facilities that comply with all local, domestic, in-country, state and or Federal and NIH regulations. The Contractor shall maintain QA documentation to support adherence to these areas. Also, to provide for safe and secure operation/access to facilities. Contractor’s shall establish processes and procedures limiting access to only approved and qualified staff to physical sites, systems, equipment, technology, internet, and or data. Along with provide Biohazard, Environmental and Occupational Health Safety, Emergency Management/Preparedness, Security, Transportation and Logistics Services. All work with hazardous biological materials shall be in compliance with all local, domestic, in-country, state and or Federal and NIH regulations. The Contractor shall comply with the physical security, protection of Government property, and protection of information (FISMA), cyber security, agent protection, control and accountability, safe disposal and waste handling and personal security set forth local, domestic, in-country, state and or Federal and NIH regulations. Also be responsible for maintaining Government Furnished Property per FAR 52.245-1. The Contractor is required to develop and implement a Preventive Maintenance (PM) plan that includes Service Agreements. The Contractor shall maintain a library of operating and maintenance manuals for all scientific equipment and other essential equipment required for the completion of the activity in English and when appropriate to local language and make them accessible for inspection of Government personnel. The Contractor shall take full advantage of manufacturer warranty obligations and maintain a log of all active warranties for the facility. Finally, establish and maintain adequate and reasonable controls and procedures for the custody and safe keeping of all equipment, space, and other resources. The Contractor shall designate a Property Custodial Officer (PCO) /Property Management Representative, who is responsible for the day-to-day custody, use, care, and safekeeping of property in a defined custodial area. Capability statement / information sought Capability Statements should clearly convey information regarding the respondent's capabilities, including: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. Interested contractors must submit a capability statement (ten page limitation, excluding resumes) describing their company's experience and ability to perform this effort that includes the following: (1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement under the Task Area they are qualified for, not to exceed 10 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). 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 https://www.sam.gov/index.html/#1. 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: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Matt Lear, Contract Specialist, at Matt.Lear@nih.gov in MS Word or Adobe Portable Document Format (PDF). One electronic copy must of your response must be provided. The e-mail subject line must specify SBSS019R00025 - CARR. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 12 pm EST on 03/18/2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award an IDIQ contract or Task Order 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 in Federal Business 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).”