Radiation/Nuclear Medical Countermeasure Product Development Support

SOURCES SOUGHT NOTICE RADIATION/NUCLEAR MEDICAL COUNTERMEASURE PRODUCT DEVELOPMENT SUPPORT Sources Sought Reference Number: NIAID-DAIT-NIHAI201800019 Type of Requirement Follow-on (Contract No.: HHSN272201500013I) Place of Performance is unknown at this time. Recompetition: SRI International 333 Ravenswood Ave, Menlo Park, CA 94025 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 World events over the last fourteen years have highlighted the growing threat of terrorism and its many forms, including the 1995 Oklahoma City bombing, the 1995 Tokyo sarin gas attack, the terrorist attacks in the U.S. on September 11, 2001, and the deliberate spread of anthrax and ricin through the U.S. Postal Service and Congressional office buildings. These incidents generate increasing awareness into the range of approaches used by terrorists, including the potential to use chemical, biological, and radiological/nuclear weapons. Acts of radiological or nuclear terrorism could involve the use of stolen or improvised nuclear devices, attacks on nuclear power plants or reactors, the detonation of radiological dispersal devices ("dirty bombs," which combine radioactive material with conventional explosives), or the placement of radiation sources in public locations or in food or water supplies. Besides terror threats, nuclear disasters, such as the Fukushima Daiichi meltdowns and explosions of March 11, 2011, have increased awareness of radiation exposure to civilians. The effects of radiation on the body may appear within minutes or develop many years after exposure. Radiation injury is directly proportional to the dose absorbed by the body and radiosensitive tissues. Depending on the dose of whole-body or partial-body exposure to external radiation, the effects can range from an increased risk of cancer years after exposure to more acute effects, including transient nausea and vomiting; hematopoietic and gastrointestinal injury, leading to immunosuppression and infection; metabolic abnormalities; hemorrhage and anemia; damage to the cardiovascular, pulmonary, and central nervous systems; and death. Purpose and Objectives The United States Government has recognized the need for improved medical countermeasures against such threats. The Department of Health and Human Services (HHS) charged the National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH) with building and managing a program to develop products for the mitigation or treatment of radiation injuries from exposures due to nuclear and radiological attacks. This solicitation will support research and development of radiation and nuclear medical countermeasures towards licensure or approval. The supported work will encompass work performed in the drug development pathway as well as the administrative foundation necessary to facilitate and coordinate these activities in partnership with NIAID. One Indefinite Delivery, Indefinite Quantity (ID/IQ) type contract will be awarded to an organization to provide the comprehensive suite of product development tasks. The work will be directed and funded using Task Orders. Project requirements The purpose of proposed solicitation, entitled "Radiation/Nuclear Medical Countermeasure Product Development Support," is to recompete the effort to provide facilities, expertise and capabilities for the development of radiation/nuclear medical countermeasures (MCMs) for 1) the mitigation or treatment of acute radiation syndrome (ARS) and delayed effects of acute radiation exposure (DEARE). The Contractor will not identify or conduct basic research on new medical countermeasures. NIAID anticipates that products selected by the government for screening, testing, and development will come from industry, academia, and government agencies. The work to be performed under this contract will be initiated by NIAID. NIAID intends to solicit proposals for a multi-year Product Development Contract that will encompass some or all of the work described below, depending on contract type and program need: - Animal models of radiation injury; - MCM testing in animal models of radiation injury; - Sample collection to detect biomarker for radiation injury - The spectrum of existing and planned Investigational New Drug (IND)-enabling product development support services. Anticipated period of performance The anticipated period of performance will start around June 2020 and continue for 7 years. Other important considerations Capability statement / information sought Potential sources must demonstrate and document the following in their capability statements: - Good Laboratory (GLP)-compliant facilities that can perform radiation exposure in large animals (non-human primates, dogs and rodents.) - Facilities capable of manufacturing MCM candidates in compliance with current Good Manufacturing Practice (cGMP) guidelines. - GLP-compliant facilities capable of performing non-clinical safety testing. - Good Clinical Practice (GCP)-compliant facilities capable of performing human safety studies. - Capability statements submitted as a result of this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: - The performance of GLP efficacy studies for hematopoietic and gastrointestinal acute radiation syndromes in rodents and large animals (non-human primates). - Development and refinement of rodent and large animal (non-human primates) models for hematopoietic and gastrointestinal acute radiation syndromes and lung models for radiation injury. - 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. - 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. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement 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). 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 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: Please submit one (1) electronic 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 Debbie Blyveis, Contract Specialist, at blyveisd@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify NIAID-DAIT-NIHAI201800019. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM ET on 09/21/2018. 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)."