cGLP Compliant Contract Research Organizations For Non-Clinical Animal Model Development Studies, and Testing Medical Countermeasures (MCM) Against Pathogens That Require Containment in Biosafety Level 4 (BSL-4) Laboratories

U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) Biomedical Advanced Research and Development Authority (BARDA) Division of Non-Clinical Development REQUEST FOR INFORMATION August 31, 2019 1.0 Description 1.1 The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is seeking information from the public regarding availabilities, capabilities and other pertinent marketplace data for developing animal models, and testing Medical Countermeasures (MCM) against pathogens that require containment in Biosafety Level 4 (BSL-4) laboratories. BARDA seeks this information to strengthen its understanding of the current and future marketplace, enhance its ability to obtain quality services economically, and to efficiently and lawfully establish potential vendor source files and listings. The requirements are as follows: 1.1.1 Qualifications, experience and capability to 1) develop animal models for pathogens requiring BSL-4 containment and 2) test MCM against such pathogens. 1.1.2 Capabilities should include adequate facilities to develop small and large animal models for BSL-4 pathogens, CDC registration for Select Agent use, and the ability to conduct studies under quality systems. 1.2 THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This RFI is issued in accordance with Federal Acquisition Regulation (FAR) provision 52.215-3, Request for Information or Solicitation for Planning Purposes, and is solely for information gathering and planning purposes. The RFI does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. BARDA intends to use responses to this RFI for planning purposes towards the possible establishment of a network of capable BSL-4 laboratories that would be able to develop and test diagnostics, develop animal models, and test MCM for pathogens requiring BSL-4 containment. This notice does not commit the Government to contract for any supply or service whatsoever. Further, BARDA is not seeking proposals at this time and will not accept unsolicited proposals. Respondents to the RFI are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. Not responding to this RFI does not preclude participation in any future RFPs, if any are issued. If a solicitation is released, it will be synopsized on the Federal Business Opportunities/FedBizOpps website (https://www.fbo.gov/). It is the responsibility of the interested parties to monitor the site for additional information pertaining to this RFI or potential requirement. 2.0 Background The U.S. Department of Health and Human Services, through the BARDA, requires the establishment of animal models, for the development of medical countermeasures (MCMs) against Chemical, Biological, Radiological and Nuclear (CBRN) threats, Pandemic Influenza, and Emerging Infectious Diseases (EID). The mission and priorities of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) are articulated in the PHEMCE Implementation Plan (link: https://www.medicalcountermeasures.gov/BARDA/documents/2017-phemce-sip.pdf). The Pandemic and All-Hazards Preparedness Act (PAHPA), signed into law on December 19, 2006 and reauthorized in June 2019 under the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAIA), codifies HHS as the lead entity of Federal public health and medical response to public health emergencies and National Response Plan incidents, and specifies that one of the duties of the HHS Assistant Secretary for Preparedness and Response is to oversee advanced research, development, and procurement of qualified countermeasures and qualified pandemic or epidemic products. Section 319L (a)(6): Advanced Research and Development subsection (b) "activities includes": ii) Design and development of tests or models, including animal models, for such testing. BSL-4 Pathogens and Need for Laboratory Capacity BARDA is currently developing MCMs against multiple pathogens requiring BSL-4 containment (Zaire ebolavirus, Sudan ebolavirus, and Marburg virus). There are a number of other pathogens that would require BSL-4 containment should BARDA be tasked with establishing MCM programs in the future (i.e. Nipah virus, Lassa virus, Hendra virus, etc.). The 2014 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies Ebola and Marburg viruses as high-priority threats as determined by the Secretary of Homeland Security. There are currently no MCMs that are licensed for use against Zaire ebolavirus, Sudan ebolavirus, or Marburg virus. The same is true for other pathogens that would require BSL-4 containment. Development of MCMs against these pathogens would require extensive non-clinical testing, as approval would likely occur via the FDA Animal Rule. The capacity of BSL-4 laboratories is limited in terms of numbers and availability. BARDA is seeking to establish a contracting mechanism that enhances this critical MCM infrastructure and provides the ability to rapidly engage BSL-4 laboratories via task order. 3.0 Requested Information The following outline shall be used in the response document: Quality Components: 1.1 Compliance - 1.1.1 Does your facility have a Quality Management System? 1.1.2 Has your facility conducted a GLP study? If yes, has your facility conducted a GLP study(ies) under BSL-4 containment? 1.2 Organization and Personnel 1.2.1 How many staff are available to work in BSL-4 suites? 1.2.2 Does your laboratory have the following personnel? If not, do you have plans for staffing these positions? i. Testing Facility Management ii. Principal Investigator iii. Program Manager iv. Contracting Officer v. Study Director vi. Virologist/Analytical Team Lead vii. Animal Technician(s) viii. Assay Technicians(s) ix. Pathologist x. Statistician xi. Veterinarian xii. Quality Control 1.2.3 Quality Assurance Unit - Do you have a QAU? 1.3 Facilities 1.3.1 How much total BSL-4 space do you have (sq.ft.) at your facility? 1.3.2 Of the total BSL-4 space, how much of that is in animal rooms (sq.ft.)? And how much of the BSL-4 space is able to accommodate large animal studies (nonhuman primates)? 1.3.3 How many separate animal rooms are available in the BSL-4 space and what size are they? How many animals can be accommodated in a given study? 1.3.4 Can your facility house nonhuman primates? If so, with which species does your facility have experience? 1.3.5 List other animal species that your lab has worked with in BSL-4. 1.3.6 What regulations do you comply with for animal research? 1.4 Equipment 1.4.1 What types of equipment do you have in house for: 1.4.1.1 Hematology 1.4.1.2 Clinical chemistry 1.4.1.3 PCR 1.4.1.4 Plaque assays and immunological assays 1.4.1.5 Diagnostics 1.4.2 Is all equipment in the BSL-4 space tested, calibrated, and/or standardized? 1.5 SOPs 1.5.1 Do you have study specific SOPs? 1.5.2 Do you have facility specific SOPs? 1.6 Nonclinical Study Test System 1.6.1 Does your facility qualify animal vendors and routinely use those qualified vendors? 1.6.2 Do you have an attending veterinarian? 1.6.3 Describe the animal caging used for the various species (more specifically NHPs) with which your facility is currently working. 1.6.4 How many animals can be housed for a single study? Please specify the animal species and number accommodated per study. 1.7 Good Documentation Practice 1.7.1 How do you handle data generated in the BSL-4? 1.7.2 Do you verify exact copies of data scanned out of the BSL-4? 1.7.3 Specify your process for QC of data. 1.8 Study Protocol/Amendments/Deviations/Investigations 1.8.1 Are study protocols generated for each BSL-4 study? If not, can they be generated as needed? 1.8.2 Are planned changes to the protocol documented in amendments? 1.8.3 Are unplanned changes to the protocol documented in deviations? 1.8.4 Are investigations conducted for aberrant data? 1.9 Challenge Material and Reagents 1.9.1 List your available filovirus strains that could be used in animal challenge studies. List other viral species that your facility currently maintains and require BSL-4 containment. 1.9.2 Describe your source of challenge stocks. Do you develop and maintain Master/Working Virus stocks? If yes, are the stocks on stability protocols? 1.9.3 Describe your methods for challenge stock characterization. 1.9.4 How are the stocks stored? 1.10 Computer Systems 1.10.1 Do you use any electronic data capture systems? 1.10.2 Describe the controls for your computer systems. 1.11 Final Report 1.11.1 Do you generate a final report for each study to include clinical observations, body weights, body temperature, hematology, clinical chemistry, ELISA, viral plaque assay, PCR, necropsy, and histopathology? 1.12 Data/Specimen/Sample Handling 1.12.1 How do you ship samples to a 3rd party (both pre- and post-challenge samples, if applicable)? 1.12.2 Can you store samples? Do you have protocols in place for extended storage (>1 year) and sample disposition? If needed, what is your capacity for sample storage? 1.12.3 How long do you retain raw data? 1.13 Availability 1.13.1 Provide a rough estimate of availability of your ABSL-4 space for calendar year 2020 as of DATE of RFP. 1.13.2 Provide a rough estimate of the average time it would take from an award to an ABSL-4 slot being available. 1.14 Audits/Monitoring Visits 1.14.1 Has your facility been audited by a regulatory agency? 1.14.2 Has a study conducted in your BSL-4 been audited? 1.14.3 Have sponsor monitoring visits been conducted for BSL-4 studies at your facility? In all cases described above, the USG seeks laboratories with the capability to perform these procedures and studies in animal models that may be predictive of human response within all populations, including at-risk and special populations (e.g., pediatric, geriatric, pregnancy, etc.). 4.0 Responses - RFI White Paper 4.1 Interested parties are requested to respond to this RFI with a white paper. 4.2 RFI white papers shall be in Microsoft Word 2016-compatible format, include two sections as requested below, and due no later than 12:00PM ET on Monday, September 23, 2019. White papers shall be submitted via e-mail only to the Contracting Officer listed below. Please be advised that all submissions become Government property and will not be returned. Enrique Man, Contracting Officer Division of Contracts Management and Acquisition (DCMA) Biomedical Advanced Research and Development Authority (BARDA) E-mail: enrique.manan@hhs.gov 4.3 Page limitations: Section 2 of the white paper shall be limited to five (5) letter-sized pages. The number of pages in Section 1 of the white paper do not count against the 5-page limitation indicated for Section 2 (i.e. the 5-page limitation applies only to Section 2 of the white paper). 4.4 Section 1 of the white paper shall provide administrative information, and shall include the following as a minimum: 4.4.1 Respondent name, mailing address, overnight delivery address (if different from mailing address), phone number, and e-mail address of designated point of contact. 4.4.2 Business type (large business, small business, small disadvantaged business, 8(a)-certified small disadvantaged business, HUBZone small business, woman-owned small business, very small business, veteran-owned small business, service-disabled veteran-owned small business) based upon North American Industry Classification System (NAICS) code 541714, Biotechnology research and development laboratories. "Small business concern" means a concern, including its affiliates that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria and size standards in 13 CFR part 121. A small business concern for the purposes of this RFI is generally defined as a business, including its affiliates, with no more than one thousand (1,000) employees. Respondents are cautioned, however, that this is a general description only. Additional standards and conditions apply. Please refer to FAR Part 19 for detailed information on Small Business Size Standards. The FAR is available at http://www.acquisition.gov. 4.5 Section 2 of the white paper shall answer the issues addressed in Section 3.0, Requested Information, of this RFI. Proprietary information, if any, should be minimized and MUST BE CLEARLY MARKED. To aid the Government, please segregate proprietary information. 5.0 Questions Questions regarding this announcement shall be submitted via e-mail only to the Contracting Officer listed in Section 4.0 of this RFI. Verbal questions will NOT be accepted. The Government does not guarantee that questions will be addressed if received after Wednesday, September 11, 2019. 6.0 Summary THIS IS A REQUEST FOR INFORMATION (RFI) ONLY, IAW FAR 52.215-3, issued to identify current Good Laboratory Practice (cGLP)-compliant contract research organizations that are capable of executing non-clinical animal model development studies and testing MCM against pathogens requiring BSL-4 containment. The information provided in the RFI is subject to change and is not binding on the Government. BARDA has not made a commitment to procure any of the services discussed, and release of this RFI should not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned.