SOURCES SOUGHT
B -- Conducting Risk and Benefit Analysis on Gain-of Function Research Involving Pathogens with Pandemic Potential
- Notice Date
- 11/21/2014
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Office of Research Facilities, 9000 Rockville Pike, Bldg. 13, Rm. 2E47, MSC 5738, Bethesda, Maryland, 20892-5738, United States
- ZIP Code
- 20892-5738
- Solicitation Number
- HHS-NIH-OD-OLAO-SS-15-002
- Archive Date
- 12/20/2014
- Point of Contact
- Susan Apter, Phone: 3014029671
- E-Mail Address
-
apters@od.nih.gov
(apters@od.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a "Sources Sought Notice". This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. a. Background. Given the recent biosafety incidents in U.S. Federal laboratories and renewed concerns regarding laboratory safety and biosecurity, the U.S. government (USG) has determined that the risks and benefits of Gain-of Function (GOF) research must be re-evaluated. A robust and broad deliberative process that results in the adoption of a new Federal GOF research policy will be undertaken. While this process takes place, the USG will institute a pause in the provision of new USG funding for GOF research on influenza, MERS or SARS viruses. In parallel, the USG has encouraged the research community (both those who receive USG funding and those who do not) to join in adopting a voluntary pause in any ongoing research that involves the types of studies that are subject to the funding restriction above. The deliberative process that will ensue during the pause will involve both the National Science Advisory Board for Biosecurity (NSABB) and the National Academy of Sciences National Research Council (NRC), and will explicitly evaluate the possible risks and potential benefits of GOF research with potential pandemic pathogens. The NSABB will serve as the official federal advisory body for providing advice on oversight of this area of dual use research, in keeping with federal rules and regulations. The NSABB is to provide the USG with specific recommendations regarding a conceptual approach to the evaluation of proposed GOF studies. The NRC will convene a forum which will provide a mechanism to engage the life sciences community and provide for discussion of principles important for and key considerations in the design of risk and benefit assessments of GOF research. The final NSABB recommendations and the discussions at the NRC forum will inform the development and adoption of a new USG policy governing the funding and conduct of GOF research. b. Purpose and Objectives. In order to inform the deliberative process, and in particular, to provide the NSABB and the USG with objective and comprehensive information about the risks and benefits of GOF research, thorough and scientifically rigorous risk and benefit analyses (RBAs) on GOF research involving pathogens with pandemic potential are needed. The USG has determined that an independent third-party contractor shall undertake the required efforts to provide such analyses. The contractor will provide personnel and expertise, as well as technical and administrative support and materials, for preparation of risk and benefit analyses (RBAs) on GOF research involving pathogens with pandemic potential, as further described in the detailed list of tasks below. The RBAs will explicitly evaluate the possible risks and the potential benefits of GOF research in a number of areas, also listed below. The RBAs will be comprehensive, sound, and credible. Their preparation should be guided by the overall principles of RA: transparency, clarity, consistency, and reasonableness. In planning and conducting the RBAs, the contractor will take into account issues raised by recent biosafety/biosecurity incidents in USG laboratories. The scope and depth of analysis for the RBAs must be appropriate and sufficient to: inform NSABB deliberations and recommendations to the USG; and to support development and adoption of USG policies about whether GOF research should be supported and how best to conduct it. The work must be able to withstand rigorous scrutiny by a variety of stakeholders. Conduct of the RBAs will be directed and controlled by the contractor, in accordance with this SOW, but the deliberative process will be a cooperative effort involving participation by NIH, NSABB, and NRC. Staff from the Program on Biosafety and Biosecurity Policy (PBBP) at the NIH will manage the overall deliberative process, provide the interface and facilitate the communications between the contractor and other entities, and oversee the work by the contractor. The studies and resulting reports must comply fully with USG requirements, both procedurally and analytically, using existing guidance from federal agencies and peer-reviewed sources and well-established methods. c. Project Requirements. Within three weeks of issuance of contract, the contractor will initiate and complete Tasks 1 through 3: Task 1. Contractor Project Team. Formally propose for PBBP approval the contractor project team, which will include all essential personnel to conduct and manage the RBAs; no more than one project leader will be supported. A description of how the team will be managed must be included, as well as a description of how QA-QC of the work will be implemented. Once approved, the members of the project team may not be changed or substituted, and the number may not be increased without prior written approval. Task 2. Project Timelines. Based on the USG timeline for the deliberative process, the contractor will develop initial project timelines for the RBAs and an estimate of the hours required for the various team members to complete their work. It must be consistent with the USG plan, and have sufficient flexibility included to accommodate schedule delays. The timeline will include all key milestones (tasks and sub-tasks), as well as the sequence of work with dates of inception and expected completion. Indicate who will do what for each portion of each task, and provide dates for submission of all deliverables. Task 3. Kickoff Meeting. The contractor will conduct with NIH (to include the NIH Project Manager and others TBD by PBBP) a Kickoff Meeting where the proposed project team and the project timelines will be discussed. In order to facilitate rapid progress of the project, the contractor will establish weekly standing technical scientific working group (TSWG) teleconferences (or occasionally face-to-face meetings) to include necessary subject matter experts (appropriate contractor team members and those designated by NIH) to update NIH on current activities. Teleconferences will be used to discuss progress, review plans, and address problems or other issues that arise. At the kickoff meeting, participants will determine a mutually agreeable time for TSWG teleconferences. Brief summary reports for each teleconference will be provided by the contractor to all meeting participants within two working days of each call. Once tasks 1-3 have been completed tasks related to conducting the RBAs may commence. This will involve three phases, to include: a planning phase, an execution phase, and a writing phase; these may partially overlap to expedite the overall process. Task 4. Planning Phase. The main objective of this phase is to develop an overall project plan or Risk and Benefit Work Plan (RBWP) that encompasses all three phases for both assessments. Issues to be addressed in the RBWP (not necessarily to be done in this order) will include, but may not be limited to: A. The contractor will: identify data and other information needed to conduct the RBAs; describe how such data will be obtained and how gaps will be addressed; and discuss how data quality will be validated. The contractor will create, maintain and update a “needs list” of any data or other items needed by the contractor from agencies of the USG. B. With input from NIH, the contractor will establish the list of pathogens to be included in the RBAs, which will include influenza (several strains), SARS, and MERS, pathogens within the scope of the funding pause, and possibly others. The list may include other known agents, “novel” (not currently known) agents, and/or “hypothetical” agents that could arise from GOF studies on naturally occurring known pathogens. The contractor will identify the pathogen characteristics that are needed for conducting RBAs, and describe how characteristics of “novel” and “hypothetical” stains will be estimated, and provide the rationale for the assumptions made; and based on input, define the kinds of GOF experiments that will be included in the RBAs. C. With input, the contractor will define the overall range of categories of scenarios and events such as lab accidents, malevolent acts, natural hazards, and others that may lead to risks of all types (Task 5. E.); describe how individual events will be identified and collected; and review previous RAs to assure completeness and identify possible additions. The events should include all types of events that might reasonably result from the conduct and dissemination GOF research on the selected pathogens. The contractor will prepare an event matrix for which events relate to which risks. D. The contractor will propose ways to deal with the fact that the sites of GOF research are unknown and may vary with regard to population size and density and other factors; provide a rationale for the proposed approaches. E. The contractor will propose for NSABB review the levels of containment features and biosafety/biosecurity practices that will be analyzed to encompass the overall range of risks. Currently existing biosafety recommendations for these agents will be the lowest acceptable level, and higher levels may be included. F. The contractor will propose for review inventory estimates for each pathogen to be analyzed that will encompass the plausible overall range of pathogen quantities likely to be on hand as working materials and in storage; provide a rationale for choices made. G. The contractor will describe methodologies that will be used for all tasks of the RBAs. These must be established, accepted methods in the field. H. The contractor will review qualitative and quantitative modeling methods, and evaluate recent advances; formulate a proposal for review regarding methods to be used. I. Based on NSABB discussions, views expressed at a forum to be held by the NRC, and input from NIH, the contractor will define the approaches and methods that will be used to evaluate risks other than biosafety and biosecurity (Task 5. E. 3) to 7) below. J. Based on NSABB discussions, views expressed at a forum to be held by the NRC, and input from NIH, the contractor will define methods and approaches that will be used to evaluate benefits of all types (see Task 5. F. below). K. Based on the overall scope of the RBAs, the contractor will develop a list of areas where additional expertise may be needed, beyond that in the approved project team. L. The contractor will present the draft RBWP for PBBP review and approval; in addition to submission of written materials, this may involve attending meetings or teleconferences with PBBP and others. M. The contractor will present the draft RBWP to NSABB and obtain advice and guidance about how to finalize plans. Task 5. Execution Phase The objective of this phase, which may overlap with planning, is to conduct the RBAs, based on the approved RBWP. A. The contractor will update and expand existing literature compilations to include recent, pertinent information for the selected pathogens regarding key pathogen characteristics such as R o, dose-response relationship and other input data needed for qualitative and quantitative analysis. The literature search should include attempts to find any specific examples of risks associated with engineered pathogens with pandemic potential as well as novel pathogens. B. The contractor will develop a global accident and event “list” to include all categories in Task 4. C. above plus any new types of “events” that may be meaningful because of the expanded risk categories list 5. E. below C. The contractor will analyze all events, and then select a small group of events for detailed analysis that encompasses the overall range of risks, and provide a rationale for choices with regard to all categories of risk. The selected events will include frequent to rare and high-consequence to low. D. D. For the selected events, the contractor will determine event frequencies using all available data or estimates, extrapolations, and documented experiences, and describe the consequences in terms of exposure levels, people affected, loss of information, etc. for each of the pathogens in the list for all risk categories. E. The contractor will conduct RA (qualitative and quantitative) for the selected pathogens and events; based on the results, develop options for risk mitigation. Based on NIH input, the RA may include risks relating to: 1) Biosafety, particularly initial infections, transmission leading to secondary infections, and outbreaks of various sizes in humans or animals. Also examine the risks for fully mitigated situations (everything works as it is supposed to), less mitigated circumstances, and catastrophic failures. Quantitative analyses must include sensitivity and uncertainty analyses. 2) Physical and personnel security: including physical security of pathogens, risks associated with shipping, and personnel security. Risks include physical breach, theft, loss or intentional release by lab personnel, malevolent acts and other vulnerabilities. This analysis will be based on current recommendations from the BMBL, NIH rDNA guidelines, and other existing guidance. 3) Proliferation: how permitting GOF research to continue may lead to expanded amounts of GOF research and, as a result, might increase levels of risks. 4) Information risk: how information generated by GOF studies if available could enable others to replicate such studies or generate pathogens for malevolent actions or threats to national security; how easily could this be done? 5) International relations: how conduct and communication of GOF research may influence perceptions of the US abroad, and would US relations with the international community be affected in a negative sense. 6) National security: how threats against the US may ensue based on the results of GOF research; how terrorists may be targeting labs to gain access to materials or expertise relating to GOF research; whether terrorists are actually capable of using information from GOF research. How great is the threat? 7) Risk due to establishment of pathogens in the environment. F. The contractor will conduct BA (qualitative and quantitative to the extent possible), and identify alternatives to GOF research that might lead to the similar benefits with fewer concerns. Based on NIH input the BA may include benefits relating to: 1) Fundamental scientific knowledge: what is the value of information from GOF research for understanding the agents/diseases being studied or others agents/diseases; if possible, find real examples in literature, and also predict likely benefits. 2) Surveillance: how may GOF research aid efforts to detect the pathogens and better recognize or predict outbreaks. 3) Therapeutics, diagnostics, and vaccines: find actual examples of how GOF studies have aided development of countermeasures; create examples of likely possibilities; and identify whether particular types of experiments are of particular value. Also,. 4) International relations: same as E. e. above, but in a positive sense. 5) National security: how might GOF research improve global health security or reduce risks to the United States. G. The contractor will present status reports to NIH and NSABB at key points describing progress, key data and findings. Specific times and milestones for such presentations will be decided as the work proceeds. Task 6. Writing Phase The objective of this phase, which may overlap with execution, is to write the RBAs. A. The contractor will finalize conceptual plans for how to present results, both quantitative and qualitative, in ways to be determined mutually with PBBP. B. The contractor will develop, for PBBP approval, report outlines for the RBAs to include: lists of chapters with brief indications of contents, lists of other materials to be included such as appendices, an executive summary, etc. The final reports must have detailed tables of contents, a glossary of key terms, and an index, plus a search function (but not capability to edit) that is operable in the final electronic version that will be made publically available. C. The contractor will submit for PBBP review draft chapters and other materials as they are completed; some draft chapters also may be reviewed by NSABB. Consolidated drafts of the RBAs (containing all revised chapters and other required materials) will be submitted to PBBP for additional PBBP review and comments as soon as all components are completed. The contractor will write an executive summary for each report once the consolidated drafts have been approved. D. The contractor will submit “final revised drafts” for NSABB review which may also involve a presentation. All “final draft” and completed “final” materials must have been read, reviewed and edited by a professional technical writer, whose credentials have been evaluated and approved by PBBP. E. Finally, the contractor will incorporate changes necessitated by PBBP and NSABB comments and submit the final RBAs. F. Written text will be in a format mutually agreed upon, with line numbering on all pages and page numbers that run continuously from beginning to end of the document, with 8.5 x 11 inch page size, using a type size and font to be determined and approved by PBBP. All draft materials will be submitted electronically; final revised drafts and completed final reports will also be submitted as bound paper copies, with five copies submitted to the NIH Project Manager in addition to the electronic submission. G. All final documents must be developed to be 508 compliant and be certified as such by a 508 expert/consultant whose credentials have been approved by PBBP before final acceptance. Task 7. Other Requirements. The following requirements pertain to all aspects of the project and how the contractor will conduct the work, submit deliverables, and manage communications. A. The contractor will submit a monthly progress report to include: work performed during the report month, progress in relation to the established schedule, updated schedule, work planned for upcoming month, and any problems encountered and how they were resolved. B. The contractor will develop and maintain the project schedule which will include all milestones, with dates for starting and completion. The project schedule will be updated and submitted monthly with the monthly progress report. C. The contractor will maintain a central file of all documents, data, analytical tools, work records methodologies and other essential materials used by the contractor project team in preparing the RBWP and the RBAs. An index to the materials will also be prepared as the project proceeds. The record should be sufficiently detailed so that a qualified person could replicate analyses in the RBAs. Documentation of all sources must be included. The contractor will also maintain an equivalent file for NIH to be delivered at the completion of the project. D. The contractor will establish and continually update a bibliography of published papers, data sources and other materials that are cited in the written RA and BA reports. The citation format will be one that is standard for peer reviewed journals using widely known reference management software, to be mutually agreed upon with PBBP; live links to the full article or source cited will be included in the bibliography. The final bibliography including all citations found in the final written reports will be part of the reports, and will be provided to NIH electronically. E. The USG shall have ownership of the work products generated in performance of the contract. All files, work products, records, and other materials the contractor team generates will become property of the USG. Reports, data, analyses resulting from this work will be owned by the USG, and prior written permission is required for any use by the contractor beyond the scope of this SOW. Any subsequent publications by the contractor that may be derived from this work will require NIH review and approval. F. In the course of the project some members of the contractor team will be required to attend and/or conduct various meetings, teleconferences, workshops, and other gatherings as NIH deems necessary to advance the project. This includes weekly teleconferences (Task 1), NSABB meetings, NRC forums, and others that may arise during the course of the project. G. Throughout the course of the project it may be desirable to have discussions with subject matter experts or to convene groups of experts for consultations. Such consultations will require prior approval, and will be planned and conducted collaboratively between the contractor and PBBP. H. The contractor will not release any data, analyses, written materials, reports, or other work products resulting from this contract to anyone other than PBBP without written prior approval from PBBP. I. In the course of the project the contractor may be required to undertake other tasks not specifically described above but that are needed to meet the overall objectives of the RBAs. These may arise as a result of the deliberative process, particularly ones arising from NSABB and/or NRC activities, or they may be requested as found necessary by PBBP. d. Anticipated period of performance. The period of performance is expected to be for a twelve month period, commencing in early calendar year 2015. e. Capability statement/information sought. Respondents’ capability statement should address the following important aspects of the requirement: Technical Capability to meet the Requirement: (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 and techniques employed (d) Corporate experience and management capability (e) Examples of prior completed Government contracts, references, and awards/commendations received. In 20 pages or less any interested business organization should submit a capability statement of their organization which demonstrates their ability to supply the services described above. Respondents should also include any other information that may be helpful in developing or finalizing the acquisitions requirements. The NAICS code for this requirement is 541690. Responses must reference the Sources Sought Number HHS-NIH-OD-OLAO-SS-15-002 and include the following: (1) Name and Address of the organization. (2) Size and Type of business, pursuant to the applicable NAICS code 541690. (3) Point of Contact with name, title, phone, fax, and email. (4) DUNS number. (5) Contractors capability statement should address the deliverables described above and other information requested. (6) List of organizations to whom similar types of services have been previously provided to include contract number, dollar value, name and phone number of contracting officer. All information submitted in response to this announcement must be received on or before the closing date of: December 5, 2014 at 3 pm EST. Emailed responses are authorized (either in Microsoft Word or PDF), but it is up to the vendor to ensure that the email is received by the Government by the deadline to the address provided. The Government is not responsible for acknowledging receipt or capability statements sent by email, mail, or courier. All capability statements, questions, and/or comments must be in writing and may be emailed to Susan Apter at apters@od.nih.gov. Comments and questions will NOT be answered, but will assist in creating a solicitation for this requirement. Three (3) copies of the capability statement are required if submission is via mail. Submissions via mail shall be sent to: Susan Apter (Ref. HHS-NIH-OD-OLAO-SS-15-002), National Institutes of Health, Office of Acquisitions, 6011 Executive Blvd, Room 537C (MSC 7663) Bethesda, MD 20892-7663. (NOTE: If you are using a courier service, Federal Express, UPS, or Express Mail, the city, state, and zip code should read ROCKVILLE, MD 20852). Facsimile copies WILL NOT be accepted. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract 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).
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