RBASOW.pdf

STATEMENT OF WORK

“Conducting Risk and Benefit Analyses on Gain-of-Function Research Involving Pathogens with

Pandemic Potential”

BACKGROUND

Most genetic manipulations of microorganisms do not raise safety or security concerns; these studies are routinely conducted for many valid scientific purposes using non-pathogenic organisms or biologic systems and are subject to appropriate Federal and institutional oversight. However, safety and security concerns may arise when such genetic manipulations are employed to better understand pathogens or toxins, sometimes enhancing the ability of those agents to harm their hosts.

Recently, the phrase “gain-of-function (GOF) research” has come to describe studies that increase the ability of a pathogen to cause disease. This phrase gained prominence after two groups published findings demonstrating that highly pathogenic avian influenza H5N1 viruses with a small number of engineered mutations could become transmissible between mammals by respiratory droplets.1,2 Such studies are undertaken to help define the fundamental nature of human-pathogen interactions, thereby enabling assessment of the pandemic potential of emerging infectious agents, informing public health and preparedness efforts, and furthering medical countermeasure development. However, such GOF studies may entail biosafety and biosecurity risks, and significant concerns have been raised about whether these studies generate information that could be misused to cause harm or whether the engineered viruses could pose a pandemic threat if they were to be accidentally or intentionally released.

In 2012, a voluntary suspension of certain GOF studies involving H5N1 viruses was undertaken by the influenza research community.3 During that time, policymakers considered whether certain GOF studies should be conducted using Federal funds, and if so, how those studies could be safely conducted. The Centers for Disease Control and Prevention and the National Institutes of Health issued new biosafety guidelines for working with highly pathogenic avian influenza strains.4,5 The U.S. Department of Health and Human Services developed a framework for guiding its funding decisions about projects that may generate highly pathogenic H5N1 viruses that are transmissible between mammals by respiratory droplets.6 This funding framework was expanded to include H7N9 influenza viruses as well.7 HHS

Imai et. al. Experimental adaptation of an influenza H5 HA confers respiratory droplet transmission to a reassortant H5

HA/H1N1 virus in ferrets. Nature 486, 21 June 2012 Herfst et. al. Airborne Transmission of Influenza A/H5N1 Virus Between Ferrets. Science 336, 22 June 2012

Fouchier et. al. Pause on avian flu transmission studies. Nature 481, 26 January 2012.

Gangadharan D, Smith J, and Weyant R. Biosafety Recommendations for Work with Influenza Viruses Containing a

Hemagglutinin from the A/goose/Guangdong/1/96 Lineage, Morbidity and Mortality Weekly Report 62(RR06); 1-7.

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6206a1.htm NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines Framework for Guiding Funding Decisions about Research Proposals with the Potential for Generating Highly Pathogenic Avian

Influenza H5N1 Viruses that are Transmissible among Mammals by Respiratory Droplets, February 21, 2013.

http://www.phe.gov/s3/dualuse/Documents/funding-hpai-h5n1.pdf Jaffe, HW, Patterson, AP, and Lurie, N. Avian Flu: Extra Oversight for H7N9 Experiments. Nature 500, 07 August 2013.

http://www.nature.com/nature/journal/v500/n7461/full/500151a.html http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6206a1.htm http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines http://www.phe.gov/s3/dualuse/Documents/funding-hpai-h5n1.pdf http://www.nature.com/nature/journal/v500/n7461/full/500151a.html considers research project proposals for their scientific and public health benefits as well as associated biosafety, biosecurity, and dual use risks. HHS also identifies appropriate risk mitigation measures that are required. Studies that are deemed acceptable for funding may then proceed in accordance with any agreed-upon risk mitigation measures.

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 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 has instituted a pause in the provision of new USG funding for GOF research on influenza, MERS or SARS viruses, as defined below. Restrictions on new funding apply as follows:

New USG funding will not be released for gain-of-function research projects that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route. This restriction would not apply to characterization or testing of naturally occurring influenza, MERS, and SARS viruses, unless the tests are reasonably anticipated to increase transmissibility and/or pathogenicity.8

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 on 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 Academies 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 forums will inform the development and adoption of a new USG policy governing the funding and conduct of GOF research.

SCOPE OF WORK 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. This SOW describes the USG’s needs and requirements.

U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-

Function Research Involving Influenza, MERS, and SARS Viruses, October 17, 2014.

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.

DESCRIPTION OF WORK AND SERVICES

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.

Deliverables for Task 1.

Names and credentials for the contractor’s project team with roles, responsibilities and expertise described. Support staff does not need to be named, but positions should be included so that hours may be estimated. The team members shall have demonstrated expertise in their fields and adhere to the highest professional and ethical standards.

A written team management plan.

Deliverables will be submitted 10 working days following issuance of the contract, approximately one week before the kickoff meeting (Task 3).

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) that are part of this SOW, 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.

Deliverables for Task 2.

Written timelines for the RA and BA with milestones and dates, phase by phase and task by task.

The timeline will include Gantt charts plus written explanatory materials, including a plan for controlling delays in meeting the schedule.

An estimate of hours required, person by person for the contractor’s project team.

The above will be submitted 10 working days following issuance of the contract, approximately one week before the kickoff meeting (Task 3).

Task 3. Kickoff Meeting.

The contractor will conduct with NIH a Kickoff Meeting where the proposed project team and the project timelines will be discussed. The time, date, location and meeting participants will be mutually agreed upon before the meeting.

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.

Deliverables for Task 3.

Proposed agenda for the Kick-Off Meeting and contractor attendees (due to PBBP for approval one week before the meeting).

Agreement on TSWG weekly standing teleconference times.

Kickoff Meeting notes and action items plus revised project team and timelines (if needed) prepared after the meeting (due no later than one week after the meeting).

Once tasks 1-3 have been completed and the deliverables accepted, 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 intention is to employ “real” data from the published literature to extent possible, although other sources may be acceptable which may include expert consultations. 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 viruses 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. While the focus will be on analyzing risks and benefits of research on viruses arising from GOF studies, it may be appropriate to analyze naturally occurring strains as a basis for comparison, or to provide a baseline of risk. 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 and the rationale for choices. As part of this process, experts in the modeling field should be consulted for their views.

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); this may include use of literature derived data, consultation with experts and other approaches, such as modeling the effects of knowledge gained from GOF research on the speed of vaccine development.

J. Based on NSABB discussions, views expressed at a forum held by the NRC on December 15-16, 2014, 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). Options may include review of the literature to find specific examples of benefits, structured discussions with key subject matter experts (public health, drug industry, etc.), engagement of suitable subcontractors with appropriate expertise and experience, as well as other approaches that may inform the analysis.

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 describe how reports on the RBAs will be written and particularly how data

(qualitative and quantitative) will be compiled, analyzed and presented (graphical, tables, text, pictures, etc.); indicate how data sources and methodology will be documented; and discuss approaches to ensure quality writing and editing. The required standard is the level of quality, transparency and rigor necessary for submission to a high-quality peer-reviewed journal.

M. 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.

N. The contractor will present the draft RBWP to NSABB and obtain advice and guidance about how to finalize plans.

Deliverables for Task 4.

Written descriptions of plans relating to items A-L above in a format to be mutually decided with

PBBP.

A draft RBWP for NIH review will be due early March 2015; the “final revised draft RBWP”, which incorporates PBBP comments, will be due mid-March, 2015.

The “final revised draft RBWP” plus supporting materials for presentation to an NSABB meeting in early April will be due by the end of March 2015.

The final RBWP, incorporating all necessary changes, will be submitted one week after the

NSABB meeting.

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 Ro, 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. 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 (all containment features work as intended), 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 how US relations with the international community may be affected in a negative sense by conducting GOF studies.

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 or selection/development of vaccines; create examples of likely possibilities; and identify whether particular types of experiments are of particular value.

4) International relations: how conduct and communication of GOF research may influence perceptions of the US abroad and how US relations with the international community may be affected in a positive sense by conducting GOF studies.

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.

Deliverables for Task 5.

Bibliography of recent relevant literature and summary of key information found.

Event list and categories of risks they relate to. Provide a matrix of events vs. risks.

List of selected events for further detailed analysis, and rationale for choices. Results of event frequency analysis and consequences.

Data, results, and written analyses, section by section, for all of the RA topics included above.

Data, results, and written analyses, section by section, for all of the BA topics included above.

Data, results, and analyses will be in a form suitable for review by PBBP to be decided as work proceeds. Materials will submitted whenever suitable portions of the overall work have been completed.

Mitigation strategies for risks.

Alternatives to GOF research that might provide similar benefits.

The deliverables will be submitted during the period of April through July 2015, with all to be completed by late July 2015.

Task 6. Writing Phase

The objective of this phase, which may overlap with execution, is to write reports describing 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.

Deliverables for Task 6.

Draft chapters, draft reports and subsequently final RBAs, as described above, prepared as required and meeting a high professional level of writing quality.

Draft reports to be done in time for review by PBBP and then review by NSABB in early August, so that additional writing and editing may be completed by the end of September 2015.

The final RBA reports will be submitted by the end of September 2015.

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. All deliverables, with a clear indication of the task/subtask they pertain to, will be submitted electronically by the contractor to the NIH Project Manager, with the final draft reports and final completed versions also provided in bound paper form to the NIH Project Manager.

B. 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. The report will be in a letter format and contain no more than five pages of text, plus any necessary attachments.

C. 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. The contractor will be responsible for providing sufficient, qualified personal to ensure execution of the work in accordance with the approved schedule. Every effort shall be made to prevent delays in meeting the schedule.

D. 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. Reports and other documents will be provided electronically except for the final documents as described above. File names for all electronic materials will be done in a format to be mutually determined with PBBP.

E. 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. The bibliography will be prepared using EndNote or another commonly accepted reference management program. The bibliography should be organized chapter-by-chapter, and citations in the text should be in a format that includes the first author last name and year of publication. In addition a compilation containing paper copies all referenced materials will be submitted to NIH at the end of the project.

F. 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.

G. 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.

H. Travel by the contractor team members for work associated with the contract may be necessary.

Such travel may not be undertaken without prior written approval from PBBP. Travel shall be restricted to essential trips by essential people. Teleconferences and other alternative means should be used whenever possible. No site visits or field studies are anticipated.

I. The use by the contractor of subcontractors with desirable experience or expertise may at times be appropriate to advance the project. If the contractor wants to engage subcontractors to perform certain aspects of the project, a request must be submitted to NIH for prior approval. The request will include: description of the work to be done, a justification for why a subcontract is needed, names and qualifications of the proposed person and/or company, a detailed budget, and a schedule.

J. 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.

K. 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.

L. 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.

Deliverables for Task 7.

Work executed as described and delivered as indicated.