SST BAA 12-100-SOL-00013 Solicitation.pdf

Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development

Broad Agency Announcement

BARDA Strategic Science and Technology Division Announcement Soliciting Advanced Research & Development Proposals

BARDA-BAA-12-100-SOL-00013

Biomedical Advanced Research and Development Authority (BARDA) 330 Independence Avenue, SW, Room G640

Washington, DC, 20201

SST BAA

Table of Contents

Table of Contents Overview Information Background Introduction Pre-Proposal Conference Part I: SST Areas of Interest

SST Area of Interest #1: Technologies to accelerate evaluation of candidate vaccines and therapeutics SST Area of Interest #2: Formulation, delivery, and manufacturing improvements SST Area of Interest #3: Therapeutics to treat novel and emerging pathogens SST Area of Interest #4: Methods and technologies to advance development of tests for rapid diagnosis of human injury and infection

Part II: Reserved Part III: Reporting Requirements and Deliverables Part IV: Proposal Preparation and Submission

Section 1: The Application Process Section 2: Stage 1 Quad Chart and White Paper Preparation Section 3: Quad Chart and White Paper Submission Section 4: Stage 2 Full Proposal Preparation Section 5: Full Proposal Submission Section 6: General Information

Part V: Proposal Evaluation A. Evaluation Criteria B. Evaluation Techniques C. Evaluation Ratings D. Past Performance Information

Part VI: Reserved Part VII: Attachments

Attachment 1: Reserved Attachment 2: Volume II - Breakdown Of Proposed Estimated Cost (Plus Fee) and Labor Hours Attachment 3: Reserved Attachment 4: Summary of Related Activities Attachment 5: Government Notice for Handling Proposals Attachment 6: Quad Chart Template Attachment 7: Contractors Guide for Government Property

Overview Information

Agency Name: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Room G640, Washington, DC, 20201

Issuing Office: Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Acquisitions Management, Contracts, and Grants 330 Independence Avenue, SW, Room G640, Washington, DC, 20201

Announcement Type and Open Period: This Broad Agency Announcement (BAA) is a continuation of a previous BAA (BARDA-BAA-11-100-SOL-00001) and is continuously open and valid throughout the period from June 8, 2012 through June 7, 2013, unless otherwise amended. Submissions can be made at any time throughout the open period.

Opportunity Title: Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development (Innovations BAA)

Eligible Applicants: This BAA is open to ALL responsible sources. Offerors may include single entities or teams from private sector organizations, Government laboratories, and academic institutions.

To be eligible for award, a prospective recipient must meet certain minimum standards pertaining to financial resources, ability to comply with the performance schedule, prior record of performance, integrity, organization, experience, operational controls, technical controls, technical skills, facilities, and equipment.

Historically Black Colleges and Universities (HBCU), Minority Institutions (MI), Small Business concerns, Small Disadvantaged Business concerns, Women-Owned Small Business concerns, Veteran-Owned Small Business concerns, Service-Disabled Veteran-Owned Small Business concerns, and HUB Zone Small Business concerns are encouraged to submit proposals and to join other entities as team members in submitting proposals.

Awards: BARDA anticipates awarding multiple contracts and/or other transactions from this BAA that have sufficient potential for success, are of interest to BARDA, and support one or more of the listed SST Areas of Interest. Selection of the most suitable contract type will be based on the effort proposed within context of the Offer’s request.

Contact/Submission Information: Potential Offerors are encouraged to ask questions regarding this announcement. All correspondence, including white papers and proposal submissions shall be sent to the Contracting Officer as follows unless otherwise specified.

Carolyn Keeseman, Contracting Officer (CO) HHS/ASPR/AMCG Email: SST-BAA@hhs.gov 330 Independence Avenue, SW, Room G640, Washington, DC 20201 Phone: 202-260-0950

Elizabeth Steiner, Contract Specialist (CS) HHS/ASPR/AMCG Phone: 202-205-8926 mailto:SSTD-BAA@hhs.gov�

Background

Just over ten years ago, the United States experienced an intentional attack with a biological agent in the form of the anthrax letters. Naturally emerging outbreaks of high-consequence infectious diseases, including pandemic influenza (2009) and SARS (2003) have occurred also.

These events represented national security threats and public health emergencies. The past several decades also witnessed the dramatic spread of antimicrobial resistance and community outbreaks of multidrug-resistant bacteria that had previously were confined to hospitals.

Concerns persist about the potential use of chemical, biological, radiological and nuclear (CBRN) agents by terrorists. Effective medical countermeasures such as vaccines, antimicrobials, therapeutics, and diagnostics have the potential to mitigate the medical consequences of such threats and serve as a bulwark of our national defense and public health emergency preparedness.

The mission of the Biomedical Advanced Research and Development Authority (BARDA) is to support development and availability of medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) events, pandemic influenza, and emerging infectious diseases. Specifically, BARDA supports the advanced development and procurement of drugs, vaccines and other products that are considered priorities for national health security. BARDA funding bridges the “valley of death” characterizing the late stages of product development. BARDA’s support ensures continuity of funding at a critical point for medical countermeasures developed by industry or emerging from the basic research and preclinical development activities sponsored by the National Institutes of Health (NIH). In procuring medical countermeasures for the Strategic National Stockpile, BARDA enhances the capabilities of the Centers for Disease Control and Prevention (CDC) to organize an effective response.

The Pandemic and All Hazard Preparedness Act (PAHPA) directs BARDA to promote (i) innovations in technologies that may assist countermeasure and product advanced research and development, (ii) research on and development of research tools and other devices and technologies, and (iii) research to promote strategic initiatives. The 2011 BARDA Strategic Plan defines BARDA’s vision and lays out a series of capability goals over a five year period (2011- 2016). Amongst BARDA’s guiding principles is supporting the development of novel platform technologies that provide flexible systems for the production of medical countermeasures against a variety of threats. Through this Broad Agency Announcement (BAA), BARDA seeks to address, in part, BARDA’s Goal 4, responsive and nimble programs and capabilities to address novel and emerging threats, as well as support the technological and scientific advancements of medical countermeasures for biodefense and pandemic influenza. The PAHPA and BARDA Strategic Plan are located on the ASPR website:

http://www.phe.gov/Preparedness/legal/pahpa/pages/default.aspx and http://www.phe.gov/about/barda/Pages/2011barda-stratplan.aspx.

This Broad Agency Announcement (BAA) is a continuation of a previous BAA (BARDA-BAA-11- 100-SOL-00001) and is similarly designed to promote science and technology advancements of platforms applied to MCM development for the Strategic Science and Technology Division (SST) of BARDA.

http://www.phe.gov/Preparedness/legal/pahpa/pages/default.aspx� http://www.phe.gov/about/barda/Pages/2011barda-stratplan.aspx�

Introduction This BAA solicits innovative science and technology proposals that fall within several broad Areas of Interest with application to medical countermeasure (MCM) development. Specific interest exists in the promotion of science and technology advancements focused on (1) pipeline acceleration of products to respond to novel and emerging pathogens, (2) product repurposing to treat novel and emerging pathogens, (3) product improvements to enhance the safety, efficacy, ease of use, and manufacturability of medical countermeasures (MCM), and (4) in vitro diagnostic platforms for the rapid diagnosis of human infection.

The specific application of the platform technologies is focused on biodefense, pandemic influenza, and other emerging infectious diseases (EID). BARDA is open to evaluation of technologies at multiple stages of development, but advanced development activities of products specific for CBRN and Influenza will not be considered. Development activities are to be fully integrated with regulatory activities associated with product development efforts. This BAA is issued pursuant to competitive acquisition procedures as described in paragraph 6.102(d)(2) of the Federal Acquisition Regulation (FAR).

Proposal evaluation for this BAA will be conducted in two stages:

In Stage 1, Offerors shall submit a Quad Chart and White Paper summarizing the proposed project. All Quad Charts and White Papers must be prepared in accordance with the instructions contained in Part IV, and may be submitted at any time during the open period of the BAA.

Brochures or other descriptions of general organizational or individual capabilities will not be accepted. Acknowledgement of receipt (electronic) will be made within one week. Decision letters to Offerors will be sent within 90 days of white paper receipt.

In Stage 2, Offerors receiving a favorable evaluation will be invited to prepare a Full Proposal and submit to BARDA within 45 days. Instructions for completing the Full Proposal are found in Part IV of this announcement. A request to submit a Full Proposal does not assure an award.

There are no specified funding limitations identified for proposals submitted under this BAA. The budget shall be commensurate with the nature and complexity of the proposed research. The Government intends to make an award decision within 180 days after submission of Full Proposals.

Offerors contemplating submitting Quad Charts, White Papers, and Full Proposals are strongly encouraged to contact BARDA with any questions. All questions should be submitted to SST- BAA@hhs.gov identifying in the subject line the name of the Offeror and if the questions are Technical, Administrative or both. Offerors are advised that only a Contracting Officer may obligate the Government to any agreement involving expenditure of Government funds. Once a White Paper or Full Proposal has been submitted, all communications must be through the Contracting Officer.

The costs of preparing responses to this BAA are not considered an allowable direct charge on any resultant award.

mailto:SST-BAA@hhs.gov�

Pre-Proposal Conference

Note: Offerors are encouraged to attend the conference. However, the conference will have limited seating.

The conference will provide a short presentation of the requirements for each BAA, followed by scheduled individual meetings between attendees and a Project Officer for an Area of Interest.

Contracts staff and a representative from the Office of Small and Disadvantaged Business Utilization (OSDBU) will also be present to answer any questions about the BAA process. In addition, the conference will provide a unique opportunity to interact with others in the field.

Pre-proposal Conference: July 16, 2012 2:00 – 4:00PM EDT, for all research areas of interest.

200 Independence Avenue S.W.

Hubert H. Humphrey Building, Great Hall Washington, DC 20201

REGISTRATION

1. To register for the conference, please email the name of your company, as well as the names and *citizenship of registrants to AMCG-Opportunities@hhs.gov by 3:00 PM EDT Thursday, July 12, 2012.

2. Registration is limited to the maximum room occupancy, and may be suspended without prior notice. Companies may not register for multiple BAAs. However, information about all BAAs will be available to every attendee.

3. When registering, please indicate your primary and secondary area of interest and the appropriate BAA. We will assign you a 5 minute meeting with Program staff. Every effort will be made to accommodate everyone’s first choice; depending upon the number of registrants, a second meeting may be assigned. Meeting assignments will be provided upon arrival at the conference. If, after registering, you find that you must cancel, please let us know so that we can open up your meeting slot(s) to other attendees.

Please note the following regarding the pre-proposal conference:

• Enter the Humphrey Building at the Independence Avenue Street entrance and register with the guard at the front desk to receive a visitor pass.

• Arrive 30 minutes early to allow time to clear security.

• Bring your identification (photo identification).

• The closest metro stop is Federal Center SW, serviced by the Blue and Orange Metrorail lines. At the top of the escalator turn left. The Humphrey Building is two blocks ahead on the right at the corner of 3rd St., SW and Independence Avenue, SW.

• At this time, attendance is limited to one (1) representative per company. For domestic participants, please email the name of your attendee to AMCG-Opportunities@hhs.gov by July 12, 2012. For international participants, please email the name of your attendee to AMCG-Opportunities@hhs.gov

• Tape recorders and videos are by June 28, 2012.

prohibited.

• Presentation material from the conference will be posted on FedBizOpps in an amendment to the BAA following the pre-proposal conference

NOTE: For those who are unable to attend, please use the following dial-in information:

Domestic Line: 888-677-3402

Participant code #: 14961 International: 1-517-268-4531

* Be advised that in order to obtain security clearance, advanced notification must be provided by all attendees who are not United States citizens. This includes residents holding Green Cards.

Notification must be received no later than June 28, 2012. You will be advised what information we need (passport, visa information, etc.) when you register.

Part I: SST Areas of Interest Science and Technology platforms should fit within one of the following SST Areas of Interest (AOI) and be applicable to vaccines, therapeutics, or diagnostics across BARDA threat space.

The sub-AOIs should be considered guidance and not absolute requirements for proposals to be eligible under this BAA.

SST Area of Interest #1: Technologies to accelerate evaluation of candidate vaccines and therapeutics The vision of this AOI is to solicit technologies for rapid, cost-effective design, discovery, and development of new MCMs in response to a novel or emerging pathogen. Projects could be designed to demonstrate the speed of the technology and demonstrate proof of concept of the candidate MCM.

1.1 In vitro and ex vivo systems to rapidly identify vaccine antigens (e.g. viral receptors, T-cell epitopes, etc.) or candidate therapeutics (e.g. monoclonal antibodies).

1.2 In vitro and ex vivo systems that are predictive of vaccine and therapeutic safety (e.g.

toxicity) and/or efficacy (e.g. immunogenicity) in vivo.

SST Area of Interest #2: Formulation, delivery, and manufacturing improvements The vision of this AOI is to identify innovative technologies that can enhance the product profile, accelerate availability, or increase accessibility of MCMs. Projects could be designed to compare performance of the innovative technology to current technologies, either head-to-head or from historical data, applied to licensed or late-stage development products relevant to BARDA’s mission.

2.1 Formulation chemistry, novel adjuvants, protein stabilization, and delivery technologies.

2.2 Innovative methods in bioprocess development and bulk/fill-finish manufacturing.

SST Area of Interest #3: Therapeutics to treat novel and emerging pathogens The vision of this AOI is to identify innovative therapeutics with mechanisms of action that do not directly target a pathogen. These products should have the potential to be effective against multiple threats, including bioterror and naturally emerging pathogens, by targeting common pathogenic disease or protective host response mechanisms. It is anticipated that these products would ultimately be developed and licensed for a commercial indication and available in response to novel and emerging threats. Products can be evaluated at multiple development stages, and proposed projects are not required to go all the way to licensure.

3.1 Therapeutics such as small molecule immune modulators, anti-inflammatory agents, and regulators of innate immunity.

3.2 Therapeutics with broad-spectrum mechanisms of action that target a host-response such as presentation of cell-surface markers of infection.

SST Area of Interest #4: Methods and technologies to advance development of tests for rapid diagnosis of human injury and infection The vision of this AOI is to support platforms that facilitate laboratory diagnostic development for existing and novel emerging pathogens. Proof of concept or further development with biothreat agents should be limited to the list of material threats in the PHEMCE Implementation Plan.

4.1 Accelerating biomarker discovery predictive of clinical disease applicable for use with multiple platforms.

4.2 Instrumentation and analysis algorithms to provide for a rapid and accurate in vitro diagnostic test result.

4.3 Developing reagents and reference materials that can be manufactured for use in laboratory diagnostic test systems.

4.4 Collecting, processing (e.g. concentrating), and preparing human specimens for laboratory diagnostic testing.

Note: Individual proposals may address any Area of Interest but not multiple areas.

Submit a separate proposal for each Area of Interest.

Part II: Reserved

Part III: Reporting Requirements and Deliverables

Some reports and other deliverables are relevant to specific activities that may or may not be performed during the contract period of performance. The Contractor, the Contracting Officer, and the Contracting Officer’s Representative (COR) shall agree in the final contract negotiations on which reports and other deliverables are relevant and shall be required as deliverables as determined in the negotiated SOW.

As part of the work to be performed under this BAA, the Contractor shall prepare and deliver the following reports throughout the period of performance. For all reports the Contractor shall submit two (2) paper copies and one (1) electronic copy to the Contracting Officer.

Reports:

1. Technical Progress Reports

On the fifteenth (15) day of each month for the previous calendar month, the contractor shall submit to the COR and the Contracting Officer a Technical Progress Report covering the previous calendar month. The frequency of Technical Progress Reporting will be determined by the Contracting Officer and Contracting Officer’s Representative during negotiations of the contract. The format and type of Technical Progress Report and Executive Summary will be provided by the Contracting Officer’s Representative.

The Technical Progress Reports will include project timelines and milestones summaries of product manufacturing, testing, and clinical evaluation. A Technical Progress Report will not be required for the period when the Final Report is due. The Contractor shall submit one copy of the Technical Progress Report electronically via e-mail. Any attachments to the e-mail report shall be submitted in Microsoft Word, Microsoft Excel, Microsoft Project, and/or Adobe Acrobat PDF files.

2. Final Report

By the expiration date of the contract, the Contractor shall submit a comprehensive Final Report that shall detail, document, and summarize the results of the entire contract work.

The report shall explain comprehensively the results achieved. A draft Final Report will be submitted to the COR and Contracting Officers for review and comments, then the Final Report original, four copies, and an electronic file shall be submitted to the COR and Contracting Officers for distribution to the Program office.

There may be additional reports and deliverables required in the final negotiated contract.

Meetings and Conferences:

The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the Contracting Officer and Contracting Officer’s Representative. Such meetings may include, but are not limited to, meeting of all Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up manufacturing development, clinical sample assays development, pre-clinical/clinical study designs and regulatory issues; meetings with individual contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and meeting with technical consultants to discuss technical data provided by the Contractor.

Monthly teleconferences between the Contractor and subcontractors and BARDA shall be held to review technical progress. BARDA reserves the right to request more frequent teleconferences and face-to-face meetings depending on the criticality and nature of the work being performed. Contractor will receive feedback from BARDA during the monthly teleconference regarding contract performance. The Contractor will have an opportunity to respond and provide recommendations / remediation plan during the execution of the contract.

Regulatory and Quality Management:

FDA Submissions and meetings:

a. The contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for appropriate BARDA staff to attend FDA meetings.

b. The contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA. The contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the contractor.

c. The contractor shall forward the initial draft minutes and final draft minutes of any formal meeting with the FDA to BARDA.

d. The contractor shall forward the final draft minutes of any informal meeting with the FDA to BARDA.

e. The contractor shall forward Standard Operating Procedures (upon request from Contracting Officer’s Representative /Contracting Officer).

f. The contractor shall provide upon request animal study and/or other technology packages developed under this contract. Packages shall include complete protocols and critical reagents for animal models developed and/or improved with contract funding.

g. The contractor shall provide upon request raw data and/or specific analysis of data generated with USG funds.

Audits / Site Visits:

FDA Audits Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, the Contractor shall provide copies of the audit findings, final report, and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report.

BARDA Audits The United States Government (USG) reserves the right to conduct an audit of the Contractor with 48 hours notice. The USG reserves the right to accompany the Contractor on routine and for-cause site-visits/audits of subcontractors. At the discretion of the USG and independent of testing conducted by the Contractor, BARDA reserves the right to conduct site visits/audits and collect samples of product held by the Contractor and subcontractors.

Program Management Plans and Documentation:

1. An Integrated Master Schedule (IMS) [Gantt chart] shall be developed and will be used to monitor performance of the contract. Contractor shall include the key Contract Go/No Go Milestone and Milestone Decision Review decision gates into the contract. The IMS for the period of performance will be accepted by BARDA at the Performance Measurement Baseline Review (PMBR) following contract award.

2. Within fourteen (14) calendar days of the effective date of the BAA award, the Offeror may be required to submit an updated Integrated Product Development Plan (IPDP) which shall be approved by the Project Officer and the Contracting Officer prior to initiation of any activities related to their implementation.

During the course of contract performance, in response to a need to change the IPDP, the Offeror shall submit a Deviation Report. This report shall request a change in the agreed-upon Plan and timelines. This report shall include:

a. Discussion of the justification/rationale for the proposed change.

b. Options for addressing the needed changes from the approved timelines, including a cost-benefit analysis of each option.

c. Recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.

3. The Offeror will propose a risk management plan to identify potential risks that may arise during the life of the contract and the impact of these risks on cost, schedule and performance, and appropriate remediation plans. This plan should reference relevant WBS elements where appropriate.

Additional program management information and templates are available online under AMCG Business Toolkit (http://www.phe.gov/about/amcg/toolkit/Pages/default.aspx).

Performance Metrics Reporting:

Performance Metrics Reporting may be required for proposals that fall within a certain dollar amount and technology readiness level (TRL) https://www.medicalcountermeasures.gov/Integrated_TRLs.aspx.

Contractor shall deliver the IMS status with performance data and should include actual start/finish and projected start/finish dates. The status schedule should be delivered 15 business days after reporting month end. Contractor shall deliver a program level Integrated Master Schedule that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the following fields at a minimum; baseline start and finish, forecast start and finish;

actual start and finish, predecessor and/or successor. Contractor shall deliver the Integrated Master Schedule, viewed at the work package level in MS Project file format.

Integrated Master Schedule

Contractor shall initially provide high level subcontractor budget information at the milestone level, however; Contractor will then be required (when requested by the Government) to provide a detailed subcontractor budget.

Subcontractor Budget http://www.phe.gov/about/amcg/toolkit/Pages/default.aspx�

Contractor shall provide a monthly report that displays the Contractor labor for both budget and actual costs time phased by month. It shall be reported by milestone oversight and program management accounts. This report shall be delivered 15 business days after reporting month end.

Contractor Labor Budget and Actuals

Contractor will be responsible to provide an explanation of variances when requested by the government. The format will be written questions provided by the government to be verbally explained in the bi-weekly Project Coordination Team (PCT) meetings, followed by a written explanation in the meeting minutes.

Variance Reporting

Part IV: Proposal Preparation and Submission

Section 1: The Application Process The application process is in two stages as follows:

Stage 1: Complete a cover sheet, Quad Chart, and White Paper in accordance with the preparation guidance below. Quad Chart and White Paper should describe the effort in sufficient detail to allow evaluation of the concept's technical merit and its potential contribution to the BARDA mission. Offerors whose Quad Chart and White Paper receive a favorable evaluation will be invited to submit a Full Proposal. Offerors whose Quad Chart and White Paper did not receive a favorable evaluation will be notified by e-mail and will be informed of what technical issues the product needs for further BARDA consideration for another White Paper submission or invitation for a full proposal.

Stage 2: Offerors must submit their Full Proposals in accordance with the instructions provided below. Full Proposals will be evaluated against criteria as described in the Evaluation Factors.

Proposals that do not conform to the requirements outlined in the BAA or in the invitation will not be reviewed or considered for further action.

Proposal Stage Deadline for Submission USG Response Stage 1: Quad Chart and White Paper

A Quad Chart and White Paper may be submitted on any day during the open period of the BAA

Receipt confirmation within 1 week Decision within 90 days

Stage 2: Full Proposal Within 45 days of Invitation Receipt confirmation within 1 week

Source Selection Notification (pending availability of funds)

Within 180 days Full Proposal receipt

Section 2: Stage 1 Quad Chart and White Paper Preparation Interested Offerors shall submit a Quad Chart, and White Paper which expands on the information provided in the Quad Chart. The initial submission is limited to a cover page, one-page Quad Chart, White Paper not to exceed ten (10) pages, and an addendum (not to exceed two (2) pages) as discussed below. This results in a submission packet not to exceed 14 pages. If submissions exceed these limitations, only those pages previously defined will be reviewed.

Combine all files and forms into a single searchable PDF file before submitting.

Quad Chart Format: All quad charts should include the information indicated on the sample template located in Attachment 6. All Quad Charts should be laid out in landscape format.

1. Heading: Title, Area of Interest addressed, Offeror’s point of contact, Offeror’s Name

2. Upper left: Objective, description of effort

3. Lower left: Benefits of proposed technology, challenges, Specify the maturity of technology research area addressed as indicated by the TRL

4. Upper right: Picture or graphic

5. Lower Right: Milestones, cost, period of performance.

White Paper Technical Information:

1. The white paper should focus on the technical discussion of the Offeror’s objective, technical background, scientific approach, level of effort, and the nature and extent of the anticipated results. Additionally, the white paper should include the following core elements:

a. brief discussion on how the proposed technology and/or countermeasure aligns with BARDA’s mission as described in the Background section.

b. brief description of the regulatory plan for the proposed technology and/or countermeasure.

c. high-level Gantt chart showing an overview of the proposed activities and timelines.

d. brief description of the Offerors intellectual property ownership of the proposed technology and/or countermeasure.

e. overview of Offeror’s capabilities and experience (past and current) as they relate to the proposed program.

2. Brief cost estimate revealing all the component parts of the proposal.

3. As an addendum to the White Paper, include biographical sketches (two pages) of the key personnel who will perform the research, highlighting their qualifications and experience.

Restrictive markings on White Papers: Proposal submissions will be protected from unauthorized disclosure in accordance with FAR Subpart 15.207, applicable law and HHS regulations. Offerors that include in their proposal data that they do not want disclosed shall mark their proposal in accordance with the instructions contained FAR 52.215-1(e) ‘Restrictions on disclosure and use of data.’ Please note that any white paper submitted under this solicitation may be shared with other government agencies for non-BARDA funding considerations.

Section 3: Quad Chart and White Paper Submission

White Papers must be emailed directly to the following e-mail address: SST-BAA@hhs.gov

Include “BARDA-BAA-12-100-SOL-00013 QUAD CHART & WHITE PAPER for AOI #_” in the e-mail subject line. White Papers must be submitted in the following format but do not require any special forms:

• Single PDF formatted file as an attachment

• Page Size: 8 ½ x 11 inches

• Spacing – single

• Font – Arial, 11 point

The file will not exceed 2 Megabytes of storage space. Movie and sound file attachments, URL Links, or other additional files, will not be accepted.

Classification: All Quad Chart and White Paper submissions must be UNCLASSIFIED.

Notification to Offerors: All Offerors will receive a letter and/or an e-mail acknowledging receipt of their Quad Chart and White Paper submission. Offeror’s should receive a letter or e-mail within 90 calendar days of submission expressing whether a Full Proposal will be requested.

Offeror may receive a decision letter sooner than 90 calendar days depending on the number of White Papers submitted to BARDA or if otherwise specified in a special instructions amendment to the BAA.

Debriefings for Quad Chart and White Paper will not be provided, however, technical feedback will be provided in the response letter from BARDA.

IMPORTANT NOTE: Titles given to the White Papers and Full Proposals should be descriptive of the work proposed and not be merely a copy of the title of this solicitation.

Section 4: Stage 2 Full Proposal Preparation

The Full Proposal must be prepared as four separate volumes as follows: Volume I Technical Proposal; Volume I Technical Proposal Appendices; Volume II Cost Proposal; and Volume II Cost Proposal Appendices.

A. Volume I - Technical Proposal

The technical proposal page limit, including figures, tables and graphs, will be communicated to Offerors in the letter inviting full proposals. If the proposal exceeds the number of pages specified, only the pages up to the limit will be reviewed. A page is defined as 8.5 X 11 inches, single-spaced, with one-inch margins in type not smaller than Arial 11 point font.

1. Cover Page: This should include the words “Technical Proposal” and the following:

a. BAA number

b. Title of proposal

c. Date of submission

d. Identity of prime Offeror and complete list of subcontractors, if applicable

e. Technical contact (name, address, phone/fax, electronic mail address)

f. Administrative/business contact (name, address, phone/fax, electronic mail address)

g. Duration of effort

2. Official Transmittal Letter. This is an official transmittal letter including:

a. The name, title, mailing address, telephone number, and fax number of the company or organization;

b. The name, title, mailing address, telephone number, fax number, and e-mail address of the division point of contact regarding decisions made with respect to the Offeror and who can obligate the proposal contractually;

c. The name, title, mailing address, telephone number, fax number, and e-mail address and those individual(s) authorized to negotiate with the USG; and

d. A statement indicating you are submitting a Full Proposal for consideration.

3. Table of contents: an alphabetical/numerical listing of the sections within the proposal, including corresponding page numbers.

4. Executive Summary

5. Introduction and Technical Background

6. Statement of Work: The SOW should clearly detail the scope and objectives of the effort and the technical approach. It is anticipated that the proposed SOW will be incorporated as an attachment to the resultant award instrument. To that end, the proposal should be specific, non-severable, discrete work segments, and be written as a self-standing document without any proprietary restrictions. The SOW should include a detailed listing of the technical tasks/subtasks organized by phases (base and option segments) including appropriate WBS references for each task.

7. Development Approach: A detailed description of the experimental design, including the rationale for experimental approaches, and a description of alternative approaches to be employed if these methods do not achieve the defined goals.

8. Gantt Chart/Integrated Master Schedule (IMS), Work Breakdown Structure (WBS) and Contract Go/No-Go Milestones: A detailed Gantt Chart/IMS with associated WBS and Contract Go/No – Go Milestones for each phase (base and options) will be provided as part of the technical submission. The break points of different phases proposed in the contract should be indicated.

9. Deliverables: A detailed description of the results and products to be delivered inclusive of the timeframe in which they will be delivered.

10. A listing of key personnel (including proposed consultants) who possess the necessary education, training, and experience to successfully perform the work identified in the technical proposal (resumes to be included in the Appended material).

11. Contractor provided Facilities, Infrastructure and other Resources Representative Activities. Depending on the stage of development of the candidate product, this may include but is not limited to:

a. Current facility design including quality control labs for testing & release, laboratory areas supporting formulation and assay development, manufacturing process flow, and animal studies.

b. Major equipment and layout (preliminary piping and instrumentation drawing).

c. Manufacturing capacity expansion plans to match the proposed manufacturing scale up.

d. Overview of the management of Quality Systems at the facility.

e. List of capabilities for clinical activities conducted in house and at contract research organizations.

f. Qualified animal facilities where GLP studies would be conducted and appropriate certifications for humane care and use of vertebrate animals.

g. The handling, storing and shipping of potentially dangerous biological and chemical agents, including Select Agents, under biosafety levels required for working with the biological agents under study.

h. Validation master plan for key equipment, analytical methods and manufacturing process.

B. Volume I – Appendices

Appendices to Volume I contain supplemental data that should accompany the technical proposal. The combined page total of Appendices in Volume I will be specified in the full proposal invitation letter. Additional specific information to be included is referenced below. If a particular item in not relevant to the proposed effort, state that it is not applicable along with any supporting justification.

Item Required Reference 1 Updated

Quad Chart Yes Template in Attachment #6

2 Protection of Human Subjects

If Applicable

Part IV, Section 4, para F http://www.hhs.gov/ohrp/humansubjects/guid ance/45cfr46.html

3 Animal Use If Applicable

Part IV, Section 4, para G

4 Intellectual Property

Yes Part IV, Section 4, para I

5 Biographical Sketches

Yes Part IV, Section 4, para J

6 Use of Select Agents

If Applicable

Part IV, Section 4, para L http://www.cdc.gov/od/sap http://www.aphis.usda.gov/programs/ag_sele ctagent

7 Laboratory License Requirements

If Applicable

Part IV, Section 4, para M

C. Volume II – Cost Proposal

A Rough Order of Magnitude (ROM) of costs may initially be requested. If a ROM is provided, at some point a full cost proposal will be requested. The cost proposal shall contain sufficient information for meaningful evaluation, and should not exceed the page limitation specified in the full proposal invitation letter. Additionally, a cost summary (not to exceed 2 pages) must be prepared and submitted in conjunction with the detailed cost proposal. The detailed costs must readily track back to the cost presented in the summary and the WBS, IMS, and SOW. The Offeror must also provide a narrative to support the requirements in each cost element. The cost breakdown by tasks should reference the WBS task in the Technical Proposal SOW.

Options should be priced separately.

Proposal Cover Sheet: The following information shall be provided on the first page of your pricing proposal:

1. BAA Number;

2. Title of proposal:

3. Topical Area:

4. Name and address of Offeror;

5. Name and telephone number of point of contact;

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6. Name, address, and telephone number of Contract Administration Office, (if available);

7. Name, address, and telephone number of Audit Office (if available);

8. Proposed cost and/or price; profit or fee (as applicable); and total;

9. The following statement: By submitting this proposal, the Offeror, if selected for discussions, grants the Contracting Officer or an authorized representative the right to examine, at any time before award, any of those books, records, documents, or other records directly pertinent to the information requested or submitted.

10. Date of submission; and

11. Name, title and signature of authorized representative.

12. DUNS number and CAGE code.

This cover sheet information is for use by Offerors to submit information to the Government when cost or pricing data are not required but information to help establish price reasonableness or cost realism is necessary. Such information is not considered cost or pricing data, and shall not be certified in accordance with FAR 15.406-2.

Basic Cost/Price Information: The business proposal shall contain sufficient information to allow the Government to perform a basic analysis of the proposed cost or price of the work. This information shall include the amounts of the basic elements of the proposed cost or price. These elements will include the following elements by milestone event and/or proposed period as applicable:

1. Direct Labor- Individual labor category or person, with associated labor hours and unburdened direct labor rates;

2. Indirect Costs – Fringe Benefits, Overhead, G&A, etc. (Must show base amount and rate);

3. Travel – Separate by destinations and include number of trips, durations-number of days, number of travelers, per diem (hotel and meals in accordance with the Federal Travel Regulations,), airfare, car rental, if additional miscellaneous expense is included, list description and estimated amount, etc;

4. Subcontract – A cost proposal shall be submitted by the subcontractor. The subcontractor’s cost proposal should include on company letterhead the complete company name and mailing address, technical and administrative/business point of contacts, e-mail address, and telephone number. Include the DUNS number. If the subcontractor’s work entails any unpredictable aspects (e.g. includes experimentation, process development, etc.) a cost proposal conforming to all requirements of this section (IV.C.) shall be provided, and shall reference the WBS of the prime contractor’s proposal. If the subcontractor/vendor is providing commercially available, routine services/products (e.g. facilities audits; manufacturing from a defined protocol; off-the-shelf reagents, hardware, or software; etc.) then a less detailed price quote is allowable. In each case where the latter level of detail is provided, the Offeror should assign subcontractor/vendor costs to the WBS, and should be prepared to document multiple competitive quotes for the service/product.

5. Consultant – Provide consultant agreement or other document which verifies the proposed loaded daily/hourly rate and labor category;

6. Materials should be specifically itemized with costs or estimated costs. Where possible, indicate pricing method (e.g., competition, historical costs, market survey, etc.). Include supporting documentation, i.e. vendor quotes, catalog price lists and past invoices of similar purchases,

7. Other Direct Costs, especially any proposed items of equipment. Equipment generally must be furnished by the Offeror. Justifications must be provided when Government funding for such items is sought.

8. Fee/profit including percentages.

If a ROM is initially requested the above elements will be at a high level to be followed by a full cost proposal when the final technical scope of the program is finalized.

Proposal Cover Sheet: The following information shall be provided on the first page of your pricing proposal:

1. BAA Number;

2. Title of proposal:

3. Topical Area:

4. Name and address of Offeror;

5. Name and telephone number of point of contact;

6. Name, address, and telephone number of Contract Administration Office, (if available);

7. Name, address, and telephone number of Audit Office (if available);

8. Proposed cost and/or price; profit or fee (as applicable); and total;

9. The following statement: By submitting this proposal, the Offeror, if selected for discussions, grants the Contracting Officer or an authorized representative the right to examine, at any time before award, any of those books, records, documents, or other records directly pertinent to the information requested or submitted.

10. Date of submission; and

11. Name, title and signature of authorized representative.

12. DUNS number and CAGE code.

A draft template for the breakdown of proposed estimated costs and labor hours is provided in - Attachment 2.

The offeror should ensure that each phase of work (base or options) includes a detailed cost budget that references the corresponding scope of work (technical activities) proposed in the SOW. The budget for each phase must align with the SOW and be presented in specific, non-severable, discrete work segments.

D. Volume II – Cost Proposal Appendices

Appendices to Volume II contain supplemental data of a cost and non-cost nature that should accompany the cost proposal. The combined total of all appendices should not exceed the page limitation specified in the full proposal invitation letter. Additional specific information to be included is referenced below. If a particular item in not relevant to the proposed effort, state that it is not applicable along with any supporting justification.

Item Required Reference 1 DUNS, TIN and

NAICS

Yes

2 Representations and Certifications

Yes Part IV, Section 4, para E

3 CCR Yes

4 Security Yes Part IV, Section 4, para H 5 HHS Small

Business Subcontracting Plan

If

6 Summary of Related Activities

Yes Template in Attachment #4

7 Disclosure of Lobbying Activities

Yes Part IV, Section 4, para K

8 Contractor’s Guide to Government Property

If

Attachment # 7

E. Representations and Certifications

In accordance with FAR 4.1201 prospective Offerors shall complete the Online Representations and Certifications Application (ORCA) at http://orca.bpn.gov. Offerors should make mention of its ORCA completion in its proposal and provide it “Certification Validity” period.

F. Studies That Involve Human Subjects

All research under this BAA must address the involvement of human subjects and protections from research risk related to their participation in the proposed research plan and comply with 32 CFR 219, 10 U.S.C. 980, and, as applicable, 21 CFR Parts 11, 50, 54, 56, 312) (45 CFR Part 46) and the ICH as well as other applicable federal and state regulations. HHS Policy also requires that women and members of minority groups and their subpopulations: children and the elderly (pediatric and geriatric) must be included in the study population of research involving human subjects, unless a clear and compelling rationale and justification is provided with respect to the health of the subjects or the purpose of the research. The HHS policy on studies that involved human subjects can be accessible through the HHS website:

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html.

G. Animal Welfare

If the Offeror proposes to use contract funds to conduct animal studies, the Offeror must demonstrate its understanding and ability to comply with the Public Health Services (PHS) Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/olaw.htm). If the Offeror has an Animal Welfare Assurance on file with the Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW), provide the Assurance number with the proposal. If the Offeror proposes animal studies, the Offeror must submit a plan that describes how the Offeror will comply with the PHS Policy and addresses the five points listed below:

1. Provide a detailed description of the proposed use of the animals in the work outlined in the experimental design and methods section. Identify the species, strains, ages, sex, and numbers of animals to be used in the proposed work.

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2. Justify the use of animals, the choice of species, and the numbers used. If animals are in short supply, costly, or to be used in large numbers, provide an additional rationale for their selection and their numbers.

3. Provide information on the veterinary care of the animals involved.

4. Describe the procedures for ensuring that discomfort, distress, pain, and injury will be limited to that which is unavoidable in the conduct of scientifically sound research.

Describe the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices where appropriate to minimize comfort, distress, pain, and injury.

5. Describe any euthanasia method to be used and the reasons for its selection. State whether this method is consistent with the recommendations of the Panel on Euthanasia of the American Veterinary Medical Association (http://www.avma.org/issues/animal_welfare/euthanasia.pdf). If not, present a justification for not following the recommendations.

H. Security Planning

The work to be performed under this contract may involve access to sensitive BARDA program information. Therefore, the Offeror(s) shall briefly describe their procedures and policies to defend against theft, tampering, or destruction of product-related material, equipment, documents, information, and data.

I. Intellectual Property

For issued patents or published patent applications that will be used in the performance of the contract

, provide the patent number or patent application publication number, a summary of the patent or invention title, and indicate whether the Offeror…