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BARDA Broad Agency Announcement (BAA) for Advanced Research and Development of Personal Protective Equipment, Ventilators, and Diagnostics

Solicitation Number: BAA-11-100-SOL-00021
Agency: Department of Health and Human Services
Office: Office of the Secretary
Location: Acquisitions Management, Contracts, & Grants (AMCG)
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BAA-11-100-SOL-00021
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Added: Jun 20, 2011 5:55 pm
BARDA BAA-11-100-SOL-00021
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, Biomedical Advanced Research and Development Authority, 330 Independence Avenue SW, Room G640, Washington, DC, 20201


Research Opportunity Title: BARDA Broad Agency Announcement for Advanced Development of Medical Countermeasures for Pandemic Influenza.


Announcement Type and Date: Initial Announcement, June 20, 2011.


Eligible Applicants: This BAA is open to ALL responsible sources. Offerors may include single entities or teams from private sector organizations, Government laboratories, Federally Funded Research and Development Centers (FFRDCs), and academic institutions.


Federally Funded Research and Development Centers (FFRDCs) are eligible to respond to this BAA, individually or as a team member of an eligible principal Offeror, so long as they are permitted under the sponsoring agreement between the Government and the specific FFRDC.


To be eligible for award, a prospective recipient must meet certain minimum standards pertaining to financial resources, an 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.


Research Opportunity Description: The Biomedical Advanced Research and Development Authority (BARDA) is soliciting advanced research and development projects to improve available medical countermeasures to protect the US population from influenza pandemics. BARDA anticipates that development activities supported under this BAA will improve the utility, availability and effectiveness of existing medical countermeasures (diagnostics and respiratory devices) and/or mature candidate medical countermeasures towards FDA clearance/approval.


Table of Contents


BARDA BAA-11-100-SOL-00021 1
Overview Information 1
Table of Contents 2
Introduction 4
Pre-Proposal Conferences 8
Part I: Development Areas of Interest 8
Area of Interest #1: Personal Protective Equipment (Mask & Respirators) and Full-Featured Continuous Ventilators for Influenza Infection and All-Hazards 8
Area of Interest #2: Clinical Influenza Test Systems and Diagnostic Tools 9
Part II: Product Development and Technical Objectives 10
Part III: Reporting Requirements and Deliverables 14
Part IV: Proposal Preparation and Submission 18
Section 1: The Application Process 18
Section 2: Stage 1 Quad Chart and White Paper 18
Section 3: Quad Chart and White Paper Submission 19
Section 4: Stage 2 Full Proposal Preparation 20
A. Volume I - Technical Proposal 20
B. Volume I - Appendices 21
C. Volume II - Cost Proposal 22
D. Volume II - Cost Proposal Appendices 23
E. Representation and Certifications 24
F. Studies That Involve Human Subjects 24
G. Animal Welfare 24
H. Security Planning: 25
I. Intellectual Property: 25
J. Biographical Sketches: 25
K. Prohibition on the Use of Appropriated Funds for Lobbying Activities HHSAR 352.270-10 Anti-Lobbying (Jan 2006) 25
L. Use of Select Agent 26
M. Laboratory License Requirements 26
N. Advanced Understandings 26
Section 5: Full Proposal Submission 28
Section 6: General Information 29
Part V: Proposal Evaluation 31
A. Evaluation Criteria 31
B. Past Performance Information 32
Part VI: Special Instructions 34
Part VII: Attachments 35
Attachment 1: Technology Readiness Level (TRL) Criteria 35
Attachment 1A: Draft Technology Readiness Level (TRL) Definitions for Medical In-Vitro Diagnostic Devices 35
Attachment 1B: Department of Defense Technology Readiness Assessment Deskbook 37
Attachment 2: Full Proposal Volume II - Breakdown Of Proposed Estimated Cost (Plus Fee) And Labor Hours 61
Attachment 3: Summary of Related Activities 63
Attachment 4: Government Notice for Handling Proposals 64
Attachment 5: Quad Chart and White Paper Format Template 65
Attachment 6: Target Product Profile Template 67
Attachment 7: BAA Instruction Language for Earned Value Management (EVM) 72




BARDA BAA-11-100-SOL-00021
Introduction


This Broad Agency Announcement (BAA) sets forth research and development areas of interest for the Office of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). This BAA is issued under paragraph 6.102(d)(2) of the Federal Acquisition Regulation (FAR), and proposals selected for award are considered to be the result of full and open competition and in full compliance with the provision of Public Law 98-369, "The Competition in Contracting Act of 1984" and subsequent amendments.


BARDA is the lead federal agency for the advanced development of medical countermeasures (MCM) to protect the United States against public health emergency threats, including chemical, biological, radiological and nuclear agents, emerging infectious diseases, and pandemic influenza. The 2009 H1N1 influenza pandemic exemplified the unpredictability and rapidity with which a novel influenza strain can impact the world's population. With a historic effort from both government and industry partners, vaccines were developed and available to the public six months after the initial outbreak. Despite high infection rates, the 2009 H1N1 virus was only mildly pathogenic, with relatively low rates of accompanying morbidity and mortality in the overall population. However, it is possible that future pandemics will feature morbidity and mortality rates comparable with historically more severe pandemics such as 1918, and 1957. The ever-present and ever-evolving threat of pandemic influenza presents a compelling need to optimize available medical countermeasures and develop entirely new modalities for prevention and treatment of influenza disease. Vaccines, therapeutics and diagnostics are essential to protect all segments of the civilian population. This BAA will support advanced development activities to improve candidate products and diagnostic tools and incorporate considerations of the challenging lifecycle requirements of these products before and during a pandemic (e.g. shelf life, storage, distribution, and dispensing).


The Pandemic and All Hazard Preparedness Act directs BARDA to promote (i) innovations in technologies that may assist MCM advanced research and development, (ii) research and development of tools, devices, and technologies, and (iii) research to promote strategic initiatives, such as rapid diagnostics, broad spectrum antimicrobials, and vaccine manufacturing technologies. The priorities of the BARDA Influenza Division are closely aligned with the National Strategy for Pandemic Influenza (Nov, 2005), the National Pandemic Influenza Implementation Plan (May, 2005), recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review (Aug, 2010) and the President's Council of Advisors on Science and Technology report on influenza vaccines manufacturing (Aug, 2010). The HHS Public Health Emergency Medical Countermeasures Enterprise Review emphasizes the need to improve medical countermeasure technologies and move towards a "nimble, flexible capacity to produce MCMs rapidly in the face of any attack or threat".


This BAA is open to all responsible sources. Offerors may include single entities or teams from private sector organizations, Government laboratories, Federally Funded Research and Development Centers (FFRDCs), and academic institutions.


Federally Funded Research and Development Centers (FFRDCs) are eligible to respond to this BAA, individually or as a team member of an eligible principal Offeror, as long as they are permitted under the sponsoring agreement between the Government and the specific FFRDC.


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.


The purpose of this BAA is to solicit proposals that focus on one or more of the following solicited areas of interest as listed here and further described in Part I of this announcement.


Development Areas of Interest:
• Personal Protective Equipment and Full-Featured Continuous Ventilators for Influenza Infection & All-Hazards
• Clinical Influenza Test Systems and Diagnostic Tools


Given the future availability of funds, this BAA may be expanded to incorporate development of other medical countermeasure products. Any such changes would be incorporated as BAA Amendments, and would be posted on http://www.fbo.gov.


Development and technical objectives are described in Part II, and efforts proposed by Offerors may include such activities as Non-Clinical Product Development, Manufacturing Process Development, Formulation, and Clinical Evaluation.


Offerors must identify in their Quad Chart and White Paper the current Technology Readiness Level (TRL) of their medical countermeasure product. See Attachment 1: Technology Readiness Level (TRL) CriteriaAttachment 1: Technology Readiness Level (TRL) Criteria. Two TRL criteria are provided to evaluate diagnostics products and to provide Offerors greater insight into the complexities of the diagnostics development process. Either diagnostics TRL criteria document may be used to assess product maturity. Please note that all activities within a TRL level (or sublevel) must be completed to have achieved that TRL status.


The 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. Brochures or other descriptions of general organizational or individual capabilities will not be accepted. Electronic acknowledgement of receipt of white papers will be made within one week. For Stage 1 there are four submission deadlines: July 15, 2011, October 14, 2011 January 13, 2012 and April 13, 2012. Decision letters will be sent to Offerors within 90 days of submission or within 90 days after the submission deadline.


In Stage 2, Offerors receiving a favorable evaluation will be asked to prepare a Full Proposal and submit to BARDA within 45 days depending on time and funding constraints. 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. The Government intends to make an award decision within 120 days after submission of Full Proposals.


The success of a product development program requires a relentless focus on the desired characteristics of the resulting medical countermeasure product. During Stage 2, in addition to the Full Proposal, Offerors are requested to provide a Target Product Profile. A template for a Target Product Profile is included in Attachment 1 as a tool for Offerors to describe the objectives of their advanced research and development activities, and to update dynamically as supporting data about their product is obtained. All Offerors are encouraged to submit a Target Product Profile for the proposed medical countermeasure, with a particular focus on elements 1-4. For those products for which the Target Product Profile format is not applicable, appropriate equivalent information regarding the desired outcome of the proposed development activities should be provided.


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 activities; however, contract awards and level of funding may be impacted by the availability of Congressional annual and/or supplemental appropriations. The costs of preparing responses to this BAA are not considered an allowable direct charge on any resultant award.


Offerors contemplating submitting Quad Charts, White Papers, and Full Proposals are strongly encouraged to contact the appropriate technical Point of Contact (POC) at BARDA (e-mail addresses are provided in Part I of this announcement). 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 conducted through the BARDA Contracting Officer (The Office of Acquisitions Management, Contract & Grants).


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


Quad Chart and White Papers and/or Full Proposals WILL NOT BE ACCEPTED after 3:00 PM (Eastern Standard Time) on September 13, 2011.


In accordance with federal statutes, regulations, and HHS policies, no person on grounds of race, color, age, sex, national origin, or disability shall be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving financial assistance from the HHS.


BARDA reserves the right to fund all, some, or none of the proposals submitted. While award is anticipated to occur according to the stated schedule, Offerors that are not responsive to BARDA requests for information in a timely manner, will not be considered for an award.


BARDA reserves the right to award the contract instrument best suited to the nature of the development activities proposed and may award any appropriate contract type under the Federal Acquisition Regulation. BARDA may also elect to make awards in the form of grants and cooperative agreements, with the possibility of awarding Other Transactions (OT) agreements in the future as appropriate, as authorized for BARDA under the Pandemic and All Hazards Preparedness Act (2006).


Multiple awards at various funding levels, base periods, and options are anticipated and are dependent upon the proposals' scientific and technical merits, how well the proposals fit BARDA's areas of interest, and available funding.


Special instructions will be advertised via the BAA as they become apparent. These additional instructions are tailored to specific topic areas and may have unique submittal dates. The information requested in these instructions should be used along with Part IV of the BAA to format and prepare the Technical and Business Proposals.


Anticipated funding for the program (not per contract or award) may range from $15-75M dollars subject to Congressional appropriations. This funding profile is an estimate only and does not represent a contractual obligation for funding. All funding is subject to change due to government discretion and availability.


All administrative inquires regarding this BAA shall be addressed to FLU-BAA@hhs.gov. Technical questions shall be referred to the Point Of Contacts (POCs) shown following each development area of interest. Please include contact information with any inquiry.


This BAA is available on the following websites:


https://www.fbo.gov
https://www.medicalcountermeasures.gov/
http://www.hhs.gov/aspr/barda/


This BAA is a continuously open announcement valid for the period from the date of issuance through June 20, 2012, unless announced otherwise. Amendments to this BAA will be posted to the websites listed above. Interested parties are encouraged to periodically check these websites for updates and amendments.

Pre-Proposal Conferences


Note: Offerors are encouraged to attend the conference however, seating will be limited.

Pre-proposal Conference #1: July 13, 2011 1:00 PM - 4:00 PM for all development areas of interest.

Hubert H. Humphrey Building
1st Floor Auditorium
200 Independence Avenue S.W.
Washington, DC 20201

Please note the following regarding the pre-proposal conference:
1. Attendance is limited to a maximum of two (2) people per company. Email the names of your attendees and Development Area of Interest to FLU-BAA@hhs.gov by June 30, 2011. To ensure an equal distribution of attendees in each Development Area of Interest, registration for each section will be controlled and a wait-list established.
2. Enter the Humphrey Building at the Independence Avenue Street entrance.
3. Arrive 30 minutes early to allow time to clear security.
4. Bring your identification
5. The closest metro stop is Federal Center SW
6. Tape recorders and videos are prohibited.
7. 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: (866) 880 0098 Passcode: 3458287#. Dial-in attendees will be muted.


Pre-proposal Conference #2: A second pre-proposal conference may be announced in a subsequent FedBizOps amendment to this BAA.
Questions from industry may be emailed to Flu-BAA@hhs.gov no later than June 30, 2011. Submitted questions will be address during the July 13, 2011 Pre-Proposal Conference.


Part I: Development Areas of Interest
Through this solicitation, BARDA seeks to support development strategies in the following product development areas of interest. This section presents the influenza-related technical objectives that BARDA seeks to achieve through this BAA. Each Offeror shall also review Part II: Research and Technical Objectives.
Area of Interest #1: Personal Protective Equipment (Mask & Respirators) and Full-Featured Continuous Ventilators for Influenza Infection and All-Hazards
Offerors for Area of Interest #1 should propose activities for products which can currently be described as having a maturity level equal to or greater than Technology Readiness Level (TRL) 6. A product can be described as achieving a TRL if it has completed all activities identified in that TRL. The Technology Readiness Level ranking criteria can be found in Attachment 1B of this solicitation.


1.1 Development and characterization of improved personal protective equipment such as masks or N95 respirators to prevent influenza infections or harmful effects of all-hazard events.


1.2 Development of improved full-featured continuous ventilators. Advanced development of new or improved ventilator to provide life support in clinical and non-clinical environments for severe respiratory conditions resulting from influenza infections or all-hazards events. Ideal ventilators would support neonate to adult populations and be capable of operation by unskilled or minimally trained care providers with considerations for ease of stockpiling/maintenance, accommodation/provision of accessories typically used in ventilatory standard of care, low cost per unit, and domestic surge capacity.


Technical inquiries can be directed to FLU-BAA-MITIGATE@HHS.GOV
Area of Interest #2: Clinical Influenza Test Systems and Diagnostic Tools
Offerors for Area of Interest #2 should propose activities for products which can currently be described as having a maturity level equal to or greater than the Technology Readiness Level (TRL) indicated below. A product can be described as achieving a TRL if it has completed all activities identified in that TRL. For diagnostics, two Technology Readiness Level ranking criteria are provided in Attachment 1A & 1B of this solicitation; either criterion can be used for evaluation. Design, manufacturing, and assembly of reagents and system components must be consistent with U.S. Quality Systems Regulations (21 CFR Part 820).
Offerors should indicate an understanding of CLIA requirements for influenza diagnostics.


2.1 Development of better rapid influenza diagnostic tests. To include: Advanced development of new or improved rapid tests, including point of care (POC) type tests that facilitate more timely diagnosis of influenza infections in outpatient/ambulatory healthcare practices. Ideal tests would have a simplicity level that could enable home use, or use in minimally resourced settings with beneficial clinical and public health impact. Critical technology component should be at a maturity level equal to or greater than TRL 6.


2.2 Development of improved respiratory specimen collection materials and methods. Approaches should enable direct testing (using viral antigen or nucleic acids) and evaluation in on-site laboratories, and with available transport systems to maintain viability and nucleic acid integrity for reference and confirmatory testing. Materials and methods can enable reliable and consistent self-collection or collection by non-expert personnel.


2.3 Development of expanded respiratory pathogen tests on existing test platforms. Transfer and validation of established molecular, or other target signatures for influenza and other respiratory pathogens, to existing platforms. Critical technology component should be at a maturity level equal to or greater than TRL 8.


2.4 Development of advanced sequence detection methods for identifying novel influenza strains. Advanced development and implementation of methods applying targeted or whole genome sequencing for known influenza reassortant genes to enable more rapid identification of human-animal reassortant influenza viruses with the goal of diagnosis of unusual influenza infections. Critical technology component should be at a maturity level equal to or greater than TRL 6.


2.5 Rapid identification of antiviral resistant influenza strains. Advanced development of reagents for reference methods to identify antiviral resistance and standardize functional resistance testing; adaptation of these methods for use in clinical hospital laboratories with interpretive criteria correlating to clinical outcomes in patients with antiviral resistant infections.


2.6 Rapid identification of influenza immunological response. Advanced development and evaluation of methods to rapidly determine presence/absence of significant circulating antibodies specific for influenza viruses, or adaptation of such methods, procedures, standards and controls to an OTS platform for use in clinical and research laboratory settings. Critical technology component should be at a maturity level equal to or greater than TRL 6.


2.7 Development and characterization of stable diagnostic reagents or reference material and controls for applications with existing diagnostic test systems on established platforms. Capability should be available for maintaining inventories and assuring stability sufficient to enable rapid distribution on-demand (including to remote locations), and capability for rapid surge production. Critical technology component should be at a maturity level equal to or greater than TRL 8.


Technical inquiries can be directed to FLU-BAA-DIAGNOSTIC@HHS.GOV
Part II: Product Development and Technical Objectives
This information is provided to assist and guide Offerors in preparing their Statement of Work (SOW). Offerors shall submit a SOW in their proposal that addresses these topics as appropriate, and shall provide as much detail as may be necessary to fully explain the proposed technical approach or method. The topics listed below exemplify some of the typical developmental activities in the areas of clinical research, manufacturing, clinical evaluation, project management, and regulatory strategy contained in a typical drug, biologic or device development effort.


Proposal preparation and submission instructions are contained in Part IV.


A. Development Approach:


Personal Protective Equipment (PPE) and Full-Featured Continuous Ventilator Activities may also include but are not limited to:


a. Integration and Verification:
• Establish technical specifications based on design controls.
• Establish qualification of components and accessories.
• Produce pre-production (beta) prototype.


b. Internal and External Validation Studies:
• Design and validate performance test protocols and acceptance criteria (e.g., bench, animal and/or clinical studies) to enable standardized safety and effectiveness measures.
• Field evaluations of PPEs to filter influenza viruses and other respiratory pathogens.
• Field evaluations of ventilators to provide respiratory support in comparison to predicate devices on the market.
c. Manufacturing:
• Produce pilot or finished lots of test units in sufficient quantities for clinical and non-clinical evaluations.
• Maintain appropriate quality assurance with processes, procedures, and documentation consistent with design controls (as applicable), Quality Systems, and relevant standards (e.g., deviation and risk management strategies).
• Identify critical manufacturing process parameters for domestic scale-up production.
d. Other Product Development Activities:
• Collaborate with relevant technical guidance and standards organizations to develop consensus test methods and parameters.
• Provide equipments and/or necessary materials along with technical support to programs evaluating the safety and effectivenss of these devices in relevant environments.
• Evaluate diagnostic value of test methods for informing clinical and public health management decisions.
• Design and coordinate conduct of clinical evaluations including device performance and usability by non-skilled or minimally trained care providers in collaboration with institutional or public health programs.


Influenza Test System and Diagnostic Tool Activities may also include but are not limited to:
a. Integration and Verification:
• Establish QA criteria based on implemented design controls.
• Produce pre-production (beta) instrument platform
• Initiate accelerated and real-time stability studies
• Establish technology transfer agreements and implement qualification of sourced reagents, components, and materials.


b. Internal and External Validation Studies:
• Assessments of specimen processing methods and specimen target stability using modified or new collection and transport materials.
• Collaborate with clinical entities to assess feasibility for use of specific specimen collection methods.
• Optimize new or modified assays on existing platforms.
• Design and validate protocols for analytical and clinical studies to enable standardized performance measures.
• Field evaluations with rapid in vitro diagnostic test systems to detect and identify influenza viruses and optionally distinguish other respiratory pathogens.


c. Manufacturing:
• Produce pilot or finished lots of test units (e.g., cartridges, assay plates) in sufficient amounts for clinical and non-clinical evaluations
• Maintain appropriate quality assurance with processes, procedures, and documentation consistent with design controls (as applicable), Quality Systems, and relevant standards (e.g., deviation and risk management strategies).
• Identify critical manufacturing process parameters for scale-up production.


d. Other Product Development Activities:
• Use publicly available gene sequences in collaboration with CDC, NIH and others with advanced influenza genetic informatics expertise to characterize influenza viruses for device, assay, or test design.
• Collaborate with guidance and standards organizations to develop laboratory and practice guidance or standards for specific methods.
• Evaluate specimen types, test methods, and testing algorithms for assessing positive and negative likelihood ratios of influenza infections in specific clinical settings.
• Evaluate diagnostic value of respiratory disease test methods for informing clinical management decisions.
• Provide equipment, reagents and necessary materials along with technical support, as requested, to programs monitoring influenza prevalence and characterizing circulating virus types, subtypes, and resistance.
• Design and coordinate clinical evaluations in collaboration with institutional or public health programs to monitor influenza virus and other respiratory pathogens causing community respiratory disease outbreaks.
• Validate clinical assessment strategies for guiding influenza testing decisions in outpatient practice, to include at-risk groups (e.g., pediatrics and obstetrics).


B. Management Approach:


1. Representative Activities for the Integrated Product Development Plan (IPDP) must include as applicable, but are not limited to:
a. A detailed project plan that indicates the activities that the Offeror is proposing to perform under contract funding in both the base period and option period(s), including all of the functional areas of development listed below.
b. 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.
c. Key steps in the product development pathway that represent opportunities for "go/no go" decisions for advancing to the next stage of the Integrated Product Development Plan (IPDP).
d. The qualitative and quantitative criteria and accompanying data that will be used to assess the scientific merit and technical feasibility of each stage of product development.
e. Milestones and timelines for the initiation, conduct, and completion of product development activities for each stage with a budget (in direct costs) linked to each stage.
f. A listing and resumes of key personnel (including proposed consultants) who possess the necessary education, training, and experience to successfully perform the work identified in the technical proposal.
g. A staffing plan that indicates personnel resources (in-house and contracted) and the percentage of time to be dedicated to perform the work.
h. A clear and comprehensive regulatory master plan that identifies the critical path integrating risk evaluation and mitigation at all development stages (non-clinical testing, clinical testing, and manufacturing activities) using the most current available information, including documented and time-relevant consultation with FDA.
i. A plan for additional studies to support future filing for FDA-approval/clearance.
j. Summary of any prior communication with the FDA relevant to product development, including a summary of audits and inspections.
k. A tentative schedule of anticipated regulatory milestones.
l. A plan for potential use of the product under Emergency Use Authorization (EUA). (http://www.cdc.gov/eid/content/13/7/1046.htm)
m. A clear and consistent work breakdown structure (WBS) that may include data at the cost account level, at the work package level, or at a lower level if there is significant complexity and risk associated with the task.
n. An approach for tracking milestones, costs, risks, subcontractor effort (if applicable), and deliverables, and any proposed internal procedures for assuring timely responses to the Government's needs.
o. An approach for performance measurement that shall include establishing an initial plan; defining measurable parameters; defining how these parameters relate to cost and schedule impacts; presenting a detailed schedule that includes a critical path for the project; and a description of the cost-accounting system based on budget estimates to monitor all costs related to the contract award for both prime- and sub-contractors on a real-time basis.


Within fourteen (14) days of the effective date of the BAA award, the Offeror shall submit an updated 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 include a requested change in the previously approved IPDP and associated timelines, and shall include:


a. Discussion of the justification/rationale for the proposed change.
b. Options for addressing the needed changes, including a cost-benefit analysis of each option.
c. Recommendation that includes a full analysis of the effect of the change on the entire product development program, timelines, and budget.


The Offeror shall carry out activities within the contract SOW only as requested and approved by the Contracting Officer, and may not conduct work on the contract without prior approval from the Contracting Officer, including the initiation of any work that deviates from the approved IPDP.


Offeror shall comply with all applicable regulatory requirements. Filing of regulatory submissions shall be made to the relevant FDA center.


The Offeror shall use Earned Value Management to monitor the progress of their project. Additional instructions can be found in Attachment 1.


2. Target Product Profile (TPP): In their proposal, Offerors shall include a draft TPP for their proposed candidate medical device or system objective. Offerors should use the template in Attachment 6 to develop the TPP, and should include the following elements:
a. The intended use or indication of the proposed medical countermeasure.
b. The intended product profile (strength, quality, purity and identity) noting the performance specifications and features of the medical countermeasure that provide benefit.
c. A description of the medical countermeasure as it is currently configured.
d. A description of the manufacturing process or mode of distribution including expected formulation (configuration) of the final product.
e. A description and developmental status of the assays or methods for product release which will be used for characterization, strength, identity, and purity, as well as any needed assays for product activity and efficacy.
f. Any discussions with appropriate FDA reviewers that are relevant to development activities for the proposed medical countermeasure, including plans for generating data to support an Investigational New Drug (IND), Biologics License Application (BLA) or New Drug Application (NDA), Investigational Device Exemption (IDE), Premarket Approval (PMA) and/or 510(k) application; summary of any prior, time-relevant communication with FDA relevant to the product development for the indication noted; and summary of audits and inspections relative to the current development or proposed manufacturing of the intended product (including key subcontractors).


3. Representative Activities for Contractor-Provided Facilities, Infrastructure and other Resources must include as applicable but are 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 analytical 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. Detailed instructions on proposal preparation and submission are contained in Part IV.
g. The handling, storing and shipping of potentially dangerous biological and chemical agents, including Select Agents, under biosafety levels required for working with the particular biological agents under study. Detailed instructions on proposal preparation and submission are contained in Part IV.
h. Validation master plan for key equipment, analytical methods and manufacturing process.


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 Project Officer and the Contracting Officer 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 to the Contracting Officer one (1) electronic copy and one (1) paper copy.



Reports:


1. Technical Progress Reports


The frequency of Technical Progress Reporting will be determined by the Contracting Officer and Project Officer during negotiations of the contract. Typically, on the fifteenth (15) day of each month for the previous calendar month, the contractor shall submit to the Contracting Officer. The format and type of Technical Progress Report and Executive Summary will be provided by the Project Officer. Each Technical Progress Report will include project timelines and milestone summaries of all activities funded under the contract, such as 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 Technical Progress Report documents shall be submitted in Microsoft Word, Microsoft Excel, Microsoft Project, and/or Adobe Acrobat PDF files. Such reports shall include the following specific information:
a. Title page containing: Technical Progress Report, the contract number and title, the period of performance or milestone being reported, the contractor's name, address, and other contact information, the author(s), and the date of submission;
b. Introduction/Background: An introduction covering the purpose and scope of the contract effort;
c. Progress: The report shall detail, document and summarize the results of work performed, test results, milestones achieved during the period covered and cumulative milestones achieved. Also to be included is a summary of work planned for the next two (2) reporting periods on a rolling basis;
d. Issues: Issues resolved, new issues and outstanding issues are enumerated with options and recommendation for resolution. An explanation of any difference between planned progress and actual progress, why the differences have occurred, and, if progress activity is delinquent, then what corrective steps are planned. Revised timelines are provided.
e. Invoices: Summary of any invoices submitted during the reporting period.
f. Action Items: Summary table of activities or tasks to be accomplished by certain date and by whom.
g. Distribution list: A list of persons receiving the Technical Report
h. Attachments: Results on the project are provided as attachments


2. The Executive Summary, which shall accompany each Technical Progress Report, will be provided in Microsoft Power Point format and shall include the following:
a. Title page containing Executive Title, the contract number and title, the period of performance or milestone being reported, the contractor's name and the date of submission;
b. Project Progress presented as milestone events, test results, tasks, and other activities achieved during the reporting period as talking point bullets;
c. Project issues presented headings and each item as a talking point bullet.


3. The Earned Value Management Report shall accompany each Technical Progress Report.


4. 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 all work performed under the entire contract. The report shall comprehensively explain the results achieved, and clearly document and justify any instance in which desired results were not achieved. A draft Final Report will be submitted to the Project Officer and Contracting Officer for review and comment. Once all requested changes are made, the Final Report shall be submitted to the Contracting Officer as one original paper copy, four additional paper copies, and an electronic copy.


Meetings and Conferences:


The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the Contracting and Project Officers. Such meetings may include, but are not limited to, meeting of all Contractors 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 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 will be expected to develop remediation plans based on BARDA recommendations and the progress of the project during the execution of the contract.


Regulatory and Quality Management:


FDA Submissions and meetings:
a. The contractor shall forward the initial draft minutes and final draft minutes of any formal meeting with the FDA to BARDA.
b. The contractor shall forward the final draft minutes of any informal meeting with the FDA to BARDA.
c. The contractor shall inform BARDA of the dates and times of any meeting with the FDA and make arrangements for appropriate BARDA staff to attend FDA meetings as appropriate.
d. 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 ten (10) business days in which to review and provide comments back to the contractor.
e. The contractor shall forward Standard Operating Procedures upon request from the Project Officer and/or 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 using USG funds.
h. The contractor shall maintain and provide on request regulatory and legal strategies related to the scope of work. Identify any federal, state or local requirements pertaining to patient safety and welfare.
i. The contractor shall maintain appropriate quality assurance with respect to processes, procedures, and documentation.



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.



Part IV: Proposal Preparation and Submission
Section 1: The Application Process
The application process occurs in two stages as follows:


Stage 1: Complete a cover sheet, Quad Chart, and White Paper in accordance with the preparation guidance below. The 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 email.


Stage 2: Offerors who are invited to submit Full Proposals must do so in accordance with the instructions provided below. Full Proposals will be evaluated against the Evaluation Factors as described in Part V. Proposals that do not conform to the requirements outlined herein will not be reviewed or considered for further action.



Proposal Stage Deadline for Submission USG Response
Stage 1: Quad Chart and White Paper July 15th, 2011, October 14, 2011, January 13th, 2012 and April 13th, 2012. 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 120 days of receipt of Full Proposal


Section 2: Stage 1 Quad Chart and White Paper
Interested Offerors shall submit a Quad Chart, a White Paper, and an addendum. The Quad Chart is not to exceed one (1) page, the White Paper is not to exceed ten (10) pages, and the addendum is not to exceed two (2) pages. If a submission exceeds these page limitations, only those pages that fall within the page limits will be reviewed. Combine all files 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. Quad Charts should be laid out in landscape format.
1. Heading: Title; Research Area Addressed; Offeror point of contact; Company Name
2. Upper left: Objective; description of effort
3. Lower left: Benefits of proposed technology; challenges; maturity of technology research area addressed as indicated by TRL (see Attachment 1)
4. Upper right: Picture or graphic
5. Lower Right: Milestones; costs; period of performance


White Paper Technical Information:
1. In general, the white paper should provide a brief technical discussion of the Offeror's objective, approach, level of effort, and the nature and extent of the anticipated results. Specifically, the white paper should include, at a minimum, the following core elements:
a. brief discussion on how the proposed countermeasure aligns with the objectives of the National Strategy for Pandemic Influenza, the HHS Pandemic Influenza Implementation Plan, and other federal government strategies and plans.
b. a brief description of the maturity level of the proposed countermeasure using the appropriate Technology Readiness Level (TRL) criteria provided in Attachment 1.
c. a clear, concise development plan that includes all non-clinical, clinical, manufacturing, and regulatory activities required for the proposed countermeasure.
d. a high-level Gantt chart showing an overview of the proposed activities and timelines.
e. a brief description of the Offeror's intellectual property
ownership of the proposed countermeasure.
f. overview of Offeror's capabilities and experience (past and current) as they relate to the proposed program.
2. The cost portion of the White Paper shall contain a brief cost estimate including all the component parts of the proposal.
3. A two-page addendum shall include biographical sketches of the key personnel who will perform the research, highlighting their qualifications and experience.


Restrictive markings on White Papers: Classification: All Quad Chart and White Paper submissions must be UNCLASSIFIED. Proposal submissions will be protected from unauthorized disclosure in accordance with FAR Subpart 15.207, HHS regulations, and all applicable laws. Offerors that include data in their proposal 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 to the following email address:
FLU-BAA@hhs.gov


Include "BAA BARDA 11-100-SOL-00021 QUAD CHART & WHITE PAPER for Research Area #_" in the email subject line. White Papers must be submitted in the following format but do not require any special forms:


• Single PDF formatted file as an email attachment
• Page Size: 8 ½ x 11 inches
• Page limit: 10 pages• Margins - 1 inch
• Spacing - single
• Font - Arial, 11 point


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


Notification to Offerors: All Offerors will receive a letter and/or email acknowledging receipt of their Quad Chart and White Paper submission. Offerors should receive a letter or e-mail within 90 days of submission on the status of whether or not the Offerors will be invited to submit a Full Proposal. An Offeror may receive a decision letter in fewer than 90 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 submissions 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 should not be merely copy the title of the 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 12 point font.
1. Cover Page: This should include the words "Technical Proposal" and the following:
• BAA number
• Title of proposal
• Identity of prime Offeror and complete list of subcontractors, if applicable
• Technical contact (name, address, phone/fax, electronic mail address)
• Administrative/business contact (name, address, phone/fax, electronic mail address)
• Duration of effort
2. Official Transmittal Letter. This is an official transmittal letter with authorizing official signature.
3. Table of contents: an alphabetical/numerical listing of the sections within the proposal, including corresponding page numbers.
4. Executive Summary
5. Introduction
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 must include a self-standing SOW, without any proprietary restrictions, which can be attached to the contract or agreement award. Include a detailed listing of the technical tasks/subtasks organized by base and option periods of performance, inclusive of the tasks in the following areas as appropriate.
a. Non Clinical Research and Development
b. Process Development, Formulation and Manufacturing Development
c. Clinical and Non-Clinical Evaluation
d. Regulatory Tasks.
7. Risk Management Plan: Offerors also must provide a comprehensive evaluation of the risks to product development and quality. A Risk Management Plan should identify any potential risks, impediments that could require a revision in the work plan or milestones with a discussion of alternative approaches. The Risk Management Plan should include at a minimum the process for periodic review and updates, a risk assessment matrix with the events and severity of impact as well as the mitigation, and a risk register that links to the WBS and Gantt.
8. Gantt Chart, Work Breakdown Structure and Milestones: A detailed Gantt Chart with associated Work Breakdown Structure (WBS) and program Milestones will be provided as part of the technical submission.
9. Deliverables Schedule: A detailed description of the results and products to be delivered inclusive of the timeframe in which they will be delivered.
10. Milestones and Timeline: A developmental milestone is completion of clear specific interim objective to be achieved during the course of the project.
a. Detailed quantitative criteria by which milestone achievement will be assessed.
b. A detailed schedule or timeline for the anticipated attainment of each milestone and the overall goal(s), over the base year and optional periods of performance.
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 5
2 Protection of Human Subjects If Applicable Part IV, Section 4, para F
http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf
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_selectagent


7 Laboratory License Requirements If Applicable Part IV, Section 4, para N
8 Target Product Profile As Applicable; see criteria below Template in Attachment 6


• Target Product Profile: The success of a product development program requires a relentless focus on the desired characteristics of the resulting medical countermeasure product. A template for a Target Product Profile is included in Attachment 6 as a tool for Offerors to describe the objectives of their advanced research and development activities, and to update dynamically as supporting data about their product is obtained. All Offerors are encouraged to submit a Target Product Profile for the proposed medical countermeasure, with a particular focus on elements 1-4. For those products for which the Target Product Profile is not applicable, appropriate equivalent information regarding the desired outcome of the proposed development activities should be provided.
C. Volume II - Cost Proposal
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 in the associated Project Gantt Chart. The Offeror must also provide a narrative to support the requirements in each cost element. The cost breakdown by tasks should use the same task numbering as the WBS in the Technical Proposal SOW. Options should be priced separately.


• 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 fiscal or calendar year as applicable:
i. Direct Labor- Individual labor category or person, with associated labor hours and unburdened direct labor rates;
ii. Indirect Costs - Fringe Benefits, Overhead, G&A, etc. (Must show base amount and rate);
iii. 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;
iv. 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, email address, and telephone number. Include the DUNS number.
v. Consultant - Provide consultant agreement or other document which verifies the proposed loaded daily/hourly rate and labor category;
vi. 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,
vii. 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.
viii. Fee/profit including percentages.


• 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;
12. DUNS number and CAGE code.
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;
11. Name, title and signature of authorized representative;


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.


A draft template for the breakdown of proposed estimated costs and labor hours is provided in Attachment 2.
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 Certifications and Representations Yes Part IV, Section 4, para E
3 CCR Yes
4 Security No
5 HHS Small Business Subcontracting Plan If Applicable
6 Summary of Related Activities Yes Template in Attachment #4
7 Disclosure of Lobbying Activities Yes Part IV, Section 4, para K
8 Report of Government Owned , Contractor Held Property If Applicable http://www.niaid.nih.gov/contract/forms.htm


E. Representation 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/policy/ohrpregulations.pdf.
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:
a. 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.
b. 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.
c. Provide information on the veterinary care of the animals involved.
d. 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.
e. 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/resources/euthanasia.pdf). If not, present a justification for not following the recommendations.
H. Security Planning:
The work to be performed under this BAA is exempt from the security requirements normally required for other BARDA programs.
I. Intellectual Property:
All proposals shall include the Offeror's approach to obtaining access to all Intellectual Property (IP) necessary for performance of a contract awarded in response to the BAA in accordance with the IP requirements specified under Federal Acquisition Regulations ("FAR") Part 27-Patents Data and Copyrights. The term IP as used in this section, as well as Section 3.6 below, shall include any and all Inventions as defined under FAR Section 27.301, and any and all Data as defined under FAR Section 27.401. Prior to award the contractor will be responsible for securing all licenses necessary to utilize any and all inventions and data incorporated into the proposal. In contract awarded in response to this BAA will incorporate during performance. 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 is the patent or invention owner. FAR Clause 52.227-1, FAR Clause 52.227-3, FAR Clause 52.227-11, FAR Clause 52.227-14 and FAR Clause 52.227-16 are incorporated by reference into this Solicitation and will be specifically incorporated by reference into all Contracts awarded in response to this Solicitation
J. Biographical Sketches:
This Section shall contain the biographical sketches for only the key personnel from both the contractor, consultant(s) and subcontractor(s): The Full Proposal must list the names and proposed duties of the professional personnel, consultants, and key subcontractor employees assigned to the project. Their resumes should be included in the appendices in Volume I of the Full Proposal. The resumes should contain information on education, background, recent experience, and specific or technical accomplishments as they pertain to their ability to support the objectives of this project. The approximate percentage of time each individual will be available for this project must be stated. The proposed staff hours of each individual should be allocated against each project task or subtask.
K. Prohibition on the Use of Appropriated Funds for Lobbying Activities HHSAR 352.270-10 Anti-Lobbying (Jan 2006)
The contractor is hereby notified of the restrictions on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies.


Section 1352 of Title 31, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.


In addition, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself as stated in P.L. 109-149, Title V, section 503(a), as directed by P.L. 110-5, Div. B, Title I, section 104.


The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature as stated in P.L. 109-149, Title V, section 503(b), as directed by P.L. 110-5, Div. B, Title I, section 104.
L. Use of Select Agent
An HHS chaired committee of contracting, security, safety and scientific program management will assess the applicability of the facilities, regulations, policies, and procedures for meeting the U.S. requirements described in 42 CFR part 73, 7 CFR part 331, and/or 9 CFR part 121.
M. Laboratory License Requirements
The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended). This requirement shall also be included in any subcontract for services under the contract.
N. Advanced Understandings


1. Invoices: Cost and Personnel Reporting, and Variances from the Negotiated Budget:
i. The contractor agrees to provide a detailed breakdown on invoices of the following cost categories:
a. Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.
b. Fringe Benefits - Cite rate and amount
c. Overhead - Cite rate and amount
d. Materials & Supplies - Include detailed breakdown when total amount is over $1,000.
e. Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.
f. Consultant Fees - Identify individuals and amounts.
g. Subcontracts - Attach subcontractor invoice(s).
h. Equipment - Cite authorization and amount.
i. G&A - Cite rate and amount.
j. Total Cost
k. Fixed Fee
l. Total CPFF


Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.


ii. The contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Cost (FAR 52.232-20) clause in the contract.


2. Publications: Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted for BARDA Project Officer review no less than thirty (30) calendar days for manuscripts and fifteen (15) calendar days for abstracts before submission for public presentation or publication. Contract support shall be acknowledged in all such publications. A "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information.


3. Press Releases: The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. Misrepresenting contract results or releasing information that is injurious to the integrity of BARDA may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Project Officer has received an advance copy of any press release related to this contract not less than four (4) working days prior to the issuance of the press release. The Contractor shall not release any press releases about the work being performed under this contract without written notice in advance to the Government, for additional information, see HHSAR 352.270-6.


4. Human Subjects: Research projects involving humans and/or human specimens can only be initiated with written approval by the BARDA Project Officer.


The Good Clinical Practice Regulations (GCP)(21 CFR Parts 50, 54, 56 312)(45 CFR Part 46)(ICH E6) as well as other applicable federal and state regulations will be standards that apply for use of human subject and/or human specimens in clinical studies.


If at any time during the life of the contract, the Contractor fails to comply with GCP as identified by regulations outline above , the Offeror shall have thirty (30) calendar days from the time such material failure is identified to cure such or initiate cure to the satisfaction of the USG Project Officer. If the Offeror fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.


5. Conference Calls: A conference call between the USG Project Officer and the Offerors shall occur as directed by the Project Officer. The Project Officer will set the agenda, but commonly the Principal Investigator will discuss the activities since the last conference call, any problems that have arisen and the activities planned for the ensuing reporting period. Offerors may choose to include other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Project Officer.


6. Reporting period report: The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.


6. Export control notification: Offerors are responsible for ensuring compliance with all export control laws and regulations that maybe applicable to the export of and foreign access to their proposed technologies. Offerors may consult with the Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22 CRF Parts 120-130) and /or the Department of Commerce regarding the Export Administration Regulations (15 CRF Parts 730-774).


7. Manufacturing Standards: The Current Good Manufacturing Practice Regulations (CGMP)(21 CFR Parts 210-211) and regulations pertaining to biological products (21 CFR Part 600) and regulations pertaining to diagnostic products and medical devices (21 CFR Part 820) will be the standard to be applied for manufacturing, processing, packaging, storage and delivery of this product.


If at any time during the life of the contract, the Contractor fails to comply with CGMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA , the Offeror shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Offeror fails to take such an action to the satisfaction of the USG Project Officer within the thirty (30) calendar day period, then the contract may be terminated.


8. Prohibition on contractor Involvement with Terrorist Activities: The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to Executive Order 13224 and Public Law 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.


9. Subcontracting Plans: Successful contract proposals that exceed $550,000, submitted by all but small business concerns, will be required to submit a Small Business Subcontracting Plan in accordance with FAR 52.219-9.


10. Identification and Disposition of Data: the Contractor will be required to provide certain data generated under this contract to the HHS. HHS reserves the right to review any other data determined by HHS to be relevant to this contract. The contractor shall keep copies of all data required by the FDA relevant to this contract for the time specified by the FDA.


11. Confidentiality of Information: The following information is covered by HHSAR Clause 352.224-70, confidentiality of Information (January 2006): Data obtained from human subjects.
Section 5: Full Proposal Submission
Mail an original and one (1) copy* of the Full Proposal and two (2) electronic copies (CD or DVD) to the following address:


Dorothy McMillan
Contracting Officer
Office of Acquisitions Management, Contracts and Grants (AMCG)
Office of the Assistant Secretary for Preparedness and Response (ASPR)
U.S. Department of Health and Human Services (HHS)
330 Independence Ave., SW Room G640
Washington, DC 20201


*Note: Additional copies may be requested in the Full Proposal Invitation Letter.


Offeror shall include in the Full Proposal Cover Sheet:
• The name, title, mailing address, telephone number, and fax number of the company or organization;
• 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;
• The name, title, mailing address, telephone number, fax number, and e-mail address and those individual(s) authorized to negotiate with the USG; and
• A statement indicating you are submitting a final Full Proposal for consideration.


Submission file format for the electronic copy: Each volume of the proposal must be submitted as a separate and searchable Portable Document File (PDF) compatible with Adobe Acrobat version 7.0 or earlier. Each individual file shall not exceed 10 megabytes of storage space.


Notification to Offerors: All Offerors will receive an email acknowledging receipt of their Full Proposal.


Withdrawal of Proposals:
1. Proposal may be withdrawn by written notice received at any time before award. Withdrawals are effective upon receipt of notice by the Contracting Officer via email.
2. The government may reject Full Proposal submissions that are deemed non-compliant, i.e., that significantly deviate from the instructions in the Broad Agency Announcement or invitation to submit a full proposal


Information to be requested from Successful Offerors: Offerors whose proposals are selected for potential award will be contacted to provide additional administrative information if required for award. Such information may include explanations and other information applicable to the proposed award.


Offerors that are not responsive in a timely manner to Government requests for information (defined as meeting Government deadlines established and communicated with the request) may be removed from award consideration. Offerors that request significant revisions to their proposal subsequent to their selection for potential award may be removed from award consideration. Offerors may also be removed from award consideration if the Offeror and the Government fail to negotiate mutually agreeable terms within a reasonable period of time.


All proposals are treated as privileged information prior to award and the contents are disclosed only for the purpose of evaluation. The Offeror must indicate any limitation to be placed on disclosure of information contained in the proposal in accordance with the instructions contained FAR 52.215-1(e) ‘Restrictions on disclosure and use of data.'
Section 6: General Information
PRELIMINARY INQUIRIES: BARDA realizes that the preparation of a proposal often represents a substantial investment of time and effort by the Offeror. Therefore, in an attempt to minimize this burden, BARDA encourages organizations and individuals interested in submitting proposals to make preliminary inquiries as to the general need for the type of research effort contemplated, before expending extensive effort in preparing a detailed proposal or submitting proprietary information. The POCs for each area of interest are identified in Part I of this announcement.


CLASSIFIED SUBMISSIONS: Classified proposals will not be accepted.


USE OF COLOR IN PROPOSALS: All proposals received shall be stored as electronic images. Electronic color images require a significantly larger amount of storage space than black-and-white images. As a result, Offerors' use of color in proposals should be minimal and used only when absolutely necessary for details. Do not use color if it is not necessary.


POST EMPLOYMENT CONFLICT OF INTEREST: There are certain post employment restrictions on former federal officers and employees, including special government employees (Section 207 of Title 18, U.S.C.). If a prospective Offeror believes a conflict of interest may exist, the situation should be emailed to this address FLU BAA@hhs.gov, prior to expending time and effort in preparing a proposal. The appropriate BARDA personnel will discuss with any conflict of interest with prospective Offeror.


UNSUCCESSFUL PROPOSAL DISPOSITION: Unless noted in an Offeror's proposal to the contrary, unsuccessful full proposals will be retained for six (6) months from declination and then properly destroyed.

Part V: Proposal Evaluation
A. Evaluation Criteria
The selection of one or more sources for award will be based on an evaluation of each Offeror's Quad Chart and White Paper and Full Proposal. The Quad Chart and White Paper and Full Proposal will be evaluated by a peer or scientific review process and will be evaluated based on the following criteria that are listed in descending order of importance pursuant to FAR 35.016. The sub-criteria listed under a particular criterion are of equal importance to each other.


a. Program relevance
1. Medical countermeasures including medical devices that align with the objectives outlined in the National Strategy for Pandemic Influenza, the HHS Pandemic Influenza Implementation Plan, and other federal government strategy documents
2. Medical countermeasures that address the priorities outlined in Part I: Research Areas of Interest.


b. The overall scientific and technical merits of the proposal
1. The degree of innovation and potential to offer a revolutionary increase in capability or a significant reduction in cost commensurate with the potential risks of the innovative approach.
2. The soundness, feasibility, and validity of the proposed plans, methods, techniques, and procedures of the technical proposal.
3. The Offeror's understanding of the scope and the technical effort needed to address it.
4. The reasonableness of the proposed schedule.
5. The Offeror's understanding of the statutory and regulatory requirements..
6. Ownership of Intellectual Property.


c. The Offeror's capabilities, related experience, and past performance, including the qualifications, capabilities, and experiences of the proposed key personnel
1. The quality of technical personnel proposed.
2. The Offeror's experience in relevant efforts with similar resources.
3. The ability to manage the proposed effort, and to avoid interference with other current projects.


d. Cost realism and reasonableness. Each price/cost response will be reviewed for price/cost realism, reasonableness, and overall best value to the government. Members of the review team may presume that the technical approach provided by the Offeror serves as a rationale for the labor mix and labor hours used.


e. For contract awards to be made to large businesses, the socio-economic merits of each proposal will be evaluated, but not scored, based on the extent of the Offeror's commitment in providing meaningful subcontracting opportunities for small businesses, small disadvantaged businesses, woman-owned businesses, service disabled veteran-owned small businesses, Hub-zone small business concerns, historically black colleges and universities, and minority institutions.


f. For contracts, preference for Offerors providing U.S. based jobs in the technical and /or administrative activities needed to accomplish milestone activities associated with product development will be afforded if the assessment on other criteria is equal.


The final evaluation will be based on an assessment of the overall best value to the government based on these criteria. Awards, if any, will be made based on proposal evaluation, funds availability, and other programmatic considerations. Award is also dependent upon demonstration by the applicant that they have adequately addressed the following requirements:


a. Research involving Human Subjects/Anatomical Substances (if proposed).
b. Research involving Animals (if proposed).
c. Evidence of GLP Compliance (if appropriate).
d. Evidence of cGMP Compliance (if appropriate).
e. Evidence of GCP Compliance (if appropriate).
f. Evidence of Laboratory Licensure Requirements (if appropriate)
g. Use of Select Agents (if appropriate)
h. All required Representations and Certifications are completed and on file.


The Quad Chart, White Paper and Full Proposal will be evaluated and categorized as follows:


CATEGORY I: Well conceived, scientifically, and technically sound proposals important to program goals and objectives. Proposals in CATEGORY I need not be perfect; minor revisions may be addressed during negotiations. Proposals in CATEGORY I are recommended for acceptance subject to government needs and funds availability.


CATEGORY II: Scientifically sound proposals important to program goals and objectives that require significant revision in order to be appropriate for acceptance subject to funds availability. CATEGORY II proposals have a lower priority than CATEGORY I.


CATEGORY III: Proposals that are either not technically sound or do not meet program goals and objectives. CATEGORY III proposals have the lowest priority and will be rejected.


Offerors selected for negotiations may be subject to inspections of their facilities and Quality Assurance/Quality Control (QA/QC) capabilities. The decision to inspect specific facilities will be made by the Project Officer in coordination with the Contracting Officer. If inspections are performed during the negotiations, the results of the inspection will be considered in final selection for award of a contract. Offerors, including proposed subcontractors, will be requested to make all non-proprietary records, including previous regulatory inspection records, and staff available in response to a pre-award site visit or audit by BARDA or its designee. Pre-award site visits may be made with short notice. Offerors are expected to guarantee the availability of key staff or other staff determined by the Government as essential for purposes of this site visit.


B. Past Performance Information
Past performance information will be evaluated to the extent of determining the Offerors ability to perform the contract successfully. Offerors shall submit the following information as part of their proposal.


The Offeror shall provide a list of the last three (3) government contracts during the past three years and all contracts currently being performed that are similar in nature to the BAA work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Offerors may also submit past performance information regarding predecessor companies, key personnel who have relevant experience or subcontractors that will perform major or critical aspects of the requirement when such information is relevant to the instant acquisition. For the purposes of this BAA, a "major subcontract" is defined as a subcontract that exceeds $25,000.


Include the following information for each contract or subcontract listed:
1. Name of Contracting Organization
2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number)
3. Contract Type
4. Total Contract Value
5. Description of Requirement
6. Contracting Officer's Name and Telephone Number
7. Program Manager's Name and Telephone Number
8. North American Industry Classification System Code


The Offeror may provide information on problems encountered on the identified contracts and the Offeror's corrective actions.


The Government is not required to contact all references provided by the Offeror. Also, references other than those identified by the Offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the Offeror's past performance.

Part VI: Special Instructions
Special instructions will be posted as amendments to the BAA on FedBizOps when they become apparent. Please monitor this solicitation on FedBizOps for future special instructions and other amendments.

Part VII: Attachments
Attachment 1: Technology Readiness Level (TRL) Criteria
Criteria have been identified for each Area of Interest. Offerors must identify in their Quad Chart and White Paper that such criteria have been met for the proposed medical countermeasure product. Three different Technology Readiness Level (TRL) criteria are provided in this attachment.



Attachment 1A: Draft Technology Readiness Level Definitions for Medical In-Vitro Diagnostic Devices, may be used for Area of Interest #2: Clinical Influenza Test Systems and Diagnostic Tools.


Attachment 1B: Department of Defense Technology Readiness Assessment Deskbook, Appendix E. Biomedical Technology Readiness Levels (TRLs) may be used for Area of Interest #1: Personal Protective Equipment and Full-Featured Continuous Ventilators for Influenza Infection & All-Hazards and Area of Interest #2: Clinical Influenza Test Systems and Diagnostic Tools.


Attachment 1A: Draft Technology Readiness Level (TRL) Definitions for Medical In-Vitro Diagnostic Devices


FOR USE WITH AREA OF INTEREST 2



Notice: This document does not serve as official FDA Guidance nor does it represent the Agency's current thinking on this topic. For the purposes of a regulatory application seeking licensure/approval, additional data may be required by FDA.



TRL 1 Basic Research
Generation of scientific knowledge of fundamental phenomena. Findings are peer reviewed and serve as foundation for new technologies.
Decision Criteria: Literature reviews, market surveys, White Papers.


TRL 2 Basic Invention
Intense focus on experimental designs for possible application of scientific approach to a specific problem.
Decision Criteria: Hypothesis-based research and development efforts. Research plans and protocols are developed, peer-reviewed, and approved for funding. Design controls instituted.
TRL 3 Initial Validation of Analytical Components
Basic hypothesis-based research, data collection analysis to test hypothesis and explore alternatives. Initial test of design concepts. Critical components defined and tested independently (the term component is defined in 820.3(c)). Product design and development plan drafted.
Decision Criteria: Initial proof of concept for device demonstrated in a limited number of laboratory experiments; may use surrogate or spiked samples.


TRL 4 Transition from Research to Development
Non-GLP research to define parametric data required for assessment. Initial specifications for device, systems, and subsystems determined. Device evaluation at in-house laboratories. Procedures and methods to be used during non-clinical, pre-clinical, and clinical studies in evaluating devices and systems are identified. Potential safety problems identified through risk analysis. Ad hoc hardware in a laboratory. Basic software as applicable.
Decision Criteria: Proof of concept demonstrated for devices with laboratory procedures defined. Feasibility data collected to identify a diagnostic target or signal that will be of value in diagnosis of biothreat agents.


AT THIS POINT (IF NOT SOONER), THE FDA SHOULD BE CONTACTED FOR PRE- IDE MEETINGS TO DISCUSS PRDUCT INTENDED USE, ANALYTICAL/CLIICAL STUDY DESIGNS AND REGULATORY STRATEGY RE: NEED FOR AN IDE, PRE-MARKET APPLICATION (PMA OR 510K), AND PRODUCT DEVELOPMENT PROTOCOLS (PDP)


TRL 5 Product Development/ Begin Design Controls
Assessment of existing diagnostic modalities and how the new device relates to these other approaches. Intended use and indications for use defined. Tissue, organ, or body fluid spiked samples are evaluated. Suppliers and service providers qualified and type and extent of control defined. Purchasing assessment and receiving acceptance to ensure that products and services are acceptable for their intended use defined and balanced. Components integrated and tested as systems and subsystems.
Decision Criteria: Devices tested through simulations. Pre-IDE submitted to and reviewed by FDA-CDRH to determine if analytical and clinical evaluations proposed are appropriate for intended use.


TRL 6 Pre-Clinical / In-House Testing
Demonstrate analytical and functional characteristics of the device in a controlled laboratory setting, and initiate testing on appropriate clinical samples. Initiate validation master plan for critical processes and prepare final assembly of components. Manufacturing personnel participate in the design process up front to facilitate transfer of design to manufacturing.
Candidate Diagnostic Device: Analytical performance assessed (including analytical sensitivity, in-house precision, and analytical specificity) by testing real or simulated samples of interest.
IDE Ready: A full package, including the clinical evaluation protocol, is prepared for submission to the FDA (if a significant risk device study), for submission to an IRB (if a non-significant risk device study), or for submission to an IRB (if waived according to FDA exemptions from IDE requirements 812.2(c)(3)).
Decision Criteria: Evidence supports proceeding to pre-clinical studies.

TRL 7 Investigational Phase
Functional and pre-clinical testing begun with fully integrated device (systems and subsystems). Manufacturing process is validated and initial production units used for final design verification and validation activities. Continued interactions with FDA-CDRH.
Decision Criteria: Pre-clinical and functional testing completed. Design verification completed for the final product. Initial commercial scale devices are produced; release criteria established. Preliminary data collected and presented and discussed with CDRH. IDE submitted and approved by FDA-CDRH as applicable (21 CFR Part 812).


TRL 8 End of System Development; Use in Actual Setting with Clinical Samples
Clinical evaluations implemented for assessing diagnostic accuracy of device for its intended use. Risk/benefit for use of device is assessed. Data in support of product labeling for directions-for-use is established; any needed lot consistency/reproducibility studies completed. Design locked final review and approval prior to final transfer to manufacturing. Pre-Market Approval (PMA) and/or 510(k) application to FDA-CDRH submitted.
Decision Criteria: Approval of the PMA or as applicable clearance of the 510(k) by FDA-CDRH.


TRL 9 Used in Clinical Settings with Clinical Samples, Post-Market Studies or Data Collection as applicable
When appropriate, post-marketing surveillance data collection studies to monitor device performance under broader conditions for use.
Decision Criteria: None - continued surveillance. Corrective and Preventive Action Program to monitor performance.


Attachment 1B: Department of Defense Technology Readiness Assessment Deskbook
FOR USE WITH AREA OF INTEREST 1 & 2


The entire TRA Handbook can be accessed at:
http://www.dod.mil/ddre/doc/DoD_TRA_July_2009_Read_Version.pdf (verified 4/25/2011)
TRA Deskbook, Appendix E. Biomedical Technology Readiness Levels, Pages E3-E26:


 


 


 


 









 


 


 


 


Attachment 2: Full Proposal Volume II - Breakdown Of Proposed Estimated Cost (Plus Fee) And Labor Hours


INSTRUCTIONS FOR USE OF THE FORMAT


1. This format has been prepared as a guideline. It may require amending to meet the specific requirements of this BAA. If this BAA is phased, identify each phase in addition to each year. Total each year, phase, and sub-element.


2. This format shall be used to submit the breakdown of all proposed estimated cost elements. List each cost element and sub-element for direct costs, indirect costs and fee, if applicable. In addition, provide detailed calculations for all items. For example:


a. For all personnel, list the skill / labor category, rate per hour and number of hours proposed. If a pool of personnel is proposed, list the composition of the pool and how the cost proposed was calculated. List the factor used for prorating Year One and the escalation rate applied between years.


Offeror's proposal should be stated in the same terms as will be used to account for and record the effort under a contract. If percentages of effort are used, the basis to which such percentages are applied must also be submitted by the Offeror. The attached format should be revised to accommodate direct labor proposed as a percentage of effort.


b. For all materials, supplies, and other direct costs, list all unit prices, etc., to detail how the calculations were made.
c. For all indirect costs, list the rates applied and the base the rate is applied to.
d. For all travel, list the specifics for each trip.
e. For any subcontract proposed, submit a separate breakdown format.
f. Justification for the need of some cost elements may be listed as an attachment, i.e., special equipment, above average consultant fees, etc.


3. If the Government has provided "uniform pricing assumptions" for this BAA, the Offeror must comply with and identify each item.


4. It is requested that you use the spreadsheet that is provided below to prepare your business proposal. For security purposes, please include a hard copy of the completed spreadsheet and submit the electronic file on a diskette with your proposal.


 


BREAKDOWN OF PROPOSED ESTIMATED COST (PLUS FEE) AND LABOR HOURS
COST ELEMENT Year 1 Year 2 Year 3 Year 4 Year 5
Labor Category (Rate / Hours) (Rate / Hours) (Rate / Hours) (Rate / Hours) (Rate / Hours) Total





DIRECT LABOR COST: $ $ $ $ $ $
MATERIAL COST: $ $ $ $ $ $
TRAVEL COST: $ $ $ $ $ $
OTHER (Specify) $ $ $ $ $ $
OTHER (Specify) $ $ $ $ $ $
TOTAL DIRECT COST: $ $ $ $ $ $
FRINGE BENEFIT COST:
(if applicable)
% of Direct Labor Cost $ $ $ $ $ $
INDIRECT COST:
% of Total Direct Cost $ $ $ $ $ $
TOTAL COST: $ $ $ $ $ $
FIXED FEE:
(if applicable)
% of Total Est. Cost $ $ $ $ $ $

GRAND TOTAL ESTIMATED CPFF) $ $ $ $ $ $

Attachment 3: Summary of Related Activities
The following specific information must be provided by the Offeror pertaining to the Project Director, Principal Investigator, and each of any other proposed key professional individuals designated for performance under any resulting contract.


a. Identify the total amount of all presently active federal contracts/cooperative agreements/grants and commercial agreements citing the committed levels of effort for those projects for each of the key individuals* in this proposal.


Professional's Name and Title/Position:


Identifying Number Agency Total Effort Committed


1.
2.
3.
4.
*If an individual has no obligation(s), so state.


b. Provide the total number of outstanding proposals, exclusive of the instant proposal, having been submitted by your organization, not presently accepted but in an anticipatory stage, which will commit levels of effort by the proposed professional individuals*.


Professional's Name and Title/Position:


Identifying Number Agency Total Effort Committed
1.
2.
3.
4.
*If no commitment of effort is intended, so state.


c. Provide a statement of the level of effort to be dedicated to any resultant contract awarded to your organization for those individuals designated and cited in this proposal.


Name Title/Position Total Proposed Effort


1.
2.



Attachment 4: Government Notice for Handling Proposals


NOTE: This Notice is for the Technical Evaluation Review Panel who will be reviewing the proposals submitted in response to this BAA. THE OFFEROR SHALL PLACE A COPY OF THIS NOTICE BEHIND THE TITLE PAGE OF EACH COPY OF THE TECHNICAL PROPOSAL.


This proposal shall be used and disclosed for evaluation purposes only, and a copy of this Government notice shall be applied to any reproduction or abstract thereof. Any authorized restrictive notices which the submitter places on this proposal shall be strictly complied with. Disclosure of this proposal outside the Government for evaluation purposes shall be made only to the extent authorized by, and in accordance with, the procedures in HHSAR 352.215-1.


(f) If authorized in agency implementing regulations, agencies may release proposals outside the Government for evaluation, consistent with the following:


(1) Decisions to release proposals outside the Government for evaluation purposes shall be made by the agency head or designee;


(2) Written agreement must be obtained from the evaluator that the information (data) contained in the proposal will be used only for evaluation purposes and will not be further disclosed;


(3) Any authorized restrictive legends placed on the proposal by the prospective Contractor or subcontractor or by the Government shall be applied to any reproduction or abstracted information made by the evaluator;


(4) Upon completing the evaluation, all copies of the proposal, as well as any abstracts thereof, shall be returned to the Government office which initially furnished them for evaluation; and


(5) All determinations to release the proposal outside the Government take into consideration requirements for avoiding organizational conflicts of interest and the competitive relationship, if any, between the prospective Contractor or subcontractor and the prospective outside evaluator.


(g) The submitter of any proposal shall be provided notice adequate to afford an opportunity to take appropriate action before release of any information (data) contained therein pursuant to a request under the Freedom of Information Act (5 U.S.C. 552); and, time permitting, the submitter should be consulted to obtain assistance in determining the eligibility of the information (data) in question as an exemption under the Act. (See also Subpart 24.2, Freedom of Information Act.)



Attachment 5: Quad Chart and White Paper Format Template


I. Quad Chart Template
A quad chart that contains the following information must be included in Volume III, Supplemental Information, of the Phase II Full Proposal and must be positioned in a landscape view. Any quad chart submitted that exceeds the one-page limit will not be read or evaluated. Please note that the Title of the Project should be different than that of the Topic.


TITLE OF PROJECT, RESEARCH AREA ADDRESSED, PROGRAM DIRECTOR/MANAGER, COMPANY NAME


Objective: Clear, concise (2-3 sentences) description of the objectives and methodologies of the effort.


Description of effort: A bullet list (2-3) of the primary scientific challenges being addressed


Picture or Graphic that Illustrates the research or concept (e.g. data figures, molecule illustrations or processes)
Benefits of Proposed Technology:


Challenges:


Maturity of Technology:


Bullet list of the major goals/milestones by Project Year


Proposed Funding
Base year cost plus each option year (no more than 5 years total)
Contact Information (name, email, phone)


White Paper Technical Information:


1. In general, the white paper should provide a brief technical discussion of the Offeror's objective, approach, level of effort, and the nature and extent of the anticipated results. Specifically, the white paper should include, at a minimum, the following core elements:
a. brief discussion on how the proposed countermeasure
aligns with the objectives of the National Strategy for Pandemic Influenza and other federal government planning documents.
b. a clear, concise development plan for licensure that includes all
non-clinical, clinical, manufacturing, and regulatory activities
required for the proposed countermeasure.
c. a high-level Gantt chart showing an overview of the proposed activities and timelines.
d. a brief description of the Offerers intellectual property
ownership of the proposed countermeasure.
e. overview of Offeror's capabilities and experience (past and current) as they relate to the proposed program.
2. The cost portion of the White Paper shall contain a 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.

Attachment 6: Target Product Profile Template
The success of a product development program requires a relentless focus on the desired characteristics of the resulting medical countermeasure product. During Stage 2, in addition to the Full Proposal, Offerors are requested to provide a Target Product Profile. The template immediately below is as a tool for Offerors to describe the objectives of their advanced research and development activities, and to update dynamically as supporting data about their product is obtained. All Offerors are encouraged to submit a Target Product Profile for the proposed medical countermeasure, with a particular focus on elements 1-4. For those products for which the Target Product Profile format is not applicable, appropriate equivalent information regarding the research objectives should be provided.


Target Product Profile: Product Name
Milestone
(meeting or submission)
Date
*TPP Submitted? Y/N TPP Version Date
TPP Discussed?
Y/N
Pre-IDE
IDE Submission
510(k) or PMA
Other (specify)

1 Indications and Usage
Target Annotations
A statement that the medical device is indicated in the treatment, prevention, or diagnosis of a recognized disease or condition, OR
A statement that the medical device is indicated for the treatment, prevention, or diagnosis of an important manifestation of a disease or condition, OR
A statement that the medical device is indicated for the relief of symptoms associated with a disease or syndrome, OR
A statement that the medical device is indicated for a particular indication only in conjunction with a primary mode of therapy
Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date
When listing studies, consider:
The intent to develop evidence to support safety and efficacy in selected subgroups (i.e., limitations of use)
Tests needed for selection or monitoring of patients (i.e., susceptibility tests)
Whether safety considerations require the medical device to be reserved for certain situations (i.e., in refractory patients)
Whether the medical device is to be used on a chronic basis
What evidence will be developed to support comparator statements regarding safety or effectiveness

Comments:


2 Dosage and Administration
Target Annotations
For each indication, state the following:
Usage
Recommended timing and/or intervals
Proceduresfor usage to be safe and effective
Exposure (dose- or blood level-response relationship, if any)
Usage intervals or titration schedule
Usual duration of illness
Usage adjustments (e.g., in specific genotypes, pediatric patients, geriatric patients, or patients with renal or hepatic disease)
Limitations for usage Summary information regarding completed or planned studies to support the safety and effectiveness of the proposed usage:
Protocol #, Serial #, Submission date

Comments:

3 Contraindications
Target Annotations
List situations in which the product might be contraindicated, including:
Increased risk of harm because of age, sex, concomitant therapy, disease state
Adverse events which would limit use
Known, not theoretical, hazards Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date
Or, literature references describing contraindication for product class.
Comments:

4 Warnings and Precautions
Target Annotations
Include a description of clinically significant adverse events and potential safety hazards and limitations of use because of safety considerations, as reasonable evidence of these issues is established or suspected during the drug development program. A causal relationship need not be demonstrated.
Include information regarding any special care to be exercised for safe use, including precautions that are not required under any other section of the label.
Identify any laboratory tests helpful in following the patient's response or in identifying possible adverse reactions. Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date
Or, literature references describing significant adverse reactions shared by the drug class of the new drug.
Comments:

5 Adverse Events
Target Annotations
Describe overall adverse reaction profile of the product based on entire safety database. List adverse events that occur with the product and with products in the same related class, if applicable. Within a listing, adverse events should be categorized by body system, severity, or in order of decreasing frequency, or by a combination of these, as appropriate. Within a category, adverse events should be listed in decreasing order of frequency.
Include the studies in the development program that will address adverse events associated with a particular product class. Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date

Comments:


6 Product Interactions
Target Annotations
Describe clinically significant interactions, either observed or predicted (e.g.,., prescription drugs or over-the-counter drugs, class of drugs, or foods such as grapefruit juice or dietary supplements); practical advice on how to prevent drug-drug interactions; (description of results from studies conducted or observations from the integrated safety summary); drug-laboratory test interactions (known interference of drug with lab test outcome). Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date

Comments:

7 Use in Specific Populations
Target Annotations
Consider the following:
Limitations, need for monitoring, specific hazards, differences in response, or other information pertinent to the population. Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date
If there are no plans to study the product in a specific population, include rationale.

Comments:

8.1 Pregnancy (This subsection can be omitted if the drug is not absorbed systemically):
Teratogenic effects: Pregnancy Categories: A, B, C, D, X
Nonteratogenic effects: Other effects on reproduction, the fetus, or newborn.
8.2 Labor and Delivery: Use during labor or delivery, effects on mother, fetus, duration of labor, delivery, and effects on later growth of newborn.
8.3 Nursing Mothers: If the drug is absorbed systemically, information about excretion of drug in human milk and effects on the nursing infant. Describe pertinent adverse events in animal offspring or tumorigenicity potential if it is detected or suspected.
8.4 Pediatric Use: Statements relevant to the use of the drug product in the pediatric population (birth to 16 years of age). Cite any limitations, need for monitoring, specific hazards, differences in response, or other information pertinent to the pediatric population.
8.5 Geriatric Use: Statements relevant to the use of the drug product in the geriatric population (age 65 and older). Cite any limitations, need for monitoring, specific hazards, differences in response, or other information pertinent to the referenced population.
8.6 Additional Subsections: Use of product in other specified populations (e.g., those with renal or hepatic impairment).

9 Description
Target Annotations
Include the proprietary name and established name, conditions of use, qualitative and quantitative reagent ingredients, critical componentsand any other important physical and chemical characteristics. Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date

Comments:

10 Clinical Studies
Target Annotations
Provide a description of studies that support statements about the efficacy or safety benefits. Consider including a description of supporting tables and graphs. Summary information about completed or planned studies regarding the intent to develop evidence to support benefits of treatment (i.e., safety or efficacy benefits of primary or secondary endpoints in the selected population):
Protocol #, Serial #, Submission date
Measurement instruments (e.g., patient-reported outcomes instrument) and references to supporting development and validation documentation
Also consider including where the studies will be (or have been) run (i.e., geographical area).

Comments:

11 References - Can include when labeling must summarize or otherwise rely on recommendation by authoritative scientific body, or a standardized methodology, scale, or technique, because information is necessary for safe and effective use.


 



12 How Supplied/Storage and Handling
Target Annotations
Include information about the available product forms to which the labeling will apply and for which the manufacturer or distributor will be responsible. For example:


Special handling and storage conditions Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date

Comments:

13 Patient Counseling Information
Target Annotations
Include information for prescribers to convey to patients. For example:


Proper use and disposal of syringes and needles
Adverse events reasonably associated with use of the product
Lab tests and monitoring required
Indicate whether a Patient Package Insert or MedGuide are planned. Summary information regarding completed or planned studies to support the target:
Protocol #, Serial #, Submission date

Comments:


1. This guidance has been prepared by the Office of New Drugs in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration.
2. For the purposes of this guidance, all references to product include in vitro diagnostic and other device products.
3. To make sure you have the most recent information on the federal laws and regulations governing medical devices, check the CDRH Web page at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm.
http://www.fda.gov/MedicalDevices/default.htm


Attachment 7: BAA Instruction Language for Earned Value Management (EVM)
For the purposes of preparing both a Technical and Business Full Proposal under the BAA, the Contractor shall propose and provide performance measurement data and analysis. Contractor can use the Seven Principles of Earned Value Management as a guideline. The Seven Principles are:
1. Plan all work scope for the program to completion of the contract.
2. Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule, and cost objectives.
3. Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be measured. Control changes to the baseline.
4. Use actual cost incurred and recorded in accomplishing the work performed.
5. Objectively assess accomplishments at the work performance level.
6. Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.
7. Use Performance Based information in the company's management processes.


In addition, within the Technical Volume of the Full Proposal, the Offeror(s) shall as stated in the BAA develop a Work Breakdown Structure (WBS) to an appropriate level and a WBS dictionary which lists and defines the WBS elements that also is inclusive of the applicable EVM requirements.
Contractors required to provide Earned Value Management to their project can obtain additional instruction from the 7 Principles of EVM Intent Guide.


The Offeror shall anticipate the following EVM requirements and deliverables to be contained within a potential contract with BARDA under this BAA:


Prime contracts with Educational Institutions are exempt from EVMS.


Tier 1 - Contracts greater than $25M in total value (includes base and options)


Deliverables


Performance Measurement Baseline Review (PMBR) and Documentation
The Contractor shall submit a Performance Measurement Baseline Documentation package for submission to BARDA within 90 days of contract award. This document package will include the following:
a) Description of the work scope through Work Breakdown Structure Dictionary/Work Authorization Documents at WBS Level 3;
b) An Integrated Master Schedule (IMS) with the inclusion of agreed major milestones;
c) A control account plan (CAP) for all control accounts;
d) Baseline revision documentation and program logs;
e) And a risk register.


BARDA will review the documentation package and provide written comments and questions to the contractor or BARDA may set up a meeting to discuss open issues. Once final clarifications and responses have been exchanged, BARDA will execute a formal approval of the Performance Measurement Baseline.


Earned Value Contract Performance Report (EV-CPR)
a) The Contractor shall deliver an Earned Value Contract Performance Report (EV-CPR) on monthly basis per the instruction in DI-MGMT-81466A (see http://www.acq.osd.mil/pm/). Contractor shall provide preliminary EV-CPR, Format 1, WBS reporting Level 3 summarized up to Level 1 of the WBS on the 15th business day after end of Contractor reporting period and final EV-CPR and Format 1 and Format 5 (VARs) and a supplemental Control Account Plan (CAP) report on the 20th business day after end of Contractor reporting period. The variance narrative reports shall describe what the variance and indices may be indicating regarding the overall performance, the reasons for the variances, the adequacy of corrective action plans, and forecasts of future performances. The USG shall use best efforts to respond within 5 business days.


b) The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted cost of work performed (BCWP)) and actual costs of work performed (ACWP) as captured in Contractor's EVM systems. The contractor shall provide a rational in the package of its use of % complete as EVMS methodology or identify if any other EVMS methodology is being used.


Integrated Master Schedule (IMS)
The Contractor shall deliver the Integrated Master Schedule (IMS) status with performance data and should include actual start/finish and projected start/finish dates. The status schedule should be delivered 10 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. The Contractor shall deliver the Integrated master Schedule, viewed at the work package level in MS Project file format


Risk Register
The Contractor shall provide 90 days after contract award and quarterly or as needed thereafter. The Contractor shall incorporate the work proposed to meet the technical objectives (above) into the program risk register highlighting potential problems and/or issues that may arise during the life of the contract, their impact on cost, performance and timelines, and appropriate remediation plans.


Tier 2 - Contracts between $10M and $25M in total value (includes base and options)


Deliverables


Monthly Performance Metrics Report
The contractor shall deliver a monthly Performance Metrics Report. The report shall have two formats:


Format 1 - Work Breakdown Structure Performance Metrics
The contractor shall provide both monthly and cumulative metrics data (Work Scheduled (in dollars), Work Accomplished, and Actual Costs) for WBS reporting Level 3 summarized up to Level 1 of the WBS. Work scheduled (difference between the Work Scheduled and the Work Accomplished) and Cost (difference between Work Accomplished and Actual Costs). For each WBS reporting leg there will also be a requirement to provide the Work Scheduled Budget at Completion and the Estimated Cost at Completion. Management Reserve and Undistributed budget should also be included.

Format 2 - Explanations and Problem Analysis
Contractor will provide written discussion to include but not limited to:
Summary Analysis
Summary of overall Contract Variances


Analysis of Significant Variances (identify and describe each at Level 2)
Type and Magnitude of Variance
Explanation of Significant Reasons
Impact on Immediate Task and Project
Corrective Actions Taken or Planned


Integrated Master Schedule (IMS)
The Contractor shall deliver the Integrated Master Schedule (IMS) status with performance data and should include actual start/finish and projected start/finish dates. The status schedule should be delivered 10 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; WBS #, Control Account #, Activity # (if different from WP#), task name, baseline start and finish, forecast start and finish; actual start and finish, predecessor and/or successor. The Contractor shall deliver the Integrated master Schedule, viewed at the work package level in MS Project file format.


The Offeror is responsible for including the above EVM requirements (Depending on whether or not Tier 2 or 3 EVM requirements are applicable to a contract), and potential contractual requirements and deliverables within the total proposed amount contained in the Business Volume of the Full Proposal submitted under this BAA.


If the Offeror has specific questions related to these EVM requirements, please contact the Contracting Officer (CO) that is identified in the letter of invitation for the Full Proposal submission. The cognizant CO can then forward any EVM questions to the BARDA EVM specialist and provide back answers and clarifications.


Risk Register
The Contractor shall provide 90 days after contract award and quarterly or as needed thereafter. The Contractor shall incorporate the work proposed to meet the technical objectives (above) into the program risk register highlighting potential problems and/or issues that may arise during the life of the contract, their impact on cost, performance and timelines, and appropriate remediation plans.


GLOSSARY OF EVM TERMS
Actual Cost of Work Performed (ACWP) The costs actually applied and recorded in accomplishing the work performed within a specified period.

Baseline (See Performance Measurement Baseline).

Budget at Completion (BAC) The sum of all budgets (BCWS) allocated to the contract. Synonymous with the term Performance Measurement Baseline.

Budgeted Cost for Work Performed (BCWP) The sum of the budgets for completed Work Packages and completed portions of open Work Packages, plus the appropriate portion of the budgets for level of effort and apportioned effort (Also see Earned Value).
Control Account A management control point at which actual costs can be accumulated and compared to budgeted cost for work performed. A control account is a natural control point for cost/schedule planning and control since it represents the work assigned to one responsible organizational element on one contract work breakdown structure (CWBS) element.

Control Account Manager (CAM) A member of a functional organization responsible for task performance detailed in a Control Account and for managing the resources authorized to accomplish the tasks.

Control Account Plan (CAP) Report A CAP report is a time phased report which reflects all the work and effort to be performed in a control account. The CAP report will reflect the hours and dollars by element of cost (labor, subcontract, ODC, etc).


Contract Performance Report (CPR) The monthly report submitted to the customer showing the current, cumulative and at completion status, the performance measurement baseline, manpower loading, and a narrative explanation of significant program variances.

Contract Target Cost The dollar value (excluding fee or profit) negotiated in the original contract plus the cumulative cost (excluding fee or profit) applicable to all definitized changes to the contract. It consists of the estimated cost negotiated for a cost plus fixed fee contract and the definitized target cost for an incentive contract. The contract target cost does not include the value of authorized/un-negotiated work, and is thus equal to the contract budget base only when all authorized work has been negotiated/definitized.

Earned Value See Budgeted Cost for Work Performed (BCWP)

Earned Value Management System (EVMS) A project management system utilized for measuring project progress in an objective manner. Combines measurements of scope, schedule, and cost in a single integrated system.


Estimate at Completion (EAC) A value (expressed in dollars and/or hours) developed to represent a realistic appraisal of the final cost of tasks when accomplished. It's the sum of direct & indirect costs to date plus the estimate of costs for all authorized Work remaining. The EAC = ACWP + the Estimate-to-Complete.

Estimate to Completion (ETC) A value (expressed in dollar and/or hours) developed to represent a realistic appraisal of the cost of the work still required to be accomplished in completing a task.

Integrated Master Schedule (IMS) The IMS expands the IMP to the work planning level. It defines the tasks, their durations, milestones, milestone dates which relate to the IMP completion criteria, and interdependencies required to complete the program. The IMP and IMS are used to track and execute the program.

Negotiated Contract Target Cost The estimated cost negotiated in a Cost Plus Award Fee (CPAF), Cost Plus Fixed Fee (CPFF), Cost Plus Incentive Fee (CPIF) or Fixed Price Incentive Fee (FPIF) contract.


Performance Measurement
Baseline (PMB) The time-phased budget plan against which contract performance is measured. It is formed by the budgets assigned to scheduled Control Accounts and the allocation of overhead costs. For future effort, not planned to the Control Account level, the performance measurement baseline also includes budgets assigned to higher level WBS elements, and undistributed budgets. It equals the total assigned budget less management reserve.

Risk Register Is a tool commonly used in project planning and organizational risk assessments. It is often referred to as a Risk Log. It is used for identifying, analyzing and managing risks.

Variance Analysis Report (VAR) The internal report completed by the Control Account Manager and submitted, through the Intermediate Manager, to the program manager for those Control Accounts which have variances in excess of established thresholds.


Work Authorization Document (WAD) A form used to formally authorize and budget work to the Control Account Manager. This document must include, as a minimum, the Control Account number, Statement of Work, scheduled start and finish dates, budget, and the identity of the CAM. It must be approved by Intermediate Manager, and be agreed to by the Control Account Manager.


 

:
Office of the Assistant Secretary for Preparedness & Response (ASPR)
Department of Health and Human Services
330 Independence Ave. SW
G640
Washington, District of Columbia 20201
United States
:
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, District of Columbia 20201
United States
:
Flu-BAA@hhs.gov