DRIVe_EZ_BAA_-_Amendment_0004.pdf

U.S. Department of Health and Human Services Office of the Secretary for Preparedness and Response

Office of Biomedical Advanced Research and Development Authority (BARDA) Division of Research, Innovation, and Ventures (DRIVe)

Easy Broad Agency Announcement (EZ-BAA)

Title: DRIVe EZ-BAA Solicitation Number: BAA-18-100-SOL-00018 (rev. 4/19/2019)

200 C Street SW Washington, DC 20201

Table of Contents (TOC)

I. INTRODUCTION

II. OVERVIEW INFORMATION

A. Agency and Issuing Office B. Objective C. Announcement Type and Date D. Eligible Respondents E. Number of Awards F. Type of Award

III. Submission Process A. EZ-BAA DRIVe Portal Instructions B. DRIVe EZ-BAA Pre-proposal Teleconference C. Abstract Instructions Section 1 – Preparation and Abstract Section 2 – Abstracts must include the following components Section 3 – Abstract Handling and Submission Information Section 4 – Review of Abstracts Section 5 – Review Definitions

IV. Contact Information V. Limitation on Communication after Submission VI. Special Instructions VII. Areas of Interest (AOI) VIII. Reporting Requirements and Deliverables A. Reports B. Meetings C. Program Management Plans and Documentation

IX. Additional Information

I. INTRODUCTION

This Easy Broad Agency Announcement (EZ-BAA), which sets forth areas of interest (AOI) for the Division of Research, Innovation and Ventures (DRIVe) in the Office of Biomedical Advanced Research and Development Authority (BARDA), is issued under paragraph 6.102(d)(2)(i) of the Federal Acquisition Regulation (FAR). Abstracts selected for award are considered to be the result of full and open competition and in full compliance with 41 U.S.C. § 3301. A formal Request for Abstract will not be issued. Paper copies of this announcement will not be issued.

The U.S. Government reserves the right to select for award and fund all, some, or none of the abstracts in response to this announcement. All abstracts will be treated as sensitive competitive information and the contents only disclosed for the purposes of evaluation to authorized personnel. Other data you provide (e.g., general location, business size and type) may be displayed in aggregate reports but will not identify your organization specifically.

The mission of the US Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st Century health security threats. Within ASPR, BARDA was established to aid in securing our nation from chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza and emerging infectious diseases. BARDA supports the transition of medical countermeasures such as vaccines, drugs, diagnostics, and medical devices from research through advanced development towards consideration for approval by the Food and Drug Administration (FDA) and inclusion into the Strategic National Stockpile (SNS). BARDA’s support includes providing funding, technical assistance, and core services. To date, BARDA’s support has resulted (or led to) 43 FDA approvals for 32 unique products addressing CBRN, pandemic influenza, and emerging infectious disease threats.

Today we face new health security threats that require breakthrough solutions. ASPR under HHS has charged BARDA with launching DRIVe to accelerate innovations, and improve the availability of transformative countermeasures to protect Americans from natural and intentional health security threats. DRIVe’s Mission is to accelerate innovations, and improve availability of transformative countermeasures to protect Americans from natural and intentional health security threats.

Additional information about DRIVe can be found at www.drive.hhs.gov.

http://www.drive.hhs.gov/

II. OVERVIEW INFORMATION

A. Agency and Issuing Office

U.S. Department of Health and Human Services (HHS) Office of the Secretary (OS) Office of the Assistant Secretary for Preparedness and Response (ASPR) Office of Biomedical Advanced Research and Development Authority (BARDA) Division of Research, Innovation and Ventures (DRIVe)

200 C Street SW Washington, DC, 20201

B. Objective

This DRIVe EZ-BAA aims to accelerate innovations and improve the availability of transformative products and technologies to protect Americans from natural and intentional health security threats. DRIVe is seeking abstracts for efforts to develop revolutionary health security products, technologies and innovations in order to increase the Government’s capability and capacity to respond to national security health threats. DRIVe is seeking unconventional approaches that are outside the mainstream, challenge assumptions, require multi-disciplinary teaming, and have the potential to radically change established practice, lead to extraordinary outcomes, and create entirely new fields.

Specifically excluded is research or innovations that primarily result in incremental improvements to the existing state of the art.

The projects awarded under this DRIVe EZ-BAA may be at varying stages of technological readiness and prototype development. DRIVe is interested in projects that span the entire development spectrum and are hyper-focused on the specific Areas of Interest (AOI) described in the Areas of Interest (AOI) of this EZ-BAA. Respondents may propose feasibility demonstration, non-clinical development, prototype and process development, formulation, engineering, fabrication, model development, data science and development of novel algorithms, descriptive clinical studies, regulatory activities, etc. Areas of Interest (AOI) of this announcement provides more details.

The total proposed value including fees of any effort awarded under this EZ-BAA shall not exceed $749,000. Abstracts exceeding this amount will be considered non-responsive and not evaluated, and notified thereof. DRIVe anticipates a high-volume of abstract submissions, with only a small number of awards.

C. Announcement Type and Date

Type: Broad Agency Announcement (BAA) Date: June 4, 2018 Title: DRIVe EZ-BAA Solicitation Number: BAA-18-100-SOL-00018

Applications may be continuously submitted electronically via www.drive.hhs.gov until November 15th, 2019, at 1500 HRS ET

D. Eligible Respondents

This EZ-BAA is open to all responsible sources. Respondents may include single entities or teams from private sector organizations, Non-Governmental Organizations (NGOs), and academic institutions.

To be eligible for award, the Respondent must be able to demonstrate its ability to achieve the stated goals and objectives in the submitted abstract. The Respondent must have the ability and capacity to perform. More specifically, the Respondent must have at a minimum the financial resources, ability to comply with the performance schedule, satisfactory performance, integrity, organization, experience, operational controls, technical controls, technical skills, facilities, and equipment as required for performance.

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 abstracts and to join other entities as team members in submitting abstracts.

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.

Respondents must be registered in the System for Award Management (SAM) with the appropriate NAICS code prior to submission. Registration can be completed here: https://www.sam.gov/

E. Number of Awards

Multiple awards of various values are anticipated and dependent upon technical importance to agency programs, and funding availability.

https://www.sam.gov/

F. Type of Award

Respondents should submit a cost-share proposal in which the Respondent clearly delineates which costs will be covered by the Respondent and which of those will be covered by the Government. The amount of cost participation should depend on the extent to which the R&D effort or results are likely to enhance the Respondent’s capabilities, expertise, or competitive position. The target cost-share range is 30- 50% by the Respondent

If the Government contemplates the award of a cost-reimbursement type contract, the Respondent must demonstrate prior to award that its accounting system is adequate for administering a cost-reimbursement contract.

During negotiations a decision will be made as to the most appropriate procurement instrument that will be used for a tentative award. Based on the procurement instrument selected, the Respondent may negotiate with either a Contracting Officer (CO), a Grants Officer (GO), or Other Transaction Agreement Officer (OTAO).

Awards under this EZ-BAA may be Cost-Reimbursement, Fixed Price, Cost- Sharing (CS), Other Transactions Agreements (OTA), Grants, or Cooperative Agreements, as authorized for BARDA under the Pandemic and All Hazards Preparedness Reauthorization Act and 21st Century Cures Act.

The expectation is that awards resulting from this BAA will be Cost-Sharing. In the rare circumstance an Respondent doesn’t believe a cost-sharing contract is appropriate, the Respondent may present a written justification as to why there is no probability that Respondent will receive any present or future benefits from an award made under this EZ-BAA pursuant to HHSAR 335.070

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

III. Submission Process

a. EZ-BAA DRIVe Portal Instructions

All applications in response to the DRIVe EZ-BAA must be submitted on the DRIVe Portal via the process described below and on www.drive.hhs.gov. Abstract submissions will not be accepted via physical mail nor email after May 8th, 2019 at 1500 HRS ET.

IMPORTANT: Offerors will be required to apply for a DRIVe Portal account. This account can be requested by visiting the DRIVe Portal site or via the process as described on www.drive.hhs.gov/partner.html and following the applicable prompts.

https://drive.rti.org/ http://www.drive.hhs.gov/ https://drive.rti.org/ http://www.drive.hhs.gov/partner.html

The account request process is simple, but may take up to one business week for approval and access. Account requests will require a Respondent to enter a set of basic information about the organization, including its DUNS number and CAGE code. Upon receipt of a DRIVe Portal account, the Respondent will login using the prescribed two-factor authentication method.

Once login is complete, the Respondent will be prompted to confirm the previously entered information about the organization and to input the abstract submission with other project-specific information.

Failure to submit the application on-time due to late registration will result in the application not being for award. The EZ-BAA will expire on November 15th, 2019 at 1500 HRS ET.

Respondents will be provided automated confirmation of abstract receipt upon successful submission.

b. DRIVe EZ-BAA Pre-proposal Teleconference

A pre-proposal teleconference was held on June 22, 2018, at 2:00PM EDT. This meeting was designed to address any questions associated with the application process. Applicants can visit www.drive.hhs.gov to obtain information on the pre-proposal teleconference.

c. Abstract Instructions

The open period for receipt of abstracts for all areas of interest under the EZ-BAA is from June 4, 2018 to November 15th, 2019 at 1500 HRS ET. Respondents must submit their abstract(s) per the instructions provided below in accordance with Section VI of this solicitation.

Abstract Submission Process

Deadline for Submission

Government Response

Abstract Submission

November 15th, 2019 at 1500 HRS ET

Receipt confirmation within 1 week.

Decision within 30 to 120 days (pending availability of funds)

The Government realizes that the preparation of abstracts often represents a substantial investment of time and effort by a Respondent. While not required, in an attempt to minimize this burden, BARDA DRIVe encourages organizations and individuals interested in submitting abstracts to schedule a call with DRIVe to discuss the general need for the type of R&D effort before expending effort in preparing a detailed proposal or submitting proprietary information.

Requests to schedule a call for the applicable areas of interest may be sent to the following:

AOI #1: Solving Sepsis SolvingSepsis@hhs.gov

AOI #2: ENACT ENACT@hhs.gov

AOI #3: Other Donna.Boston@hhs.gov

Section 1 – Preparation and Abstract

The abstract must be no more than 12,500 characters (approximately 2,000 words) for the Technical component and an additional 12,500 characters for the Cost component, and submitted electronically via the process described on www.drive.hhs.gov.

Abstracts submitted via the process described on www.drive.hhs.gov will be text-based submissions only. No other documents, files, templates, or other items will be authorized for upload or submission as part of abstract.

Section 2 – Abstracts must include the following components:

Technical

Relevance to the identified DRIVe Area of Interest (AOI) Technical Approach o Clearly describe what is being proposed and what difference it will make

(qualitatively and quantitatively).

o Include specific aims/objectives, milestones, deliverables , and success metrics that are expected during the course of the project

Ability to transition technology and expand use of application

Cost

In preparing the cost estimate, please use the EZ BAA Sample Cost Proposal located under the Resources tab on the DRIVe website (HERE), while using the below cost elements as guidance:

a. Direct Labor

Name, position/labor category, annual rate, level of effort

b. Materials, Supplies, and Equipment

Include detailed breakdown when total amount is over $10,000

c. Travel

Identify travelers, number of trips, destination (e.g., city and state), purpose of trip, and total amount. List separately, domestic travel, general scientific meeting travel, and foreign travel.

Travel may be limited or not authorized based on the final negotiated award type

d. Other Direct Costs (ODCs) mailto:SolvingSepsis@hhs.gov mailto:ENACT@hhs.gov mailto:Donna.Boston@hhs.gov http://www.drive.hhs.gov/ https://drive.hhs.gov/files/DRIVe_EZ-BAA_Sample_Cost_Proposal_Final.pdf

Consultants, subcontractors, etc.

e. Total Proposed Cost Abstracts exceeding $749,000 in proposed Government funding will be considered non-conforming and not reviewed

f. Proposed Cost-Share

Clearly delineate what the proposed Respondent cost-share is which can be cash or in-kind contributions. This must be quantified.

The proposed cost elements should include a breakdown for the entire project value, not just the Government’s portion of the cost-share.

As previously mentioned, the $749,000 limitation applies only to the proposed amount of Government funding. It is possible that the total proposed cost (i.e.

Respondent cost-share +Government funding) exceeds $749,000.

More detailed cost proposals may be requested by the CO, GO, or OTAO for those selected for negotiations.

Period of performance (POP) for awards resulting from the EZ-BAA for all Areas of Interest (see Areas of Interest (AOI) will be based on the procurement instrument selected and the specific project requirements (stage of development) under the award. Establishing the POP gives consideration to the unknown or unexpected results of advanced research and development, industry practices, market conditions, and capabilities of small business concerns.

Section 3 – Abstract Handling and Submission Information

Treatment of Submission Documents: All abstracts are treated as the Respondent’s proprietary information prior to award and the contents are disclosed only for the purpose of review. Other data provided (e.g. general location, business size and type) may be displayed in aggregate reports but will not specifically identify your organization.

IMPORTANT: Classified abstracts, in part or in whole, will not be accepted. All submissions must be Unclassified unless coordinated and authorized by a DRIVe CO prior to submission.

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 an Respondent believes a conflict of interest may exist, the situation should be addressed with the Contracting Office by contacting DRIVeContracting@hhs.gov prior to abstract submission. The appropriate Government personnel will discuss any conflict of interest with the Respondent.

Compliant with FAR 37.203(d), input on aspects of the proposals may be provided by non-federal consultants /experts who are strictly bound by the appropriate non-disclosure requirements.

mailto:DRIVeContracting@hhs.gov

Unsuccessful Abstract Disposition: The original copy of each abstract received will be retained by ASPR pursuant to FAR 4.805 and all other non-required copies destroyed.

Section 4 – Review of Submissions

Abstracts shall comply with all requirements detailed in this EZ-BAA. Abstracts that fail to do so will be deemed non-conforming and will not be reviewed.

DRIVe will review each abstract and respond whether DRIVe is interested in the concept. If DRIVe is not interested in the concept, feedback will be provided to the Respondent describing the rationale for the decision. Respondent abstracts which are initially reviewed favorably may be invited to submit additional information explaining the concept. This proposal will be evaluated pursuant to the criteria below. The outcome of that evaluation will ultimately result in an Acceptable or Unacceptable rating, as defined in Section 5 below.

The following are the evaluation factors listed in descending order of importance, pursuant to FAR Part 35. When combined, technical evaluation factors are significantly more important than non-technical evaluation factors.

i. Relevance to identified DRIVe Area of Interest (AOI)

ii. Technical Approach

iii. Ability to transition technology and expand use of application

iv. Cost Realism & Proposed Cost Share

The technical and cost realism evaluations will be conducted through a scientific review process for each conforming abstract.

Past Performance evaluations will be conducted utilizing CPARS and other available government searches. If no relevant past-performance exists, an Respondent will not be negatively impacted and rated as “Neutral” for that component. Cost or price reasonableness evaluations will occur to the extent necessary. In accordance with FAR Part 35, abstracts will not be evaluated against each other since they are not submitted in accordance with a common work statement.

It is the responsibility of the CO, GO, OTAO and COR, OTTR, or other Government technical representatives to be impartial, equitable, and comprehensive when evaluating abstracts.

Abstract evaluations will result in a finding of either Acceptable or Unacceptable, with definitions listed in this BAA.

Section 5 – Review Definitions

Acceptable and Unacceptable are defined as follows:

Acceptable: The submission is within scope of the AOI identified in the EZ-BAA solicitation, illustrates a clear and feasible technical approach, is cost realistic, and is likely to result in achievable or disruptive advancements in the AOI to DRIVe. A finding of Acceptable results in the submission being considered for award and funding based on the appropriate procurement instrument to be determined by the CO, GO, OTAO, subject to successful negotiations and the availability of funding.

Unacceptable: The submission is not within scope of the AOI identified in the EZ-BAA solicitation, does not illustrate a clear and feasible technical approach, is not cost realistic, or is not likely to result in achievable or disruptive advancements in the AOI to DRIVe. A finding of Unacceptable will result in the submission not being considered for award or funding.

IMPORTANT: All Respondents will be notified regarding the status of submissions. The target date for this notification is 30-120 days after receipt of abstract.

IV. Contact Information

Primary Contracting Officer:

Troy Francis Contracting Officer Email – Troy.Francis@hhs.gov

Secondary Point of Contact:

Matthew McCord Contracting Officer Email – Matthew.McCord@hhs.gov

If you have specific questions you may contact a CO above. However, you must submit all inquiries to include contact made with the CO regarding this EZ-BAA to DRIVeContracting@hhs.gov. This is to ensure review and response to all inquiries submitted regarding this EZ-BAA.

V. Limitation on Communication after Submission

Be advised that while you can contact DRIVe before submitting an abstract, the opposite is true after an EZ-BAA abstract has been submitted. After that point, all communications related to that submission must be through the Contracting Officer and only submitted through DRIVeContracting@hhs.gov , which is closely tracked and monitored. All communications in response to a submission will be from the CO, GO, or OTAO as required.

VI. Special Instructions mailto:Troy.Francis@hhs.gov mailto:Francine.Hemphill@hhs.gov

Special instructions may be required and will be advertised via the EZ-BAA solicitation. These additional instructions would be tailored to a specific AOI and may have unique submission and performance requirements.

VII. Areas of Interest (AOI)

DRIVe is soliciting abstracts for technologies and innovations to increase our capability and capacity to respond to national security health threats, with an emphasis on the areas of interest described herein. BARDA DRIVe anticipates that awards made as a result of this EZ-BAA may occur at any stage of development. This EZ-BAA will also serve to advance the knowledge and scientific understanding of platform technologies, inventions, modeling and forecasting, and visual analytics.

DRIVe wants to emphasize revolutionary approaches that are hyper-focused on the areas of interest described herein. DRIVe seeks novel approaches that may not have been applied to the field previously, which could include approaches that are outside the mainstream, and could help populate the health security innovations development pipeline.

For additional information please visit:

Section 301 of the Public Health Service (PHS) Act (42 U.S.C. 241), “Research and Investigations.”

Section 319L of the PHS Act (42 U.S.C. 247d-7e), “Biomedical Advanced Research and Development Authority.”

The DRIVe website: www.drive.hhs.gov

Descriptions of Areas of Interest

1. Early Notification to Act, Control and Treat (ENACT): Through ENACT, DRIVe is seeking technologies and methods to identify, characterize, and broadly adapt biological, biometric, behavioral and physiological signatures that can signal health security threat infections or exposures prior to symptoms.

ENACT areas of interest include discovery and validation of biomarkers and other health signatures, diagnostics suitable for use in the home and on the body, novel sensors and other wearable technologies, cloud-based reporting and data analytics, and disease prediction to empower individuals with early notification to act, control, and treat illnesses.

2. Save lives by Solving Sepsis: DRIVe is seeking technologies and methods to eliminate the effects of sepsis through the development of clinical management strategies, multimodal detection technologies and diagnostic platforms, as well as integrating health analytic technologies, novel biomarkers and predictive platforms. Performers are expected to propose efforts that will achieve a new paradigm for the clinical management of sepsis, identification and application of biological indicators (chemical, physical, molecular, immunological, serological), and diagnostics. Additionally, DRIVe seeks to develop machine and deep learning methods for early identification and intervention in both patient and pre-symptomatic populations. DRIVe is interested in a suite of approaches as an initial investment towards "solving sepsis".

Please consider the following:

Solving Sepsis is interested in medical countermeasures that address sepsis of any etiology (i.e. bacterial, viral, other) versus approaches that are limited to sepsis induced by a subset of pathogens.

Proposed approaches must include demonstration of effectiveness in sepsis relevant models (e.g. utilizing sepsis patient samples, sepsis patient data).

Solving Sepsis aims to mitigate the adverse host response to sepsis and therefore is only interested in host-based approaches when considering development of diagnostics or devices. BARDA has existing programs (outside of these special instructions) for pathogen-targeted approaches.

Solving sepsis is interested in funding translational science, not exploring fundamental research questions.

A clear FDA regulatory path for approval/clearance (if appropriate) and evidence of initial engagement with regulatory authorities is desired.

A commercialization strategy is desired. This may include establishment of partnerships with appropriate device fabricators/manufacturers, addressing the potential to scale, intellectual property and the means to address adoption in hospitals (considering costs/unit, reimbursement strategy as well as hospital and physician desire to use).

3. Other Innovative Products with potential to radically transform Health Security: DRIVe will seek a limited number of additional extremely bold, radical and disruptive innovative solutions that will have the ability to transform Health Security.

VIII. Reporting Requirements and Deliverables

Some reports and other deliverables are relevant to specific activities performed during the period of performance under the contract, grant, or agreement. The Respondent and the Government will agree during final negotiations which reports and other deliverables are relevant and will be required as deliverables as determined in the negotiated final work statement (SOW, SOO, PWS, etc.). Reports required will be prepared and delivered throughout performance, and should be submitted electronically in Microsoft Word, Microsoft Excel, Microsoft Project, Adobe Acrobat PDF, and/or data-fields to a Government identified system.

a. Reports

Technical Progress Reports: The frequency of Technical Progress Reporting will be determined by the Government during negotiations. Typically, on the 20th day of each month, the Respondent must submit a Technical Progress Report describing activities performed during the previous calendar month. The appropriate formats for the Technical Progress Report will be provided by the Government. The Technical Progress Reports may include project timelines and summaries of product manufacturing, testing, and clinical evaluation activities as applicable. A Technical Progress Report will not be required for the month in which the Final Report is due.

Final Report: By the expiration date of selected procurement instrument, the Respondent will submit a Final Report that details, documents, and summarizes the results of all work performed under the contract.

b. Meetings

The Respondent will participate in regular meetings to coordinate and oversee the contract effort as directed by the CO, GO, OTAO, and Contracting Officer Representative (COR), Other Transaction Agreement Technical Representative (OTTR) and other Government technical representatives as required. Such meetings may include, but are not limited to, all Respondent and subcontractors to discuss biomarker discovery, platform development, clinical manufacturing progress, product development, product assay development, scale-up manufacturing development, clinical sample assay development, preclinical/clinical study designs and regulatory issues, or other relevant activities; meetings with individual Respondents and other Government officials to discuss the technical, regulatory, and ethical aspects of the program; and meeting with Government technical consultants to discuss technical data provided by the Respondent.

Reccurring teleconferences between the Respondent and subcontractors and Government may be held to review technical progress. Government reserves the right to request more frequent teleconferences and face-to-face meetings depending on the nature and importance of the work being performed. The Respondent will receive feedback from Government during the teleconference regarding contract performance. The Respondent will have an opportunity to respond and recommend corrective actions. The only contractual relationship will be between the Government and the prime Respondent.

c. Program Management Plans and Documentation

Integrated Master Schedule (IMS): Also known by its graphical representation as a Gantt chart, may be required and submitted following award. The IMS shall include the key milestones and Go/No-Go decision criteria per the final negotiated award or agreement.

Product Development Plan (PDP): Within 1 month of the effective date of an award, the successful Respondent may be required to submit a PDP, which will be approved by the CO, GO, or OTAO prior to initiation of any activities related to their implementation.

Deviation Report: During the course of performance, in response to a need to change the PDP, the successful Respondent may be required to submit a Deviation Report. All changes identified in the Deviation Report will be reviewed and agreed-upon by the CO, GO, or OTAO prior to updating the PDP.

IX. Additional Information

Inspection of Facilities

Respondents selected for negotiations may be subject to inspections of their facilities and Quality Assurance/Quality Control (QA/QC) capabilities; Regulatory and Quality Management:

FDA submissions and meetings; Audits/Site Visits, as applicable will be discussed during negotiations.

The decision to inspect specific facilities will be made by the CO, GO, OTAO in coordination with the COR, OTR, or other Government technical representative as required. If inspections are performed during the negotiations, the results of the inspection will be considered in final selection for award of a contract, grant or agreement.

Inspection of Records

Respondents, 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 a Government representative. Pre-award site visits may be made with short notice. Respondents are expected to guarantee the availability of key staff or other staff determined by the Government as essential for purposes of this site visit.