Comprehensive guidance and full-form template for use of GiveNeeds 3-D printed face shield for the prevention of COVID_19 in healthcare settings. This guidance and template are for use by other organizations who wish to use the GiveNeed design and apply for funding.

1. Stage 1 Guidance for BARDA Submission Package – 3-D Printed Face Shields
Prepared by – Jacob Wolf
Purpose – This document intends to provide a template for completing a white paper in reference
to the government solicitation, ‘BAA-18-100-SOL-00003’. Please note, this template is informed
from the criteria, requirements, and guidance as presented in the original solicitation.
Table of Contents
Overview................................................................................................................................ 3
Critical Information Regarding the Original Solicitation.......................................................... 4
Process Flow Chart Graph....................................................................................................... 4
Explanation...................................................................................................................................... 5
Templates .............................................................................................................................. 5
Quad Chart ...................................................................................................................................... 5
Quad Chart Template..........................................................................................................................................6
Quad Chart Example/Reference..........................................................................................................................6
Cover Page....................................................................................................................................... 7
Cover Page Template ..........................................................................................................................................7
Cover Page Example............................................................................................................................................8
White Paper..................................................................................................................................... 9
White Paper Format............................................................................................................................................9
TechWatch Information........................................................................................................ 12
TechWatch Meeting Benefits ......................................................................................................... 13
Submission Information........................................................................................................ 13
Approval or Denial................................................................................................................ 13

2. ******Disclaimer******
This document and its associated documents are the results of non-legal advice. By reading,
using or, disseminating this information, you agree that the information contained herein and in
associated documents is considered friendly advice and nothing more. Should your submission
be accepted or denied, you agree that this document and associated documents are not at fault.
Finally, if you have feedback, please send such requests to Jacob Wellinghoff
(jacobw@phasespace.com).
************

3. Overview
This document details specific guidance for the submission of a BARDA grant for the production
of 3-D printed face shields to help prevent COVID-19 infections in healthcare settings. We first
begin with information from the original solicitation, which you should be aware of before
attempting to create a submission package. There are two stages to the BARDA submission. You
must create and submit stage 1. Upon approval of your stage 1 submission, you may be invited to
submit a full proposal in stage 2. This document covers guidance for stage 1; please refer to our
separate “BARDA_STAGE_2_GUIDANCE” for more information regarding stage 2. Next,
there are three templates, along with examples and explanations for a quad chart, cover page, and
white paper. After reading these three templates and their corresponding examples, we present
the three templates as one cohesive document for your reference in creating your full stage 1
submission.
Further on, we present information regarding why and how to schedule a TechWatch meeting
before your submission of your stage 1 package. There is also necessary submission information
such as where and when to send your package. We also provide some of the grading criteria used
by BARDA. Finally, we detail steps to take whether your stage 1 submission is accepted or
denied.

4. Critical Information Regarding the Original Solicitation
The original government solicitation contains critical information, which should be known
BEFORE you attempt to complete any template or submission.
This solicitation is open to the private sector, meaning any for-profit, as well as non-profit
organizations, may apply. The BARDA program has temporarily suspended any submissions not
directly related to COVID-19. It is, therefore, paramount that you highlight your plan to help
fight COVID-19. If you follow our template, this should not be a problem. Our template follows
the interest in producing 3-D printed face shields to prevent the spread of COVID-19 for
healthcare professionals using PhaseSpace face shield designs. These templates do not offer any
guidance or support for areas of interest other than previously stated. If you are interested in
guidance for other areas of interest (AOI), please contact Jacob Wellinghoff at
jacobw@phasespace.com. Please note, your inquiry may not be answered or instead re-directed
to other resources.
Please note there are two stages to this solicitations award program. Stage 1 includes the
submission of your quad chart, cover page, and white paper. Stage 2 includes the submission of a
full proposal. You should first complete stage 1 and wait for an invitation to continue to stage 2.
The solicitation segments the process in this way to reduce time investment in preparing a
proposal should you not be selected. In other words, less time is spent using this approach as
opposed to preparing all documents at once. In conjunction with these stages, we have developed
a detailed process flow chart for stage 1 (and are working on one for stage 2). Therefore, this
document and the following information ONLY applies to stage 1.
Process Flow Chart Graph
BARDA PROCESS FLOW CHART - S age
1
Fill- Tem la e
Q ad Cha , C e Shee , Whi e
Pa e
Sched le TechWa ch
Mee ing
Re i i n & Re ie S age
S bmi i n & E al a i n
A ed
C n in e F ll P al
Denied
Re-e al a e

5. Explanation
This document and any guidance for stage 1 follow the outline of the process flow chart. This
document supplies templates necessary to create the quad chart, cover sheet, and white paper.
We then provide information on how and why you should schedule and conduct a TechWatch
meeting as well as guidance on reviewing and revising your submission package. Next, there is
information on how to submit your package as well as the criteria used to evaluate your
submission. If approved, you will be invited to submit a full proposal. Please note, we are still
working on preparing templates and guidance for stage 2.
Templates
In this section, we offer three templates for the required submission materials. The first template
is an empty template for the quad chart, which is followed by an example quad chart for your
reference. Secondly, we present a cover page template and example. Third, we provide a white
paper template with explanations/guidance.
Please note, separate documents serving as templates and examples are contained within this
guidance package. Please note; however, all three of these documents MUST eventually be
submitted as one cohesive PDF document. Additionally, your full stage 1 submission must NOT
exceed 14 pages. Please prepare 1 page for the quad chart, 1 page for the cover page, 1-10 pages
for the white paper, and 0-2 pages for the addendum.
Quad Chart
The purpose of this part of the submission is to provide a brief overview of your submission. The
white paper provides more detailed information about the quad chart. Please follow the template
and guidance we have provided.

6. Quad Chart Template
Quad Chart Example/Reference
Objective: Clear, concise (two to three sentences) description
of the objective and methodologies of the effort
Description of effort: A bullet list (2-3 points)
of primary scientific challenges being addressed
Benefits of proposed technology
Challenges
Maturity of Technology
Picture of graphic that illustrates the
research or concept
Bullet list of major goals/milestones by project year
Proposed funding
Base year cost plus each option year
(Rough order of magnitude estimate)
Title of project, BAA#, Development area of interest, technical/administrative point of contact
(name email and phone), company name and address
Objective: To manufacture and distribute 30,000 face shields. Each unit
is 3-D printed using local plastic vendor supplies. All units
are donated to local healthcare professionals/facilities in
order to provide face protection against the spread of COVID-19.
Challenges Being Addressed:
• Mass produce critical PPE for healthcare professionals in need.
• Manufacture PPE (face shields) without putting a burden on necessary
healthcare supply chains.
• Distribute cheap, yet effective PPE during emergencies.
Benefits of proposed technology: PhaseSpace designed face shields offer
cheap, local, and effective means of producing face shields for the prevention
of COVID-19 infections in healthcare settings. Supplies may be acquired locally,
thus reducing shipping time while supporting small American businesses.
Challenges
To secure necessary funding to produce adequate number of 3-D printed masks.
Distribution network capable of delivering mass quantities of masks.
Maturity of Technology: Face shields for prevention of infectious diseases
have been prevalent in American healthcare since at least 2003. Current
PhaseSpace design implements a conglomeration of other successful face shields.
Milestones (2020-2021)
Securing Materials to mass produce
Production of 30,000 face shields
Batch quality testing and passing scores
Distribution of 30,000 face shields
Proposed funding: $150,000
$50,000 towards materials and printing
$50,000 towards labor
$25,000 towards operating costs
$25,000 towards distribution
3-D Printed Face Shield For HealthCare Professionals Fighting COVID-19, BAA-18-100-SOL-00003
AOI #10, Jacob Wellinghoff jacobw@phasespace.com (XXX)-XXX-XXXX, PhaseSpace 1937 Oak Park Boulevard # A
Pleasant Hill, CA 94523
Budget
Materials Labor
Distribution Operating Costs

7. Cover Page
This page provides necessary information regarding who is applying for the solicitation and
general information about your submission. Therefore, the cover page should be the second page
of the overall submission. Please follow our template and guidance to meet the original
solicitations criteria.
Cover Page Template
Cover Page
Title of White Paper
--Solicitation—
Date of Submission (DAY/MONTH/YEAR)
Organization Name
Address
Point of Contact
Name
Email
Phone #
Signature of official authorized to obligate the organizations contractually (Generally point of
contact)

8. Cover Page Example
Cover Page
3-D Printed Face Shields For HealthCare Professionals Fighting COVID-19
BAA-18-100-SOL-00003
07APRIL2020
PhaseSpace
1937 Oak Park Boulevard # A
Pleasant Hill, CA 94523
Jacob Wellinghoff
jacobw@phasespace.com
(XXX)-XXX-XXXX

9. White Paper
The white paper should be 1-10 pages, generally speaking, a length of 5-8 pages is preferable as
this length can give ample details, be wary if your white paper is 4 pages or less. The purpose of
the white paper is to expand upon information from your quad chart. Therefore, our guidance
incorporates the practice of using the quad chart as a summary of the white paper. Please note the
white paper template is a separate document.
White Paper Format
This section offers guidance and explanations for specific portions of the white paper. Please
read each section carefully as the requirements and desired information for each section are
highly specific; in other words, it is impossible to properly create the whitepaper without reading
the below criteria and guidance.
Background Section
Summary: 2-3 Pages, Cite Sources, Introduce Problem and Solution
This section serves as an introduction to the problem as well as the solution. In this case, we have
provided a strong background on the use of face shields, their efficacy in healthcare, and specific
design metrics that make a good face shield (expanded upon later in the white paper). Please feel
free to use the background we have provided as you see fit. Also, be careful to properly cite any
sources or claims as the grading committee checks for sources. Also, worth noting, the
background section should NOT divulge any more information than previous common
knowledge about face shields. In other words, the background does not discuss your
organization's new approach or anything else.
Experience Section
Summary: 1-2 pages, graphics welcome, create a robust picture that establishes your
organization as competent and sure of success.
Detail your organizations, as well as possible subcontractors, experience in matters related to
your submission for the BARDA grant. For instance, since we are submitting for funding to
produce and distribute face shields, your organization or subcontractors should have experience
in one or more of the following:
• Medical Community
• Manufacturing
• 3-D Printing
• Distribution Channels
• Supply Chain Management
• FDA Approval
Please note that your involvement in these categories does not necessarily need to be topic-
specific. In other words, if your organization has experience with manufacturing and distributing
napkins, then mention it as that experience is transferrable to this submission. Try to keep in
mind; however, the more relevant and prevalent your (or subcontractors) experience is, the
better.

10. Approach
Summary: 2-3 pages, graphics welcome, detail on how to fix the problem you presented in the
background. Detail your face shield design and manufacturing process. Address TRL 4.
This section details your approach to solving the problem you mentioned in the background
section. Therefore, ensure your approach section highlights why your unique approach is
beneficial over others. Begin by discussing the face shield design, and its benefits. More
specifically, the BARDA committee wants to see a selection of the following benefits as a result
of your approach:
• Reduced cost of at least an order of magnitude to acquire and stockpile
• Manufacturing efficiency or speed
• Decontamination and re-use
• Functionality
• Fit flexibility to support a broad population (e.g., pediatric through adult)
• Elimination of fit testing
• Usability, comfort
You also need to detail your method of producing the face shields, how they are handled and
shipped as well as how distribution occurs to hospitals. You may also want to mention batch
testing. Finally, you must demonstrate that the face shield design has a TRL (technology
readiness level) of 4 or greater. To reach level 4 or higher, you must complete all previous stages
as well. For instance, you must have completed TRL’s 1-3 in conjunction with TRL 4.
TRL Description
A product can be described as achieving a TRL only if all relevant activities identified in that
TRL have been completed.
1
Review of Scientific Knowledge.
Active monitoring of scientific knowledge base to identify clinical pathological markers for diagnostic
countermeasure candidates. Scientific findings are reviewed and assessed as a foundation for
characterizing approaches to intervene in disease. Basic research needs identified.
2
Concept Generation and Development of Experimental Designs
Develop research plans to answer specific questions and experimental designs for addressing the
related scientific issues and to establish feasibility. Focus on practical applications based on basic
principles.
3
Characterization of Preliminary Candidates(s) and Feasibility Demonstration
Begin R&D, data collection, and analysis in order to verify feasibility. Explore alternative concepts,
identify and evaluate critical technologies and components, and begin characterizing specifications
required. Demonstrate the performance of candidate diagnostic targets and high risk components.
Develop a business case for the proposed product.
4
Optimization and Preparation for Assay, Component, and Instrument Development
Prepare for test system development. Finalize diagnostic target(s) and methods for detecting or
quantitating target(s). Develop detailed plans and finalize critical design requirements. Execute
commercial agreements with key external development partners. Identify manufacturing resources,
vendor sourcing, and experimental designs
5
Product Development – Reagents, components, subsystems and modules
Develop reagents and buffers. Build and test non-GLP prototypes of components and subsystems.
Code and unit test software. Begin pilot scale manufacturing preparations. Develop protocols for assay
and integration testing Initiate reagent stability testing. Hold pre-IDE meeting with FDA. Initiate Design
History file.
6 System integration & testing

11. Integrate and test alpha and beta instruments/devices, software and assays, evaluating performance
and updating specifications. Implement design improvements to address defects discovered during
testing. Produce and evaluate pilot lots of reagents and beta (pilot) instruments. Increase the maturity of
software. Prepare for clinical testing. Complete short term stability testing of reagents.
7
Analytical Verification and Preparation for Clinical Studies
Evaluate assay and integrated diagnostic system performance utilizing contrived, retrospective human
and animal samples. Make preparations for clinical evaluation. Begin preparation for full scale
production of instruments and assays.
8
Clinical Studies and/or evaluation with Animal Studies, FDA Clearance or Approval, Finalize
GMP manufacturing preparations.
Complete clinical evaluations. Prepare and submit FDA filing.
End of TRL8: Acquire FDA approval, or clearance.
Objectives
Summary: 1-2 pages, objectives, and pathways to milestones.
In this section, you need to present multiple objectives. Start by first listing the proposed
objectives, for example:
• Secure Suppliers to Plastic Materials
• Find tooling shop with X amount of 3-D printers
• Produce prototype face shield and conduct a fit test
• Produce first test batch of 100 face shields
And so on. Next, you need to present a clear and concise plan for meeting the product
development objectives, including key activities such as manufacturing, procurement, design,
testing, and more. To meet this requirement, you need to create a Gantt chart showing an
overview of the proposed activities and timelines.
Participants
Summary: 2 pages, all of those involved as an addendum.
Please note this section must be an addendum and therefore, an index at the end of the document.
In this section, you need to detail who is involved in the activities of this submission. You also
need to detail those involved from start to finish. Be sure to include their relevant qualifications
as well. We recommend you do this using several categories, for example:
Category: Manufacturing
Activities – 3-D printing face shields using transparent plastic materials.
Entity – XX Industries, XX Address, XX point of contact

12. Period of Performance
Summary: 1-page, significant milestones.
This section should detail the entire timeline and specific events on that timeline for your
submission. In other words, the duration of time when the award money is in use, you must
provide a timeline for all activities. We recommend you do create a timeline detailing significant
milestones.
Cost Share
Summary: 1-page, other funders.
In this section, you must detail what if any additional funding you are receiving, which is related
to the proposed activities. For example, if a private organization has given you X dollars to
produce face shields, then you must include the organization as well as the dollar amount, they
donated as well as the use of said money. If this is not the case, then please indicate your
organization is not receiving any other funding for the proposed activities in the white paper.
Rough Order of Magnitude Pricing
Summary:1-page, project costs.
This section is your budget section, perhaps one of the most critical parts of the white paper. In
this section, you need to provide a budget breakdown for the proposed activities, including:
• Labor
• Subcontractors
• Materials/Equipment
• Other Direct Costs
• Travel (if necessary)
• Indirect Costs
• Total Projected Costs
Full Template
We have provided a full template and example documents that incorporate all templates and
examples within this document. Please fill out the full template and use the full example as well
as this document as guidance.
TechWatch Information
“Participation in the TechWatch program affords Offerors an opportunity to present their
capabilities to BARDA scientific subject matter experts and program managers, as well as
Contracts Management & Acquisition (CMA) acquisition professionals. These personnel can
evaluate products/technologies, suggest techniques and strategies for meeting technical and
regulatory challenges, provide insight on how a product or technology may address BARDA's
objectives, and provide general information about BARDA's mission and programs.”
TechWatch Website to request a meeting: CLICK HERE

13. *Please select scroll down the page and select “Other CoronaWatch Request”. You will need to
login or create an account to make the request*
TechWatch Meeting Benefits
• Gain visibility for your solution
• Receive feedback from USG experts
• Hear techniques and strategies for addressing technical and regulatory challenges
• Get insight on how your solution could fit within the Government
• Better prepare you for a formal proposal submission
Submission Information
Deadline to Submit – 31OCT2020
Full submissions (quad chart, cover page, and white paper) must be submitted to
“BARDA-BAA@hhs.gov” .
*PLEASE NOTE* We highly recommend submitting your stage 1 package as soon as possible.
Should you be invited to submit a full proposal, you will need additional time to create the full
proposal as well as additional time for the BARDA staff to review the proposal. Finally,
additional time will be needed for the contract/award negotiations.
IMPORTANT: The subject line of the email should consist of the announcement number, area
of interest number, and purpose of the email (e.g., BAA-18-100-SOL-00003 AOI #3 Quad Chart
& White Paper Submission). White Papers do not require any special forms, but must be
submitted in the following format:
• Single PDF file as an email attachment
• Page Size: 8 1⁄2 x 11” with 1” Margins
• Spacing – single
• Font – Arial, 11 point
• The file should not exceed 10 Megabytes of storage space.
• Movie and sound file attachments, URL Links, or other additional files, will not be accepted.
• Classification: All Quad Chart and White Paper submissions must be UNCLASSIFIED.
Approval or Denial
After submitting your stage 1 package, your submission will either be approved or denied.
Should your submission be approved, you will then be invited to submit a full proposal. For
guidance on stage 2, please see our other document titled “BARDA-STAGE-2-GUIDANCE”.
Should your submission be denied, we recommend you only continue with a revision and
resubmission if it requires less than 15% of changes. In other words, if you estimate your original
stage 1 submission package needs to change by more than 15%, then we propose canceling that
submission altogether.