RFP Amendment 0003 W81XWH-21-R-0054 SM Wearble TBI 12-14-2021.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to:

a) Revise Section L (Instructions to Offerors) and Section M (Evaluation Criteria).

b) Extend the Proposal Due Date to 04 January 2022.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 18

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 14-Dec-2021

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81XWH21R0054

X 9B. DATED (SEE ITEM 11)

07-Oct-2021

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

14-Dec-2021

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81XWH21R0054

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been modified:

INSTRUCTIONS TO OFFERORS

1. General Instructions

This section provides general guidance for preparation of proposals as well as specific instructions on the format and content of the proposal. The Offeror’s proposal must include all data and information requested and must be submitted in accordance with these instructions. The proposal shall also be compliant with all requirements as stated in the Request for Proposal (RFP.)

The Offeror shall submit documentation illustrating its approach for satisfying the requirements of this solicitation.

Proposals must be clear, coherent, and prepared in sufficient detail for effective evaluation of the Offeror’s proposal against the evaluation criteria. Proposals must clearly demonstrate how the Offeror intends to accomplish the Government’s objectives and must include convincing rationale and substantiation of all claims. Unnecessarily elaborate brochures or other presentations beyond those sufficient to present a complete effective response to the solicitation are not desired.

The Offeror shall describe its proposal through the use of narrative as well as graphs, charts, and diagrams. The proposal shall be in sufficient detail for the Government to understand and evaluate the nature of the approach. The Government will evaluate only one proposal from each prime Offeror. The Government will not accept alternate proposals, or proposals which include contingency provisions.

Offerors’ proposals must include a statement that the proposal shall remain valid for a minimum of 120 days from the date of submission.

Offerors are prohibited from modifying any documents, printed or electronic, associated with this solicitation and any amendments in any way, shape or form, unless specifically authorized to do so. The electronic solicitation documents posted on https://www.sam.gov shall be the official documents for this solicitation.

Offers submitted in response to this solicitation shall be in the English language. Offers received in any language other than English shall be removed from consideration for award.

If proprietary information is included in a proposal submitted by a contractor, the Contractor shall mark its proposal accordingly.

All proposal information is subject to verification by the Government. Falsification of any proposal submission, documents, or statements may subject the Offeror to civil or criminal prosecution under Section 1001 of Title 18 of the United States Code.

All Offerors must comply with FAR Clause 52.204-7 System for Award Management (SAM). In complying with this clause, the Offeror must ensure that ALL representations and certifications contained in Solicitation Section K are completed and uploaded to its SAM record at http://www.sam.gov by the date specified for receipt of proposals.

Any Offeror that does not have an active SAM record nor has a record that does not include all representations and certifications required in Section K may be found ineligible and may not be considered for award.

Any data previously submitted in response to another solicitation to the U.S. Army Medical Research Acquisition Activity (USAMRAA) or another agency shall be assumed to be unavailable during this proposal evaluation and source selection process. Proposal data shall not be incorporated into this proposal by referring to another proposal or other source.

The Government will not reimburse any Offerors for costs incurred as a result of preparation and submission of a proposal in response to this solicitation.

All dollar figures in the Offeror’s proposal shall be in U.S. Dollars. Proposals submitted that are not in U.S. Dollars may be considered ineligible and may be removed from consideration for award.

a. Teaming Arrangements

The use of contractor teaming arrangements (as defined in the Federal Acquisition Regulation (FAR) 9.601) and subcontractor relationships are acceptable. Any subcontracting/teaming arrangements contemplated by the Offeror must be presented in detail. The details shall disclose those portions of the task which will be subcontracted and the anticipated organizations with which subcontracting or teaming arrangements are planned. Since there is a direct relationship from the Cost proposal to the Program Management Approach, teaming and functional capabilities, and Past Performance proposal, the Offeror shall include enough information on subcontracting/teaming arrangements to allow for a thorough proposal review from a technical and management perspective.

The Offeror shall include evidence (e.g., statement of intent to enter into a teaming agreement) of all subcontractor relationships (with both large and small businesses) in the Administrative Information Section.

Offerors submitting a proposal as a prime Offeror SHALL NOT be included as a subcontractor to any other prime Offeror’s proposal. If an Offeror submits a proposal as a prime Offeror and it is also included as a subcontractor in another prime Offeror’s proposal, it will NOT be eligible to receive an award as a prime contractor and will be eliminated from further consideration, but may serve as a subcontractor.

For Large Business Offerors, Small Business Subcontracting Plans are required in accordance with (IAW) FAR

19.702 and shall address all the requirements specified in FAR 19.704 (the same requirements are found in FAR 52.219-9). IAW FAR 19.705-2, Subcontracting Plans are required to be submitted with initial offers. However, IAW FAR 19.705-4, the acceptability of the Subcontracting Plan will be determined prior to award based on the negotiation of the plan. Negotiations surrounding the elements of the Subcontracting Plan are not considered “discussions” pursuant to FAR Part 15. As stated in FAR 19.702(a)(1), failure of the apparently successful Offeror to negotiate a subcontracting plan acceptable to the contracting officer by time of award, will result in the Offeror being ineligible for award. Based on information received during negotiation of the Subcontracting Plan, the contracting officer reserves the possibility of making a determination pursuant to FAR 19.705-2(c) that there are no subcontracting possibilities for this contracting action.

b. Discussions

The Government intends to award without discussions. Therefore, the Offeror’s proposal is presumed to represent the Offeror’s best effort in response to the Solicitation. If discussions are required they will be conducted with Offerors in the competitive range to the extent deemed necessary by the Contracting Officer, in accordance with FAR 15.306, Exchange With Offerors After Receipt of Proposals. Discussions will be conducted on the content of the proposal and, if discussions have been conducted, a Final Revised Proposal (FRP) will be solicited from Offerors. A common cut-off date will be established for receipt of all FRPs.

c. Solicitation Questions

Questions concerning this Request for Proposal are due no later than 10:00am Eastern Time on 20 October 2021.

Questions received after this time will not be accepted or answered. Questions shall be submitted in writing to the Contract Specialist, Mr. Christopher Sult, at Christopher.m.sult.civ@mail.mil by the closing date and time as stated.

The e-mail must have a subject title of “W81XWH-21-R-0054: Solicitation Questions.” Telephone inquiries will NOT be accepted at any time. The Government will issue a solicitation amendment containing answers to questions.

d. Proposal Due Date

Proposals shall only be electronically submitted to the primary POC via e-mail. The e-mail must have a subject title of “W81XWH-21-R-0054 Proposal Submission.” The Offeror is responsible for verifying receipt by the POC. One electronic copy shall be submitted for each proposal volume. Each proposal volume shall be a separate attachment.

PROPOSAL DUE DATE: No later than 10:00 AM Eastern Time on 04 January 2022. Any proposals received after this date and time may not be considered for evaluation. Offerors’ proposals shall remain open for a minimum of 120 days from the date of submission.

2. Proposal Format and Content Instructions

The Offeror’s submission shall include three separate volumes: Volume I – Administrative, Volume II – Non-Cost Proposal, Volume III – Cost Proposal. All documents shall be submitted in MS Word or searchable PDF format. The Completed Cost Template shall be submitted in MS Excel. All documents shall be in MS Word or MS Excel 2003 or higher, but not greater than MS Word or MS Excel 2010 format. The firewall utilized by the Government contracting office does not authorize or accept zip files. The proposal shall be submitted in Times New Roman font, size 10, with 1” margins.

Page Limits: Proposal pages are limited to those stated in the chart below. Pages shall be numbered by section. All pages of each volume shall be numbered and dated. For any sections of a proposal with a defined page limit, pages exceeding the specified limit will be removed and not forwarded for evaluation.

The following volumes of material shall be submitted:

Volume I – Administrative

Section Title Required Sections and Titles Page Limits

Administrative Information Section

SF33 Cover Page 1 Executive Summary of the Overall Proposal 1 Representations, Certifications and Other Statements of Offerors No Limit Organizational Conflict of Interest (OCI) Certification and/or Mitigation Plan No Limit

Non-Disclosure Statement (NDS) No Limit Teaming or Subcontractor Arrangement and Subcontracting Plan 20

Volume II – Non-Cost Proposal

Technical Approach

Technical Approach 15 Statement Of Work (SOW) No Limit Product Development Plan (PDP) No Limit

Regulatory Approach

Regulatory Approach 30 Regulatory Development Plan (RDP) No Limit FDA Communication Plan No Limit

Management Approach

Management Approach 15 Quality Management Plan (QMP) No Limit Project Management Plan (PMP) No Limit Work Breakdown Structure (WBS) No Limit Integrated Master Schedule (IMS) No Limit Cost and Data Reporting No Limit

Experience

Key Personnel No Limit Experience 10 CVs/Resumes No Limit Past Performance References 6

Volume III – Cost Proposal

Cost Proposal Completed Cost Template No Limit Supplemental Cost Information No Limit

Volume I – Administrative

Section Title Required Sections and Titles Page Limits

Completed Certificate of Current Cost or Pricing Data No Limit

3. Non-Cost Proposal Content Instructions:

The Offeror’s Non-Cost Proposal shall clearly reflect how it proposes to comply with the requirements identified in the Statement of Objectives (SOO). The Non-Cost Proposal, including any supporting documentation, is to be clear and concise. The level of effort proposed must be consistent with the proposed solution.

The Non-Cost Proposal shall contain the following sections:

- Administrative Information Section

- Technical Approach

- Regulatory Approach

- Management Approach

- Experience

- Past Performance

The Administrative Information Section shall contain the following:

a. SF33 Cover Page: The Offeror shall fill out page 1 of the Solicitation Form (SF) 33, Solicitation, Offer and Award. The Offeror shall fill out blocks 12 through 19 accordingly:

The Government requires a minimum acceptance period of not less than 120 calendar days. The Offeror shall complete Block 12 with full cognizance of the minimum acceptance period of 120 calendar days. “Acceptance Period” means the number of calendar days available to the Government for awarding a contract from the date specified in this solicitation for receipt of an offer. The offer may specify for a longer acceptance period than the Government’s minimum requirement but shall not specify a shorter period.

If any amendments to the solicitation are issued, the Offeror must acknowledge each amendment number and date in Block 14 of the SF 33. Failure to acknowledge all solicitation amendments may render the Offeror non-responsive.

The Offeror’s legal name and address in Block 15A on the SF33 must match the information for the Offeror in SAM.gov at http://www.sam.gov including the corresponding Commercial and Government Entity (CAGE) code number and Data Universal Numbering System (DUNS) number (Note: the address listed in Block 15A will be the official mailing address used by the Government for letter correspondence, if necessary).

The name, title, signature and date identified in Block 16, 17 and 18 must be an authorized representative with authority to commit the Offeror to contractual obligation.

b. Executive Summary: The Executive Summary shall be a short, overall summary of the entire proposal, excluding cost information.

c. Representations, Certifications and Other Statements of Offerors (Section K): The Offeror shall complete and submit the required information in Section K of this solicitation for the listed provisions as part of the Administrative Volume. Failure to submit, complete, or sign the required representations, certifications and other statements may render the Offer ineligible for award.

d. Organizational Conflict of Interest Certification and/or Mitigation Plan: The Offeror shall complete the attached OCI Certification (Attachment 1) and provide (if necessary) an OCI Avoidance or Mitigation Plan.

4. Non-Cost Factors

(1) Technical Approach

The Offeror shall submit a written technical approach which effectively demonstrates the Offeror’s clear understanding of all the objectives outlined in the SOO and how the approach is likely to yield the required results within the required time frame. Additionally, the Offeror shall demonstrate the methodology and flexibility that will be used in accomplishing any resultant award. The Offeror shall describe, in detail, its technical approach and overall ability to perform the work laid out in the SOO. This description shall, at a minimum, include a written Statement of Work (SOW) and Product Development Plan (PDP).

The Offeror’s SOW shall include a series of concise statements which demonstrate a fundamental understanding of the problem(s) and outline the approach to each of the major goals or objectives of the proposed work. The statements should outline the specific tasks, systems and materials that are reasonable estimates for accomplishing work described in the SOO. An outline should be included which shows the work statements to be accomplished over the Period of Period of Performance.

The SOW should include standards, which will establish specific goals and conditions for each phase of the proposed project.

The SOW should detail tasks to be performed to accomplish the Government’s Objectives to meet all phases, on schedule, and within budget.

The Offeror shall provide a Product Development Plan (PDP) describing all proposed activities that will be managed to achieve the Government’s objectives and how the Offeror will ensure that all deliverables produced will be acceptable prior to delivery to the Government. The plan shall have sufficient detail, so the Government can assess associated project risks and shall include, but is not limited to:

- Product characterization of the wearable TBI prevention device to reach threshold values for the Performance Attributes listed in the SOO.

- Analysis of technical and schedule risks associated with the proposed approach.

- Regulatory timeline that includes sequence and timing of key regulatory activities, tasks, and decision points (meetings/communications with U.S. Food and Drug Administration (FDA), submissions including authoring and publishing, and marketing application submission)

The Offeror’s proposal shall address the Technology Readiness Level (TRL):

The Contractor shall provide the current TRL of the proposed device.

The Contractor should include any publications, scientific data, and white papers that demonstrate proof of concept and device specificity of the proposed technology. (See Appendix A: DOD Deskbook5000.2-R and Appendix 6 Technology Readiness Levels and Their Definitions).

(2) Regulatory Approach

The Offeror’s regulatory approach shall address the elements described below and demonstrate the Offeror’s ability to accomplish the requirements of the SOO. The Offeror's regulatory approach shall include the following elements:

A proposed Regulatory Strategy that describes the regulatory pathway for FDA regulatory approval/licensure and includes any possible post-marketing commitments that include, but are not limited to, the following:

a. Product Nomenclature and Classification,

b. Device Description,

c. Intended use/indications for use statement,

d. Regulatory Pathway,

e. Current development status and regulatory status of the product and previous FDA interactions or submissions,

f. For those devices that will potentially require a 510(k), provide information about the proposed predicate and approach to substantial equivalence, and

g. Life Cycle Considerations.

A proposed Regulatory Development Plan (RDP) that describes specific steps, elements, and project deliverables to meet the objectives defined in the regulatory strategy. The Offeror’s proposal shall describe regulatory-specific deliverables that include, but are not limited to, the following:

a. Regulatory timeline,

b. Regulatory communication plan,

c. Previous regulatory communication information,

d. Analysis of testing requirements based on established standards and guidance,

e. Specific facility or pre-Inspection requirements such as Pre-Approval Inspections (PAI).

A proposed FDA Communication Plan that will ensure the Government has visibility and the opportunity to comment on all communications and documents submitted to the FDA regarding the medical device. The Government recognizes that the Offeror will be the FDA sponsor and ultimately is responsible for communication with the FDA. The plan will be evaluated for the following, but not limited to:

a. Interactions,

b. Meetings,

c. Communications,

d. Submissions packets,

(3) Management Approach

The Offeror shall submit a written management approach which effectively demonstrates the Offeror’s approach for accomplishing the requirements of the SOO in a SOW format. This shall, at a minimum, include a written Quality Management Plan (QMP), Project Management Plan (PMP), and all Contractor Cost and Data Reporting.

The Offeror’s Management Approach shall include:

A management approach in sufficient detail, including managing and integrating various aspects of the proposed effort according to milestones, decision points, risk mitigation plans, and related processes. The proposal shall include the Offeror’s approach to managing and interfacings with key subcontractors, to include the approach for assuring subcontractors meet cost, schedule, and performance requirements. The Offeror shall present, in detail, their management strategies and fully describe their management structure, key personnel, and lines of authority to include the team balance including mechanical, electrical, and software design and engineering, interface and human factors design, and regulatory expertise.

The Offeror’s Quality Management Plan (QMP) shall describe the quality standards for facilities, equipment, methods, practices, records, controls, and documentation supporting implemented, comprehensive Current Good Manufacturing Practice (cGMP) compliant systems. The plan shall be in sufficient detail, so the Government may can assess associated project risks and shall include, but is not limited to, approaches for the following activities:

a. Product characterization / compatibility of the wearable TBI prevention device to reach threshold values for the Performance Attributes listed in the SOO

b. Product validation and verification of wearable TBI prevention device

c. Qualification/validation activities to achieve and ensure a cGMP-compliant manufacturing facility. The Offeror shall show cGMP-compliance for production of test materials for clinical trials, requirements for FDA submission package(s) and subsequent FDA approval to market

d. Analysis of technical and schedule risks associated with the proposed approach

The Offeror’s Project Management Plan (PMP) shall include, but is not limited to, an Integrated Master Schedule (IMS) and a Work Breakdown Structure (WBS) that encompasses the entire scope of the contract based on the SOO.

The Offeror’s WBS shall include the following elements:

a. An analysis of whether the Offeror’s WBS is extended in detail to accurately define the complete contract scope.

b. A WBS dictionary that accurately depicts the Offeror’s proposed effort and correlates with the SOW (which follows the SOO format),

c. An IMS and Contract Line Item Numbers (CLINs)

The Offeror’s IMS shall include the following elements:

a. An analysis of the critical path, major tasks/activities, duration, delivery dates, schedule relationships, and schedule to assess if these IMS components are reasonable, realistic, and complete.

b. A proposed delivery date for the intended product including mapping to the SOW, CLINs, and WBS.

c. A description of tasks/activities in the IMS that link together showing predecessor/ successor relationships that account for the entire program/project under contract. A description of how technical approach, associated risks, and the feasibility of accomplishing these within the proposed timeline are reflected in the IMS.

The Offeror’s contractor cost and data reporting shall include the following elements:

a. A proposed cost integration of the measurement of development performance with cost and schedule objectives.

b. The Offeror’s cost understanding, and whether implementation for monitoring/reporting technical performance, accounting, cost, and schedule is feasible.

(4) Experience

The Offeror‘s proposal shall demonstrate the Offeror’s relevant experience identical to, similar to or related to performing services contained within the proposed SOW. Additionally, the Offeror’s proposal shall include documented evidence of the Offeror’s experience (for this purpose, experience refers to what an Offeror has done, not how well it was accomplished) in performing proposed processes and procedures.

The Curriculum Vitae or resumes of proposed Key Personnel and consultants to be assigned to this effort will be evaluated on their scientific qualifications, depth and breadth of expertise, and credentials relative to the projects.

Key Personnel are:

a. Program Manager

The proposed Key Personnel’s experience should include Team experience and expertise in similar projects, including resumes for key personnel describing knowledge, training, and education, to include:

a. Both individual and team experience relevant to similar or related to performing services sought to complete the proposed research and development.

b. Evidence of experience of supporting subcontractors, consultants, and business partners.

(5) Past Performance

The Offeror shall submit no more than three (3) references of relevant contracts within the past three (3) years for its own performance. The Offeror shall also submit no more than one (1) reference for each Subcontractor proposed.

The contracts may be past or current as long as the performance did not end more than three (3) years prior to the due date for the submission of the task order proposal, and the contracts may have been with Federal, State and/or City agencies and commercial customers.

a. Reference Content. It is the Offeror’s responsibility to provide valid, current and verifiable references. References must include:

1) Name of the Organization that will be providing the reference,

2) Name of the Point of Contact (POC),

3) POC Telephone Number,

4) POC Email address,

5) Contract Number,

6) Total Contract Value,

7) Period of Performance, and

8) Scope of Work.

b. Points of Contracts (POC). The above POCs must be either Government personnel (civil service or military) or employees of private sector clients (such as public or private sector medical facilities) with whom you have provided services. Information provided by or for POCs who work directly for your company, or indirectly (i.e. in a prime or subcontractor relationship), will NOT be considered relevant. Offerors shall ensure that contact information for designated references is accurate and up-to-date.

c. Information From Other Sources. The Government may consider information obtained through other sources.

(6) Cost

a. Cost Proposal Content Instructions

The Offeror’s Cost Proposal shall consist of all information required to support proposed costs and will be evaluated separately from past performance and other Non-Cost factors. The Offerer’s Cost Proposal will be evaluated for fairness, reasonableness, and realism. The total evaluated cost will be evaluated for reasonableness and to the degree to which it addresses:

1) Consistency with labor categories proposed as they relate to the carrying out of tasking outlined in the proposed statement of work.

2) Level of effort, in that the proposed labor mix and labor hours are based on reasonable assumptions.

3) Consistency with the technical approach, in that the costs are consistent with and reflect the proposed staffing requirement for all years.

The Government will also conduct an appropriate analysis to determine whether the proposed Cost is realistic in that the level of effort, labor mix, and other direct costs (ODCs) are realistic given the nature of the work to be performed.

The evaluated cost will be the total of all the priced line items, including fee.

Unsubstantiated costs that are considered unreasonable, not fully supported, or both, may cause the overall technical evaluation to be adjusted in one or more of the Non-Cost evaluation factors.

b. Cost Attachments

Completed Cost Template. The proposal will be evaluated for evidence that the Offeror included a completed version of the Cost Proposal Form (Solicitation Attachment 3). The Cost Template will be evaluated for evidence of completeness and that the Offeror ensured all mathematical computations were correct.

Completed Certificate of Current Cost or Pricing Data. The proposal will be evaluated for evidence that the Offeror completed and submitted the Certificate of Current Cost or Pricing Data (Solicitation Attachment 4) in accordance with FAR 15.406-2, Certificate of Current Cost or Pricing Data as part of the Cost Proposal Volume. Failure to submit, complete, or sign the certificate may render the Offer ineligible for award.

c. Supporting Cost Information

Supplemental Information. The Offeror’s proposal will be evaluated for evidence that it included supplemental pricing information that provided a detailed breakdown of its proposed pricing including but not limited to: labor, Fringe, Overhead, G&A, profit or fee, other direct costs, and any sub elements of each. The proposal will be evaluated for evidence that the supplemental information included all other direct and indirect costs including materials, equipment, travel, shipping, and any other costs associated with the performance of the resulting contract.

Offerors shall provide supplemental information for travel ODCs in their own format and shall include: destination to and from, number of days, number of nights, lodging, meals, airfare, rental car, other transportation costs, and number of people.

Subcontractor Cost. The proposal will be evaluated for evidence that the Offeror provided an analysis of how it determined subcontractor Cost to be fair and reasonable and the basis for their determination. Reference FAR Part

15.404. The proposal will be evaluated for evidence that the Offeror provided sufficient information regarding the subcontractor Cost analysis that the Government could recreate the analysis and come to the same conclusion.

Accounting System. A Contractor interested in participating in Cost-Reimbursement (CR) type contracts as defined in FAR 16.301-1 will be required to demonstrate that they have an accounting system that is adequate for determining costs applicable to the contract by the time the contract is awarded. This is an accounting system that the Defense Contract Audit Agency (DCAA), the Defense Contract Management Agency (DCMA), or any federal civilian audit agency, has deemed adequate for determining costs applicable to this contract in accordance with FAR 16.301-3(a)(1).

Special Standards: (FAR 9.104-2)

To successfully perform the requirements of the SOO, the successful Offeror’s proposed device must be assessed as having a current Technology Readiness Level (TRL) of at least a 5. The definitions of the various TRL’s and the supporting information required to substantiate a TRL determination are found in the DOD DESKBOOK 5000.2-R APPENDIX 6 TECHNOLOGY READINESS LEVELS AND THEIR DEFINITIONS. The successful Offeror must confirm by time of award that their proposed device has a TRL of at least a 5 through the submission of the supporting information outlined in Table E-1 of the TRA Deskbook. The GAO has stated that an agency’s exchanges with an Offeror regarding matters of responsibility do not constitute discussions. Therefore, exchanges prior to time of award regarding the TRL determination are anticipated. Exchanges of information will facilitate confirmation by time of award that the apparently successful Offeror’s proposed device has a TRL of at least a 5.

The contracting office anticipates initiating exchanges of information beginning on 20 December 2021.

SECTION M - EVALUATION FACTORS FOR AWARD

The following have been modified:

EVALUATION CRITERIA

Section M – Evaluation Factors for Award

A. Basis For Award

Award of this contract shall be made on a competitive best value basis, using “best value tradeoff” among cost and non-cost factors. A best value tradeoff process will be used, thus the Government may award to other than the lowest priced Offeror, or other than the Offeror with the highest rated non-cost proposal. Award will be made based on the overall “Best Value” proposal that is determined to be most beneficial to the Government, with appropriate consideration given to the evaluation factors: Technical Approach, Regulatory Approach, Management Approach, Experience, Past Performance, and Cost Approach. All proposals shall be subject to evaluation by a Source Selection Evaluation Board (SSEB).

The Non-Cost evaluation factors are numbered in descending order of importance as follows:

(1) Technical Approach

(2) Regulatory Approach

(3) Management Approach

(4) Experience

(5) Past Performance

The Non-Cost factors when combined are more important than Cost.

B. Factors To Be Evaluated

The Offeror’s proposal shall be compliant with the requirements of the RFP as stated in Section L, the Statement of Objectives (SOO), the Contract Data Requirements Lists (CDRLs), and other parts of this solicitation. Non-conformance with the instructions in Section L may result in submission of a deficient proposal, which may receive an unfavorable proposal evaluation and lead to expulsion from the competition/source selection. Any incomplete package submitted by any Offeror may be deemed unacceptable and not considered for award. Proposals judged unsuitable in terms of technical capability, commitments, or cost may be rejected as indicating a lack of understanding of the requirements.

The Offeror's proposal shall be evaluated to the degree to which it meets the below evaluation factors. Award will be made to the Offeror whose proposal is most advantageous to the Government based upon an integrated assessment of the evaluation factors described below.

(1) Technical Approach

(2) Regulatory Approach

(3) Management Approach

(4) Experience

(5) Past Performance

(6) Cost

Government evaluators will not assume that the Offeror possesses any capability or knowledge, unless itis specified in the proposal.

After each of the above Non-Cost factors are rated individually, an overall consensus rating will be assigned collectively to these factors. If any of the above Non-Cost evaluation factors receives an individual rating of “Unacceptable,” the collective overall rating will also be “Unacceptable.” Only proposals receiving an overall rating of “Acceptable” or higher will be considered for award.

Past Performance will be evaluated independently from the other Non-Cost evaluation factors utilizing different standards.

The Government will utilize information contained within the Offeror’s proposal as well as external sources consulted during the past performance evaluation to determine contractor responsibility in accordance with the criteria in FAR 9.104-1. An award will not be made to any Offeror determined to be non-responsible regardless of the ratings given to any of the evaluation factors above.

C. Non-Cost Factors. The following criteria will be used to evaluate the Non-Cost factors.

(1) Technical Approach

The Offeror’s proposal will be evaluated to the degree to which the technical approach demonstrates a clear understanding of all of the objectives outlined in the SOO and how the approach is likely to yield the required results in the required time frame. The Offeror’s proposal will be evaluated to the degree the Offeror demonstrates the methodology and flexibility that will be used in accomplishing any resultant award.

The Offeror's proposal will be evaluated to the degree to which it meets the following parameters:

The Offeror’s Statement of Work (SOW) will be evaluated to the degree that it demonstrates a series of concise statements which demonstrate a fundamental understanding of the problem(s) and comprise the approach to each of the major goals or objectives of the proposed work. The statements should outline the specific tasks, systems and materials that are reasonable estimates for accomplishing work described in the SOO. An outline should be included which shows the work statements to be accomplished over the Period of Performance (PoP).

The SOW shall include standards, which will establish specific goals and conditions for each phase of the proposed project.

The Offeror’s SOW will be evaluated to the degree that it details tasks to be performed to accomplish the Government’s objective to meet all phases, on schedule, and within budget.

The Offeror’s proposal will be evaluated on how their Product Development Plan (PDP) describes all proposed activities that will be managed to achieve the Government’s objectives and how the Offeror ensures that all deliverables produced will be acceptable prior to delivery to the Government. The plan will be evaluated on it having sufficient detail, including:

- Product characterization of the wearable TBI prevention device and it’s ability to reach threshold values for the Performance Attributes listed in the SOO.

- Analysis of technical and schedule risks associated with the proposed approach.

- Regulatory timeline that shall include sequence and timing of key regulatory activities, tasks, and decision points (meetings/communications with U.S. Food and Drug Administration (FDA), submissions including authoring and publishing, and marketing application submission)

The Offeror’s Technology Readiness Level (TRL) will be evaluated to the degree that it demonstrates:

The TRL will be evaluated as part of the technical approach. The Offeror’s proposal will be evaluated to the degree that the following elements are addressed:

The Offeror has included any publications, scientific data, and white papers that demonstrate proof of concept, and device specificity of the proposed technology. (DOD DESKBOOK 5000.2-R APPENDIX 6 TECHNOLOGY

READINESS LEVELS AND THEIR DEFINITIONS).

(2) Regulatory Approach

The Offeror's proposal will be evaluated to the degree to which the regulatory approach demonstrates the following elements:

A proposed Regulatory Strategy that describes the regulatory pathway for FDA regulatory approval/licensure and includes any possible post-marketing commitments that include, but are not limited to, the following:

a. Product Nomenclature and Classification,

b. Device Description,

c. Intended use/indications for use statement,

d. Regulatory Pathway,

e. Current development status and regulatory status of the product and previous FDA interactions or submissions,

f. For those devices that will potentially require a 510(k), provide information about the proposed predicate and approach to substantial equivalence, and

g. Life Cycle Considerations.

A proposed Regulatory Development Plan (RDP) that describes specific steps, elements, and project deliverables to meet the objectives defined in the regulatory strategy. The Offeror’s proposal has described regulatory-specific deliverables that include, but are not limited to, the following:

a. Regulatory timeline,

b. Regulatory communication plan,

c. Previous regulatory communication information,

d. Analysis of testing requirements based on established standards and guidance

e. Specific facility or pre-Inspection requirements such as Pre-Approval Inspections.

A proposed FDA Communication Plan that will ensure the Government has visibility and the opportunity to comment on all communications and documents submitted to the FDA regarding the medical device. The Government recognizes that the Offeror will be the FDA sponsor and ultimately is responsible for communication with the FDA. The plan will be evaluated for the following, but not limited to:

a. Interactions,

b. Meetings,

c. Communications,

d. Submissions packets,

(3) Management Approach

The Offeror’s proposal will be evaluated to the degree to which the management approach demonstrates the following:

A management approach in sufficient detail, including managing and integrating various aspects of the proposed effort according to milestones, decision points, risk mitigation plans, and related processes. The proposal should have included the Offeror’s approach to managing and interfacings with key subcontractors, to include the approach for assuring subcontractors meet cost, schedule, and performance requirements. The Offeror should have presented, in detail, their management strategies and fully describe their management structure, key personnel, and lines of authority to include the team balance including mechanical, electrical, and software design and engineering, interface and human factors design, and regulatory expertise.

A Quality Management Plan (QMP) that describes the quality standards for facilities, equipment, methods, practices, records, controls, and documentation supporting implemented, comprehensive Current Good Manufacturing Practice (cGMP) compliant systems. This includes:

a. Product characterization / compatibility of the wearable TBI prevention device and its ability to reach threshold values for the Performance Attributes listed in the SOO

b. Product validation and verification of wearable TBI prevention device

c. Qualification/validation activities to achieve and ensure a cGMP-compliant manufacturing facility. cGMP-compliance for production of test materials for clinical trials, requirements for FDA submission package(s) and subsequent FDA approval to market

d. An analysis of technical and schedule risks associated with the proposed approach.

A Project Management Plan (PMP) that demonstrates the Offeror’s approach for accomplishing the requirements of the SOO. This includes an Integrated Master Schedule (IMS) and Work Breakdown Structure (WBS) that encompasses the entire scope of the contract based on the SOO.

A WBS which includes the following elements:

a. An analysis of whether the Offeror’s WBS is extended in detail to accurately define the complete contract scope.

b. A WBS dictionary that accurately depicts the Offeror’s proposed effort and correlates with the SOW (which follows the SOO format),

c. An IMS and Contract Line Item Numbers (CLINs).

An IMS that includes the following elements:

a. An analysis of the critical path, major tasks/activities, duration, delivery dates, schedule relationships, and schedule to assess if these IMS components are reasonable, realistic, and complete.

b. A proposed delivery date for the intended product. Whether the IMS is directly traceable to the SOW, CLINs and the WBS.

c. Whether the description of tasks/activities in the IMS link together showing predecessor/successor relationships and are sufficient to account for the entire program/project under contract. Whether the technical approach, associated risks, and the feasibility of accomplishing these within the proposed timeline are reflected in the

IMS.

Contractor Cost and Data Reporting that includes the following elements:

a. A proposed cost integration of the measurement of development performance with cost and schedule objectives.

b. The Offeror’s cost understanding, and whether implementation for monitoring/reporting technical performance, accounting, cost and schedule is feasible.

(4) Experience

The Offeror‘s proposal will be evaluated to the degree to which it demonstrates the Offeror’s relevant experience identical to, similar to, or related to performing services contained within the proposed SOW. Additionally, the Offeror’s proposal will be evaluated on the documented evidence of the Offeror’s experience (for this purpose, experience refers to what an Offeror has done, not how well it was accomplished) in performing proposed processes and procedures.

The Curriculum Vitae or resumes of proposed Key Personnel and consultants to be assigned to this effort will be evaluated on their scientific qualifications, depth and breadth of expertise, and credentials relative to the projects.

Key Personnel are:

a. Program Manager

The Key Personnel’s experience will be evaluated on Team experience and expertise in similar projects, including resumes for key personnel describing knowledge, training, and education, to include:

a. Both individual and team experience relevant to similar or related to performing services sought to complete the proposed research and development.

b. Evidence of experience of supporting subcontractors, consultants, and business partners.

(5) Past Performance

The Government will conduct a Past Performance evaluation of the Offerors Past Performance as well as that of its subcontractors. Past Performance consists of two aspects for evaluation, past performance relevancy and performance confidence; thus, the Offeror will be assigned two ratings for past performance. First, the Government will evaluate the Offeror’s past performance references to determine how relevant a recent effort accomplished by the Offeror is to the requirement to be acquired through this source selection. Common aspects of relevance include similarity of service/support, complexity, magnitude of effort, dollar value, and contract type. Second, the Government will evaluate the Offeror’s past performance references to determine the quality of work performed and assess the level of expectation that the Offeror can successfully perform the required effort.

(6) Cost

a. Cost Proposal

The Offeror’s Cost Proposal will be evaluated separately from past performance and other Non-Cost factors. The Offeror’s Cost Proposal will be evaluated for fairness, reasonableness, and realism. The total evaluated cost will be evaluated for reasonableness and to the degree to which it addresses:

1) Consistency with labor categories proposed as they relate to the carrying out of tasking outlined in the proposed statement of work.

2) Level of effort, in that the proposed labor mix and labor hours are based on reasonable assumptions.

3) Consistency with the technical approach, in that the costs are consistent with and reflect the proposed staffing requirement for all years.

The Government will also conduct an appropriate analysis to determine whether the proposed Cost is realistic in that the level of effort, labor mix, and other direct costs (ODCs) are realistic given the nature of the work to be performed.

The evaluated cost will be the total of all the priced line items, including fee.

Unsubstantiated costs that are considered unreasonable, not fully supported, or both, may cause the overall technical evaluation to be adjusted in one or more of the non-Cost evaluation factors.

b. Cost Attachments

Completed Cost Template. The proposal will be evaluated for evidence that the Offeror included a completed version of the Cost Proposal Form (Solicitation Attachment 3). The Cost Template will be evaluated for evidence of completeness and that the Offeror ensured all mathematical computations were correct.

Completed Certificate of Current Cost or Pricing Data. The proposal will be evaluated for evidence that the Offeror completed and submitted the Certificate of Current Cost or Pricing Data (Solicitation Attachment 4) in accordance with FAR 15.406-2, Certificate of Current Cost or Pricing Data as part of the Cost Proposal Volume. Failure to submit, complete, or sign the certificate may render the Offer ineligible for award.

c. Supporting Cost Information

Supplemental Information. The Offeror’s proposal will be evaluated for evidence that it included supplemental pricing information that provided a detailed breakdown of its proposed pricing including but not limited to: labor, Fringe, Overhead, G&A, profit or fee, other direct costs, and any sub elements of each. The proposal will be evaluated for evidence that the supplemental information included all other direct and indirect costs including materials, equipment, travel, shipping, and any other costs associated with the performance of the resulting contract.

Subcontractor Cost. The proposal will be evaluated for evidence that the Offeror provided an analysis of how it determined subcontractor Cost to be fair and reasonable and the basis for their determination. Reference FAR Part

15.404. The proposal will be evaluated for evidence that the Offeror provided sufficient information regarding the subcontractor Cost analysis that the Government could recreate the analysis and come to the same conclusion.

Accounting System. A Contractor interested in participating in Cost-Reimbursement (CR) type contracts as defined in FAR 16.301-1 will be required to demonstrate that they have an accounting system that is adequate for determining costs applicable to the contract by the time the contract is awarded. This is an accounting system that the Defense Contract Audit Agency (DCAA), the Defense Contract Management Agency (DCMA), or any federal civilian audit agency, has deemed adequate for determining costs applicable to this contract in accordance with FAR 16.301-3(a)(1).

Special Standards: (FAR 9.104-2)

To successfully perform the requirements of the SOO, the successful Offeror’s proposed device must be assessed as having a current Technology Readiness Level (TRL) of at least a 5. The definitions of the various TRL’s and the supporting information required to substantiate a TRL determination are found in the DOD DESKBOOK 5000.2-R

APPENDIX 6 TECHNOLOGY READINESS LEVELS…