HT001426RE0010003.pdf

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Traumatic Brain Injury Center of Excellence Warfighter Brain Health Research and Translation Support Services
Solicitation number
HT001426RE001
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This is Amendment 0003 to Solicitation HT001426RE001, issued by the Defense Health Agency (DHA) on January 27, 2026. The amendment extends the proposal submission deadline and modifies key solicitation requirements.

The response due date has been extended from February 3, 2026 at 2:00 PM to February 17, 2026 at 10:00 AM EDT. The solicitation seeks a Cost-Plus-Fixed-Fee (CPFF) contract for clinical investigation and research support services. Proposals must be submitted in eight separate volumes: Business Proposal (15 pages), Technical Approach/Capability (20 pages), Management Capability (20 pages), Personnel Qualifications (10 pages), Past Performance Risk (on government form plus 5-page summary), Prior Experience (10 pages), Small Business Participation (no page limit), and Cost/Price (no page limit). A complete Volume V on Past Performance must be submitted by February 10, 2026 at 10:00 AM EDT, with all remaining volumes due by February 17, 2026 at 10:00 AM EDT. Proposals are submitted via email to four identified DHA representatives. The Government will evaluate proposals based on seven factors in descending order of importance: Technical Approach/Capability, Management Capability, Personnel Qualifications, Past Performance Risk, Prior Experience, Small Business Participation Commitment (Pass/Fail), and Cost/Price. A minimum "acceptable" rating on all non-price factors is required for consideration. The amendment also incorporates revised clauses addressing contractor personnel identification, privacy and HIPAA compliance, organizational conflicts of interest, compensation standards, and small business subcontracting requirements at 25 percent of total contract value.

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TBICoEResearchPWS_20260113_HT001426RE001_PubRelease.docx DOCX document
TBICoEResearchPWS_20260113_HT001426RE001.docx DOCX document
PROPOSAL ADEQUACY CHECKLIST.docx DOCX document
Questions and Answers to Solicitation HT001426RE001.pdf PDF
WD 2015-4269 Rev 31.pdf PDF
HT001426RE0010002.pdf PDF
HT001426RE001 Cost and Pricing Rev 12 Jan 26.xlsx XLSX spreadsheet
Solicitation Amendment HT001426RE0010001 SF 30.pdf PDF
Revised-Attachment 3 HT001426RE001 Past Performance Questionnaire.docx DOCX document
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CDRL A037 -- TBICoEs Annual Report.pdf PDF
CDRL A035 -- Strategic Communications Plan.pdf PDF
CDRL A032 -- Research Metrics Reports.pdf PDF
CDRL A031 -- Telwork Agreement and Schedules.pdf PDF
CDRL A030 -- R and E Metrics Report.pdf PDF
CDRL A027 -- Clinical Recommednations Status Report.pdf PDF
CDRL A015 -- Staff Roster.pdf PDF
CDRL A013 -- Subcontractor Progress Report.pdf PDF
CDRL A012 -- Financial Burn Rate Report.pdf PDF
CDRL A010 -- Research study close-out reports.pdf PDF
CDRL A001 -- Quality Control Plan.pdf PDF
CDRL A038 -- Vendors Achievement of Objectives Analysis Report.pdf PDF
CDRL A024 -- NDC Report.pdf PDF
CDRL A023 -- Distribution Lists.pdf PDF
CDRL A022 -- D and I Product Status Reports.pdf PDF
CDRL A016 -- Organizational Charts.pdf PDF
CDRL A014 -- Vacancy Report.pdf PDF
CDRL A011 -- Dissemination and Implementation Plans.pdf PDF
HT001426RE001.pdf PDF
CDRL A033 -- Research Quad Charts.pdf PDF
CDRL A029 -- Web Control Management Report.pdf PDF
CDRL A025 -- Surveillance Report.pdf PDF
CDRL A020 -- TBI Literature Review.pdf PDF
CDRL A019 -- Support Agreement Dashboard.pdf PDF
CDRL A017 -- Training Compliance Report.pdf PDF
CDRL A008 -- Meeting Minutes.pdf PDF
CDRL A007 -- Travel Exsum Site Visit Report.pdf PDF
CDRL A003 -- Non-Disclosure Agreement.pdf PDF
CDRL A002 -- Transition-in Transition-out.pdf PDF
CDRL A036 -- Composite Publications Bibliography.pdf PDF
CDRL A034 -- Training Plan.pdf PDF
CDRL A026 -- Outcomes Effort Status Report.pdf PDF
CDRL A021 -- Communications Metrics Report.pdf PDF
CDRL A018 -- Government Furnished Property and Equipment Inventory.pdf PDF
CDRL A009 -- TBICoE Relevant Policies Database.pdf PDF
CDRL A006 -- Weekly Significant Activity Report.pdf PDF
CDRL A005 -- Contract Work Breakdown Structure.pdf PDF
CDRL A004 -- Continuity of Operations Plan.pdf PDF
Attachment 3 HT001426RE001 Past Performance Questionnaire.docx DOCX document
TBICoE Research Recompete PWS v11 (Final).docx DOCX document
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R

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offers 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 electronic communication 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 letter or electronic communication, provided each letter or electronic communication 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 NUMBER AS DESCRIBED IN ITEM 14.

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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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.)

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

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBE

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

Section A - Solicitation/Contract Form

The following modifications were made:

INFORMATION FROM TO

Response Due Time 02:00 PM 10:00 AM Response Due Date 03 Feb 2026 17 Feb 2026

Section H - Special Contract Requirements

Header Miscellaneous Text (Modified):

PD 33-01 - AGENCY LEVEL PROTESTS (APRIL 14, 2014)

An interested party filing a protest with Defense Health Agency (DHA) has the option of requesting review by either the Contracting Officer (CO) or an independent review Official (IRO), who is a DHA official at a level above the CO. Alternately, an interested party may request IRO review as an appeal of the CO's protest decision.

Where applicable, an interested party must clearly state in the protest that IRO review is requested, and must specify the nature of the independent review sought -whether as an alternative to CO review or as an appeal of the CO's decision.

Regardless of which review is requested, all protests must be complete and submitted to the CO within the timeframes specified in FAR Subpart 33.1.

(End of requirements language)

PD 03-03 ENCLOSURE 2 - IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST (AUGUST 21, 2014)

H.1 DFARS 252.203-7000, Requirements Relating to Compensation of Former DoD Officials (Sep 2011)

(a) Definition. "Covered DoD official," as used in this clause, means an individual that--

(1) Leaves or left DoD service on or after January 28, 2008; and

(2) (i) Participated personally and substantially in an acquisition as defined in 41 U.S.C. 131 with a value in excess of $10 million, and serves or served--

(A) In an Executive Schedule position under subchapter II of chapter 53 of Title 5, United States Code;

(B) In a position in the Senior Executive Service under subchapter VIII of chapter 53 of Title 5, United States Code; or

(C) In a general or flag officer position compensated at a rate of pay for grade O-7 or above under section 201 of Title 37, United States Code; or

(ii) Serves or served in DoD in one of the following positions: program manager, deputy program manager, procuring contracting officer, administrative contracting officer, source selection authority, member of the source selection evaluation board, or chief of a financial or technical evaluation team for a contract in an amount in excess of $10 million.

(b) The Contractor shall not knowingly provide compensation to a covered DoD official within 2 years after the official leaves DoD service; without first determining that the official has sought and received, or has not received after 30 days of seeking, a written opinion from the appropriate DoD ethics counselor regarding the applicability of post-employment restrictions to the activities that the official is expected to undertake on behalf of the Contractor. (c) Failure by the Contractor to comply with paragraph (b) of this clause may subject the Contractor to rescission of this contract, suspension, or debarment in accordance with 41 U.S.C. 2105(c).

(End of clause)

PD 09-01 ENCLOSURE 3 - ORGANIZATIONAL CONFLICTS OF INTEREST (APRIL 23, 2015)

H.1 The Contractor's attention is directed to FAR, Subpart 9.5, "Organizational and Consultant Conflicts of Interest." DHA has made a determination that an actual or significant potential organizational conflict of interest exists, or the nature of the work to be performed may create an actual or significant potential organizational conflict of interest in future acquisitions.

H.2 For the purpose of these clauses, the term "Contractor" means the contractor, its subsidiaries, affiliates, partners, market consultants, as defined by FAR, Subpart 9.501, or any of its successors or assignees.

H.3 It may become necessary in the performance of this contract to review proprietary information from other contractors. The Contractor shall protect all proprietary information from unauthorized use or disclosure and refrain from using the information for any purpose other than that for which it was furnished. At the request of the Contracting Officer, the Contractor agrees to execute agreements with third party companies furnishing data in connection with work performed under this contract. Safeguards shall be implemented to restrict access to proprietary information and to avoid, neutralize, or mitigate potential conflicts of interest. Non-disclosure agreements shall be completed by the Contractor, all employees, and subcontractors who obtain access to proprietary information, and provided to the Contracting Officer.

H.4 The Contractor agrees that if an actual or potential organizational conflict of interest is discovered after the award of this contract, the Contractor will immediately notify the Contracting Officer, in writing, of the nature of the conflict. The Contractor shall submit a mitigation plan to the Contracting Officer within 30 days of notification, outlining the actions the Contractor has taken or proposes to take to avoid, neutralize, or mitigate the actual or potential organizational conflict of interest.

H.5 The above restrictions shall be included in all subcontracts, teaming arrangements, and other agreements calling for performance of work which is subject to the organizational conflict of interest restrictions identified in these clauses.

H.6 The Contractor acknowledges the full force and effect of the above clauses. The Government reserves the right, in case of a breach, misrepresentation or nondisclosure, to terminate this contract, disqualify the Contractor from subsequent related contractual efforts, or pursues any remedy permitted by law or this contract.

HT001426RE0010003

(End of clause)

DHA PGI 211.106 - PROPER IDENTIFICATION OF CONTRACTOR PERSONNEL (APRIL 4, 2014)

C.1. Contractors, including subcontractors at all tiers, shall provide for a clear distinction from Government personnel. Contractor employees shall not act, advertise, or presume to be Government employees, agents, or representatives. Contractor employees are required to appropriately identify themselves as contractor employees at all times, including in telephone conversations, formal and informal written correspondence, paper and electronic, and in any other situation where their actions could be construed as acts of Government officials, unless, in the judgment of the Government, no harm can come from failing to identify themselves. Contractor employees shall be introduced as contractor personnel and display distinguishing visible identification at all times whether in conversations, meetings, or other forms of communication with Government personnel.

C.2. Contractor personnel, while performing in a contractor capacity, shall refrain from using their retired or reserve component military rank or title (if applicable) in written or verbal communications associated with the contracts for which they provide services.

(End of requirements language)

DHA Procedures, Guidance, and Information (PGI)

DHA PGI 224 - PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION

224.1 - Protection of Individual Privacy 224.1-90 - Personally Identifiable Information (PII), Protected Health Information (PHI), and Federal Information Requirement

(1) Procurement Directive - None

(2) Overview - PGI 224.1-90 provides implementing language and Defense Health Agency (DHA) processes for compliance with requirements set forth in Federal Acquisition Regulation (FAR) Part 24 and Defense Federal Acquisition Regulation Supplement (DFARS) Part 224, pertaining to federal privacy and information laws, including the Health Insurance Portability Accountability Act (HIPAA) Privacy, Security and Breach Rules, 45 CFR Parts 160 and 164, as amended, issued by the Department of Health and Human Services (DHHS). This PGI provides standard language that shall be included in all purchased and non-purchased care solicitations and contracts where the contractor's performance involves access to PII/PHI (unless those solicitations and contracts incorporate the TRICARE Manuals in their entirety, in which case this PGI does not apply).

(3) Implementation instructions for contracts that do not incorporate the TRICARE manuals in their entirety:

a. Solicitations issued or contracts shall include the standard language set forth in (4) if the contractor accesses PII/PHI for any purpose during the performance of the contract.

b. Contracts that have incorporated some but not all of the TRICARE Manuals must be reviewed to determine if the contract includes the provisions in (3)b. i. and (3)b. ii. If any of those provisions are missing from the contract, a determination must be made of whether to incorporate the missing provisions into the contract by modification or to incorporate the standard language as provided in (4). The DHA Privacy and Civil Liberties Office (Privacy Office) should be consulted on these determinations. The TRICARE Manual sections are the following:

i. TRICARE Operations Manual Chapter 1, Section 5, and Chapter 19, Section 3.

ii. TRICARE Systems Manual Chapter 1, Section 1.1.

(4) If the contractor's performance involves access to PII/PHI for any purpose, the Contracting Officer (CO) shall review the "Decision Tree Matrix" (Attachment 1) to determine whether the solicitation/contract action must incorporate the language in DHA Procedures, Guidance, and Information (PGI) DHA PGI 224 - PROTECTION OF PRIVACY AND FREEDOM OF INFORMATION Attachment 2. This document is available at the link "standard contract language" on the page http://www.health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Privacy-Contract-Language/DHAStandard-Contract-Language. If it is determined that the Attachment 2 language is required, the incorporation by reference to Attachment 2 is accomplished by including the following provision in the applicable section of the solicitation/contract: "The contractor shall comply with the document entitled 'Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements,' which is incorporated by reference in its entirety." However, the "in its entirety" language may be replaced with "except for paragraph __," if it is determined that a paragraph is not applicable to the contract. For example, if the contractor is determined not to be a HIPAA business associate, then the "in its entirety" language may be replaced with "except for paragraph 8, HIPAA Business Associate Provisions."

a. Contracts awarded by the Contracting Office, and not utilizing another Department of Defense (DoD) or Non-DoD Agency contract, shall incorporate PII/PHI language in its entirety into the applicable section of the solicitation/contract.

b. For those solicitation/contract actions awarded by another DoD or Non-DoD Agency, on behalf of the Contracting Office, the CO shall coordinate with the respective Agency CO to determine if their contract complies with the privacy compliance requirements addressed in the PGI, including the HIPAA Rules and DoD HIPAA Issuances.

c. The DoD / Non-DoD Agency making the award on behalf of Contracting Office:

i. The Contracting Office CO in coordination with the Agency CO shall determine which portions of the PII/PHI language of this PGI are applicable to the contract. If the Agency contract does not include the applicable portions, the CO shall request those portions be incorporated into solicitation/contract award. The CO may consult with the DHA Privacy Office to determine language to be incorporated.

d. The Contracting Office making the award using another DoD / Non-DoD Agency contract:

i. The Contracting Office CO in coordination with the Agency CO shall determine which portions of the PII/PHI language of this PGI are applicable to the contract.

ii. If the Agency contract does not include applicable portions, the CO shall incorporate those portions into the solicitation/contract. The CO may consult with the DHA Privacy Office to determine language to be incorporated.

Section I - Contract Clauses

Additional Information/Notes

The following Clauses modifications were made:

52.222-42 Statement of Equivalent Rates for Federal Hires. May 2014 hereby reads as follows:

Statement of Equivalent Rates for Federal Hires (May 2014)

In compliance with the Service Contract Labor Standards statute and the regulations of the Secretary of Labor ( ), this clause identifies the classes of 29 CFR Part 4 service employees expected to be employed under the contract and states the wages and fringe benefits payable to each if they were employed by the contracting agency subject to the provisions of 5 U.S.C.5341 or 5 332.

This Statement is for Information Only: It is not a Wage Determination

Employee Class Monetary Wage-Fringe Benefits

01020 Administrative Assistant $45.06 (hour)

(End of clause)

Section L - Instructions, Conditions, & Notices to Offerors or Quoters

Header Miscellaneous Text (Modified):

PROPOSAL INSTRUCTIONS

PROPOSAL CONTENT AND INSTRUCTIONS FOR PREPARATION OF PROPOSALS

Introduction and Purpose - This section specifies the format and content that Offerors shall use in this Request for Proposals (RFP). The intent is not to restrict the Offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. Offerors must submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are of the utmost importance. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified in Section L. Any proposal which does not provide, as a minimum, that which is required in this solicitation may be determined to be substantially incomplete and not warrant any further consideration.

Proposals must be submitted and received in eight (8) separate volumes (I, II, III, IV, V, VI, VII, and VIII).

A complete Volume V, Past Performance, shall be submitted no later than .10:00 a.m. EDT, 10 February 2026

A complete Volume I, Business Proposal (Solicitation, Offer and Award Documents and Certifications/Representations), Volume II, Technical Approach/Capability, Volume III, Management Capability; Volume IV, Personnel Qualifications; Volume VI, Prior Experience; Volume VII, Small Business; and Volume VIII, Cost/Price, shall be submitted no later than .10:00 a.m. EDT, 17 February 2026

Proposals shall be submitted consistent with the instructions below. Proposals shall be submitted to the following email addresses:

john.a.cowgill4.ctr@health.mil ; sou.j.walls.civ@health.mil ; gregory.m.crump.civ@health.mil ; and judith.s.meynard.ctr@health.mil .

Questions concerning this solicitation must be submitted in writing via email no later than .10:00 a.m. EDT, 9 January 2026

Questions must be sent via email to: john.a.cowgill4.ctr@health.mil ; sou.j.walls.civ@health.mil ; gregory.m.crump.civ@health.

; Subject: HT001426RE001. No telephonic questions will be accepted. Answers to questions will be mil ; and judith.s.meynard.ctr@health.mil addressed by amendment to the solicitation which will be posted on the SAM.gov Contracting Opportunities website. In the event that multiple questions address the same issue, the Government reserves the right to answer a representative question that best exemplifies the same issue.

L.1 Contract Award. The Government intends to evaluate offers and may award a contract without discussions or exchanges with Offerors. Therefore, the Offerors' initial offer should contain the best terms from a price and technical standpoint. The Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest. The Government anticipates awarding a Cost-Plus-Fixed-Fee (CPFF) contract from this solicitation.

L.2 Alternate Proposal Information. Multiple and/or alternate proposals will not be considered.

L.3 Solicitation Response. The Offeror shall include all information requested in the solicitation. The Government will not pay, or be responsible for, any proposal costs incurred by the Offeror or any costs attributed to the proposal preparation.

L.4 Submission of Offers.

L.4.1. Time and Date: .10.00 a.m. EDT, 17 February 2026

L.4.1.1. Place of Delivery: The Offeror shall deliver its proposal (via email only) as specified below:

Email to: john.a.cowgill4.ctr@health.mil ; sou.j.walls.civ@health.mil ; gregory.m.crump.civ@health.mil ; and judith.s.

meynard.ctr@health.mil .

L.4.1.2. Offerors may email the above four individuals to confirm receipt of proposals.

L.5 Debriefing of Unsuccessful Offerors. The debriefing of unsuccessful Offerors shall be conducted upon each Offerors' written request consistent with

FAR 15.506.

L.6 Offeror Questions and Clarifications. Any questions, comments or clarifications concerning any aspect of the solicitation shall be submitted in writing via e-mail to ; no later than john.a.cowgill4.ctr@health.mil gregory.m.crump.civ@health.mil ; sou.j.walls.civ@health.mil ; and judith.s.meynard.ctr@health.mil 10:00 a.m.

. Questions or clarifications submitted should identify the topic (e.g., technical, price), and must reference the applicable section of the EDT, 9 January 2026 solicitation (e.g., Section, paragraph, and subparagraph) and RFP number.

L.7 Proposal Instructions. Proposals shall only be accepted via email.

L.7.1. Page Limitation.

l. Page limitations shall be treated as maximums. If exceeded, the excess pages will not be read or considered in the evaluation of the proposal.

2. Each page shall be counted except the following:

a. Volume Cover Pages

b. Table of Contents

c. Summary Section

d. Glossaries

e. Tabs

f. Dividers

g. Blank pages

h. Online Representation and Certifications Application (ORCA Information)

i. Price proposal

j. Consent Letters/Client Authorization Letters

k. Resumes

l. Past Performance Risk Assessment Questionnaires

m. Points of contacts list completing past performance questionnaires

n. Sub-Contractor Consent Letters authorizing release of adverse past performance information

L.7.2 Proposal Files. Proposals shall be prepared with eight (8) separate volumes as follows:

V ol u m e

Volume Title Number of Copies Maximum Page Limit

I Business Proposal

2 - 1 Original + 1 Sanitized (in PDF format) 15

II

Technical Approach /Capability

2 - 1 Original + 1 Sanitized (in PDF format) 20

III

Management Capability

2 - 1 Original + 1 Sanitized (in PDF format) 20

IV

Personnel Qualifications

2 - 1 Original + 1 Sanitized (in PDF format)) 10

V Past Performance Risk

1 Original (in PDF format) On Government provided form, plus up to a 5-page summary detailing the relevance of past performance data provided

VI

Prior Experience

2 - 1 Original + 1 Sanitized (in PDF format) 10

VI

I

Small Business

2 - 1 Original + 1 Sanitized (in PDF format) No Limit

VI

II Cost/Price 2 - 1 Original (in Excel and PDF format) (Must evidence small business participation at 25% of total contract dollars) No Limit

L.8 Proposal Content Requirements. All information shall be confined to the appropriate volume/section. The offeror shall confine submission to essential matters, sufficient to define the proposal and provide adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each proposal. Each volume of the proposal shall include a Table of Contents and Summary Section. The Summary Section shall contain a brief abstract of the volume. Summary section for each volume shall consist of no more than 2 pages. Proprietary information shall be clearly marked. Proposals must include the following written documentation:

L.8.1. Volume I - Business Proposal. Volume I shall include the following (in the order listed):

Standard Form (SF) 33, Solicitation, Offer and Award, to include acknowledgment of all amendments as applicable: Two (2) copies, sanitized copy shall not contain corporate logos, signatures, or any other company identifiable information.

The Offeror shall complete Items 12 through 18, of the SF33 as appropriate.

The Offeror shall acknowledge all amendments by signing and returning SF 30 or by acknowledging the amendments in Item 14 of the SF33.

Names, titles, and telephone numbers and e-mail address of persons authorized to negotiate on the Offeror's behalf with the Government in connection with this solicitation;

Section K, Representation, Certifications and Other Statements of Offerors: completed copies containing completed fill-ins.

Unless specifically agreed upon between the prime and individual team members, company financial information shall not be accessible between the offering parties.

L.8.2. Volume II -Technical Approach/Capability. This volume consists of your organization's capabilities and the means that the Offeror intends to use to satisfy the requirements stated in this Solicitation. The technical proposal shall describe the offeror's understanding of and methods for providing quality services, particularly regarding the conduct and support of clinical investigations and studies, and procedures for accounting for and safeguarding Government furnished property. The proposal shall also describe the offeror's plan for an effective and orderly transition of services during the phase-in of the contract. It will be evaluated in accordance with the criteria contained in Section M of the solicitation and it should be specific and complete in every detail. A proposal that includes a mere repetition of the requirements as stated in performance work statement document will not be acceptable and may cause the Government to reject the proposal as technically unacceptable. Be specific and complete by demonstrating a thorough understanding of the requirements.

L.8.3. Volume III - Management Capability. The Offeror's proposal shall demonstrate how the Contractor's proposed management approach and organization, to include the key personnel designated in the PWS, will achieve the goal of delivering timely high quality services within stated timelines for this requirement if awarded the contract. The Offeror's proposal shall demonstrate an understanding of the services and major deliverables identified in the solicitation in sufficient detail to provide the Government an understanding of the manner and method of management during contract performance and should detail the effectiveness of the Offeror's overall contract/program management, integration of the effort with the Offeror's proposed partner(s), if any, subcontract management, vendor management, preliminary timeline and sequence of events. The offeror shall describe how it will manage the performance of quality services of a geographically dispersed workforce at multiple locations and of multiple subcontractors, as applicable. The offeror shall also describe its methods for controlling costs and projecting and reporting cost disparities and growth to the Government. Describe your Retention Plan and company policy to retain employees and subcontractors with minimum turnover and to achieve contractually established fill rates for each professional grouping (physicians, clinical investigators/researchers, nurses, and ancillary personnel) for all locations stated in the solicitation. Describe applicable retention incentives and training programs and methods to achieve the required fill rates.

L.8.4. Volume IV - Personnel Qualifications. The Offeror proposal shall document how the Contractor will meet and comply with the personnel qualification standards established in the PWS. At a minimum, provide an outline of the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in this solicitation.

L.8.5 Volume V - Past Performance Risk (Past and Present Performance)

L.8.5.1 General.

Each Offeror shall submit recent, present and past performance information with its proposal in accordance with the below guidance. This information is required on the Offeror and subcontractors, teaming partners, and/or joint venture partners who are proposed to perform at least 25 percent of the contract effort. Along with the information required in this section, the Offeror shall submit a consent letter executed by each subcontractor, teaming partner, and/or joint venture partner, authorizing release of adverse past performance information to the Offeror so the Offeror can respond to such information. For each identified effort for a commercial customer, the Offeror shall also submit a client authorization letter, authorizing release to the Government of requested information of the Offeror's performance.

L.8.5.2. Early Proposal Information.

Each offeror shall submit the Past Performance Risk Assessment and a list of primary point of contacts that will be submitting/ completing the questionnaires by 10:

. Questionnaires received after the date and time required will be deemed late and will not be considered for evaluation. The early 00 a.m. EDT, 15 January 2026 submission of the Past Performance Risk Assessment Questionnaires will aid the Government in the evaluation of the past performance factor.

L.8.5.3. Offerors shall submit past performance information on at least three (3) but not more than five (5) recent contracts (within the past three years from the date of the solicitation). If more than 5 contract references are submitted, only the first five will be evaluated in the order received by the Government. Information must include a minimum of three (3) recent contracts performed by the prime contractor. References may include performance on contracts for Federal, State and local Governments as well as private commercial firms.

L.8.5.4 The Government reserves the right to evaluate Contractor Performance Assessment Reporting System (CPARS) data in conjunction with received completed past performance questionnaires.

L.8.5.5. Specific Content.

This section shall include the following information/format:

Submit on provided Past Performance Questionnaire.

L.8.6 VOLUME VI - Prior Experience. The offeror shall provide examples of projects being performed or performed in the past that are representative of their technical approach.

L.8.7 VOLUME VII - Small Business Participation Commitment/ Plan. DHA is committed to maximizing small business opportunities at both the prime and subcontractor level. All Offerors (other than small business and small business) shall prepare a summary list of proposed subcontractors, which includes the following information: Company name, CAGE code, Size Status, Socio-Economic Status, Description of the Subcontracted work, Subcontract Dollars, and Percentage of Total Contract Value proposed. For Small Business Participation Commitment evaluation purposes, the Total Contract Value proposed is considered to be the numerical sum of the total contract dollar value as contemplated under this solicitation (see Section I, FAR 52.216-18). DHA will use the System for Award Management (SAM) website (https://www.sam.gov/portal/public/SAM), which provides for registration and online representations and certification to verify proposed small business entities meet the assigned RFP NAICS (541990), small business size standard ($19.5M) and the socioeconomic categories in which they are counted. The Offeror shall describe its approach and ability to team with small or disadvantaged companies to meet the Small Business participation commitment of 25% outlined in the contract. The Offeror's proposal will be evaluated for commitment also to small business, as evidenced in the first page (identifying the subcontractor or protege) and signature page of teaming agreements, Mentor-Protege Agreements and/or letters of commitment; identifying the type of work subcontracted; percentage of total contract value subcontracted to small businesses. The Offeror's small business participation commitment also will be evaluated relative to meeting the Small Business subcontracting requirement, based on total contract value, in the chart below. Alaska Native Corporation (ANC) and Native American, and Tribally-owned subcontractors may be counted as part of the Small Business subcontracting percentage in accordance with FAR 19.703(c).

In the case of minor errors or omissions that do not affect the other areas of the proposal, and may be corrected with minor clarification, the Offeror may be contacted by the Procuring Contracting Officer for immediate clarification. In the case that an Offeror meets the criteria as specified in paragraph L.8.7 and through discussions provides a Final Proposal Revision (FPR), the criteria for paragraph L.8.7 must be met. Offerors must submit the 1st page (identifying the subcontractor or protege) and signature page of teaming agreements, mentor-protege agreements and/or letters of commitment as evidence of commitment to small business. These agreements and letters of commitment do not count in the page count.

SMALL BUSINESS SUBCONTRACTING PLAN

In accordance with FAR 19.704 and DFARS 219.704 Other Than Small Business Offerors shall submit a small business subcontracting plan in accordance with FAR 52.219-9 and DFARS 252.219-7003 (or DFARS 252.219-7004 if the Offeror has a comprehensive subcontracting plan). The small business subcontracting plan is a requirement for award to a Large Business and will be incorporated into any resultant contract. Subcontracting plans shall reflect and be consistent with the commitments offered in the Small Business Participation Commitment Proposal. The small business subcontracting plan will be assessed in accordance with FAR 19.704, and must be deemed acceptable prior to award. Note: Any exchanges with the Procuring Contracting Officer regarding the small business subcontracting plan shall not be considered discussions. For Small Business Subcontracting Plan evaluation purposes, the Total Contract Value proposed is considered to be the numerical sum of the total contract dollar value as contemplated under this solicitation, such that subcontracted percentages are based on Total Contract Value as the denominator rather than total amount of subcontracted value as the denominator. NOTE: The Small Business Participation Commitment and Small Business Subcontracting Plan are separate requirements.

L.8.8 Volume VIII - .Cost/Price Proposal

L.8.8.1 VOLUME VIII - COST/PRICE

L.8.8.2 .Cost/Price Reasonableness and Realism

These instructions provide the offeror guidance in submitting information other than cost or pricing data that is required to evaluate the reasonableness and realism of their proposed cost/price. Compliance with these requirements is mandatory and failure to comply may result in rejection of your proposal. Note that unrealistically low or high-proposed costs or prices, initially or subsequently, may be grounds for eliminating a proposal from competition either on the basis that the offeror does not understand the requirement or has submitted an unrealistic proposal. Additionally, unbalanced pricing poses an unacceptable risk to the Government and may be a reason to reject an offeror's proposal. Offers shall be sufficiently detailed to demonstrate their reasonableness and realism. The burden of proof for credibility of proposed costs/prices rests with the offeror.

L.8.8.3 Cost/Price Information

Information beyond that required by this instruction shall not be submitted, unless you consider it essential to document or support your cost/price position. All information relating to the proposed price including all required supporting documentation must be included in the section of the proposal designated as the Cost /Price volume. Under no circumstances shall this information and documentation be included elsewhere in the proposal.

L.8.8.4 Cost or Pricing Information Requirements

In accordance with FAR 15.403-I(b) and I 5.403-3(a), information other than cost or pricing data may be required to support price reasonableness Information shall be provided in accordance with FAR 15.403-5. If, after receipt of proposals, the PCO determines that there is insufficient information available to determine price reasonableness and none of the exceptions in FAR 15.403-1 apply, the offeror shall be required to submit cost or pricing data. The Contracting Officer reserves the right in appropriate circumstances to also require that such data be certified.

L.8.8.5 Cost/Pricing Volume Content

The format of the Cost/Price volume shall be as follows:

Tab 1: Table of Contents, Glossary, and Definitions Tab 2: Estimating System/Methodology Tab 3: Purchasing System Tab 4: Accounting System Tab 5: Financial Capability Tab 6: Identification of Subcontracts Tab 7: Compensation Plan Tab 8: Cost and Supporting Information

Tab 9: Additional Information

Tab I -Table of Contents, Glossary, and Definitions

Provide a detailed table of contents for this volume. Provide a glossary of all abbreviations and acronyms used, with an explanation for each. However, use of abbreviations and acronyms should be limited. Provide definitions as necessary.

Tab 2 - Estimating System

Provide a summary description of your standard estimating system or methods, current policies, and/or new policies. State whether you have Government approval of your estimating system and if so, provide evidence of such approval. The summary description shall cover separately each major cost element (e.g., Direct Labor by major labor category, Indirect Costs, Other Direct Costs, Overhead, G&A, etc.). Provide any known/cited estimating system deficiencies. Also, identify any deviations from the offeror's established/standard estimating procedures used in preparing this proposal.

Tab 3 - Purchasing System

Provide a summary description of your purchasing system or methods. State whether you have Government approval of your purchasing system and if so, provide evidence of such approval. Provide any known/cited purchasing system deficiencies. Also, identify any deviations from the offeror's established /standard purchasing procedures used in preparing this proposal.

Tab 4 - Accounting System

State whether you have DCAA approved CAS compliant accounting system and if so, provide evidence of such approval. No Cost-Plus-Fixed-Fee (CPFF) contract may be awarded unless the limitations in FAR 16.301-3 and 15.404-4(c) (4) (i) are met. One of the limitations is that the contractor's accounting system be adequate for determining costs. Therefore, no award can be made of this contract to an offeror whose accounting system has not been determined to be adequate for cost-reimbursement contracts. This affects all team member/subcontractors if the prime anticipates awarding cost-reimbursement contracts to any of the subcontractors. If no cost-reimbursement subcontracts are to be awarded, the offeror shall so state. If cost-reimbursement subcontracts are to be awarded, the offeror shall provide the necessary information from the subcontractors.

Tab 5 - Financial Capability

You must demonstrate that you have or can obtain adequate financial resources to perform the contract in accordance with FAR 9.104-l(a) and DFARS

232.072. Provide the information and documentation required by DFARS 232.072-2(b) and 232.072-3.

Financial Information. Financial information will be used as part of the contractor responsibility determination in accordance with FAR/DFARS/AFARS Part 9. The Offeror shall describe the Company's financial condition and capability. State what percentage of the company's estimated total business the work required by this solicitation will represent. Include an organizational matrix that reflects how the prospective contract would fit into the company. Provide a current statement of financial condition, that includes:

Income (profit-loss) Statement for the past three years;

Balance Sheet that shows the assets owned and the claims against those assets for the past three years, or what the firm owns and what it owes for the past three years; and, Cash Flow Statement that shows the firm's sources and uses of cash during the past three years of accounting periods. This will help the Government assess a firm's ability to pay its obligations.

Line of Credit: The Offeror shall clearly show its total amount of credit available from each financial institution where a line of credit has been established, amount of credit used to date or balance available, and each line of credit repayment terms. Offeror shall provide point of contact and phone number for the lender.

Tab 6 - Identification of Subcontracts

Provide the information required by FAR 52.215-22, Excessive Pass-Through Charges- Identification of Subcontract Effort. In accordance with FAR 52.215-22 Limitations on Pass-Through Charges - Identification of Subcontract Effort: The contractor shall utilize Table LX-1 to identify the cost of work to be performed by each subcontractor as applicable.

Tab 7 - Compensation Plan

1. Additionally, a comprehensive compensation plan must be submitted for all specialties listed on the provided cost/price matrix. The Contractor shall be responsible to provide a compensation plan that allows them to recruit and retain qualified personnel to perform the required services at all locations.

2. For purposes of evaluating the compensation plan, offerors shall propose compensation hourly rates based upon hours as a full time equivalent. Failure to 1872 provide compensation hourly rates based upon hours may result in the proposal being deemed unacceptable and the offeror being rejected for consideration 1872 for award. It is understood that the ours represents I full time equivalent (FTE). The compensation plan shall include, but not be limited to allowances for 1872 h sick leave, vacation, other types of fringe benefits, etc. The comprehensive compensation plan shall be submitted in detail for Year I only.

3. The offeror shall identify all benefits offered and show these broken out by dollar amount along with the hourly salary rate to show the individual components of the total hourly compensation rate. Do not provide salary or fringe benefits as annual dollar amounts.

4. Include the following support documentation:

a) Description of the market research data used to estimate the compensation hourly rate for each location. The contractor must include the name of the source, how recent the information is and how the proposed rates were calculated.

b) In addition, the offeror shall provide a narrative describing the individual fringe benefits.

Tab 8 - Cost and Supporting Information

Offerors shall:

Ensure that all direct labor rates and indirect expense rates and estimating factors used in the proposal have been submitted for review by the cognizant Defense Contract Audit Agency prior to cost proposal submission. If an offeror currently has a Forward Pricing Rate Agreement (FPRA) in place, this must be stated and reflected in the proposal. Unless the offeror has more current cost and pricing data than the FPRA, the offeror should submit the most current information along with the FPRA.

TABLE LX-1

SUBCONTRACT/INTERORGANIZATIONAL TRANSFERS

& CONSULTANTS

PRICE SUMMARY

SUBCONTRACTOR

NAME

SUBCONTRACT

TASKS**

SUBCONTRACT

TYPE

SUBCONTRACT

QUOTED PRICE

SUBCONTRACTOR COST

PROPOSED BY PRIME

DIFFERE

NCE

TOTALS

Tab 9 - Additional Information

Use this section to submit any additional information or supporting documents the offeror considers essential to support the cost/price position, including Government-furnished property or services not identified in the PWS.

Section M - Evaluation Factors for Award

Header Miscellaneous Text (Modified):

SECTION M EVALUATION FACTORS FOR AWARD

M.1. Contract Evaluation and Award

The Government intends to award a Cost-Plus-Fixed-Fee (CPFF) contract to the Offeror whose proposal provides the overall best value to the Government, price and other factors considered. The Government reserves the right to make award to other than the lowest-priced Offeror and other than the highest technically rated Offeror.

The Government intends to evaluate offers and may award a contract without discussions or exchanges with Offerors. The Government may establish a competitive range in the evaluation of proposals and discussions may be held only with Offerors within the competitive range. If the Contracting Officer determines that the number of proposals that would otherwise be in the competitive range exceeds the number at which an efficient competition can be conducted, the Contracting Officer may limit the number of proposals in the competitive range to a number that will permit an efficient competition among the most highly rated proposals. Therefore, the offeror's initial proposal should contain the offeror's best terms from a price and technical standpoint. In the evaluation of all Offerors' proposals, appropriate consideration is given to seven (7) evaluation factors:

Technical Approach/Capability, Management Capability, Personnel Qualifications, Past Performance Risk, Prior Experience, Small Business Participation Commitment/Plan, and Cost/Price. The evaluation factors are listed in descending order of importance. The combined non-price factors (Technical Approach /Capability, Management Capability, Personnel Qualifications, Past Performance Risk, Prior Experience, and Small Business Participation Commitment/Plan) are significantly more important than Price. To receive consideration for award, a rating of no less than "acceptable" must be achieved on all non-price factors, except for past performance. An offeror which receives a substantial The Small Business Participation Commitment will be evaluated on a PASS/FAIL basis.

confidence, satisfactory confidence, or unknown confidence (neutral) past performance rating shall be considered for award. Cost/Price is of least importance.

It is the offeror's responsibility to insure the completeness of its proposal. The Government will evaluate on the basis of the information provided in the proposal. The Government shall not make assumptions regarding the offeror's proposal or capabilities, unless specifically discussed in the proposal. Proposals that are unrealistic technically or unrealistically low in price or cost may be considered indicative of a lack of understanding of the contract's requirements.

M.2. Rejection of Offers

The Government reserves the right to reject an offer if the offeror fails to submit any of the required proposal documents required by Section L.

M.3. Basis for Award

The award decision will be based on the evaluation of all factors set forth in this solicitation. Award will be made to the responsible Offeror whose proposal conforms to the solicitation requirements and represents the best value to the Government. The Government evaluation process will permit tradeoffs among the specific evaluation factors and will allow award to other than lowest priced Offerors(s) or other than the highest technically rated Offeror(s). Each proposal will be evaluated against the factors described herein. An Offeror's failure to address any factors may be considered indicative of the Offeror's lack of understanding of the Government's requirements and may result in the offer being determined unacceptable. Offerors must ensure all information pertaining to the factor is addressed in that particular portion of the proposal.

Proposals will be adjectivally rated against each of the evaluation factors set forth in Section M and will be given an overall adjectival rating. The adjectival ratings to be used for Technical Approach/Capability, Management Capability, Personnel Qualifications, and Prior Experience factors are: Outstanding, Good, Acceptable, Marginal, and Unacceptable, and will be factually based. The past performance confidence assessments are substantial, satisfactory, limited, no, and unknown confidence. The Small Business Participation Factor will be evaluated on a PASS/FAIL BASIS.

M.3.1. FACTOR I - TECHNICAL APPROACH/CAPABILITY - The Government will evaluate the offeror's technical approach on its completeness, quality, feasibility, practicability, innovativeness, and appropriateness in accomplishing the tasks and deliverables of this requirement from a technical perspective, to include the management of Government Furnished Equipment (GFE). The Government will also evaluate the offerors on the clarity of their approach and their ability to convey to the Government their ability to perform the requirements in the PWS. The evaluation assesses the offeror's Technical Approach/Capability to meet the Government's requirements. It assesses the offeror's understanding and capability of performing the Government's Requirements, and the effectiveness of its proposed plan for the orderly and effective transition of services during the initial phase-in of the contract.

M.3.2. FACTOR II - MANAGEMENT CAPABILITY: The offeror shall demonstrate an understanding of the requirement for the support described in the PWS, and demonstrate how the offeror's proposed management approach and management organization, to include key personnel, will deliver timely quality services. The offeror shall also be evaluated regarding the effectiveness of its proposed management plan in integrating the effo1is of a geographically dispersed workforce at multiple locations and the effectiveness of its management of its proposed partners, subcontractors, and vendors. The Government will also evaluate the offeror's plan for managing and controlling costs and projecting and reporting cost disparities and growth to the Government. The retention plan and company policy will be evaluated to determine the offeror's ability to retain employees and subcontracts with minimum turnover and to achieve contractually established fill rates for each professional grouping (physicians, nurses, clinical investigators/researchers and ancillary personnel) for all locations stated in the solicitation. Applicable retention incentives, training programs and methods to achieve the required fill rates will be evaluated.

M.3.3 FACTOR III - PERSONNEL QUALIFICATIONS: The Government will evaluate the Offeror's proposed Personnel Qualifications on its ability to accomplish the requirements of the PWS, to include its completeness, quality, feasibility and practicality, and understanding of the Government's requirements. Offerors should demonstrate how key personnel qualifications supports their proposed technical approach.

M.3.4 FACTOR IV - PRIOR EXPERIENCE: The Government will evaluate the Offeror's demonstrated Prior Performance in performing projects representative of its technical approach as described in its proposal. Offerors should demonstrate how that performance supports their proposed technical approach.

The technical approach/capability, management capability, personnel qualifications, and prior experience will be separately evaluated using the following adjectival ratings:

COMBINED TECHNICAL RATING

RAT

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