Amendment_W81XWH-19-R-0036-0001_20190604.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 subject solicitation is amended for the follow ing purpose:

1) Provide Vendor questions and the Government's responses (Solicitation Attachment 10 - Questions & Answ ers).

2) Revise the Solicitation/RFP (SF33) in accordance w ith the Government's answ ers to Vendor questions.

a) Section C, SOO, Paragraph 1.0 Background and Overview .

b) Section C, SOO, Paragraph 3.0 Product Characteristics, Table 1. Product Performance Requirements.

c) Section J, Exhibits & Attachments.

The proposal due date is not extended. All other terms and conditions remain unchanged. See 'Summary of Changes' for details.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 5

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

16C. DATE SIGNED

BY 04-Jun-2019

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 W81XWH19R0036

X 9B. DATED (SEE ITEM 11)

24-May-2019

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 is extended, X 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 1 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

04-Jun-2019

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:

W81XWH19R0036

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been modified:

STATEMENT OF OBJECTIVES (SOO)

Extracorporeal Life Support (ECLS) Reduced Dialysate

1.0 Background and Overview

The US Army Medical Materiel Development Activity’s (USAMMDA’s) mission is to develop and deliver quality medical capabilities to protect, treat, and sustain the health of our Service Members and the Joint Program Committee-6’s (JPC-6’s) mission seeks to drive medical innovation through the development of knowledge and materiel solutions for the acute and early management of combat-related trauma.

Extracorporeal life support (ECLS) is administered to critically ill patients suffering from life-threatening renal injuries. For the purposes of this requirement extracorporeal life support is defined as any system that pulls blood out of the body and performs an action on the blood replacing the function of a critically injured organ. In this sense, it can be applicable to the lungs, heart, kidneys, or liver. This requirement is specifically for reducing dialysate required to run continuous renal replacement therapy (CRRT) for kidney support when treating patients with acute kidney injury (AKI).

Although ECLS is a life-saving intervention, current technology is limited by the immense logistical footprint required to support these devices. Current standard of care ECLS devices that provide support to the kidneys require ~70L of replacement fluid per patient per day. This is an immense logistical burden in the far forward environment where supply lines are limited or non-existent making the support of these devices infeasible. Therefore, the aim of this effort is to reduce the amount of replacement fluid required to support these patients in a logistically constrained environment.

2.0 Scope of Work

2.1 Scope

USAMMDA & JPC-6 anticipate the need for the following activities to be performed during the contract period:

Phase I:

2.1.1 Task #1: Food and Drug Administration (FDA) pre-submission meeting(s).

2.1.2 Task #2 (if required): Risk based assessment of the biocompatibility tests required for Investigational Device Exemption (IDE) acceptance.

2.1.3 Task #3: IDE preparation and submission.

2.1.4 Task #4 (if required): Performance, physical, & chemical property assessments of the device.

2.1.5 Task #5 (if required): Preclinical animal testing: testing ex vivo Good Laboratory Practices (GLP) safety and efficacy testing on uninjured and injured large animals with human like physiology in an Acute Kidney Injury (AKI) model. All testing shall be conducted following approval from an Institutional Animal Care and Use Committee (IACUC) and the US Army Medical Research and Materiel Command’s (USAMRMC’s) Animal Care and Use

Review Office (ACURO) (https://mrmc.amedd.army.mil/index.cfm?pageid=Research_Protections.acuro_Animalappendix)

2.1.6 Task #6: Clinical animal testing: testing ex vivo GLP safety and efficacy testing on uninjured and injured large animals with human like physiology in an Acute Kidney Injury (AKI) model. All testing shall be conducted following approval from an IACUC and USAMRMC’s ACURO (https://mrmc.amedd.army.mil/index.cfm?pageid=Research_Protections.acuro_Animalappendix)

Phase II:

2.1.7 Task #1 (if required): Human feasibility studies as required by FDA. The device(s) will demonstrate proof of concept safety and efficacy in sustaining critically ill patients with AKI using less than or equal to 0.5L of replacement fluids per day for a minimum of 72 hours of support. All testing shall be conducted following approval from an Institutional Review Board (IRB) and USAMRMC’s Human Research Protection Office (HRPO) (https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.hrpo)

2.1.8 Task #2: Prototype finalization and lock down based on the Department of Defense (DoD) specifications.

Prototypes must be developed in compliance with Title 21 Code of Federal Regulations Part 820 (21 CFR 820) requirements. Design control and Quality Management System (QMS) documentation shall be available for assessment by the Government.

2.1.9 Task #3: Finalized product design freeze as per 21 CFR 820 compliant QMS.

2.1.10 Task #4: Delivery of two (2) Good Manufacturing Practices (GMP) (ISO 9001 and/or ISO 13485 compliant) representative devices to the Government (including 2 sets of consumables per device) following product design freeze.

2.1.11 Task #5 (if required): Human pivotal study. The device will be demonstrated to be safe and effective in sustaining critically ill patients with AKI using less than or equal to 0.5L of replacement fluids per day for a minimum of 72 hours of support. All testing shall be conducted following approval from an IRB and USAMRMC’s HRPO (https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.hrpo)

2.1.12 Task #6: FDA Submission.

2.1.13 Task #7: Delivery of six (6) FDA market authorized devices to the Government (including 2 sets of consumables per device).

3.0 Product Characteristics

The USAMMDA’s & JPC-6’s objective is to develop a small, lightweight, rugged ECLS device that provides renal support to critically injured patients. The following performance thresholds (minimum acceptable value) and objectives (desired value) have been developed for this requirement. Upon completion of the contract the device must meet the thresholds and will ideally meet the objectives.

Table 1. Product Performance Requirements

Parameter Threshold Objective

Regulatory Status FDA market authorized to provide renal support for treatment of AKI patients T=O

Catheter/Cannula Insertion Lengths

15cm & 24cm 15cm, 24cm, & 50cm

Weight* ≤20lbs ≤10lbs

Power 110/220Volt alternate current (AC) and/or 11-28Volt direct current (DC)

T=O

Battery Type Rechargeable T=O Battery Life 8 Hours 16 Hours

Hot Swappable Battery(ies) Device remains in operation while battery(ies) is/are swapped out T=O

Replacement Fluid ≤3.0L of renal replacement fluid per patient per day ≤0.5L of renal replacement fluid per patient per day

Ruggedization Suitable for military use according to the JECETS** T=O

*The weight requirement includes the device itself and new dialysate reduction technology even if the new technology is a consumable. The weight requirement does not include other standard consumables used for CRRT (e.g. dialysate, dialyzer, tubing, catheters, etc.). In other words, the solution shall not swap out 25lbs.

of dialysate for 25lbs. of a different consumable that is meant to reduce the dialysate.

**Joint Enroute Care Equipment Standard (JECETS) (Solicitation Attachment 1).

4.0 Period of Performance

The period of performance shall be up to 36 months from contract award.

(End of Statement of Objectives)

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

The following have been modified:

EXHIBITS & ATTACHMENTS

DOCUMENT TYPE DESCRIPTION PAGES DATE

Exhibit A Exhibit A, CDRL A001 - FDA Interactions 3 Exhibit B Exhibit B, CDRL A002 - Product Development

Planning Documents

Exhibit C Exhibit C, CDRL A003 - Pre-clinical Testing and Trials Data

Exhibit D Exhibit D, CDRL A004 - Clinical Trials Data 3 Exhibit E Exhibit E, CDRL A005 - Manufacturing Data 3 Exhibit F Exhibit F, CDRL A006 - System Engineering

Data

Exhibit G Exhibit G, CDRL A007 - Quality Assurance Data

Exhibit H Exhibit H, CDRL A008 - Scientific and Technical Reports: Test Reports

Attachment 1 Joint Enroute Care Equipment Standard

(JECETS)

Attachment 2 Data Item Description DI-TCSP-82040 33 Attachment 3 Data Item Description DI-MISC-80711A 1 Attachment 4 Standard Form (SF) 298 - Report

Documentation Page

Attachment 5 Draft Quality Assurance Surveillance Plan (QASP) Template

Attachment 6 Non-Disclosure / Non-Use Agreement 2 Attachment 7 Organizational Conflict of Interest (OCI)

Certification

Attachment 8 Proposed Level of Effort Template 1 Attachment 9 Cost Proposal Spreadsheet (.xls) 6 Attachment 10 Questions & Answers 1

(End of Exhibits & Attachments)

(End of Summary of Changes)