RFP Amendment 0002 W81XWH-21-R-0054 SM Wearble TBI 11-18-2021.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 incorporate questions and answ ers received in response to the RFP.

1. CONTRACT ID CODE PAGE OF PAGES

S 1 3

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

16C. DATE SIGNED

BY 18-Nov-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 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 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

18-Nov-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 added by full text:

QUESTIONS AND ANSWERS

Questions and Answers in response to Request For Proposal (RFP) W81XWH-21-R-0054 For

Service Member (SM) Wearable Traumatic Brain Injury (TBI) Device

1. Does the Customer envision the wearable to be a retrofit TBI reducing technology that is attachable/incorporated into combat helmets (i.e new padding)?

a. There is no requirement to retrofit or be incorporated/attached into current Personal Protective Equipment, including the advanced combat helmet. The only requirement is that the solution does not interfere with the efficacy or wear of current PPE.

2. Do they envision a FDA approved wearable medical device that is separate from combat helmets completely?

a. The requirement is for an FDA-approved solution with an indication for use that is inclusive of the performance attributes noted in SOO Table 1. Solutions can be completely independent of the advanced combat helmet, but there is no requirement for it to be completely independent of it. The only requirement is that the solution does not interfere with the efficacy or wear of current PPE (ACH, protective eyewear, uniforms).

3. Could you please confirm the timeline for the period of performance and completion of each of the aims?

a. We expect that Aim 1 could be completed with 36 months or less.

4. The RFP states that FDA approval must be achieved during Aim 1 prior to moving on to Aim 2. Should the first aim occur within the period of performance of 36 months, or should all four aims be completed in that timeframe?

a. This question is no longer applicable as Aims 2 – 3 were removed from the RFP.

5. We would like to understand if all activities must be completed by the end of the three year PoP?

a. Aim 1 should be completed with 36 months or less.

6. Could you please tell me if the Combined Synopsis/Solicitation posted as solicitation number W81XWH21R0054 will be a follow-on requirement to any work performed currently or in the past, or will this be a new requirement? If possible, can you please provide the most recent contract or task order number?

a. W81XWH-21-R-0054 is not a follow-on requirement for work performed in the past.

7. With regards to the Statement of Objectives, we would appreciate clarification if the solicitation exclusively is seeking direct interventional product solutions that would be worn by warfighters to protect the brain as a prophylactic system?

a. This SOO seeks solutions whose mechanism of action provides direct prophylaxis of TBI risk/severity.

W81XWH21R0054

8. If diagnostic systems are considered out of scope for the solicitation, we respectfully ask that the Statement of Objectives be expanded to include diagnostics systems meeting all the attributes in the solicitation.

a. This SOO seeks solutions whose mechanism of action provides direct prophylaxis of TBI risk/severity. Therefore post-injury event diagnostic solutions would be outside the scope of this RFP.

9. Looking for attachment 7, Cost Template for RFP W81XWH-21-R-0054.

a. Attachment 7, Cost Template will be included in amendment 0001.

10. In Section 4. Place and Period of Performance, it is stated that Deliverable 20 for Aim 2 must be completed before performance on Aim 3 can start. Do you mean Deliverable 21? Deliverable 20 test articles are for the OA and IOT&E (AIM 2 activities).

a. This question is no longer applicable as Aims 2 – 3 were removed from the RFP.

11. Also in Section 4 it is stated that Deliverable 22 (Clinical Study Approval), 23 (FDA Submission), and 24 for Aim 3 must be completed before performance on Aim 4 can start. Does that include Deliverable 25 (100 production Items) which is due 11 (SOO) /12 (Table) months after PoP begins?

a. This question is no longer applicable as Aims 2 – 3 were removed from the RFP.

12. Additionally is delivery 25 required 11 months and award according to text in 6.1.25 or 12 months according to table in Section 6?

a. This question is no longer applicable as Aims 2 – 3 were removed from the RFP.

13. With the expectation that this will be a Cost-Plus contract, are small business required or are they exempt from having to have a DCAA/DCMA certified accounting System at time of award?

a. All Offerors regardless of their socio economic size will be required to demonstrate they have an adequate accounting system.

(End of Summary of Changes)