Amendment_0001.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

1. CONTRACT ID CODE PAGE OF PAGES

S 1 4

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

16C. DATE SIGNED

BY 26-Mar-2018

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 W911QY-18-R-0019

X 9B. DATED (SEE ITEM 11)

12-Mar-2018

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.)

Respond to Offeror's questions. Make changes to Section L of RFP.

10A. MOD. OF CONTRACT/ORDER NO.

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

6. ISSUED BY

3. EFFECTIVE DATE

26-Mar-2018

CODE

W6QK ACC-APG NATICK

1564 FREEDMAN DRIVE

FORT DETRICK MD 21702

W911QY 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W911QY-18-R-0019

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

Solicitation W911QY-18-R-0019 Request for Proposal (RFP) and Product Demonstration Model (PDM) Questions and Responses

1. Would the Government consider the potential cost savings for LFI’s without Hook effect, e.g. false negative results in the presence of high concentrations of an antigen? Multiple dilutions and tests are often required for traditional LFIs in order to avoid the Hook effect during each sample analysis, while only one test is needed for the LFIs without the Hook effect.

Response: No. There is no requirement to address the Hook effect therefore it is not being evaluated under this solicitation.

2. On page 64 of the solicitation, Table 1: “Government Furnished Material” states that 620 tops and 620 bottom carriers will be provided. Are more carriers available for participant internal PDM testing?

Response: Yes. Although the DBPAO feels that the amount of housings (620) provided is sufficient, an additional 200 housing will be provided to better align with each participants internal testing procedures. This has been revised in solicitation in Section L, Section L, Attachment 2: Product Demonstration Model Plan - 3.0 TECHNICAL REQUIREMENTS - 3.1 GOVERNMENT FURNISHED MATERIAL (GFM) - Table 1.

3. On page 64 of the solicitation, Table 1: “Government Furnished Material” states that 1mg of each antibody will be provided. This amount is inadequate for a completely new assay development effort. Would the government be able to provide more antibody for development of the assay?

Response: Yes. Although DBPAO feels that 1mg of antibody is sufficient to develop a new assay, an additional 2 mg of each antibody, for a total of 3 mg of each antibody will be provided to meet each participant’s needs. This has been revised in solicitation Section L, Attachment 2: Product Demonstration Model Plan - 3.0 TECHNICAL REQUIREMENTS - 3.1 GOVERNMENT FURNISHED MATERIAL (GFM) - Table 1.

4. Is it permissible to use a composite pad consisting of additional pads at both sample addition and receiving ends provided its length and width meet specification for this PDM?

Response: Yes. The Government has no specific layer of quantities requirement within a single conjugate pad as long as it meets the physical specifications laid out in Section L, Attachment 4 LFI Strip Drawing.

5. On page 71 Section L attachment 4 – LFI Strip Drawing is very difficult to see the specific dimensions.

Furthermore, it is also very difficult or even impossible to read the small text within the boxes corresponding to critical features of the specifications. Is there a better copy available to participants?

Response: Yes. An enhanced copy is now provided as a separate link on the solicitation main page at http://www3.natick.army.mil/(S(2yp5lhgmmbl2yrrjsfnrtrn5))/w911qy-18-r-0019.aspx

6. In Section C12, the solicitation states that the offeror shall; “Have and maintain a Quality Management System (QMS) equivalent to ISO 9001: 2008 standards to ensure the LFI strips are produced, stored and distributed in accordance with the Government requirements.” Since ISO Standard of 9001:2008 will be phased out by the end of September 2018, upon the start of the contract, does the Government mean that the offeror must have ISO9001:2015 certification?

Response: No. The solicitation requires offerors to have and maintain a QMS equivalent to ISO 9001:2008.

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been modified:

L.2 SEQUENCE OF EVENTS

L.2.1 The Government will employ informal source selection techniques to evaluate proposals, conduct discussions, if necessary, and determine the successful Offeror in this acquisition. “Offer,” for the purposes of this solicitation, shall be defined as a response to the solicitation that, if accepted, would bind the Offeror to perform the resultant contract. The following Table summarizes the anticipated sequence of events from RFP Release through contract award:

Event Completion Date RFP release 3/12/2018 Submit any questions for clarifications 3/19/2018 Receive intent to participate in Product Demonstration Model (PDM) 3/27/2018 GFM to Participants 3/28/2018 Product Demonstration Model (PDM) submission 4/25/2018 Proposal Receipt 5/31/2018 Contract Award 9/26/2018

Section L, Attachment 2: Product Demonstration Model Plan

2.0 PDM PROCESS

Upon release of the Request for Proposals (RFP), 12 March 2018, Respondents must submit a Request to Participate and a signed LFI PDM Participation Agreement by 27 March 2018. A Request to Participate and Acceptance Memorandum (PAM) will be sent by email to each Respondent by 27 March 2018. The Respondent’s unique PDM identification number to be used in lieu of company name and Government Furnished Material (GFM) will be shipped to all Respondents by 28 March 2018. Respondents will be notified by email on the day of shipment. The Government will consider PDM questions from Respondents beginning with the RFP release up to the date of GFM shipment.

Individual PDMs are comprised of a single LFI strip assembled into a plastic test carrier. Each Respondent will manufacture LFI strips that conform to performance specifications provided below, load strips into Government provided carriers, and submit PDMs for independent performance testing at a Government appointed Conformance Test Laboratory in accordance with packaging and shipping procedures to be provided in Section L.4. PROPOSAL and PRODUCT DEMONSTRATION MODEL (PDM) SUBMISSIONS and Section L Attachment 3. PDM materials do not require Biosafety Level (BSL) 3 containment but it is recommended they are handled under BSL2 conditions.

Respondents must prepare and ship PDMs to Aberdeen Proving Ground (APG) such that they are received by or before 25 April 2018. Respondents are solely responsible for the timely delivery of PDMs to the APG by the deadline. Respondents who did not submit the required Request to Participate and signed LFI PDM Participation Agreement before the deadline specified in Section 2.0, OR who executed a PAM, BUT failed to submit the minimum number of PDMs OR SUBMITTED PDMs THAT WERE received after the PDM submission deadline, will receive an overall Unacceptable rating for the PDM Evaluation sub factor in the RFP. No PDMs will be accepted after 25 April 2018. Respondents still must reply to the RFP portion of the procurement by 31 May 2018. However, an Unacceptable rating for the PDM Evaluation sub factor will result in an overall Unacceptable result on Technical Factor. Failure to submit a PDM may result in rejection of your proposal.

3.1 GOVERNMENT FURNISHED MATERIAL (GFM)

Eligible Respondents will be provided GFM specified in Table 1.

Table 1: Government Furnished Material Item Description Antigens (Ag) • Antigen 1 – 3.0 ml (2.6E8 units/ml)

• Antigen 2 – 3.0 ml (1.58 mg/ml) Specificity panel • Panel of 11 relevant environmental and biological entities Antibody set for Antigen 1* (Ab are not affinity purified)

• Polyclonal Antibody 1 (1 mg)

Antibody set for Antigen 2* (Ab are not affinity purified)

• Polyclonal Antibody 2 (1 mg)

Carrier (top and bottom) • 820 tops

• 820 bottoms

Specifications and Procedures • LFI physical specifications (drawing)

• PDM assembly instructions

• Packaging and shipping procedures Scanner Reference Standard** • Scanner units (intensity) ladder

*Labeling or conjugating of antibodies is the responsibility of the Respondent **Reference standard will have several test line intensities that can be used to normalize Respondents scanner to the CAMAGTM TLC-3 scanner values.

5.3 INSTRUCTIONS TO RESPONDENTS

The Respondent shall submit PDMs, as specified below (Table 5) and in accordance with the shipping and packaging SOPs, at no expense to the Government. Respondents must prepare and ship PDMs to Aberdeen Proving Ground (APG) such that they are received at APG by 25 April 2018.

Table 5: PDM Quantities to be provided

Item Number required PDMs for Antigen 1 300 PDMs for Antigen 2 300

A Respondent may withdraw at any time. Respondents who withdraw from the acquisition are requested to advise the Government in writing. A Respondent who withdraws from the PDM and responds to the RFP will receive an Unacceptable evaluation rating for the PDM Evaluation sub factor in the RFP.

(End of Summary of Changes)