RFP_NIHDA201800084_Amendment_01.pdf

NSN 7540 - 01 - 152 – 8070 STANDARD FORM 30 (REV. 10-83)

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FAR (48CFR) 53.243

OMB No. 0990-0115 AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

1 6

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

01 See Block 16C

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

NIDA Section, Contracts Management Branch Blue Office of Acquisition, NIDA 6001 Executive Boulevard, Room 4211 – MSC 9559 Bethesda, Maryland 20892-9559

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

To All Potential Offerors

9A. AMENDMENT OF SOLICITATION NO.

NIHDA201800084

9B. DATED (SEE ITEM 11)

May 1, 2018

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

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 Offer 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 Item 8 and 15, and returning 1 copies of the amendment; (b) 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 ACKNOWLEDG- MENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR 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 hours 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 data, etc.) SET FORTH IN ITEM 14, 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.)

PURPOSE: To amend the Request for Proposal (RFP) and to respond to formal questions submitted in response to the solicitation. All other terms and conditions of the RFP remain unchanged.

Proposal Due Date: 4:00 p.m. (Eastern) on June 15, 2018 (UNCHANGED)

Note: The offeror should acknowledge on the cover page or first page of its business and technical proposals receipt of the RFP and this Amendment.

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)

Andrew R. Hotaling, Contracting Officer, NIDA Section, CMB Blue

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY

(Signature of Contracting Officer) 6/5/2018

Request for Proposal

Amendment No. 01

Request for Proposal (RFP) No. NIHDA201800084 is amended as follows:

ARTICLE C.2. REPORTING REQUIREMENTS, paragraph b. Other Reports/Deliverables, is amended to add the following:

4. Multiple Principal Investigators Leadership Plan

The Contractor shall submit a revised/updated Leadership Plan in the event of a change in any of the Principal Investigators named in the Key Personnel Article in SECTION G of this contract. The revised plan is subject to review and approval by the Contracting Officer.

ARTICLE F.2. DELIVERIES is amended to add the following to the table under paragraph a.:

Item Description Quantity Delivery Schedule

(21) Revised/Updated

Leadership Plan 1 hard copy and 1 electronic copy to COR;

1 hard copy and 1 electronic copy to the CO

Prior to any change in Principal Investigators named in ARTICLE G.2. KEY

PERSONNEL

ARTICLE F.2. DELIVERIES, paragraph b., is superseded as follows:

b. The above items shall be addressed and delivered to:

Addressee Deliverable Item No

Contracting Officer NIDA Section Contracts Management Branch Blue 6001 Executive Boulevard., Suite 4211, MSC 9559 *Bethesda, MD 20892-9559

2 - 21

Contracting Officer's Representative 6001 Executive Boulevard *Bethesda, MD 20892

1 - 4, 10 - 21

*For delivery service or hand delivery, use Rockville, MD 20852

ARTICLE H – SPECIAL CONTRACT REQUIREMENTS, is amended to add the following:

ARTICLE H.35. MULTIPLE PRINCIPAL INVESTIGATORS

The NIH awarded this contract as a multiple Principal Investigators project. The Key Personnel Article in SECTION G of this contract designates the Contact Principal Investigator and all other Principal Investigators.

Request for Proposal

Amendment No. 01

Contracts designating multiple Principal Investigators require a current Leadership Plan with updates as needed. The Contractor's Leadership Plan, dated (to be determined prior to award) , (and as modified thereafter, in accordance with the Reporting Requirements Article in SECTION C of this contract), is hereby incorporated by reference.

SECTION L – Instructions, Conditions, And Notices To Offerors, paragraph 2.b.1.b.

Personnel, is amended to add the following:

5. Multiple Principal Investigators

The NIH now provides offerors the opportunity to propose a multiple Principal Investigator (PI) model on research and development contracts. The multiple PI model is intended to supplement, and not replace, the traditional single PI model. The NIH chose this RFP as a candidate for the multiple PI model. Ultimately, the decision to submit a proposal using the multiple PI versus single PI is the decision of the investigators and their institutions. The decision should be consistent with and justified by the scientific goals of the project.

It is essential that organizations consider all aspects of this approach before submitting a proposal. While there are some projects that clearly are appropriate for the multiple PI model, the "fit" of other projects may not be so clear. Offerors should base the selection of either the single PI or multiple PI option on the research proposed, to ensure optimal facilitation of the science. Projects suitable for the multiple PI model could include as few as two PIs who are jointly responsible for the scientific and technical direction of the project. The multiple PI option is based on the proposed project, not on the number of performance sites or the number of participating institutions.

Multiple PIs under research contracts shall use the Subcontract Model. In this approach, offerors submit a single proposal, and a single award is made to the prime contractor. The prime contractor, when appropriate, will award subcontracts to fund the components of the project at the other institutions. The relationship between the contractor and subcontractors must be designed to support all components of the project.

To facilitate communication with the NIH, the offeror must designate a Contact PI at the time of proposal submission. The Contact PI must be employed at the prime contractor's organization. The designation of the Contact PI may rotate on an annual basis. However, this rotation is restricted to PIs located at the prime contractor's organization. The Contact PI is responsible for: relaying communications between all of the PIs and the NIH, and coordinating progress reports for the project. Being named Contact PI does not confer any special authority for the project.

Leadership Plan Offerors proposing multiple PIs will need to submit a Leadership Plan as part of the Technical Proposal. The Leadership Plan shall describe the governance and

Request for Proposal Amendment No. 01 NIHDA201800028 Page 4 of 5 organizational structure of the research project including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, and procedures for resolving conflicts.

The Leadership Plan shall follow the Table of Contents provided below:

I. Rationale Include a discussion of how the project will be enhanced by the multiple PI approach.

II. Identification of all proposed PIs Identify the proposed PIs, their point of contact information and affiliated organizations, and the percentages of time proposed for this project. Identify the Contact PI and plans for rotation of that role, if any.

III. Roles and Responsibilities Identify both the scientific and administrative roles and responsibilities of all named PIs.

IV. Approach to Fiscal and Management Coordination Describe how the project will be performed and monitored from a fiscal and management perspective. Discuss organizational administrative coordination and support.

V. Project Direction and Resource Allocation Address how decisions will be made regarding scientific direction, and, how resources will be allocated and redistributed if needed during performance.

Address plans for shared resources such as IT or other shared data considerations. If joint standard operating procedures will be developed, describe this process.

VI. Communication and Lines of Authority Address communication and lines of authority within and among PIs and within and among organizations.

VII. Data sharing, Intellectual Property, Publication, and other Proprietary Considerations Data sharing plans, intellectual property considerations, publication agreements, and any other proprietary or confidential information sharing should be addressed in this section.

VIII. Conflict Resolution Address how conflicts will be avoided, identified, and resolved.

IX. Other Address any other information relative to the leadership approach to Multiple PI projects.

Offerors submitting single PI proposals do not need to submit a Leadership Plan.

NIHDA201800084 Page 5 of 6

RESPONSES TO QUESTIONS

QUESTION 1: Does the instruction for a Single Principal Investigator/Project Director preclude a Multiple-PI proposal?

ANSWER 1: Offerors may propose Multiple Principal Investigators. For more information, see ARTICLE H.23. MULTIPLE PRINCIPAL INVESTIGATORS and SECTION L.2.b.1.b.5. Multiple Principal Investigators.

QUESTION 2: Do the unique cell repository IDs have to be consecutively numbered or can they be random and unique numbers that are not replicated with any current or future sample IDs?

ANSWER 2: Offerors may propose either sequential ID or random ID numbers. An argument for one vs the other should be provided in the response. It is important to note that whatever method is proposed, IDs should not repeated.

QUESTION 3: Does the fixed priced schedule referred to in Task 10 (7) need to be included in the technical proposal as well as the business proposal?

ANSWER 3: The fixed price schedule should only be included with the business proposal.

QUESTION 4: Is RNA extraction required from any other tissue besides whole blood and cell lines?

ANSWER 4: In additional to whole blood and cell lines, Offerors will also be required to extract RNA from lymphocytes. Furthermore, Offerors should also address extractions from brain and liver, and subfractionation of lymphocyte cell types.

QUESTION 5: What are the whole genome sequencing metrics required so costing for that activity can be accomplished?

ANSWER 5: Offerors should provide costing for 30X and 50X sequencing.

Additionally, Offerors should account for Paired-End sequencing with 100bp reads or longer.

QUESTION 6: Is whole exome sequencing of interest to NIDA as part of the high-throughput sequencing task? If so, what are the metrics required so costing for that activity can be accomplished?

ANSWER 6: No, whole exome sequencing is not of interest to NIDA as part of the high-throughput sequencing task.

QUESTION 7: The RFP states that “serum” is to be processed yet the description of tubes seems to indicate plasma processing. Is the word “serum” an error?

NIHDA201800084 Page 6 of 6

ANSWER 7: Yes, that reference to “serum” is an error. The RFP should read "plasma is to be processed".

QUESTION 8: The introduction to the solicitation specifies that a hard copy of the Excel spreadsheet must be included in the business proposal. Please confirm this should be an Excel file to be uploaded.

ANSWER 8: Offerors should upload the Excel spreadsheet electronically in accordance with the instructions detailed in Attachment 1, a hard copy of the Excel spreadsheet is not needed.

QUESTION 9: The introduction to the solicitation makes a reference to the “… proposed prices in the Schedule of Contract Prices (Attachment 23).” Please confirm the Schedule of Contract Prices is the Estimated Task Order Volume Worksheet, which is Attachment 22.

ANSWER 9: Offerors should note that this specific section of the introduction should read:

“Also include with your business proposal:

• Separate cost/prices for the task order listed in the Statement of Work (SOW) in Part E.

Tasks for Price Proposal Evaluation (also see Attachment 21); and

• Your proposed prices in the Schedule of Contract Prices (Attachment 22).”