Amendment No 5 to RFP 75N95022R00043.pdf

AMENDMENT OF SOLICITATION NO.: RFP- 75N95022R00043

Title: The NIH National NeuroHIV Tissue Consortium Clinical Sites

AMENDMENT NO.: 5

EFFECTIVE DATE: 09/06/2022

ISSUED BY:

NIDA Office of Acquisition National Institutes of Mental Health National Institutes of Health 16071 Industrial Drive Gaithersburg, MD 20877

Point of Contact: Kristina Jenkins, Contracting Officer and Christine Frate, Contracting Officer

NAME AND ADDRESS OF CONTRACTOR: To All Offerors

The above numbered solicitation is amended as set forth below. Offerors must acknowledge receipt of this amendment on each copy of the offer submitted. 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 updating your proposal submission in eCPS, so long as your revised proposal submission is uploaded to eCPS prior to the closing date and time.

All other terms and conditions of the RFP remain unchanged.

PURPOSE:

1. To provide the solicitations questions and responses – see attachments.

2. To provide a copy of attachment 10 “HHS Section 508 Product Assessment

Template and attachment 12 – HHS Subcontracting Plan Template

3. Section A- Solicitation/Contract Form, item No. 8. is hereby amended as follow. (Deletions are in red strikeouts and changes are highlighted in yellow)

Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3PM (EST) local time on 09/30/2022 10/14/2022. ALL QUESTIONS PERTAINING TO THIS RFP MUST BE SUBMITTED TO KRISTINA JENKINS VIA EMAIL (SEE ITEM NO. 11) NO LATER THAN 12:00 P.M. (EST) ON 08/10/2022.

Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

4. Attachment 1 -Packaging and Delivery of Proposals for eCPS is hereby amended to state that there are no Page limitations. (Changes are highlighted in yellow) see attachment 1

5. Technical Proposal Instructions (1)(b), on page 75 of the RFP is hereby amended as follow. (Deletions are in red strikeouts and changes are highlighted in yellow)

b) Personnel

Describe the experience and qualifications of personnel who will be assigned for direct work on this program. Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program.

OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND

ALLOTHER PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON

FEDERALGRANTS AND CONTRACTS FOR MORE THAN A TOTAL OF 100% OF

THEIR TIME.IF THE SITUATION ARISES WHERE IT IS DETERMINED THAT A

PROPOSEDEMPLOYEE IS COMMITTED FOR MORE THAN 100% OF HIS OR HER

TIME, THEGOVERNMENT WILL REQUIRE ACTION ON THE PART OF THE

OFFEROR TOCORRECT THE TIME COMMITMENT.

1. Single Principal Investigator/Project Director

List the name of the Principal Investigator/Project Director responsible for overall implementation of the contract and key contact for technical aspects of the project.

Even though there may be co-investigators, identify the Principal Investigator/Project Director who will be responsible for the overall implementation of any awarded contract. Discuss the qualifications, experience, and accomplishments of the Principal Investigator/Project Director. State the estimated time to be spent on the project, his/her proposed

2. 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 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.

2. 3. Other Investigators

List all other investigators/professional personnel who will be participating in the project.

Discuss the qualifications, experience, and accomplishments. State the estimated time each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.

3. 4. Additional Personnel

List names, titles, and proposed duties of additional personnel, if any, who will be required for full-time employment, or on a subcontract or consultant basis.

The technical areas, character, and extent of subcontract or consultant activity will be indicated and the anticipated sources will be specified and qualified. For all proposed personnel who are not currently members of the offeror's staff, a letter of commitment or other evidence of availability is required. A resume does not meet this requirement.

Commitment letters for use of consultants and other personnel to be hired must include:

The specific items or expertise they will provide.

Their availability to the project and the amount of time anticipated.

Willingness to act as a consultant.

How rights to publications and patents will be handled.

4. 5. Resumes

Resumes of all key personnel are required. Each must indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

End of Amendment 5