SF30-Amendment 1 signed.pdf

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 items 8 and 15, and returning or (c) By separate letter or electronic communication 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

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 Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER 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, 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)

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.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

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

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Erin Dwyer, Contracting Officer

Purpose: 1) To update SECTION C, SECTION G, SECTION H, SECTION L and the IDIQ-Statement of Work and 2) to extend the proposal due date to 4:00PM (EST) on June 13, 2022.

National Institutes of Health National Cancer Institute Frederick, MD 21701

TO ALL CONTRACTORS

NCI-DCTD-23-00001

06/03/2022

Erin C. Dwyer -S Digitally signed by Erin C. Dwyer -S Date: 2022.06.03 12:59:06 -04'00'

RFP: NCI‐DCTD‐23‐00001 2

Amendment No: 0001 Date: 06/03/2022

This amendment updates SECTION C‐DESCRIPTION/SPECIFICATIONS/WORK STATEMENT, SECTION G‐

CONTRACT ADMINISTRATION, SECTION H‐SPECIAL CONTRACT REQUIREMENTS, SECTION L‐

INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS and the IDIQ‐STATEMENT OF WORK.

1) ARTICLE C.2. REPORTING REQUIREMENTS – item 5. is incorporated as follows:

5. Multiple Principal Investigators Leadership Plan

The Contractor must 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.

2) ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237‐75 (December 2015) ‐ is modified as follows:

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the

Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

The following individuals are considered to be essential to the work being performed hereunder:

Name Title

To be specified at time of award Principal Investigator

To be specified at time of award Co‐Principal Investigator

To be specified at time of award Acquisition/Documentation Manager

3) ARTICLE H.22. MULTIPLE PRINCIPAL INVESTIGATORS – is incorporated as follows:

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.

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

[incorporated by reference./included as an Attachment in SECTION J of this contract.]

RFP: NCI‐DCTD‐23‐00001 3

Date: 06/03/2022

4) SECTION L.2.b.1.b (Personnel) – item 5. is incorporated as follows:

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 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.

RFP: NCI‐DCTD‐23‐00001 4

Date: 06/03/2022

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.

5) IDIQ – STATEMENT OF WORK – is modified as follows:

B. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment and facilities, not otherwise provided by the

Government, as needed to perform the Statement of Work below. Note to offerors: Unexpected requests for detailed and accurate data/information/reports will be requested, in most cases daily.

Based on the needs of the Program, a response to the unexpected request shall be delivered to the

Contracting Officer’s Representative (COR) or the COR’s designee within 30 ‐ 90 minutes during

RFP: NCI‐DCTD‐23‐00001 5

Date: 06/03/2022 business hours. All other requests for data surfacing/information/reports shall be delivered to the

Contracting Officer’s Representative (COR) or the COR’s designee within 24‐48 hours.

C. PERSONNEL QUALIFICATIONS

a. The Contractor shall 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 and 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.

b. The Contractor shall provide resumes of all key personnel required. Each resume shall indicate educational background, recent experience, specific or technical accomplishments, and a listing of relevant publications.

c. The Contractor shall describe the education, training, relevant experience (including a background in the understanding of chemical structures, chemical reactivity, chemical hazards, safety procedures, regulatory requirements, domestic and international shipping procedures) suitability and availability of each of the following:

1) Project Director/Manager (Principal Investigator)

The Project Director/Manager (Principal Investigator) shall be onsite (unless otherwise directed by the Contracting Officer’s Representative (COR) or the Contracting Officer

(CO)) and trained in an appropriate discipline with at least a Bachelor’s degree from an accredited school with ideally ten years relevant and recent (within the past two (2) years) experience, or with a Master’s degree with ideally seven years’ experience in areas relevant to this work and include supervisory or managerial level responsibilities.

List the name of the Project Director/Manager responsible for overall implementation of the contract and key contact for technical aspects of the project. Discuss the qualifications, recent experience, and accomplishments of the Project

Director/Manager. State the estimated time (and percent) to be spent on all areas of the project, their proposed duties, and the areas or phases for which they will be responsible.

2) Co‐Principal Investigator AND Acquisitions/Documentation Manager

The Co‐Principal Investigator AND Acquisitions/Document Manager shall be onsite

(unless otherwise directed by the Contracting Officer’s Representative (COR) or the

Contracting Officer (CO)).

List all other Professional personnel, including separately the Co‐Principal Investigator and the Acquisitions/Document Manager, who will be participating in the project.

Discuss their qualifications, experience, and accomplishments. State the estimated time

RFP: NCI‐DCTD‐23‐00001 6

Date: 06/03/2022 each will spend on the project, proposed duties on the project, and the areas or phases for which each will be responsible.

3) Support Staff, including provisions for IT‐related support staff.

List all other Support Staff, who will be participating in the project. Discuss their 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.

4) Additional Personnel

List names, titles, and proposed duties of additional personnel, if any, who will be required for employment, or on a subcontract or consultant basis. This shall include information technology personnel who will support work performed under the contract.

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. Commitment letters for use of consultants and other personnel to be hired shall include the following items:

‐ The specific items or expertise provided.

‐ Availability to the project and the amount of time anticipated.

‐ Handling of rights to publications and intellectual property consistent with the Bayh‐

Dole Act.