75N91023R00036_Ukraine_RFP_8_15_23.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92.218 as amended

2. Request for Proposal (RFP) Number:

75N91023R00036

3. Issue Date:

08/15/2023

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Cancer and Other Health Effects Following the Chernobyl Accident in Ukraine

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E610 Bethesda, MD 20892-9705

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. 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 2:00 PM local time on 09/14/2023. 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.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at https://www.sam.gov/SAM/.

11. FOR INFORMATION CALL: Kristi-Jo Noel, Contract Specialist

PHONE: 240-760-7279

e-MAIL: kristi-jo.noel@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Requests for clarification, additional information, or correction must be made in writing to the Contract Specialist at kristi-jo.noel@nih.gov on or before 2:00PM EST on August 30, 2023 with the subject line RFP 75N91023R00036.

Secondary Point of Contact Kari Peterson, Contracting Officer Office of Acquisitions, National Cancer Institute https://www.sam.gov/SAM/

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1. Requisition or other Purchase Authority: Public Law 92.218 as amended kari.peterson@nih.gov

RFP Number: : 75N91023R00036

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.3. CERTIFICATE OF CONFIDENTIALITY

ARTICLE H.4. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. COMMITMENT OF PUBLIC FUNDS

e. PROMOTING EFFICIENT SPENDING

f. COMMUNICATIONS PRIOR TO CONTRACT AWARD

g. RELEASE OF INFORMATION

h. PREPARATION COSTS

i. SERVICE OF PROTEST

j. LATE PROPOSALS AND REVISIONS

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Evaluation of Proposals

6. Potential Award Without Discussions

7. Use of the Metric System of Measurement

8. Standards for Privacy of Individually Identifiable Health Information

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9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Past Performance Information

13. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

14. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

5. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

4. HUBZone Small Business Concerns

5. Total Compensation Plan

6. Other Administrative Data

7. Qualifications of the Offeror

8. Subcontractors

9. Proposer's Annual Financial Report

10. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF OPTIONS

6. TECHNICAL EVALUATION FACTORS

7. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

8. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The proposed acquisition is to provide follow-on support in financial management and logistical administrative services to continue the ongoing projects on cancer and other health effects following the Chernobyl accident supported by NCI in Ukraine. The Contractor shall provide support to continue project tasks/activities at the NCI collaborating institutions in Kyiv, Ukraine, National Research Center for Radiation Medicine (NRCRM) and Institute of Endocrinology and Metabolism (IEM). The progress and financial status of the projects undertaken at the IEM and NRCRM will be reported to NCI through the Contractor.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. PRICES/COSTS

a. This is an Indefinite Quantity contract as contemplated by FAR 16.504. The Contractor shall be reimbursed by the Government in an amount not less than a total of $10,000 (minimum) nor more than a total of $9,900,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period 4/1/2024 through 3/31/2034.

c. The Government will complete and award Task Orders based on the work described in SECTION C of this contract.

d. Ordering procedures are described in the TASK ORDER PROCEDURE Article in SECTION G of this contract.

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

IT Security – The Contractor shall abide by Data Security Laws and practices of Ukraine and submit data to NCI using an encrypted manner.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to 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, dated July 20, 2023, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format and shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at https://www.hhs.gov/web/section-508/index.html and at: https://www.section508.gov/create/documents , "Create Accessible Documents."

The Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or National Institutes of Health (NIH) Manuscript Submission reference number when citing publications that arise from its NIH funded research.

a. Scientific and Technical Reports

1. Quarterly Task Order(s) Progress Report

The Contractor shall provide Quarterly Task Order Progress Reports that summarizes all Task Order activities, these reports shall be broken out for each task area as outlined in the Statement of Work.

Reports shall be tailored by task area and include: 1) Summary of progress; 2) Summary of tasks that have been completed and the completion date; 3) Summary of tasks yet to be completed, whether or not these projects are on schedule, and discussion of any problems encountered in the collection, handling, or processing of data, including resolution of each problem; 4) Suggestions for modification of the project plan; and 5) Copies of the shipping list of all biologic or environmental samples delivered to laboratories or individuals.

The reporting period for the Quarterly Task Order Progress Report is every quarter during the period of performance, which will commence upon award of Task Order. This report shall be delivered as specified in the order.

2. Annual Task Order(s) Progress Reports (Draft Annual and Annual)

The Annual Task Order(s) Progress Report shall include a summation of the results of the work performed for the entire Task Order period covered. The period covered shall be twelve (12) months from the start date of the Task Order period of performance. A Quarterly Report shall not be submitted when an Annual Report is due.

The Contractor shall provide the Contracting Officer (CO) and the Contracting Officer’s Representative (COR) with 1 copy of the Draft Annual Progress Report in accordance with the DELIVERIES Article in SECTION F of this Contract thirty (30) calendar days prior to the end of the current Task Order period of performance. The COR will review the Draft Annual Task Order Progress Report and provide the Contractor with comments within fourteen (14) calendar days after receipt.

%20https:/www.hhs.gov/web/section-508/index.html%20 https://www.section508.gov/create/documents

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The Draft Annual Progress Report shall be corrected by the Contractor, if necessary, and the final version of the Annual Task Order Progress Report shall be delivered as specified in the order.

3. Final Task Order(s) Reports (Draft Final and Final)

The Final Task Order(s) Report shall include a summation of the work performed and the results obtained for the entire Task Order period of performance. This report shall be in sufficient detail to comprehensively describe the results achieved. Neither a Quarterly or Annual Report shall be submitted when a Final Report is due.

The Contractor shall provide the CO and the COR with 1 copy of the Draft Task Order(s) Report thirty

(30) calendar days prior to the end of the Task Order period of performance. The COR will review the Draft Final Task Order(s) Report and provide the Contractor with comments within 14 calendar days after receipt. The Final Task Order(s) Report shall be corrected by the Contractor, if necessary, and the final version delivered on or before the last day of the period of performance of the Task Orders.

4. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

b. Other Reports/Deliverables

Contractor will not develop, access, maintain or host a Federal Information System in performance of this acquisition.

The overall security level is moderate as the contract is foreign based. The contractor and the collaborating sites will not have any access to NCI systems in performance of this acquisition. No use of cloud computing services is anticipated in performance of this acquisition. Data is owned by Ukraine and pertains to Ukraine citizens only. Security requirement is to abide by Data Security Laws and practices of Ukraine as this is a foreign acquisition.

Contractor shall ensure that all project related deliverables are encrypted when sent to the NCI. Contractor may at their discretion either encrypt files locally before sending (i.e., by using a file compression tool like 7Zip or WinZip) and protecting the archive with AES256 encryption and locking with a password that is shared separately from the encrypted file or they may encrypt the data in transit by using one of NIH's approved file exchange tools like Secure Electronic File Transfer (SEFT) or NIH.Box.com. Other comparable encryption solutions may be proposed by the contractor and will be evaluated by the NCI Information Systems Security Officer.

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part

94. 45 CFR Part 94 is available at: https://www.ecfr.gov/current/title-45/part-94.

See Part 94.5, Responsibilities of Institutions regarding Investigator financial conflicts of interest for complete information on reporting requirements.

(Reference the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Data Files https://www.ecfr.gov/current/title-45/part-94

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The NCI collaborative institutions, National Research Center for Radiation Medicine (NRCRM) and Institute of Endocrinology and Metabolism (IEM), shall provide the data obtained and accumulated under this contract directly to NCI Principal Investigator(s) (PIs) and NCI Contracting Officer's Representative (COR). The data provided shall be edited and corrected (suitable for analysis) and sent with appropriate documentation on a storage medium to facilitate easy transfer to NCI equipment. Data files shall include the study databases with information in format as requested by the NCI. No personally identifiable information should be sent to NCI (e.g., no first and last names, birth year/month only).

3. Biological specimens

The Contractor shall deliver biological samples collected from the study subjects (blood, buccal cells samples, etc.) properly coded to the NCI upon request. Samples shall be maintained at appropriate temperatures for each sample type throughout the shipping period; e.g., blood sample temperature (-80ºC) during the shipping process.

4. Technical Documentation

The Contractor shall submit to the Contracting Officer's Representative (COR) the Operations Manuals for epidemiological and dosimetry aspects of the studies, User's Guide to Data Files, and Manuals for Quality Control Procedures.

5. Section 508 Checklists

The Contractor shall submit Section a 508 Checklist with each deliverable. The contract holder shall complete and submit applicable Section 508/Accessibility Conformance Checklists from the US Health and Human Services (HHS)'s HHS Accessibility & Section

508. These checklists aid in the creation and testing of digital contents as well as serving as verification or conformance reports.

These HHS Accessibility Conformance Checklists shall be submitted for all reports, files, or other digital contents submitted as part of this contract. Note that one representative Section 508 checklist-as-Conformance Report per file type shall suffice – that is, one Microsoft Word checklist shall represent all Word files submitted under this contact, one Microsoft Excel checklist shall represent all Excel files, one Adobe PDF checklist shall represent all PDF files, etc. Such representative Checklists shall be submitted each reporting period.

● Web Sites, Web Applications & Software

● Microsoft Word

● Microsoft PowerPoint

● Microsoft Excel

● Adobe PDF

Comparable, additional guidance and checklists may be found at Create Accessible Digital Products | Section508.gov

● Create Accessible Documents | Section508.gov

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● Create Accessible Spreadsheets | Section508.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute National Institutes of Health 9609 Medical Center Drive Bethesda, MD 20892-9704

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-7, Inspection of Research and Development - Fixed Price (August 1996).

FAR Clause 52.246-16, Responsibility for Supplies (April 1984).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from 04/01/2024 through 03/31/2034.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below [and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract]:

Item Description Delivery Schedule

Scientific and Technical Reports

(1) Quarterly Task Order(s) Progress Reports

Defined at Task Order

(2) Annual Task Order Progress Reports (Draft and Annual)

Defined at Task Order

(3) Final Task Order Reports (Draft Final and Final)

Defined at Task Order

(4) Summary of Salient Results Defined at Task Order

Other Reports/Deliverables

(5) Reporting of Financial Conflict of Interest (FCOI)

Defined at Task Order

(6) Data Files Defined at Task Order

(7) Biological Specimens Defined at Task Order

(8) Technical Documentation Defined at Task Order

(9) Section 508 Checklists Defined at Task Order

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

Addressee Deliverable Item No Quantity

Contracting Officer’s Representative

(COR)

ncibrancheinvoices@mail.nih.gov

1-9 One (1) Electronic Copy

Contracting Officer (CO) ncibrancheinvoices@mail.nih.gov

1-9 One (1) Electronic Copy mailto:ncibrancheinvoices@mail.nih.gov mailto:ncibrancheinvoices@mail.nih.gov

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ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEB 1998).

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989).

Alternate I (April 1984) is applicable to this contract.

52.242-17, Government Delay of Work (April 1984).

https://www.acquisition.gov/?q=browsefar

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER REPRESENTATIVE (COR)

The following Contracting Officer Representative (COR) will represent the Government for the purpose of this contract:

TBD

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

[The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.]

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015).

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 individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

TBD

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed

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Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Proposals.

The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order.

If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFP. An election not to propose on a given TORFP will not negatively affect or prohibit a Contractor from competing on future TORFPs. However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the TORFP.

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a Contractor for award. Generally, technical factors will be significantly more important than cost or price However, each TORFP will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor whose proposal is most advantageous to the government

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

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ARTICLE G.4. INVOICE SUBMISSION

a. Invoice Instructions for NIH Fixed-Price Type Contracts, NIH(RC)-2, are attached and made part of this contract.

The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. Until the Contract has transitioned to IPP as specified on the OALM IPP website, the Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic Invoicing Instructions for NIH Contractors/Vendors, which is included as an attachment in Section J of this contract. The invoice submitted to the NIH/OFM must be transmitted as an attachment via email to the address listed above in one of the following formats: Word, or Adobe Portable Document Format (PDF).

The Contractor must submit only one invoice per email. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your invoice unless specified elsewhere in the contract or requested by the Contracting Officer.

1. The Contractor must submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer Representative:

Approving Official: Contracting Officer

Name- Kari Peterson Email Address- kari.peterson@nih.gov

Contracting Officer Representative

Name- TBD Email Address- TBD

For inquiries regarding the status of invoices, contact OFM Customer Service via email at ofm_customer_service@mail-cmp.niceincontact.com or via phone at 301-496-6088. To send your inquiries via other available communication methods refer to the OFM Customer Service website at https://ofm.od.nih.gov/Pages/Customer-Service.aspx.

Note: The OFM Customer Service is open Eastern Standard Time Monday - Friday from 8:30 a.m. to 5:00 p.m. and is closed between 12:00 p.m. to 1:00 p.m.

One courtesy copy of the original invoice shall be submitted electronically as follows:

The Central Point of Distribution:

NCI OA Branch B - ncibranchbinvoices@mail.nih.gov

Invoices shall be submitted in accordance with Electronic Invoicing Instructions for NIH Contractors/ Vendors, which is included as an attachment in Section J of this contract.

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Cancer Institute.

b. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the mailto:ofm_customer_service@mail-cmp.niceincontact.com https://ofm.od.nih.gov/Pages/Customer-Service.aspx mailto:ncibranchbinvoices@mail.nih.gov https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files https://oamp.od.nih.gov/DGS/DGS-workform-information/attachment-files

- 17 -number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, Unique Entity Identifier (UEI), or VIN, contact the Contracting Officer. Note: The Contractor shall not include TIN if it is a Social Security Number.

c. Unique Entity Identifier (UEI). The UEI is located in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number. The UEI number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid UEI number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [ Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, UEI, or VIN, contact the Contracting Officer.

d. Invoice Matching Option. This contract requires a two-way match.

e. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

f. The Contract Title is:

Cancer and Other Health Effects Following the Chernobyl Accident in Ukraine

g. Contract Line Items as designated in each Task Order.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually as follows on TBD.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

https://www.cpars.gov https://www.cpars.gov

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015).

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

c. Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP Website at: https://www.hhs.gov/ohrp/index.html).

d. If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part.

(End of clause).

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH

PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated August 25, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

https://www.hhs.gov/ohrp/index.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

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Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.3. CERTIFICATE OF CONFIDENTIALITY

Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act.

Effective October 1, 2017, all research that was commenced or ongoing on or after December 13, 2016 and is within the scope of the NIH Policy for Issuing Certificate of Confidentiality (CoC) NOT-OD-17-109, the Contractor shall protect the privacy of individuals who are subjects of such research in accordance with subsection 301(d) of the Public Health Service Act as a term and condition of the contract. The certificate will not be issued as a separate document.

NIH considers research in which identifiable, sensitive information is collected or used, to include:

● Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

● Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

● Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

● Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

The Contractor shall not:

● Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of the research, unless such disclosure or use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or

● Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research.

The Contractor is permitted to disclose only in below circumstances. The Contractor shall notify the CO minimum ten

(10) calendar days prior to disclosure.

● Required by Federal, State, or local laws (e.g., as required by the Federal Food, Drug, and Cosmetic Act, or state laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding;

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● Necessary for the medical treatment of the individual to whom the information, document, or biospecimen pertains and made with the consent of such individual;

● Made with the consent of the individual to whom the information, document, or biospecimen pertains; or

● Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research.

In accordance with 45 CFR Part 75.303(a), the Contractor shall maintain effective internal controls (e.g., policies and procedures) that provide reasonable assurance that the award is managed in compliance with Federal Statutes and regulations.

The recipient of CoCs shall ensure that any…