RFP_PREVENT_75N91023R00024.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:

75N91023R00024

3. Issue Date:

01/06/2023

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : PREVENT Cancer Preclinical Drug Development Program

6. ISSUED BY:

Office of Acquisitions National Cancer Institute (NCI) National Institutes of Health (NIH) Treatment and Support Branch 8490 Progress Drive, Ste 400 Frederick, MD 21701

7. SUBMIT OFFERS TO:

See Part III, Section J, "eCPS Proposal Delivery Instructions." 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, "eCPS Proposal Delivery Instructions." until 2:00 PM Eastern local time on February 21, 2023. Offers will be valid for 270 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043. The deadline for receipt of questions is 1/23/2023 at 2:00 PM Eastern Time per the instructions in Section L.1 General Instructions.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "eCPS Proposal Delivery Instructions." 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," and HHSAR Clause 352.215-70, "Late Proposals and Revisions" 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: Rich Taylor

PHONE: 717-339-9735

https://www.sam.gov/SAM/

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1. Requisition or other Purchase Authority: Public Law 92-218, as amended e-MAIL: rich.taylor@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Submit all questions in writing to rich.taylor@nih.gov. Responses to questions will be provided in amendments to the solicitation.

Questions received after the deadline (stated above in Box 8) may not be addressed.

Rich Taylor Contracting Officer Office of Acquisitions

RFP Number : 75N91023R00024

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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

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. NAICS CODE AND SIZE STANDARD

b. TYPE OF CONTRACT AND NUMBER OF AWARDS

c. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

d. COMMITMENT OF PUBLIC FUNDS

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. PREPARATION COSTS

h. SERVICE OF PROTEST

i. LATE PROPOSALS AND REVISIONS

j. USE OF NON-GOVERNMENT REVIEWERS

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. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

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11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. CERTIFICATION REGARDING TAX MATTERS (OCT 2020)

15. Past Performance Information

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. LIVE VERTEBRATE ANIMALS EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

7. EVALUATION OF PLAN FOR SHARING MODEL ORGANISMS FOR BIOMEDICAL RESEARCH

8. TECHNICAL EVALUATION FACTORS

9. PAST PERFORMANCE FACTOR

10. SUBCONTRACTING PROGRAM EVALUATION CRITERIA

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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 overall objective of the current acquisition, designated as the PREVENT Cancer Preclinical Drug Development Program, is to provide a structured approach to drug and vaccine development, from discovery to the clinic. To achieve these goals, this acquisition is broken out into three separate multiple-award Indefinite Delivery Indefinite Quantity (IDIQ) pools:

PREVENT Efficacy Pool:

The Preclinical Efficacy and Intermediate Endpoint Biomarkers IDIQ contracts will encompass the continued evaluation of the efficacy of potential chemopreventive and immunopreventive regimens, and the identification of pharmacodynamic and/or efficacy biomarkers which will enhance the development of these regimens for clinical trials.

Resources from these contracts will be used to support development of several candidate cancer preventive agents.

PREVENT CGMP (Current Good Manufacturing Practice) Pool:

The PREVENT Preclinical Services for Biopharmaceutical Product Development and Manufacturing encompasses four main technical task areas: (1) product development planning and evaluation; (2) analytical assay development and product characterization; (3) process development and related activities; and (4) CGMP manufacturing, related activities and documentation, as described in detail in the Statement of Work. The key objective of the PREVENT CGMP pool is to provide preclinical product and CGMP manufacturing support for candidate cancer preventive vaccines for preclinical and clinical testing.

PREVENT Toxicology and Pharmacology Pool:

The PREVENT Preclinical Cancer Program: Toxicology and Pharmacology Testing IDIQ contracts will continue evaluation of the pharmacological and toxicological effects of potential cancer preventative agents. Resources from these contracts will be used to support development of several candidate cancer preventive agents.

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 a Multiple Award Indefinite Delivery 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 $3,500 (minimum) nor more than a total of $149,995,000 (shared maximum) for successful performance of the contracts. The

- 6 -maximum IDIQ ceiling amount across all PREVENT IDIQ contracts issued under the PREVENT Program, cumulatively, shall not exceed $149,995,000 for successful performance of the contracts. The maximum (ceiling) is shared among all PREVENT IDIQ contracts issued under the PREVENT Program (across all three pools).

b. The Prices/ costs set forth in this ARTICLE will cover the approximate contract period of 11/01/2023 through 10/28/2028.

c. The Government will compete 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. OPTION PRICES

a. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base five (5)-Year Ordering Period specified in the contract as defined in SECTIONS C and F, for the shared PREVENT Program maximum (ceiling) set forth in ARTICLE B.2. of this contract.

b. Pursuant to FAR Clause 52.217-9 set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract.

Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The shared maximum amount of this contract will NOT be increased if one or two of the 12-month option periods outlined in SECTION F are exercised.

ARTICLE B.5. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

ARTICLE B.6. 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.

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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 separate PREVENT Pool IDIQ Base Statements of Work, dated 11/07/2022, for Efficacy and Pharmacology/Toxicology, and 11/07/2022 for CGMP, 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. In addition, one electronic (PDF or Word or Excel) copy of each report shall be submitted to the Contracting Officer.

All electronic reports and other digital files submitted shall be conformant with Section 508 of the Rehabilitation Act of 1973. Additional information about formatting and testing documents for Section 508 conformance, including guidance and specific checklists, can be found at: https://www.hhs.gov/web/section-508/index.html and at:

https://www.section508.gov/create/documents , "Create Accessible Documents."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

1. Accessibility @ HHS | HHS.gov

a. Accessibility Compliance Checklists | HHS.gov https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

b. Accessibility Training Resources | HHS.gov https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html

2. Create Accessible Digital Products | Section508.gov

a. Create Accessible Documents | Section508.gov https://www.section508.gov/manage/laws-and-policies/

b. Create Accessible PDFs | Section508.gov https://www.section508.gov/create/

a. Technical Task Order Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required for any task order issued under the base contracts resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to task order award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that only electronic version(s) of reports will be required as follows:

[X] Monthly - CGMP Pool [X] Quarterly - Efficacy, Toxicology and Pharmacology Pools [ ] Semi-Annually https://www.hhs.gov/web/section-508/index.html https://www.section508.gov/create/documents https://www.section508.gov/create/documents https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/hhs-policy-section-508-compliance-accessibility-information-communications-technology.html https://www.section508.gov/manage/laws-and-policies/ https://www.section508.gov/create/

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[ ] Annually [ ] Annually (with a requirement for a Draft Annual Report) [ ] Final - Upon final completion of the contract [X] Final - Upon final completion of the task order (with a requirement for a Draft Final Task Order Report. Draft Report may be submitted in MS Word, Final should be PDF.)

A basic description of each task order report is provided below; however, any changes or additional requirements may be specified at the individual task order level.

PREVENT Efficacy Pool

1. Quarterly Task Order Progress Reports

The Contractor shall provide 508 Compliant: Electronic Documents compliant Quarterly Task Order Progress Reports during performance of each task order. These reports shall include: 1) Introduction to the study; 2) Overall research strategy section; 3) A brief description of specific milestone task(s) undertaken during the reporting period; 4) Materials and methods section pertinent to the specific task(s) undertaken during the reporting period, clearly describing how studies have been performed, including a description of any statistical tests utilized to analyze data if applicable; 5) Summary of results and findings obtained over the reporting period; 6) Summary of deliverables that have been completed on the task order as applicable and the completion date; 7) Summary of deliverables in progress on the task order, indicating whether or not these task activities are on schedule; whether any problems have been encountered in the collection, handling, and/ or processing of data; and whether resolution of the problems has been achieved or still pending; and 8) Information regarding Investigational New Drug (INDs), Drug Master File (DMF), and New Drug Applications (NDA) if applicable. The reporting period is every three

(3) months, which shall commence upon award of the task order. This report is due 15 calendar days after the end of each reporting period. The first reporting period may include the fractional portion of the first month if less than 30 days.

The Quarterly Task Order report shall not be due when the Final Task Order report is due.

2. Draft Final Task Order Reports

These reports shall contain all collected/processed, analyzed, and summarized data, and shall be submitted 45 calendar days prior to the end of each task order. Accompanying the report, all raw data shall be submitted as specified in the base contracts. Reports shall be formatted and contain information necessary for regulatory FDA submission as applicable.

a. Draft Final Task Order Reports shall be organized and formatted into the following specific sections:

1. Table of Contents

2. Summary of Salient Results

3. Key Personnel

4. Introduction

5. Purpose and Objectives

6. Experimental Design

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7. Materials and Methods (including a detailed description of statistical methods used in the study)

8. Regulatory Compliance

9. Results

10. Discussion and Conclusions

11. Quality Assurance Statement

12. Appendices: Tables, Figures, Figure Legends, and High-resolution Photographs or Digital Images of Pertinent Data (e.g., Tumor Lesions, Histopathology, Immunohistochemistry Data, etc.)

13. Supporting document and statement indicating that the study was conducted under GLP when appropriate

b. The PDF file shall contain a bookmarked Table of Contents.

c. Comments or needed corrections/clarifications will be returned by the Contracting Officer within 30 calendar days of receipt of the Draft Final Task Order Report.

3. Final Task Order Reports

These reports shall contain all collected/processed, analyzed, and summarized data, and shall be submitted on or before the end of the performance period of each task order. Accompanying the report, all raw data shall be submitted as specified in the base contracts. Reports shall be formatted and contain information necessary for regulatory FDA submission as applicable. The Final Task Order Reports shall be due on or before the task order expiration date.

a. Final Task Order Reports shall be organized and formatted into the following specific sections:

1. Table of Contents

2. Summary of Salient Results

3. Key Personnel

4. Introduction

5. Purpose and Objectives

6. Experimental Design

7. Materials and Methods (including a detailed description of statistical methods used in the study)

8. Regulatory Compliance

9. Results

10. Discussion and Conclusions

11. Quality Assurance Statement

12. Appendices: Tables, Figures, Figure Legends, and High-resolution Photographs or Digital Images of Pertinent Data (e.g. Tumor Lesions, Histopathology, Immunohistochemistry Data, etc.)

13. Supporting document and statement indicating that the study was conducted under GLP when appropriate

b. The Final Task Order Report shall contain a summary (not to exceed 500 words) of salient results achieved during the performance of the task order.

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c. The PDF file shall contain a bookmarked Table of Contents.

PREVENT CGMP Pool

1. Monthly Task Order Progress Reports

The Contractor shall provide Monthly Task Order Progress Reports during performance of each task order. These reports shall include: 1) Introduction to the study; 2) Overall technical strategy section; 3) A brief description of specific milestone task(s) undertaken during the reporting period;4) Materials and methods section pertinent to the specific task(s) undertaken during the reporting period, describing how studies have been carried out, including a description of analytical assays and methods utilized to analyze produced materials and data as applicable; 5) Summary of results and findings obtained over the reporting period; 6) Summary of deliverables that have been completed on the task order as applicable and the completion date; 7) Summary of deliverables in progress on the task order, indicating whether or not these task activities are on schedule and within compliance, whether any problems have been encountered, and whether resolution of the problems has been achieved or still pending; and 8) A Manufacturing Report, Chemistry, Manufacturing and Controls (CMC) Information, a Master File, and other regulatory documents appropriate for submission to the FDA, if applicable. The reporting period is every month, which shall commence upon award of the task order. This report is due 15 calendar days after the end of each reporting period. The first reporting period may include the fractional portion of the first month if less than 30 days.

2. Draft Final Task Order Reports

The Draft Final Task Order Report shall describe a summation of the work performed and results obtained over the entire task order period of performance, and shall be submitted 45 calendar days prior to the end of each task order.

Accompanying the report, all analytical data pertinent to the work performed shall be submitted as specified in the base contract. Reports shall be formatted and contain information necessary for regulatory FDA submission, as applicable.

3. a. Draft Final Task Order Reports shall be organized and formatted into the following specific sections:

i. Table of Contents

ii. Draft Summary Statement

iii. Key Personnel

iv. Introduction

v. Purpose and Objectives

vi. Technical Strategies

vii. Materials and Methods

viii. Regulatory Compliance

ix. Results: Master production records, assay profiles, in-process and final product testing reports, batch reports, certificate of analysis, released drug substance, released drug product

x. Discussion and Conclusions

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xi. Quality Assurance Statement

xii. Supporting document and statement indicating that all studies were conducted under CGMP when appropriate

xiii. Appendices: Tables, figures, figure legends, high resolution, illustrative photographs or digital images of analytical and other pertinent data as appropriate

xiv. A Manufacturing Report, CMC Information, a Master File, and other regulatory documents appropriate for submission to the FDA

b. The PDF file shall contain a bookmarked Table of Contents.

c. Comments or needed corrections/clarifications will be returned by the Contracting OfficerCOR) within 30 calendar days of receipt of the Draft Final Task Order Report.

3. Final Task Order Reports

This report shall describe a summation of the work performed and results obtained over the entire task order period of performance. Accompanying the report, all analytical data pertinent to the work performed shall be submitted as specified in the Base Contracts. Reports shall be formatted and contain information necessary for regulatory FDA submission as applicable. The Final Task Order Reports shall be due on or before the task order expiration date.

a. a. Final Task Order Reports shall be organized and formatted into the following specific sections:

i. Table of Contents

ii. Final Summary Statement

iii. Key Personnel

iv. Introduction

v. Purpose and Objectives

vi. Technical Strategies

vii. Materials and Methods

viii. Regulatory Compliance

ix. Results: Master production records, assay profiles, in-process and final product testing reports, batch reports, certificate of analysis, released drug substance, released drug product

x. Discussion and Conclusions

xi. Quality Assurance Statement

xii. Supporting document and statement indicating that all studies were conducted under CGMP when appropriate

xiii. Appendices: Tables, figures, figure legends, high resolution, illustrative photographs or digital images of analytical and other pertinent data as appropriate

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xiv. A Manufacturing Report, CMC Information, a Master File, and other regulatory documents appropriate for submission to the FDA

b. The PDF file shall contain a bookmarked Table of Contents.

PREVENT Toxicology and Pharmacology Pool

1. Quarterly Task Order Progress Reports

The Contractor shall provide Quarterly Task Order Progress Reports during performance of each task order. These reports shall include: 1) summary of progress on the task order during the past three months, 2) summary of deliverables that have been completed on the task order, and the completion date, 3) summary of deliverables in progress on the task order and whether or not these projects are on schedule, and whether any problems were encountered in the collection, handling, or processing of data, including resolution of the problems, and 4) information regarding INDs, DMF, and NOA. The reporting period is every three (3) months which shall commence upon award of the task order. This report is due 15 calendar days after each reporting period. The first reporting period may include the fractional portion of the first month if less than 30 days.

2. Draft Study Task Order Reports The Contractor shall prepare a QA-audited Draft Study Report for each GLP-compliant study performed under this contract, in accordance with 21 CFR PART 58, Subpart J. Under certain circumstances, QA audited Draft Study Reports will be required for non-GLP-compliant studies. Data generated from GLP compliant studies, and in certain circumstances, from some non-GLP-compliant studies, shall also be submitted in a validated SEND format, per FDA’s requirement.

A Draft Study Task Order Report for non-GLP-compliant and GLP-compliant studies shall be submitted to the COR for review and comment within 45 and 60 business days, respectively, after the end of in-life phase of the study. These reports shall contain all summarized and raw data, and shall contain all information necessary for regulatory FDA submission.

a. Draft Study Task Order Reports shall be organized and formatted into the following specific sections:

i. Table of Contents

ii. Summary

iii. Key Personnel

iv. Introduction

v. Purpose and Objectives

vi. Experimental Design

vii. Materials and Methods

viii. Regulatory Compliance

ix. Results

x. Discussion and Conclusions

xi. Quality Assurance Statement

xii. Tables

xiii. Figures

xiv. Appendices

xv. High Resolution, illustrative photographs or digital images of drug lesions

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xvi. Description of Statistical Analysis used

xvii. Document and state that the study was conducted under Good Laboratory Practice

b. The PDF file shall contain a bookmarked Table of Contents.

c. Comments or needed corrections/clarifications will be returned by the COR within 30 calendar days of receipt of the Draft Study Report.

3. Final Study Task Order Report

The Contractor shall prepare a QA-audited Final Study Report for each GLP- compliant study performed under this contract, in accordance with 21 CFR PART 58, Subpart J. Under certain circumstances, QA-audited Final Study Reports will be required for non-GLP-compliant studies.

Data generated from GLP-compliant studies, and in certain circumstances, from some non-GLP-compliant studies, shall also be submitted in a validated SEND format, per FDA’s requirement.

A Final Study Report shall be submitted to the COR within 15 business days upon receipt of the COR’s comments. The Contractor shall implement and/or address all COR comments in the Final Study Report.

This report shall contain all summarized and individual animal data and shall contain all information necessary for regulatory FDA submission.

a. Final Task Order Reports shall be organized and formatted into the following specific sections:

i. Table of Contents

ii. Summary

iii. Key Personnel

iv. Introduction

v. Purpose and Objectives

vi. Experimental Design

vii. Materials and Methods

viii. Regulatory Compliance

ix. Results

x. Discussion and Conclusions

xi. Quality Assurance Statement

xii. Tables

xiii. Figures

xiv. Appendices

xv. High Resolution, illustrative photographs or digital images of drug lesions

xvi. Description of Statistical Analysis used

xvii. Document and state that the study was conducted under Good Laboratory Practice

b. The PDF file shall contain a bookmarked Table of Contents.

c. The Contractor shall also prepare Final Study Reports with study data generated in the electronic Common Technical Document (eCTD) format. Final tabular data and raw data will also be transmitted to the NCI electronically as requested in the project. Data from each study will also be provided to the NCI in Excel and SEND compliant formats. The latter requirement is currently an FDA requirement for toxicology studies; however, if this requirement is expanded to other studies

- 14 -conducted under this contract (e.g. pharmacology), data from these studies conducted under this contract will also be submitted to the NCI in SEND-compliant format. The Excel datasets and SEND formatted data shall be submitted at the same time as the PDF format of the Final Study Report.

4. Draft Final Task Order Reports

These reports shall contain all summarized and raw data, and shall be submitted 45 calendar days prior to the end of each task order. Reports shall be formatted and contain information necessary for regulatory FDA submission. Draft reports may be in MS Word format and documents or files should be Sec. 508-conformant, Final Reports should be in PDF and 508 Compliant.

5. a. Draft Final Task Order Reports shall be organized and formatted into the following specific sections:

i. Table of Contents

ii. Summary

iii. Key Personnel

iv. Introduction

v. Purpose and Objectives

vi. Experimental Design

vii. Materials and Methods

viii. Regulatory Compliance

ix. Results

x. Discussion and Conclusions

xi. Quality Assurance Statement

xii. Tables

xiii. Figures

xiv. Appendices

xv. High Resolution, illustrative photographs or digital images of drug lesions

xvi. Description of Statistical Analysis used

xvii. Document and state that the study was conducted under GLP

b. The PDF file shall contain a bookmarked Table of Contents.

c. Comments or needed corrections/clarifications will be returned by the COR within 30 calendar days of receipt of the Draft Final Task Order Report.

5. Final Task Order Reports

This report shall contain all summarized and raw data, shall be submitted on or before the end of the performance period of each task order. Reports shall be formatted and contain information necessary for regulatory FDA submission. The Final Task Order Reports shall be due on or before the Task Order expiration date.

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1. a. Final Task Order Reports shall be organized and formatted into the following specific sections:

i. Table of Contents

ii. Summary

iii. Key Personnel

iv. Introduction

v. Purpose and Objectives

vi. Experimental Design

vii. Materials and Methods

viii. Regulatory Compliance

ix. Results

x. Discussion and Conclusions

xi. Quality Assurance Statement

xii. Tables

xiii. Figures

xiv. Appendices

xv. High Resolution, illustrative photographs or digital images of drug lesions

xvi. Description of Statistical Analysis used

xvii. Document and state that the study was conducted under GLP

b. The PDF file shall contain a bookmarked Table of Contents.

2. FOR ALL PREVENT IDIQ Pools

a. 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 task order. This report will be required on or before the expiration date of the task order.

b. Other Reports/Deliverables

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.

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

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

2. Report of USDA-Designated Biobased Products

In accordance with FAR clause 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts, the Contractor shall report to https://www.sam.gov/SAM/, with a copy to the Contracting Officer any USDA-designated biobased products purchased during the period of October 1-September 30 of each contract year. This report shall be submitted no later than October 31 of each year during contract performance and on the expiration date of the contract.

3. Service Contract Report (SCR)

In accordance with FAR clause 52.204-15, Service Contract Reporting Requirements for Indefinite Delivery Contracts (Oct 2016), the Contractor shall enter and submit the following Service Contract Report data elements into System for Award Management (SAM), with a copy to the Contracting Officer annually, by October 31st for services performed under this contract during the preceding Government fiscal year (October 1 - September 30). SCR data elements:

a. Contract Number and Order Number;

b. The total dollar amount invoiced for services performed during the previous Government fiscal year under the contract;

c. Total number of Contractor direct labor hours expended on the services performed during the previous Government fiscal year; and

d. Data reported by first-tier subcontractors that have provided services under this contract,as applicable.

1) First-tier subcontract number (including subcontractor name and unique entity identifier)

2) The number of first-tier subcontractor direct-labor hours expended on the services performed during the previous Government fiscal year.

Reporting on Select Agents or Toxins and/or Highly Pathogenic Agents

4. Reporting on Select Agents or Toxins and/or Highly Pathogenic Agents (as applicable)

For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent , the following information shall also be included in each [Annual] Progress Report:

1. Any changes in the use of the Select Agent or Toxin including initiation of "restricted experiments," and/or a Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.

2. If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

a. A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

b. A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b https://www.selectagents.gov/regulations/index.htm ) or listed on the U.S. Federal Select Agents Registry restricted experiments website ( https://www.selectagents.gov/ compliance/guidance/restricted/index.htm );

https://www.sam.gov/SAM/ https://www.selectagents.gov/regulations/index.htm https://www.selectagents.gov/compliance/guidance/restricted/index.htm https://www.selectagents.gov/compliance/guidance/restricted/index.htm

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c. The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.

d. For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each [Annual] Progress Report.

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each [Annual] Progress Report.

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

5. INFORMATION AND/OR PHYSICAL SECURITY

Data and Information Technology (IT) falls into the category of Controlled Unclassified Information in Nonfederal Systems and needs to follow NIST 800-171 https://csrc.nist.gov/publications/detail/ sp/800-171/rev-2/final guidelines and provide/submit Controlled Unclassified Information (CUI) System Security Plan (SSP) within 60 days, and the Controlled Unclassified Information (CUI) Plan of Action & Milestones (POA&M) documents to the NCI for approval within 90 days.

INFORMATION AND/OR PHYSICAL SECURITY

A. Controlled Unclassifed Information (CUI) System Security Plan (SSP) - due within 60 days after contract award. The SSP shall comply with the NIST SP 800-171 Rev2 , Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations ( https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final ). The SSP shall be consistent with and detail the CUI Plan of Action template https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-SSPTemplate-final.docx.

The SSP shall provide an overview of the system environment and security requirements to protect the information system as well as describe all applicable security controls in place or planned for meeting those requirements. It should provide a structured process for planning adequate, cost-effective security protection for a system. The Contractor shall update the SSP at least annually thereafter.

B. Controlled Unclassifed Information (CUI) Security Assessment Plan of Action - due 90 days after the contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-171 Rev2, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations ( https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final ). The Assessor will supplya plan of action report using the CUI Plan of Action template https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Planof-Action-Template-final.docx outlining failed controls from the assessment and plans for remediation.

C. The 2 deliverables would be

1. The CUI SSP on the CUI SSP template.

https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-SSPTemplate-final.docx

2. The CUI Plan of Action on the template.

https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Planof-Action-Template-final.docx

D. Confidentiality and Nondisclosure of Information- Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-SSPTemplate-final.docx https://csrc.nist.gov/publications/detail/sp/800-171/rev-2/final https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Planof-Action-Template-final.docx https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Planof-Action-Template-final.docx https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-SSPTemplate-final.docx https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Planof-https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Planof-Action-Template-final.docx https://csrc.nist.gov/CSRC/media/Publications/sp/800-171/rev-2/final/documents/CUI-Planof-Action-Template-final.docx

- 18 -of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

1. a. i. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

ii. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

iii. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

D. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf, as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

E. Records Management and Retention The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 --Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/NIH policies and shall not dispose of any records unless authorized by HHS/NIH. In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/NIH policies.

F. Secure Email file Transfer Service (SEFT) All sensitive data/information involved in performance of this contract that may be provided to Contractors by the Government and/or generated by Contractors during performance of the contract shall be transmitted in a secure manner (e.g., using Secure Email and File Transfer Service (SEFT). The SEFT service will be provided by NCI to the Contractors to utilize in transmitting any sensitive data in performance of this contract.

*Note: The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government or generated by the contractor during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided or will generate during the performance of the contract is of a sensitive nature. Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

G. [ ] Information security is not applicable for this solicitation.

[x] Information security is applicable and the following information is required for solicitation preparation:

INFORMATION TYPE

NOTE: Based on information provided by the ISSO, CISO, or other security representative, select the appropriate general information type(s) below AND list the specific element(s) within those information types that are relevant to the acquisition. [x ] Mission Based Information: [Insert Description].

D14.5 Health Care Research and Education Type

H. SECURITY CATEGORIES AND LEVELS

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NOTE: Based on information provided by the ISSO, CISO, or other security representative, select the appropriate Security Level for each Security Category as well as the Overall Security Level. The Overall Security Level shall be the highest level given to any of the three individual factors (Confidentiality, Integrity, and Availability). For additional information, see NIST SP 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories.

Confidentiality Level: [x ] Low [ ] Moderate [ ] High Integrity Level: [ ] Low [x ] Moderate [ ] High Availability Level: [x] Low [ ] Moderate [ ] High Overall Level: [ ] Low [ x] Moderate [ ] High

I. PERSONALLY IDENTIFIABLE INFORMATION (PII) CONFIDENTIALITY IMPACT LEVELS

NOTE: Based on information provided by the ISSO, CISO, or other security or privacy representative, select the PII Confidentiality Impact Level. For additional information, see NIST SP 800-122, Guide to Protecting the Confidentiality of Personally Identifiable Information.

Overall Level: [x ] No PII [ ] Low [ ] Moderate [ ] High

POSITION SENSITIVITY DESIGNATIONS

NOTE: Based on information provided by the ISSO, CISO, or other security representative, check all levels that apply.

The following position sensitivity designations and associated clearance and investigation requirements apply under this contract:

[ ] Tier 3: Public Trust - High Risk (Requires Suitability Determination with a Background Investigation (BI). Contractor (and/or any subcontractor) employees assigned to Level 6 positions shall undergo a Suitability Determination and a BI.

Description:

Level 6 Public Trust positions include positions in which the incumbent’s actions or inactions could diminish public confidence in the integrity, efficiency, or effectiveness of assigned government activities, whether or not actual damage occurs; and positions in that the incumbents are being entrusted with control over information that the Department has legal or contractual obligations not to divulge. These positions include:

• Policymaking and major program responsibility;

• Law enforcement duties that are associated with a “High Risk;”

• Access to or control of unclassified sensitive, proprietary information, or financial records; and

• Duties through which the incumbent can realize a significant personal gain or cause very serious damage to the program or Department.

Examples:

Positions having the following duties: law enforcement, investigations, audit, security, policymaking, major program responsibility, and unlimited access and control over sensitive, proprietary, or financial information, including access through and/or control over automated information systems (computer data systems), or access to data covered by the Privacy Act.

[ ] Tier 2: Public Trust - Moderate Risk (Requires Suitability Determination and a Minimum Background Investigation [MBI]). Contractor (and/or any subcontractor) employees assigned to Level 5 positions with no previous investigation and approval shall undergo a Suitability Determination and an MBI.

Description:

Level 5 Public Trust positions include those involving policymaking with moderate program responsibility, and law enforcement duties that are associated with a “Moderate Risk.” Also included are those positions involving access to positions involving access to personal, private, proprietary, financial records, or sensitive but unclassified/controlled unclassified information.

The unauthorized disclosure of which could cause moderate damage to the program or realizing moderate personal gain to individuals, business entities, or government programs or operations.

HHS Security and Privacy Language for Information and Information Technology Acquisitions Page 3 [ ] Tier 1: Non Sensitive (Requires Suitability Determination with a National Agency Check and Inquiry Investigation (NACI)). Contractor (and/or any subcontractor) employees assigned to Level 1 positions shall undergo an NACI.

Description:

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Level 1, Non-Sensitive positions, are those positions deemed low risk by the Office of Personnel Management.

PROSPECTIVE OFFEROR NON-DISCLOSURE AGREEMENT

[ ] Offerors WILL NOT require…