N01PC65003-74_W_attachments_FINAL.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: PHS Act, 42 USC 285a-2(B)(8)

2. Request for Proposal (RFP) Number:

N01PC65003-74

3. Issue Date:

05/03/2017

4. Set Aside:

[X] No [ ] Yes See Part IV Section L

5. Title : Surveillance, Epidemiology, and End Results (SEER) Program

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Dr.

Room 1E642, MSC 9705 Bethesda, MD 20892-9705

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 04:00pm Eastern Time on 07/10/2017. 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, "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 http://www.sam.gov

11. FOR INFORMATION CALL: Lee Oliver, Contract Specialist

PHONE: 240-276-6527

e-MAIL: NCISEER_2018@mail.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Submit all questions in writing to: NCISEER_2018@mail.nih.gov.

Responses to questions will be provided in Amendments to the Solicitation. Questions received after 3:00 P.M. Eastern Time on June 16, 2017 may not be addressed.

Marla Jacobson Contracting Officer

PCPSB

Office of Acquisitions, NCI

RFP Number : N01PC65003-74

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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. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. PRE-PROPOSAL CONFERENCE

f. COMMITMENT OF PUBLIC FUNDS

g. PROMOTING EFFICIENT SPENDING

h. COMMUNICATIONS PRIOR TO CONTRACT AWARD

i. RELEASE OF INFORMATION

j. REFERENCE MATERIALS

k. PREPARATION COSTS

l. SERVICE OF PROTEST

m. LATE PROPOSALS AND REVISIONS

n. 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

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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

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

13. ROTC Access and Federal Military Recruiting on Campus

14. Certification of Filing and Payment of Taxes

15. Past Performance Information

16. Information and Physical Access Security

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

18. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

Notice to Offerors of Requirements, Protection of Human Subjects, HHSAR 270-4(a)

Instructions to Offerors Regarding Protection of Human Subjects

Required Education in the Protection of Human Research Participants

Inclusion of Women and Minorities in Research Involving Human Subjects

Inclusion of Children in Research Involving Human Subjects

Research Involving Human Fetal Tissue

Human Embryonic Germ Cell (HEGC) Research

Human Stem Cell Research

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. Salary Rate Limitation

5. Small Business Subcontracting Plan

6. Mentor Protege Program, HHSAR 352.219-70

7. HUBZone Small Business Concerns

8. Total Compensation Plan

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

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3. HUMAN SUBJECT EVALUATION

4. EVALUATION OF DATA SHARING PLAN

5. TECHNICAL EVALUATION FACTORS

6. 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 Contractor shall collect population-based cancer data and report on population-based cancer incidence, treatment, and survival data on all patients in the legally described geographic coverage area. The Contractor shall participate in cancer surveillance research efforts supported under the Statement of Work. These may include activities such as the Virtual Tissue Repository, Virtual Pooled Registry, Patterns of Care Studies, and other ancillary studies.

ARTICLE B.1. PRICES/COSTS

a. This is a Multiple Award 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 $1,000 (minimum) nor more than a total of $500,000,000 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period 05/01/2018 through 04/30/2028.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract and the following schedule. Upon delivery and acceptance of the item(s) described in each Task Order, the Government shall pay to the Contractor the [unit price(s)/costs] set forth below:

SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD

Description of Item Unit(s) Price/Unit

d. Ordering procedures are described in The METHOD OF ORDERING Article in SECTION G of this contract.

ARTICLE B.3. 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)

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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.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which require prior written approval of the Contracting Officer before incurrence of the cost (e.g. consultant, subcontracts, software licenses, overtime) may be included under this Article pursuant to a Task Order.

ARTICLE B.5. COST SHARING

Task Orders under this IDIQ may be cost-sharing. The total estimated cost of performing the work under this contract is to be determined at the Task Order level. For further provisions regarding the specific cost-sharing arrangement, refer to the ADVANCE UNDERSTANDINGS Article in SECTION B of the individual Task Order(s).

The Contractor shall maintain records of all Task Order costs, including costs claimed by the Contractor as being its share. These records shall be subject to the Audit and Records-Negotiation and Final Decisions on Audit Findings clauses of the General Clauses.

Costs contributed by the Contractor shall not be charged to the Government under any other contract, Task Order, grant, or cooperative agreement (including the allocation to other grants, contracts, or cooperative agreements as part of an independent research and development program). The Contractor shall report the organization's share of the costs expended by category, on the Financial Report of Individual Project/Contract, NIH 2706, as referenced in SECTION G and SECTION J of this IDIQ.

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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 TBD, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

b. The applicable Privacy Act System of Records Number will be specified and shall be used in any design, development, or operation work to be performed under the resultant contract. Disposition of records shall be in accordance with SECTION C of the contract, and by direction of the Contracting Officer's Representative (COR).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format via email as attachments to the following designated NCI Branch Distribution Mailbox: ncibranchbinvoices@mail.nih.gov.

Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50 MB, the Contractor shall divide the deliverable into files of 50 MB each. All deliverables shall be limited to five file attachments or less.

The subject line of the email and file attachment name shall read as follows:

Deliverable_Contract Number_Task Order Number_Vendor's Name_Deliverable Description_Due Date

All electronic reports submitted 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: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

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 in any contract 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 contract 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.]

2. Programmatic Meeting Summary Reports

The Programmatic Meeting Summary Report shall be submitted within 60 calendar days of contract award.

This report shall include, but is not limited to:

a. The Contractor's recommendations for best practices.

b. The Contractor's recommendations for potential expansion and improvement of the SEER program.

c. A summary of the Programmatic Meeting.

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3. Monthly Task Order Progress Reports

Monthly Task Order Progress Reports shall be submitted within 15 days following the 1st full month of the task order. A Monthly Task Order Progress Report is not required for the period when a Quarterly Task Order Progress Report is due.

This report shall include but is not limited to:

a. A brief discussion of the activities and tasks completed.

b. A brief discussion of any barriers or challenges and plans to overcome them or indicate N/ A if none.

c. A brief discussion of plans for the next reporting period.

4. Quarterly Task Order Progress Reports

The Contractor shall submit Quarterly Task Order Progress Reports within 15 days following the 1st full quarter (3-month period) of the task order. A Quarterly Task Order Progress Report is not required for the period when an Annual Task Order Progress Report is due. This report shall:

a. Discuss the activities and tasks completed.

b. Discuss any barriers or challenges and plans to overcome them.

c. Discuss plans for the next reporting period.

d. For Patterns of Care Task Orders Only: for each of the cancer sites include the numbers completed during each reporting period and cumulative through the end of the reporting period for each of the following:

1) hospital records abstracted

2) Physician Verification Forms sent

3) Physician Verification Forms completed

4) unified record verifications completed

5) hospital only verifications completed

6) abstracts with no verification

7) abstracts completed by cancer site

e. For Ancillary Studies and Additional Projects Task Orders Only: include

1) Discussion of Study methods

2) Discussion of Data collection instruments

3) Feasibility Assessment Report

4) Data Analysis Report

5. Semi-Annual Task Order Progress Reports

The Contractor shall submit Semi-Annual Task Order Progress Reports within 15 days following the 2nd quarter (6-month period) of the task order. A Semi-Annual Task Order Progress Report is not required for the period when an Annual Task Order Progress Report is due. This report shall include but is not limited to:

a. Discussion of work completed by task including:

i. Discussion of in progress work by task

ii. Discussion of any challenges and barriers and steps taken to overcome them

iii. Discussion of changes made from the Preliminary Task Order Implementation/ Project Plan providing details by task.

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6. Draft Annual Task Order Progress Report

The Contractor shall provide the Annual Progress Report in draft form 60 calendar days prior to the delivery date for the Final Version of the Annual Progress Report. The Contracting Officer's Representative (COR) will review the draft report and provide the Contracting Officer with comments within 15 Calendar days after receipt. The Contractor, if necessary shall correct the Annual Progress Report and final version delivered as specified.

7. Annual Task Order Progress Reports

The Contractor shall submit an annual Task Order Progress Report to include a summary of the results for the period covered. This report shall include but is not limited to:

a. Progress in the performance of the task order in accordance with each item of the task order Statement of Work

b. A discussion of any problems the Contractor has in maintaining an effective operating program.

c. A list of all current ongoing studies which utilize the cancer registry and their status.

d. If applicable, a report on the status of the Contractor's registry's residual tissue repository and the status of current studies which utilize the repository.

e. Any other points specifically requested by the Contracting Officer's Representative (COR) or which the Contractor feels are of interest.

Annual Task Order Progress Reports shall be submitted within 30 days after the anniversary date of the task order. An Annual Progress Report is not required for the period when a Final Task Order Progress Report is due.

8. Draft Final Task Order Progress Report

The Contractor shall provide the Final Report in draft form 60 Calendar days prior to the expiration date of the task order. The Contracting Officer's Representative (COR) will review the draft report and provide the Contracting Officer with comments within 15 Calendar days after receipt. The Final Progress Report shall be corrected by the Contractor, if necessary and the final version delivered as specified.

9. Final Task Order Progress Reports

The Final Task Order Progress Report is to include a summation of the work performed and results obtained for the entire task order period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Final Task Order Progress Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The content and format shall be specified by the COR. This shall include but is not limited to:

a. For Core Infrastructure Support Activities Task Orders:

1) Progress in the performance of the task order in accordance with each item of the Statement of Work.

2) A discussion of any problems the Contractor had in maintaining an effective operating program.

3) A list of all current ongoing studies which utilize the cancer registry and their status.

4) If applicable, a report on the status of the registry's residual tissue repository and the status of current studies which utilize the repository.

5) Any other points specifically requested by the Contracting Officer's Representative (COR) or which the Contractor feels are of interest.

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b. For Patterns of Care/Quality of Care Studies Task Orders:

1) Progress in the performance of the task order in accordance with each item of the Statement of Work

2) Describe barriers, challenges, problems and resolution including actions taken

3) Describe sampling process for the initial sample and for the subsequently identified patients

4) Discussion of Results

5) Data on the following:

a) Number of cases sampled

b) Percent of patients having the data verified by physicians/unified record, hospital only, or not verified.

c) Number of cases completed

d) Number missing substantial data

6) Provide a chart to include all of the following for each of the cancer sites:

a) number of hospital records abstracted

b) number of Physician Verification Forms sent

c) number of Physician Verification Forms completed

d) number of unified record verifications completed

e) number of hospital only verifications completed

f) number of abstracts with no verification

g) number of abstracts completed by cancer site

c. For Ancillary Studies and Additional Projects Task Orders:

1) Progress of the work by task

2) Discussion of challenges and barriers and steps taken

3) Discussion of Study methods

4) Discussion of Data collection instruments

5) Feasibility Assessment Report

6) Data Analysis Report

A final report shall be due on or before the expiration or completion date of the task order.

10. Summary of Salient Results per Task Order

The Contractor shall 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 is due on or before the expiration or completion date of the task order.

11. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this task order. The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Enrollment Report," which is set forth in SECTION J of this contract.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended October 2001 applies. If this contract is for Phase Ill clinical trials, see 11.B of these guidelines. The Guidelines may be found at the following website: http://grants.nih.gov/ grants/funding/women_min/women_min.htm .

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For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice.

The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/ gender, race and/or ethnicity.

B. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI) (Applicable as needed)

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: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

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

2. Report of USDA-Designated Biobased Products (Applicable under the Base Contract)

In accordance with FAR clause 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts, the contractor shall report to http://www.sam.gov, 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. Source Code and Object Code ( As applicable)

Unless otherwise specified herein, the Contractor shall deliver to the Government, upon the expiration date of the contract or applicable Task Order, all source code and object code developed, modified, and/or enhanced under this contract or applicable Task Order.

4. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract. Note: Each report listed below includes a reference to the appropriate subparagraph of this article.

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative

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(COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP)

The contractor shall submit the IT-SP within thirty (30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

The contractor shall submit the IT-RA within thirty (30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy.

The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. FIPS 199 Assessment

The Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract.

e. IT Security Certification and Accreditation (IT-SC&A)

The Contractor shall submit written proof to the Contracting Officer that an IT-SC&A was performed within three (3) months after contract award.

The Contractor shall perform an annual security control assessment and provide to the Contracting Officer verification that the IT-SC&A remains valid.

(Reference subparagraph D.c.4. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

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f. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

1. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

2. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

g. Contractor - Employee Non-Disclosure Agreement(s) The contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information

- Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/ Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

h. Vulnerability Scanning Reports

The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under separate cover on a monthly basis.

(Reference subparagraph E.5. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

i. Management of Sensitive Information Plan

The Contractor shall develop and submit a draft plan for review within 30 days of Contract Award. The COR must approve this plan.

j. Report on Status of Minimum Background Investigation Clearances (HSPD-12 Security Requirements)

The Contractor shall perform and report on status of background investigations according to Homeland Security Presidential Directive 12.

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5. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule in SECTION F, Article 2, Deliveries, and in accordance with the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY Article in SECTION H of the contract. The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/ contracting/technology/vendors.html under "Vendor Information and Documents."

6. Disaster Recovery Plan

The Contractor shall develop and submit a draft plan for review and approval by the COR within 30 days of Contract Award.

7. Data Collection Plan

The Contractor shall develop and submit a draft plan in accordance with HHSAR 352.224-70 Privacy Act for review and approval by the COR within 30 days of Contract Award.

8. Service Contract Report (SCR)

In accordance with FAR clause 52.204-15, Service Contract Reporting Requirements for Indefinite Delivery Contracts (Jan 2014), 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

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.

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 DUNS number)

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

9. Data Files

The Contractor shall submit data to the NCI on each resident cancer case diagnosed from the first full year of data collection forward in the format specified at http://seer.cancer.gov/tools/submission.html).

The Data Files shall be submitted in accordance with the DELIVERIES Article in SECTION F of the base contract and of the applicable task order. The primary submission shall be on the last business day of February and the first business day of November of each Task Order.

These submissions shall contain complete data for all patients diagnosed prior to January 1st of the preceding year (for example, data submitted in February and November of 2019 will include all cases diagnosed through calendar year 2018).

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10. Data Files of Abstracts

The Contractor shall submit Data Files of Abstracts for each cancer site. These electronic data files shall be submitted to the Biomedical Computing Support Services Contractor via a secured password protected portal.

11. SEER Bibliography Entries

a. For Core Task Orders: The Contractor shall submit a bibliography of publications by registry staff each year on the first business day of September of the task order period of performance. This report shall be submitted as a Word document.

b. For Ancillary Studies Task Orders: As applicable, submit manuscripts published before the expiration date of the task order.

12. Training Report

The Contractor shall submit a Training Report to include name and position of personnel who attended or will attend and plan to implement training to conduct the Statement of Work within 30 days of task order award.

13. Preliminary Task Order Implementation/Project Plan

The Contractor shall submit a Project Plan within 30 calendar days of task order award to include but not limited to:

a. Outline of proposed work to be completed, by task

b. A Description of how each task will be accomplished

c. Who will be responsible for each task

d. Resources to be utilized for each task

e. A timeline for completion of each task

14. SEER*DMS Migration Plan

The Contractor shall submit a SEER*DMS Migration Plan within 45 days of task order award. This plan will be developed in coordination with the Task Order COR and Division of Cancer Control and Population Sciences (DCCPS) Biomedical Computing Support Contract staff and will address the migration activities addressed in the Base Statement of Work and the timeline for implementing these activities.

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

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

Invention Reporting Requirement (Applicable to all Task Orders)

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980

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(Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

DEITR

OPERA, OER

National Institutes of Health

6705 Rockledge Drive Suite 310, MSC 7980, Room Bethesda, Maryland 20892- 7980

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

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.

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 (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

National Cancer Institute Surveillance Research Program Division of Cancer Control and Population Sciences 9609 Medical Center Drive Room 4E448, MSC 9765 Bethesda, MD 20892-9765

Supplies or services delivered as a result of this solicitation will be accepted based in part on satisfaction of identified Section 508 requirements for accessibility. 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 clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make the full text available.

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FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996).

FAR Clause 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984).

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (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 05/01/2018 through 04/30/2028.

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:

The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered in electronic format to the designated NCI Branch Distribution Mailbox: ncibranchbinvoices@mail.nih.gov 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. The subject line of the email shall read as follows: Deliverable_Contract Number_Task Order Number_Vendor'sName_Deliverable Description_Due Date.

Deliverable # Description Schedule Technical Progress Reports

1 Programmatic Meeting Summary Report In accordance with Task Area 1, due no later than 60 calendar days from date of Task Order award

2 Monthly Task Order Progress Reports Due no later than the 15th calendar day following the 1 st full month (30-days) as specified in the Task Order

3 Quarterly Task Order Progress Reports Due no later than the 15th calendar day following the 1 st full quarter (3-month period) of the Task Order 4 Semi-Annual Task Order Progress Reports Due no later than the 15th calendar day following the 2 nd quarter (6-month period) of the Task Order

5 Draft Annual Task Order Progress Report Due in draft form 60 calendar days prior to the Annual Task Order Progress Report due date as specified in the Task Order

6 Annual Task Order Progress Reports Due no later than the 30th calendar day from the anniversary date of each Task Order.

The Annual Report is not required when the Final Task Order Progress Report is due 7 Draft Final Task Order Progress Report Due 60 calendar days prior to the expiration or completion date of each Task Order 8 Final Task Order Progress Reports Due on the expiration or completion date as specified in each Task Order 9 Summary of Salient Results per Task Order Due on the expiration or completion date as specified in each Task Order 10 Annual Technical Progress Report for

Clinical Research Study Populations Due on the expiration or completion date as specified in each Task Order

Other Reports/Deliverables 11 Reporting of Financial

Conflict of Interest (FCOI) Due as FCOI arises

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Deliverable # Description Schedule 12 Report of USDA-Designated

Biobased Products Report at www.sam.gov annually by October 31 st and on the expiration date of the base contract

13 Source Code and Object Code Due by the expiration of completion date as specified in each Task Order

14 Roster of Employees Requiring Suitability Investigations per Task Order

Due no later than 14 calendar days after the effective date of each Task Order

15 IT Security Plan (IT-SP) Due no later than 30 days after the effective date of the Task Order and annually thereafter

16 IT Risk Assessment (IT-RA) Due no later than 30 days after Task Order effective date and due annually thereafter

17 FIPS 199 Assessment Due no later than 30 days after Task Order effective date

18 IT Security Certification and Accreditation (IT-SC&A)

Due no later than 3 months after Task Order effective date and annually thereafter provide verification that IT-SC&A remains valid 19 Reporting of New and Departing Employees Due no later than five working days of staffing changes for positions that require suitability determinations

20 Contractor-Employee Non- Disclosure Agreement(s)

Due no later than five days from Task Order effective date

21 Vulnerability Scanning Reports Due no later than 10 calendar days following the end of each calendar month of the Task Order

22 Management of Sensitive Information Plan Due no later than 30 days of Task Order effective date

23 Report on Status of Minimum Background Investigation Clearances

(HSPD-12 Security Requirements)

Due as applicable in accordance with Section H.

Information and Physical Access Security Clause

24 Section 508 Annual Report Due annually as specified in each Task Order for a period of performance over 12 months

25 Disaster Recovery Plan Due no later than 30 days of Task Order effective date

26 Data Collection Plan Due no later than 30 days of Task Order effective date

27 Service Contract Report Report at www.sam.gov annually by October 31st and on the Task

Order expiration or completion date 28 Data Files Due as specified in each Task Order 29 Data Files of Abstracts Due as specified in each Task Order 30 SEER Bibliography Entries Due the 1st business day of September of the

Task Order period of performance and due on e Task Order expiration or completion date

31 Training Report Due no later than 30 calendar days from Task Order effective date

32 Preliminary Task Order Implementation/Project Plan

Due no later than 30 calendar days from Task Order effective date

33 Invention Reporting Requirement Due in accordance with Section C. Invention Reporting Article

34 SEER*DMS Migration Plan As specified in the task order, due no later than 45 calendar days of Task Order effective date

35 Individual Subcontract Report (ISR) Due on base contract in accordance with Section H. Subcontracting Provisions Article

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Deliverable # Description Schedule 36 Summary Subcontract Report (SSR) Due on base contract in accordance with

Section H. Subcontracting Provisions Article 37 Annual Report of Government Owned-

Contractor Held Property Report Due annually, no later than 30 days from the anniversary date of the base contract in accordance with Section

G. Government Property Article

The above items shall be addressed and emailed to ncibranchbinvoices@mail.nih.gov. The following addresses are provided for general correspondence and other deliveries.

Addressee Deliverable Item No.

Quantity

Contracting Officer National Cancer Institute Office of Acquisitions, Room 1E642 9609 Medical Center Drive, MSC 9705 Bethesda, MD 20892-9705

1-12, 14-27, 30-32, 34-37

Deliverable Items 12 and 27 due at www.sam.gov. Items 35 and 36 due at www.esrs.gov. Items 1-11, 13-26, 30-32, and 34-37 electronically to the email address above

Contracting Officer's Representative COR National Cancer Institute Division of Cancer Control and Population Sciences 9609 Medical Center Drive Room 4E448, MSC 9765 Bethesda, MD 20892-9705

1-11 and 13-34 Items 13, 28, and 29 due electronically in accordance Article C.2

Items 1-11, 14-25, and 30 - 34 electronically to the email address above

OPERA, OEH, NIH

6705 Rockledge Drive Suite 310, MSC 7980 Bethesda, Maryland 20892-7980

33 One (1) hard copy or to iEdison at http:// public.era.nih.gov/iedison

Government Property Officer Contract Property Section, Division of Logistics Services, Office of Management, NIH 6011 Executive Blvd., Room 639M Rockville, MD 20852 NIHContractProperty@mail.nih.gov

37 Electronically to the email address:

NIHContractProperty@mail.nih.gov

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

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: http://www.acquisition.gov/far .

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to cost reimbursement task orders.

Alternate I (April 1984) is not applicable to fixed-price task orders.

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

52.211-11, Liquidated Damages--Supplies, Services or Research and Development (September 2000).

"(a) If the Contractor fails to deliver the supplies or perform the services within the time specified in this contract, the Contractor shall, in place of actual damages, pay to the Government liquidated damages, to be determined at each Task Order, per calendar day of delay."

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

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

To be specified prior to award. Additional COR's may be specified at the individual Task Order level.

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 To be determined

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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…