75N91019R00029 - Amendment 3.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:

75N91019R00029

3. Issue Date:

August 29, 2019

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 1E158, MSC 9705 Bethesda, MD 20892-9705

7. SUBMIT OFFERS TO:

See Part III, Section J, "Delivery of Proposal Using eCPS," Attachment 03 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 03, "Delivery of Proposal Using eCPS," until 4:00 Eastern Time on February 24, 2020. 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".

9. This solicitation requires delivery of proposals as stated in Attachment 03, "Delivery of Proposal Using eCPS".

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 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: John Turner, Contracting Officer / Team Lead

PHONE: 240-276-7756

e-MAIL: john.turner@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

John Turner Contracting Officer / Team Lead Office of Acquisitions, NCI, NIH http://www.sam.gov

RFP Number : 75N91019R00029

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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. CONCEPT REVIEW

l. PREPARATION COSTS

m. SERVICE OF PROTEST

n. LATE PROPOSALS AND REVISIONS

o. 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

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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

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

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Approach

2. Technical Evaluation

3. 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 Stem Cell Research

4. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Cost and Pricing Data

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

3. HUMAN SUBJECT EVALUATION

4. MANDATORY QUALIFICATION CRITERIA

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5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

7. TECHNICAL EVALUATION FACTORS

8. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

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

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Surveillance, Epidemiology, and End Results (SEER) Program. 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.2. PRICES/COSTS

a. This is a Multiple Award Indefinite Delivery, Indefinite Quantity (IDIQ) 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 11/01/2020 through 04/30/2028.

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.3. PROVISIONS APPLICABLE TO DIRECT COSTS

a. This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer.

Notwithstanding the clause, ALLOWABLE COST AND PAYMENT, incorporated into the resultant contract, unless authorized in writing by the Contracting Officer, the costs of the following items or activities shall be unallowable as direct costs:

1. Conferences and Meetings

2. Food for Meals, Light Refreshments, and Beverages

3. Promotional Items [includes, but is not limited to: clothing and commemorative items such as pens, mugs/ cups, folders/folios, lanyards, and conference bags that are sometimes provided to visitors, employees, grantees, or conference attendees.]

4. Acquisition, by purchase or lease, of any interest in real property;

5. Special rearrangement or alteration of facilities;

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6. Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

7. Travel to attend general scientific meetings;

8. Foreign travel;

9. Consultant costs;

10. Subcontracts; Subcontracts requiring consent pursuant to FAR 44.201 - Consent and Advance Notification Requirements.

11. Patient care costs;

12. Accountable Government Property (defined as non-expendable personal property with an acquisition cost of $1,000 or more) and "sensitive items" (defined as items of personal property (supplies and equipment that are highly desirable and easily converted to personal use), regardless of acquisition value.

13. Printing Costs (as defined in the Government Printing and Binding Regulations).

b. Travel Costs

The Contractor shall invoice and be reimbursed for all travel costs in accordance with:

1. Federal Acquisition Regulations ( FAR) 31.2 - Contracts with Commercial Organizations, Subsection 31.205-46, Travel Costs ,

2. FAR 31.3 - Contracts with Educational Institutions,

3. FAR 31.6 - Contracts with State, Local, and Federally Recognized Indian Tribal Governments, or

4. FAR 31.7 - Contracts with Nonprofit Organizations

ARTICLE B.4. ADVANCE UNDERSTANDINGS

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

ARTICLE B.5. COST-SHARING

Task Orders under this IDIQ may be Cost-Sharing Contracts as contemplated by FAR 16.303. 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.

ARTICLE B.6. RAMP-ON

The Contracting Officer will periodically review the total number of contractors under this Multiple Award IDIQ contract to ensure adequate competition for task orders throughout the period of performance. Over time, the total number of contractors may fluctuate for various reasons including but not limited to: advancement of the SEER Program's mission of collecting continuously reported population based data through the inclusion of genomic and longitudinal treatment data; increasing the percentage of the overall US population represented, specifically minority and underrepresented groups; leveraging the expertise of a robust network of registries and Principal Investigators;

and improving the data collection tools and methodologies through registry participation and feedback.

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If the Contracting Officer determines that it is in the best interest of the government to open the SEER Multiple Award IDIQ contract to new contractors, the Contracting Officer has the discretion to announce an open season at any time during the effective period of the base contract but no earlier than one year from date of award.

The Contracting Officer will announce this open season by publishing a notice in Federal Business Opportunities.

The open season will be subject to applicable federal procurement laws and guidance at the time the open season is announced. The Open Season announcement will provide an estimate of the number of new awards that the Contracting Officer intends to make. Under the Open Season, the Contracting Officer will issue a solicitation. Any offeror meeting the eligibility requirements identified in the new "ramp on" solicitation may submit a proposal in response to the solicitation. However, the Contracting Officer has the discretion to award more or fewer contracts than the number anticipated in the solicitation depending upon the quality of the offers received.

Any resulting contracts awarded under this provision will not exceed the remaining period of performance of the existing SEER Multiple Award IDIQ contract. Any contractor receiving a contract under this open season will be eligible to compete on future task orders with the same rights and obligations of any other SEER contractor.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. The Base Statement of Work, dated November 01, 2020, is attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments). The Base Statement of Work describes the general scope, nature, complexity, and purpose of the services the Government may acquire under this contract during the specified period.

The specific requirements will be identified in each Task Order Statement of Work. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform each Task Order Statement of Work.

b. Privacy Act System of Records Number 09-25-0200 is applicable 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

IDIQ Contract Deliverables: Deliverables shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract.

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order. Deliverables shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract and with the requirements of Task Orders issued here under.

[Note: Beginning May 25, 2008, the Contractor shall include, in any technical progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.

a. Reports/Deliverables

1. Programmatic Meeting Summary Report

Within 60 calendar days of Task Order award, the Contractor shall submit a Meeting Summary Report. 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.

2. Monthly Task Order Progress Report

This report will typically 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.

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

When this report is required, the frequency and specific content will be specified within each individual Task Order.

3. Quarterly Task Order Progress Report

This report will typically 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.

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

When this report is required, the frequency and specific content will be specified within each individual Task Order.

4. Semi-Annual Task Order Progress Report

This report will typically 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.

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

When this report is required, the frequency and specific content will be specified within each individual Task Order.

5. Draft Annual Task Order Progress Report

When this report is required, the frequency and specific content will be specified within each individual Task Order.

6. Annual Task Order Progress Report

When this report is required, the frequency and specific content will be specified within each individual Task Order.

7. Draft Final Task Order Progress Report

When this report is required, the frequency and specific content will be specified within each individual Task Order.

8. Final Task Order Progress Report

When this report is required, the frequency and specific content will be specified within each individual Task Order.

9. Summary of Salient Results

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The Contractor shall prepare and submit a summary (not to exceed 200 words) of salient results achieved during the performance of the Task Order. When this report is required, the frequency and specific content will be specified within each individual Task Order..

10. 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 a 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 the Task Order.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended October 2001 applies.

11. 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: 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.)

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

13. Security Assessment and Authorization (SA&A)

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

14. System Security Plan (SSP)

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

15. Security Assessment Plan/ Report (SAP/SAR)

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

16. Independent Assessment 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 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

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When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

17. Plan of Actions and Milestones ( POA& M)

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

18. Contingency Plan and Contingency Plan Test

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

19. Roster of Employees Requiring Suitability Investigations per Task Order

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

20. Contractor-Employee Non-Disclosure Agreement(s)

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

21. Vulnerability Scanning Reports

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

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

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

23. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). 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."

24. Disaster Recovery Plan

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

25. Management of Sensitive Information Plan

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html

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26. Data Collection Plan

When required, 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 Task Order Award.

27. Data Management Plan

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

28. Configuration Management Plan

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order

29. 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.

30. Data Files

The Contractor shall submit data to the NCI twice a year on each resident cancer cases diagnosed from 2000 forward in the format specified by the COR. The primary submission shall be prior to the end of November of each year, which shall contain complete data for all patients diagnosed prior to January 1st of the preceding year (22 months prior to submission). Data files submitted to NCI should follow the most current SEER Data Submission Requirements posted on the NCI SEER website under the Registry Operations webpage (https://seer.cancer.gov/tools/submission.html). The second data submission shall be submitted on the last day of February of each calendar year. This submission shall provide case data for patients diagnosed prior to January 1st of the calendar year just concluded (Submission in February 2020 will include all cases in the registry diagnosed prior to January 1, 2020). Cases diagnosed during the most recently concluded year will not be included in the DQP evaluation or required to pass the SEER Edits checks. New contractors to the SEER Program shall provide the data submission file in paragraph (d) above on the last day of the first February following Task Order award. For this first submission, no quality markers/indicators need to be passed at the time of the evaluation of this data file. The Contractor shall utilize the most current version of the NACCR Data Standards and Data Dictionary available at https://www.naaccr.org/ https://seer.cancer.gov/tools/submission.html https://www.naaccr.org/data-standards-data-dictionary/

- 13 -data-standards-data-dictionary/. Additional information on Data File submission may be found in SECTION F of the base contract and of the applicable Task Order.

CONFIRMATION OF DATA FILE SUBMISSION MUST BE SUBMITTED IN ACCORDANCE WITH

ARTICLE F.2.a TO THE NCI BRANCH DISTRIBUTION MAILBOX.

31. 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 the SEER*DMS portal or via file transfer protocol (FTP) for those registries not on SEER*DMS.

32. SEER Bibliography Entries

When required, the frequency and specific content of this deliverable will be specified within each individual Task Order. The bibliography of publications typically only includes those publications which relied on the registry's data or infrastructure and include registry staff as authors.

33. Training Report

When required, the frequency and specific content of this deliverable will be determined within each individual Task Order.

34. Preliminary Task Order Implementation/ Project Plan

When required, the frequency and specific content of this deliverable will be specified within each individual Task Order. Typically this deliverable will include but is 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

35. Annual Utilization Report

Due in accordance with Article C.3 Invention Reporting Requirement; submit electronically to http:// public.era.nih.gov/iedison

36. Final Invention Statement

Due in accordance with Article C.3 Invention Reporting Requirement; submit electronically to http:// public.era.nih.gov/iedison

37. Individual Subcontract Report (ISR)

Due on base contract in accordance with Section H. Subcontracting Provisions Article; submit electronically to http://esrs.gov https://www.naaccr.org/data-standards-data-dictionary/

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38. Summary Subcontract Report (SSR)

Due on base contract in accordance with Section H. Subcontracting Provisions Article; submit electronically to http://esrs.gov

39. 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; submit electronically to NIHContractProperty@mail.nih.gov

40. SEER*DMS Migration Plan

The Contractor shall submit a draft SEER*DMS Migration Plan within 90 days of Task Order award.

The Contractor shall submit a final SEER*DMS Migration Plan 30 days following the COR's feedback on the draft plan. 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 Task Order Statement of Work and the timeline for implementing these activities.

41. 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.

42. Protection of Human Subjects Annual Certification

Pursuant to Article H.1 Protection of Human Subjects, HHSAR 352.270-4(b), provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

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 (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 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

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http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

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

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SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, the Contracting Officer's Representative (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 4E450, MSC 9765 Bethesda, MD 20892-9765

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

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

FAR Clause 52.246-9, 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 11/01/2020 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:

a. 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: Contract Number_ Task Order Number_ Deliverable Number_ Deliverable Description.

Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50MB, the Contractor shall divide the deliverable into files of 50 MB each. All deliverables shall be limited to five (5) files attachments or less.

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".

Deliverable

No.

Description Delivery Schedule

1 Programmatic Meeting Summary Report

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

2 Monthly Task Order Progress Reports Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

3 Quarterly Task Order Progress Reports Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

4 Semi- Annual Task Order Progress Reports

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

5 Draft Annual Task Order Progress Report

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

6 Annual Task Order Progress Reports Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

mailto:ncibranchbinvoices@mail.nih.gov http://www.hhs.gov/web/508/index.html

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Deliverable

No.

Description Delivery Schedule

7 Draft Final Task Order Progress Report Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

8 Final Task Order Progress Reports Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

9 Summary of Salient Results per Task Order

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

10 Annual Technical Progress Report for

Clinical Research Study Populations

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

11 Reporting of Financial Conflict of Interest (FCOI)

Task Order Deliverables: Due as FCOI arises

12 Source Code and Object Code Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

13 Security Assessment and Authorization (SA&A)

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

14 System Security Plan (SSP) Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

15 Security Assessment Plan/ Report

(SAP/ SAR)

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

16 Independent Assessment Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

17 Plan of Actions and Milestones

(POA& M)

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

18 Contingency Plan and

Contingency Plan Test

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

19 Roster of Employees Requiring

Suitability Investigations per Task Order

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

20 Contractor- Employee Non-

Disclosure Agreement(s)

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

21 Vulnerability Scanning Reports Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

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Deliverable

No.

Description Delivery Schedule

22 Report on Status of Minimum

Background Investigation Clearances (HSPD- 12 Security Requirements)

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

23 Section 508 Annual Report Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

24 Disaster Recovery Plan Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

25 Management of Sensitive

Information Plan

Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

26 Data Collection Plan Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

27 Data Management Plan Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

28 Configuration Management Plan Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

29 Service Contract Report Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

30 Data Files Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

31 Data Files of Abstracts Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

32 SEER Bibliography Entries Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

33 Training Report Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

34 Preliminary Task Order

Implementation/ Project Plan

Due no later than 30 calendar days from Task Order effective date. Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

35 Annual Utilization Report IDIQ Contract Deliverables: Due in accordance with Article C.3 Invention Reporting Requirement; submit electronically to http://public.era.nih.gov/iedison

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Deliverable

No.

Description Delivery Schedule

36 Final Invention Statement IDIQ Contract Deliverables: Due in accordance with Article C.3 Invention Reporting Requirement; submit electronically to http://public.era.nih.gov/iedison

37 Individual Subcontract Report (ISR) IDIQ Contract Deliverables: Due on base contract in accordance with Section H. Subcontracting Provisions Article;

submit electronically to http://esrs.gov

38 Summary Subcontract Report (SSR) IDIQ Contract Deliverables: Due on base contract in accordance with Section H. Subcontracting Provisions Article;

submit electronically to http://esrs.gov

39 Annual Report of Government Owned-

Contractor Held Property Report

IDIQ Contract Deliverables: Due annually, no later than

30 days from the anniversary date of the base contract in accordance with Section G. Government Property Article;

submit electronically to NIHContractProperty@mail.nih.gov

40 SEER*DMS Migration Plan Task Order Deliverables: The frequency and specific content of these deliverables will be determined within each individual Task Order.

41 Multiple Principal Investigators Leadership Plan

IDIQ Contract Deliverables: Due on base contract in accordance with ARTICLES C.2 and G of this contract.

42 Protection of Human Subjects Annual Certification

IDIQ Contract Deliverables: Due on base contract in accordance with ARTICLES C.2 and H of this contract.

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

Address Deliverable Item No

Contracting Officer National Cancer Institute Office of Acquisitions, Room 1E642 9609 Medical Center Drive, MSC

Bethesda, MD 20892- 9705

All Items, to be delivered to cibranchbinvoices@mail.nih.gov

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

All Items excluding 29, 37, and 38.

http://esrs.gov/ http://esrs.gov/ mailto:NIHContractProperty@mail.nih.gov

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Address Deliverable Item No

OPERA, OEH, NIH

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

35 and 36

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

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to cost reimbursement Task Orders.

Alternate I ( April 1984) is not applicable to fixed-price Task Orders.

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

mailto:NIHContractProperty@mail.nih.gov mailto:NIHContractProperty@mail.nih.gov https://www.acquisition.gov/?q=browsefar

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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:

Steve Friedman, COR

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 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

ARTICLE G.3. TASK ORDER PROCEDURE

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

a. General

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

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

b. Requesting Task Order Proposals.

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

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

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

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

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

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

c. Competitive Ordering Process.

1. All Contractors within a technical area will receive e-mail notification advising of the availability of each proposed task order requirement. All proposed task orders will incorporate all terms of this contract unless otherwise specified in the proposed task order.

2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in FAR Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with FAR Part 16. Each TORFP will indicate the criteria for the evaluation of proposals.