Attachment_05_-_Additional_Technical_Proposal_Instructions.pdf

Attachment 05: Additional Technical Proposal Instructions RFP: 75N91019R00029 Page 1 of 14

Attachment 05 Additional Technical Proposal Instructions

Surveillance, Epidemiology, and End Results (SEER) Program

NOTE: All uses of the term “Government” refer to the United States Federal Government.

Refer to SECTION L.2.b Technical Proposal Instructions of the Solicitation for a complete list of instructions. The following Additional Business Proposal Instructions reflect additional requirements of this Request for Proposal (RFP) and are meant to provide additional instructions as well as a uniform format for Technical Proposals. The information provided and requested in these instructions should be used as a guide for formatting and preparing the Technical Proposal. This information is provided in addition to instructions provided in Section L of the Solicitation.

Offerors are required to organize and submit the Technical Proposal in the following order and as noted below, separating the sections with a page that indicates the section number. If an Item or Section is not applicable, retain the section and item number and write ‘Not Applicable’ or ‘No Response’ after the Item’s Part Name or Section’s Title.

Organization of Technical Proposal

SECTION 1 – INTRODUCTION

No Page Limitation

ITEM PART INSTRUCTIONS

1.1 Technical Proposal Cover Page See below for specific information required

1.2 Proposal Summary and Data Record

(NIH-2043)

Refer to Solicitation Section J - Attachment 11. Do not include SSN numbers on the form

1.3 Table of Contents (TOC) Include the PDF page number or working link for each Section, Part, Attachment, and Appendix

SECTION 2 – MANDATORY QUALIFICATION CRITERIA

No Page Limitation

ITEM PART INSTRUCTIONS

2.1 Mandatory Qualification Criteria

Response Refer to Solicitation Section M and below for instructions

SECTION 3 - CORE INFRASTRUCTURE

Limited to 85 Pages

ITEM PART INSTRUCTIONS

3.1 Technical Approach Refer to Solicitation Sections L and M and see 3.1 below

3.2 Organizational Experience, Capabilities, Resources, and Facilities Refer to Solicitation Sections L and M and see 3.2 below

3.3 Personnel Refer to Solicitation Sections L and M and see 3.3 below

3.4 Other Considerations Refer to Solicitation Section L and see 3.4 below

ATTACHMENTS AND APPENDICES

Limited to 100 Pages

3.5 Technical Proposal Cost Summary –

Task Order 1 – Core Infrastructure Refer to Solicitation Section J - Attachment 06 and see

3.5 below

3.6 Staffing Plan – Task Order 1 – Core

Infrastructure

Scored as part of Technical Approach; Refer to Solicitation Section M and see 3.6 below

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3.7 Resumes, CVs, NIH Biosketchs Scored as part of Personnel; Refer to Solicitation Section M and see 3.7 below

3.8 Subcontractor Technical Proposal See 3.8 below

3.9 Subcontractor Commitment Letters See 3.8 below

SECTION 4 - RESEARCH SUPPORT

Limited to 10 Pages

ITEM PART INSTRUCTIONS

4.1 Technical Approach Refer to Solicitation Sections L and M and see 4.1 below

4.2 Organizational Experience, Capabilities, Resources, and Facilities Refer to Solicitation Sections L and M and see 4.2 below

4.3 Personnel Refer to Solicitation Sections L and M and see 4.3 below

4.4 Other Considerations Refer to Solicitation Section L and see 4.4 below

ATTACHMENTS AND APPENDICES

Limited to 50 Pages

4.5 Resumes, CVs, NIH Biosketches Scored as part of Personnel; Refer to Solicitation

Section M and see 4.5 below

SECTION 5 - ADDITIONAL ATTACHMENTS AND APPENDICES

Limited to 100 Pages

ITEM PART INSTRUCTIONS

5.1 Data Sharing Plan Scored as part of Organizational Experience, Capabilities, Resources, and Facilities. Refer to Solicitation Section L and M and see 5.1 below

5.2 Population Characteristics and Special

Registry Features

Scored as part of Organizational Experience, Capabilities, Resources, and Facilities. Refer to Section L and M of the Solicitation and see 5.2 below

5.3 Human Subjects Non-Scored Factor; Refer to Solicitation Section L and M and see 5.3 below

5.4 Protection of Human Subject

Assurance/ Identification/IRB Certification/Declaration of Exemption Form

Non-Scored Factor; Refer to Solicitation Section J – Attachment 07 and see 5.4 below

5.5 Demonstration of a Strong Scientific

Premise for the Technical Proposal

Non-Scored Factor; Refer to Solicitation Section L and M and see 5.5 below

5.6 Relevant Publications Scored as part of Organizational Experience, Capabilities, Resources, and Facilities; See 5.6 below

5.7 Summary of Related Activities Forms Non-Scored Factor; Refer to Solicitation Section J – Attachment 08 and see 5.7 below

5.8 Planned Enrollment Plan Non-Scored Factor; Refer to Solicitation Section J – Attachment 09 and see 5.8 below

5.9 Authentication of Key Biological

and/or Chemical Resources Discussion

Non-Scored Factor; See 5.9 below

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SUBMISSION, FORMATTING, AND PAGE LIMITATIONS

1. The Technical Proposal shall be submitted electronically using the Electronic Contract Proposal

System (eCPS). Refer to Attachment 03 - Delivery of Proposal Using eCPS for instructions. No hardcopies are to be submitted.

2. Submit one Technical Proposal divided into the sections in the chart above. Refer to Attachment 03 - Delivery of Proposal Using eCPS for instructions.

3. The Technical Proposal shall be a ‘searchable’ PDF to the maximum extent practicable vs. a scanned/unreadable PDF.

4. Proposals must adhere to the page limits specified in the chart above. Pages that exceed the specified limitations will be removed prior to evaluation.

5. All proposal information and documentation required as specified in the Solicitation should be included and listed in the Table of Contents with a PDF page number or working link.

6. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

7. Font size must be 12 points.

8. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

9. Margins must be at least one inch on all sides.

10. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

GENERAL INSTRUCTIONS:

1. Reference the NCI SEER Glossary for Registrars as needed:

https://seer.cancer.gov/seertools/glossary/

2. The Offeror is responsible for ensuring that all required information and documentation is included in their Technical Proposal in accordance with the Solicitation. Refer to the Statements of Work and Solicitation Section L and Section M. The following is additional information and does not include all required information and documentation for the technical proposal.

3. Please reference Sections 3 and 4 of this document for detailed descriptions of the “Core Infrastructure” and “Research Support” components of the proposal. Offeror’s are encouraged to submit a proposal for both components but may choose to submit a proposal against only one component.

4. “Core Infrastructure” and “Research Support” will be evaluated against the three Technical Evaluation Factors detailed in Solicitation Section M: (1) Technical Approach, (2) Organizational Experience, Capabilities, Resources and Facilities, and (3) Personnel. The following weights and weighted subfactors will be used in the evaluation. Subfactors without weights are of equal importance.

Core Infrastructure 85%:

Evaluation Factors Core Infrastructure Technical Approach 45% Organizational Experience, Capabilities, Resources, and Facilities 30% Personnel 25% Total 100% https://seer.cancer.gov/seertools/glossary/

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Research Support 15%:

Evaluation Factors Research Support Technical Approach 45% Organizational Experience, Capabilities, Resources, and Facilities 30% Personnel 25% Total 100%

5. Determination of Technical Acceptability.

a. A Technically Acceptable proposal contains no major deficiencies, is complete in itself, and no additional information is required for reviewers to determine that the Offeror can fulfill the minimum requirements of the RFP, although additional information may be required for clarification.

b. A Technically Unacceptable proposal contains deficiencies which are so substantive as to preclude any possibility of it being upgraded to a level that meets the minimum requirement of the RFP, except through major revisions and additions which would be tantamount to submission of a new proposal.

6. The determination of Technical Acceptability will be based only on the proposal component(s) submitted. Offerors that respond to both components of “Core Infrastructure” and “Research Support” will be given an overall score out of 100%, with “Core Infrastructure” weighted at 85% and “Research Support” weighted at 15%. The determination of Technical Acceptability will be based on the proposal in its entirety. Offerors that respond to only one component will be given a score out of 100% and a Technical Acceptability determination for that individual component only.

7. An Offeror must submit a proposal and be determined Technically Acceptable for that component to compete for future Task Orders for that component. For example, Offerors that do not provide a Research Support proposal under this solicitation will not be eligible to compete for future Research Support Task Orders. However, Offerors that provide a Technically Acceptable Core Infrastructure proposal and receive a Base IDIQ Contract but are not selected for an initial Core Infrastructure Task Order will be eligible to compete for future Core Infrastructure Task Orders.

8. Offerors that are only interested in responding to one component should simply indicate “No Response” for the other proposal components. For example, Offerors that choose to respond to Research Support only should mark Section 3 – Core Infrastructure with “No Response”. Your proposal must retain the section and item numbering detailed at the beginning of these instructions.

9. The Government must determine all non-scored proposal attributes to be minimally acceptable for an Offeror’s proposal to be considered for award. Therefore, these non-scored proposal sections are also important to the overall contract award decision. Non-scored proposal factors include: Mandatory Qualification Criteria, Human Subjects Protections, Demonstration of a Strong Scientific Premise, Population Characteristics and Special Registry Features, and Evaluation of Option Periods.

10. Offerors are apprised that for the evaluation under each technical evaluation factor, the Government shall confine its consideration to the section of an Offeror’s proposal that corresponds to that technical evaluation factor. Therefore, in the technical proposal, the Offeror should clearly mark each section to correspond with each technical evaluation factor and ensure that all information which the Offeror wants the Government to consider for that technical evaluation factor is within the designated section, or, in the case of any attachments, is clearly referenced as incorporated into the correct

RFP: 75N91019R00029 Page 5 of 14 section. Failure to do so means that the inappropriately placed information may not be considered under the technical evaluation factor.

11. Except for Section 3 – Attachment 5 - Technical Proposal Cost Summary, no cost or price information shall be included within your Technical Proposal. Inclusion of cost or price information in your Technical Proposal may result in your proposal being removed from consideration.

SPECIFIC INSTRUCTIONS:

SECTION 1 – INTRODUCTION (No Page Limitation)

1.1 TECHNICAL PROPOSAL COVER PAGE. The following must be provided on the first page of the

Technical Proposal:

a. Identification of the Proposal Part (Technical Proposal);

b. Solicitation number (75N91019R00029) and title (Surveillance, Epidemiology, and End Results

(SEER) Program);

c. Name and address Offeror;

d. Offeror’s DUNS number;

e. Date of submission;

f. Name, title, telephone number, email, and signature of person authorized to sign the proposal.

Proposals signed by an agent shall be accompanied by evidence of that agent's authority; and

g. Name, title, telephone number, email, and signature of the Principal Investigator.

1.2 PROPOSAL SUMMARY AND DATA RECORD (NIH-2043); Do not include any Social Security

Numbers (SSNs) on the form. Refer to Solicitation Section J - Attachment 11.

1.3 TABLE OF CONTENTS. Include a Table of Contents (TOC) that provides the PDF page number or working link of each proposal Section or Part that at a minimum uses the headings and subheadings that appear in the chart above. Additional subheadings may be entered at the Offeror’s discretion.

Refer to Other Considerations within Section L of the Solicitation.

SECTION 2 – MANDATORY QUALIFICATION CRITERIA RESPONSE (No Page Limitation)

2.1 MANDATORY QUALIFICATION CRITERIA RESPONSE. Review Solicitation Section M -

Mandatory Qualification Criteria. The Mandatory Qualification Criteria establishes conditions that must be met prior to proposal evaluation by the Government. The Offeror shall include all information which documents and/or supports the Mandatory Qualification Criteria in one clearly marked section of its Technical Proposal. If an Offeror proposes a consortium comprised of groups of counties/parishes within a state(s) or groups of states/territories/federal districts, then the total proposed consortium shall meet all Mandatory Qualification Criteria.

SECTION 3 - CORE INFRASTRUCTURE

(Limited to 85 Pages)

Technical Proposal Section 3 shall address all requirements of Solicitation Section J – Attachment 02- Task Order 1 – Core Infrastructure – Statement of Work (SOW). The Core Infrastructure SOW includes Task Area 1 - Programmatic Meetings, Task Area 2 - Administrative Activities, Task Area 3 - Core Infrastructure Support Activities, and Task Area 5 - SEER*DMS Migration Activities.

RFP: 75N91019R00029 Page 6 of 14

For each Offeror whose proposal represents the best value to the Government after evaluation, the Government anticipates awarding an Indefinite Delivery-Indefinite Quantity (IDIQ) Base Contract and simultaneously awarding Task Order 1 – Core Infrastructure (note the exception discussed in Attachment 10 – Additional Business Proposal Instructions – Section 4). Therefore, Section 3 of the Offeror’s Technical Proposal must include sufficient detail to allow the Government to conduct a thorough evaluation and make a Task Order award decision.

Offerors are advised to consider the Task Order 1 – Core Infrastructure Statement of Work and all reference material, attachments, the technical evaluation factors, and the Solicitation as a whole in the development of their Technical Approach. Proposals which merely restate the requirements of the Government's Statement of Work will not be eligible for award.

3.1 TECHNICAL APPROACH. Refer to Solicitation Sections L - Technical Proposal Instructions and M - Technical Evaluation Factors.

(If Subcontractors are proposed the Subcontractor’s Technical Proposals must also include the information below and include all required documentation)

a. Discuss the Offeror’s understanding of the technical, scientific and operational problems and solutions associated with accomplishing the requirements of all tasks in the SOW. Please describe any innovative methods or tools to accomplish these goals.

b. Discuss the Offeror’s understanding of the problems and solutions of collecting population level cancer surveillance data associated with accomplishing the requirements of the SOW. Please describe any innovative methods or tools to accomplish these goals.

c. Describe the Offeror’s use of NAACCR Edits metafile and clarify any potential issues with the implementation of SEER*Edits into the Offeror’s registry operations. Additionally, the Offeror is required to review all NAACCR Data items required for collection as listed in the Required Status Table of the NAACCR Data standards (https://www.naaccr.org/data-standards-data-dictionary/). The Offeror shall use a table to indicate the start and end year for the collections of each data item listed as required for collection by SEER (i.e. field is not there or there is ‘no recommendation’). For data items that are collected but could not be transmitted to SEER, Offerors should explain the reason (i.e. state law) or explain the reason why any data item required by SEER is not collected by the registry.

d. Describe the Offeror’s procedures for Death Clearance Operations, de-duplication, interstate exchanges, and all active and passive follow-up in place at the time of response. Please describe any innovative methods or tools to accomplish these goals.

e. Describe the Offeror’s adherence to NAACCR Standards for Tumor Inclusion and Reportability and to list any exceptions required by law, regulation or registry standard operating procedures.

f. Describe the Offeror’s ability to Conduct Data Linkages as outlined in the SOW for both NCI coordinated linkages and linkage feasibility investigations.

g. Describe the Offeror’s ability to re-release data including discussion on the Offeror’s interpretation of applicable statutory language.

h. Describe the Offeror’s managerial approach to accomplishing the requirements of the SOW.

i. Describe the Offeror’s management approach to supervising and managing contractor personnel, subcontractor personnel and consultants proposed to conduct the SOW.

j. Describe the Offeror’s management approach to staffing, training and the efficient use of staff or other resources to conduct the SOW.

k. Describe in detail the Offeror’s staffing plan delineating lines of authority and areas of responsibility associated with accomplishing the requirements of the SOW. Include a Staffing Plan in the Attachment and Appendices Section.

https://www.naaccr.org/data-standards-data-dictionary/ https://www.naaccr.org/data-standards-data-dictionary/

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l. Describe the Offeror’s proposed methods for ensuring quality assurance and adhering to milestones and timely submission of reports and deliverables.

m. Describe the Offeror’s proposed quality control and quality assurance procedures to ensure the requirements of the SOW are met.

n. Describe the Offeror’s plan to ensure confidentially of information.

o. Describe the Offeror’s methods for ensuring the prevention of conflicts of interest for the SOW.

p. Offerors who propose subcontracts to perform portions of the SOW should clearly identify the specific task areas for which they plan to utilize subcontractors, as well as the method and level of integration between the prime and subcontractor(s), and the expected advantages of such an approach. The Prime Offeror’s Technical Proposal should refer to the Subcontractor’s Technical Proposal for detailed discussion. The Subcontractor’s Technical Proposal should be included under Section 3 - Attachments and Appendices. The Subcontractor’s Technical Proposal must describe each item listed above. Subcontractor Commitment Letters shall also be provided under Section 3 - Attachments and Appendices.

3.2 ORGANIZATIONAL EXPERIENCE, CAPABILITIES, RESOURCES, AND FACILITIES. Refer to Solicitation Sections L - Technical Proposal Instructions and M - Technical Evaluation Factors.

(If Subcontractors are proposed the Subcontractor’s Technical Proposals must also include the information below and include all required documentation)

a. Describe organizational experience and ability to carry out the specific tasks and requirements of the SOW including the organization’s experience that:

1. Supported regional/central cancer registry operations

2. Supported research which directly utilized the regional/central cancer registry's data collection infrastructure; case control studies, patterns of care, comparative effectiveness or patient outcomes, or studies requiring tissue acquisition

3. Established and maintained data sharing agreements with other population-based cancer registries and other entities

4. Established relationships with the Offeror's local cancer research and cancer control communities and collaborated with other organizations

5. Supported the release of the Offeror's cancer surveillance data to outside investigators

6. Worked with Institutional Review Boards

7. Provided and maintained an available, adequate and a secure data processing environment including information security, security of computer network systems, data security, physically secure office space, and related support. In addition, address each of the following items as they relate to your local IT environment. If these items are addressed in other parts of your proposal, please reference the applicable section.

i. Is your organization considered the owner of the data collection system utilized by the regional/central registry for data collection purposes?

ii. Provide a high-level architecture drawing.

a. Show all systems involved in SEER related data collection, storage, and transmission.

b. Illustrate data flows.

iii. Describe the flow of information you collect.

a. Who provides the information?

RFP: 75N91019R00029 Page 8 of 14

b. Once it’s collected, how do you process it?

c. How is the information stored?

d. With whom do you share the de-identified information?

e. If you share any information before it is de-identified, with whom do you share it?

iv. Before the information is de-identified, how is it protected?

a. Do you have state standards with which you must comply?

b. Is the information encrypted at rest?

c. Is the information encrypted during transmission?

d. What organizations and kinds of roles have access to the information?

v. Does your organization have its own relationship with the SEER’s current biomedical computing contractor Information Management Services, Inc. (IMS)? If so, please describe.

b. Describe availability and adequacy of the facilities to perform the tasks of the SOW including administrative support and dedicated space for personnel and equipment.

c. Describe availability and adequacy of the secure environment for confidential storage of information including physically secure office space, data, and physical security.

d. Describe availability and adequacy of the equipment to perform the tasks of the SOW including all computers, hardware, software, and servers.

e. Describe and document availability of qualified personnel to conduct the SOW.

f. Describe organizational experience for assuring quality of work, products and deliverables and capability to conduct quality assurance.

g. Describe organizational experience and capability of maintaining stable workforce and ability to recruit and retain staff.

h. Describe organizational experience in the appropriate use of and managing of subcontractors to supplement areas of expertise to carry out the tasks of the SOW.

i. If Subcontractors are proposed, the Prime Offeror’s Technical Proposal should briefly discuss the Subcontractor’s organizational experience, capabilities, resources and facilities and refer to the Subcontractor’s Technical Proposal for detailed discussion. The Subcontractor’s Technical Proposal should describe and discuss each item listed above.

3.3 PERSONNEL. Refer to Solicitation Sections L - Technical Proposal Instructions and M - Technical

Evaluation Factors.

Describe and document the education, training, experience and expertise of the proposed personnel required to carry out the tasks of the SOW.

(If Subcontractors are proposed the Subcontractor’s Technical Proposals must also include the information below and include all required documentation)

a. Key Personnel (Principal Investigator (PI)/Program Director): Describe and document evidence of education, training, expertise, and experience of the Principal Investigator/ Program Director:

1. to perform the tasks described in the SOW

2. in cancer epidemiology and conducting population-based epidemiological studies including supervisory and budget experience

3. to manage the overall SOW

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4. in procedural aspects of managing and coordinating population-based cancer registry data collection including supervisory and budget experience

5. include Resume, CV or NIH Biosketch for each named key personnel in Section3

- Attachments and Appendices

6. refer to Solicitation Article G Key Personnel and Article H Multiple Principal Investigators

b. Key Personnel (Registry Operations Supervisor/Registry Director/Registry Manager):

Describe and document evidence of education, training, expertise, knowledge, and experience of Registry Operations Supervisor/Registry Director/Registry Manager:

1. to manage the requirements of the SOW that pertain to registry operations.

2. in all procedural aspects of managing and coordinating population-based cancer registry data collection including supervisory and budget experience

3. include Resume, CV or NIH Biosketch for each named key personnel in Section

3 - Attachments and Appendices

4. refer to Solicitation Article G Key Personnel

c. Other (Non-Key) Personnel: Describe and document evidence of education, training, expertise and experience of proposed personnel to carry out the tasks of the SOW, including specific area of expertise to be contributed to the project. Include:

1. proposed contractor personnel

2. proposed subcontractor personnel

3. proposed consultants

4. Submit one resume, CV or NIH Biosketch for each named personnel including proposed subcontractor personnel and proposed consultants.

5. If To Be Named (TBN) or To Be Determined (TBD) positions are proposed, include a discussion of the qualifications and requirements of the position, a description of the “ideal” candidate, the plan for recruitment, and an estimate of the time required to fill the position

3.4 OTHER CONSIDERATIONS. Refer to Solicitation Section L - Technical Proposal Instructions –

Other Considerations. Include as needed. Information provided will be scored under the appropriate evaluation factor.

SECTION 3 - ATTACHMENTS AND APPENDICES (Limited to 100 Pages)

3.5 TECHNICAL PROPOSAL COST SUMMARY – TASK ORDER 1 – CORE INFRASTRUCTURE.

Provide the completed form found at Solicitation Section J - Attachment 06. Include total hours and amounts, inclusive of both the Government-Share and Contractor-Share.

3.6 STAFFING PLAN – TASK ORDER 1 – CORE INFRASTRUCTURE. Provide the Staffing Plan referenced in your Technical Approach. The Staffing Plan will be scored as part of Technical Approach. Refer to Solicitation Section M – Evaluation Factors for Award.

3.7 RESUMES, CVS, NIH BIOSKETCHS. Provide the Resumes, CVs, NIH Biosketchs referenced as part of your Technical Approach. Resumes, CVs, NIH Biosketchs will be scored as part of Personnel.

Refer to Solicitation Section M – Evaluation Factors for Award.

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3.8 SUBCONTRACTOR TECHNICAL PROPOSAL. Provide a Subcontractor Technical Proposal from each proposed Subcontractor or state “No Subcontracts Proposed”. The Subcontractor’s Technical Proposal shall be in the same level of detail and basic format as the Prime Offeror’s Technical Proposal.

3.9 SUBCONTRACTOR COMMITMENT LETTERS. Provide a Signed Letter of Commitment from each proposed Subcontractor or state “No Subcontracts Proposed”. The letter must be signed by the Subcontractor’s Business Official and include all the following:

a. A statement regarding willingness to perform as a subcontractor for specific services to be provided during the period of performance;

b. What priority the work will be given and how it will relate to other work.

c. The amount of time and facilities available to this project.

d. Information on their cognizant field audit offices.

e. How rights to publications and patents are to be handled.

f. A list the Government Property (equipment) proposed or include a statement that none is proposed

SECTION 4 - RESEARCH SUPPORT (Limited to 10 Pages)

Technical Proposal Section 4 shall address Section J – Attachment 01 – Base Statement of Work Task Area 4 – SEER*Educate, Task Area 5 - SEER*DMS Migration Activities, Task Area 6 – Patterns of Care/Quality of Care Studies, Task Area 7 – Ancillary Studies and Additional Projects, Task Area 8 – Virtual Tissue Repository, and Task Area 9 – Virtual Pooled Registry. These Task Areas may sometimes be referred to generically as “Research Support” throughout the Solicitation and Attachments.

At time of the IDIQ Base Contract award, the Government does not anticipate making any Task Order awards for Research Support Task Areas as a result of this Solicitation. Therefore, Technical Proposal Section 4 shall provide a general overview of the Offeror’s Technical Approach, Organizational Experience, Capabilities, Resources, and Facilities, and Personnel in meeting these requirements at a high-level. All items under Solicitation Section L.2.b. “Technical Proposal Instructions” need not be addressed. As future Government needs for Research Support arise during the period of the IDIQ Base Contract, the Government may issue detailed Requests for Task Order Proposals to meet these future requirements. Reference Solicitation Article G – Task Order Procedure for more information on the Task Order process.

As indicated by Solicitation Section J - Attachment 10 – Additional Business Proposal Instructions a corresponding Business/Cost Proposal is not required for Research Support Task Areas as part of this Solicitation.

4.1 TECHNICAL APPROACH. Your technical approach should be in as much detail as you consider necessary to explain your technical understanding or approach to meeting the Research Support Task Areas.

a. For Task Area 9 – Virtual Pooled Registry (VPR), please reference https://www.naaccr.org/about-vpr-cls/

b. The NCI recognizes that the base SOW provides limited detail for Task Area 9 – Virtual Pooled

Registry (VPR), however please provide a general discussion of your understanding of the technical, scientific and operational risks and solutions associated with accomplishing VPR as the task area is currently defined in the base SOW. Provide a general discussion of risks and solutions https://www.naaccr.org/about-vpr-cls/

RFP: 75N91019R00029 Page 11 of 14 related to managing a VPR effort, including acquiring the necessary personnel or other resources required for completion.

c. The NCI recognizes that the base SOW provides limited detail for Task Area 4 – SEER*Educate, Task Area 5 - SEER*DMS Migration Activities, Task Area 6 – Patterns of Care/Quality of Care Studies, Task Area 7 – Ancillary Studies and Additional Projects, and Task Area 8 – Virtual Tissue Repository, however please provide a general discussion of your understanding of the technical, scientific and operational risks and solutions associated with accomplishing each of these task areas as currently defined. Provide a general discussion of risks and solutions related to managing these efforts, including acquiring the necessary personnel or other resources required for completion.

d. Due to the nature of base Task Area 6 – Quality of Care Studies and Task Area 9 – Virtual Pooled Registry (VPR), the NCI expects maximum participation from SEER contract holders in response to any Request for Task Order Proposal (RFTOP) issued in these areas. Please state your organization’s level of commitment to responding to all future RFTOPs related to Quality of Care Studies and Virtual Pooled Registry (VPR).

e. Please state your organization’s interest in responding to future RFTOPs related to Task Area 4 – SEER*Educate, Task Area 6 – Patterns of Care Studies, Task Area 7 – Ancillary Studies and Additional Projects, and Task Area 8 – Virtual Tissue Repository.

4.2 ORGANIZATIONAL EXPERIENCE, CAPABILITIES, RESOURCES, AND FACILITIES.

Your Organizational Experience, Capabilities, Resources, and Facilities response should be in as much detail as you consider necessary to explain your experience, capabilities, and resources to meeting the Research Support Task Areas.

a. The NCI recognizes that the base SOW provides limited detail for Task Area 9 – Virtual Pooled

Registry (VPR), however please provide a brief description of your organization’s experience with activities such as the VPR or other linkages that leverage your registry data for linkages with external research studies.

b. The NCI recognizes that the base SOW provides limited detail for Task Area 4 – SEER*Educate, Task Area 5 - SEER*DMS Migration Activities, Task Area 6 – Patterns of Care/Quality of Care Studies, Task Area 7 – Ancillary Studies and Additional Projects, and Task Area 8 – Virtual Tissue Repository, however please briefly describe your organization’s experience with these activities. Describe any organizational experience with rapid (early) case ascertainment, other special studies such as collection of nonstandard variables (e.g. treatment, biomarkers, outcomes, patient contact studies) or work with investigators or pathology laboratories for tissue collection (e.g. residual tissue repository, clinical trial support, etc.) Describe your organization’s experience with performing special short term research projects using your registry data, such as to support clinical or other research or to develop methodologies that would enhance or improve the capture of surveillance data.

4.3 PERSONNEL. Your Personnel response should be in as much detail as you consider necessary to describe and document any specialized education, training, experience and expertise for the personnel that may be available to carry out the various Research Support Task Areas.

a. The NCI recognizes that the base SOW provides limited detail for Task Area 9 – Virtual Pooled

Registry (VPR), however please provide a brief description of the personnel available with experience in activities such as the Virtual Pooled Registry or other linkages that leverage your registry data for linkages with external research studies.

b. The NCI recognizes that the base SOW provides limited detail for Task Area 4 – SEER*Educate, Task Area 5 - SEER*DMS Migration Activities, Task Area 6 – Patterns of Care/Quality of Care Studies, Task Area 7 – Ancillary Studies and Additional Projects, and Task Area 8 – Virtual Tissue Repository, however please provide a brief description of the personnel available with

RFP: 75N91019R00029 Page 12 of 14 experience in activities such as rapid (early) case ascertainment, other special studies such as collection of nonstandard variables (e.g. treatment, biomarkers, outcomes, patient contact studies) or work with investigators or pathology laboratories for tissue collection (e.g. residual tissue repository, clinical trial support, etc.) Describe the personnel available with experience in performing special short term research projects using registry data, such as to support clinical or other research or to develop methodologies that would enhance or improve the capture of surveillance data.

4.4 OTHER CONSIDERATIONS. Refer to Solicitation Section L - Technical Proposal Instructions –

Other Considerations. Include as needed. Information provided will be scored under the appropriate evaluation factor.

SECTION 4 - ATTACHMENTS AND APPENDICES (Limited to 50 Pages)

4.5 RESUMES, CVS, NIH BIOSKETCHS. Provide the Resumes, CVs, NIH Biosketchs referenced as part of your Technical Approach. Resumes, CVs, NIH Biosketchs will be scored as part of Personnel.

Refer to Solicitation Section M – Evaluation Factors for Award.

SECTION 5 - ADDITIONAL ATTACHMENTS AND APPENDICES (Limited to 100 Pages)

5.1 DATA SHARING PLAN. Refer to Sections L and M of the Solicitation. The Offeror shall describe their Data Sharing Plan. This plan should document the Offeror’s approach for directly sharing the data collected (not the public access of the SEER data provided by the NCI). At a minimum the plan should address:

a. the statutory language governing data sharing and re-release

b. what types of data can be shared?

c. who will have access to the data?

d. where the data will be available?

e. when the data will be shared?

f. how researchers will locate and access the data?

g. what data cannot be shared?

h. how new types of data will be considered for sharing and re-release, such as genomic or genetic data?

i. what the process is to modify statutory language as needed?

5.2 POPULATION CHARACTERISTICS AND SPECIAL REGISTRY FEATURES. Refer to Section L and M of the Solicitation.

The Offeror shall provide the following information on population characteristics and special registry features. Information provided in this attachment will support your Organizational Experience, Capabilities, Resources, and Facilities. Reference this Attachment within your technical discussions as applicable.

a. Population Characteristics

When providing race/ethic population information the Offeror should use the definitions that are used by the Bureau of the Census in the Official 2010 U.S. Census Form. For an overview of the 2010 Census use of Race and Hispanic Origin see http://www.census.gov/prod/ cen2010/briefs/c2010br-02.pdf.

http://www.census.gov/prod/%20cen2010/briefs/c2010br-02.pdf

RFP: 75N91019R00029 Page 13 of 14

1. Total Population size

2. Hispanic: Where possible provide population information on subcategories of the

Hispanic population represented in the catchment (for example, Cuban Hispanic or Hispanic of Mexican origin).

3. Asian and Pacific Islander: Where possible provide population information on subcategories of the Asian and Pacific Islander population represented in the catchment (for example, Japanese, Chinese, etc.).

4. African American

5. American Indians or Alaska Natives

6. White Non-Hispanic

7. Non-Metro: Non-Metro populations should be based on the most recent United

States Department of Agriculture’s (USDA) Rural-Urban Continuum Codes. They include counties categorized as 4 through 9 on the Rural-Urban Continuum.

8. Poverty: State level poverty rates should be based on the latest figures from the Bureau of the Census’s American Community Survey.

9. Non-Metro Poverty: Non-Metro populations should be based on the most recent United States Department of Agriculture’s (USDA) Rural-Urban Continuum Codes.

They include counties categorized as 4 through 9 on the Rural-Urban Continuum.

State level poverty rates should be based on the latest figures from the Bureau of the Census’s American Community Survey.

10. Older Adults: Provide the percent of the population who are 65+, 75+, and 85+ for all race, white, African American, Asian Pacific Islander, American Indian and Alaska Native, and Hispanic

11. Overall Cancer mortality: Latest 3-year cancer mortality rate (standardized to US

2000 SM)

12. Overall Cancer incidence: Latest 3-year invasive cancer incidence rate (standardized to US 2000 SM)

13. Other Special Populations: Offerors should provide population information on other special populations within their catchment that represent groups not included in the above categories

b. Special Registry Features

1. Percent of yearly cases covered by electronic pathology reporting

2. Reporting laws covering pathology laboratories, physicians, and other non-hospital health care providers

3. Discussion and examples as appropriate of the Offeror’s capacity to modify the reporting law as needed.

4. Affiliation or documented collaborations with an NCI Designated Cancer Center

5. Demonstrated support and collaboration with investigators who have NIH funded research with incorporation of the registry data that is critical to the research.

6. Documented release of registry data to investigators

7. Discussion of any demonstrated innovative processes that are scalable and applicable to other population-based cancer registries such as automation of data collection, scalable processes for physician reporting, or innovative quality control processes

5.3 HUMAN SUBJECTS. Non-Scored Factor; Discussion should address all requirements under

Solicitation Section J- Attachment 01 - Base Statement of Work as appropriate for each Task Area.

Refer to Solicitation Section L and M and see below.

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a. The Offeror should provide a thorough and complete description of the procedures, policies, and systems that demonstrate how the Offeror is going to assure the protection of human subjects with respect to collecting and maintaining data if such activities are subject to provisions of the Confidentiality of Information clause, the Privacy Act, or the Health Insurance Portability and Accountability Act. Additionally, describe any plans that may derive from statutory requirements regarding the notification of patients that their data are in a state cancer registry as well as any plans and activities to educate and inform the public about the existence of cancer registries and their role in reducing the cancer burden.

b. Include a discussion of protection of human subjects, required education in the protection of human subjects’ research participant’s discussion and data collection analysis plan. Refer to specific information provided in Section L Human Subjects of the Solicitation and address the subparagraphs within.

5.4 PROTECTION OF HUMAN SUBJECT ASSURANCE/ IDENTIFICATION/IRB

CERTIFICATION/DECLARATION OF EXEMPTION FORM. Provide the completed form found at Solicitation Section J – Attachment 07.

5.5 DEMONSTRATION OF A STRONG SCIENTIFIC PREMISE FOR THE TECHNICAL

PROPOSAL. Refer to Section L and M of the Solicitation. Provide a brief discussion of how; if the aims of the Base and Task Order 1- Core Infrastructure SOWs are achieved, scientific knowledge, technical capability, and/or clinical practice would be improved.

5.6 RELEVANT PUBLICATIONS. Scored as part of Organizational Experience, Capabilities, Resources, and Facilities. The Offeror should provide a list of research activities and publications for which your organization played an integral role (e.g. an investigator used the registry). Include studies that were active during the period 2011 to 2016. Reference this Attachment within your technical discussions as applicable.

5.7 SUMMARY OF RELATED ACTIVITIES FORMS. Refer to Solicitation Section J – Attachment 08.

Submit one completed form for each of the Key Personnel proposed. Under item “c” of the form specify the amount of effort he or she is being proposed for Task Order 1 – Core Infrastructure.

5.8 PLANNED ENROLLMENT PLAN. Provide the completed form found at Solicitation Section J –

Attachment 09.

5.9 AUTHENTICATION OF KEY BIOLOGICAL AND/OR CHEMICAL RESOURCES

DISCUSSION. Review Section M and determine whether this topic is relevant to your proposal. If not, the Offeror should merely make a statement that this area does not apply with a brief description as to why.