Amendment 1 75N91019R00017.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Amendment 0001

Lisa V. Bielen

The purpose of this amendment is to: (1) Provide responses to questions; (2) amend Article F.3; (3) amend Article L.2; and (4) amend Attachments 3,5,11, and 15.

[All other terms and conditions of the Solicitation remain unchanged.]

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Dr Bethesda, MD 20892-9705

75N91019R00017

03/06/2020

03/18/2020

75N91019R00017 Amendment 1

Article F.3 a. is modified as follows:

During the period of performance of this contract, the Contractor shall provide direct labor hours as provided in each task order. The labor hours exclude vacation, holiday, and sick leave.

These labor hours exclude consultant and subcontractor labor hours. Task orders awards will specify the estimated labor hours in a format similar to that specified below:

Labor Hours

Labor Category Sample Task Order 1

Sample Task Order 2

Sample Task Order 3a

Sample Task Order 3b

Sample Task Order 4

Professional (ex: PI, Project/Task Manager, System Manager

Professional

Support (ex:

Biostatistician, Programmer)

Administrative Support

Totals

Article L.2a. is modified as follows:

2. Authorized Official and Submission of Proposal

The proposal must be signed by an official authorized to bind your organization and must stipulate that it is predicated upon all the terms and conditions of this RFP. Your proposal shall be submitted in the number of copies, in accordance with Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website, Part Ill, Section J hereof. Proposals will be typewritten, paginated as required by FAR 4.302(b), and will be legible in all required copies. To expedite the proposal evaluation, all documents required for responding to the SOLICITATION should be placed in the following order:

COVER PAGE

Include RFP title, number, name of organization, DUNS No., identification of the proposal part, and indicate whether the proposal is an original or a copy.

TECHNICAL PROPOSAL

It is recommended that the technical proposal consist of a cover page, a table of contents, and the information requested in the Additional Technical Proposal Instructions (Attachment 11) as specified in SECTION J, List of Attachments.

BUSINESS PROPOSAL

It is recommended that the business proposal consist of a cover page, a table of contents, and the information requested in the Business Proposal Instructions and as specified in SECTION J, List of Attachments.

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75N91019R00017 Biomedical Information Management and Analytic Support Services

STATEMENT OF WORK

Biomedical Information Management and Analytic Support Services

A. BACKGROUND AND OBJECTIVES

The Division of Cancer Epidemiology and Genetics (DCEG), NCI conducts broad-based, high quality, high impact research to uncover the causes of cancer and the means of its prevention. DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies, and other appropriate bodies. The Division develops research resources and strategic partnerships in cancer epidemiology and genetics across NCI, NIH, and the global research community.

The goal of this acquisition is to identify biomedical computing in support of the ongoing epidemiology and genetic research programs, conducted in the Branches and Laboratories in DCEG which include domestic and international studies with diverse study designs in epidemiology and genetics research including prospective cohort studies, case-control studies, family studies, and randomized clinical trials.

These studies span several geographic areas (potentially in any continent), are of varying size and complexity, and include dense, high-dimensional data on exposures, endpoints, clinical information, and biomarkers from molecular technologies.

B. DESCRIPTION FOR INDIVIDUAL TASK AREAS

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 the work as defined below. The Contractor shall coordinate and integrate all activities including staffing decisions, prioritizing support for projects, and managing and monitoring any subcontracts for task orders which will include one or more of the task areas as defined below. As much as possible, the management of data assets and configuration of computational services should be programmatically interoperable with DCEG and NCI cloud infrastructure.

B.1. Task Area A: Contract Initiation/Kick-Off

The goal of this Task Area is to establish the necessary integrated infrastructure and procedures for effective communication for the period of the contract. Activities performed by the Contractor include, but are not limited to:

1. Establish a consistent method of invoicing and reporting that tracks labor hours to a study/project identifier and to the requestor and provides detailed reports of the work completed within the period of performance. This method shall be flexible to accommodate for any changes to NIH, NCI, DCEG business needs that may occur in the future; including, but not limited to, changes to the process of submitting invoices using web-based systems.

2. Establish a method for data and knowledge transfer from incumbent contract, as required.

3. Establish a method to allow DCEG investigators and staff access to status reports and invoices for contract-related charges as real-time as technically feasible, as discussed with the COR. This https://dceg.cancer.gov/

75N91019R00017 Attachment 3

75N91019R00017 Biomedical Information Management and Analytic Support Services method shall be flexible to accommodate for any changes to NIH, NCI, DCEG accounting systems or processes that may occur in the future.

4. Provide a summary of capabilities to the Contracting Officer’s Representative (COR), including a menu of services offered. Summary shall include the labor categories required and corresponding rates for each service for the purpose of informing all Division staff of the expertise and expected cost of the Contractor

5. Attend meetings and/or seminars to present capabilities, as required by the COR.

B.2. Task Area B: Data Modeling, Acquisition and Management

Under Task Area B the Contractor shall perform all activities necessary to provide biomedical data management support including manual and automated secure and standardized processes to enter, store and retrieve data and documents for DCEG research studies. This support is for DCEG studies which: a) vary by size and study design; b) include diverse data variables from diverse sources; and c) involve data exchange with multiple collaborators/repositories.

Activities performed by the Contractor shall include, but are not limited to:

1. Transition all activities and services from the incumbent contractor.

2. Provide data modeling, acquisition and management services for studies with diverse variables, clinical and laboratory data, including environmental exposure (radiation, nutrition, microbial, hormonal, and others), occupational exposure/industrial hygiene parameters, demographics, medical history (i.e. clinical signs, imaging), and high-dimensional molecular data from biospecimens. It is expected that data will increase in size and complexity due to ongoing data collection efforts and additional data generated from molecular technologies (e.g. sequencing, tissue imaging). This shall correspond with scalable computational infrastructure, when possible, leveraging Cloud Computing made available by NIH programs such as STRIDES).

3. Provide services to store and manage data from diverse sources including data collection instruments such as questionnaire surveys, hospital/clinic medical record databases, pathology reports, laboratory results, death certificates, public records of environmental exposures, biospecimen inventory systems, or other databases including cancer registries and the National Death Index, which require standardized processes for data collection. Data storage services shall be configured, whenever possible, with interoperability with DCEG infrastructure to enable subsequent aggregation of data.

4. Provide support to collect and maintain field-data with appropriate work-flows and built-in mechanisms to help monitor the progress and accuracy of project-specific work.

5. As defined by the COR, store and annotate study data variables, including molecular data, to facilitate interpretation of such data in the context of biological information. This includes, but is not limited to, coding services for categorizing information based on demographic, reproductive, medical, radiation, occupational, or lifestyle factors as well as complex laboratory or genetic data. The Contractor shall provide instruction manuals to ensure consistent coding and to minimize errors in transcription and to enable automated entry where possible.

6. Implement effective and innovative data management techniques that are optimized to enable efficient data retrieval for downstream integrative analyses of data from studies with complex

75N91019R00017 Attachment 3

75N91019R00017 Biomedical Information Management and Analytic Support Services and evolving study-designs, complex variables, and high-dimensional data variables. This should include the ability for DCEG investigators and Contractor staff to directly access, retrieve and/or analyze multiple data sets for a study in a comprehensive way, using appropriate, best-in-class business intelligence (BI) tools.

7. Implement standardized processes for timely, accurate and efficient data exchange with DCEG investigators, collaborators, and third-party Contractors, as authorized by the NCI DCEG Principal Investigator and as directed by the COR. In some cases, collaborators include large cooperative groups or research consortia. The Contractor shall also facilitate routine exchange of data with data repositories.

8. Maintain data and associated documentation in an efficient way to foster transition of data from the Contractor’s infrastructure to a NCI DCEG Principal Investigator or third-party Contractor with minimal effort. Ensuring that data systems being used to employ fast read/write capabilities and possess storage/processing capabilities to enable efficient storage, retrieval and analysis of the data.

9. As agreed upon by the COR, implement robust, comprehensive, periodic, and coordinated quality control (QC)/quality assessment (QA) plans and an update/versioning strategy to accommodate the volume and diversity of data collected, ongoing updates, and to enable diverse types of data usage.

10. Provide reliable, scalable data storage and computing infrastructure with built-in redundancies, as well as automated, reliable and secure back-up and recovery procedures for all data, tools, and services the Contractor is hosting, analyzing and providing for DCEG. Support for cloud-based systems and services are expected, wherever possible; including programmatic interoperability mechanisms in line with the Findable Accessible Interoperable Reusable (FAIR) Guiding Principles of data management and stewardship. Data management tasks may include data that contains Personally Identifiable Information (PII) and thus should be handled in accordance with the Federal Information Security Management Act (FISMA) law and all DHHS, NIH and NCI standards, regulations, guidelines and policies.

11. Implement physical, network and user-level data security, as required, to ensure confidentiality/privacy requirements are met in accord with the Federal Information Security Management Act (FISMA) law and all DHHS, NIH and NCI standards, regulations, guidelines and policies.

12. Explore Government, commercial and/or open source solutions, including certified FedRAMP cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions.

13. Comply with all DHHS, NIH and NCI policies, guidelines and regulations, in accordance with Section H of the contract.

14. Provide, as required, staff with appropriate expertise to address the requirements as defined in each Task Order and coordinate training and certification for all Contractor staff, as required.

15. Ensure quality assessment and quality control of the work performed, as required, fostering excellent internal/external communications, tracking projects, and monitoring the budget.

16. For planning purposes, the Contractor shall provide details of the work required to complete a requested task to the DCEG requestor, within timeframe discussed for each task order, as required. The documentation shall be provided in a summary and detailed format and must be clear, and easily available to the requestor.

17. Work cooperatively with the NCI and relevant NCI third-party Contractors, as defined by the COR, in all relevant aspects of project management and execution to maximize cost-effectiveness and efficiency. NCI will prioritize the order of tasks and activities.

https://www.nature.com/articles/sdata201618 https://www.nature.com/articles/sdata201618

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75N91019R00017 Biomedical Information Management and Analytic Support Services

18. Provide general program support in planning, managing and reporting for this contract. This includes, but not limited to, project and risk management for the task orders.

B.3. Task Area C: Data Analytics, Statistical and Bioinformatic Analysis and Tool Development

Under Task Area C the Contractor shall perform all activities necessary to provide statistical programming, analytic support and tool/software development for DCEG research studies.

Activities performed by the Contractor shall include, but are not limited to:

1. Prepare analytic datasets for derived variables and associated documentation.

2. Provide knowledgeable and skilled staff for statistical programming and analysis support of data from studies similar to those described in the Background (Section A) of this document.

3. Provide support for preparation of routine and ad hoc reports that may draw on information from one or more systems managed by the Contractor or the NIH, as defined by the COR.

4. Provide support for manuscript preparation including independent verification of analysis performed by DCEG investigators, and production of tables, charts, figures and specialized graphics as requested.

5. Provide routine statistical programming and analysis of epidemiological data.

6. Provide statistical and bioinformatics analyses of data resulting from molecular technologies.

7. Develop new analytical approaches/models for data analysis and study design. Such development of new methods may require simulations to test theories underlying new algorithms and validate the proposed method, or to compare these with existing ones.

8. Maintain flexibility to accommodate analysis in a variety of packages, including but not limited to, newer molecular technologies and methods to perform analyses of the data from these technologies.

9. Maintain flexibility to be able to deliver data in many formats, as defined by the NCI COR.

10. Provide support, as required, in a manner that assigns expertise to the requested task and does not assign individuals to specific studies or the Branches. Underlying work documentation and resources shall be made available to increase efficiency in performing tasks and avoid duplication of effort.

11. Streamline communication and information sharing between the Contractor and NCI DCEG staff to harmonize similar analytic and programming efforts and remove duplication of work, to whatever extent possible.

12. Provide documentation of all software and tools to provide an understanding of how the product was developed and is to be used.

13. Provide all statistical programming and analytic coding to the NCI DCEG Principal Investigators (PIs) for future use.

14. Maintain and enhance software systems with version control, as well as web-sites and tools previously developed. Examples of such tools can be found at: https://dceg.cancer.gov/tools, git-based versioning services such as GitHub are generally recommended.

15. Develop all systems and websites in compliance with federal regulations and adhere to NCI templates wherever feasible. This includes, but is not limited to, Section 508 compliance, where applicable.

16. Comply with all DHHS, NIH and NCI policies, guidelines and regulations, in accordance with Section H of the contract.

17. Maintain interoperability and compatibility with any existing or planned IT systems.

https://dceg.cancer.gov/tools

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75N91019R00017 Biomedical Information Management and Analytic Support Services

18. If Government Property is provided by the contracting agency), the Contractor shall comply with all provisions incorporated into the contract related to government property. Ensure that no existing federal, HHS, or NIH system can be leveraged, reused and/or slightly modified where possible to meet the mission need [i.e. no Government Off-the-Shelf (GOTS) solution]. If no GOTS solution will meet the requirement, the Contractor shall explore the use of commercial and/or open source solutions, including cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions.

19. Coordinate and integrate all Task Order activities including staffing decisions, prioritizing support for projects, and managing and monitoring any subcontracts.

20. Provide, as required, staff with appropriate expertise to address the requirements as defined in each Task Order and coordinate training and certification for all Contractor staff, as required.

21. Ensure quality assessment and quality control of the work performed, as required, fostering excellent internal/external communications, tracking projects, and monitoring the budget.

22. Provide an estimate of the time to complete the task and the accompanying documentation to the NCI COR, within the timeframe defined within the task order, as required. The documentation must be provided in a summary and detailed format and must be clear, and easily available to the requestor. Estimates of the budget to perform the task shall be provided by the Contractor at the discretion of the task requestor.

23. Work cooperatively with the NCI and relevant NCI third-party Contractors, as defined by the COR, in all relevant aspects of project management and execution to maximize cost-effectiveness and efficiency. NCI will prioritize the order of tasks and activities.

75N91019R00017 Attachment 5

Task Order 2

PROJECT TITLE: Services for Data Modeling, Acquisition and Management; Data Analytics, including Statistical Programming and Bioinformatics; and Tool and Software Development

TASK AREAS A, B and C

NOTE: Offerors are to include in their proposals a response that specifies the methods by which this Task Order will be accomplished and the project management plan, with associated costs. Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

STATEMENT OF WORK

I. PERIOD OF PERFORMANCE

The period of performance for this task order will be for a base period of twelve (12) months with three

(3) option periods of twelve (12) months. The fourth option period will be 10 months.

II. SCOPE

The goal of this Task Order is to transition all activities and services of the incumbent and to provide biomedical data management support including manual and automated secure and standardized processes to enter, store, retrieve and analyze data and documents for DCEG research studies. Data management tasks may include data containing Personally Identifiable Information (PII).

III. TECHNICAL REQUIREMENTS

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 the Statement of Work (SOW).

In addition, the Contractor shall provide:

1) Data Modeling, Acquisition and Management - the Contractor shall perform all activities necessary to provide biomedical data management support including manual and automated secure and standardized processes to enter, store and retrieve data and documents for the Division of Cancer Epidemiology and Genetics (DCEG) research studies. This includes biomedical data management support for DCEG studies which: a) vary by size and study design; b) include diverse data variables from diverse sources; and c) involve data exchange with multiple collaborators/repositories. Activities performed by the Contractor include, but are not limited to:

75N91019R00017 Attachment 5

a. Coordinate with other support Contractors and DCEG collaborators to ensure accurate and efficient transfer of data collected by Contractors and collaborators, implementing standardized processes for timely and accurate data capture/transfer.

b. Implement effective and innovative data management techniques that are optimized to enable efficient data retrieval for downstream integrative analyses of data from studies with complex and evolving study-designs, complex variables, and high-dimensional data variables. This should include appropriate, best-in-class business intelligence (BI), tools for access to, and analysis of, study data by the investigators directly.

c. Store and annotate study data variables including molecular data within a meaningful and valid manner to facilitate interpretation of such data in the context of biological information.

d. Implement robust, comprehensive, periodic, and coordinated quality control (QC)/quality assessment (QA) plans and an update/versioning strategy to accommodate the volume and diversity of data collected, ongoing updates, and to enable diverse types of data usage.

e. Provide support to collect field-data which may involve developing web-based systems with appropriate work-flows and built-in mechanisms to help monitor the progress and accuracy of project-specific work.

f. Document, store, manage and maintain data in a manner that is conducive to seamless access, export, and movement of datasets and institutional knowledge from the Contractor to DCEG investigators or other support Contractor(s), as directed and authorized by the Principal Investigator.

g. Exploration of Government, commercial and/or open source solutions, including certified FedRAMP cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions.

h. Support for cloud-based systems and services, wherever possible; including programmatic interoperability mechanisms in line with the Findable Accessible Interoperable Reusable (FAIR) Guiding Principles of data management and stewardship.

2) Data Analytics, including Statistical and Bioinformatic Analysis - the Contractor shall perform all activities necessary to provide statistical programming and analytic support of data from DCEG research studies. Activities performed by the Contractor include, but are not limited to:

a. Prepare analytic datasets for derived variables and associated documentation.

b. Provide knowledgeable and skilled staff for statistical programming and analysis support of data from studies as described in the Background (Section A) of this document.

c. Provide support for preparation of routine and ad hoc reports that may draw on information from one or more systems managed by the Contractor or the National Institutes of Health (NIH), as defined by the Contracting Officer’s Representative (COR).

d. Provide support for manuscript preparation including independent verification of analysis performed by DCEG investigators, and production of tables, charts, and figures as requested.

75N91019R00017 Attachment 5

e. Provide routine statistical programming and analysis of epidemiological data.

f. Provide statistical and bioinformatics analyses of data resulting from molecular technologies.

g. Develop new statistical methods/models for data analysis and study design. Such development of new methods may require simulations to test theories underlying new algorithms and validate the proposed method, or to compare these with existing ones.

h. Maintain flexibility in the support provided to accommodate for of newer molecular technologies and methods to perform analyses of the data from these technologies.

i. Streamline communication and information sharing between the Contractor and Division staff to harmonize similar analytic and programming efforts and remove duplication of work, to whatever extent possible.

j. Provide all statistical programming and analytic coding to the scientific staff for future use.

NOTE: Examples of types of analyses that may be required, but are not limited to, are included in the Additional Business Proposal Instructions.

3) Tool and Software Development - the Contractor shall provide systems analysis, design, programming, testing and documentation, support to develop new, and/or maintain and enhance existing, systems including web-based systems to support DCEG investigators/studies.

Activities performed by the Contractor include, but are not limited to:

a. Ensure that no existing federal, HHS, or NIH system can be leveraged, reused and/or slightly modified to meet the mission need [i.e. no Government Off-the-Shelf (GOTS) solution]. If no GOTS solution will meet the requirement, the Contractor shall explore the use of commercial and/or open source solutions, including cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions.

b. Rely upon an Agile development approach for all design projects.

c. Comply with all DHHS, NIH and NCI policies, guidelines and regulations, in accordance with Section H of the contract.

d. Develop all systems and websites in compliance with federal regulations and adhere to

NCI templates wherever feasible.

e. Maintain and enhance software systems, web-sites and tools previously developed.

Examples of such tools can be found at: https://dceg.cancer.gov/tools.

f. Maintain interoperability and compatibility with any existing or planned IT systems.

4) Transition-Out Plan – The Contractor shall ensure the orderly, efficient, and safe transition of all task order activities and materials within the last the last 120 days of the task order period of performance. At the direction of the COR, the Contractor shall develop a transition plan to transition all ongoing activities to a successor Contractor to assume all responsibilities to conduct the ongoing management of data, systems and research operations.

Prior to termination of this contract, the Contractor shall work with DCEG and any successor Contractor(s) to carry out transition activities. The incumbent Contractor shall affect a smooth, 75N91019R00017 Attachment 5 seamless transition of the management, operations, data, tools, resources, and other products generated through use of this contract to DCEG or any successor Contractor without prolonged interruption of the normal day-to-day operations. During the 90-day transition period, the incumbent Contractor shall continue to assume full responsibility for all essential activities, especially those that involve maintenance of existing study management. Sub-tasks include, but are not limited to:

1. Ensure that all documentation is current and available.

2. Ensure that all software code, deployment scripts, hardware and software hosting requirements, dependencies on third-party applications, documentation, and any other material necessary to maintain DCEG operations are current and available.

3. Submit a Final Transition Plan to the COR. At a minimum the plan must address how software and information will be successfully transitioned to a subsequent Contractor or DCEG business owners. A draft of this transition plan is due to the COR 120 calendar days prior to the completion date of the contract. The final plan is due at least 90 days prior to the completion date of the contract for final review and approval by the COR.

IV. DELIVERABLES

Deliverable Name Submission requirements Monthly progress report Reports should include status updates of all projects within period-of-performance, as well as the corresponding costs related to those tasks. Data elements that may be required include, but are not limited to, project codes, descriptions of services rendered, requestor name, hours billed for each activity, and total amount.

Annual progress report Summary of the monthly progress reports.

Documentation for work conducted under this task order should be maintained for the life of the task order. Pertinent documentation may include, but is not limited to, methods, coding and version control for analytic services rendered.

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75N91019R00017 Biomedical Information Management and Analytic Support Services

Additional Technical Proposal Instructions

These Additional Technical Proposal Instructions reflect the requirements of the RFP and provide specific instructions and formatting for the Technical Proposal. While Section L of the RFP provides a generic set of Technical Proposal Instructions applicable to all NIH solicitations, these Additional Technical Proposal Instructions are tailored to the specific requirements of the RFP. The information requested in these instructions should be used, along with Section L. to format and prepare the Technical Proposal and should be used as a Table of Contents for your Technical Proposal.

Offerors are advised to give careful consideration to the Statement of Work (SOW), Task Orders and Sample Task Orders, Technical Evaluation Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

A. Proposals submitted shall be a “searchable” PDF format to the maximum extent practicable and must adhere to the page limits. 50-pages will be the maximum if offerors respond to all task orders.

Specific page limit maximums are as follows: Base SOW (5 pages), TO1 (3 pages), TO2 (12 pages), TO3a (10 pages), TO3b (10 pages), TO4 (10 pages). Pages that exceed the specified limitations will be removed prior to evaluation.

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

C. Pages shall be standard size 8.5x11 with font size of 12 points and margins must be at least one inch on all sides.

D. Proposal page limits exclude the cover sheet, resumes, all appendices or attachments.

ALL OFFERORS MUST SUBMIT A TECHNICAL PROPOSAL ON THE BASE SOW.

ALL OFFERORS MUST RESPOND TO THE BASE SOW AND TASK ORDER 1. IN ADDITION, ALL OFFERORS MUST, AT THEIR DISCRETION, RESPOND TO EITHER TASK ORDER 2, SAMPLE TASK ORDER 3A, 3B OR 4, BUT MUST PROVIDE A RESPONSE TO AT LEAST ONE ADDITIONAL TASK ORDER OR SAMPLE TASK

ORDER RESPONSE IN ORDER TO BE ELIGIBLE TO RECEIVE AN AWARD. ALL OFFERORS MUST SUBMIT A

TECHNICAL PROPOSAL THAT IDENTIFIES A SEPARATE, CLEARLY LABELED SECTION FOR EACH

TECHNICAL RESPONSE (BASE SOW, TASK ORDER 1 AND ONE OF YOUR CHOICE). ALL SUCCESSFUL AWARDEES WILL RECEIVE TASK ORDER 1 AND ONE SUCCESSFUL AWARDEE WILL ALSO RECEIVE TASK

ORDER 2 UPON AWARD OF THE BASE CONTRACTS.

At the time of the Base IDIQ contract awards, the Government does not anticipate making any awards for Sample Task Orders 3a, 3b and 4 as a result of this solicitation. Therefore, Technical Proposals for Sample Task Orders shall provide a general overview of the Offeror’s Technical Approach; Organizational Experience And Capabilities Of Team And Key Personnel; Resource Management And Staffing Approach;

and Facilities And Equipment in meeting the requirements of the Statement of Work. All items under Solicitation Section L.2.b. “Technical Proposal Instructions” need not be addressed. As future

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Government needs for these services arise during the ordering period of the IDIQ Base Contract, the Government will issue detailed Requests for Task Order Proposals to meet those needs. Reference Solicitation Article G – Task Order Procedure for more information on the ordering process.

Each task order or sample task order requires the Offeror to address one or more task areas of the Statement of Work. Discussions of the task areas should be clearly identified in the proposals as outlined in the SOW: Contract Initiation/Kick-Off; Data Modeling, Acquisition Management; and Data Analytics, Statistical and Bioinformatic Analysis and Tool Development.

If the proposed approach will involve a subcontracting arrangement, then the Offeror shall include a letter(s) of commitment from the subcontractor(s), plus documentation of subcontractor’s expertise, qualifications and prior performance, as well as a narrative describing how the Offeror will manage the subcontractor(s).

SECTION 1: COVER PAGES AND TABLE OF CONTENTS

It is strongly recommended that Offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

E. PROPOSAL TITLE PAGE – Include RFP title and number, Task Order or Sample Task Order title, name of organization, DUNS number, and proposal part.

F. PROJECT OBJECTIVES

G. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043)

H. TABLE OF CONTENTS – Include a Table of Contents indicating pages of proposal sections that at a minimum uses the underlined Headings and Subheadings that appear below. Additional subheadings may be entered at the Offeror’s discretion.

SECTION 2: TECHNICAL DISCUSSIONS

1. A detailed technical plan must be submitted in the Offeror’s Technical Proposal indicating how each aspect of the Statement of Work is to be accomplished. The Sample Task Orders are provided to assess the Offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under contracts awarded in response to this solicitation. The Technical Proposal should reflect a clear understanding of the nature of the work being undertaken. The Offeror shall submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives. Proposals should not merely restate the requirements of the Government’s scope of work. Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work.

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SECTION 3: TECHNICAL APPROACH

1. Offerors should submit a proposal that addresses the Task Areas of the Statement of Work. The technical approach should be in as much detail as necessary to fully explain your proposed technical approach or method to perform each task order.

2. Offeror’s proposal should reflect a clear understanding of the nature of the work being undertaken, as well as potential technical and operational problems and solutions associated with accomplishing the Statement of Work.

3. Offeror’s proposal must include information on how the project is to be organized, staffed, and managed and information that demonstrates your understanding of management of timelines for planning and accomplishing the work to be performed.

4. Describe proposed methods for compliance with FISMA security for databases, documentation, related software, and all necessary elements.

SECTION 4: ORGANIZATIONAL EXPERIENCE AND CAPABILITIES OF TEAM AND KEY PERSONNEL

1. The Offeror’s Technical Proposal should include all information relevant to document individual training, education, experience (e.g. up to three references for similar services done within the past 5-years, etc.), qualifications and expertise necessary for the successful completion of all task order requirements. Each CV must indicate educational background, recent experience, and specific or technical accomplishments including experience with projects of similar scope, size and complexity.

2. Document the ability to provide and retain an adequate mix of disciplines at optimal staffing levels as needed.

3. Certain unique labor categories, as well as individuals with unique skills that are not available in the contractor’s existing personnel, may be required. Unique professional skills are defined as those bona fide executive, professional, or administrative skills for which the expertise required or duties performed are within the scope of a Task Area but are so specialized or rare that they are not explicitly defined in any of the labor categories needed to address the requirements as defined in the activities below. In the event that the offeror does not have facilities, equipment, or personnel for performing any component of the described in each section, then the offeror shall be prepared to implement the work through a suitable subcontractor(s). The proposal shall include the subcontractor’s prior experience with projects of similar size and scope to those in the SOW. Letters of commitment from and qualifications of all proposed subcontractors shall be included in the proposal. The offeror shall describe any previous working relationship with proposed subcontractors. Furthermore, the offeror shall address how they will handle privity of contract issues, i.e., the offeror should explain how information will flow between the NCI, the prime contractor (offeror), and any subcontractors since the prime contractor’s presence is required for any discussions.

SECTION 5: RESOURCE MANAGEMENT AND STAFFING APPROACH

1. Document the Offeror’s ability to provide 24 hour 7 days per week operational support levels to meet task order objectives.

2. Provide management and communication plan as relevant to the Statement of Work to include lines of authority and management of any proposed subcontractors and or consultants.

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3. Document use of information and other resources including staffing approach for efficiency of contract task orders without duplication of effort.

SECTION 6: FACILITIES AND EQUIPMENT

1. Offeror’s proposal shall document capacity, adequacy, suitability and availability of its facilities and equipment and other resources that will be provided to support all facets of the proposal.

2. The Offeror shall describe processes, and procedures to ensure privacy, data security protections, data storage and data backup in accordance with Federal policies including measures to avoid cyber threats.

3. Offerors should discuss applicable federal security policies and compliance.

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Additional Business Proposal Instructions

In addition to the format requirements for the Business Proposal that are contained in Section L of the solicitation, the information presented in this section of the RFP is intended to provide uniform cost assumptions and business clarifications based on each Sample Task Order.

Offerors are advised to give careful consideration to each Task Order or Sample Task Order Statement of Work, all reference material provided as attachments, the Technical Evaluation Criteria, and, the RFP as a whole, in the development of your proposal. The information requested in these instructions should be used as a guide for the development and formatting of your Business Proposal. Offerors should consider and include the information requested here, as well as any other information which will benefit the proposal.

Awardees of any task order shall be expected to provide monthly budget reports included with monthly progress reports using a standardized format approved by the NCI. Data elements that may be required include, but are not limited to, project codes, descriptions of services rendered, requestor name, hours billed for each activity, and total amount.

NOTE: All Base IDIQ awards will include an award for Task Order 1 to satisfy the minimum amount of $2,000. It is also anticipated that at least one Offeror will receive an award for Task Order 2. The Government does not anticipate making any awards for Sample Task Orders 3a, 3b and 4 as a result of this solicitation. The proposals for the Sample Task Orders will be used to evaluate the Offerors technical acceptability and for cost realism purposes only. However, a complete budget must be provided for each Task Order or Sample Task Order proposed.

Task Order 1

Task Order Type: Fixed Price Period of Performance: Two Months

Labor/Scope Assumptions The goal of this task order for contract initiation and to acclimate the Division to the services provided by the Contractor(s).

1. Prepare for and attend Kick-Off meeting and separate Capability Seminar in Rockville, MD. Both meetings will be held on the same day. Meeting can be face-to-face or via WebEx held within 60 days of task order award. Include travel costs as necessary for two company representatives.

2. Anticipate a total of 8 hours for both Kick-Off meeting and Capability Seminar including preparation of presentations.

3. Kick-Off meeting with Program and NCI Office of Acquisitions, Offeror shall provide NCI a Power Point presentation 10 days prior to meeting date.

4. Capability Seminar with Program and NCI Investigators, provide vendor capabilities based on Statement of Work.

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Task Order 2

Task Order Type: Cost Reimbursement, Level of Effort Period of Performance: Base Period of twelve months, three twelve-month option periods, and one 10-month option period.

Labor/Scope Assumptions

The goal of this task order is to identify biomedical computing in support of, but not limited to, two ongoing epidemiology and genetic research programs, conducted by seven Branches and two Laboratories of the Division of Cancer Epidemiology and Genetics (DCEG), NCI whose portfolio includes studies with diverse study designs in epidemiology and genetics research including cohort, cross-sectional, case cohort, nested cohort, family studies, and randomized clinical trials. Support may be required for approximately 70 DCEG Investigators and 400+ projects or studies with varying degrees of size and complexity.

The table below includes the estimated level of effort for direct labor hours for each period of performance. The Government estimates that the Contractor will need to provide not less than 80% nor more than 120% of the labor hours noted for each period. Negotiated fixed fee will be reduced in the event the actual hours worked are less than 80% of the negotiated hours included in the award. No additional fee will be paid for hours provided in excess of 100% - 120% of the hours negotiated and included in the award.

Infrastructure Capability Assumptions

The data management work required under for the DCEG necessitates the use of computing resources equivalent or exceeding the following capabilities:

• Support for hundreds of biostatisticians, statistical programmers, and systems developers in a highly scalable environment.

• Support for the VMware, Linux, and Windows operating systems on over 200 servers.

• Provide at least 50 TBs of active data storage on NetApp servers capable of being expanded to hundreds of TBs.

• Ensures that daily backup is off-site, automated, reliable, secure, and scalable.

• Include at least two equally capable datacenters to host operations.

• Include a 100 Mbit/sec Internet connection at each datacenter which can be increased if it is determined that additional capacity is needed.

• Include a 1 gigabit internal connection between both datacenters.

• Include a firewall and intrusion detection system (IPS) for each Internet connection.

• Include VPN services for offsite DCEG and offeror staff

• Include a data archival system to safely store at least 100 TBs of content off-line.

• Include production and development Web services and Web applications.

• Reliable 24/7 availability. Regular maintenance procedures that impact the use of the resource shall be performed during nights or weekends and with at least 48 hours notice to users.

• Ensure limited and controlled physical access to the computing resources.

75N91019R00017 Biomedical Information Management and Analytic Support Services

• Include built-in redundancies for all mission critical services and components.

• Center-wide disk backups and virus detection routines are executed to ensure data integrity throughout the center.

• User ID and password protected access to the network.

Analytic Capability Assumptions

The Contractor should assume that analytic needs of the Division will have varying degrees of size and complexity as described in the Data Management assumptions above. Populations to be analyzed will range from small studies including a hand-full of subjects (e.g. family-based studies) to large pooling projects analyzing complicated covariate and laboratory data from tens of thousands of subjects spanning multiple time-points.

A few examples of analytic tasks to be supported under the contract include, but are not limited to, those listed below. This list is meant to be illustrative only and not comprehensive and support shall evolve to meet the changing analysis needs of the Division.

Routine statistical programming and analysis tasks

1. Create sample Statistical Analysis System (SAS) and STATA programs to extract data from analytic files.

2. Performing tests of significance including Chi-square, Student t and Wilcoxon t, Fisher’s exact, and Kolmogorov-Smirnov tests, ANOVA, ANCOVA which are routinely used for univariate analyses.

3. Utilizing techniques such as Linear and Logistic Generalized Linear Modeling (GLM) procedures to identify and control for the effects of confounding factors in multivariate analyses.

4. Performing correlation and regression methods for analyses of case-control studies (e.g., logistic regression, polytomous regression) and cohort studies (e.g., Poisson regression and Cox Proportional Hazards regression); tests for trends, interactions, and joint effects may be necessary.

5. Utilizing techniques for missing value imputations.

6. Analyzing data from repeated measurements for marginal and conditional analysis of longitudinal data.

7. Analyzing data from studies with complex design features, such as correlated observations, clustering,…