N02CP71026-72.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 92-218 as amended

2. Request for Proposal (RFP) Number:

N02CP71026-72

3. Issue Date:

February 15, 2018

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Agricultural Health Study Phase V

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive, Room 1E644 Bethesda, MD 20892, MSC 9704

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 12:00 PM EST time on March 19, 2018. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors--Competitive Acquisition," LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Charles Park

PHONE: 240-276-5896

e-MAIL: charles.park@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cutoff day for questions is 10:00 AM EST February 28, 2018.

Secondary Point of Contact:

Jame Chang Contracting Officer jame.chang@nih.gov http://www.sam.gov mailto:jame.chang@nih.gov

RFP Number : N02CP71026-72

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RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. LEVEL OF EFFORT

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

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11. Selection of Offerors

12. Past Performance Information

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

15. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

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

Instructions to Offerors Regarding Protection of Human Subjects

Required Education in the Protection of Human Research Participants

Inclusion of Women and Minorities in Research Involving Human Subjects

Inclusion of Children in Research Involving Human Subjects

Research Involving Human Fetal Tissue

Human Stem Cell Research

5. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

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

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Total Compensation Plan

10. Other Administrative Data

11. Qualifications of the Offeror

12. Subcontractors

13. Proposer's Annual Financial Report

14. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. EVALUATION OF OPTIONS

5. EVALUATION OF DATA SHARING PLAN

6. TECHNICAL EVALUATION FACTORS

7. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

8. PAST PERFORMANCE FACTOR

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PART I - THE SCHEDULE

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

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

CONTRACT AWARD.

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

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

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

In this Phase V contract, the Contractor shall serve as the coordinating center for all study activities of cohort maintenance and follow-up of the cohort. The Contractor shall be responsible for handling the daily operations of the Agricultural Health Study, scheduling regular and ad hoc meetings, maintaining secure data records, and updating cohort member contact information. The Contractor shall conduct data linkages to state cancer registries, mortality files, other types of records (e.g. Medicare, United States Renal Data System, Internal Revenue Service, Drivers’ Licenses, LexisNexis). The Contractor shall conduct communication activities to the cohort and stakeholders, maintain and update the study’s website, and develop the layout of an annual newsletter. The Contractor shall also facilitate preparation of compliance documents.

ARTICLE B.2. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ To Be Negotiated (TBN).

b. The fixed fee for the Base Period of this contract is $ TBN. The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended. Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Base Period is $ TBN.

d. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Core Work/Main Study

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period TBN TBN TBN

Option Period 1 TBN TBN TBN

Option Period 2 TBN TBN TBN

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option Period 3 TBN TBN TBN

Option Period 4 TBN TBN TBN

Option to Extend Services TBN TBN TBN

Total

[Base Period and Option(s)]

TBN TBN TBN

BEEA

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option A TBN TBN TBN

Option B TBN TBN TBN

Option C TBN TBN TBN

Option D TBN TBN TBN

Option E TBN TBN TBN

Iowa Pilot

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option F TBN TBN TBN

Iowa Tumor Collection

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option G TBN TBN TBN

Option H TBN TBN TBN

Option I TBN TBN TBN

North Carolina Pilot

Estimated Cost

Fixed Fee

Plus Fixed Fee

Option J TBN TBN TBN

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North Carolina Tumor Collection

Fixed Fee

Estimated Cost

Option K TBN TBN TBN

Option L TBN TBN TBN

Option M TBN TBN TBN

ARTICLE B.3. ESTIMATED COST - INCREMENTALLY FUNDED CONTRACT

a. The total estimated cost to the Government for full performance of this contract, including all allowable direct and indirect costs, is $ TBN.

b. The following represents the schedule* by which the Government expects to allot funds to this contract:

Core Work/Main Study

CLIN, Task, Number, or Description

Start Date of Period or Increment of Performance

End Date of Period or Increment of Performance

Estimated Cost ($)

Fee ($) (as appropriate)

Estimated Cost Plus Fee ($) (as appropriate)

Base Period September 23, September 22, TBN TBN TBN

Option Period 1 September 23, September 22, TBN TBN TBN

Option Period 2 September 23, September 22, TBN TBN TBN

Option Period 3 September 23, September 22, TBN TBN TBN

Option Period 4 September 23, September 22, TBN TBN TBN

Option to Extend Services

6 months TBN TBN TBN

BEEA

Start Date of Period or Increment of Performance

End Date of Period or

Increment of Performance

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option A September 23, September 22, TBN TBN TBN

Option B September 23, September 22, TBN TBN TBN

Option C September 23, September 22, TBN TBN TBN

Option D September 23, September 22, TBN TBN TBN

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Start Date of Period or Increment of Performance

End Date of Period or

Increment of Performance

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option E September 23, September 22, TBN TBN TBN

Iowa Pilot

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option F TBN TBN TBN

Iowa Tumor Collection

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Option G TBN TBN TBN Option H TBN TBN TBN Option I TBN TBN TBN

North Carolina Pilot

Fixed Fee

Option J TBN TBN TBN

North Carolina Tumor Collection

Estimated Cost

Fixed Fee

Estimated Cost

Option K TBN TBN TBN Option L TBN TBN TBN Option M TBN TBN TBN

*To be inserted after negotiation

c. Total funds currently obligated and available for payment under this contract are $ TBN.

d. The Contracting Officer may issue unilateral modifications to obligate additional funds to the contract and make related changes to paragraphs b. and/or c., above.

e. Until this contract is fully funded, the requirements of the clause at FAR 52.232-22, Limitation of Funds, shall govern. Once the contract is fully funded, the requirements of the clause at FAR 52.232-20, Limitation of Cost, shall govern.

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f. Payment of fee shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, ARTICLE I.1. of this contract.

The fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

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

ARTICLE B.5. ADVANCE UNDERSTANDINGS

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

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated February 15, 2018, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

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

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

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

NOTE: Hard copies of reports are no longer required and shall no longer be mailed to the NCI OA. Each email submission shall contain only one deliverable. If the attached file for the deliverable exceeds 50MB, the contractor shall divide the deliverable into files of 50MB each. All deliverables should be limited to five file attachments or less. In cases where it is necessary, more than five attachments will be accepted.

The subject line of the email shall read as follows:

Deliverable_Contract Number_Vendor's Name_Deliverable Description_Due Date

All data transfer of PII or sensitive information to the NCI must be encrypted.

a. Technical Progress Reports

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

a) Main Study Monthly Technical Progress Report

This report shall include a description of the activities conducted for the Agricultural Health Study (AHS) during the reporting period, as well as the activities planned for the ensuing reporting period. The activities, as listed in the Statement of Work, include, but are not limited to: 1) updating personal identifying information of cohort, 2) obtaining data from http://www.hhs.gov/web/508/index.html mailto:ncibrancheinvoices@mail.nih.gov

- 10 -various data sources and linking these data to the AHS cohort; 3) updating and maintaining all AHS databases and website; 4) data file preparation, data cleaning and quality control;

5) main and add-on study progress and publications; 6) biological specimen tracking; 7) communication activities; 8) management and administrative study activities; 9) study transition activities; 10) execution and tasks performed for Options listed in the Statement of Work.

The report shall include a budgetary summary of monthly expenditures incurred since the start of the project, projected expenses to complete each task, and remaining funds to date. Current hours used by the contractor's staff and any problems encountered for each task shall also be provided in the report. The financial report shall break out costs for tasks funded 100% by the National Cancer Institute (NCI) and National Institute of Environmental Health Sciences (NIEHS).

The first report shall cover the first full calendar month following the effective date of the contract and any fractional part of the initial month. Reports shall be due on or before the 15th calendar day following the end of each reporting period. A monthly report shall not be submitted when the final report is due.

b) Main Study Final Report

This report shall consist of a description of the work performed during the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the tasks listed above. A draft of the final report shall be submitted 60 days prior to the last day of the contract performance period, and the final report shall be submitted on or before the last day of the contract performance period.

c) BEEA Monthly Reports (Only required if an option for BEEA is exercised)

This report shall include a description of the activities conducted for BEEA during the reporting period, as well as the activities planned for the ensuing reporting period.

The activities, as listed in the Statement of Work, include, but are not limited to: 1) the maintenance of the BEEA database; 2) participation in meetings; 3) document changes to datasets; 4) summary of requests for biological samples and data; 5) specimen tracking.

The report shall include a budgetary summary of monthly expenditures incurred since the start of the project, projected expenses to complete each task, and remaining funds to date.

Current hours used by the contractor's staff and any problems encountered for each task shall also be provided in the report.

The first report shall cover the first full calendar month following the effective date of the contract and any fractional part of the initial month. Reports shall be due on or before the 15th calendar day following the end of each reporting period. A monthly report shall not be submitted when the annual or final report is due.

d) BEEA Final Report (Only required if an option for BEEA is exercised)

This report shall consist of a description of the work performed during the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the tasks listed above. A draft of the final report shall be submitted 60 days prior to the last day of the contract performance period, and the final report shall be submitted on or before the last day of the contract performance period.

e) Options F, G, H, I, J, K, L, and M Reporting (Only required if any of these options are exercised)

If the Government exercises any of the Options F through M listed in the Statement of Work, the Contractor shall address the progress in obtaining tissue samples from AHS participants in the monthly and final reports for the main study. For Option F, this includes information on

- 11 -the number of discarded formalin fixed paraffin embedded prostatectomy blocks obtained from the Iowa Residual Tumor Repository, any related reports or documentation, number of samples shipped to the PI, or returned to the Repository, shipment tracing, etc. For Options G through M the reports shall include information on the progress of obtaining tumor tissue samples from the specified locations (e.g., hospital, laboratories, registries) in either Iowa or North Carolina. This shall include the number of samples obtained by tumor site, any related reports or documentation, number of samples shipped to the PI, or returned to the originating location, shipment tracing, etc. All samples shall be appropriately packaged and labeled, with accompanying subject data sheets clearly marked for ready identification.

b. Other Reports/Deliverables

1. Main Study Yearly Data File

A master data file including, but not limited to, subject ID, vital status, cancer incidence status, all interview and biological specimen receipt and use data shall be prepared. No personal identifiers shall be included. The file shall be a SAS file, appropriate for analysis. Data documentation and descriptions shall accompany the file. The first data file shall cover the first full year following the effective date of the contract. The first data file and subsequent data files shall be due on or before the 15th calendar day following the end of each annual reporting period.

2. Main Study Final Data Files

For study closeout, a final master data file, including the same variables included in the yearly data file shall be prepared in the same format. In addition, a comprehensive and complete inventory of all biological specimens and laboratory data shall be prepared as a SAS file. Another data file including personal identifiers (e.g., study subject, full name, most recent address and telephone number, social security number, and latitude and longitude of residence) shall be prepared as a SAS file. All files shall be linkable by study subject ID.

At the end of the contract performance period, all databases and data files shall be delivered to a specified location designated by the COR.

3. Main Study Analytic Data Files

Analytic data files, generally prepared from the most recent annual version of the master data file, shall be delivered to investigators with data requests approved by the AHS Executive Committee.

Analytic data files shall be prepared in the format specified by the investigator, typically SAS, STATA, SPSS, or text files, and delivered within 10 working days of the data request.

4. BEEA Yearly Data File (Only required if an option for BEEA is exercised)

A master data file including, but not limited to, subject ID, CATI and CAPI BEEA interview data, and biological specimen receipt and use data shall be prepared. No personal identifiers shall be included.

The file shall be a SAS file, appropriate for analysis. Data documentation and descriptions shall accompany the file. The first data file shall cover the first full year following the effective date of the first BEEA option exercised in the contract. The first data file and subsequent data files shall be due on or before the 15th calendar day following the end of each annual reporting period.

5. BEEA Final Data File (Only required if an option for BEEA is exercised)

For study closeout, a final master data file, including the same variables included in the yearly data file shall be prepared in the same format. No personal identifiers shall be included. The file shall be a SAS file, appropriate for analysis. Data documentation and descriptions shall accompany the file.

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At the end of the contract performance period, all databases and data files shall be delivered to a specified location designated by the COR.

6. BEEA Analytic Data Files (Only required if an option for BEEA is exercised)

Analytic data files, generally prepared from the most recent annual version of the master data file, shall be delivered to investigators with approved data requests. Analytic data files shall be prepared in the format specified by the investigator, typically SAS, STATA, SPSS, or text files, and delivered within 10 working days of the data request.

7. Final Transition Plan

The Final Transition Plan, which is due nine months prior to the completion date of the contract, shall include:

1. Recommended steps with a detailed cost estimate to ensure all data, specimens, and documentation are prepared and packaged for delivery to the government or successful contractor.

2. Detailed list of complete inventory of all records and materials accumulated by the contractor to be transferred.

8. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

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

INFORMATION AND/OR PHYSICAL SECURITY

A. Security Assessment and Authorization (SA&A)- A valid authority to operate (ATO) certifies that the Contractor's information system meets the contract's requirements to protect the agency data. If the system under this contract does not have a valid ATO, the Contractor (and/or any subcontractor) shall work with the agency and supply the deliverables required to complete the ATO within the specified timeline(s) within three (3) months after contract award. The Contractor shall conduct the SA&A requirements in accordance with HHS IS2P, NIST SP 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems: A Security Life Cycle Approach (latest revision).

For an existing ATO, Contracting Officer Representative must make a determination if the existing ATO provides appropriate safeguards or if an additional ATO is required for the performance of the contract and state as such.

NIH acceptance of the ATO does not alleviate the Contractor's responsibility to ensure the system security and privacy controls are implemented and operating effectively.

B. SA&A Package Deliverables - The Contractor (and/or any subcontractor) shall provide an SA&A package within 30 days of contract award to the CO and/or COR. The following SA&A deliverables are required to complete the SA&A package.

i. System Security Plan (SSP) - due within 30 days after contract award. The SSP shall comply with the NIST SP 800-18, Guide for Developing Security Plans for Federal Information Systems, the Federal Information Processing Standard (FIPS) 200, Recommended Security Controls for Federal Information Systems, and NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline requirements, and other applicable NIST guidance as well as HHS and NIH policies and other guidance. The SSP shall be consistent with and detail the approach to IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The SSP shall provide

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

ii. Security Assessment Plan/Report (SAP/SAR) - due 30 days after the contract award. The security assessment shall be conducted by the assessor and be consistent with NIST SP 800-53A, NIST SP 800-30, and HHS and NIH policies.

The assessor will document the assessment results in the SAR. Thereafter, the Contractor, in coordination with the NIH shall conduct/assist in the assessment of the security controls and update the SAR at least annually.

iii. Independent Assessment - due 90 days after the contract award. The Contractor (and/or subcontractor) shall have an independent third-party validate the security and privacy controls in place for the system(s). The independent third party shall review and analyze the Security Authorization package, and report on technical, operational, and management level deficiencies as outlined in NIST SP 800-53. The Contractor shall address all "high" deficiencies before submitting the package to the Government for acceptance. All remaining deficiencies must be documented in a system Plan of Actions and Milestones (POA&M).

iv. POA&M - due 30 days after contract award. The POA&M shall be documented consistent with the HHS Standard for Plan of Action and Milestones and NIH policies. All high-risk weaknesses must be mitigated within 30 days and all medium weaknesses must be mitigated within 60 days from the date the weaknesses are formally identified and documented. The NIH will determine the risk rating of vulnerabilities. Identified risks stemming from deficiencies related to the security control baseline implementation, assessment, continuous monitoring, vulnerability scanning, and other security reviews and sources, as documented in the SAR, shall be documented and tracked by the Contractor for mitigation in the POA&M document. Depending on the severity of the risks, NIH may require designated POAM weaknesses to be remediated before an ATO is issued. Thereafter, the POA&M shall be updated at least quarterly.

C. Contingency Plan and Contingency Plan Test - due 60 days after contract award. The Contingency Plan must be developed in accordance with NIST SP 800-34, Contingency Planning Guide for Federal Information Systems, and be consistent with HHS and NIH policies. Upon acceptance by the System Owner, the Contractor, in coordination with the System Owner, shall test the Contingency Plan and prepare a Contingency Plan Test Report that includes the test results, lessons learned and any action items that need to be addressed. Thereafter, the Contractor shall update and test the Contingency Plan at least annually.

i. E-Authentication Questionnaire - The contractor (and/or any subcontractor) shall collaborate with government personnel to ensure that an E-Authentication Threshold Analysis (E-auth TA) is completed to determine if a full E-Authentication Risk Assessment (E-auth RA) is necessary. System documentation developed for a system using E-auth TA/E-auth RA methods shall follow OMB 04-04 and NIST SP 800-63, Rev. 2, Electronic Authentication Guidelines.

Based on the level of assurance determined by the E-Auth, the Contractor (and/or subcontractor) must ensure appropriate authentication to the system, including remote authentication, is in-place in accordance with the assurance level determined by the E-Auth (when required) in accordance with HHS policies.

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D. POSITION SENSITIVITY DESIGNATIONS

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

[ ] Level 6: Public Trust - High Risk. Contractor/subcontractor employees assigned to Level 6 positions shall undergo a Suitability Determination and Background Investigation (MBI).

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

[X] Level 1: Non-Sensitive. Contractor/subcontractor employees assigned to Level 1 positions shall undergo a Suitability Determination and National Check and Inquiry Investigation (NACI).

1. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

a. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster shall be submitted to the COR and/or CO within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven (7) calendar days of the change. The COR will notify the Contractor of the appropriate level of investigation required for each staff member. An electronic template, "Roster of Employees Requiring Suitability Investigations," is available for contractor use at: https://ocio.nih.gov/aboutus/ publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx .

b. If the Contractor is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

c. Upon receipt of the Government's notification of applicable Suitability Investigations required, the Contractor shall complete and submit the required forms within 30 days of the notification.

d. The Contractor shall notify the Contracting Officer in advance when any new personnel, who are subject to a background check/investigation, will work under the contract and if they have previously been the subject of national agency checks or background investigations.

e. All contractor and subcontractor employees shall comply with the conditions established for their designated position sensitivity level prior to performing any work under this contract.

Contractors may begin work after the fingerprint check has been completed.

f. Investigations are expensive and may delay performance, regardless of the outcome of the investigation. Delays associated with rejections and consequent re-investigations may not be excusable in accordance with the FAR clause, Excusable Delays - see FAR 52.249-14.

Accordingly, the Contractor shall ensure that any additional employees whose names it submits for work under this contract have a reasonable chance for approval.

g. Typically, the Government investigates personnel at no cost to the Contractor.

However, multiple investigations for the same position may, at the Contracting Officer's

- 15 -discretion, justify reduction(s) in the contract price of no more that the cost of the additional investigation(s).

h. The Contractor shall include language similar to this "HHS Controlled Facilities and Information Systems Security" language in all subcontracts that require subcontractor personnel to have the same frequency and duration of (1) physical access to an HHS-controlled facility; (2) logical access to an HHS-controlled information system; (3) access to sensitive HHS data/information, whether in an HHS-controlled information system or in hard copy; or (4) any combination of circumstances (1) through (3).

i. The Contractor shall direct inquiries, including requests for forms and assistance, to the Contracting Officer or designee.

j. Within 7 calendar days after the Government's final acceptance of the work under this contract, or upon termination of the contract, the Contractor shall return all identification badges to the Contracting Officer or designee.

E. CONTRACT INITIATION AND EXPIRATION

1. General Security Requirements- The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the HHS EPLC framework and methodology or and in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here: https://www.hhs.gov/ocio/ea/ documents/proplans.html

2. System Documentation- Contractors (and/or any subcontractors) must follow and adhere to NIST SP 800-64, Security Considerations in the System Development Life Cycle, at a minimum, for system development and provide system documentation at designated intervals (specifically, at the expiration of the contract) within the EPLC that require artifact review and approval.

3. Sanitization of Government Files and Information- As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with the NIH Media Sanitization and Disposal Policy to the CO and/or COR to certify that, at the government's direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

4. Notification- The Contractor (and/or any subcontractor) shall notify the CO and/ or COR and system ISSO within fifteen days before an employee stops working under this contract.

5. Contractor Responsibilities Upon Physical Completion of the Contract- The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or NIH policies.

6. The Contractor (and/or any subcontractor) shall perform and document the actions identified in the NIH Contractor Employee Separation Checklist

- 16 -https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Emp-sep-checklist.pdf when an employee terminates work under this contract within 2 days of the employee's exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

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

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

H. Government Access for Security Assessment. In addition to the Inspection Clause in the contract, the Contractor (and/or any subcontractor) shall afford the Government access to the Contractor's facilities, installations, operations, documentation, information systems, and personnel used in performance of this contract to the extent required to carry out a program of security assessment (to include vulnerability testing), investigation, and audit to safeguard against threats and hazards to the confidentiality, integrity, and availability of federal data or to the protection of information systems operated on behalf of HHS, including but are not limited to:

a. At any tier handling or accessing information, consent to and allow the Government, or an independent third party working at the Government's direction, without notice at any time during a weekday during regular business hours contractor local time, to access contractor and subcontractor installations, facilities, infrastructure, data centers, equipment (including but not limited to all servers, computing devices, and portable media), operations, documentation (whether in electronic, paper, or other forms), databases, and personnel which are used in performance of the contract.

The Government includes but is not limited to the U.S. Department of Justice, U.S.

Government Accountability Office, and the HHS Office of the Inspector General (OIG). The purpose of the access is to facilitate performance inspections and reviews, security and compliance audits, and law enforcement investigations. For security audits, the audit may include but not be limited to such items as buffer overflows, open ports, unnecessary services, lack of user input filtering, cross site scripting vulnerabilities, SQL injection vulnerabilities, and any other known vulnerabilities.

b. At any tier handling or accessing protected information, fully cooperate with all audits, inspections, investigations, forensic analysis, or other reviews or requirements needed to carry out requirements presented in applicable law or policy. Beyond providing access, full cooperation also includes, but is not limited to, disclosure to investigators of information sufficient to identify the nature and extent of any criminal or fraudulent activity and the individuals responsible for that activity. It includes timely and complete production of requested data, metadata, information, and records relevant to any inspection, audit, investigation, or review, and making employees of the contractor available for interview by inspectors, auditors, and investigators upon request. Full cooperation also includes allowing

- 17 -the Government to make reproductions or copies of information and equipment, including, if necessary, collecting a machine or system image capture.

c. Segregate Government protected information and metadata on the handling of Government protected information from other information. Commingling of information is prohibited. Inspectors, auditors, and investigators will not be precluded from having access to the sought information if sought information is commingled with other information. Cooperate with inspections, audits, investigations, and reviews.

9. Section 508 Annual Report

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

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

- 18 -

SECTION D - PACKAGING, MARKING AND SHIPPING

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

- 19 -

SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, the Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Division of Cancer Epidemiology & Genetics National Cancer Institute National Institutes of Health 9609 Medical Center Drive Bethesda, MD 20892 MSC 9704

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

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

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

- 20 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from September 23, 2018 through September 22, 2019.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period Option Period 1 September 23, 2019 - September 22, 2020 Option Period 2 September 23, 2020 - September 22, 2021 Option Period 3 September 23, 2021 - September 22, 2022 Option Period 4 September 23, 2022 - September 22, 2023 Option to Extend Services Six Months

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract:

Item # Type of Report No. of Copies Due Date

1. Main Study Monthly

Technical Progress Report 1 Copy - COR

1 Copy-Contracting Officer

(CO)

Reports shall be due on or before the15th calendar day following the end of each reporting period. A monthly report shall not be submitted when the final report is due.

2. Main Study Final Report 1 Copy - COR

1 Copy-Contracting Officer

(CO)

A draft of the final report shall be submitted 60 days prior to the last day of the contract performance period, and the final report shall be submitted on or before the last day of the contract performance period.

3. BEEA Monthly Reports

1 Copy - COR

1 Copy-Contracting Officer

(CO)

Reports shall be due on or before the15th calendar day following the end of each reporting period. A monthly report shall not be submitted when the final report is due.

4. BEEA Final Report

1 Copy - COR

1 Copy-Contracting Officer

(CO)

A draft of the final report shall be submitted 60 days prior to the last day of the contract performance

- 21 -

Item # Type of Report No. of Copies Due Date period, and the final report shall be submitted on or before the last day of the contract performance period.

5. Options F through M Reporting

1 Copy-COR

1 Copy-Contracting Officer

(CO)

To be included in the Main Study Reports if exercised.

6. Main Study Yearly Data File

1 Copy-COR Due on or before the 15th calendar day following the end of each annual reporting period.

7. Main Study Final Data Files

1 Copy-COR At the end of the contract performance period, all databases shall be delivered to a specified location designated by the

COR.

8. Main Study Analytic Data Files

1 Copy-COR Within 10 days upon request

9. BEEA Yearly Data File

1 Copy-COR Due on or before the 15th calendar day following the end of each annual reporting period

10. BEEA Final Data Files 1 Copy-COR On or before the expiration date of the contract.

11. BEEA Analytic Data Files

1 Copy-COR Within 10 days upon identification of laboratory by COR

12. Final Transition Plan 1 Copy-COR 1 Copy-Contracting Officer

(CO)

9 months prior to the completion of the contract

13. Security Assessment and Authorization (SA&A)

1 Copy-COR 1 Copy-Contracting Officer

(CO)

Within 3 months after contract award. The Contractor shall update this on an annual basis.

14. System Security Plan

(SSP)

1 Copy-COR 1 Copy-Contracting Officer

(CO)

Within 30 days after contract award. The Contractor shall update this on an annual basis.

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

1 Copy-COR 1 Copy-Contracting Officer

(CO)

Within 30 days after contract award. The Contractor shall update this on an annual basis.

16. Independent Assessment 1 Copy-COR 1 Copy-Contracting Officer

(CO)

Within 90 days after contract award.

17. POA&M 1 Copy-COR 1 Copy-Contracting Officer

(CO)

Within 30 days after contract award. The Contractor shall update this on an annual basis.

18. Contingency Plan and Contingency Plan Test

1 Copy-COR 1 Copy-Contracting Officer

(CO)

Within 60 days after contract award. The

- 22 -

Item # Type of Report No. of Copies Due Date Contractor shall update this on an annual basis.

19. Roster of Employees

Requiring Suitability Investigations

1 Copy - COR

1 Copy-Contracting Officer

(CO)

Within fourteen (14) calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within seven

(7) calendar days of the change.

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

1 Copy-COR 1 Copy-Contracting Officer

(CO)

On an as-needed basis

21. Vulnerability Scanning Reports

1 Copy-COR 1 Copy-Contracting Officer

(CO)

No later than 10 days following the end of each reporting period

22. Section 508 Annual Report 1 Copy-COR 1 Copy-Contracting Officer

(CO)

Annually on the anniversary date of the contract.

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

Addressee Deliverable # Quantity Contracting Officer (to be determined) ncibrancheinvoices@mail.nih.gov

1 through 5 and 12 through 22 One (1) Electronic Copy

Contracting Officer Representative (to be determined)

1 through 22 One (1) Electronic Copy

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide TBD direct labor Hours . The labor Hours Exclude vacation, holiday, and sick leave. These labor Hours Exclude subcontractor labor Hours .

It is estimated that the labor Hours are constituted as specified…