RFP_N02CP71028-70.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:

N02CP71028-70

3. Issue Date:

03/06/2018

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Metabolic Epidemiology Branch Support Services

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E604, MSC 9705 Bethesda, MD 20892-9705

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 2:00PM local time on April 5, 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: Helen Wesley

PHONE: 240-276-6669

e-MAIL: helen.wesley@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The deadline for receipt of questions concerning this RFP is 2:00PM Eastern Time on March 19, 2018. Helen Wesley

Contracting Officer Office of Acquisitions National Cancer Institute http://www.sam.gov

RFP Number : N02CP71028-70

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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. Certification of Filing and Payment of Taxes

13. Past Performance Information

14. HHS SECURITY AND PRIVACY LANGUGAGE FOR INFORMATION AND IT

PROCUREMENTS

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

16. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

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. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. 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

The Metabolic Epidemiology Branch (MEB) of National Cancer Institute (NCI) requires the assistance of an organization highly experienced in providing technical support for all phases of epidemiologic studies, including support for pilot and feasibility efforts to launch multidisciplinary studies, development of precise methods of defining exposures to identify new causes of cancer and to adequately characterize the shape of the exposure-response relationship, and to understand the interaction of genetic and environmental factors related to cancer risk. Thus, this support services contract shall provide staff with logistical skills, knowledge of epidemiological studies and diverse biological specimens, and capability of specimen collection and handling requirements to enable technologically sophisticated assay development and performance.

ARTICLE B.2. PRICES/COSTS

The final contract will contain the price/cost provisions agreed upon by the Government and the Offeror.

ARTICLE B.3. ESTIMATED COST - OPTION

a. The estimated cost of the Base Period of this contract is $ TBD.

b. The fixed fee for the Base Period of this contract is $ TBD. 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 $ TBD.

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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:

Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Base Period (12/01/2018 - 08/31/2019): TBD TBD TBD

Option Period 1 (09/01/2019 - 08/31/2020): TBD TBD TBD

Option Period 2 (09/01/2020 - 08/31/2021): TBD TBD TBD

Option Period 3 (09/01/2021 - 08/31/2022): TBD TBD TBD

Option Period 4 (09/01/2022 - 08/31/2023): TBD TBD TBD

Option Period 5 (09/01/2023 - 11/30/2023): TBD TBD TBD

Option to Extend Services (6months): TBD TBD TBD

Total [Base Period and Option(s)] TBD TBD TBD

ARTICLE B.4. 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 $TBD.

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

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 12/01/2018 08/31/2019 Option Period 1 09/01/2019 08/31/2020 Option Period 2 09/01/2020 08/31/2021 Option Period 3 09/01/2021 08/31/2022 Option Period 4 09/01/2022 08/31/2023 Option Period 5 09/01/2023 11/30/2023 Option to Extend Services 12/01/2023 05/31/2024

Total

*To be inserted after negotiation

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

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.

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.

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ARTICLE B.5. 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.6. 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. DESCRIPTION - 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 March 6, 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 and Budget Progress Reports

1. Monthly Technical and Budget Progress Reports

In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring reports will be required in any contract resulting from this solicitation.

These reports will require descriptive information by project about the activities undertaken during the reporting period and planned activities for future reporting periods. True progress (not merely "having a meeting, etc.") is expected for all active studies. Studies that failed to make progress, which are exceeding budget, and any and all other problems encountered during the month, shall be specifically described at the beginning of each monthly report. Each project performed under the contract shall be identified by (1) a project name to be provided by the NCI COR, (2) the NCI CAS code, provided by the NCI COR, (3) a unique code that distinguishes the project from all others (many projects may have the same CAS code), and (4) NCI and Contractor personnel with primary responsibility for the study.

http://www.hhs.gov/web/508/index.html

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The Monthly Technical Progress Report shall be accompanied by a Monthly Budget Report in Excel that contains the following for each project: (1) a starting budget that is mutually agreed upon by the Contractor and the NCI COR, (2) a listing of each month's expenditures since the beginning of the project's start-up, (3) total expenditures on the project, (4) remaining funds to date, and (5) projected expenses to complete the project. The budget report contains detailed expenditures for labor and other study activities for the past month by individual project and a summary for the entire contract.

Future activities and projected expenses by project are also included to provide the information necessary to monitor progress and make any required adjustments. They will also include for each project and for the contract as a whole; a budgetary summary of monthly expenditures incurred since the beginning of the project's start-up; total expenditures on the project; projected expenses to complete each study; and remaining funds to date. Current hours used by the Contractor's staff will also be identified by project. It will also include the expenditures incurred and problems encountered.

The reporting period shall consist of each calendar month. The first report shall cover the period consisting of 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 of each month following the end of each reporting period. A Monthly Report shall not be submitted when the Annual or Final Report is due.

2. Annual Technical and Budget Progress Reports

The reports shall be similar in format and content to the monthly report, albeit summarizing each annual interval. This report shall include a summation of the results of the entire work for the period covered. The reporting period shall consist of 12 full calendar months. The first report shall cover the period consisting of the first full 12 months following the effective date of the contract and any fractional part of the initial month. Reports shall be due on or before the 30th calendar day of the month following the end of the reporting period. An Annual report shall not be submitted when the final report is due.

3. Final Technical and Budget Report

This report shall consist of the work performed and results obtained for the entire contract period of performance of this contract. This report shall be in sufficient detail to describe comprehensively the results achieved. A draft of the Final Report shall be submitted 90 days prior to the completion date of the contract for COR review. The Final Report shall be submitted on or before the expiration date of the contract. A Monthly and Annual Report shall not be required when the Final Report is due.

b. Other Reports/Deliverables

1. Initial Transition Plan

The Contractor shall ensure the orderly, efficient, and safe transition of all contract activities and materials within three (3) months of the inception of the contract. The Contractor shall deliver a Draft Initial Transition Plan to the NCI COR and Contracting Officer for review and approval within fourteen

(14) days of contract award and a Final Initial Transition Plan no later than two (2) weeks after receipt of Government comments.

2. Final Transition Plan

Six (6) months prior to the completion date of the contract, a Draft Final Transition Plan shall be submitted to the NCI COR for review and approval, delineating the transition activities to be undertaken, timelines for the completion of each transition activity, and the staff to be assigned. The Final Transition Plan shall be submitted to the Government no later than four (4) months prior to the completion date of the contract.

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3. Computerized Data and Source Code

Edited and corrected data, with appropriate documentation, suitable for analysis, shall be delivered to the NCI COR within 10 days of request. Unusual problems with verification rates, discrepancy rates, and error rates for data collection, preparation and keying should be summarized in a quarterly report.

Maintain a clearly documented history of the development and updating of databases.

4. Raw Data

Questionnaires, abstract forms, log books, death certificates, etc., shall be made available to the NCI COR within 10 days of request. The Contractor shall maintain a clearly documented history of the development and updating of databases.

5. Study Manuals

The Contractor shall deliver manuals developed and used in conducting studies.

6. Biological Specimens

Specimens shall be delivered by the Contractor within 10 days of request to locations or laboratories designated by the NCI COR, appropriately packaged and labeled, with accompanying subject data sheets clearly marked for ready identification and matched with each corresponding specimen, including multiple aliquots, if applicable.

7. Monthly Cost Accounting Systen (CAS) Transactions Data File

The Division of Cancer Epidemiology and Genetics (DCEG) implemented a Cost Accounting System(CAS) to accommodate the requirement for study level cost reporting for individual NCI investigators. The Contractor shall contribute to CAS by submitting monthly personnel expenditures and other direct charges itemized by study and investigator. This information shall be submitted by the Contractor directly to DCEG's IT (information technology) support contractor, who will input the data into the CAS. The monthly submission should contain an entry representing the combined costs associated with each unique investigator/study combination that received support during the month.

The Contractor's monthly submission will be concatenated into a centralized reporting database with all other transactions from the Division's support services contractors.

A website has been created that allows contractors to search for the unique identification codes for each DCEG investigator and existing study. This website can be found at: http:// www.dceg.cancer.gov/codes/index.html. For studies that do not have an established study code, the NCI investigator can request one from the DCEG Intramural System. The format for reporting, and the name and number of the contact person for the DCEG IT contractor, will be provided by the NCI

COR.

The monthly CAS data shall be submitted to the DCEG IT contractor no later than the 18th of each month for the previous month's expenditures. This requirement does not take the place of any other financial reporting required elsewhere in this contract.

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8. Study Specific Meeting Reports

The Contractor shall submit information about any study specific technical meetings attended by Key Personnel that are supported by contract funds within 7 days after each meeting. Each report shall contain a summary of the meeting, salient points as they pertain to new technologies or methodologies that could improve the implementation of the contract scope of work (SOW). Study specific meetings are considered program review and general staff meetings and are therefore allowable. The use of contract funds for any conference or meeting that is not a study specific meeting will be prohibited unless otherwise approved by the Contracting Officer.

9. Software/Programs Supporting MEB Activities Using Contract Funds

All computer software/programs supporting MEB activities using contract funds will be delivered to the NCI COR at the conclusion of the Contract, including programming code, program documentation, and user manuals.

10. Source Code and Object Code

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

11. HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT

PROCUREMENTS

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).

B. 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 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.

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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.

iii. 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.

iv. 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).

v. 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.

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).

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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 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 https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/SuitabilityRoster_10-15-12.xlsx https://www.hhs.gov/ocio/ea/documents/proplans.html https://www.hhs.gov/ocio/ea/documents/proplans.html

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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 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:

1. 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.

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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.

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

3. 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.

4. Cooperate with inspections, audits, investigations, and reviews.

12. SECTION 508 ANNUAL REPORT

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/ vendors.html under "Vendor Information and Documents."

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

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SECTION D - PACKAGING, MARKING AND SHIPPING

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

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SECTION E - INSPECTION AND ACCEPTANCE

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

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

c. Inspection and acceptance will be performed at:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E604 Rockville, MD 20850

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).

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from 12/01/2018 through 08/31/2019.

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 09/01/2019 - 08/31/2020 Option Period 2 09/01/2020 - 08/31/2021 Option Period 3 09/01/2021 - 08/31/2022 Option Period 4 09/01/2022 - 08/31/2023 Option Period 5 09/01/2023 - 11/30/2023 Option to Extend Services 12/01/2023 - 05/31/2024

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:

Item Description Delivery Schedule 1 Monthly Technical and Budget Progress

Report Due on or before the 15 th of each month following the end of each reporting period.

2 Annual Technical and Budget Progress Report

Due on or before the 30 th calendar day after the completion of each reporting period.

3 Final Technical and Budget Progress Report

Draft Final Report due 90 days prior to expiration date of the contract. Final Report due on or before the expiration date of the contract.

4 Initial Transition Plan Draft Initial Transition Plan due 14 calendar days after contract award. Finalized Initial Transition Plan due no later than 14 calendar days after receipt of Government comments.

5 Final Transition Plan Draft Final Transition Plan due six (6) months prior to expiration date of the contract. Finalized Final Transition Plan due no later than four (4) months prior to expiration date of the contract.

6 Computerized Data and Source Code Within ten (10) days upon request.

7 Raw Data Within ten (10) days upon request.

8 Study Manuals Due on or before the expiration date of the contract.

9 Biological Specimens Within ten (10) days upon identification of laboratory by COR.

10 Monthly Cost Accounting System (CAS)

Transactions Data File No later than the 18 th of each month for the previous month's expenditures.

11 Study Specific Meeting Reports Within seven (7) days after each meeting.

12 Software/Programs Supporting MEB

Activities Using Contract Funds Due on or before the expiration date of the contract.

13 Source Code and Object Code Due on the expiration date of the contract.

14 System Security Plan (SSP) Due within 30 days after contract award.

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Item Description Delivery Schedule 15 Security Assessment Plan/Report (SAP/

SAR)

Due 30 days after contract award.

16 Independent Assessment Due 90 days after contract award.

17 POA&M Due 30 days after contract award.

18 Contingency Plan and Contingency Plan

Test Due 60 days after contract award.

19 Roster of Employees Requiring Suitability Investigations

Due within 7 calendar days after the effective date of this contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change.

20 Contractor Non-Disclosure Agreement

(NDA)

Prior to work being performed by Contractor personnel.

21 Vulnerability Screening Report Due within 10 days following the end of each reporting period on a monthly basis.

22 Section 508 Annual Report Due prior to the expiration date of the Base period and all subsequent Option periods.

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

Addressee Deliverable Item No. Quantity Contracting Officer

National Cancer Institute

Office of Acquisitions

9609 Medical Center Drive

Room 1E604

Rockville, MD 20850

Items 1- 5, 14-22 1

NCI COR

National Cancer Institute

9609 Medical Center Drive

Room TBD

Rockville, MD 20850

Items 1-8, 11-22 1

Designated Laboratory and/or Storage Identified by NCI COR

Item 9 1

DCEG IT Contractor Item 10 1

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 Include vacation, holiday, and sick leave. These labor Hours Include subcontractor labor Hours .

It is estimated that the labor Hours are constituted as specified below and will be expended approximately as follows:

Labor Hours

Labor Category

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Professional TBD Other Professional Support

Totals

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b. The Contractor shall have satisfied the requirement herein if not less than 80% nor more than 120% of the total direct labor Hours specified herein are furnished. These terms and conditions do not supersede the requirements of either the "Limitation of Cost" or "Limitation of Funds" clause.

c. In the event fewer Hours than the minimum specified number of direct labor Hours in the total categories are used by the Contractor in accomplishing the prescribed work and the Government has not invoked its rights under FAR Clause 52.249-6, TERMINATION (Cost-Reimbursement) incorporated in this contract, these parties agree that the fee will be adjusted based solely upon the quantity of Hours by which the number of direct labor Hours furnished is less than the number of direct labor Hours specified in this ARTICLE. The resulting adjustment shall be evidenced by a contract modification.

ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

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

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SECTION G - CONTRACT ADMINISTRATION DATA

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

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

To be specified at time of award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other…