RFP_N02CP71025-72_11.03.17_Portfolio.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:

N02CP71025-72

3. Issue Date:

November 3, 2017

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Clinical Genetics Branch Support Services

6. ISSUED BY:

Office of Acquisitions National Cancer Institute National Institutes of Health 9609 Medical Center Drive Room 1E610 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 December 5, 2017 . 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: Jame Chang, Contracting Officer

PHONE: 240-276-5424

e-MAIL: jame.chang@nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

The cutoff day for questions is 10:00 AM EST on November 15, 2017.

Secondary Point of Contact:

Rosa Lopez, Contracting Officer rosa.lopez@nih.gov http://www.sam.gov mailto:rosa.lopez@nih.gov

RFP Number : N02CP71025-72

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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 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. ESTIMATE 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

11. Selection of Offerors

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12. Certification of Filing and Payment of Taxes

13. Past Performance Information

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

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

The Clinical Genetics Branch (CGB), Division of Cancer Epidemiology and Genetics (DCEG), of the National Cancer Institute (NCI) requires a Contractor to provide support services to conduct a wide variety of domestic and international family studies and field (case-control and cohort) studies. The proposed support services contract will provide the services of research nurses, genetic counselors, research assistants, study and data managers, biospecimen coordinators, support staff for questionnaire design, coding, keying and database creation, as well as management tools for these activities.

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 installments based on the percentage of completion of work, as determined by the Contracting Officer. 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:

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

Option Period 3 TBN TBN TBN

Option Period 4 TBN TBN TBN

Option to Extend Services TBN TBN TBN

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Estimated Cost

Fixed Fee

Estimated Cost Plus Fixed Fee

Total

[Base Period and Option(s)]

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:

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 August 1, 2018 July 31, 2019 TBN TBN TBN Option Period 1 August 1, 2019 July 31, 2020 TBN TBN TBN Option Period 2 August 1, 2020 July 31, 2021 TBN TBN TBN Option Period 3 August 1, 2021 July 31, 2022 TBN TBN TBN Option Period 4 August 1, 2022 July 31, 2023 TBN TBN TBN Option to Extend Services

6 months 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.

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 fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer.

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.

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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 November 3, 2017, 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) Initial Transition Plan

If applicable, within fourteen (14) calendar days of the contract effective date, the Contractor will develop and submit, for Government review and approval, a Draft Initial Transition Plan to ensure full assumption of all contract responsibilities and functions no later than three (3) months following the contract effective date. The Draft Initial Transition Plan shall delineate http://www.hhs.gov/web/508/index.html mailto:ncibrancheinvoices@mail.nih.gov

- 8 -the transition activities to be undertaken, timelines for the completion of each transition activity, and the staff to be assigned. The Contractor will revise the draft Initial Transition Plan to accommodate COR comments, and submit the Final Initial Transition Plan no later than two (2) weeks after receipt of COR comments.

b) Monthly Technical Progress Report

This report shall include a study-by-study description of the activities during the reporting period, and the activities planned for the ensuing reporting period. The progress shall be reported and accounted by specific project number and by principal investigator code. The report shall include text and use a "current month" and "project-to-date" format for tabular summaries of referrals, subject recruitment, data collection, numbers of clinic visits, blood draws, cancers detected, data management, processing and delivery, follow-up status, specimens received (by type), medical records obtained, pathology materials received, log of decisions made during each study, and other such variables as required by the Study PI or the COR. In addition to the primary report, the report will include information on how each study is being monitored, and document the performance and progress of any work done under any subcontract in performance of a study that is reviewed by the COR. Both monthly and cumulative expenditures shall be reported.

The first reporting period consists of the first full month of performance plus any fractional part of the initial month. The first monthly report shall be due as specified at the time of award. Thereafter, monthly reports shall be due on or before the 15th calendar day after the completion of each reporting period. A monthly report shall not be submitted for the period when an annual report or the final report is due. The monthly report shall include a listing of all individuals employed, the project(s) to which they are assigned, and the percentage of their time allocated to each specific project.

c) Annual Technical Progress Report

This report shall include a summation of the results of the entire contract work for each 12-month period during which the contract is in place. Each report shall be similar in format and content to the monthly reports, except that it will summarize a 12-month interval.

The first reporting period shall consist of the first full twelve-month period of performance including any fractional part of the initial month. The first annual report shall be due as specified at the time of award. Thereafter, annual reports shall be due on or before the 30th calendar day after the completion of each reporting period. An annual report shall not be submitted for the period when the final report is due.

d) Final Report

This report shall include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved, and again should be accounted/stratified by project and by principal investigator. A draft final report shall be provided 60-days prior to the expiration date of the contract for review by the NCI COR. The Final Report is due on or before the completion date of this contract.

e) Final Transition

The Contractor shall develop and implement a Final Transition Plan to ensure the orderly, efficient, and smooth transition of all contract activities and materials. Six (6) months prior to the completion date of the contract, a Draft Final Transition Plan shall be submitted to the COR and Contracting Officer 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 Draft Final Transition Plan shall include a listing of and plans for

- 9 -transferring contract-generated materials. The Final Transition Plan shall be submitted to the Government no later than four (4) months prior to the completion date of the contract.

f) Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website http://grants.nih.gov/grants/funding/women_min/women_min.htm .

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subset differences, a brief statement to that effect, indicating the subsets analyzed, will suffice. The Government strongly encourages inclusion of the results of subset analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/gender, race and/or ethnicity.

b. Other Reports/Deliverables

1. Computerized Data, Source Code, and Software

Edited and corrected data, with appropriate documentation, suitable for analysis, shall be delivered by the Contractor to the NCI COR at the completion of each study. Unusual problems with verification rates, discrepancy rates, and error rates for data collection, preparation and keying should be summarized in the monthly report. The Contractor shall maintain a clearly documented history of the development and updating of databases.

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

2. Edited Data

The Contractor shall deliver edited, cleaned and fully documented data to the NCI COR or his/her designee within 10 days upon the completion of components of each study, to be specified by the COR. This will typically be in the form of an analytic data file in SAS or SPSS format, although other formats may be chosen.

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3. Raw Data

Questionnaires, abstract forms, data dictionaries, decision logs, other log books, etc., shall be made available by the Contractor to the NCI COR within 10 days upon request. The delivery of the data will be as directed by the COR and will vary by study.

4. Final Data

The Contractor shall deliver previously undeliverable data to the NCI COR on or before the expiration date of the contract, along with full documentation.

5. Biologic Specimens

Specimens shall be delivered by the Contractor to laboratories designated by the NCI COR, appropriately packaged and labeled, with accompanying subject data that are clearly identifiable and matched to each corresponding specimen, including multiple aliquots, if applicable. Labeling shall comply with the maintenance of confidentiality specified in the study protocol. Specimens shall be delivered within 10 days upon identification of laboratory by the COR.

The COR shall be immediately notified by the Contractor of any adverse circumstances associated with the collection or delivery of biospecimens.

6. Monthly Cost Accounting System (CAS) Transactions Data File

The Division of Cancer Epidemiology and Genetics (DCEG) employs a Cost Accounting System (CAS) to accommodate the requirement for study-level cost reporting for individual NCI investigators.

The Contractor shall contribute financial data 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 system. This 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.

7. Meeting Minutes

Drafts of the meeting minutes shall be delivered by the Contractor to the NCI COR within 5 days after meetings and a final version shall be submitted no later than 5 days after the draft is delivered.

8. Data Processing

The Contractor shall edit programs, edit data, and correct computer files as requested by the COR.

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9. Quality Control Log

The Contractor shall maintain a log of daily decisions that affect study design, conduct, or analysis, updated for the COR monthly, separately for each study. This shall be delivered to the COR within 5 days of request from the COR.

10. 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.

• 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.

• 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.

• 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

- 12 -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).

• 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.

• 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).

1. HOMELAND SECURITY PRESIDENTIAL DIRECTIVE (HSPD)-12

Roster-

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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

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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:

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

- 15 -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 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.

11. 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

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SECTION D - PACKAGING, MARKING AND SHIPPING

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

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SECTION E - INSPECTION AND ACCEPTANCE

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

b. For the purpose of this SECTION, the Contracting Officer's Representative 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).

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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 August 1, 2018 through July 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 August 1, 2019 - July 31, 2020 Option Period 2 August 1, 2020 - July 31, 2021 Option Period 3 August 1, 2021 - July 31, 2022 Option Period 4 August 1, 2022 - July 31, 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 a.1.a. Initial Transition Plan 1 Copy - COR

1 Copy-Contracting Officer

(CO)

Draft Initial Transition Plan for review and approval within fourteen (14) days of contract award; Final Initial Transition Plan no later than two (2) weeks after receipt of Government comments a.1.b. Monthly Technical 1 Copy - COR

1 Copy-Contracting Officer

(CO)

Reports due on/before the 15 th of each month following the end of each reporting period. The first report shall be due as specified at the time of award.

a.1.c. Annual Technical

1 Copy - COR

1 Copy-Contracting Officer

(CO)

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

a.1.d. Final Report

(CO)

Draft Final Report due 60 days prior to expiration date of contract. Final Report due on or before the expiration date of the contract.

a.1.e. Final Transition Plan 1 Copy-COR Draft Plan due six (6) months prior to the

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Item # Type of Report No. of Copies Due Date 1 Copy-Contracting Officer

(CO)

completion date of the contract; Final Transition Plan due no later than four (4) months prior to the completion date of the contract.

a.1.f. Annual Technical Progress Report for Clinical Research Study Populations

(CO)

First report due one month prior to the due date for submitting that study's Annual Continuing Review to the Institutional Review Board. Thereafter, the report due on or before the

30 th calendar day following each reporting period. The final report due on [to be determined] b.1. Computerized Data, Source Code, and Software

1 Copy - COR Upon the completion of each study and by the expiration date of the contract.

b.2. Edited Data

1 Copy-COR Within 10 days upon request at completion of study.

b.3. Raw Data 1 Copy-COR Within 10 days upon request b.4. Final Data

1 Copy-COR On or before the expiration date of the contract.

b.5. Biological Specimens

Lab specified by COR Within 10 days upon identification of laboratory by COR b.6. Monthly Cost Accounting System (CAS) Transactions Data File

DCEG IT Contractor No later than the 18th of each month for the previous month's expenditures b.7. Meeting Minutes 1 Copy - COR Drafts of the meeting minutes shall be delivered by the Contractor to the NCI COR within 5 days after meetings and a final version shall be submitted no later than 5 days after the draft is delivered.

b.8. Data Processing 1 Copy - COR Reports due on or before the 30th calendar day after the completion of each reporting period.

b.9. Quality Control Log 1 Copy - COR Within 5 days after receipt of request from COR b.10.a. Security Assessment and Authorization (SA&A)

1 Copy-Contracting Officer

(CO)

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

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Item # Type of Report No. of Copies Due Date b.10.b. System Security Plan

(SSP)

1 Copy-Contracting Officer

(CO)

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

b.10.b. Security Assessment Plan/ Report (SAP/SAR)

1 Copy-Contracting Officer

(CO)

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

b.10.b. Independent Assessment 1 Copy-Contracting Officer

(CO)

Within 90 days after contract award. The Contractor shall update this on an annual basis.

b.10.b. POA&M 1 Copy-Contracting Officer

(CO)

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

b.10.c. Contingency Plan and Contingency Plan Test

(CO)

Within 60 days after contract award. The Contractor shall update this on an annual basis.

b.10.d. 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.

b.10.e. Contractor - Employee Non-Disclosure Agreement(s)

1 Copy-Contracting Officer

(CO)

On an as-needed basis b.10.f. Vulnerability Scanning Reports

1 Copy-Contracting Officer

(CO)

No later than 10 days following the end of each reporting period b.11. Section 508 Annual Report 1 Copy-Contracting Officer

(CO)

Annually on…