RFQAttachmentNo.1CytelSOW_orEquivalent.pdf

STATEMENT OF WORK

Cytel Software Contract

08/21/2018

1. BACKGROUND

Statisticians, particularly those in CDER, require specialized software to assist with drug development and evaluation. For more than 20 years, statisticians in the Office of Biostatistics have used Cytel software products such as StatXact, LogXact, StatXact Procs for SAS, and EAST to perform their analyses. Exact statistical procedures have proven to be needed for safety, carcinogenicity and other applications. Additionally, specialized clinical trial designs for complex, innovative designs and analyses of those designs can be realized with EAST. Within EAST, various modules have been added to facilitate drug development processes. The products sought are listed below. Releases subsequent to those listed are acceptable.

• StatXact 11.1

• LogXact 11.1

• StatXact Procs (at least version 11.1)

• EAST 6.4 Premium Edition (including all available modules)

2. OBJECTIVES

The objective of this acquisition is to renew existing software product licenses for specialized software used to design and analyze clinical trials, observational studies, animal studies, bioequivalence determination, and chemical and manufacturing controls. A particular emphasis of this acquisition is exact statistical analyses in both stand alone and SAS programming environments, power and sample size determination, and adaptive designs clinical trials and other complex innovative designs.

Additionally, this acquisition will provide for software maintenance, including upgrades and software patches, as well as technical support for both current licenses and equivalent.

3. SCOPE

• The contractor shall provide software, licenses, maintenance, and technical support during standard business hours. Electronic delivery of software products is acceptable.

4. REQUIREMENTS

StatXact 11.1, LogXact 11.1, StatXact Procs 11.1 , EAST 6.5 (or greater) including: all available modules at the inception of the contract, such as Adapt, Base, Endpoints, Escalate, Exact, Multiarm, Predict, R Integration, Sequantial, SurvAdpat, and Survival modules, or equivalent. To be equivalent, the software must be able to the following analyses and simulations via a Windows 7/10 GUI.

A. Technical Requirements; To be considered, the product must possess the following

Salient Characteristics for Equal to Quotes:

The software shall be compatible and operate seamlessly under the current operating system and hardware parameters:

‐ Windows 7 Service Pack 1 ‐ 4‐6 GB Disk Space

‐ 4G RAM:

‐ No specific graphics card is required.

‐ Hardware accelerated graphics card supporting OpenGL 3.3 with 1GB GPU memory.

‐Intel or AMD x86‐64 processor

B. Salient Characteristics for Cytel Licenses

StatXact To be considered equivalent to StatXact, the software package should shall be capable of carrying out performing the following statistical procedures:

• One‐sample Goodness‐of‐Fit o Chi‐Square o Kolmogorov o Lilliefors o Runs

• Paired Samples o Sign o Wilcoxon Signed‐Rank o Hodges Lehman Estimates o Permutation o McNemar ‐ Conditional o McNemar ‐ Unconditional o Marginal Homogeneity

• Two Independent Samples o Wilcoxon‐Mann‐Whitney o Hodges Lehman estimates o Normal Scores o Savage Scores o Siegel‐Tukey o Ansari‐Bradley o Klotz o Mood o Conover o Permutation o Logrank o Wilcoxon‐Gehan o Kolmogorov‐Smirnov o Wald‐Wolfowitz Runs

• K Related Samples o Friedman o Kendall's W o Cochran's Q o Quade o Page

• K Independent Samples o Median o Kruskall‐Wallis o Normal Scores o Savage o ANOVA with General Scores o Jonckheere‐Terpstra o Linear by Linear o Logrank o Wilcoxon‐Gehan o Tarone and Ware Trend

• One‐Sample Rates and Proportions o Binomial o Multinomial o Poisson

• Poisson Rates o Homogeneity of Relative Risks o CI on Common Relative o Trend in C Ordered Poisson Rates

• Two Independent Binomials o Fisher's Exact o Pearson's Chi‐square o Likelihood Ratio o CI on Odds Ratio o Barnard's Test for Superiority o Tests of Non‐inferiority o Tests of Equivalence o CI on Difference of Proportions o CI on Ratio of Proportions

• Two Related Binomials o McNemar o CI on odds Ratio o Test for Superiority o Tests of Non‐inferiority o Tests of Equivalence o CI on Difference of Proportions

• Stratified 2x2 Tables o Homogeneity of Odds Ratios o CI on Common Odds Ratios

• C Ordered Binomials (with or without strata) o Cochran‐Armitage Trend o Permutation with General Scores o Trend Test for Clustered Data o Test for Interaction Across Strata

• Two Ordered Multinomials (with or without strata) o Wilcoxon‐Mann‐Whitney o Savage Scores o Normal Scores o Permutation with General Scores o Test for Interaction Across Strata

• Unordered RxC Table o Pearson's ChiSquare o Likelihood Ratio o Fisher‐Freeman‐Halton

• Single Ordered RxC Table o Kruskal‐Wallis o Normal Scores o Savage o ANOVA with Arbitrary Scores

• Doubly Ordered RxC Table

• Jonckheere‐Terpstra

• Linear by Linear Association

• Stratified RxC Tables o Unordered RxC Table o Single Ordered RxC Table o Doubly Ordered RxC Table

• Correlated Categorical Data o C Binomial Population o Test of Correlation o Test for Trend o Multiple Binary Outcomes o Test for Trend

• Measures of Association (nominal) o Contingency Coefficients o Goodman‐Kruskal‐Tau o Uncertainty Coefficient

• Measures of Association (ordinal) o Pearson's Correlation o Spearman's Correlation o Kendall's Concordance o Kendall's Tau and Somers' D o Gamma Coefficient

• Measures of Agreement o Cohen's Kappa o Weighted Kappa

• Power & Sample Size o One Binomial o Paired Binomials: Difference o Two independent Binomials:Difference o Superiority (conditional) o Non‐inferiority o Equivalence o K ordered Binomials

• Two Ordered Multinomials (power) o Superiority (unconditional) o Two Binomials: Ratio o Non‐inferiority Equivalence o Superiority (unconditional) o Two Ordered Multinomials o Wilcoxon Ranksum o Savage Scores o Normal Scores o Permutation with General Score

To be considered equivalent to the StatXact Procs, the above statistical procedures must be callable from within a SAS statistical computing environment.

To be considered equivalent to LogXact, software must be able to:

• Perform regression analysis for continuous, binary, polytonomous and count data.

• Apply advanced regression techniques to data sets with missing values.

• Negative Binomial and Poisson Regression: regression procedures for count

• Data, offering Firth’s bias correction for the MLE

• Additional procedures for Bias Corrected (Firth) including Probit and ClogLog regression for binary data, Poisson regression for stratified and unstratified data

• Profile Likelihood based Confidence Intervals for likelihood and penalized likelihood estimates

• Profile Likelihood Based Confidence Intervals: Determine confidence intervals for the MLE and

PMLE

• Accurately fit general linear models in cases of missing categorical covariates (models include

Logit, Probit, CLoglog, Poisson and Normal.)

• Handle large data sets using exact methods, Monte Carlo sampling and Markov Chain Monte

Carlo sampling.

• Methods to include: Firth’s PMLE procedure; the calculation of mid‐p corrected confidence intervals for a variety of models; best subset selection in binary logistic regression; the force inclusion of variable to the best subsets; and profile likelihood confidence intervals for parameters of binary logistic regression.

To be considered equivalent to EAST and the listed modules, the software product/modules should possess the following features:

• Fixed Sample Size and Group Sequential Designs

• Normal Designs o Superiority (one and two sample designs) o Non‐inferiority o Equivalence

• Binomial Designs (including exact binomial tests) o Superiority (One, two and many samples) o Non‐inferiority (two sample) o Equivalence (two sample)

• Survival o Superiority o Non‐inferiority

• Information Based Designs

• Adaptive Designs and Simulations o Cui, Hung and Wang methods (Hung and Wang are in the Office of Biostatistics) o Mueller and Schafer binomial methods o Proshan and Hunsberger multi‐stage designs o Reanalysis with modified error spending function

• Enhanced Survival Designs and Simulations o Superiority o Non‐inferiority o allow for random drop outs and accrual rate specification functions o Proportional and non‐proportional hazard alternatives o Non‐uniform accrual o Study duration estimation o Accommodate differential drop out and varying hazard functions o Allow sample size re‐estimation based on unblended interm analysis

• Graphics and Charts o Boundaries o Error Spending functions o Power versus sample size

• Sample Size Re‐estimation o Normal o Binomial o Survival

• Interim Monitoring o Nominal Critical Point o Error Spending o Conditional Power o Post‐Hoc Power

• Traditional rule‐based algorithms for ease of use (3+3)

• Continuous Reassessment Methods (mCRM; Goodman et al. 1995)

• Modified Toxicity Probability Model (mTPI; Ji et al. 2010)

• Bayesian Logistic Regression Model (BLRM; Neuenschwander et al. 2008)

• Predicted Interval Plots: Enhanced visual summaries of interim data enable trial statisticians to communicate complex statistical findings to members of the DMC in an intuitive, easy‐to‐read format

• Flexible Interim Computation: Accommodate unexpected changes in number of looks and their timing to make designs more efficient

• Practical Monitoring Dashboard: Access snapshot of key performance indicators during trial progress

• Simulations of trial endpoints for feasibility studies during design stage

• Accurate calculations of power and Type 1 error for ongoing trials

• Updating methods for information about trial deadlines and milestones

• Predictions of enrollment milestones

• Predictions of patient recruitment and country performance

• Multiple primary endpoints

• Multiple primary and secondary endpoints

• Serial gatekeeping

• Parallel gatekeeping

• R integration

C. Maintenance and Technical Support

Maintenance shall include technical support, product upgrades, enhancements, and corrections.

Technical support must include the following:

• Telephone and/or email support for StatXact 11.1, LoXact 11.1, StatXact Procs, and EAST 6.4 Premium.

• Releases of Cytel software package upgrades

• Corrections to Cytel software packages

5. DELIVERABLES / SPECIFIC TASKS

Vendor will provide software, license files, upgrades, as well as ongoing maintenance and support for the software. Delivery method for the software may be either via CD/DVD or download.

Deliverable To Whom When

StatXact 11 COR On or before 07Sept2018

LogXact 11 COR On or before 07Sept2018

StatXact Procs 11.1 COR On or before 07Sept2018

EAST 6.5 Premium Edition COR On or before 07Sept2018

Annual Training (8‐hours, web‐ based or in person)

End users Before 30Sept2018

6. GOVERNMENT FURNISHED EQUIPMENT (GFE)/ GOVERNMENT FURNISHED INFORMATION

(GFI)

• No Government Furnished Equipment or Government Furnished Information will be provided

7. PLACE OF PERFORMANCE

• Unless otherwise specified, all meetings between the Contractor and FDA/CDER will be held at FDA’s White Oak Campus at 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

8. PERIOD OF PERFORMANCE

• The Period of Performance will be a 12‐month Base period plus two (2) 12‐month Option Periods.

Est. Base Period of Performance : 9/7/2018‐9/6/2019

Est. Option Period 1 Period of Performance: 9/7/2019 – 9/6/2020

Est. Option Period 1 Period of Performance: 9/7/2019 – 9/6/2020

9. PLACE OF PERFORMANCE

The contractor's primary work location shall be offsite

Contract Management

Notwithstanding the Contractor’s responsibility for total management during the performance of this contract, the administration of the contract will require maximum coordination between the Government and the Contractor.

Communications pertaining to the contract administration will be addressed to the Contracting Officer. No changes to the statement of work are authorized without a written modification to the contract executed by the Contracting Officer.

The Contractor is advised that only the Contracting Officer can change or modify the contract terms or take any other action, which obligates the Government. Then, such action must be set forth in a formal written modification to the contract.

Contractors who reply on direction from other than the Contracting Officer do so at their own risk and expense. Such actions do not bind the Government contractually. Any contractual questions shall be directed to the Contracting Officer, or Contract Specialist.

Government Points of Contact

Address and phone number of the Contracting Staff:

Contracting Officer:

Jody O’Kash Systems Technology Acquisitions Branch (STAB) Office of Acquisition and Grants Services U.S. Food & Drug Administration 5630 Fishers Lane, Room 2084, HFA‐500, Rockville MD 20857 Phone 240‐402‐4995 Jody.OKash@fda.hhs.gov

Contracting Officer Representative

The COR shall serve as the Contractor’s first point of contact for any technical questions and is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (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; (5) assisting in the resolution of technical problems encountered during performance; and (6) providing technical direction in accordance with Technical Direction section below; and, (7) reviewing of invoices/vouchers.

The Government may unilaterally change its COR designation.

Technical Leads may assist the COR. The Technical Leads will not have the authority to provide technical direction; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) performing technical evaluation as required; (3) performing technical inspections and acceptances as required by this performance; and (5) reviewing of invoices/vouchers.

Technical Direction Performance of the work under task order shall be subject to the technical direction of the Task Order COR.

The term “technical direction” is defined to include, without limitation, the following:

Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work descriptions.

Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the general scope of work stated in the contract. The COR does not have the authority to and may not issue any technical direction which:

Constitutes an assignment of additional work outside the general scope of work of the contract.

Constitutes a change as defined in the applicable contract clause entitled FAR 52.212‐4(c) Contract

Terms and Conditions – Commercial Items.

In any manner cause an increase or decrease in the total estimated contract cost, fixed‐fee, or the time required for contract performance.

Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction shall be issued in writing by the IDIQ or Task Order COR or shall be confirmed by him/her in writing within 5 working days after issuance.

The Contractor shall proceed promptly with the performance of technical direction duly issued by the COR in the manner prescribed by this article and within his/her authority under the provisions of this article.

If, in the opinion of the Contractor, any instructions or direction issued by the COR is within one of the out of scope categories described above, the Contractor shall not proceed, but shall notify the Contracting Officer in writing within 1 working day after the receipt of any such instructions or direction. Upon receiving such notification from the Contractor, the Contracting Officer will advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this contract.

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The Government is not required to reimburse any out of scope work performed by the Contractor.

Key Personnel

Pursuant to HHSAR Clause 352.270‐5 Key Personnel are considered essential to work being performed hereunder:

Title Project Manager Technical Lead

Contractor’s Contract Administration Information

The Contractor’s contract administration functions will be performed at the following address:

Name and Title:

Responsible Office: ¬ Address:

Telephone Number:

Fax Number:

E‐mail Address:

DUNS#:

TIN:

Notification Regarding Administrative Problems If at any time during the performance of this contract, administrative problems should arise which will have an adverse impact on the timely performance by the Contractor or affect the contract costs or funding, the Contractor is required to immediately notify the Contracting Officer.

Government Furnished Equipment/Information (GFE/GFI)

FDA will provide laptops and any essential accessories along with FDA network access to all members under this contract. FDA will provide access to the development, test, pre‐production and production environments for Database as well as an Extract/Transform/Load (ETL) environment; and access to any other server based environment necessary to accomplish the stated work.

The Contractor shall propose to the FDA COR any additions and amendments to the software tools to be used in the Development, Test, Pre‐Production, and/or Production environment(s) which it deems necessary for the success of the project.

SECTION 508 COMPLIANCE

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access‐board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule

Page 11 of implementing Section 508 can be found at http://www.section508.gov . The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites ‐ including text, audio or video ‐ must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS‐ funded or HHS‐managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, shall be the responsibility of the contractor or consultant retained to produce the Web‐suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products.

The following Sections apply to this acquisition:

Appendix A: Scoping E203 Access to Functionality E204 Functional Performance Criteria E205 Electronic Content E207 Software E208 Support Documentation Services

FDA security requirements

Procurements Requiring Information Security and/or Physical Access Security A. Baseline Security Requirements

1) Applicability. The requirements herein apply whether the entire contract or order (hereafter “contract”), or portion thereof, includes either or both of the following:

2) Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

a. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor) will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of “information technology” (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

3) Safeguarding Information and Information Systems. In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

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a. Protect government information and information systems in order to ensure:

• Confidentiality, which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity, which means guarding against improper information modification or destruction, and ensuring information non‐repudiation and authenticity; and

• Availability, which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an FDA network or operated by the Contractor on behalf of FDA regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less, bring the situation to the attention of the other party. This includes notifying the FDA Systems Management Center (SMC) within one (1) hour of discovery/detection in the event of an information security incident.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS/FDA Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the FDA Information Security Program security requirements, outlined in the FDA Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing your ISSO.

d. Comply with the Privacy Act requirements and tailor FAR clauses as needed.

4) Information Security Categorization. In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800‐60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Appendix C, and based on information provided by the ISSO or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ ] Low [ X] Moderate [ ] High

Integrity: [ ] Low [ X ] Moderate [ ] High

Availability: [ ] Low [ X ] Moderate [ ] High

Overall Risk Level: [ ] Low [ X ] Moderate [ ] High

Based on information provided by the Privacy Office, system/data owner, or other privacy representative, it has been determined that this solicitation/contract involves:

[ ] No PII [ X] Yes PII http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

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Personally Identifiable Information (PII). Per the OMB Circular A‐130, “PII is information that can be used to distinguish or trace an individual's identity, either alone or when combined with other information that is linked or linkable to a specific individual.” Examples of PII include, but are not limited to the following: Social Security number, date and place of birth, mother’s maiden name, biometric records, etc.

PII Confidentiality Impact Level has been determined to be: [ ] Low [ X] Moderate [ ] High

5) Controlled Unclassified Information (CUI). CUI is defined as “information that laws, regulations, or Government‐wide policies require to have safeguarding or dissemination controls, excluding classified information.” The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa). As implemented the term “handling” refers to “…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re‐ using, and disposing of the information.” 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

a. marked appropriately;

b. disclosed to authorized personnel on a Need‐To‐Know basis;

c. protected in accordance with NIST SP 800‐53, Security and Privacy Controls for Federal

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800‐171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. returned to FDA control, destroyed when no longer needed, or held until otherwise directed.

Destruction of information and/or data shall be accomplished in accordance with NIST SP 800‐88, Guidelines for Media Sanitization and the FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media.

6) Protection of Sensitive Information. For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M‐06‐16, Protection of Sensitive Agency Information by securing it with a FIPS 140‐2 validated solution.

Confidentiality and Nondisclosure of Information. Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

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The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS/FDA sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

7) Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol shall comply with OMB Memorandum M‐05‐22, Transition Planning for Internet Protocol Version 6 (IPv6).

8) Government Websites. All new and existing public‐facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal‐facing websites, the HTTPS is not required, but it is highly recommended.

9) Contract Documentation. The Contractor shall use FDA‐provided templates, policies, forms and other agency documents to comply with contract deliverables as appropriate.

Document Section Deliverable Title/Description Due Date Applicable (y/n)

F- Roster Roster Within 60 days of the effective date of this contract, updated quarterly

Y

A – Contractor Employee Non- Disclosure Agreement (NDA)

Contractor Employee Non-Disclosure Agreement (NDA)

Prior to performing any work on behalf of HHS/FDA

Y

A – Privacy Threshold Analysis(PT A)/Privacy Impact Assessment (PIA)

Assist in the completion of a PTA/PIA form

Per timeline as specified by the FDA Privacy POCs after contract award. As needed for each release (per PPA).

Y

B – Training Records Copy of training records for all mandatory training

In conjunction with contract award and annually thereafter or upon request

Y

C – Rules of Behavior

Signed ROB for all employees Initiation of contract and at least annually thereafter

Y

D – Incident Response

Incident Report (as incidents or breaches occur)

As soon as possible and without reasonable delay and no later than 1 hour of discovery

Y

D – Incident Response

Incident and Breach Response Plan Upon request from Government Y

2 – Personnel Security Responsibilities

List of Personnel with defined roles and responsibilities

Within a time directed by the COR that is before an employee begins working on this contract.

N (Roster is sufficient)

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G – Personnel Security Responsibilities

Off-boarding documentation, equipment and badge when leaving contract

The last day that work is being performed after the Government’s final acceptance of the work under this contract, or in the event of a termination of the contract.

Y

E – Background Investigation

Onboarding documentation when beginning contract.

Prior to performing any work on behalf of HHS/FDA

Y

G - Certification of Sanitization of Government and Government Activity- Related Files, Information and Devices.

Form or deliverables required by

FDA.

At contract expiration.

Y

G – Contract Initiation and Expiration

If the procurement involves a system or cloud service, additional documentation will be required, such as Disposition/Decommission Plan

At contract initiation and expiration, or as directed by

COR.

A – Security Assessment and Authorization

(SA&A)

SA&A Package

SSP

SCF

SAR

POA&M

Authorization Letter ISCP and ISCPT Report E-Auth (if applicable) PTA/PIA/SPP (if applicable) Interconnection/Data Use

Agreements (if applicable) Authorization Letter Configuration Management Plan (if applicable) Configuration Baseline documents

Due for each system as requested by the COR and/or identified in the PPA after contract award.

Y

A – Reporting and Continuous Monitoring

POA&M updates; Revised security documentation/Agreements

As requested by COR

10) Standard for Encryption. The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140‐2 validated encryption solution.

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c. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non‐public FDA information should utilize FDA‐provided or FDA information security authorized devices that meet HHS and FDA‐specific encryption standard requirements.

Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use are compliant with FIPS 140‐2. The Contractor shall provide a written copy of the validation documentation to the COR.

e. Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys (PIV card) shall be provided to the COR upon request and at the conclusion of the contract.

Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

11) 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 FDA non‐disclosure agreement (3398 Form), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

12) Privacy Threshold Analysis (PTA)/Privacy Impact Assessment (PIA) – The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee with conducting a PTA for the information system and/or information handled under this contract to determine whether or not a full PIA needs to be completed.

a. If the results of the PTA show that a full PIA is needed, the Contractor shall assist procuring activity representative, program office and the FDA SOP or designee with completing a PIA for the system or information after completion of the PTA and in accordance with HHS and FDA policy and OMB M‐03‐22, Guidance for Implementing the Privacy Provisions of the E- Government Act of 2002. The PTA/PIA must be completed and approved prior to active use and/or collection or processing of PII and is a prerequisite to agency issuance of an authorization to operate (ATO).

b. The Contractor shall assist the procuring activity representative, program office and the FDA SOP or designee in reviewing and updating the PIA at least every three years throughout the Enterprise Performance Life Cycle (EPLC) /information lifecycle, or when determined by the agency that a review is required based on a major change to the system, or when new types of PII are collected that introduces new or increased privacy risks, whichever comes first.

B. Training http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf

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1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees shall complete FDA Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS and FDA training policies.

2) Role-based Training. All Contractor (and/or any subcontractor) employees with significant security responsibilities (as determined by the program manager) must complete role‐ based training annually commensurate with their role and responsibilities in accordance with HHS and FDA policy and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures (SOP).

3) Training Records. The Contractor (and/or any subcontractor) shall maintain training records for all its employees working under this contract in accordance with HHS and FDA policy. A copy of the training records shall be provided to the CO and/or COR within 30 days after contract award and annually thereafter or upon request.

C. Rules of Behavior

1) The Contractor (and/or any subcontractor) shall ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior.

2) All Contractor employees performing on the contract must read and adhere to the Rules of Behavior (ROB) before accessing HHS and FDA data or other information, systems, and/or networks that store/process government information, initially at the beginning of the contract and at least annually thereafter, which may be done as part of annual FDA Information Security Awareness Training. If the training is provided by the contractor, the signed ROB must be provided as a separate deliverable to the CO and/or COR per defined timelines.

D. Incident Response

The Contractor (and/or any subcontractor) shall respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA SMC /Incident Response Team (IRT) teams within 24 hours, whether the response is positive or negative.

FISMA defines an incident as “an occurrence that (1) actually or imminently jeopardizes, without lawful authority, the integrity, confidentiality, or availability of information or an information system; or (2) constitutes a violation or imminent threat of violation of law, security policies, security procedures, or acceptable use policies.” The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines incidents as events involving cybersecurity and privacy threats, such as viruses, malicious user activity, loss of, unauthorized disclosure or destruction of data, and so on.

A privacy breach is a type of incident and is defined by FISMA as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an

Page 18 of authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

In the event of a suspected or confirmed incident or breach, the Contractor (and/or any subcontractor) shall:

1) Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract to avoid a secondary sensitive information incident with FIPS 140‐ 2 validated encryption.

2) NOT notify affected individuals unless so instructed by the Contracting Officer or designated representative. If so instructed by the Contracting Officer or representative, the Contractor shall send FDA approved notifications to affected individuals as directed by FDA’s SOP.

3) Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, including incidents involving PII, in any medium or form, including paper, oral, or electronic, as soon as possible and without unreasonable delay, no later than one (1) hour of discovery/detection, and consistent with the applicable FDA and HHS policy and procedures, NIST standards and guidelines, as well as US‐CERT notification guidelines. The types of information required in an incident report must include at a minimum: company and point of contact information, contract information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor shall:

a. cooperate and exchange any information, as determined by the Agency, necessary to effectively manage or mitigate a suspected or confirmed breach;

b. not include any sensitive information in the subject or body of any reporting e‐mail; and

c. encrypt sensitive information in attachments to email, media, etc.

4) Comply with OMB M‐17‐12, Preparing for and Responding to a Breach of Personally Identifiable Information and HHS and FDA incident response policies when handling PII breaches.

5) Provide full access and cooperate on all activities as determined by the Government to ensure an effective incident response, including providing all requested images, log files, and event information to facilitate rapid resolution of sensitive information incidents. This may involve disconnecting the system processing, storing, or transmitting the sensitive information from the Internet or other networks or applying additional security controls. This may also involve physical access to contractor facilities during a breach/incident investigation demand.

E. 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

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5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract:

F. Homeland Security Presidential Directive (HSPD)‐12

The Contractor (and/or any subcontractor) and its employees shall comply with Homeland Security Presidential Directive (HSPD)‐12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M‐05‐24; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD‐12 policy; and Executive Order 13467, Part 1 §1.2.

Roster. 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 and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

If the employee is filling a new position, the Contractor shall provide a position description and the Government will determine the appropriate suitability level.

G. 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 FDA EPLC framework and methodology in accordance with the HHS Contract Closeout Guide (2012).

HHS EA requirements may be located here:

https://www.hhs.gov/ocio/ea/documents/proplans.html

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

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with FDA OAGS SMGs 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 and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media http://www.hhs.gov/ocio/ea/documents/proplans.html

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4) Notification. The Contractor (and/or any subcontractor) shall notify the CO and/or COR as soon as it is known that an employee will stop 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 FDA policies.

6) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, coping the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/defau lt.htm as soon as it is known that an employee will terminate work under this contract within days of the employee’s exit from the contract. All documentation shall be made available to the CO and/or COR upon request.

H. Records Management and Retention

The Contractor (and/or any subcontractor) shall maintain all information in accordance with Executive Order 13556 ‐‐ Controlled Unclassified Information, National Archives and Records Administration (NARA) records retention policies and schedules and HHS/FDA policies and shall not dispose of any records unless authorized by HHS/FDA.

In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, it shall be documented and reported as an incident in accordance with HHS/FDA policies.

I. Privacy Act

It has been determined that this contract is subject to the Privacy Act of 1974, because this contract provides for the design, development, or operation of a system of records about individuals.

The FDA is developing a System of Records Notice (SORN) applicable to the FAERS II effort.

The design, development, or operation work the Contractor is to perform is: 1) The Contractor (and/or any subcontractor) shall ensure IT modules designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm

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2) The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

3) The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS/FDA or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the HHS/FDA environment. No sensitive data shall be used during software testing.

4) The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

The disposition to be made of the Privacy Act records upon completion of contract performance is:

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 FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here:

http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePage…