F-RFP.pdf

Request for Proposal-121020

Document Type Combined Synopsis/Solicitation Solicitation Number FDA-RFP-121020 Questions Response Date: 10AM EST on 06/18/2024 Proposal Response Date: 10AM EST on 06/28/2024 NAICS Code: 541690 (Other Scientific and Technical Consulting Services)

PART 1 – DESCRIPTION

BACKGROUND

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. (For more details on what FDA regulates, visit:

https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate.) The Economics Staff of the FDA’s Office of Policy, Legislation, and International Affairs (OPLIA) has a requirement to provide accurate and timely economic assessments of FDA regulatory actions. These analyses have high public visibility and, therefore, must withstand intense scientific and technical review and scrutiny by diverse audiences including the public, regulated entities, Government agencies such as the Department of Health and Human Services and the Office of Management and Budget (OMB), the U.S. Congress, professional economists, and the scientific and medical community. The need of the Economics Staff for support by a contractor arises from the variety and complexity of the work, the need to have access to specialized resources to rapidly gather data to meet tight deadlines, and the need for research involving direct contact with regulated entities.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Contractor shall furnish all necessary facilities, materials, and personnel, and shall perform all non-personal services and program support necessary in a requirement titled, “Economic Studies of FDA Regulations” as further defined in the Statement of Work (SOW) contained herein.

CONTRACT TYPE

The Government intends to make award to no more than three (3) awardees as a multiple award Indefinite Delivery, Indefinite Quantity (IDIQ) contract with a five (5) year ordering.

The Government may use a variety of task order types when issuing orders under this contract, including: Firm-fixed Price (FFP), Time and Materials (T&M), Labor Hour (LH), or a combination thereof. Each Request for Task Order Proposal (RFTOP) issued under this contract will identify the Government’s determination of contract type.

https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate

PRICING TERMS

The agreed upon negotiated labor rates shall be fixed for the duration of this contract. Labor rates proposed for each task order issued against the resulting IDIQ contract(s) must be in accordance with the defined labor categories and fixed labor rates. If a task order’s stated period of performance must be extended as a result of a Government delay, the Contractor may request that the most current labor rates be used to price the work effort during the extended period. However, in no event shall the Contractor perform, or be paid for, any work which exceeds the stated not to exceed dollar amount of a task order.

For Firm-Fixed Price (FFP) task orders issued under this contract, the applicable FFP for a task order shall be based on a combination of the proposed level of effort and fixed labor rate for the labor mix proposed. The total FFP is the amount agreed upon by the Government and the Contractor at the time the task order is issued.

Each Time and Materials or Labor Hour task order shall contain a ceiling price. The Contractor shall comply with FAR 52.232-7 in regard to the ceiling price for the individual task order(s).

MINIMUM AND MAXIMUM QUANTITIES

The minimum guarantee under this IDIQ contract is $1,000.00. The maximum aggregate dollar value of task orders awarded over the 5-year IDIQ ordering period shall not exceed the established ceiling of $5 million.

PERIOD OF PERFORMANCE

The ordering period of this contract shall be five (5) years (i.e., base year and four 1-year option periods).

PART 3 – DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

OBJECTIVES

The objective of this contract is to provide FDA with accurate information, data, and analytical models for use in assessments of the economic impacts of FDA actions or contemplated actions.

SCOPE OF WORK

Activities under the proposed contract shall include, but are not limited to, the following:

Methods

While the economic impact of certain FDA regulatory actions can be analyzed via established methods, other FDA initiatives will require novel analytical approaches to evaluate potential effects. For example, estimating the societal effects of initiatives to modernize FDA’s regulatory oversight of product safety and efficacy may require innovative approaches to collect or generate data, such as Internet panels, laboratory or field experiments, expert elicitations, contingent valuation, and data-based simulations.

Baseline Measurement

The FDA needs data on the economic characteristics of regulated industries, so that changes in regulatory policies can be empirically examined. This data will include, for example, the number, size, and location (domestic or foreign) of firms and their employment, sales, and number of stock-keeping units (labels). In some instances, industry profile studies require supporting documentation for OMB survey clearance procedures.

Estimating Effects of Potential Regulatory Actions

The Agency’s planned regulatory agenda includes numerous potential regulations that would have economic consequences. The FDA requires data and models that can be used to estimate the effects likely to be associated with many different policies and provisions that could become regulations. These effects include the distribution of behavioral changes of consumers and producers in response to potential agency actions and the changes in risk that would result.

Analyses and Evaluations to Be Performed by the Contractor

• Conduct baseline assessment of industry characteristics, including, but not limited to, estimating employment levels, profits, prices, competitive structure, domestic and foreign location, and industry practices (or performance), including all international effects. The baseline should include projected changes over time.

• Develop methods and collect data to estimate the economic costs of existing or potential regulatory actions. FDA regulations may alter the expected use of a product, as well as result in higher costs of manufacture or distribution. Each component of these costs shall be identified, defined, and quantified, with all data compiled and sorted to facilitate statistical analyses.

• Develop methods and collect data to estimate the reduction in risk attributable to existing or potential regulatory actions and assess any potentially offsetting increases in risk.

• Develop methods and measures of the effects of regulations and other exogenous factors on innovation and productivity. Research and development (R&D) and future innovation may be either encouraged or hindered by regulatory requirements.

• Develop methods and measures of the effects on the competitive vitality of small business in accordance with requirements of the Regulatory Flexibility Act. Many of the firms FDA regulates are small. Record keeping and reporting requirements, for example, may impose disproportionate effects on smaller businesses, because fixed costs are spread over a smaller sales base. FDA is required by law to take these effects into account and to grant regulatory relief, where possible, to small firms.

• Develop adaptable methods and databases that can cover various regulatory alternatives. Many new options to meet stated objectives arise during regulation development. A critical task is to develop general methods and databases that can be applied to assess the effects of these options as they are proposed or considered.

• Develop methods and empirical measures for a section in regulatory analyses in which FDA states prospectively how it will measure the effectiveness of regulations over time. These measures will meet the need for retrospective reviews.

• Consult with subject matter experts in FDA-regulated industries.

Past Analyses and Evaluations Performed by Contractors for the Economics Staff

The following list includes general examples of task orders issued by the Economics Staff in recent years.

Actual task orders will reflect agency priorities at the time of initiation. The contractor shall demonstrate the ability to conduct analyses for both quick response and long-range studies.

• Conduct expert elicitations to understand the size and scope of FDA regulated industries and the types and quantities of products distributed in the U.S.

• Collect data on the cost of implementing Good Manufacturing Practices (GMPs) for FDA regulated products; identify the benefits to the U.S. of implementing GMPs for and estimate the monetary value of those benefits.

• Perform scoping literature review on consumer and producer issues related to FDA regulated products and industries (i.e., prevalence and market share, positive and negative health outcomes, consumer preferences and attitudes, risk communications, substitution and complement effects, supply chain, domestic and foreign production, distribution channels, regulatory concerns, production costs).

• Develop industry profiles and provide FDA with data and information on compliance with CGMP requirements, adverse event reporting requirements, and other post market reporting requirements.

• Conduct survey to obtain an economic characterization of FDA regulated industries to understand the current manufacturing practices and to obtain estimates of the costs to the industry of implementing GMPs.

• Develop models to estimate the behavioral effects for a broad range of FDA-regulated products and perform systemic literature review to support model development.

LABOR CATEGORY DESCRIPTIONS

Project Director

Manages and is responsible for all aspects of a single project, including overseeing quality control.

Communicates clearly and articulately in written and oral form. Assesses complex research questions; applies appropriate economic, statistical, and analytic methods; interprets data; and presents study results.

The Government has a preference for a Ph.D. or advanced degree in economics or a related field, and at least five (5) years of experience in economic analyses and experience managing research projects involving economic analysis and quantitative methods for this position.

Program Manager

Leads the analysis team, applies appropriate economic, statistical, and analytic methods, interprets data and presents study results.

The Government has a preference for an advanced degree in economics or a related field, and at least five (5) years of experience in economic analyses and experience managing research projects involving economic analysis and quantitative methods for this position.

Senior Statistician

Plans data collection and sampling plans; analyzes numerical data from experiments, studies, surveys, and other sources; and applies statistical methodology to provide information for scientific research and statistical analysis. Shall assist in the preparation and presentation of results of statistical analyses in written reports.

The Government has a preference for an advanced degree in statistics or an equivalent field and extensive professional experience providing statistical analysis support for projects similar to the Statement of Work, with at least three (3) years of experience in statistics and statistical and analytical methods, for this position.

Senior Economist

Plans data collection and work requirements with project director; collects and analyzes qualitative and quantitative economic data for studies; applies appropriate mathematical and statistical methodology. Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for a Ph.D. or advanced degree in economics, statistics, or equivalent fields and extensive professional experience providing economic analysis support for projects similar to the Statement of Work, with at least three (3) years of experience in statistics and statistical and analytical methods, for this position.

Junior Economist

Collects and analyzes qualitative and quantitative economic data for studies; applies appropriate mathematical and statistical methodology. Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for a bachelor’s degree in economics or a related field, with some experience in assisting with economic analysis support for projects similar to the Statement of Work, for this position.

Senior Programmer

Plan and organize the computer modeling needs required to complete projects in the Statement of Work with the Project Director. Write, update, and maintain computer programs developed for the economic or other quantitative models required by projects in the Statement of Work.

The Government has a preference for a bachelor’s degree in computer science or information technology and professional experience providing IT support for projects similar to the Statement of Work, with considerable experience in IT support.

Junior Programmer

Write, update, and maintain computer programs developed for the economic or other quantitative models required by projects in the Statement of Work.

The Government has a preference for a bachelor’s degree in computer science or information technology and must have experience with IT support for projects similar to the Statement of Work for this position.

Senior Analyst

Plans data collection and work requirements with the Project Director; collects and analyzes qualitative and quantitative data for studies; and applies appropriate mathematical and statistical methodology. Shall assist in the preparation and presentation of results and written reports.

The Government has a preference for a bachelor’s degree and extensive professional experience providing analytical support for projects similar to the Statement of Work, with at least three (3) years of experience in providing analytic support for projects similar to the Statement of Work, for this position.

Junior Analyst

Collects and analyzes qualitative and quantitative data for studies; applies appropriate mathematical and statistical methodology; and assists in the preparation and presentation of results and written reports.

The Government has a preference for a bachelor’s degree in a field related to the Statement of Work, with experience in assisting with economic analysis support for projects similar to the Statement of Work, for this position.

Senior Editor

Prepares reports, presentations, and written deliverables for publication by assuring reports are written clearly, adequately documented, well organized, and logically and grammatically correct.

The Government has a preference for a bachelor’s degree or equivalent experience in technical report writing and editing, with at least two (2) years of experience in editing technical documents that are similar to the requirements of the Statement of Work, for this position.

Junior Editor

Assists with preparing reports, presentations, and written deliverables for publication by assuring reports are written clearly, well organized, and logically and grammatically correct.

The Government has a preference for a bachelor’s degree or equivalent experience in technical report writing and editing, with experience in assisting with reviewing and editing of technical documents, for this position.

KEY PERSONNEL

Key Personnel will be identified in the individual task orders issued against the resulting IDIQ Contract(s).

Prior to placing an individual in a key personnel position, the Contractor shall ensure the individual has the knowledge, skills, and abilities necessary to successfully perform the tasks in this SOW.

PART 4 – PERFORMANCE AND DELIVERABLES

DELIVERABLES SCHEDULE

Note: Actual deliverables and deliverable schedules shall be established in the issuance of each individual task order under the contract.

Periodic Progress Reports

The Contractor shall submit one (1) electronic copy of the Progress Report that includes a status update on deliverables, any problems encountered, and suggestions for addressing problems each period. The Periodic Progress Report shall be delivered as outlined in the individual task order.

Interim Draft Work Product

The Contractor shall submit to the COR an Interim Draft Work Product. Comments on this report will be provided by FDA within fifteen (15) calendar days after receipt. The Interim Draft Work Product shall also include:

• A prototype, example, or draft of the work product specified in the task order. The prototype should include preliminary data validation.

• An indication of any current problems which may impede performance and proposed corrective action.

• A description of personnel who have actually worked on this portion of the task and the number of hours worked. Include any current or proposed deviations from the original task proposal and a brief explanation as to why this change is in the best interest of the Government.

Draft Final Work Product

The Contractor shall submit to the COR a Draft Final Work Product, which will be after the completion and approval of FDA’s review of the Interim Draft Work Product. The Contractor shall also submit, where applicable, electronic raw data collected, software and computer programs for implementation of models, guidance to data and models, and, in some instances, a final report. Documentation to support datasets should include explanatory materials such as information about the data collection methods and sources, information about the structure of the dataset, a complete list of variables, and full details of coding and classifications used.

The Contractor shall be prepared to present results to FDA at this point. This Draft Final Work Product is subject to the review and approval of FDA. Such approval or disapproval, with any comments, will be provided by FDA within fifteen (15) calendar days after receipt. The Draft Final Work Product shall also include:

• An indication of any current problems which may impede performance and proposed corrective action.

• An outline of the work to be accomplished during the reporting period.

• A quantitative description of overall progress and how it relates to earlier work.

• A description of personnel who have actually worked on this portion of the task and the number of hours worked. Include any current or proposed deviations from the original task proposal and a brief explanation as to why this is in the best interest of the government.

Final Work Product

The Contractor shall submit to the COR the Final Work Product which incorporates any recommended revisions and other changes. The Contractor shall also submit, where applicable, electronic raw data, software, and computer programs for implementation of economic models, a written guide to data and models, and, in some instances, a final report. Documentation to support datasets should include explanatory materials such as information about the data collection methods and sources, information about the structure of the dataset, a complete list of variables, full details of coding and classifications used, and data validation. The final guide shall include tables, graphs, diagrams, curves, sketches, photographs, and drawings as necessary and in sufficient detail to comprehensively explain the creation and use of the work product, which can be a database, model, survey, or a written report.

SECURITY AND PRIVACY LANGUAGE

I. Procurements Requiring Information Security and/or Physical Access Security

1. Baseline Security Requirements

a. Applicability. The requirements herein apply whether the entire contract or modification (hereafter "contract"), or portion thereof, includes either or both of the following:

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

ii. 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 FDA 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.

b. Safeguarding Information and Information Systems. All government information and information systems must be protected in accordance with FDA policies and level of risk. At a minimum, the Contractor (and/or any subcontractor) must

i. Protect the:

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.

ii. Categorize all information owned and/or collected/managed on behalf of FDA and information systems that store, process, and/or transmit FDA information 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. Based on information provided by the System/Data Owner, ISSO, privacy representative, or other POC, the impact level for each Security Objective (Confidentiality, Integrity, and Availability) and the Overall Impact Level, which is the highest watermark of the three factors of the information or information system are the following:

Confidentiality: ☐Low ☒Moderate ☐High

Integrity: ☐Low ☒Moderate ☐High

Availability: ☐Low ☒Moderate ☐High

Overall Impact Level: ☐Low ☒Moderate ☐High

iii. Based on the agreed-upon level of impact, implement the necessary safeguards to protect all information systems and information collected and/or managed on behalf of FDA regardless of location or purpose.

iv. Report any discovered or unanticipated threats or hazards by either the agency or contractor, or if existing safeguards have ceased to function immediately after discovery, within one (1) hour or less, to the government representative(s). This includes notifying the FDA Cybersecurity and Infrastructure Operations Coordination Center (CIOCC) within one (1) hour of discovery/detection in the event of a cybersecurity or privacy incident.

v. Adopt and implement all applicable policies, procedures, controls, and standards required by the 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 Protection (IS2P) policy, by contacting the CO/COR or emailing your ISSO.

c. Privacy Act. Comply with the Privacy Act requirements (when applicable), and tailor FAR and HHSAR clauses as needed.

d. Privacy Compliance. Comply with the E-Government Act of 2002, NIST SP 800-53, and applicable FDA privacy policies and complete all the requirements below:

i. Per the Office of Management and Budget (OMB) Circular A-130, Personally Identifiable Information (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 http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf 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.

ii. Based on information provided by the ISSO, System/Data Owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

☐ No PII ☒ PII

iii. The Contractor must support the agency with conducting a Privacy Threshold Analysis (PTA) for the information system and/or information handled under this contract to determine whether or not a full Privacy Impact Assessment (PIA) needs to be completed.

1. If the results of the PTA show that a full PIA is needed, the Contractor must support the agency 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).

2. The Contractor must support the agency in reviewing the PIA at least every three years throughout the system development lifecycle (SDLC)/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.

e. Controlled Unclassified Information (CUI). Executive Order 13556 defines CUI 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. The requirements below apply only to nonfederal systems that process, store, or transmit CUI, or that provide security protection for such components. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, must be:

i. Marked appropriately;

ii. Disclosed to authorized personnel on a Need-To-Know basis;

iii. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for 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

iv. Returned to FDA control, destroyed when no longer needed, or held until otherwise directed.

Information and/or data must be disposed of in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

f. 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) must protect all government information that is or may be sensitive by securing it with a solution that is validated with current FIPS 140 validation certificate from the

NIST CMVP.

g. Government Furnished Equipment (GFE) for Foreign Travel. FDA personnel are prohibited from taking GFE when participating in personal, unofficial travel to foreign countries. FDA personnel are strictly prohibited from teleworking using GFE in foreign countries. FDA personnel must also request loaner GFE from the FDA Foreign Travel program for official travel to any foreign country. Please see the FDA IS2P, Appendix T Government Furnished Equipment for Foreign Travel.

h. 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 must be used only for the purpose of carrying out the provisions of this contract and must 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 must ensure that all work performed by its employees and subcontractors must 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 must 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.

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

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

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

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

i. Internet Protocol Version 6 (IPv6). All procurements using Internet Protocol must comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

j. Information and Communications Technology (ICT). ICT products and services from prohibited entities/sources must not be used/acquired in compliance with Public Law 115-232, Section 889 Parts A and B, FAR 4.21, FAR 52.204.23, FAR 52.204.24, and FAR 52.204.25. The contractor (and/or any subcontractor) must notify the government if they identify prohibited ICT products and/or services are used during the contract performance.

k. 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 must 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, HTTPS is not required, but it is highly recommended. Consult the HHS Policy for Internet and Email Security for additional information.

l. Contract Documentation. The Contractor must use provided templates, policies, forms, and other agency documents to comply with contract deliverables as appropriate.

m. Standard for Encryption. The Contractor (and/or any subcontractor) must:

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

ii. 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 an encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

iii. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices 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).

iv. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with current FIPS 140 validation certificates from the NIST CMVP. The Contractor must provide a written copy of the validation documentation to the

COR.

v. 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 http://csrc.nist.gov/publications/.

Encryption keys must be provided to the COR upon request and at the conclusion of the contract.

http://csrc.nist.gov/publications/

n. Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract must complete the FDA non-disclosure agreement (3398 Form)], as applicable. Contractors (and/or subcontractors) must submit a copy of each signed and witnessed NDA to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

2. Training Requirements

a. Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract must complete the applicable FDA information security awareness, privacy, and records management training (provided upon contract award) before performing any work under this contract. Thereafter, the employees must complete FDA information security awareness, privacy, and records management training at least annually, during the life of this contract. All provided training must be compliant with HHS training policies.

b. 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.

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

3. Rules of Behavior

a. The Contractor (and/or any subcontractor) must ensure that all employees performing on the contract comply with the HHS Information Technology General Rules of Behavior, HHS Rules of Behavior for Privileged Users, and FDA policies and standards.

b. All Contractor employees performing on the contract must read and adhere to the Rules of Behavior before accessing Agency 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 above.

4. Incident Response

a. The Contractor (and/or any subcontractor) must respond to all alerts/Indicators of Compromise (IOCs) provided by HHS Computer Security Incident Response Center (CSIRC)/FDA CIOCC /Incident Response Team 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. In accordance with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information (PII), an incident is "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" and a privacy breach is "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 authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose." For additional information on the HHS breach response process, please see the FDA IS2P Appendix F: Incident Response and the HHS Policy and Plan for Preparing for and Responding to a Breach of Personally Identifiable Information (PII)."

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

i. Protect all sensitive information, including any PII created, stored, or transmitted in the performance of this contract, with encryption solution that is validated with current FIPS 140 validation certificates from the NIST CMVP.

ii. 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 must send FDA approved notifications to affected individuals as directed by FDA’s SOP.

iii. Report all suspected and confirmed information security and privacy incidents and breaches to the FDA CIOCC, COR, CO, FDA SOP (or his or her designee), and other stakeholders, including breaches 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, 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, contact information, impact classifications/threat vector, and the type of information compromised. In addition, the Contractor must:

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

Not include any sensitive information in the subject or body of any reporting e-mail; and

Encrypt sensitive information in attachments to email, media, etc.

iv. Comply with OMB M-17-12, Preparing for and Responding to a Breach of Personally Identifiable Information, and HHS and FDA breach response policies when handling PII breaches.

v. 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 on demand.

5. Position Sensitivity Designations

a. 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:

☐ Does not apply

☐ Tier 1 Low Risk, Non-Sensitive, including HSPD-12 Credentialing

☒ Tier 2 Moderate Risk Public Trust (MRPT)

☐ Tier 3 Non-Critical Sensitive, National Security, including SECRET & "L" access eligibility

☐ Tier 4 High Risk Public Trust (HRPT)

☐ Tier 5 Critical Sensitive and Special Sensitive National Security, including Top Secret, SCI, and "Q" access eligibility

6. Homeland Security Presidential Directive (HSPD)-12

a. The Contractor (and/or any subcontractor) and its employees must comply with Homeland Security Presidential Directive (HSPD)-12, Policy for a Common Identification Standard for Federal Employees and Contractors; OMB M-05-24; OMB M-19-17; FIPS 201, Personal Identity Verification (PIV) of Federal Employees and Contractors; HHS HSPD-12 policy; and Executive Order 13467, Part 1 §1.2.

7. Roster

a. The Contractor (and/or any subcontractor) must 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 must 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 must be submitted within a timeline as directed by the COR and/or CO. The COR will notify the Contractor of the appropriate level of investigation required for each staff member.

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

8. Contract Initiation and Expiration

a. General Security Requirements. The Contractor (and/or any subcontractor) must 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 must 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/SitePages/v2/EPLCHome.aspx and in accordance with the HHS Contract Closeout Guide (2012).

b. System Documentation. Contractors (and/or any subcontractors) must follow and adhere to HHS System Development Life Cycle requirements, 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.

c. Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) must provide all required documentation in accordance with SMGs published by FDA’s Office of Acquisitions and Grant Services (OAGS) 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.

d. Notification. The Contractor (and/or any subcontractor) must notify the CO and/or COR and system ISSO as soon as it is known that a contract employee will stop working under this contract.

e. Contractor Responsibilities upon Physical Completion of the Contract. The contractor (and/or any subcontractors) must 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 must 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 FDA policies.

http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/EPLCHome.aspx

f. The Contractor (and/or any subcontractor) must perform and document the actions identified in the FDA eDepart system http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm as soon as it is known that a contract an employee will terminate work under this contract. The Contractor (and/or any subcontractor) shall coordinate with the COR via email, copying the Contract Specialist, to ensure that the appropriate person performs and documents the actions identified in the FDA eDepart system. All documentation must be available to the CO and/or COR upon request.

9. Records Management and Retention

a. The Contractor (and/or any subcontractor) must 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 Policy for Records Management and HHS and FDA policies and must not dispose of any records unless authorized by HHSFDA. In the event that a contractor (and/or any subcontractor) accidentally disposes of or destroys a record without proper authorization, he/she must document and report the incident in accordance with HHS and FDA policies.

b. High Value Asset (HVA). If a system is identified as HVA, the contractor must comply with the FDA IS2P Appendix AB: High Value Asset (HVA) Program, the HHS Policy for the High Value Asset (HVA) Program, and the DHS HVA Control Overlay in addition to the above requirements.

II. Security Requirements for GOCO and COCO Resources

a. Desktops, Laptops, and Other Computing Devices Required for Use by the Contractor. The Contractor (and/or any subcontractor) must ensure that all IT equipment (e.g., laptops, desktops, servers, routers, mobile devices, peripheral devices, etc.) used to process information on behalf of FDA are deployed and operated in accordance with approved security configurations and meet the following minimum requirements:

i. Encrypt equipment and sensitive information stored and/or processed by such equipment in accordance with HHS and FDA encryption standard and current FIPS 140 validation certificate from the NIST CMVP.

ii. Configure laptops and desktops in accordance with the latest applicable United States Government Configuration Baseline (USGCB), FDA Configuration Baselines, FDA Minimum Security Configuration Standards, and HHS Minimum Security Configuration Standards;

iii. Maintain the latest operating system patch release and anti-virus software definitions, per FDA patch management policy;

iv. Validate the configuration settings after hardware and software installation, operation, maintenance, update, and patching and ensure changes in hardware and software do not alter the approved configuration settings; and http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm

v. Automate configuration settings and configuration management in accordance with HHS and FDA security policies, including but not limited to:

Configuring its systems to allow for periodic Federal, HHS, and FDA vulnerability and security configuration assessment scanning; and

Using FDA-approved Security Content Automation Protocol (SCAP)-validated tools with capabilities to scan its systems at least on a monthly basis and report the results of these scans to the CO and/or COR, Project Officer, and any other applicable designated POC.

b. Rights to Data. All contracts that require data to be produced, furnished, acquired, or used in meeting contract performance requirements, must contain terms that delineate the respective rights and obligations of the Government and the contractor regarding the use, reproduction, and disclosure of that data. Data rights clauses do not specify the type, quantity or quality of data that is to be delivered, but only the respective rights of the Government and the contractor regarding the use, disclosure, or reproduction of the data. Accordingly, the contract must specify the data to be delivered.

III. Contracts Involving Cloud Services

1. HHS FedRAMP Privacy and Security Requirements

The Contractor (and/or any subcontractor) must be responsible for the following privacy and security requirements:

a. FedRAMP Compliant ATO. Comply with FedRAMP Assessment and Authorization (A&A) requirements and ensure the information system/service under this contract has a valid FedRAMP compliant (approved) authority to operate (ATO) in accordance with Federal Information Processing Standard (FIPS) Publication 199 defined security categorization. If a FedRAMP compliant ATO has not been granted, the Contractor must submit a plan to obtain a FedRAMP compliant ATO prior to production implementation.

i. Implement applicable FedRAMP baseline controls commensurate with the agency-defined security categorization and the applicable FedRAMP security control baseline (www.FedRAMP.gov). The FDA Information Security and Privacy Protection (IS2P) Policy, HHS Information Security and Privacy Protection (IS2P) policy and HHS Cloud Computing and Federal Risk and Authorization Management Program (FedRAMP) Guidance further define the baseline policies as well as roles and responsibilities. The Contractor must also implement a set of additional controls identified by the agency when applicable.

ii. A security control assessment must be conducted by a FedRAMP third party assessment organization (3PAO) for the initial ATO and annually thereafter or whenever there is a significant change to the system's security posture in accordance with the FedRAMP Continuous Monitoring Plan.

http://www.fedramp.gov/

b. Data Jurisdiction. The contractor must store all information within the security authorization boundary, including data at rest, data backups, or other copies within the Continental United States

(CONUS).

c. Service Level Agreements.