Draft_Rare Diseases Study_SOW_8 May 2023.docx updated 6 20 2023.pdf

Center for Drug Evaluation and Research (CDER) Office of Center Director (OCD) and Office of New Drugs (OND)

“Evaluating the Safety and Efficacy of Drugs for Rare Diseases or Conditions in the United States and the European Union”

Statement of Work

May 8, 2023

Table of Contents

1. Introduction

2. Background

3. Objective

4. Scope

5. Assumptions and Constraints

6. Tasks

6.1 Project Management

6.2 Committee Nominations

6.3 Committee Meetings

6 Deliverables

7 Contract Administration

7.1 Contract Type

7.2 Period of Performance

7.3 Place of Performance

8 Security

1. Introduction

The U.S. Food and Drug Administration (FDA) is charged with protecting the public health by ensuring the safety, effectiveness, and security of human and veterinary drugs, biological products, and medical devices; ensuring the safety of foods, cosmetics, and radiation-emitting products; and regulating tobacco products.

As part of FDA, the Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.

The FDA has a unique responsibility to provide education to a variety of constituents, including the FDA staff, clinical investigators, the public, medical professionals, healthcare professionals, industry, consumers, and academia. Education and training are of the highest priority to the FDA, and the FDA continues to be responsive to the needs of these stakeholders by offering training opportunities leveraging various forums and formats.

2. Background

In the United States, between 6,000-8,000 rare diseases affect an estimated 30 million people[1], and place tremendous burden on patients, their families and caregivers, communities, and the health care system. Given that the number of people affected by any particular rare disease is relatively small and the number of rare diseases is large, a host of challenges complicates the development and approval of safe and effective medical products to prevent, diagnose, treat, or cure these conditions.[2]

To help address these challenges, Congress passed the Orphan Drug Act in 1983 - 40 years ago - which provides financial and marketing incentives for companies to develop drugs for rare diseases.[3] The law defines a rare disease or condition as one affecting fewer than 200,000 people in the United States. The European Medicines Agency defines orphan medical products somewhat differently, as being prevalent in 5 persons in 10,000, or less.[4]

In 2016, the European Medicines Agency (EMA) and the FDA announced a working group on rare diseases to share draft documents (e.g., policies under development), experiences, and best practices on each other's regulatory approach to the development of medicines for these diseases.[6] The working group has exchanged information on topics, such as:

• the design of clinical trials in small populations and the use of statistical analysis methods;

• the selection and validation of trial endpoints;

• preclinical evidence to support development programs;

• the design of post-marketing studies, in particular in the context of early access mechanisms, such as EMA's conditional marketing authorization and FDA's accelerated approval; and

• risk management strategies for long-term safety issues with medicines for rare diseases.

At the same time, a number of public and private organizations, including the National Institutes of Health (NIH) Office of Rare Diseases Research, small and large pharmaceutical companies, 3 and patient/disease advocacy groups, have worked to support innovation in rare disease drug research and development.

Prior to 1983, few drugs were approved to treat rare diseases. Since the passage of the Orphan Drug Act, over 1,100 orphan indications for treatments have obtained FDA approval.[5] Despite these efforts, there remains unmet medical need - only around 5% of rare diseases have an FDAapproved treatment.[7]

As highlighted in the recent FY 2023 Consolidated Appropriations Act, there is a need to improve the treatment of rare diseases and conditions, including a review of the processes for evaluating the safety and efficacy of drugs for rare diseases or conditions in the United States and the European Union.[8]The proposed study would help inform actions that federal agencies, the pharmaceutical industry, and nongovernmental organizations can take to support collaborative efforts between United States and European Union regulators.

Subsequently, the FDA in conjunction with other federal agencies and European entities intends to issue a Sole Source contract to National Academies of Science Engineering, and Medicine (NASEM) per Sec. 3202 (Improving the Treatment of Rare Diseases and Conditions) of the Helping Experts Accelerate Rare Treatments Act of 2022 (https://www.congress.gov/117/bills/s4071/BILLS-117s4071is.pdf). The proposed study would help inform actions that federal agencies, the pharmaceutical industry, and nongovernmental organizations can take to address the challenges related to rare diseases.

References:

[1] https://rarediseases.info.nih.gov/about (accessed April 10, 2023).

[2] National Academies of Sciences, Engineering, and Medicine. 2010. Rare Diseases and Orphan Products: Accelerating Research and Development. Washington, DC: The National Academies Press. https://doi.org/10.17226/12953.

[3] A NORD Commissioned Report with Avalere. 2021. Orphan Drugs in the United States:

An Examination of Patents and Orphan Drug Exclusivity.

[4] Official Journal of the European Communities, Regulation (EC) No 141/2000 of the https://www.congress.gov/117/bills/s4071/BILLS-117s4071is.pdf https://doi.org/10.17226/12953

European Parliament and of the Council of 16 December 1999 on Orphan medicinal products, at Art. 3.1(a).

[5] https://rarediseases.org/the-orphan-drug-act-turns-40-nord-celebrates-its-impact-on-rare diseases/ (accessed April 10, 2023).

[6] https://www.ema.europa.eu/en/news/eu-us-collaboration-boost-medicine-development-rare diseases (accessed April 10, 2023).

[7] Public Law 97-414 (1983), 96 Stat. 2049, codified at 21 U.S.C. §§ 360aa-360ee (2020).

[8] H.R. 2617, the Consolidated Appropriations Act, 2023, Enacted as Public Law 117-328 on December 29, 2022.

3. Objective In response to a Congressional request, an ad hoc committee of NASEM will conduct a study on processes for evaluating the safety and efficacy of drugs for rare diseases or conditions in the United States and the European Union, including:

• Flexibilities, authorities, or mechanisms available to regulators in the United States and the European Union applicable to rare diseases or conditions;

• Consideration and use of supplemental data submitted during review processes in the United States and the European Union, including data associated with open label extension studies and expanded access programs specific to rare diseases or conditions;

• Assessment of collaborative efforts between United States and European Union regulators related to— o Product development programs under review;

o Policies under development and those recently issued; and o Scientific information related to product development or regulation.

4. Scope The FDA seeks to acquire full professional and technical support services necessary to conduct a study on the safety and efficacy of drugs for rare diseases or conditions in the United States and European Unions.

5. Assumptions and Constraints Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, materials, services, facilities, and otherwise do all things, except as provided in the schedule, necessary for or incident to the performance of the work as described in the Statement of Work (SOW).

https://rarediseases.org/the-orphan-drug-act-turns-40-nord-celebrates-its-impact-on-rare https://www.ema.europa.eu/en/news/eu-us-collaboration-boost-medicine-development-rare https://www.ema.europa.eu/en/news/eu-us-collaboration-boost-medicine-development-rare

6. Tasks

6.1 Project Management

6.1.1 Kick-off meeting

The Contractor shall conduct a project Kick-off meeting via conference call within five (5) business days of contract award, which the Contractor shall present its team and comprehensive understanding of the tasks and deliverables. This meeting serves to establish initial coordination of activities and meeting schedules. The agenda shall be submitted within two (2) business days prior to the Kick-Off meeting.

Minutes/Notes shall be submitted within two (2) business days after Kick-Off meeting.

Deliverables:

1. Kick-off Meeting Agenda

2. Kick-off Meeting Minutes/Notes

6.1.2 Quarterly Progress Reports

The Contractor shall develop quarterly progress reports and deliver reports to the Government Task Lead and the Contracting Officer Representative (COR) on the 15th of the month beginning the third month after the contract award. Quarterly progress reports shall include at a minimum the following components:

• Status and progress of tasks

• Significant risks to scheduled deliverables and plans to mitigate the risks

Deliverable:

1. Quarterly Progress Report

6.1.3 Ad hoc Committee Virtual Meetings

The Contractor shall on an as needed basis conduct virtual meetings; these ad hoc calls will consist of both chair and committee calls as well as group calls. These ad hoc calls will serve as means to discuss major issues, gain sponsor perspectives, obtain stakeholder input and other topics as required. The Contractor shall provide a meeting agenda two (2) business days prior to the scheduled ad hoc and minutes/notes within two (2) business days after the ad hoc meeting.

Deliverables:

1. Meeting Agenda

2. Status Meeting Minutes/Notes

6.2 Committee Nominations

The Contractor (National Academies’ Health and Medicine Division) shall convene an expert committee of approximately 12–15 members in accordance with National Academies' nomination policies.

6.2.1.1 Committee Establishment

The Contractor shall seek committee nominations, assemble, and appoint the committee in accordance with the National Academies’ nomination policies within ninety (90) business days of contract award. Once the committee is established, the Contractor shall: meet with National Academies research center staff to begin background research and initiate initial literature search, plan, and schedule committee meetings, and prepare background briefing materials for first committee meeting.

6.3 Committee Meetings

A Committee of approximately 12-15 members shall be convened and meet a minimum of five (5) times. During at least three (3) of the meetings, the committee shall hold hybrid meetings. Further, at least two (2) of the meetings, the committee shall allocate time for public comment to be received. Additionally, the committee shall identify other avenues for receiving input from interested stakeholders. The specifications for each committee meeting is described below:

6.3.1 Committee Meeting # 1 –

The first committee meeting shall convene virtually within 4-6 months after the contract award. Virtual meetings will likely take place over several hours for multiple days to accommodate the virtual format. Moreover, first committee meeting shall:

• Include the required composition, balance, and conflict of interest discussion.

• Include a public session for the sponsor to deliver the charge to the committee.

• Including an in-depth discussion with the sponsor about the task and discussion of available sources of information. During the public session the sponsor will be asked to provide background and context for the study to enable the committee to identify data sources and examine specific issues related to the statement of task.

6.3.2 Committee Meeting # 2 –

The second committee meeting shall convene in a hybrid format within 4-6 months after contract award and may be held in conjunction with open public sessions, including an open public comment period. Hybrid meetings will be hosted at National Academies facilities in Washington DC. Moreover, the second committee shall:

• Include time for the committee to discuss the outcomes, deliberate in closed session, and organize the writing of the report.

6.3.3 Committee Meeting # 3

The third committee meeting shall convene in a hybrid format within 7-8 months after contract award and shall include open sessions for additional public comment, if deemed necessary by the committee. Hybrid meetings will be hosted at National Academies facilities in Washington DC. Moreover, the third committee shall:

• Begin the committee's deliberations on the findings and recommendations.

6.3.4 Committee Meeting # 4

The fourth committee meeting shall convene virtually within 9-10 months after the contract award. This meeting shall be held in an entirely closed session to enable the committee to draft and finalize recommendations and the report text. Virtual meetings will likely take place over several hours for multiple days to accommodate the virtual format.

6.3.5 Committee Meeting # 5

The fifth committee meeting shall convene in a hybrid format within 11 months after the contract award. This meeting shall be held in an entirely closed session to enable the committee to draft and finalize recommendations and the report text. Virtual meetings will likely take place over several hours for multiple days to accommodate the virtual format.

6.4 Report

The committee shall prepare a final report that provides recommendations as it relates to improving treatments for rare diseases. The final report is subject to standard NRC review procedures prior to release. Further the report will go through the National Academies of Sciences, Engineering, and Medicine report review process and be subject to standard Report Review Committee (RRC) institutional review procedures prior to release. A prepublication copy (uncorrected proof) of the committee's report shall be provided to the sponsor 14 months after the project is initiated and then subsequently will be publicly released.

Moreover, the report and its key messages shall be disseminated via email lists and social media channels within 16 months of contract award. Lastly the final report shall then be formatted by the National Academies Press and printed in final books, which will be sent to the sponsors on or before October 31, 2024.

Deliverables:

1. Draft committee report

2. Key messages

3. Final Report

6 Deliverables

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary personnel, materials, services, facilities, and otherwise do all things, except as provided in the schedule, necessary for or incident to the performance of the work as described in the Statement of Work (SOW). All work performed under this contract shall be monitored by the Contracting Officer’s Representative (COR).

All deliverables shall be provided to the Government Task Lead and Contracting Officer’s Representative (COR) via formats specified in the Deliverables Table below.

Task/Deliverable Name

Distribution/Allocatio n

Format Due

6.1.1 Kick- off

Meeting Agenda

Govt. Lead or other Designee and COR

Microsoft Word Due within two (2) business days prior to kick-off meeting

6.1.1 Kick-off

Meeting Minutes/Notes

Govt. Lead or other Designee and COR

Microsoft Word Due within two (2) business days after kick-off meeting

6.1.2 Quarterly

Progress Reports

Govt. Lead or other Designee and COR

Microsoft Word Due the 15th of the month beginning the 3rd month after contract award

6.4 Draft Committee

Report

Govt. Lead or other Designee and COR

Microsoft Word Due within 14 months after contract award

6.4 Key Messages Govt. Lead or other

Designee and COR

Email/Social Media within 16 months of contract award

6.5 Final Committee

Report

Govt. Lead or other Designee and COR

Microsoft Word Due on or before October 31, 2024

7 Contract Administration

7.1 Contract Type

The Government intends to award a Sole Source Cost Reimbursement type contract.

7.2 Period of Performance

The period of performance for this contract is 16 months (July 1, 2023, through October 31, 2024).

7.3 Place of Performance

The work shall be performed at the Contractor’s site.

8 Security

1) Baseline Security Requirements

a) Applicability. The requirements herein apply whether the entire contract or order (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) employee 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 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.

b) 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:

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.

c) 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 [ ] Moderate [ ] High Integrity: [ ] Low [ ] Moderate [ ] High Availability: [ ] Low [ ] Moderate [ ] High Overall Risk Level: [ ] Low [ ] 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:

[ X ] No PII [ ] Yes PII

Complete this section using the information obtained from the Security and Privacy Checklist in Appendix A, parts A and B.

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 [ ] Moderate [ ] High

d) 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:

i) marked appropriately;

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

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 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

iv) 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.

e) 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.

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).

f) 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).

g) 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.

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

See Appendix D for baseline deliverables.

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

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 FIPS 140-2 validated encryption solution.

iii) 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).

iv) 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.

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.

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.

j) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf 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.

k) 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.

i) 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).

ii) 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.

2) Training

a) 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.

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 and FDA Role-Based Training (RBT) of Personnel with Significant Security Responsibilities Standard Operating Procedures (SOP).

c) 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 http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf within 30 days after contract award and annually thereafter or upon request.

3) Rules of Behavior

a) 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.

b) 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.

4) 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 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:

a) 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.

b) 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.

c) Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, (Recommend adding the FDA Senior Official for Privacy with contact information and either defining or deleting “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:

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

ii) not include any sensitive information in the subject or body of any reporting e-mail;

and

iii) encrypt sensitive information in attachments to email, media, etc.

d) 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.

e) 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.

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

6) 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 shall 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.

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

7) Contract Initiation and Expiration

a) 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/SitePages/v2/EP LCHome.aspx HHS EA requirements may be located here:

https://www.hhs.gov/about/agencies/asa/ocio/index.html

b) 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.

c) 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

d) 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.

e) 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.

f) 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 http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSyste m/default.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.

8) 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.

11 Contractor Personnel Security Clearance Standards and Residency Requirements (October 2017)

1. BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that Contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, must undergo a background investigation that results in a favorable determination.

Contractor employees who will work in DHHS-owned or leased space for less than thirty

(30) days are considered visitors and are exempted from background investigation requirements; and therefore, will not be issued a Personal Identity Verification (PIV) Card. These contractor employees go through visitor screening each day and must be escorted at all time while in DHHS- owned or leased space.

http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm http://inside.fda.gov:9003/EmployeeResources/NewEmployee/eDepartDepartureSystem/default.htm

2. GENERAL - The Contractor must submit the following items to the Contracting Officer’s Representative (COR), within five (5) business days of commencement of work under this contract:

• A roster of contractor employee names, identifying Key Personnel and Tier designation(s);

• Confirmation all individual employee security information has been submitted properly;

and

• "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in the roster.

Pursuant to HSPD-12, the Contractor must advise its prospective employees about the security and background requirements stated herein.

For any individual who does not obtain a favorable background investigation he/she must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the Contractor must notify the COR, and the Government will make a determination whether an additional security clearance is required.

In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change. In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be submitted to the Contracting Officer and COR for review and approval. If approved, the Contracting Officer will execute a Contract Modification prior to that individual commencing work under the contract.

3. BACKGROUND INVESTIGATIONS - With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the Contractor.

The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor. Employees who hold or have previously held a Government security clearance must advise the FDA Personnel Security Staff of the details of such clearance.

Note: Background investigations will be conducted by the Office of Personnel Management

(OPM)

4. CONTRACT RISK DESIGNATION(S) - Contractor employees who will be in DHHS-owned or leased space for thirty (30) days or more must be able to obtain and shall obtain a PIV card pursuant to Homeland Security Presidential Directive-12 (HSPD-12) in order to access to DHHS-owned or leased property without an escort. (See Section 6 for details on the PIV Card process) However, in the event that work must commence before a security screening can be completed, contractor employees will be considered visitors, as described above, and allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing system (e-Qip) system. The FDA Personnel Security Specialist will provide access to the e-Qip as well as guidance as to which forms will be required. The forms required vary with the position risk designations for the contract.

All standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) to initiate background investigations. The assigned FDA Personnel Security Specialist will resolve with the contractor employee any issues arising out of inaccurate or incomplete forms.

The Risk Designation(s) for this contract is/are Tier(s):

There are three (3) potential position risk designations, which are:

• Non-Sensitive Low Risk (Tier 1) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by the FDA Personnel Security Specialist are required for Non-Sensitive Low Risk Positions.

• Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) - Public Trust

Positions - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

In order to access the e-QIP system, Contractor employees must provide the appropriate FDA Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. This information will be provided on the e-Qip form that will be electronically sent to the employee. The FDA Personnel Security Specialist https://www.dhs.gov/homeland-security-presidential-directive-12 will use this information to enter each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the background investigation.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed. Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights, and remedies available at law and equity retained by the Government.

5. PERSONAL IDENTITY VERIFICATION (PIV) CARDS - All PIV Cards (and any other type of Government-issued Access Card) shall remain the property of the Federal Government. At any time, if a Contractor employee is terminated or otherwise ceases work under the contract, or no longer requires a PIV Card for contract performance purposes, the Contractor must collect the individual’s PIV card and immediately notify FDA Personnel Security Staff in writing, with copies to the respective COR and Contracting Officer. The Contractor must immediately return the PIV Card(s) to the COR.

Because PIV Cards, like other Government-issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law.

Unauthorized possession of a PIV Card, or any other type of Government-issued Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above-listed actions or failure to act.

6. PIV CARD PROCESS - The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card. In order to obtain a PIV card, a Contractor employee must receive a favorable FBI fingerprint return and complete required security forms. The FDA Personnel Security Specialist will provide the Contractor employee(s) direction for scheduling fingerprinting appointments at the FDA location or other approved location.

During a fingerprint appointment, each contractor employee must present two (2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government-issued photo identification document. Acceptable forms of identification are listed in Appendix A, provided below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

Required background investigations may include, but are not limited to:

• Review of prior Government/military personnel records;

• Review of FBI records and fingerprint files;

• Searches of credit bureaus;

• Personal interviews; and

• Written inquiries covering the subject's background.

7. RESIDENCY REQUIREMENTS FOR FOREIGN NATIONALS - Under the requirements for Homeland Security Presidential Directive-12 (HSPD-12), OPM can complete a background investigation only for persons who have resided in the U.S. for a total of at least three (3) of the past five (5). The residency requirements apply only to foreign nationals.