FDA-RFP-116785.pdf

Title: CBER Vaccine Adverse Event Reporting System (VAERS) and Safety Monitoring Support for

COVID19Vaccines

Document Type: Combined Synopsis/Solicitation

Solicitation Number: FDA-RFP-116785 Posted Date: April 18, 2023 Response Date: 4:30 pm April 25, 2023 NAICS Code: 541714 - PROFESSIONAL, SCIENTIFIC, AND

TECHNICAL SERVICE

PART 1 – DESCRIPTION

1.1 Background

The Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER)’s Office of Biostatistics and Pharmacovigilance (OPBV)’s Division of Pharmacovigilance (DPV) is responsible for monitoring the safety of vaccines and biologics once they are approved for use under a Biologic Licensing Application (BLA) or authorized for use under an Emergency Use Authorization

(EUA).

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

2.1 Price Schedule

Deliverable

Description # of

Hours

Price

COVID-19

VAERS

Support Services

Bi-Weekly Meetings

Monthly Reports

Provide review of literature and scientific evidence for potential safety issues involving neurologic complications following COVID-19 vaccination

Summary of notable cases of adverse events reported following COVID-19 vaccination

TOTALS

PART 3 – DESCRIPTION/SPECIFICATIONS

3.1 Objective

This project will fund a senior physician with Vaccine Adverse Event Reporting Subject Matter expertise to work on adverse neurological and other events associated with COVID-19 vaccinations. Currently there are two FDA-approved COVID-19 vaccines:

• Comirnaty (COVID-19 Vaccine, mRNA)

• Pikevax (COVID-19 Vaccine, mRNA)

There are four COVID-19 vaccines authorized for emergency use in the U.S.:

• Janssen (J&J) COVID-19 Vaccine

• Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine, Bivalent

• Novavax COVID-19 Vaccine, Adjuvanted

• Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent

As with all vaccines and other medical products, although the vaccine development process and FDA’s evaluation are rigorous and comprehensive, after a vaccine for COVID-19 is authorized under EUA by FDA, or following licensure (approval) of a BLA, additional pharmacovigilance will be conducted to monitor COVID-19 vaccine safety and effectiveness. Additionally, the senior physician will be tasked with various projects identified by OBPV/DPV to fulfill statutory obligations, user fee commitments, specific Center or Agency goals.

3.2 Scope of Work

The contractor shall furnish the necessary services and qualified personnel needed to perform the Statement of Work as stated herein:

COVID-19 VAERS Support Services:

• Assists with passive surveillance, managed review, pharmaco-vigilance plan assessment for COVID-19 vaccines and other products. Reviews postmarketing commitment or requirement (PMC or PMR) observational epidemiologic safety studies, and research activities assigned to the Branch.

• Reviews and evaluates passive surveillance related to COVID-19 vaccines and other products, and pharmacovigilance studies with a focus on neurologic adverse events of interest.

• Reviews and evaluates product safety issues for COVID-19 vaccines and other products as identified by Branch staff through routine surveillance of assigned products.

• Analyzes clinical outcomes and data related to safety evaluations with a focus on neurologic safety issues.

Develop and prepare in written form a monthly status report that identifies VAERS review work and other project work performed in the previous month. The deliverables will be reviewed and approved by the CBER core team before finalized.

3.3 Post-Award Conference

This meeting shall provide an introduction between the Contractor and Government personnel who will be involved with the contract. The meeting shall provide the opportunity to discuss technical, management and security issues. The Post-Award Conference will aid both the Government and Contractor in achieving a clear and mutual understanding of all requirements and identify and resolve any potential issues. The Contractor shall be prepared to discuss any items requiring clarification and gather information as necessary to support each deliverable and complete the following:

• Attend Kick-Off Meeting

• Draft written summary of the Post-Award Conference

PART 4 – PERFORMANCE REQUIREMENTS AND MEASURES/DELIVERABLES

4.1 Deliverables

The Contractor shall provide all required deliverables in accordance with the following schedule:

Description Delivery Date 1 Regular meetings with CBER core team Weekly Meeting

2 Summary of notable cases of adverse events reported following COVID-19 vaccine

Weekly reports

3 Provide review of literature and scientific evidence for potential safety issues involving neurologic complications following COVID-19 vaccination

Within 90 days of award

4 (Kick-Off Meeting) (Post Award Conference Summary)

No later than 2 weeks after award

Deliverable products shall be reviewed, validated, and tested as appropriate to ensure that they meet applicable/specified standards, policy, business requirements, and quality measures. In the event of the rejection of any deliverable, the Contractor shall be notified in writing by the Contracting Officer’s Representative (COR), giving the specific reason(s) for rejection. The Contractor shall have ten (10) business days to respond to the rejected deliverable and return it to the COR.

All deliverables shall be developed using Microsoft Office products that are compatible with the versions currently utilized by the FDA (i.e., MS 2010). Daily, weekly, interim, informal, and working-copy products shall be provided by email upon request by FDA CO, COR, and designated SMEs.

The Contractor shall deliver all products to the COR and other technical customers, as appropriate per policy and/or agreed upon when assigned. For the formal reports the COR or other technical staff will notify the Contractor of deliverable acceptance regarding overall compliance with the guideline’s requirements of the task.

The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. Reports and presentations shall be concise and clearly written; errors, misleading or unclear statements, incomplete or irrelevant information, and/or excessive rhetoric, repetition, or excessive length if a page limit is imposed, shall be considered deficiencies and will be subject to correction by the contractor at no additional cost to the Government. Unless specified otherwise, the COR will review and approve all deliverables, which may require multiple revisions by the Contractor prior to being finalized.

4.2 Position Requirements

Education and Experience – The position listed in this requirement shall at minimum follow the labor category description in the base contract and specific requirements as listed in the corresponding Statement of Work.

Staffing Requirements/Labor categories

• Doctor of Medicine, Doctor of Osteopathic Medicine or equivalent from a school in the United States or Canada. This degree must have been accredited by the Council on Medical Education of the American Medical Association;

Association of American Medical Colleges; Liaison Committee on Medical Education (external link); Commission on Osteopathic College Accreditation of the American Osteopathic Association (external link), or an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained.

• Subsequent to obtaining a Doctor of Medicine or Doctor of Osteopathic Medicine degree, a candidate must have had at least 1 year of supervised experience providing direct service in a clinical setting, i.e., a 1-year internship or the first year of a residency program in a hospital or an institution accredited for such training. For purposes of this standard, graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the United States or Canada. Descriptions of such programs are described below.

• An internship program involves broadly based clinical practice in which physicians acquire experience in treating a variety of medical problems under supervision (e.g., internal medicine, surgery, general practice, obstetrics-gynecology, and pediatrics). Such programs are in hospitals or other institutions accredited for internship training by a recognized body of the Accreditation Council for Graduate Medical Education (ACGME) (external link).

• A residency program involves training in a specialized field of medicine in a hospital or an institution accredited for training in the specialty by a recognized body of the American Medical Association (external link), (AMA) or Accreditation Council for Graduate Medical Education (ACGME) (external link).

• A fellowship program involves advanced training (beyond residency training) in a given medical specialty in either a clinical or research setting in a hospital, or an institution accredited in the United States for such training.

• 5 years of graduate training in the specialty of the position to be filled or equivalent experience and training in reviewing and evaluating passive surveillance, and pharmacovigilance studies.

Demonstrated previous experience in similar projects preferably with government but in the private industry acceptable.

4.3 Government Furnished Property

The Government will provide FDA laptop to Contractor working on this order. The Contractor shall maintain an inventory of all FDA accountable property and ensure the return of the property upon completion of all work required under the order. Further, Contractor assigned to this order shall provide verification of completion of all mandatory FDA training, including Annual Security Awareness Training if assigned an FDA laptop that allows for FDA network access.

All property, data and information provided by the Government in the performance of this order remains the property of the Government and shall be surrendered to the Government upon completion or termination of this requirement. Likewise, all deliverables generated under this requirement remain the property of the Government.

The Government shall retain all rights and privileges, including those of patent and copy, to all Government-furnished data and materials. The Contractor shall neither retain nor reproduce for private or commercial use any data or other materials furnished under this contract. The Contractor agrees not to assert any rights at common law or in equity or establish any claim to statutory copyright in such data.

These rights are not exclusive and are beyond any other rights and remedies to which the Government is otherwise entitled elsewhere in this contract.

4.4 Contract Type

The Government intends to award a Firm-Fixed Price Contract

4.4 Period of Performance

09/30/2023 – 09/29/2024

4.5 Place of Performance

Work shall be performed Monday through Friday, a specific schedule for each CLIN will be agreed upon by the Contractor and the COR. The Contractor shall be able to perform work on the Government sites on a space available basis within the Washington DC Metro Area at the following location:

FDA/CBER

10903 New Hampshire Avenue Building 71 Silver Spring, MD 20993-0002

The contractor will only be paid for the hours of services delivered.

A large portion of the work will be conducted on campus since the contractor staff need to interact with the CBER staff on a daily basis particularly at the beginning of the project for the first several months. Some of the later work involving just writing can be done off site.

PART 5 – CONTRACT ADMINSTRATION

5.1 Representatives

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of the services to be provided.

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

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the FDA Contracting Officer’s Representative is the following: TBD

The contact information for the Contracting Officer is the following:

Ian Weiss U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705 Email: Ian.Weiss@fda.hhs.gov

The contact information for the Contract Specialist is the following:

Paige Eyberg mailto:Ian.Weiss@fda.hhs.gov

U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705 Email: Paige.Eyberg@fda.hhs.gov

5.2 Payment

HHSAR 352.232-71, Electronic Submission of Payment Requests

(a) Definitions. As used in this clause-

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(END OF CLAUSE)

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury's Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

mailto:Paige.Eyberg@fda.hhs.gov

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted (2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

PART 6 – SPECIAL CONTRACT REQUIREMENTS

A. Baseline Security Requirements

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

a. 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.

b. 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.

2) 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.

3) 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: [X ] Low [ ] Moderate [ ] High

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

Availability: [X ] Low [ ] Moderate [] High 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 http://csrc.nist.gov/publications/nistpubs/800-60-rev1/SP800-60_Vol2-Rev1.pdf

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

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

[ X ] No PII [ ] Yes PII

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

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

a. marked appropriately;

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

c. protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

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

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

5) 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).

6) 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).

7) 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.

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

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

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

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

c. All devices (i.e.: desktops, laptops, mobile devices, etc.) that store, transmit, or process non-public FDA information should utilize FDA-provided or FDA information security authorized devices that meet HHS and FDA-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

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

e. Use the Key Management system on the HHS Personal Identification Verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys (PIV card) shall be provided to the COR upon request and at the conclusion of the contract. Upon completion of contract, contractor ensures that COR is able to access and read any encrypted data.

10) Contractor Non-Disclosure Agreement (NDA). Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the FDA non-disclosure agreement (3398 Form), as applicable. A copy of each signed and witnessed NDA shall be submitted to the CO and/or COR prior to performing any work under this acquisition.

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

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

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

B. Training

1) Mandatory Training for All Contractor Staff. All Contractor (and/or any subcontractor) employees assigned to work on this contract shall complete the applicable FDA Contractor Information Security Awareness, Privacy, and Records Management training (provided upon contract http://csrc.nist.gov/publications/fips/fips140-2/fips1402.pdf http://inside.fda.gov:9003/downloads/administrative/forms/fda/ucm013733.pdf award) before performing any work under this contract. Thereafter, the employees shall complete FDA Information Security Awareness, Privacy, and Records Management training at least annually, during the life of this contract. All provided training shall be compliant with HHS and FDA training policies.

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

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

C. Rules of Behavior

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

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

D. Incident Response

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

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

A privacy breach is a type of incident and is defined by FISMA as the loss of control, compromise, unauthorized disclosure, unauthorized acquisition, or any similar occurrence where (1) a person other than an authorized user accesses or potentially accesses personally identifiable information or (2) an authorized user accesses or potentially accesses personally identifiable information for an other than authorized purpose. The HHS Policy for IT Security and Privacy Incident Reporting and Response further defines a breach as “a suspected or confirmed incident involving PII.”

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

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

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

3) Report all suspected and confirmed information security and privacy incidents and breaches to the FDA Systems Management Center, COR, CO, and other stakeholders, (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:

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

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

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

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

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

E. Position Sensitivity Designations

All Contractor (and/or any subcontractor) employees must obtain a background investigation commensurate with their position sensitivity designation that complies with Parts 1400 and 731 of Title 5, Code of Federal Regulations (CFR). The following position sensitivity designation levels apply to this solicitation/contract: [See the FDA Security Article, entitled Contractor Personnel Security Clearance Standards and Residency Requirements for the Position Risk Designation Tier(s) (i.e., 1, 2, and/or 4”) that apply to this award.]

F. Homeland Security Presidential Directive (HSPD)-12

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

Roster. The Contractor (and/or any subcontractor) shall submit a roster by name, position, e-mail address, phone number and responsibility, of all staff working under this acquisition where the Contractor will develop, have the ability to access, or host and/or maintain a government information system(s). The roster and any revisions to the roster as a result of staffing changes shall be submitted to the COR and/or CO per the COR or CO’s direction. Any revisions to the roster as a result of staffing changes 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.

G. Contract Initiation and Expiration

1) General Security Requirements. The Contractor (and/or any subcontractor) shall comply with information security and privacy requirements, Enterprise Performance Life Cycle (EPLC) processes, HHS Enterprise Architecture requirements to ensure information is appropriately protected from initiation to expiration of the contract. All information systems development or enhancement tasks supported by the contractor shall follow the FDA EPLC framework and methodology in accordance with the FDA EPLC Project documentation, located here:

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

HHS EA requirements may be located here: https://www.hhs.gov/about/agencies/asa/ocio/index.html

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

3) Sanitization of Government Files and Information. As part of contract closeout and at expiration of the contract, the Contractor (and/or any subcontractor) shall provide all required documentation in accordance with FDA OAGS SMGs to the CO and/or COR to certify that, at the government’s direction, all electronic and paper records are appropriately disposed of and all devices and media are sanitized in accordance with NIST SP 800-88, Guidelines for Media Sanitization and FDA IS2P Appendix T: Sanitization of Computer-Related Storage Media

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

5) Contractor Responsibilities Upon Physical Completion of the Contract. The contractor (and/or any subcontractors) shall return all government information and IT resources (i.e., government information in non-government-owned systems, media, and backup systems) acquired during the term of this contract to the CO and/or COR. Additionally, the Contractor shall provide a certification that all government information has been properly sanitized and purged from Contractor-owned systems, including backup systems and media used during contract performance, in accordance with HHS and/or FDA policies.

6) The Contractor (and/or any subcontractor) shall coordinate with the COR via email, 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/eDepartDepartureSystem/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.

H. Records Management and Retention

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

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

PART 7 – CONTRACT CLAUSES

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the CO will make their full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/far/.

FAR 52.202-1 Definitions (JUN 2020)

FAR 52.203-3 Gratuities (APR 1984)

FAR 52.203-5 Covenant Against Contingent Fees (MAY 2014)

FAR 52.203-6 Restrictions on Subcontractor Sales to the Government (JUN 2020) - Alternate 1 (JUN 2020)

FAR 52.203-7 Anti-Kickback Procedures (JUN 2020)

FAR 52.203-12 Limitation on Payment to Influence Certain Federal Transactions (JUN 2020)

FAR 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights. (JUN 2020)

FAR 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

(JAN 2017)

FAR 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020)

FAR 52.204-13 System for Award Management Maintenance (OCT 2018)

FAR 52.204-18 Commercial and Government Entity Code Maintenance. (AUG 2020)

FAR 52.204-19 Incorporation by Reference of Representation and Certifications (DEC

2014)

FAR 2.204-21 Basic Safeguarding of Covered Contractor Information Systems. (NOV 2021)

FAR 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)

FAR 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021)

FAR 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015)

FAR 52.216-24 Limitation of Government Liability (APR 1984)

FAR 52.216-25 Contract Definitization – Alternate I (OCT 2010)

FAR 52.217-8 Option to Extend Services (NOV 1999)

FAR 52-219-3 Notice of HUBZone Set-Aside of Sole-Source Award (OCT 2022) https://www.acquisition.gov/far/

FAR 52.222-3 Convict Labor (JUN 2003)

FAR 52.222-21 Prohibition of Segregated Facilities (APR 2015)

FAR 52.222-26 Equal Opportunity (SEP 2016)

FAR 52.222-35 Equal Opportunity for Veterans (JUN 2020)

FAR 52.222-36 Equal Opportunity for Workers with Disabilities (JUN 2020)

FAR 52.222-37 Employment Reports on Veterans, (JUN 2020)

FAR 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (Dec 2010)

FAR 52.222-41 Service Contract Labor Standards (AUG 2018)

FAR 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (AUG 2018)

FAR 52.222-49 Service Contract Labor Standards-Place of Performance Unknown (MAY 2014)

FAR 52.222-50 Combatting Trafficking in Persons (NOV 2021) – Alternate I (NOV 2021)

FAR 52.222-54 Employment Eligibility Verification (MAY 2022)

FAR 52.223-6 Drug-Free Workplace (MAY 2001)

FAR 52.223-18 Encouraging Contractor Policies to Ban Text messaging While Driving (JUN 2020)

FAR 52.225-1 Buy American Act—Supplies (DEC 2022)

FAR 52.225-13 Restrictions on Certain Foreign Purchases (FEB 2021)

FAR 52.232-1 Payments (APR 1984)

FAR 52.232-25 Prompt Payment (Jan 2017)

FAR 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (OCT 2018)

FAR 52.232-39 Unenforceability of Unauthorized Obligations (JUN 2013)

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

FAR 52.233-1 Disputes (MAY 2014)

FAR 52.233-2 Service of Protest (SEP 2006)

FAR 52.233-3 Protest after Award (AUG 1996)

FAR 52.233-4 Applicable Law for Breach of Contract Claim (OCT 2004)

FAR 52.249-1 Termination for Convenience of the Government (Fixed-Price) (Short-Form) (APR 1984)

PART 8. REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF

OFFERORS OR RESPONDENTS.

FAR 52.204-8 Annual Representations and Certifications (MAR 2023)

FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)

FAR 52.229-11 Tax on Certain Foreign Procurements – Notice and Representation I (JUN 2020)

PART 9. INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFEORS OR RESONDENTS

FAR 52.204-7 System for Award Management (OCT 2018)

FAR 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020)

FAR 52.204-22 Alternate Line-Item Proposal (JAN 2017)

FAR 52.214-34 Submission of Offers in the English Language (APR 1991)

FAR 52.214.-35 Submission of Offers in U.S. Currency (APR 1991)

PROPOSAL INSTRUCTIONS

The Government will award a contract resulting from this RFP to the responsible Offeror whose quote conforming to the RFP will be most advantageous to the Government.

The award decision will be made to the Lowest Priced Technically Acceptable.

Response Dates

RFP Due Date: All quotes and revisions shall be…