Attachment Statement of Work CBER-2026-133732.pdf

Statement of Work CBER-2026-133732

CBER Post Market, Safety, and Surveillance Support

INTRODUCTION

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).

OBJECTIVE

This project will fund senior physician(s) with subject matter expertise in adverse event reporting systems to work on adverse neurological and other events associated with CBER regulated biologic products. This action may also bring valuable resources in Epidemiology and Mathematical Statistics at Senior levels.

As with all vaccines and other medical products, although the vaccine development process and FDA’s evaluation are rigorous and comprehensive, after a vaccine is authorized by FDA, or following licensure (approval) of a biologics license application (BLA), additional pharmacovigilance will be conducted to monitor product safety and effectiveness in the U.S.

population, including those beyond the eligible population of clinical trial participants pre-approval. To this end, the contractor, a Senior Physician will be tasked with various projects identified by OBPV/DPV to allow the Agency surge capacity to fulfill statutory obligations, user fee commitments, specific Center or Agency goals under accelerated timelines.

SCOPE OF WORK

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

CBER OBPV Support Services:

• Reviews, summarizes, and recommends further study of passive or active surveillance techniques related to vaccines and other products, as well as pharmacovigilance studies, with a focus on neurological and other adverse events of special interest.

• Assists with safety surveillance, managed review, and pharmacovigilance plan assessment for biological products, including vaccines, cellular and gene therapies, blood and blood derived products, and tissue allografts.

• Provide technical assistance in helping inform strategy. For example, aid in setting strategic objectives; develop policies or procedures; and evaluate processes to support use of clinical data for regulatory action.

• Reviews post marketing commitment or requirement (PMC or PMR) safety studies, and other research activities assigned to OBPV.

• Monitors and analyzes national safety surveillance databases of adverse events to biological products, as well as safety data submitted by regulated industry, to provide technical assistance, and medical consultation to assist the reviewers with their surveillance work in

FDA/CBER/OBPV/DPV.

• Performs in depth reviews of case report forms, case series studies and other public health surveillance methods in order to provide product summaries, preliminary assessments, and recommendations for evaluation by FDA, with emphasis on those cases with a potential neurological involvement in a possible product safety signal, for biological products identified by OBPV staff.

• Analyzes clinical outcomes and other data related to safety evaluations as identified by OBPV staff and assists in preparation of executive summaries for review by FDA.

• Assists with performance of pharmacovigilance review of original Biological License Application (BLA) or BLA efficacy supplement as part of inter-office, interdisciplinary review teams.

• Provides input for development of informatics tools to enhance efficiency of adverse event review and provides other technical advice on process improvements to adverse event review as assigned.

• Develops and prepares in written form a monthly status report that identifies workload, turnaround time, and other project development activities performed in the previous month. The status reports and deliverables will be reviewed and approved by the CBER team before finalized.

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

DELIVERABLES

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

Description Delivery Date

1 (Kick-Off Meeting) Draft a Post-Award Conference Summary

No later than 2 weeks after award

2 Regular meetings with CBER core team Weekly Meeting

3 Summary of notable cases of adverse events reported following assigned vaccines and other products or as needed or required

Monthly reports

4 Provide review of literature and scientific evidence for potential safety issues involving neurologic complications following vaccination, for either products post-marketing, or original Biological License Applications.

Within 30 days of assignment by CBER core team (specific vaccines to be determined by CBER core team)

5 Draft Program Summary Report 90 days prior to end of period of performance

5 Final Program Report End of Period of performance

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., Microsoft 365, 64-bit). 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 for 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.

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 completed a residency program, and, if specialized such as in the medical specialty of neurology, then maintain relevant current board certification to that specialty. For the specialty in Neurology, then the American Board of Psychiatry and Neurology would be the relevant current board of certification.

• At least 5 years of experience and training in pharmacovigilance, including reviewing and evaluating active and passive surveillance methods, and performance of epidemiological studies. Publications and invited presentations within the pharmacovigilance field, or in peer reviewed journals, serve as measures of expertise.

• Demonstrated previous experience in similar projects with state or federal government, preferably within a governmental regulatory agency.

LOCATION, WORK SCHEDULE, TRAVEL

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 remotely.

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

All of the work will be conducted off campus and if the contractor staff need to interact with the

CBER staff on a daily basis they shall use remote tools such as Zoom or Microsoft Teams particularly at the beginning of the project for the first several months.

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.

PERIOD OF PERFORMANCE

9/30/2026 – 9/29/2027

CONTRACT ADMINISTRATION

The Contracting Officer’s Representative (COR) will conduct 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:

Darren Jansen Darren.Jansen@fda.hhs.gov

The contact information for the Contracting Officer is the following:

Ian Weiss mailto:Darren.Jansen@fda.hhs.gov

Ian.Weiss@fda.hhs.gov

SECURITY AND PRIVACY

The Contractor shall be responsible for determining that the individuals provided to perform under this contract will not have an adverse effect on the efficiency, effectiveness, and integrity of the FDA, and will uphold the scope of work.

The Contractor shall be expected to have all necessary credential(s) processed prior to beginning work. All Contractor personnel must have an FDA Security clearance before providing services.

All necessary administrative paperwork to hire non-FDA employees must have sufficient time to be processed in the FDA systems. The process normally takes four (4) weeks, and the Contractor shall allocate sufficient time for the new hire to be processed in the FDA system prior to the commencement of work.

The Contractor shall be responsible for determining that the individuals provided to perform under this order will not have an adverse effect on the efficiency, effectiveness, and integrity of the FDA, and will uphold the scope of work.

Due to the possible sensitive nature of the information discussed, contractor personnel shall be required to sign a Commitment to Protect Non-Public Information form 3398.

Contractor Conformance with Applicable Laws, Regulations, Policies and Standards – The contractor shall be responsible for knowledge of and compliance with all applicable federal information.

The Contractor must assure the protection of the information and data it receives in performance of this contract from unauthorized use or disclosure and must avoid actions that would cause a reasonable person to question the impartiality of the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future actions.

[x ] Information Types: Use the National Institutes 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, (http://csrc.nist.gov/publications/) to determine the applicable information type(s).Enter information types in Table 1 below (add/remove rows as needed).

[x ] Mission/Program Based Information: For all selected information types from the NIST 800-60, rate the impact of all information types. The NIST-defined impact ratings may be changed to reflect the actual impact to the agency/program mission. If changing the NIST impact ratings, an explanation for changing the ratings must be included.

[x ] Information/Information System Categorization: Use the Federal Information Processing

Standard (FIPS) Publication 199, Standards for Security Categorization of Federal Information and Information Systems, (http://csrc.nist.gov/publications/)to categorize the information and/or information system and determine the overall risk. The overall risk is based on the highest water mark (e.g., if Confidentiality is Moderate, Integrity is Low and Availability is Low, the overall rating Is Moderate.) Enter the overall risk rating in Table 2 below.

mailto:Ian.Weiss@fda.hhs.gov http://csrc.nist.gov/publications/) http://csrc.nist.gov/publications/)to

Security Categorization Level:

Information Type (Number and Title)

Confidentiality (Low, Moderate, High)

Integrity (Low, Moderate, High)

Availability (Low, Moderate , High)

Access to FDA Data Moderate Moderate Moderate

Table 1: Information Types and Risk Ratings Information/System Categorization:

Project/System Name Confidentiality (Low, Moderate, High)

Integrity (Low, Moderate, Availability (Low, Moderate, Overall Risk:

(Low, Moderate, High)

Moderate Moderate Moderate

Table 2: Information/System Categorization and Overall Risk

E-AUTHENTICATION RISK ASSESSMENT

Conduct an E-Authentication Threshold Analysis (E-Auth TA) to determine if a full E- Authentication Risk Assessment (E-Auth RA) is necessary by following the OMB 04-04, E- Authentication Guidance for Federal Agencies (https://www.whitehouse.gov/sites/default/files/omb/memoranda/fy04/m04-04.pdf) and NIST SP 800-63, Electronic Authentication Guideline. If a full E-Auth RA is required, determine the level of assurance. The potential levels of assurance are:

• Level 1: Little or no confidence in the asserted identity’s validity;

• Level 2: Some confidence in the asserted identity’s validity;

• Level 3: High confidence in the asserted identity’s validity; or

• Level 4: Very high confidence in the asserted identity’s validity.

Based on the required level of assurance determined by the E-Auth RA, select the appropriate authentication level of assurance and authentication method required to access the information system, including remote authentication.

Level of Assurance: [ ] N/A [ ] Level 1 [x ] Level 2 [ ] Level 3 [ ] Level 4 Authentication Method: [

] N/A [ ] Single-Factor [x] Two-Factor [ ] Multi-Factor

POSITIONSENSITIVITY DESIGNATIONS

PROSPECTIVE OFFEROR NON-DISCLOSURE AGREEMENT

[ ] Offerors WILL NOT require access to sensitive information in order to prepare an offer.

[X ] Offerors WILL require access to sensitive information in order to prepare an offer. A Non-Disclosure Agreement (NDA) is necessary for a prospective offeror who will require access to Government information in order to prepare an offer (i.e., a prospective offeror must https://www.whitehouse.gov/sites/default/files/omb/memoranda/fy04/m04-04.pdf) access an FDA computer room floor plan). [See Appendix B for Non-Disclosure Agreement form.]

DESCRIPTION OF SENSITIVE INFORMATION:

[ ] Tier 4: Sensitive - High Risk

[x ] Tier 2: Sensitive - Moderate Risk

Information Privacy Certification – Part B

[ ] No privacy requirements apply to this solicitation. Proceed to the signature page.

[X ] Privacy requirements27 apply to this solicitation. Complete the checklist and sign below.

[X ] Privacy Act applies to this solicitation. Complete the information below and sign the checklist. The following tailored information is required for RFP preparation.

PERSONALLY, IDENTIFIABLE INFORMATION (PII)

PII Overall Level: [ ] No PII [ X ] Yes PII

If yes for PII, insert language from the following sections/sub-sections

a. Section 2: All

b. Section 3: Applicable language as determined by the FDA Senior Official for Privacy

PRIVACY ACT

TAILORED PRIVACY ACT INFORMATION: Provide the following information if the Privacy Act applies to this solicitation (this is needed to tailor the SOW as required by the HHSAR “Privacy Act” clause, 352.224-70):

PROSPECTIVE OFFEROR NON-DISCLOSURE AGREEMENT

[ X ] Offerors WILL NOT require access to sensitive information to prepare an offer.

Privacy Act

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

The System of Records Notice (SORN) that is applicable to this contract is: General Personnel Records) and 09-90-0058 (Tracking Records and Case Files for FOIA and Privacy Act Requests and Appeals).

The design, development, or operation work the Contractor is to perform is: The contracted support services personnel will access and enter data for scientific support services subject to the Privacy Act of 1974.

The disposition to be made of the Privacy Act records upon completion of contract performance is: Records disposition instructions: OPM/GOVT-1: The OPF is maintained for the period of the employee’s service in the agency and is then, if in a paper format, transferred to the National Personnel Records Center for storage or, as appropriate, to the next employing Federal agency. If the OPF is maintained in an electronic format, the transfer and storage is in accordance with the OPM approved electronic system. Other records are either retained at the agency for various lengths of time in accordance with the National Archives and Records Administration records schedules or destroyed when they have served their purpose or when the employee leaves the agency. The transfer occurs within 90 days of the individuals’ separation. In the case of administrative need, a retired employee, or an employee who dies in service, the OPF is sent within 120 days. Destruction of the OPF is in accordance with General Records Schedule-1 (GRS– 1) or GRS 20. Records contained within the CPDF and EHRI (and in agency’s automated personnel records) may be retained indefinitely as a basis for longitudinal work history statistical studies. After the disposition date in GRS–1 or GRS 20, such records should not be used in making decisions concerning employees. 09-90-0058: Records are retained and disposed of in accordance with General Records Schedule (GRS) 4.2 “Information Access and Protection Records” (superseding GRS 14 “Information Services Records”), which prescribes retention periods ranging from approximately two years to six years after final agency action or adjudication by a court, date of closure, or last entry. For specific periods, see GRS 4.2 Items 020access and disclosure request files: 030 general administrative (tracking) records; 050 Privacy Act accounting of disclosure files; and 090 Privacy Act amendment request files.

Clauses

52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2023) applies to this acquisition. The following addenda have been attached to this clause - N/A.

Contract Terms and Conditions Required to Implement Statutes or Executive Orders— Commercial Products and Commercial Services (Jan 2025)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with

Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C.

3509)).

(3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

(4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

_X_ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

(6) [Reserved].

(7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

(9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

(11) (i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

(ii) Alternate I (Dec 2023) of 52.204-30.

_X_ (12) 52.209-6, Protecting the Government's Interest When Subcontracting With Contractors Debarred, Suspended, Proposed for Debarment, or Voluntarily Excluded. (Jan 2025) ( 31 U.S.C. 6101 note).

(13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

(14) [Reserved].

(15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) ( 15 U.S.C.

657a).

(16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns

(Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(17) [Reserved]

(18) (i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-6.

(19) (i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-7.

_X_ (20) 52.219-8, Utilization of Small Business Concerns (Jan 2025)( 15 U.S.C. 637(d)(2) and (3)).

(21) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2025) ( 15 U.S.C. 637(d)(4)).

(ii) Alternate I (Nov 2016) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Jun 2020) of 52.219-9.

(v) Alternate IV (Jan 2025) of 52.219-9.

(22) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

(ii) Alternate I (Mar 2020) of 52.219-13.

_X_ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) (15 U.S.C. 657s).

(24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) (15 U.S.C.

637(d)(4)(F)(i)).

(25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran- Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) (15 U.S.C. 657f).

_X_ (26) (i) 52.219-28, Post award Small Business Program Representation (Jan 2025) (15 U.S.C. 632(a)(2)).

(ii) Alternate I (Mar 2020) of 52.219-28.

(27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) (15 U.S.C. 637(m)).

(28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) (15 U.S.C. 637(m)).

(29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C.

644(r)).

(30) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15 U.S.C. 637(a)(17)).

(31) 52.222-3, Convict Labor (Jun 2003) (E.O. 11755).

(32) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2025)( E.O.

13126).

(33) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (34) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(ii) Alternate I (Feb 1999) of 52.222-26.

_X_ (35) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) ( 38 U.S.C. 4212).

(ii) Alternate I (Jul 2014) of 52.222-35.

_X_ (36) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) ( 29 U.S.C.

793).

(ii) Alternate I (Jul 2014) of 52.222-36.

_X_ (37) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

_X_ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (39) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and

E.O. 13627).

(ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

_X_ (40) 52.222-54, Employment Eligibility Verification (Jan 2025) ( Executive Order 12989).

(Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

(41) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

(42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) ( 42 U.S.C. 7671, et seq.).

(43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) ( 42 U.S.C. 7671, et seq.).

(44) 52.223-20, Aerosols (May 2024) ( 42 U.S.C. 7671, et seq.).

(45) 52.223-21, Foams (May 2024) ( 42 U.S.C. 7671, et seq.).

(46) 52.223-23, Sustainable Products and Services (May 2024) ( E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

(47) (i) 52.224-3 Privacy Training (Jan 2017) ( 5 U.S.C. 552 a).

(ii) Alternate I (Jan 2017) of 52.224-3.

_X_ (48) (i) 52.225-1, Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83).

(ii) Alternate I (Oct 2022) of 52.225-1.

(49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C.

chapter 29 (sections 4501-4732), Public Law 103-182, 108-77, 108-78, 108-286, 108-302, 109- 53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

(ii) Alternate I [Reserved].

(iii) Alternate II (Jan 2025) of 52.225-3.

(iv) Alternate III (Feb 2024) of 52.225-3.

(v) Alternate IV (Oct 2022) of 52.225-3.

_X_ (50) 52.225-5, Trade Agreements (NOV 2023) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

(51) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(52) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

(54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

_X_ (55) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ( E.O. 13513).

(56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

(57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

(58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) (41 U.S.C. 4505, 10 U.S.C. 3805).

_X_ (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

(60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

(61) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

_X_ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

_X_ (63) 52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub. L.

118-31, 41 U.S.C. 3901 note prec.).

(64) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(13)).

(65) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

(ii) Alternate I (Apr 2003) of 52.247-64.

(iii) Alternate II (Nov 2021) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

(1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter67).

(2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C.

chapter 67).

(4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

(5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792).

(10) 52.247-69, Reporting Requirement for U.S.-Flag Air Carriers Regarding Training to Prevent Human Trafficking (Jan 2025) ( 49 U.S.C. 40118(g)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records-Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1), in a subcontract for commercial products or commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509).

(ii) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712).

(iii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iv) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(v) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(vi) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(vii) (A) 52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

(B) Alternate I (Dec 2023) of 52.204–30.

(viii) 52.219-8, Utilization of Small Business Concerns (Jan 2025) ( 15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(ix) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(x) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

(xi) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

(xii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(xiii) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

(xiv) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222- 40.

(xv) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter 67).

(xvi) (A) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and E.O.

13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xvii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xviii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xix) 52.222-54, Employment Eligibility Verification (Jan 2025) ( E.O. 12989).

(xx) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xxi) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xxii) (A) 52.224-3, Privacy Training (Jan 2017) ( 5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xxiii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. Subtitle A, Part V, Subpart G Note).

(xxiv) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxv) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxvi) 52.240-1, Prohibition on Unmanned Aircraft Systems Manufactured or Assembled by American Security Drone Act-Covered Foreign Entities (Nov 2024) (Sections 1821-1826, Pub. L.

118-31, 41 U.S.C. 3901 note prec.).

(xxvii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014).

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

Health and Human Services Acquisition Regulation (HHSAR) 352.232-71 - Electronic Submission of Payment Requests (FEB 2022)

(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.

http://www.ipp.gov/

(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 FAR 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.

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).

http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

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.

mailto:ERIC@fda.hhs.gov