FINAL RFQ FDA-SOL-1242710_07232021.pdf

Request for Quotation (RFQ) No. FDA-SOL-21-1242710

Center for Food Safety and Applied Nutrition (CFSAN) Development of a Hazard and Risk Assessment Protocol for

Cosmetic Ingredients Needing Special Considerations

1. DESCRIPTION/COMMERCIAL ITEM PROCUREMENT

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is a Request for Quotes (RFQ) for commercial items in accordance with the procedures of FAR Part 12 Acquisition of Commercial Items and Part 13 Simplified Acquisition Procedures.

The associated North American Industry Classification System (NAICS) Code is 541611 – Administrative Management and General Management Consulting Services.

This is a small business set-aside solicitation in accordance with FAR Subpart 19.5 Set-Asides for Small Business.

2. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2021-06, effective July 12, 2021.

FAR provisions and clauses referenced in this solicitation can be found on the following website:

www.acquisition.gov

HHSAR provisions and clauses referenced in this solicitation can be found on the following website:

https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

3. PURCHASE ORDER REQUIREMENTS

See Section 6, Statement of Work, for a full description of the supplies/services to be acquired.

4. CONTRACT TYPE

The Government anticipates awarding one (1) Firm-Fixed-Price (FFP) type purchase order. The total purchase order period of performance consists of a base year and one (1) option year.

5. PRICING

Services shall be provided in accordance with the services described in the Statement of Work – Services to be performed during the anticipated periods of: September 1, 2021 through August 31, 2022 (Base Year); and if exercised from September 1, 2022 through August 31, 2023 (Option Year 1).

http://www.acquisition.gov/

Base Year: September 1, 2021 through August 31, 2022 (estimated)

Requirement Firm-Fixed Price Development of a Hazard and Risk Assessment Protocol for Cosmetic Ingredients Needing Special Considerations

Option Year 1: September 1, 2022 through August 31, 2023 (estimated)

Requirement Firm-Fixed Price Development of a Hazard and Risk Assessment Protocol for Cosmetic Ingredients Needing Special Considerations

6. STATEMENT OF WORK

DEVELOPMENT OF A HAZARD AND RISK ASSESSMENT PROTOCOL

FOR COSMETIC INGREDIENTS NEEDING SPECIAL CONSIDERATIONS

1. Background

The Food and Drug Administration (FDA) is responsible for providing regulatory oversight of the safety and proper labeling of cosmetics. In furtherance of its mission, FDA is developing protocols for assessing the safety of cosmetic product ingredients and now seeks to elaborate on its existing efforts. The present SOW focuses on expanding the existing protocol in order to assess hazards and risks of areas that were excluded from the previous protocol and updating the existing protocols which will help FDA to improve its approach for evaluating the safety of cosmetic product ingredients.

Information from related work previously done by FDA will be shared by the COR, at least in part, with the Contractor to help facilitate completion of the requirements in this SOW.

2. Purpose

The primary purpose of this requirement is to acquire a hazard and risk assessment protocol that requires special consideration to include 1) unique biological characteristics which may have an impact in the evaluation of ingredients in cosmetic products used by subpopulations such as infants and children, the elderly, people of color, and immunosuppressed individuals, 2) unique physiochemical characteristics which may have an impact in the evaluation of certain ingredients such as engineered nanomaterials used in cosmetic products. In addition, the requirement includes updating and improving the existing hazard and risk assessment protocol.

This requirement also includes an option year that consists of updating an existing aggregate risk assessment protocol and an existing education and training program.

3. Objectives

The primary objective of this requirement is for FDA to obtain a protocol that can be used to assess the hazards and risks by considering 1) the unique biological characteristics which may have an impact in the evaluation of ingredients in cosmetic products used by subpopulations such as infants and children, the elderly, people of color, and immunosuppressed individuals, 2) the unique physicochemical characteristics which may have an impact in the evaluation of certain ingredients such as engineered nanomaterials used in cosmetic products. In addition, the primary objective includes updating and improving the existing hazard and risk assessment protocol that will be shared, at least in part, by FDA.

Optional objectives of this requirement include 1) updating an existing protocol of aggregate risks presented from a single ingredient used in multiple cosmetic products via multiple routes of exposure, and 2) updating an existing education and training program that can be used to facilitate adherence to the protocols and conduct outreach about the protocol use by FDA, with stakeholders.

4. Scope

To assist FDA in the oversight of cosmetic safety and labeling, for the primary requirement, the Contractor shall develop a protocol that can assess the hazards and risks by considering 1) the unique biological characteristics which may have an impact in the evaluation of ingredients in cosmetic products used by subpopulations such as infants and children, the elderly, people of color, and immunosuppressed individuals,

2) the unique physicochemical characteristics which may have an impact in the evaluation of certain ingredients such as engineered nanomaterials used in cosmetic products. In addition, the requirement also includes updating and improving the existing hazard and risk assessment protocol to incorporated newer information from data published in the literature and making necessary modifications to the existing protocol based on FDA’s needs.

As an optional requirement, the Contractor shall update and improve an existing aggregate risk assessment protocol by incorporating updated scientific approaches/methods and demonstrate the practicality of the protocol by providing examples of aggregate risk assessment for a single ingredient used in multiple cosmetic products as well as via multiple routes of exposure. In addition, the Contractor shall update an existing education and training program for FDA to train its reviews and educate stakeholders.

5. Specific Tasks

5.1. Task 1. Draft Work Plan and Kick Off Meeting

5.1.1 The Contractor shall prepare a draft work plan two (2) week after contract award that outlines the activities and deliverables for each task along with a proposed delivery date for each task. It shall also include the names and expertise of personnel involved in each task.

The draft work plan shall be prepared using a template work plan that the Contracting Officer’s Representative (COR) will provide.

5.1.2 The Contractor shall conduct a kick-off meeting with the COR and staff of the Division of Cosmetics, Office of Cosmetics and Colors (OCAC), three (3) weeks after contract award in person or via telecom, to clarify outstanding questions and confirm the scope.

This task shall include, but not be limited to:

• The Contractor shall present via PowerPoint slides the draft work plan for discussion and possible revision.

5.2 Task 2. Revised and Final Work Plan

5.2.1 The Contractor shall revise work plan based on input from COR and OCAC.

5.2.2 After receipt of the COR’s acceptance of the revised work plan, the Contractor shall submit the final work plan five (5) weeks after contract award.

5.3 Task 3. Development of a Hazard and Risk Assessment Protocol

Under this task, the Contractor shall develop a protocol that can assess the hazards and risks by considering 1) the unique biological characteristics which may have an impact in the evaluation of ingredients in cosmetic products used by subpopulations such as infants and children, the elderly, people of color, and immunosuppressed individuals, 2) the unique physicochemical characteristics which may have an impact in the evaluation of certain ingredients such as engineered nanomaterials used in cosmetic products.

FDA will provide relevant information as a starting point; however, the Contractor is expected to identify additional relevant information available in the public domain.

5.3.1 The Contractor shall provide the technical information needed for protocol development.

A. Gathering unique biological characteristics of subpopulation that are required for assessing hazards and risks of cosmetic product ingredients.

B. Gathering unique physicochemical characteristics for ingredients of interest that are required for assessing hazards and risks of these ingredients.

C. Consulting with recognized subject matter experts in the clinical field, as well as, formulation and manufacturing of cosmetic products and their ingredients.

D. Identifying published toxicological and clinical endpoints and studies relevant to ingredients used in FDA regulated products.

E. Identifying published exposure estimates for the subpopulations under consideration as well as for those ingredients with unique physicochemical characteristics.

5.3.2 The Contractor shall provide technical support needed to identify hazard and risk assessment best practices.

A. Contractor toxicologists gathering existing hazard and risk assessment methodologies, in place or in development globally, for cosmetic ingredients and products.

B. Contractor toxicologists using results of this gathering to inform safety assessment methodologies that align with the scope of work and purpose of the proposed protocol.

C. This effort may be completed in parallel with 5.3.3 and 5.4.1 as key information that may influence the methodologies outlined in the protocol is likely to be gleaned with broader stakeholder engagement and involvement.

5.3.3 The Contractor shall draft protocol to assess the hazards and risks of cosmetic ingredients that fall within the scope of this requirement.

A. Facilitating stakeholder engagement to reach consensus on the requirements of the safety assessment protocol to create consistency and uniformity.

• Stakeholders may include: industry representatives, public health regulatory officials, user/consumer representatives, and academic researchers.

B. Reaching consensus during engagement with key stakeholders, Contractor develops an approach for drafting the protocol.

C. Demonstrate the practicality of the protocol by systematically going through examples of relevant biological characteristics of subpopulations of interest and physicochemical characteristics of ingredients of interest that might impact any risk assessment conducted.

5.3.4 The Contractor shall manage comment resolution process.

This shall include, but not be limited to:

A. Collecting and compiling comments received during the review process.

B. Providing responses to comments and working towards resolution of the comments obtained during engagement with key stakeholders.

5.3.5 The Contractor shall revise and finalize protocol document.

A. Meeting with the COR and OCAC, in person or via telecom, to discuss the protocol and possible revision.

B. Revision of the protocol based on input from COR and OCAC.

C. After receipt of the COR’s acceptance of the revised protocol, the final protocol shall be submitted.

5.4 Task 4. Update and improvement of the Existing Hazard and Risk Assessment Protocol

Under this task, the Contractor shall update and improve the existing hazard and risk assessment protocol to incorporate newer information from data published in the literature and making necessary modifications to the existing protocol based on FDA’s needs.

FDA will provide relevant information as a starting point; however, the Contractor is expected to identify additional relevant information available in the public domain.

5.4.1 The Contractor shall provide the technical information needed for protocol update and improvement.

A. Evaluating existing safety assessment methodologies, in place or in development globally, for cosmetic ingredients and products.

B. Identifying published toxicological and clinical endpoints and studies relevant to ingredients used in FDA regulated products, taking into account endpoints such as eye irritation, phototoxicity, and skin irritation that were not covered by the existing protocol.

C. Gathering recently published exposure estimates for FDA prioritized product categories.

D. Identifying potential areas, including tables, in the existing protocol that need updates based on newer information.

E. This task may be completed in parallel with 5.3.2 as the information gathered under 5.3.2 will provide technical support for completing this task.

5.4.2 The Contractor shall update and improve the existing protocol to incorporate the identified approaches and best practices to assess the hazards including the local adverse health effects and risks of cosmetic ingredients.

A. Updating the existing protocol by incorporating approaches for assessing local health endpoints such as eye irritation, phototoxicity, and skin irritation.

B. Updating the existing protocol in areas where updates are needed using newer data and information.

C. Demonstrating the practicality of the protocol by working through relevant examples in order to assess their hazards and risks under specific conditions of use.

5.4.3 The Contractor shall revise and finalize protocol document.

possible revision.

B. Revision of the protocol based on input from COR and OCAC.

5.5 Task 5. Update and improvement of an Existing Aggregate Risk Assessment Protocol for Cosmetic Ingredients

The Contractor shall update and improve an existing aggregate risk assessment protocol by incorporating updated scientific approaches/methods and demonstrate the practicality of the protocol by providing examples of aggregate risk assessment for a single ingredient used in multiple cosmetic products as well as via multiple routes of exposure.

FDA will provide relevant information as a starting point; however, the Contractor is expected to

5.5.1 The Contractor shall provide the technical information needed for protocol update and improvement.

A. Consulting with recognized subject matter experts in the formulation and manufacturing of cosmetic products and their ingredients.

B. Identifying and evaluating existing methodologies and tools for exposure estimation of the selected cosmetic products.

C. Identifying published toxicological and clinical endpoints, and studies relevant to ingredients used in FDA regulated products

D. Gathering recently published information on product use and exposure estimates for FDA prioritized product categories.

E. Identifying potential areas, including tables, in an existing protocol that need updates based on newer information.

5.5.2 The Contractor shall update and improve the protocol by incorporating the information to an existing protocol for assessing the aggregate exposure and risks of cosmetic ingredients.

A. Updating an existing aggregate exposure assessment protocol in areas where updates are needed with newer information.

B. Demonstrating the practicality of the protocol by providing examples of aggregate risk assessment for a single ingredient used in multiple cosmetic products and via multiple routes of exposure.

5.5.3 The Contractor shall revise and finalize protocol document.

possible revision.

B. Revision of the protocol based on input from COR and OCAC.

5.6 Task 6. Update of an Existing Education/Training Program

Under this task, the Contractor shall update an existing education and training program for FDA to train its reviews and educate stakeholders.

FDA will provide relevant information as a starting point; however, the Contractor is expected to

5.6.1 Contractor shall update existing education/training program requirements.

This shall include, but not be limited to:

A. Updating the criteria for the education/training program considering the protocols developed and revised under this contract.

B. Updating the education/training program including reviewer requirements by integrating the protocols developed and revised under this contract.

C. Developing new training modules and materials considering the work conducted in this present contract.

5.6.2 The Contractor shall revise and finalize education/training program documents.

A. Meeting with the COR and OCAC, in person or via telecom, to discuss the program documents and possible revision.

B. Revision of the program documents based on input from COR and OCAC.

C. After receipt of the COR’s acceptance of the revised program documents, the final program documents shall be submitted.

5.7 Task 7. Meetings with COR and OCAC

5.7.1 The Contractor shall meet with COR and OCAC bi-weekly to report the progress and clarify any questions.

5.7.2 The Contractor shall meet with COR and OCAC after the acceptance of all deliverables to present its protocols.

5.8 Task 8. Progress Report

5.8.1 The Contractor shall provide monthly electronic written progress reports of all deliverables that are being worked on at any given time, highlighting challenges which might impact the timeline.

6. Deliverables

The Contractor shall provide electronic copies of the deliverables listed in the table below in Microsoft Office. All deliverables shall be transmitted via email to the (Contracting Officer’s Representative) COR and shall become the permanent property of FDA/OCAC.

Task Number

Base/Option Year

Task Deliverables Estimated Time to Delivery

6.1.1 Base Year Draft work plan. Two (2) weeks after

contract award

6.1.2 Base Year Kick-off meeting with COR and OCAC, either in-person or via telecom, to discuss and revise work plan.

Three (3) weeks after contract award

6.2 Base Year Revised and final work plan. Five (5) weeks after contract award.

6.3.1-3 Base Year Technical information needed for protocol development;

Technical support needed to identify hazard and risk assessment best practices;

Draft protocol to assess the hazards and risks of cosmetic ingredients.

Six (6) months after contract award

6.3.4 Base Year Collect, compile, and respond to

comments.

Nine (9) months after contract award

6.3.5 Base Year Revise and finalize protocol document. Eleven (11) months after contract award

6.4.1-2 Base Year Technical information needed for protocol update and improvement;

Update and improve the existing protocol to incorporate the identified approaches and best practices to assess the hazards including the local adverse health effects and risks of cosmetic ingredients.

Six (6) months after contract award

6.4.3 Base Year Revise and finalize protocol document. Nine (9) months after contract award

6.7.1 Base Year Bi-weekly meeting (via telecom) with COR

and OCAC to report the progress and clarify any questions.

Every two (2) weeks after kick-off meeting until acceptance of all deliverables or twelve

(12) months after contract award.

6.7.2 Base Year Final meeting with OCAC to present

protocols.

Twelve (12) months after contract award

6.8.1 Base Year Progress report Every month after kick-

off meeting until acceptance of all deliverables or twelve

(12) months after contract award.

6.5.1-2 Option Year Technical information needed for protocol update and improvement;

Update and improve the protocol by incorporating the information to an existing protocol for assessing the aggregate exposure and risk of cosmetic ingredients.

Six (6) months after option year has been awarded

6.5.3 Option Year Revise and finalize protocol document. Nine (9) months after option year has been awarded

6.6.1 Option Year Update an existing education/training

program requirements

Nine (9) months after option year has been awarded

6.6.2 Option Year Revise and finalize program document. Eleven (11) months after option year has been awarded

6.7.1 Option Year Bi-weekly meeting (via telecom) with COR

and OCAC to report the progress and clarify any questions.

Every two (2) weeks after kick-off meeting until acceptance of all deliverables or twelve

(12) months after contract award.

6.7.2 Option Year Final meeting with OCAC to present

protocols.

Twelve (12) months after option year has been awarded

6.8.1 Option Year Progress report Every month after kick-

off meeting until acceptance of all deliverables or twelve

(12) months after contract award.

7. Government Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or GFI) The COR will provide a template work plan and, at least in part, information from related work previously done by FDA.

8. Place of Performance The work shall be performed at the Contractor’s site.

9. Period of Performance The period of performance will be a base of twelve (12) months plus one (1) option year for twelve (12) months. The Contractor shall report to the COR regarding any delays or setbacks concerning the project that may affect the anticipated completion date.

10. Inspection and Acceptance The COR will perform inspection and acceptance of deliverables to be provided. TBD, is the authorized representative of the Contracting Officer. FDA will review all data and deliverables and provide suggested revisions and clarifications prior to acceptance. Acceptance must be indicated in writing by the COR.

11. Contract Type Anticipated to be Firm-Fixed Price

12. Invoice Submission

FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is Michele Wiggins (Michele.Wiggins@fda.hhs.gov).

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses

52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite- Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than

NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment);

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, 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;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the 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.

1. Federal Acquisition Regulation (FAR) Clauses

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

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 Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es):

FAR: www.acquisition.gov

HHSAR:

https://www.hhs.gov/grants/contracts/contract-policies- regulations/hhsar/index.html

(End of Clause)

FAR CLAUSE # TITLE DATE

FAR 52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL

CONFIDENTIALITY

(JAN 2017)

FAR 52.204-25 PROHIBITION ON CONTRACTING FOR CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES

OR EQUIPMENT

(AUG 2020)

FAR 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES

REPRESENTATION

(OCT 2020)

FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

FAR 52.227-14 RIGHTS IN DATA – GENERAL (MAY 2014)

FAR 52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

CONTRACTORS (DEC 2013)

FAR 52.245-1 GOVERNMENT PROPERTY (JAN 2017)

FAR 52.247-34 F.O.B DESTINATION (NOV 1991)

FAR 52.247-35 F.O.B DESTINATION, WITHIN CONSIGNEE’S PREMISES (APR 1984)

FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders— Commercial Items (JUL 2021)

The additional FAR clauses cited in this clause that have a “check” or an “x” next to them are applicable to the acquisition. (Full text of this clause is in Attachment A – FAR 52.212-5 In Full Text Applicable to This Acquisition.)

(END OF CLAUSE)

2. Health & Human Services Acquisition Regulation (HHSAR) Clauses

HHSAR CLAUSE #

HHSAR 352.208-70

TITLE

PRINTING AND DUPLICATION

DATE

(DEC 2015)

HHSAR 352.211-3 PAPERWORK REDUCTION ACT (DEC 2015)

HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

HHSAR 352.224-70

INVESTIGATIONS

PRIVACY ACT

(DEC 2015)

(DEC 2015)

HHSAR 352.227-70 PUBLICATIONS AND PUBLICITY (DEC 2015)

352.224-71 Confidential Information (December 18, 2015)

(a) Confidential Information, as used in this clause, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Specific information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, which are confidential may be identified elsewhere in this contract. The Contracting Officer may modify this contract to identify Confidential Information from time to time during performance.

(c) Confidential Information or records shall not be disclosed by the Contractor until:

(1) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency.

(2) For information provided by or on behalf of the government,

(i) The publication or dissemination of the following types of information are restricted under this contract: includes any Personally Identifiable Information for attendees.

(ii) The reason(s) for restricting the types of information identified in subparagraph (i) is/are:

Any confidential information related to this contract; and personally identifiable that is covered through applicable laws and regulations shall not be published and shall be protected accordingly.

(iii) Written advance notice of at least 45 days shall be provided to the Contracting Officer of the Contractor's intent to disseminate or publish information identified in subparagraph (2)(i). The contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce

Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section- 508-standards.

(b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

The Section 508 accessibility standards applicable to this contract are:

• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

• E205 Electronic Content (Appendix A, Application and Scoping Requirements)

• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical

Requirements)

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html.

Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative

• E207 Software (Appendix A, Application and Scoping Requirements)

• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) http://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/Far/02.htm#P10_603 http://508.hhs.gov/ http://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html

• Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements)

• Chapter 6 Support Documentation and Services (Appendix C, Functional.

(a) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website:

(http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(b) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

352.203-7 ANTI-LOBBYING (DEC 2015)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive- legislative relationships, the Contractor shall not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the http://www.hhs.gov/web/508 http://www.hhs.gov/web/508

Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in subsections (a), (b), and(c) above shall include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

(End of clause)

3. Federal Acquisition Regulation (FAR) Provisions

52.217-8 Option to Extend Services (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor at any time before the contract expires.

FAR 52.217-9, OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor at any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend any time before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract including the exercise of any options under this clause, shall not exceed 30 months.

(End of Clause)

FAR 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:

FAR: www.acquisition.gov HHSAR: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

FAR PROVISION # TITLE DATE

FAR 52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN

INTERNAL CONFIDENTIALITY AGREEMENTS OR STATEMENTS-

REPRESENTATION (JAN 2017)

FAR 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

FAR 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS (JUL 2021)

FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (FEB 2021)

HEALTH & HUMAN SERVICES ACQUISITION REGULATION (HHSAR) PROVISIONS

HHSAR PROVISION # TITLE DATE

HHSAR 352.239-73 ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE (DEC

2015)

4. Food & Drug Administration (FDA) Articles

CONTRACTOR ADVERTISING OF CONTRACT AWARD

The Contractor shall not refer to the product or service awarded under this contract in commercial advertising, as defined in FAR 31.205–1, in any manner which states or implies the Food and Drug Administration's approval or endorsement of the product or service being provided; or, states or implies that the product or service being provided is considered to be superior to other industry products or services. The Contractor may request the Contracting Officer to make a determination as to the propriety of promotional material.

GOVERNMENT CLOSURES

Recognized Federal Holidays – The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

New Year's Day Columbus Day Washington's Birthday Veterans' Day Memorial Day Thanksgiving Day Juneteenth National Christmas Day Independence Day Independence Day Martin Luther King’s Birthday Labor Day

Any other day designated by Federal Statute. Any other day designated by Executive Order.

Observance of such days by Government personnel shall not be cause for an extension to the delivery schedule or period of performance or adjustment to the price, except as set forth in the contract.

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather.

In the event the Federal Government is closed by order of the President of the United States or the U.S.

Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the COR will reschedule any meetings impacted by a closure at no additional cost to the Government.

REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS (1-800-447-8477), 8:00 am – 5:30 pm Eastern Time, Monday –Friday. Fax 1-800-223-8164, TTY 1-800-377-4950. All telephone calls will be handled confidentially. The e-mail address is hhstips@oig.hhs.gov and the mailing address is:

HHS TIPS Hotline TIPS HOTLINE P.O. Box 23489 Washington, D.C. 20026

IDENTIFICATION OF CONTRACTOR EMPLOYEES

During the period of this contract, the rights of ingress and egress to and from any Government office for Contractor representatives shall be made available as required. All Contractor employees whose duties under this contract require their presence at any Government facility shall be clearly identifiable by a distinctive badge furnished by the Government. All prescribed information shall immediately be delivered to the FDA Personnel Security Branch for cancellation or disposition upon the termination of the employment of any Contractor personnel. All on-site Contractor personnel shall abide by security regulations applicable to that site.

OFFEROR’S CERTIFICATION - ORGANIZATIONAL CONFLICTS OF INTEREST

As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual, potential, or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract.

Offerors submitting quotes to perform work under this contract must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure and must avoid actions that would cause a reasonable person to question the impartiality of mailto:hhstips@oig.hhs.gov the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future contract actions. The Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found to be acceptable by the Government, and enforced.

POTENTIAL CONFLICTS OF INTEREST SPECIFIC TO THIS ORDER – Offerors shall review the Statement of Work in detail to identify any particular aspects that may present organizational or individual COI, either actual or apparent.

DEFINITION OF CONFLICT OF INTEREST - Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's or organization's objectivity in performing the contract is or might be otherwise impaired, or that the person or organization has or might acquire an unfair competitive advantage (See FAR 9.5).

ORGANIZATIONAL CONFLICT OF INTEREST

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this contract, and

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venturer, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflict. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the contract for cause, suspend or debar the contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities. Contractor shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the contract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after contract award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants the disclosure required in FAR Part 9.507

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(h) As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract action.

(i) Offerors submitting proposals to perform work under this contract must assure the protection of the information and data they receive in performance or under 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.