1. RFQ 1242552.docx .pdf

Solicitation FDA-21-RFQ-1242552 Center for Biologics Evaluation & Research (CBER)

Title: Quality System Regulation Training: 21 CFR 820 and ISO 13485

1. BACKGROUND

The development of staff in the Federal Government is important as reflected in the 1958 government Employee Training Act and codified in 5 CFR 410 which provides criteria for training and development programs. The development of leaders in the Federal Government is important with supervisor, management and executive training codified in 5 CFR 412 which provides criteria for programs offering initial training and continuous learning experiences.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.), as amended, establishes a comprehensive system for the regulation of devices intended for human use. The cGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the FD&C (21 U.S.C.

360j(f)), which was among the authorities added to the FD&C Act by the Medical Device Amendments of 1976 (Pub. L. 94-295). Under Section 520 (f) of the FD&C Act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing cGMP requirements for the methods used in, and the facilities and controls used for the manufacture, packing, storage, and installation of medical devices. This regulation became effective on December 18, 1978 and is codified under part 820.

Over the last twenty years, FDA and manufacturers have used the current Good Manufacturing Practices (cGMP) under Medical Device Quality System (QS) regulation (21 CFR part 820) to ensure the required methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of medical devices. The Agency understands and appreciates the need for Quality Management Systems (QMS) requirements that can apply to both large and small U.S. manufacturers for streamlining and harmonizing the standards for quality systems. As the Agency continues to apply least burdensome concepts for regulations, we recognize there is a need for a globally unified quality system that will reduce burdens to both industry and FDA.

FDA intends to harmonize QMS requirements for medical devices with the International Standards Organization’s (ISO) requirements for medical devices under the ISO 13485 (QMS Standard). The standard specifies requirements for a QMS where a manufacturer needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is comparable to the QS regulation, with some exceptions as it includes many of the essential requirements for ensuring manufacturing of reasonably safe and effective medical devices.

See the Section 7, Statement of Work (SOW).

2. COMMERCIAL ITEM PROCUREMENT

This is a solicitation for commercial items in accordance with the procedures of FAR Part 12 – Acquisition of Commercial Items and FAR Part 13 – Simplified Acquisition Procedures.

NAICS Code: 611430 - Professional and Management Development Training

3. 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

4. CONTRACT REQUIREMENTS

See Section 7, Statement of Work, for a full description of the supplies/services to be acquired.

5. CONTRACT TYPE

The Government anticipates awarding one (1) Firm-Fixed Price type purchase order. The total contract period of performance is for a base period of 12-months, and four option years.

6. PRICING

Services to be provided in accordance with those described in Statement of Work – Services to be performed during the period of September 1, 2021 through August 31, 2026 (estimated).

PERFORMANCE PERIOD: September 1, 2021 through August 31, 2026 (Estimated)

DESCRIPTION

QUANTITIES

UNIT PRICE

EXTENDED PRICE

Fully virtual or in-person format sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 with at least 1 instructor; Base Year Maximum 20 participants per session

3 sessions sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 with at least 1 instructor; Option Year 1

2 sessions $ $ http://www.acquisition.gov/ https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 with at least 1 instructor; Option Year 2

2 sessions sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 with at least 1 instructor; Option Year 3 sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 with at least 1 instructor; Option Year 4

FFP: $

7. STATEMENT OF WORK

Food and Drug Administration

Quality System Regulation Training: 21 CFR 820 and ISO 13485

Background The development of staff in the Federal Government is important as reflected in the 1958 government Employee Training Act and codified in 5 CFR 410 which provides criteria for training and development programs. The development of leaders in the Federal Government is important with supervisor, management and executive training codified in 5 CFR 412 which provides criteria for programs offering initial training and continuous learning experiences.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301 et seq.), as amended, establishes a comprehensive system for the regulation of devices intended for human use. The cGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the FD&C Act (21 U.S.C. 360j(f)), which was among the authorities added to the FD&C Act by the Medical Device Amendments of 1976 (Pub. L. 94-295). Under section 520(f) of the FD&C Act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing cGMP requirements for the methods used in, and the facilities and controls used for the manufacture, packing, storage, and installation of medical devices. This regulation became effective on December 18, 1978 and is codified under part 820.

Over the last twenty years, FDA and manufacturers have used the current Good Manufacturing Practices (cGMP) under Medical Device Quality System (QS) regulation) (21 CFR part 820) to ensure the required methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of medical devices. The Agency understands and appreciates the need for Quality Management System (QMS) requirements that can apply to both large and small U.S. manufacturers for streamlining and harmonizing the standards for quality systems. As the Agency continues to apply least burdensome concepts for regulations, we recognize there is a need for a globally unified quality system that will reduce burdens to both industry and FDA.

FDA intends to harmonize QMS requirements for medical devices with the International Standards Organization’s (ISO) requirements for medical devices under the ISO 13485 (QMS Standard).

The standard specifies requirements for a QMS where a manufacturer needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is comparable to the QS regulation, with some exceptions as it includes many of the essential requirements for ensuring manufacturing of reasonably safe and effective medical devices.

1. Purpose The purpose of this contract is to procure the Commercial Off the Shelf (COTS) in fully virtual format and in-person format; Quality System Regulation Training: 21 CFR 820 and ISO 13485 to ensure FDA staff are able to explain the scope and applicability of the requirements of 21 CFR 820 and ISO 13485.

2. Scope of Work FDA needs a commercial contractor to provide a total of 11 sessions of the above course in a fully virtual and/or in-person format for four days for up to 20 adult learners to support their learning and development needs. This scope consists of four (4) functional task areas, including, but not limited to:

1. Training Requirements

2. Training Instructor Qualifications and Expectations

3. Training Facilities

4. Class Materials

In performance of the tasks defined in this SOW, the Contractor shall leverage:

• Prior experience delivering quality management system training to FDA staff and industry professionals

• Standing as a Standards Developing Organization (SDO) developing and maintaining International Standards Organization (ISO) standards

• Contractor training covering ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes as well as training covering other related medical device standards

• A track record of success working with FDA to deliver training that incorporates FDA’s perspectives and expectations

• The Contractor shall also leverage subject matter experts from leading device manufacturers, the FDA, industry consultants, and the standards community, the Contractor’s existing training programs that cover relevant topics, and related standards and documentation, such as “AAMI TIR102:2019, U.S. FDA 21 CFR Mapping to The Applicable Regulatory Requirement References in ISO 13485:2016 Quality Management Systems.”

3. Task Areas Support in the following Task Areas are required under this contract. This list is not all inclusive, and additional tasks may be required.

3.1. Task 1: Training Requirements

Objective: The principle objective is to provide FDA professionals with training, exercises, and activities that will support the Center’s mission, and will help improve individual and organizational work products. Training will be delivered in fully virtual environment on a virtual training platform or the FDA White Oak campus.

Tasks:

• Provide at least one Instructor that can train on Quality System Regulation Training: 21

CFR 820 and ISO 13485 and delivery of the virtual or in-person training in partnership with the CBER Associate Director of Review Management.

• Provide a proposal that outlines the description of the course, measurable learning objectives, course duration, detailed course agenda, course activities, and training exercises. For example, use of the ADDIE model for class preparation, delivery and evaluation.

• Fully understand obligations to develop and maintain an effective Quality System under the 21 CFR 820 regulations.

• Provide interactive, real-world training through fully virtual format or in-person classroom on the essential Quality System standards, to be better prepared for future submission reviews or inspections.

• Provide a detailed training fee schedule that breaks down each cost by (the number of students permitted per class.

• Provide the maximum number of students permitted per class.

• Provide an exam assessing comprehension of the course material to all students at the end of the course

• Provide a course completion certificate to all students who complete the course and/or pass the course exam.

• Provide a course cancellation policy.

3.2. Task 2: Training Instructor Qualifications and Expectations

Objective: Obtain at least one instructor with expertise in the medical device industry regarding Quality Systems to include current instructional experience in training government personnel within the last three (3) years, and who is proficient in the English language.

Tasks:

• Instructor(s) must be considered a very high-level subject matter expert/consultant in the professional field of medical device quality management systems ISO 13485:2016.

• Instructor(s) must have 10 years of experience conducting quality management system audits to ISO 13485 and current experience auditing risk as incorporated in ISO 13485 and utilizing ISO 14971. The auditing experience must be as a notified body, registrar or regulatory authority conducting audits to ISO 13485 at different medical device manufacturers not owned by the same entity. Internal industry auditing does not meet this requirement.

• Provides at least one instructor who recognizes all the requirements and tasks that relate to security, fully virtual format and in-person classroom preparation, and course materials.

• Provides at least one instructor with the knowledge of all initial presentation and remediation procedures, training aids, and devices and equipment associated with the course.

• Provides at least one instructor proficient in performance-based practical exercises, if any, that shall be included for each block of instruction.

• Provides at least one instructor that exhibits behavior conducive to a favorable learning environment to foster high student morale and motivation.

• Provide at least one instructor who honors any FDA guidelines regarding integrity, grooming, conduct, speech, and fraternization.

• Provide at least one instructor that is capable of the following:

(a) The instructor(s) are at the fully virtual format or in-person classroom with enough time for the content, materials, and equipment to be ready and operational to begin the class at the appointed class start time.

(b) The instructor(s) are prepared to teach the class at the required level associated with the subject matter. An instructor may be deemed unprepared to teach with frequent occurrences of reading the overheads/graphics without substantive elaboration of material, failure to provide value-added insight to written materials, or an inability to deliver the material in a professional manner consistent with adult learning methodologies and professional level platform skills.

(c) The instructor(s) employ an organized manner of delivery, utilizing good time management, logical sequencing of course materials, following an established course agenda/syllabus, and the ability to provide materials in such a way as to avoid student confusion.

(d) The Instructor(s) can answer student questions consistent with the subject matter being taught thereby demonstrating knowledge of familiarity with course materials.

(e) The Instructor(s) provide instruction consistent with the course agenda/syllabus and do not alter the proposed course schedule.

3.3. Task 3: Training Facilities

Objective: Training will be provided in a fully virtual environment on a virtual training platform with the option to switch to an in-person classroom format at FDA White Oak campus. Ample notification (6 weeks) will be provided if this option is.

Tasks:

• Provide a list of instructor(s) needs no later than 6 weeks before the course begins (i.e.

Flipcharts, programs needed during the course such as MS Office, internet use, etc.).

• Provide a preferred fully virtual and/or in-person classroom format setup no later than 6 weeks before the course begins.

• Adhere to the policies of the room such as no food or no open drink containers (if applicable).

• Refrain from moving or rearranging furniture without permission (if applicable).

• Refrain from changing any settings on the computer system provided (if applicable).

3.4. Task 4: Class Materials

Objective: Each student will be able to retain the virtual reference material which will follow the outline of the course. Also provide students with copies of relevant standards, CBER-specific case studies and examples and a participant guide for easy note taking.

Tasks:

• Provide the most current virtual versions of all materials such as books, electronic documents, handouts, slides, and evaluations in support of the measurable learning objectives

• Provide electronic course materials at least 10 days prior to the start of the course.

• Provide instructor(s) PowerPoint slides or training aids at least 10 days prior to the start of the course.

• Provide to students copies with relevant standards, interactive exercises, and examples

5. Deliverables

Deliverables include:

DELIVERABLES TASKS DUE/SUBMISSION DATE

Kick-off Meeting (virtual) Meet with the TPOC and COR to determine training course needs

Within 2 weeks of contract award

Update Meetings (Virtual) Provide a detailed outline of course preparation and approach and CBER specific examples of case studies

Within 6 weeks of contract award

Implementation

Contractor will deliver up to eleven (11) four-day course sessions of approved content to FDA desired audience. Each session (virtual or in-person) will come with student virtual training manual or guides.

Within 4 weeks of contract award

See Period of Performance

Course Review and

Evaluation

Contractor will work with TPOC after each session to solicit feedback and discuss any areas of concern or adjustments.

After each course

Deliverables/Period of Performance

The Contractor shall provide:

Year Product Length FDA Staff

Base Year Sept 1, 2021 – Aug 31, Three (3) virtual or in-person training sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 scheduled in the Base

Period

Virtual or in-person sessions will be over four days with at least

1 instructor

1-20 students per session

Option Year 1 Sept 1, 2022 – Aug 31, Two (2) virtual or in-person training sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 scheduled in Option

Year 1

Virtual or in-person sessions will be over four days with at least

1 instructor

1-20 students per session

Option Year 2 Sept 1, 2023 – Aug 31, Two (2) virtual or in-person training sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 scheduled in Option

Year 2

Virtual or in-person sessions will be over four days with at least

1 instructor

1-20 students per session

Option Year 3 Sept 1, 2024 – Aug 31, Two (2) virtual or in-person training sessions for FDA staff on Quality System Regulation Training: 21 CFR 820 and ISO 13485 scheduled in Option

Year 3

Virtual or in-person sessions will be over four days with at least

1 instructor

1-20 students per session

Option Year 4 Sept 1, 2025 – Aug 31, Two (2) virtual or in-person training sessions for FDA staff on Quality System Regulation Training: 21

Virtual or in-person sessions will be over four days with at least

1 instructor

1-20 students per

CFR 820 and ISO 13485 scheduled in Option

Year 4

6. Period of Performance

The period of performance for the contract is anticipated to be from September 1, 2021 through August 31, 2026 Base Year + 4 Option years.

Base Year September 1, 2021 through August 31, 2022 Option Year I September 1, 2022 through August 31, 2023 Option Year II September 1, 2023 through August 31, 2024 Option Year III September 1, 2024 through August 31, 2025 Option Year IV September 1, 2025 through August 31, 2026

7. Place of Performance for Virtual or In-Person Training

Unless otherwise specified, the Course will be taught at various buildings on the White Oak Campus:

71, 75, CSU, 32. At the discretion of the COR, the course may be held virtually (as discussed at the kick-off meeting or subsequent planning meetings).

Food and Drug Administration, White Oak 10903 New Hampshire Ave Silver Spring, MD 20993

Consultant travel will not be paid.

FDA/CBER’s hours of operation are from 8:00 am—4:30 pm. The contractor will work hours as necessary to accomplish the contract objectives.

8. Government Furnished Equipment/Information/Property GFP/GFI is not being provided to the contractor

9. Security and Confidentially

The contract employees will need to undergo a security review and may need to obtain a security clearance. Type and details will be provided at the start of the purchase order. Failure to obtain a satisfactory security clearance from FDA may result in the termination of the purchase order.

The Contractor shall realize the regulatory nature of FDA and accept responsibility for diligence in protecting the security and confidentiality of any information acquired within the FDA.

During the course of the contract, if questions arise as to what information can be shared with any non-FDA personnel, the Contractor shall seek guidance and approval from Kei Pu’Uloa (COR).

10. Liability of Responsibility

The Contractor shall be subject to deductions for damages consequently incurred by the Government as a result of the Contractor’s nonperformance or defective performance. These deductions may apply in case of total default, partial default, or when a specific task order requirement is not performed, or, in the opinion of the CO, the Contractor has unsatisfactorily performed.

The Contractor shall be responsible for damages to Government Property and its contents that, in the opinion of the CO, result from negligence or non-compliance with the SOW. In such cases, the Contractor will be notified in writing by the CO and the Contractor will be given the opportunity to correct the damaged property at its expense within a timeline acceptable to the CO. If the Contractor fails to correct the damage under the terms agreed to with the CO, or otherwise fails to perform, the CO will determine the amount of the deduction to be imposed.

12. FEDERAL ACQUISITION REGULATIONS (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

FAR 52.212-4

Alternate I

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 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive

Orders— Commercial Items (July 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 C – FAR 52.212-5 In Full Text

Applicable to This Acquisition.)

(END OF CLAUSE)

http://www.acquisition.gov/

13. 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)

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

• Chapter 6 Support Documentation and Services (Appendix C, Functional 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://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/Far/02.htm#P10_603

(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)

14. FEDERAL ACQUISITION REGULATIONS (FAR) PROVISIONS

FAR 52.227-15 Representation of Limited Rights Data and Restricted Computer Software (DEC 2007)

a. This solicitation sets forth the Government’s known delivery requirements for data (as defined in the clause at 52.227-14, Rights in Data. General). Any resulting contract may also provide the Government the option to order additional data under the Additional Data Requirements clause at 52.227-16, if included in the contract. Any data delivered under the resulting contract will be subject to the Rights in Data. General clause at 52.227-14 included in this contract. Under the latter clause, a Contractor may withhold from delivery data that qualify as limited rights data or restricted computer software, and deliver form, fit, and function data instead. The latter clause also may be used with its Alternates II and/or III to obtain delivery of limited rights data or restricted computer software, marked with limited rights or restricted rights notices, as appropriate. In addition, use of Alternate V with this latter clause provides the Government the right to inspect such data at the Contractor’s facility.

b. By completing the remainder of this paragraph, the offeror represents that it has reviewed the requirements for the delivery of technical data or computer software and states [offeror check appropriate block].

[ ] (1) None of the data proposed for fulfilling the data delivery requirements qualifies as limited rights data or restricted computer software; or

[ ] (2) Data proposed for fulfilling the data delivery requirements qualify as limited rights data or restricted computer software and are identified as follows:

http://www.hhs.gov/web/508 http://www.hhs.gov/web/508 https://www.acquisition.gov/sites/default/files/current/far/html/52_227.html#wp1139363 https://www.acquisition.gov/sites/default/files/current/far/html/52_227.html#wp1139459 https://www.acquisition.gov/sites/default/files/current/far/html/52_227.html#wp1139363

N/A

c. Any identification of limited rights data or restricted computer software in the offeror’s response is not determinative of the status of the data should a contract be awarded to the offeror.

(End of provision)

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 this/these address (es):

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 (JAN 2017)

CERTAIN INTERNAL CONFIDENTIALITY AGREEMENTS OR

STATEMENTS-REPRESENTATION

FAR 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS (JUN 2020)

FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS— (JUN 2020)

COMMERCIAL ITEMS

This provision applies to this acquisition. Offerors are to provide required data as (Attachment B) with their quote, if reps and certs have not already been completed in SAM.gov.

HEALTH & HUMAN SERVICES ACQUISITION REGULATION (HHSAR) PROVISIONS

HHSAR PROVISION # TITLE DATE

HHSAR 352.239-73 ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE (DEC 2015)

FOOD & DRUG ADMINISTRATION (FDA) ARTICLES

15. 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 http://www.acquisition.gov/

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.

16. 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 Independence Day Christmas Day Labor Day Martin Luther King's Birthday Juneteenth National Independence 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.

17. 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

18. 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 mailto:hhstips@oig.hhs.gov 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.

19. 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 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 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 TASK 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).

20. 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. Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found acceptable by the Government and enforced

(j) POTENTIAL CONFLICTS OF INTEREST SPECIFIC TO THIS CONTRACT - Offerors shall review the Statement of Work included in each RFTOP in detail to identify any 47 particular aspects that may present organizational or individual COI, either actual or apparent.

(k) 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 9.501).

(End of clause)

21. FDA 1350 ACCESS TO NON-PUBLIC INFORMATION

All Contractor and subcontractor employees are required to sign the Contractor's Commitment to Protect Non-Public Information (NPI) Agreement (Form FDA 3398) provided as Attachment D –to this contract If a person who has signed this agreement resigns, is dismissed, or is otherwise no longer working on this contract, the Contractor shall notify the FDA Project Officer and the Contracting Officer. Any new Contractor or subcontractor employee assigned to this contract shall sign the form, and the Contractor shall hand-deliver it to the Contracting Officer ten (10) days prior to said new employee's commencement of work on this contract.

The prime Contractor, subcontractors, and consultants shall not be provided nor possess non-public information in any form unless written approval has been granted, nor shall they have unaccompanied access to an FDA facility unless a facility clearance has been granted.

22. BRIEFINGS

An FDA representative (typically, the Contracting Officer’s Representative) will conduct an orientation briefing for the Contractor and subcontractor employees. The briefing will stress: (1) the importance of protecting non-public information; (2) specified computer/IT requirements as outlined in the DHHS Automated Information Systems Security Program Handbook; and (3) the consequences of unauthorized disclosure of non-public information. Briefing updates will be conducted annually.

The Contractor shall brief all Contractor employees, subcontractors and consultants regarding the sensitivity of the information to be handled under the contract and of their responsibility to protect it.

The briefing shall stress that the information is non-public and shall not be disclosed to any unauthorized party. The Contractor shall conduct an updated briefing annually and shall submit a report to the FDA Project Officer within ten (10) days after the briefing which includes: an outline of the briefing; copies of any briefing materials; the date the briefing was conducted; and the names of the attendees.

If this is an information technology/telecommunications (IT/TC) contract, in addition to the above briefings, the FDA COR and the FDA Center/Office Information Systems Security Officer (ISSO) will brief the Contractor and subcontractor personnel on security measures required pertinent to any hardware/software being utilized. Furthermore, appropriate Contractor and subcontractor personnel shall attend training courses as directed by the FDA to fulfill requirements of the Computer Security Act of 1987. These courses are generally one (1) day in length, and attendance at one (1) course is sufficient. This training will be provided at no cost to the Contractor.

23. GOVERNMENT-FURNISHED DATA AND MATERIALS

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.

24. NOTICE TO THE GOVERNMENT OF DELAYS

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

25. NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENT FUNCTIONS

Pursuant to FAR 37.1, no personal services shall be performed under this contract. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

The Government and the Contractor understand and agree that the services delivered by the Contractor to the Government are non-personal services. The parties also recognize and agree that no employer-employee relationship will exist between the Government and the Contractor. The Contractor and the Contractor’s employees are not employees of the federal Government and are not eligible for entitlement and benefits given federal employees.

Pursuant to FAR 7.5, the Contractor shall not…