RFQ_FDA-SOL-1216425A.pdf

Request for Quotations (RFQ) No. FDA-SOL-1216425A Center for Biologics Evaluation and Research (CBER)

How to Write Clear and Concise Reviews - A Plain Writing Workshop

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 611430 – Professional and Management Development Training.

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 2019-06, effective September 10, 2019.

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. CONTRACT 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 type contract. The total contract period of performance consists of a base year and two (2) option years.

5. PRICING

Services shall be provided in accordance with the services described in the Statement of Work – Services to be performed during the periods of: September 30, 2019 through September 29, 2020 (Base Year); September 30, 2020 through September 29, 2021 (Option Year 1); and September 30, 2021 through September 29, 2022 (Option Year 2).

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

PERFORMANCE PERIOD: Base Year - September 30, 2019 through September 29, 2020

DESCRIPTION QUANTITIES UNIT PRICE EXTENDED PRICE

Technical Writing Course (Main Course/Initial Session) 12 $ $

Base Year FFP: $

PERFORMANCE PERIOD: Option Year 1 - September 30, 2020 through September 29, 2021

Technical Writing Course (Main Course/Initial Session) 4 $ $

Technical Writing Course (Refresher Session) 8 $ $

Option Year 1 FFP: $

PERFORMANCE PERIOD: Option Year 2 - September 30, 2021 through September 29, 2022

Technical Writing Course (Main Course/Initial Session) 5 $ $

Technical Writing Course (Refresher Session) 7 $ $

Option Year 2 FFP: $

GRAND TOTAL (BASE PLUS OPTION YEARS): $

6. STATEMENT OF WORK

CENTER FOR BIOLOGICS EVALUATION AND RESERACH (CBER)

HOW to WRITE CLEAR & CONCISE REVIEWS

A PLAIN WRITING WORKSHOP

1. Introduction

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 mission of Food and Drug Administration (FDA) is to protect the public health by ensuring safety of foods, drugs, cosmetics, medical devices and tobacco products. The Center for Biologics Evaluation and Research (CBER) is one of Centers that is responsible for ensuring the mission of the FDA is met. Part of CBER’s strategic plan is to 1) advance regulatory science & research and 2) manage for organizational excellence and accountability. CBER Training’s mission is to provide a comprehensive, effective program of mission critical education and training for CBER staff. To meet these key goals, CBER understands the need to focus on developing the soft and technical skills of assigned staff.

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Cures Act, states:

SEC. 3058. Least Burdensome Device Review.

(a) In General-Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following: " (j) Training And Oversight Of Least Burdensome Requirements.

(l) The Secretary shall “(A) ensure that each employee of the Food and Drug Administration who is involved in the review of premarket submissions, including supervisors, receives training regarding the meaning and implementation of the least burdensome requirements under subsections (a)(3)(D) and (i)(l)(D) of this section and section 515(c)(5); and B) periodically assess the implementation of the least burdensome requirements, including the employee training under subparagraph (A), to ensure that the least burdensome requirements are fully and consistently applied.

Medical Device user fees were first established in 2002 by the Medical Device User Fee and

Modernization Act (MDUFMA). Under the user fee system, medical device companies pay fees to the FDA when they register their establishments and list their devices with the agency, when they submit an application or a notification to market a new medical device in the U.S. and for certain other types of submissions. These fees help the FDA increase the efficiency of regulatory processes with a goal of reducing the time it takes to bring safe and effective medical devices to the U.S. market. The FDA Reauthorization Act of 2017, which includes the reauthorization of our user fee program known as Medical Device User Fee Amendment (MDUFA) IV, which was signed into law in August 2017, is effective from October 1, 2017 until September 30, 2022.

https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454029.htm https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454029.htm https://www.congress.gov/bill/115th-congress/house-bill/2430/text

2. Background

In accordance with the FDA Reauthorization Act of 2017, which includes the reauthorization of our user fee program, and the MDUFA IV Commitment Letter, it is mission critical for CBER staff to receive instruction on the process improvement and updated guidance for writing well-constructed deficiencies using “four-part harmony” that includes a statement for the basis for the deficiencies (e.g., a specific reference to applicable section of a rule, final guidance, recognized standard unless the entire or most of document is applicable). In the instance when the deficiency cannot be traced in the manner above and relates to a scientific or regulatory issue pertinent to the determination, FDA will cite the specific scientific issue and the information to support its position. All deficiency letters will undergo supervisory review prior to issuance to ensure the deficiencies cited are relevant to a marketing authorization decision (e.g., 510(k) clearance, PMA approval, and de novo classification). How to write clear and concise reviews and deficiencies will provide review staff with classroom training on the basic elements of plain writing and how to apply those elements to write lucid, logical technical documents relevant to the review of biological and related products regulated by CBER. This classroom training fosters a baseline of knowledge throughout the Center’s review staff and consistency in the review process.

3. Objective:

3.1 CBER requires the services of a commercial vendor to deliver a tailored off-the-shelf, technical writing course that teaches staff how to write clear and concise technical documents using Plain Language and is tailored to include examples of effectively writing deficiencies to manufacturers using four-part harmony to improve the manufacturer’s comprehension of FDA’s analysis of the review. CBER requires both initial and refresher classroom training for CBER personnel. The classroom training will help ensure CBER personnel provide clear and concise reviews of deficiencies when writing reports on manufacturer submissions. The course will need to be provided to the CBER population in the following number of iterations;

Base Year Option Year 1 Option Year 2 12 Initial Sessions 4 Initial Sessions 5 Initial Sessions

0 Refresher Sessions 8 Refresher Sessions 7 Refresher Sessions

4. Scope: The Contractor shall provide an off-the-shelf, CBER tailored course and refresher that covers writing clear and concise reviews that highlight deficiencies to provide CBER employees with tools and techniques on how to write clear and concise technical and regulatory documents using Plain Writing and Four-Part Harmony.

“Four-Part Harmony” is defined as a four-step process that provides the recipient of the deficiency letter with a clear and complete request. The steps are 1) What they provided; 2) What is deficient;

3) What we want; and 4) Why we want it. This consistent method of notifying manufacturers of a deficiency within their application package ensures consistency between FDA Centers and reviewers in how deficiencies meet the requirements outlined in the FDA Reauthorization Act of 2017.

5. Performance Requirements:

5.1 – Training Requirements

5.2 – Class Materials

5.3 – Training Instructor Qualifications

5.4 – Training Facilities

5.1 Training Requirements.

5.1.1 The Contractor shall be responsible for working with CBER assigned subject matter experts

(SME)/Project Officer(s) to tailor the Contractor’s off-the-shelf training using the Analysis, Design, Development, Implementation, and Evaluation (ADDIE) model to make the content applicable to the CBER environment.

5.1.2 The Contractor shall provide a full day workshop that covers writing clear and concise reviews highlighting deficiencies to provide CBER employees with tools and techniques on how to write clear and concise technical and regulatory documents using Plain English and Four-Part Harmony. Upon completion participants should be able to:

o Apply a consistent style, and approach to writing and proofreading to produce well written reviews that are identical in content, tone and style.

o Discuss the common vocabulary for talking about writing with peers and colleagues, which speeds collaborative writing projects and the editing process o Review the three causes of writers block and how to prevent them.

o Outline when and how to apply writing rules

5.2 Class Materials

The Contractor shall be responsible for providing each student with a student guide/manual, which must follow the outline of the course. The student guide/manual must include a syllabus as well as copies of the graphics shown in the class with note-taking space. Student Guides must include Terminal Learning Objectives (TLOs) and the Enabling Learning Objectives (ELOs). All material given to students must reflect the most current writing samples, tools and techniques. Other material to be included in the guide/manual is at the Contractor’s discretion, but must be supportive of the learning objectives. The student guides/manuals shall be provided to each student for retention when the training concludes.

The Contractor shall provide the COR with the following training materials (if applicable to the course):

syllabus, lesson plans, objectives, common terms study sheets, acronyms study sheets, and hands on exercises. The Contractor shall provide all necessary materials such as books, handouts, slides, and test. All student guides and training materials shall be provided to the COR for approval at least fifteen

(15) business days prior to the training start date.

The Contractor shall be responsible for ensuring all course materials arrive to the training location before each training course begins. The Contractor shall provide the COR with a complete and current set of all course related materials, tests, and test answers at least fifteen (15) business days prior to the training start date. Course related materials provided to the COR will be kept on file in CBER/OCOD. The COR will make the final determination on the appropriateness and quality of all training material.

5.3 Training Instructor Qualifications

Contractor personnel assigned to teach a course must have expertise in the subject area, must possess current instructional experience, defined as experience in training government personnel within the last three (3) years, and must be proficient in English. All instructors must understand all the requirements and tasks as they relate to security, classroom preparation, and course materials.

Instructors must be familiar with all initial presentation and remediation procedures, training aids, and devices and equipment associated with the course. Instructors must be proficient in performance-based practical exercises, if any, that will be included for each block of instruction.

Instructors must exhibit behavior conducive to a favorable learning environment to foster high student morale and motivation. Instructors shall abide by any FDA guidelines regarding integrity, grooming, conduct, speech, and fraternization.

The Contractor shall ensure that:

(a) The instructor(s) are at the classroom in enough time for the classroom, 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 have the ability to provide materials in such a way as to avoid student confusion.

(d) Instructor(s) are able to answer student questions consistent with the subject matter being taught, thereby demonstrating knowledge and familiarity with course materials.

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

5.4 Training Facilities

The Contractor shall be required to report to the FDA’s White Oak campus to the provided classroom.

Provided classrooms will include standard audiovisual equipment (i.e., overhead projector, screen, flipcharts, and projection systems for computer generated graphics) and computers required for the training course. The Contractor shall submit any additional requirements to the Contracting Officer Representative (COR) for approval prior to confirming a course date.

6. Deliverables

The following deliverables are required:

Group/Team Sessions for Teams and groups within the Offices and Divisions Deliverables Task Timeframe Participate in kick-off meetings with Subject Matter Experts

Interview Office/Division SME/Project Officer to analyze areas of need.

Within 1 Week after contract effective date

Work with subject matter experts on course content

Contractor provides design of the course based on the needs of CBER to ensure it meets review managements requirements.

Within 2 Weeks after contract effective date

Course development Contractor incorporates CBER requested elements to make the presentation relevant to a CBER audience

Within 3 Weeks after contract effective date

Submission Contractor will host a course pre- delivery meeting to review final presentation for approval.

Within 4 Weeks after contract effective date

Implementation Contractor shall deliver 12 initial sessions of approved content to CBER desired audience within the base year;

4 initial sessions and 8 refresher sessions in option year 1; and 5 initial sessions and 7 refresher sessions in option year 2.

Each session shall come with student guides and/or workbook, if applicable.

Within the first month of contract effective date for base year, option year 1, and option year 2

Course Review and Evaluation

Contractor shall work with the SME/Project Officer contacts to review and discuss any updates regarding completed sessions.

After completion of the first 12 sessions, the course will be evaluated to incorporate any updates or changes needed.

After each session

Evaluation to be complete after completion of all 12 sessions

To be arranged with the project officers

Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required throughout the period of performance of this contract must not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

7. PLACE OF PERFORMANCE

Unless otherwise specified, all meetings between the Contractor and FDA/CBER/OCOD/DMAT will be held on the White Oak Campus, located at 10903 New Hampshire Avenue (Building 71), Silver Spring, MD.

8. PERIOD OF PERFORMANCE

The period of performance for the base year shall be from September 30, 2019 through September 29, 2020. The period of performance for option year 1 shall be from September 30, 2020 through September 29, 2021, if exercised. The period of performance for the option year 2 shall be from September 30, 2021 through September 29, 2022, if exercised.

Hours of operation - CBER’s hours of operation are from 8:00 am—4:30 pm, Eastern Time. The Contractor shall work hours as necessary to accomplish the contract objectives.

9. GOVERNMENT FURNISHED EQUIPMENT/INFORMATION/PROPERTY

The Government will provide classroom class for the training to be provided, to include standard audiovisual equipment (i.e., overhead projector, screen, flipcharts, and projection systems for computer generated graphics) and computers required for the training course.

10. SECURITY AND CONFIDENTIALITY

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 task order. Failure to obtain a satisfactory security clearance from FDA may result in the termination of the contract.

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 the COR.

11. 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 (JAN 2017)

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 (Aug 2019)

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 B – FAR 52.212-5 In Full Text Applicable to This Acquisition.)

(END OF CLAUSE)

12. 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 confidental 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-http://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards 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

(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 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://www.hhs.gov/web/508 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)

352.203-70 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 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.

13. 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 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 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:

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 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 (AUG 2019)

FAR 52.212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS (OCT 2018)

FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (OCT 2018)

This provision applies to this acquisition. Offerors are to provide required data (Attachment A) with their quote, if representations and certifications 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)

14. 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 Independence Day Christmas Day Labor Day Martin Luther King's Birthday

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

CONTRACTOR PERSONNEL SECURITY CLEARANCE STANDARDS AND RESIDENCY REQUIREMENTS FOR

FOREIGN NATIONALS

See Attachment C.

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 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.

mailto:hhstips@oig.hhs.gov

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. 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).

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.

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.

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.

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.

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 perform any inherently governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government.