75F40120R00001 AMENDMENT 0002.pdf

(x)

75F40120R00001 x x

1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

ATLANTA GA 30309

SE10

60 8TH STREET NE

ATTN: LINDA TROUTMAN

DHHS/FDA/OAGS/DAP

FOOD & DRUG ADMINISTRATION

05/12/20200002

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

03/01/2020

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return ________1__________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

The purpose of Amendment 0002 is to do the following:

1. To provide responses to questions submitted in accordance with the solicitation terms and conditions labeled as FDA-SOL 75F4012R00001 Questions and Responses.

2. To revise SF 33 cover rev, RFP 75F4012R00001 rev, Attachment J-4 rev, Attachment J-6 rev, and Attachment J-7 rev.

3. To add the following FAR clauses: 52.204-4, 52.204-25, 52.209-7, 52.219-8, 52.219-9, and

52.219-16.

4. To add the following HHSAR clauses: 352.215-70, 352.231-70, 352.233-71, 352.239-73, and

352.239-74.

5. To add Section H.10 through H.13 to the RFP.

Continued ...

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

MONIFA N. COLEMAN

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

FOOD & DRUG ADMINISTRATION

DHHS/FDA/OAGS/DAP

ATTN: LINDA TROUTMAN

60 8TH STREET NE

ATLANTA GA 30309

X

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

2 2

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

75F40120R00001/0002

6. To add Attachment J-8 Non-Disclosure Agreement and Attachment J-9 Subcontract Plan.

7. To revise Section I to include HHSAR clause entitled, Security and Privacy Language for

Information Technology.

8. To clarify and revise Sections L&M in accordance with FDA-SOL 75F4012R00001 Questions and Responses.

9. To add Subcontract Plan to Section L. 5.3.3 (Tab-A).

ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED.

Period of Performance: 06/29/2020 to 06/28/2025

NSN 7540-01-152-8067 OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

Solicitation Number: 75F40120R00001

Safety Engineering Support, Industrial Hygiene, Laboratory Science, Labor security, and Occupational Health and Safety support services-IDIQ

PART I – THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Brief Description of Supplies or Services

The Office of Laboratory Safety (OLS) supports the Food Drug Administration (FDA) mission by providing services, policy, and oversight for laboratory science, laboratory security, environmental, and occupational safety and health programs.

To accomplish the OLS strategic goals the FDA requires technical assistance to promote the standardization of laboratory practices and policies at the FDA. It is anticipated that this contract will provide laboratory quality, safety, and security support services across the agency.

In performing the work as described in detail in Section “C” the Offeror shall consider the following:

This is a single Indefinite Delivery, Indefinite Quantity (IDIQ) task order contract. This IDIQ will consist of hybrid task order contract types which include: Firm-Fixed Price (FFP), Time and Materials (T&M), or Labor Hour (LH).

As the need for services covered by this contract arises, the Government will issue a Task Order (TO) to the Offeror with all the necessary documentation of project requirements, under cover of a written request for proposal to perform the required services.

B.2 Maximum Total Contract Amount

The Government guaranteed issuance of the first TO as the minimum order amount for the life of the contract. The total cumulative amount payable under this contract shall not exceed $49,500,000.00 (Contract Schedule Modification Effected by Option Exercise) for services and materials furnished to the Government under such TOs as may be issued by the Government.

This is the maximum ceiling amount allowed under this contract, and it is not intended to imply that it is an estimate of the total services that will be required.

B.3 Pricing / Equipment Schedule

The Task Areas are in spreadsheet form which contains all information about each task area under this contract. See Attachment J-6 Task Areas Worksheet.

SECTION C – STATEMENT OF WORK

C.1 Background

The FDA is a science-based regulatory agency critically important to the stability of the nation’s public health and health care systems. The FDA is responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices. In addition, the FDA is responsible for the safety and security of most of our nation’s food supply, cosmetics, and dietary supplements. To this end, the FDA has six (6) product-oriented centers in addition to a worldwide field force to carry out its mission. The FDA Headquarters is located on the 130-acre White Oak Campus in Silver Spring, Maryland.

The Industrial Hygiene program requires a supporting managerial structure to ensure services are efficiently managed and consistently delivered across the enterprise. The Industrial Hygiene program must ensure that quantitative and qualitative environmental exposure data are organized, analyzed, reported and archived as part of an institutional and employee record.

Furthermore, the future Industrial Hygiene program must determine the appropriate levels of infrastructure, budgets, and staffing to support a science-based approach to assessing and managing occupational exposures.

Approximately 40 Occupational Safety and Health Officers (OSHOs) provide occupational safety and health services across the Centers and Offices. Capabilities and scope of practice vary widely, as do protocols, procedures, data management, and local documentation. Coordination to solve common problems has been lacking. The Agency is seeking a common platform to collect, analyze, report, and archive data and manage programs.

C.2 Business Objectives

The purpose of this Indefinite-Delivery-Indefinite-Quantity (IDIQ) contract is to obtain support services for laboratory design and safety engineering reviews; to maintain and manage primary barrier equipment; to provide industrial hygiene services; and to support laboratory quality, security, and safety practices. Examples of these support services include: conducting thorough reviews of safety design plans for FDA laboratory renovations and new construction activities;

providing advice and guidance to OLS staff including professional reports; assisting the OLS with validation and acceptance phases of new research facilities, including high containment prior to occupancy; and performing general and local exhaust ventilation studies, and indoor air quality studies.

Additionally, the FDA is seeking services with Industrial Hygiene, which include: performing general and local exhaust ventilation studies, indoor air quality studies, quantitative and qualitative exposure assessments, industrial hygiene management system design and analysis, development of industrial hygiene processes, procedures, forms and records, and many other related support activities.

FDA has eight (8) sites that work with Biological Select Agents and Toxins (BSATs), seven (7) sites that manage Controlled Substances, and all twenty (20) of its sites work with some combinations of Hazardous Biological Agents and Toxins (HBATs), hazardous chemicals, and radioactive materials. These biological, chemical and radioactive materials can present usage, storage and waste management risks and hazards to FDA employees working in laboratories as well as to the public.

C.3 Scope

The Contractor shall provide technical support with Safety Engineering Support, Industrial Hygiene, Laboratory Science, Labor security, and Occupational Health and Safety support services to include but are not limited to:

1. Initiation and execution of program and project management the entire Safety Engineering and Occupational Safety (SEOSS) requirement;

2. Successful transition of new contractor personnel supporting the SEOSS requirement;

3. Design, integration, and maintenance of fully compliant laboratory equipment and environments Agency-wide;

4. Development and execution of an Industrial Hygiene Program that is Agency-wide and includes assessments / evaluations of field location requirements;

5. Perform preventative maintenance, repair, certification of primary barrier equipment in the laboratories including those in high-containment laboratories regardless of geographic location;

6. Development of recommendations for the functional, technical, and business requirements for SEOSS Management System; and

7. Development and execution of a robust Laboratory Safety, Quality and Security Management Program through communication, training, and standardization of policies and procedures in all FDA laboratory facilities.

Standards and guidelines that shall be considered in the execution of this IDIQ SOW include:

1. The Contractor shall comply with standards of the Occupational Safety and Health Administration (OSHA) Act of 1970.

a. Additionally, Contractor shall ensure that its Respiratory Protection Program complies with 29 CFR 1910.

b. The provision of all support services through this contract are therefore necessary for ongoing compliance with federal, state and local regulations, as well as

c. integrating best practices in design, testing, commissioning and certification of laboratory facilities. In consulting on the design and layout of FDA’s laboratory facilities, the contractor must comply with any FDA required specifications, the National Institutes of Health (NIH) Design Requirements Manual (DRM), the Center for Disease Control (CDC) specifications for bio-lab design, Biosafety in Microbiological and Biomedical Laboratories (BMBL), and Federal Select Agent Program (FSAP) requirements. This list of regulations, policies, and standards is not all inclusive and additional constraints will be specified within individual Task Orders.

2. The Contractor shall comply with NSF / ANSI 49 for certification biological safety cabinets.

3. The Contractor shall implement all programs and projects in accordance with American National Standards Institute (ANSI) Z-10, “Occupational Health and Safety Management Systems.”

4. The Contractor shall comply with and ensure work products are aligned with existing Office of Laboratory Science and Safety Directives and Policies.

C.4 Technical Requirements

The Contractor shall provide safety engineering and occupational safety support services throughout the performance period. This will include providing Program and Project Management services; Transition services; Safety Design and Engineering Advocacy Support services; Primary Barrier Maintenance and Support services; Industrial Hygiene services;

Management System Requirements Development support services, and Laboratory Science, Laboratory Security, and Laboratory Safety support services at the FDA White Oak Campus and multiple locations throughout the United States. (See Attachment J-2 Locations.)

C.5 Reporting Requirements

The Contractor shall provide a Monthly Status Report (MSR) to the assigned IDIQ Contracting Officer Representative (COR) incorporating all tasks at a high level and their progress. Within the first 30 calendar days after IDIQ award, the Government and the Contractor shall design and agree upon a standard reporting format and timeframe. At a minimum, unless otherwise specified within the individual order, each MSR shall contain the following information:

1. The previous month’s activities (completed and in-progress);

2. Deviation from previous month’s planned progress (either positive or negative);

3. The current month’s planned activities (complete and in-progress);

4. All current risks and planned mitigations;

5. Status of unfilled positions and actions taken to fill open positions;

6. Performance and Cost Report (P&CR): P&CR shall include all recurring and non-recurring costs, cumulative cost, total labor hours, and cumulative labor hours for each task area for the previous month;

7. The status of the action items from any Kickoff Meetings and other follow-on meetings, as appropriate; and The MSR must be submitted via email on the third business day of the month to the IDIQ COR.

C.6 Description of Task Areas

The Contractor shall provide safety engineering and occupational safety support services throughout the performance period. This will include providing Program and Project Management services; Transition services; Safety Design and Engineering Advocacy Support services; Primary Barrier Maintenance and Support services; Industrial Hygiene services;

Management System Requirements Development support services, and Laboratory Science, Laboratory Security, and Laboratory Safety support services at the FDA White Oak Campus and multiple locations throughout the United States. (See Attachment J-2 Locations).

Additionally, the Contractor shall provide both IDIQ-level Program Management services and Order-level Project Management services to establish control, management, monitoring, and notification mechanisms for the SEOSS IDIQ requirement. Moreover, the Contractor shall work with the Government Technical Lead (s) (GTL), COR, and Subject Matter Experts (SMEs) to ensure that tasks stay on track and important milestones are met.

C.6.1 Task 1: PROGRAM MANAGEMENT AND ORDER MANAGEMENT - The Contractor shall provide Program Management at the IDIQ level and order Project Management support for the SEOSS IDIQ requirement. Program Management and Project Management support services includes: the effort to plan, structure, coordinate, schedule, manage, communicate, report, and steward all respective SEOSS support services throughout the IDIQ period of performance. The Contractor shall provide both IDIQ-level Program Management services and order-level Project Management services to establish control, management, monitoring, and notification mechanisms for the IDIQ SEOSS requirements.

Additionally, the Contractor shall provide both IDIQ-level Program Management services and Order-level Project Management services to establish control, management, monitoring, and notification mechanisms for the SEOSS IDIQ requirement. Moreover, the Contractor shall work with the Government Contracting Officer (CO), GTL, COR, and SMEs to ensure that tasks stay on track and important milestones are met.

C.6.2: Program Management Plan (PMP) and Order Management Plan (OMP) - The Contractor shall provide a PMP for the IDIQ as a part of any technical submission, as well as being tasked in an individual task order. This plan shall include, but not limited to:

1. The management approach, organizational structure, organizational resources, and management controls to be used to meet the IDIQ requirements throughout the contract’s period of performance;

2. The process to oversee and manage work activities at the IDIQ level;

3. The process to recruit, train, retain, and replace personnel at the IDIQ level; and

4. A communication diagram illustrating all lines of communication between the

Government and the Contractor.

The PMP, an OMP may be requested, as directed. The OMP may include, but is not limited to:

1. Process to oversee and manage work activities at the order level;

2. A schedule that details activities, dependencies, and timeframes for meeting FDA objectives and deliverables;

3. A staffing plan and organizational chart identifying relationships, authorities, and responsibilities;

4. A level three (3) Work Breakdown Structure (WBS) to account for all the work requirements and activities, as described in the individual order. Specifically, the WBS elements illustrate the sequence and resources required for each work package;

5. A description of the management controls that the Contractor shall employ to meet the performance, cost, and schedule requirements, and other areas the Contractor deems relevant and important to the management of the order;

6. A communication diagram illustrating all lines of communication between the Government and the Contractor; and

7. The Contractor shall update the OMP when re-planning any activities and submit to the assigned task order COR, GTL, CS, and CO for approval

C.6.3: Project Meetings - The Contractor shall participate in meetings and discussions that support the overall efforts the IDIQ requirement and the order work activities (e.g. kick-off and task related meetings). The Contractor shall participate in different capacities, such as leading discussions; contributing questions and answers; raising issues, risks and concerns; and developing and giving presentations. The Contractor shall prepare, and track meeting agendas, minutes, issues, risks, and action items as requested by the Government. Meeting minutes shall be of sufficient detail to accurately document meeting date and location, meeting purpose, items discussed, decisions made, attendees, and action items. Representative activities include, but are not limited to:

1. Coordinating quarterly project meetings to plan, strategize, and execute all programs and projects;

2. Preparing and distributing agendas to include call-in/teleconference information and review materials;

3. Completing and distributing meeting minutes and action items to meeting participants;

and

4. Tracking of meeting minutes, action items, and associated materials relating to all meetings / calls.

C.6.4: Risk Management - The Contractor shall identify, report, and address for resolution to the Government any issues that prevent the Contractor from performing the work activities in any individual order that the Contractor is unable to resolve independently. For each individual order, the Contractor shall document and report the risks and opportunities within a risk registry.

The Contractor shall maintain the risk registry and provide it to the assigned IDIQ COR, CS, and CO on request. The risk registry shall contain, at a minimum, unless otherwise specified in the individual orders:

1. Issue Number: a sequential numbering of all issues;

2. Severity: assessment of issue severity i.e., likelihood and consequences

(High/Medium/Low)

3. Date Found: – date that issue was identified by the Contractor;

4. Duration: number of days that issue has been open;

5. Status: representing issue status as open or closed. The Contractor shall maintain a complete list of all issues – no issues should typically be deleted from the Contractor’s delivered list;

6. Title: short description of issue;

7. Updated: date for updated status;

8. Details: narrative description of activities that have been completed to resolve issue;

9. Assigned To: identify Government Point of Contact (POC) or Contractor that is assigned to resolve the issue; and

10. Solution or Workaround: description of the actions and activities taken to resolve or mitigate the issue.

C.7 Task 2: TRANSITION OF SERVICE - Transition activities take place to efficiently transition all activities to the new IDIQ Contractor. As tasked, the Contractor shall develop transition–in and transition-out plans and conduct transition activities for orders issued against this IDIQ vehicle.

C.7. 1 Transition-In As specified within the individual order, the Contractor shall transition-in and assume the responsibility for activities and duties in a manner that does not interrupt or negatively impact FDA’s provisioning of SEOSS operations. The purpose of the Transition-in requirement is to provide an orderly transition to the IDIQ Contractor.

For a period of time, as specified by the individual order, the Contractor shall work with the Government to ensure a smooth transition of work from the current service providers to the IDIQ Contractor. Representative activities include, but are not limited to:

1. Developing a Transition-in Plan to ensure full operating accountability and responsibility of the individual order;

2. Conducting and coordinating all on-boarding activities, to include the badging for team personnel;

3. Reviewing objectives, processes, and requirements as related to the tasks and activities being performed;

4. Participating in Transition-in meetings (initially to be held jointly with the current service providers);

5. Participating in other information exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the current service providers;

6. Ensuring Contractor personnel are available to work immediately after IDIQ individual order award;

7. Certifying that employees working on the contract have completed a review of FDA and SEOSS policies and understand the requirements, documentation, and processes prior to the completion of the Transition-in activities.; and

8. Verifying to the COR that all the Transition-in documents are available.

C.7.2 Transition-out As specified within the individual order, the Contractor shall conduct the transition-out of contracted activities and services to a follow-on Contractor by the end of the contract period of performance. If a follow-on Contractor has not been identified, the Contractor shall transition contracted activities and services to the FDA.

As specified by the individual order, the Contractor shall conduct transition-out activities. During this period, the Contractor shall ensure no degradation in support services provided under the order. Between the turnover date designated by the COR and the end of the contract period of performance, the outgoing Contractor shall ensure all order activities are closed out and it shall provide sustainment support to complete the transition. Representative activities include, but are not limited to:

1. Developing and submitting a Transition-Out Plan and Schedule to the COR;

2. Providing the FDA with current versions of all documentation developed (e.g. Standard

Operating Procedures [SOPs] and Manual of Operations);

3. Providing the FDA with a current inventory of all Government-Furnished Equipment

(GFE) and Government Furnished Information (GFI) utilized by the Contractor along with full support in the reconciliation of this inventory; and return to FDA all GFE that has not been transferred to the follow-on Contractor.

4. Providing the follow-on Contractor with the ability to “shadow” and participate in technical exchange meetings and opportunities to facilitate the transfer of information, processes, and data needed to continue the services being performed by the Contractor.

C.8 Task 3: SAFETY, DESIGN AND ENGINEERING ADVOCACY SUPPORT SERVICES - Contractor shall perform the review of construction plans to ensure specifications for general laboratory safety design (e.g. wet chemistry, vivarium), supply and exhaust systems (HVAC and local exhaust ventilation), and equipment (e.g., biological safety cabinets, safety showers, eyewash stations, laboratory fume hoods), so they meet all applicable standards and guidelines.

The Contractor shall validate air balance reports to ensure proper air flow dynamics; validating facility system controls; and other safety and health related monitoring efforts. The safety design engineer shall ensure that appropriate specialist(s) is/are included when specialized safety engineering or safety design input may be required. Representative activities include, but are not limited to:

1. Collaborate with OSHOs, facility personnel (e.g., construction Contractors, hazardous waste Contractors, leasers, commissioning teams, maintenance teams, and facility safety implementation personnel), FDA management, and Contractors before, during and/or after the commissioning process to assist with plan reviews, validation testing of the facility’s systems to identify safety and health issues specific to high containment laboratories and other laboratory and support facilities.

2. Coordinate with industrial hygienists to conduct general and local exhaust ventilation studies, indoor air quality studies, and assessments of chemical, biological, and radiological usage and disposal.

3. Consult with laboratory personnel, OSHOs, and engineering staff on design requirements and layout of rooms and docks; general flow of traffic within the lab facility to minimize the exposure to any potential hazards (i.e., radiation, biological agents, compressed gases and chemicals); reviewing the placement of emergency and primary containment equipment; and assisting with engineering support as needed.

4. Ensure the safety and efficacy of primary barrier equipment utilized in FDA laboratories, to will include the maintenance, initial commissioning, decontamination, certification, and testing of all primary barrier equipment, including, but not limited to, biological safety cabinets, chemical fume hoods, heating, ventilation, and air conditioning (HVAC) systems, high-efficiency purifying air (HEPA) filters, and down draft tables;

5. Monitor and validate air balance reports and monitor, validate, and calibrate specialized air flow systems (e.g., Differential Pressure Monitors (DPMs), Phoenix Box Controls) to ensure proper air flow dynamics

6. Coordinate with FDA OFEMS on projects involving new construction and renovations

7. Serve as a SME on construction projects, including but not limited to construction of high

8. containment laboratories and vivaria. The Contractor shall assist in the development and delivery of presentations as it relates to facility design and operation requirements, laboratory validation and certification processes, and regulatory compliance matters.

9. Performing ad hoc research and analysis activities, drafting of ad hoc presentations, and designing and developing leadership presentations to communicate the status and future state of OLSS programs and their objectives to both internal and external audiences.

10. Completing quality assurance for reports, documents, and manuals;

11. Drafting of presentations for key stakeholders to report on the progress of implementing the new operating model and to clearly articulate the change and standards.

C.9 TASK 4: PRIMARY BARRIER EQUIPMENT MAINTENANCE, TESTING,

DECONTAMINATION, AND CERTIFICATION - The Contactor shall support the collection of information and facilitation of communication with all relevant stakeholders including laboratory and operations staff to understand the needs and challenges in relation to primary barrier equipment maintenance and repair.

The Contractor shall coordinate activities between laboratory scientists and maintenance engineering and facility staff (to include OFEMS and GSA). Representative tasks in this area may include, but are not limited to:

1. Conduct a multi-phase assessment of the Primary Barrier Equipment within the FDA;

a. Identify and document current-state of Primary Barrier Equipment being employed by the FDA and each item’s certification status;

b. Perform a needs analysis to determine the appropriateness of equipment being utilized within the Agency;

c. Test Primary Barrier Equipment to certify or document necessary repairs to achieve certification status; and

d. Recommend equipment for surplus, replacement, or disposal.

2. Perform decontamination services, to include equipment, rooms, laboratories, suites, and corridors;

3. Conduct repair and certification of primary barrier equipment;

4. Proactively monitor equipment certification expiration dates to ensure all certified equipment remains compliant;

5. Maintain Primary Barrier Equipment testing and certification records.

6. Primary Barrier Equipment may include, but is not limited to:

a. Class I biological safety cabinets;

b.Class II, Type A biological safety cabinets;

c. Class II, Type B biological safety cabinets;

d.Class III biological safety cabinets;

e. Air exhaust, supply plenum, automated/fixed dampers, primary/secondary automation controls;

f. Autoclaves and autoclave vent/vent stack HEPA filters;

g.Vacuum and CO2 system HEPA filters;

h. Magnehelic HEPA equivalent filters;

i. HEPA filtered powered exhaust units (asbestos barrier filters);

j. Laboratory ventilation hoods;

k. Calibration of ventilation hood alarms;

l. Local exhaust ventilation systems (i.e., downdraft tables and sinks, slot hoods, and miscellaneous systems);

m. Laminar flow clean benches; and

7. HEPA filtered animal care modules (e.g., animal racks and turbo units).

C.10 TASK 5: INDUSTRIAL HYGIENE SUPPORT SERVICES - The Contractor shall develop, design, implement, and evaluate an agency-wide Industrial Hygiene Program, and serve as an expert in the management of Industrial Hygiene at the enterprise level. The contractor shall serve as an architect of FDA’s enterprise industrial hygiene program that provides strategic leadership and expert consultative industrial hygiene services to FDA’s Offices and Centers.

The Contractor shall support the development of new content or review existing content that assists the agency in the development of its enterprise-level Industrial Hygiene services management system.

Representative activities include, but are not limited to:

1. Analyze the current state of Industrial Hygiene at the agency, which may include field and site visits;

2. Draft and develop educational materials, written procedures, templates, plans, forms, and protocols to implement the OLS Industrial Hygiene Program;

3. Draft and develop educational materials, written procedures, templates, plans, forms, and protocols to support all FDA locations/operations to promote and implement OLS Industrial Hygiene Program;

4. Apply relevant occupational safety and health management system requirements to FDA’s enterprise-level industrial hygiene program, including programs, plans, manuals, trainings, curriculums, job aids, checklists, flow charts, guides, posters, and other resources compatible with the American Industrial Hygiene Association’s (AIHA) “A Strategy for Assessing and Managing Occupational Exposures,” AIHA’s ” Industrial Hygiene and Safety Auditing - A Manual for Practice,” and ANSI Z-10, “Occupational Safety and Health Management Systems”;

5. Conduct an assessment at FDA laboratories and facilities of industrial hygiene program gaps, exposure assessment and job hazard analysis needs, exposure control deficiencies, and other opportunities for OLS to improve the practice of industrial hygiene in the field, to include providing a written report summarizing findings at each facility visited, any best practices discovered, and opportunities for OLS to provide services including, but

6. not limited to industrial hygiene program support, exposure assessments and job hazard analyses, training, technical assistance in contaminant control;

7. Provide Industrial Hygiene support services at field locations;

8. Coordinate presentations to local managers and FDA’s professional Occupational Safety and Health staff to promote OLS’s capabilities to provide industrial hygiene services in the field;

9. Performing ad hoc research and analysis activities, drafting of ad hoc presentations, and designing and developing leadership presentations to communicate the status and future state of OLS programs and their objectives to both internal and external audiences;

10. Completing quality assurance for reports, documents, and manuals; and

11. Drafting of presentations for key stakeholders to report on the progress of implementing

C.11 TASK 6: CAPABILITY ASSESSMENT AND REQUIREMENTS DEVELOPMENT

SUPPORT FOR AN OLSS SUPPORT MANAGEMENT SYSTEM - The FDA requires the acquisition of a Management System to develop, track, implement, and evaluate OLS mission objectives and programs and their progress. The Contractor shall make recommendations regarding the technical and functional requirements of the System that will support the implementation of the mission of OLS. The evaluation will identify potential paths to close gaps between OLS’s current and desired states.

The Contractor shall supply all the necessary labor and resources to develop a work plan, conduct the assessment and produce a final report and presentation based on the assessment findings. Representative tasks in this area may include, but are not limited to:

1. Assessing the current state of OLS management systems and processes to establish, implement and maintain an OLS management system to improve the delivery of safety engineering, industrial hygiene, primary barriers, laboratory quality and security and occupational health and safety support services across the Agency;

2. Making recommendations of the technical and functional requirements of the system to ensure future improvements to the delivery of safety engineering; industrial hygiene;

primary barriers; laboratory quality and security; and occupational health and safety support services across the Agency;

3. Conducting an environmental scan and external research of current and future safety engineering and occupational safety and health systems trends to understand best practices in the Federal Government and private sector and benchmarking other Federal agencies;

4. Assist with conducting market research for acquiring Management System Platforms

5. Conducting a high-level evaluation of all Commercial-Off-The-Shelf (COTS) solutions and services to implementing an OLS Management System;

6. Leveraging assessment findings to recommend functional and business requirements for the acquisition of a Management System product; and

7. Contractor may advise and support the acquisition process, as appropriate (e.g., supporting vendor meetings and demonstrations).

C.12 TASK 7: LABORATORY QUALITY, SECURITY, AND SAFETY SUPPORT

SERVICES- Laboratory quality, security, and safety support services are needed to ensure the protection of all FDA employees, the safety of the laboratory environment, and the integrity of scientific data leading to reproducibility and informed decision-making that is vital to the overarching mission of FDA.

The Contractor shall support the assessment, standardization, and evaluation of laboratory practices and policies at the FDA. Overall, the support services utilized under this task area will assist OLS in meeting the goals and objectives of the OLS Strategic Plan 2017-2022.

Representative tasks in this area may include, but are not limited to:

1. Implementation of internationally recognized standards for safety and quality management in the laboratory through compliance with established FDA quality management documents and industry-wide quality systems (ISO 17025);

2. Assessment of the current state of material inventory control programs to fully account for inventory onsite of the laboratory, compare the inventory of the laboratory to the existing records, and update the inventory records as appropriate;

3. Providing inventory management and compliance support, to include a complete accounting of biological, radiological, chemical, and laser equipment;

4. Development of a records management plan to include inventory control systems and other lab documentation such as equipment certifications, permits, training records and items identified in the Respiratory Plans and Chemical Hygiene Plans. The records management plan will define requirements for the Environmental, Occupational Safety and Health (EOSH) document repository;

5. Recommend practices and procedures to enhance synergy, productivity, and a culture of safety and responsibility across FDA Centers and relevant stakeholders;

6. Assessment and standardization of laboratory safety practices and policies across FDA Center and Offices;

7. Provision of training and communications to support program improvements;

8. Development and updating of occupational safety and health manuals, guides, templates and surveillance program documents;

9. Conduct assessments of Center/Office leadership and other FDA and HHS staff and stakeholders to assess the effectiveness of programs and needs of the broader community;

10. Evaluation and prioritization of the hazards and risks identified in the laboratory (based on the specific mission or services, equipment, procedures and methods of the lab) to include biosafety level (BSL) 2 and 3 materials;

11. Completing inspections and audits of FDA laboratories, to include biological and chemical laboratories as well as audits of radiation safety program for machine-produced radiation and NRC licensed radioactive material programs;

12. Recommending policies and procedures to address laboratory safety training gaps;

13. Refinement of a comprehensive integrated training plan and developing training modules for Environmental, Occupational Safety and Health (EOSH) topics;

14. Development of a comprehensive training plan and modules for Laboratory Quality

Management Systems (LQMS);

15. Designing and executing strategic and proactive communication strategies to unify FDA laboratory staff and stakeholders around a central process to perform all aspects of science in a safe manner;

16. Performing ad hoc research and analysis activities, drafting of ad hoc presentations, and designing and developing leadership presentations to communicate the status and future state of OLS programs and their objectives to both internal and external audiences;

17. Completing quality assurance for reports, documents, and manuals; and

18. Drafting of presentations for key stakeholders to report on the progress of implementing

(Intentionally left blank)

SECTION D – PACKAGING AND MARKING

D.1 Marking Instructions for Reports – Unless otherwise specified within future individual orders, all reports or copies of reports shall be delivered to the COR. Requirements for inspection and acceptance are as follows:

1. The COR or the POC designated in each Order will inspect and accept the services provided to ensure they meet the requirements detailed in the relevant IDIQ order.

2. The Government will accept products and services only if they conform to all terms and conditions of the IDIQ and individual order.

3. The Government will provide written notification of acceptance or rejection within ten

(10) calendar days of receiving the service.

4. The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within fifteen (15) calendar days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan, subject to FDA approval, within ten (10) calendar days.

D.2 Payment of Postage and Fees

All postage and fees related to distribution of deliverables including forms, reports, etc., shall be paid by the Contractor.

SECTION E – INSPECTION AND ACCEPTANCE

E.1

52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates the following 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:

http://farsite.hill.af.mil/vffara.htm, http://www.hhs.gov/policies/hhsar/subpart301-1.html.

E.2 Inspection and Acceptance

Pursuant to the appropriate inspection clause as provided below, final inspection and acceptance of all items called for by this contract shall be made by the FDA Contracting Officer.

a. The CO or the CO’s duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, To Be Named at time of award is the authorized representative of the Contracting Officer.

FAR Clause Title Date 52.223-2 Affirmative Procurement of Biobased

Products Under Service and Construction Contracts

Sep 2013

52.223-9 Estimate of Percentage of Recovered Material Content For EPA Designated Items

May 2008

52.223-17 Affirmative Procurement of EPA- Designated Items in Service and Construction Contracts

May 2014

52.246-1 Inspection - Time and Material and Labor Hour

Aug 1996

52.246-4 Inspection of Services - Fixed Price May 2001 http://farsite.hill.af.mil/vffara.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html

c. Inspection and acceptance will be performed at individual FDA Facilities Nationwide.

Acceptance may be presumed unless otherwise indicated in writing by the CO or the duly authorized representative within 30 days of receipt.

The Government reserves the right to an Inspection period of 30 calendar days, unless a different time period is stated within task orders/elsewhere in the contract. The receiving report, completed and signed by the appropriate official, constitutes acceptance and shall be acknowledged to the payment office, Office of Financial Management (OFM).

SECTION F - DELIVERIES OR PERFORMANCE

F.1 Reports/Deliverables

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 https://www.acquisition.gov/far/

Number Title Date 52.242-15 Stop-Work Order Aug 1989 52.242-17 Government Delay of Work Apr 1984 52.247-35 FOB Destination Within Cosignee’s Premise Apr 1984

F.2 Period of Performance

Performance of this contract shall begin on June 29, 2020 and shall not extend beyond June 28, 2021 plus four (1) year Option Periods which may be exercised at the Government’s discretion.

Option Period Option Periods Option Period 1 June 29, 2021 to June 28, 2022 Option Period 2 June 29, 2022 to June 28, 2023

Option Period 3 June 29, 2023 to June 28, 2024

Option Period 4 June 29, 2024 to June 28, 2025

F.3 Place of Performance

The places of performance for this contract shall include, at the Contractor’s site or the FDA sites located throughout the Washington DC-Metro Area and the United States (Attachment J-2 Locations). Unless otherwise specified, all meetings between the Contractor and FDA staff will be held at FDA’s White Oak Headquarters building, located in Silver Spring, Maryland 20993 or other locations/virtually as agreed upon by FDA and the Contractor.

Place of performance will be identified within each individual order; however, it is expected the place of performance will be in the Washington, DC Metro area and those locations listed in Attachment J-2 Locations.

SECTION G - CONTRACT ADMINISTRATION DATA

G.1. Contracting Officer’s Representative (COR)

The COR is responsible for the acceptance of work provided hereunder will be designated by separate correspondence. The term ‘‘COR’’ means the person who monitors the technical aspects of contract performance. The COR is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of this contract, or changes in the delivery schedule or period of performance of this contract. The COR is not authorized to receive or act upon any notification or revised cost estimate provided by the Contractor in accordance with the Limitation of Cost or Limitation of Funds clauses of this contract.

G.2 Invoice Submission Requirements (Three-Way Match)

FDA Three-Way Match Invoicing Procedures

A. The Contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

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

MAIL HUB 2145

Silver Spring, MD 20993-0002

Phone: 301-827-3742 Email: FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

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

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

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

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

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

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

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

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

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

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

(ix) Taxpayer Identification Number (TIN);

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

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other

Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

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

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

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

C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice.

Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742);

or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

G.3 Invoice Payment

Payment will be made after performance of lump sum services on a monthly basis. It is the requirement of the Government to obtain complete and satisfactory performance in accordance with the terms of the specifications and quality standards of this contract.