Sol_Doc RFP_FDA-SOL-1236379.pdf

Solicitation Number: 75F4012R00015 (1236379)

1. TOBACCO ANALYSIS AND ENGINEERING LABORATORY SERVICES

1.1 BACKGROUND

Tobacco use is the leading cause of preventable illness in the United States and is responsible for more than 443,000 deaths annually. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) into law.

The Tobacco Control Act added sections 904(a)(1), 904(a)(3), and 915 to the Federal Food, Drug, & Cosmetic Act (FD&C Act), that requires each tobacco product manufacturer or importer, or an agent, to test and report constituents, ingredients, and additives to FDA. In addition, the Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. On August 8th, 2016 FDA published the Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic As, as Amended by the Family Smoking Prevention and Tobacco Control Act rule. FDA is extending the Agency’s “tobacco product” authorities in the FD&C Act to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, including ENDS, waterpipes, pipes, cigars, and more. This testing and reporting may require method development and validation. Given the diversity of tobacco products, it is imperative that FDA be able to conduct various tobacco-related research projects to effectively regulate all tobacco products as defined in the FD&C Act. These projects will vary in scope and specific aims/objectives depending on the needs of the FDA in fulfilling its regulatory requirements.

1.2 NOTICE OF COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This is a request for proposal (RFP) for commercial items IAW the procedures of FAR Part 12 – Acquisition of Commercial Items, in conjunction with FAR Part 15 – Contracting by Negotiation.

1.3 NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular FAC 2021-07, effective August 11, 2021.

1.4 NOTICE OF NAICS/SET ASIDE

This requirement is intended for full and open competition. The associated North American Industry Classification System (NAICS) code is 541720, (Research and Development in the Social Sciences and Humanities), Offerors must have an active registration in SAM.gov (https://beta.sam.gov), with completed representations and certifications, by the close date of the solicitation. Proposals submitted by offerors not registered in SAM.gov will not be considered.

https://beta.sam.gov/

2 DESCRIPTION OF REQUIREMENT/STATEMENT OF WORK

2.1 INTRODUCTION

Section 906 of the Tobacco Control Act provides FDA with the authority to enter into contracts for research, testing, and demonstrations of tobacco products and to obtain products for research, testing, and demonstration purposes. Based on this authority, FDA is seeking the services of a contactor capable of providing laboratories tests that at a minimum, shall include analysis of chemical and physical properties of tobacco products and tobacco smoke, analysis of the engineering of e-cigarettes, the composition of e-liquids and e-cigarette aerosols, method validation studies and other projects that FDA identifies, in order to, effectively regulate tobacco products. The contractor shall be capable of providing laboratory services for any tobacco products that FDA has the authority to regulate under the FD&C Act.

2.2 PURPOSE

The purpose of this multiple award IDIQ contract is to obtain Contractor services with the capability of providing laboratories tests that at a minimum, shall include analysis of chemical and physical properties of tobacco products and tobacco smoke, analysis of the engineering of e-cigarettes, the composition of e-liquids and e-cigarette aerosols, method validation studies and other projects that FDA identifies, in order to, effectively regulate tobacco products. The contractor shall be capable of providing laboratory services for any tobacco products that FDA has the authority to regulate under the FD&C Act.

2.3 OBJECTIVE

The objective of this IDIQ is to acquire Contractor services to analyze the specified tobacco products for specified Harmful and Potentially Harmful Constituents (HPHCs). The list of possible HPHCs is included in Appendix A (Attachment 3). Under this IDIQ, the contractor shall analyze the following classes of tobacco products:

1. Electronic Nicotine Delivery System (ENDS) liquids and devices

2. Cigars, Cigarillos, and Little Cigars

3. Waterpipes

4. Smokeless Tobacco (portioned and unportioned)

5. Cigarettes, Roll You Own Tobacco (RYO), and Pipes

For physical measurements, the contractor shall analyze the following:

1. Cigarettes, RYO, Cigars: draw resistance/pressure drop, length, mass, diameter, puff count (machine smoking)

2. Smokeless unportioned, Waterpipe, tobacco filler: particle size (sieve), moisture (OV),

3. Smokeless portioned: particle size (sieve), moisture, paper porosity (air permeability)

4. ENDS liquids: density (mass and volume)

5. ENDS device: coil temperature, draw resistance, airflow velocity, aerosol particle size, aerosol temperature

6. ENDS Battery: functional tests (voltage and current operating ranges, resistance), battery temperature, electrical load

7. Microbial plate counts (bacteria, yeast, and mold) and water activity.

For ingredient/additive measurement, the contractor shall analyze the following:

• Menthol

• Diacetyl

• PG

• Glycerol

• Diethylene Glycol

• Ethylene Glycol

• 2,3-pentanedione

• Nicotine

Note: The contractor may need to participate in collaborative studies under this IDIQ.

Proficiency testing should not be required, except as needed to maintain ISO 17025 certification.

Added this note in reference to previous IDIQ SOW to ensure this is or no longer is a note, worthy of incorporating

For engineering measurements, the contractor shall use instruments but are not limited to the following:

• infrared temperature sensors

• thermocouples

• DAQ readers

• aerosol size distribution measurement equipment (e.g. scanning mobility particle sizers

(SMPS) for cigars or waterpipe measurements, electrical, low pressure impactors (ELPI) butanol-based condensation particle counters)

• airflow meters

• pressure gauges

• viscometers

• puff topography recorders

• the laboratory inductively coupled plasma-mass spectrometry (ICP-MS)

• gas chromatography-mass spectrometry (GC-MS)

• high pressure liquid chromatography-mass spectrometry (HPLC-MS)

• high pressure liquid chromatography-diode array detector (HPLC-DAD)

• aerosol-generating machine adapted for testing e-cigarettes and other deemed tobacco products

• scanning electron microscopy (SEM)

• energy dispersive X-ray spectroscopy (EDS)

• atomic absorption spectrometer

FDA will provide all samples for testing, specify storage conditions, and set specific timeless for the samples to be analyzed at the task order level. The laboratory shall be ISO 17025-accredited and have advanced, modern day techniques to modify and analyze chemical and engineering characteristics. Note: The contractor may need to participate in collaborative studies under this

IDIQ. Proficiency testing should not be required, except as needed to maintain ISO 17025 certification.

A separate statement of work will be issued for each individual Task Order with specific aims and objectives for the contractor by the Division of Product Science in the Office of Science. An individual Task Order with complete details of the project will be issued to the contractor.

2.4 SCOPE

Independently and not as an agent of the Government, the Contractor shall furnish the necessary personnel, materials, services and facilities to do all things necessary for or incident to the performance of the work described below.

2.5 OBJECTIVE

The major task areas are:

Objective 1: The Contractor shall perform acceptable quality control analyses while performing e-cigarette engineering and compositional analyses. Examples of acceptable quality control analyses may include, but need not be limited to, analysis of blanks and check standards

Objective 2: The Contractor shall contact FDA COR immediately when quality control measures indicate that data generated by the Contractor may not be accurate.

Objective 3: All reports shall be typed (12-point font) and submitted electronically to the COR in a format specified by FDA COR. All tabulated data obtained from the studies shall be submitted in Microsoft Excel format unless otherwise specified. Each task order shall specify deliverables for the Contractor to provide and due dates for each deliverable.

Objective 4: The Contractor shall provide a report on the recovery studies and analysis of reference materials.

Objective 5: The Contractor shall provide interim reports at specific time periods as determined by the FDA COR as reflected in the separate individual task order.

Objective 6: The Contractor shall provide a final report that includes the raw data and tabulated results of all analyses for tobacco products specifically identified by FDA and for quality control samples; full descriptions of the methods used; descriptions of any laboratory issues encountered along with their solutions; and any other issues relevant to the study.

Objective 7: The Contractor shall ship all unused samples to FDA at the end of the study using an FDA FedEx or UPS account, at no additional cost to the Contractor

Objective 8: The contractor must sign a confidentiality agreement.

Objective 9: Onsite Kick-Off and Annual Meetings The Contractor shall participate in a kick-off meeting within two weeks of award and shall conduct an annual meeting on-site at the FDA campus in Silver Spring, MD. The purpose of the annual meeting is to discuss scientific issues of interest to the Agency and relevant work that the contractor has performed, as well as discussing FDA satisfaction with all deliverables.

Objective 10: C3.10 Disclosure Clearance for Aggregated Data outside the Agency As part of its regulatory activities, FDA shall, at times, require disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data the Contractor shall accept and adhere to the FDA Data Disclosure Clearance Procedures and Form found in Appendices B and C unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA.. The FDA shall continue to require the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period of performance. After ordering period year 2, the FDA shall notify the contractor of the aggregated data release and accept the Contractor’s requested revisions, but shall not require formal approval for release.

Objective 11: Clearance for Third Party Collaborations As part of its regulatory activities, FDA shall, at times engage in collaborative research projects with third parties outside of FDA for specific research projects of public health importance that are initiated by and for the benefit of FDA. These collaborations shall require FDA to have the ability to share project specific aggregated or raw data with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, the Contractor shall accept and adhere to the Data Disclosure Clearance Procedures and form to be found in Appendices B and C unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. These Procedures include terms and conditions for third party collaborations.

Objective12: Advance Understanding Notwithstanding any of the above requirements, under certain circumstances, the Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government shall take appropriate measures within its control in an effort to ensure that the information shall be shared in a manner intended to protect the information from public disclosure.

The Contractor shall ensure the protection of the information and data they receive under this contract from unauthorized use or disclosure, and shall treat the information as confidential or otherwise privileged.

3 CONTRACT TYPE AND MINUMUM/MAXIMUM AMOUNT

3.1 CONTRACT TYPE

It is anticipated that a multiple-award Indefinite Delivery-Indefinite Quantity (IDIQ) type Contract, per FAR 16.5. The Government estimates awarding up 2 contracts as a result of this solicitation. Authorized contract types under for any Task Orders issued under this IDIQ contract are Firm-Fixed-Price (FFP).

3.2 MINIMUM AND MAXIMUM CONTRACT VALUE

IDIQ Minimum: The minimum guarantee for this IDIQ is $4,500.00, which will be obligated through a separate Task Order following any IDIQ award.

IDIQ Maximum: The maximum aggregate dollar value of all task orders awarded to all awardees over the 5-year ordering period of this IDIQ shall not exceed the IDIQ ceiling amount of $45,000,000.00.

4. PRICING AND ORDERING OF SERVICES

4.1 OVERVIEW OF PRICING SCHEDULE

Offerors shall propose labor categories and labor rates as a completed version of Attachment 1 – Complete Pricing Worksheet, to be included in the “Volume III – Business Proposal”.

The Contractor’s pricing schedules for labor categories shall contain fully burdened hourly rates.

The fully burdened hourly rates for each labor category shall include wages, indirect costs, fringe benefits, overhead, general and administrative, and profit. The same hourly rates shall apply to services at both Government and non-Government sites.

By mutual agreement of the parties, additional labor categories may be added to this IDIQ contract to support the tasks of this contract.

4.2 ORDERING

A request for task order proposal (RFTOP) will be issued via email for individual task orders.

Task orders against the IDIQ contract will be issued via email and will be in accordance with FAR 16.505 and FAR clause 52.216-18.

4.2.1 ORDERING PROCEDURES

Any Contracting Officer of the Food and Drug Administration (FDA) is authorized and may place orders under this IDIQ contract. Each individual task order will describe the specific performance requirements for data volume and timeliness and may include required reporting processes and/or document handling procedures. When a need for services within the scope of this IDIQ contract arises, the process for issuing task orders is as follows:

1. All orders will be competed amongst all awardees and proposal evaluations will follow the terms and conditions of each RFTOP.

2. The Contractor will typically have a minimum of ten (10) business days, unless otherwise specified, to provide a proposal in response to the RFTOP. The proposal shall include:

a. Brief description of the technical approach to the task order requirements

b. Price buildup (including labor categories, hours for each labor category, extended pricing, total task order pricing, and concurrence with the anticipated contract type)

c. Resumes of any key personnel identified in the RFTOP

2. The FDA will evaluate the task order proposal for technical acceptability and price reasonableness. If the FDA has questions or concerns, the Contracting Officer will contact the Contractor and may request a revised proposal.

3. If the task order proposal is determined acceptable, the Contracting Officer will issue a task order. All task orders will, at a minimum, include the following:

a. Task Order number

b. Date of Task Order

c. Funding for the Task Order

d. Task order SOW and specific deliverables and due dates

e. Task order pricing

f. Period of performance of the task order

g. Any terms, conditions and instructions specific to the task order

Any work that the Contractor undertakes prior to receiving a fully executed task order that has been signed by the Contracting Officer (or the Contractor has received prior authorization to proceed from the Contracting Officer) shall be solely at the Contractor’s own risk.

4.2.2 PRICING OF ORDERS

a. Proposals submitted in response to a RFTOP must be in accordance with the Ordering Period rates in the IDIQ Price Schedule based on the performance start date of the task order, and that rate must be used for the duration of the task order performance period. The Contractor may propose lower rates in response to a RFTOP.

b. RFTOPs may include ordering periods in accordance with FAR clause 52.217-9. However, ordering periods must utilize the Ordering Period rates listed in the IDIQ Price Schedule, based on the performance start date of the option period.

c. Labor-Hour (LH) and Time-and-Materials (T&M) type task orders will include a ceiling price.

These Ordering Pricing terms and conditions apply to all task orders issued against this IDIQ contract.

4.2.3 EMERGENCY ORDERS

In emergency situations or other times when it is not practical to prepare a written work plan prior to the commencement of work, the Contracting Officer may verbally authorize performance to commence immediately, so long as the work to be performed in the emergency situation is within the scope of this contract. In those instances, a written work plan shall be submitted within 10 days following the authorization to commence work. When work is authorized to commence prior to the submission and negotiation of a work plan, the Contracting Officer will indicate, at time of authorizing work, a dollar ceiling that may not be exceeded except at the Contractor's own risk.

5 DELIVERABLES AND ACCEPTANCE

5.1 DELIVERABLE(S)

Specific deliverables and a schedule of deliverables will be identified in each task order.

A. 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 IDIQ contract including any task orders under this IDIQ shall not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

B. All non-electronically submitted deliverables required under this contract shall be packaged, marked and shipped in accordance with the requirements and specifications contained herein this contract. At a minimum, all deliverables shall be marked with the Contract Number and Contractor Name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

C. Reports not submitted electronically shall be delivered F.O.B. Destination, as set forth in FAR Clause 52.247-35, F.o.b. Destination, Within Consignee’s Premises, and as specified in the delivery schedule in the task order.

D. Unless otherwise specified, deliveries shall be made to the COR on Mondays through Fridays (excluding Federal Holidays and Executive Order), between the hours of 8:00 a.m. and 5:00 p.m., Eastern Time, only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

6 CONTRACT ADMINISTRATION DATA

6.1 PERIOD OF PERFORMANCE

The anticipated period of performance for this contract consists of five years, inclusive of 5 distinct 12-month ordering periods.

Ordering Period 1: TBD Ordering Period 2: TBD Ordering Period 3: TBD Ordering Period 4: TBD Ordering Period 5: TBD

The period of performance for task orders will be specified in individual orders. Two (2) constraints apply to the period of performance for task orders:

1. Task Orders may be awarded at any time during the Base IDIQ award’s period of performance, up to and including the final day of performance of the Base IDIQ award, and;

2. Individual task orders may not exceed five (5) years

6.2 PLACE OF PERFORMANCE

The place of performance shall be specified at the Task Order level, though it is anticipated that all performance shall be at the Contractor’s site. Task orders may be issued for performance in any of the United States or its territories.

6.3 HOURS OF OPERATION

Unless otherwise specified in the individual task order, Contractor staff must be available during normal FDA business hours, from 8:00 am – 5:00 pm Eastern Time (ET), Monday through Friday, except on Government Closures.

The Contractor may be required to deliver documents and records materials outside of normal FDA business hours. If working outside of normal business hours, the Contractor will have the flexibility to use management tools (i.e., swing shifts) to successfully meet individual task order requirements. Contractors are expected to propose adequate staffing for any orders under this IDIQ so as to eliminate the need for overtime. Any overtime incurred must be approved in advance, in accordance with FAR 52.232‐ 7 Payments under Time and Materials and Labor Hour Contracts (Aug 2012). Normal FDA business hours are defined as being from 8:00 am – 5:00 pm ET, Monday through Friday, with deliveries on some weekends and holidays.

6.4 OBSERVANCE OF GOVERNMENT CLOSURES

Recognized Federal Holidays: Contractor coverage is expected during all Federal workdays.

Except for designated around-the-clock or emergency operations and after-hour courier services, Contractor personnel shall not perform on-site under this contract on Federal holidays or any other day designated as a Federal holiday for the Washington, DC area. No services or deliveries shall be performed at Federal sites on Federal holidays unless specifically requested by the Contracting Officer.

January – New Year’s Day September – Labor Day January – Martin Luther King, Jr. Day October – Columbus Day February – President’s Day November – Veterans Day May – Memorial Day November – Thanksgiving Day June– Juneteenth December – Christmas Day July – Independence Day

Inclement Weather and other Government Closures: The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather, government closures or other emergencies. The COR will notify the Contractor of Government Closures due to inclement weather, government closure or emergencies (man-made or otherwise).

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 (OPM) for any reason, the agency is closed, or the Center or FDA building is closed for administrative or safety reasons, the Contractor shall follow directives issued by the Contracting Officer’s Representative (COR) concerning reporting for work.

If adverse weather conditions develop after the Federal Government has opened for normal business, upon notification of early release from OPM, the COR and/or CO will notify the Contractor of Facility closings and specify the time for a final document pickup.

Additional specific inclement weather plans may be specified at the task order level.

6.5 CONTRACTING OFFICER (CO)

Contracting Officer’s Authority: The Contracting Officer is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is, or may be, outside the scope of the contract. In the event the Contractor effects any changes to this contract or contracts at the direction of any person other than the CO, the changes will be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. The CO will be the only individual authorized to accept nonconforming work, waive any requirement of the contract/task order and modify any term or condition of the contract/task order. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The following person is the Contracting Officer for this contract:

TBD at time of contract award Office of Acquisitions and Grants Services 4041 Powder Mill Road Beltsville, MD 20705

Email: TBD at time of contract award Phone: TBD at time of contract award

6.6 CONTRACT SPECIALIST (CS)

The Contract Specialist supports the Contracting Officer. The following person is the Contract Specialist:

Telisha Wilson Office of Acquisitions and Grants Services 4041 Powder Mill Road

Beltsville, MD 20705 Email: Telisha.Wilson@fda.hhs.gov Phone: (240) 402-7572

6.7 CONTRACTING OFFICER’S REPRESENTATIVES (COR)

6.7.1 Contracting Officer’s Representative’s Authority:

The Contracting Officer (CO) may designate other Government personnel, known as the Contracting Officer’s Representative (COR) to act as his or her authorized representative for contract administration functions which do not involve changes to the scope, price, schedule, or terms and conditions of the contract. The designation will be in writing, signed by the Contracting Officer, and will set forth the authorities and limitations of the representative(s) under the contract. Such designation will not contain authority to sign contractual documents, order contract changes, modify contract terms, or create any commitment or liability on the part of the Government different from that set forth in the contract. CORs do not have authority to act as agent of the Government under the contract or task order. The Government may unilaterally change its COR designation.

6.7.2 IDIQ CONTRACTING OFFICER’S REPRESENTATIVE (IDIQ COR)

The IDIQ COR, to be designated at time of contract award, will represent the Government for the purpose of the IDIQ. The IDIQ COR will be responsible for the following:

• Tracking compliance with Limitations on Subcontracting clause across task orders

• Tracking and monitoring contract ceiling

• Tracking and monitoring staff allocation across task orders

• Reviewing changes to staffing matrix

• Secondary point of contact for issues that need to be escalated

• Reviewing Task Order SOWs for scope compliance

• Completing annual CPARs evaluations

The following person has been identified as the IDIQ COR:

TBD at time of contract award

6.7.3 TASK ORDER CONTRACTING OFFICER’S REPRESENTATIVE (TO COR)

For each individual task order, a Task Order (TO) COR will be assigned. The TO COR will serve as the Contractor’s first point of contact for any technical questions and is responsible for:

(1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; (5) assisting in the resolution of technical problems encountered during performance;

and (6) providing technical direction; and, (7) reviewing and approving invoices/vouchers.

6.8 TASK ORDER PROJECT MANAGERS (TO PMs)

Task Order project managers may assist the CORs, but will not have the authority to provide technical direction as described in Section 6.9; however, they may be responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and compliance with all substantive project objectives; (2) performing technical evaluation as required; (3) performing technical inspections and acceptances then reporting to the COR of the acceptance as required by this performance; and (4) reviewing of invoices/vouchers.

6.9 TECHNICAL DIRECTION

Performance of the work under this contract shall be subject to the technical direction of the COR. The term “technical direction” is defined to include, without limitation, the following:

• Directions to the Contractor which redirect the contract effort, shift work emphasis between work areas or tasks, require pursuit of certain lines of inquiry, fill in details or otherwise serve to accomplish the contractual statement of work.

• Provision of information to the Contractor which assists in the interpretation of drawings, specifications, or technical portions of the work description.

• Review and, where required by the contract, approval of technical reports, drawings, specifications, and technical information to be delivered by the Contractor to the Government under the contract.

Technical direction must be within the general Scope of Work stated in the contract. The COR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside the general Scope of Work of the contract.

• Constitutes a change as defined in the applicable contract clause FAR 52.212-4.

• Change any of the expressed terms, conditions, or specifications of the contract.

All technical direction will be issued in writing by the COR or will be confirmed by him/her in writing within five (5) business days after issuance.

If, in the opinion of the Contractor, any instructions or direction issued by the COR is within one of the categories described above, the Contractor shall not proceed but shall notify the Contracting Officer in writing within 5 working days after the receipt of any such instructions or direction and shall request the Contracting Officer to modify the task order, accordingly. Upon receiving such notification from the Contractor, the Contracting Officer will issue an appropriate contract modification or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of this contract. The Contractor shall proceed immediately with the instructions or directions and shall be subject to the “Disputes” clause within FAR 52.212‐4(d), Contract Terms and Conditions – Commercial Items.

6.10 INVOICING PROCEDURES

Specific invoicing instructions may be provided in each individual task order. Unless otherwise specified in the task order, the FDA Invoicing procedures are as follows:

A. The Contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

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

MAIL HUB 2145

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

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

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 Contract Line Item/Funding line item 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;

mailto:FDAVendorPaymentsTeam@fda.hhs.gov https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html https://www.acquisition.gov/far/current/html/52_232.html

(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.

6.11 GOVERNMENT FURNISHED PROPERTY

Specific Government furnished property will be identified in each individual task order.

The Contractor shall return all Government furnished property to the property custodian (COR) no later than the expiration date of this contract or any task order.

In addition to the requirements of FAR clause 52.245-1, Government Property (Jan 2017) incorporated in this contract, the Contractor shall comply with the provisions of HHS Publication, "HHS Contracting Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed at:

https://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf

6.11.1 GOVERNMENT FURNISHED EQUIPMENT (GFE)

FDA may provide laptops, tower computers, printers, scanners, copier, data cable line, and basic PC desktop images and Center Software Top‐Offs for FIRF in individual task orders. Upon receipt of FDA badges, FDA will provide Contractor FDA network access to staff under this contract. FDA will provide access to any server‐based environment necessary to accomplish the stated work.

The Contractor shall work with the FDA Help Desk Support to relocate/install all GFE to ensure no breaks in current work performance.

mailto:ERIC@fda.hhs.gov https://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf

Upon the expiration of the one-year manufacturer’s warranty for the Government Furnished Equipment (GFE), the Contractor shall be responsible for maintaining all GFE equipment in accordance with current commercial operating standards until replaced or returned to the FDA.

The Contractor shall be responsible for providing any supplies necessary to operate the GFE (other than maintenance/repair supplies).

6.11.2 FDA INFORMATION TECHNOLOGY (IT) HELP DESK SUPPORT

Help Desk Support will be provided by the FDA for only FDA functions inclusive of support for all Government Furnished Property (GFP) and software. FDA’s Help Desk is responsible for distributing new and replacement laptops as they are needed and configuring laptops with standard and Center specific software. FDA Help Desk Support will be provided through remote access, drop‐in support, or when the Contractor transports the equipment to the nearest FDA IT servicing location. Drop‐in support services include: transition‐in services and support for major technology changes that cannot efficiently be accomplished remotely. Upon request by FDA Help Desk Support, the Contractor shall be responsible for transporting the items in need of repair to and from the designated FDA facility for repair. In addition, the FDA’s Help Desk provides best effort support – defined as basic troubleshooting ‐ for peripheral equipment connected to FDA owned computers. FDA does not grant the Contractor administrative rights for Government‐ owned computers. If required, the Contractor shall submit a request for administrative rights using the Form 3530 and submit to FDA for approval.

6.11.3 GOVERNMENT FURNISHED INFORMATION

Government Furnished Information will be accessible through the FDA network and paper copies, as needed. The Contractor shall inform and require staff to comply with Government regulations that prohibit the use of any Government property for personal use.

The FDA will not supply the Contractor with phones. The FDA will provide the data drops (if not pre‐existing or extras are needed) and network infrastructure (e.g. DS3 circuit, network switch, network router) for connection to the FDA network, via the Verizon direct connection between the Contractor’s facility and the FDA WO Campus. The applicability of Appendix 6A or 6B will depend on the Contractor’s existing network closet.

6.11.4 CONTRACTOR EQUIPMENT REQUIREMENTS

The FDA Master Approved Technology (MAT) list contains a list of software applications and equipment approved by the Office of Information Management (OIM). The approved technologies are determined to be compatible with FDA’s Technical environment. The MAT list is posted on FDA’s intranet and will be available after contract award). In addition, FDA posts a list of technologies not approved by OIM on the intranet.

All Contractor peripheral equipment connected to FDA computers or laptops must be on the MAT List. If Contractor equipment and software is not on the MAT List, it must be approved via the formal FDA technical approval process prior to connection to FDA’s network.

The Contractor shall be responsible for identifying needed technologies that are not provided by the FDA. FDA has instituted the Information Technology Information Management (ITIM) approval process in order to track technologies across the Agency. The introduction of a new technology or a different version of an already approved technology requires the submission and approval of an ITIM request. The Contractor may be responsible for supporting the ITIM process including writing and submitting ITIM requests and tracking them from inception through completion. FDA Center IT Investment Review Boards may need to be included in a coordinated review process.

6.11.5 GOVERNMENT FURNISHED DATA

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 not 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.

6.12 POST-AWARD EVALUATION OF CONTRACTOR PERFORMANCE

A. Contractor Performance Evaluation: Interim and final evaluations of contractor performance will be prepared on this contract in accordance with FAR 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluations will be prepared annually to coincide with the anniversary date of the IDIQ period of performance start date. At the discretion of the CO, additional interim performance evaluations may be prepared as necessary.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted 14 days to review the document and to submit additional information or a rebutting statement. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via CPARS within 14 days from date the evaluation was issued by FDA. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

B. Electronic Access to Contractor Performance Evaluation:

FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of the individual who will be responsible for serving as the Contractor’s CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User ID and instructions for creating a password. Copies of the evaluations, contractor responses, and review comments, if any, will be retained in CPARS and as part of the contract file, and may be used to support future award decisions.

http://www.cpars.csd.disa.mil/cparsmain.htm

Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the

CPARS.

7 FDA-SPECIFIC CONTRACT REQUIREMENTS

7.1 NON-PERSONAL SERVICES AND INHERENTLY GOVERNMENTAL 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.

Contractor personnel under this contract shall not:

• Be placed in a position where there is an appearance that they are employed by a Federal Officer, or are under the supervision, direction, or evaluation of a Federal Officer.

• Be placed in a position of command, supervision, administration or control over personnel or personnel of other Government contractors, or become a part of the Government organization.

• Be used in administration or supervision of procurement activities.

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. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall ensure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

7.2 IDENTIFICATION OF CONTRACTOR EMPLOYEES

http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm

During the period of this contract, the rights of ingress and egress to and from any Government office for Contractor representatives will 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.

7.3 Contractor Personnel Security Clearance Standards and Residency Requirements (Oct 2017)

1. BACKGROUND - The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that Contractor employees (including subcontractors) who will be working in DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, must undergo a background investigation that results in a favorable determination.

Contractor employees who will work in DHHS-owned or leased space for less than thirty (30) days are considered visitors and are exempted from background investigation requirements; and therefore, will not be issued a Personal Identity Verification (PIV) Card. These contractor employees go through visitor screening each day and must be escorted at all time while in DHHS-owned or leased space.

2. GENERAL - The Contractor must submit the following items to the Contracting Officer’s Representative (COR), within five (5) business days of commencement of work under this contract:

• A roster of contractor employee names, identifying Key Personnel and Tier designation(s);

• Confirmation all individual employee security information has been submitted properly;

and

• "Contractor's Commitment to Protect Non-public Information Agreement" forms signed by each employee named in the roster.

Pursuant to HSPD-12, the Contractor must advise its prospective employees about the security and background requirements stated herein.

For any individual who does not obtain a favorable background investigation he/she must cease work on the contract immediately.

If a Contractor employee changes job responsibilities under this contract, the Contractor must notify the COR, and the Government will make a determination whether an additional security clearance is required.

In the event there are any proposed personnel changes in the Contractor’s staffing roster previously submitted to the COR, the Contractor must submit an updated roster to the COR, along with a brief explanation for the change. In turn, the COR will initiate the procedures stated herein to ensure any new contractor employees obtain a PIV card in a timely manner – prior to that individual commencing work under the contract.

Note: If the proposed personnel change is for a position designated Key Personnel under the contract, a complete justification – along with a resume or curriculum vitae – must be submitted to the Contracting Officer and COR for review and approval. If approved, the Contracting Officer will execute a Contract Modification prior to that individual commencing work under the contract.

BACKGROUND INVESTIGATIONS - With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the…