Full Solicitation 75F40124Q00549.pdf

RFQ# 75F40124Q00549

Food and Drug Administration (FDA)

Request for Quote (RFQ) #: 75F40124Q00549

Contractor Support Services for Disposal of Packaging Materials and Related Activities

Table of Contents

1. Overview

2. Tasks

3. Deliverables

4. Contractor Personnel

5. Contract Information

6. Period of Performance

7. Place of Performance

8. Travel

9. GFP, GFM, GFE, or GFI

10. Observance of Federal Holidays and Government Closures

11. Government Points of Contact

12. Quotation Instructions

13. Evaluation and Basis for Award

14. Evaluation Factors

15. FAR 8.405-3 Procedures

16. Submission Deadlines

17. Invoicing

18. PROCUREMENTS REQUIRING INFORMATION SECURITY AND/OR PHYSICAL ACCESS

19. FAR/HHS/FDA Clauses

Strengthening the FDA ORA Senior Executive Team’s Leadership Capability and Performance

1. Overview

The Office of Compliance and Biologics Quality (OCBQ) requires contractor support to assist with the cleanup of packaging materials and removal of boxes from laboratory spaces. This support is essential for maintaining a clean and organized working environment conducive to the operations of OCBQ.

2. Tasks

The contractor shall perform the following tasks and any additional tasks of comparable complexity established by OCBQ staff:

I. Disposal of Refrigerated Sample Boxes:

After samples and paperwork are removed from boxes by Product Review Branch (PRB)/OCBQ staff, the boxes will be placed in the hallway outside of the lab spaces.

The contractor shall:

a. Shall have at least a High School Diploma

b. Remove any loose materials from the outside of the boxes (e.g., loose tape, plastic paper holders) and dispose of them in trash bags/cans as directed.

c. Remove any cold packs and dispose them in trash bags/cans as directed.

d. Remove packing peanuts and place them in trash bags/cans as directed.

e. Remove any bubble wrap and place it into trash bags/cans as directed.

f. Break down empty boxes and stack them off to the side for removal by custodial staff.

II. Handling of Boxes containing Dry Ice (frozen carbon dioxide at -20 degrees Centigrade):

a. FDA staff will receive shipments (boxes) from the Sponsors, remove samples and paperwork from the boxes.

b. The contractor shall pool the dry ice from the boxes into containers. Training shall be provided to handle dry ice.

III. Cleanup:

a. At the end of each day or as directed by designated OCBQ staff, the contractor shall remove any full bags of trash (e.g., packing peanuts, bubble wrap) and place them in the hallway for removal by the GSA contract custodial staff.

b. Relocate dry ice in a container to outside the building for sublimation into the atmosphere.

IV. Safety and Support Activities:

The contractor shall also provide support for Division of Biologics Quality Control (DBSQC)/OCBQ objectives, including weekly safety checks of eyewash stations, assist laboratory staff when needed with waste disposal, surplus, autoclaving, moving supplies between laboratories.

Training will be provided as appropriate including participating in DBSQC division wide meetings and team building events as needed.

Safety and support goals of comparable complexity may be established by DBSQC staff.

3. Deliverables

The contractor shall ensure that all established goals are completed as established by OCBQ staff.

Documentation of activities performed may be required as directed by lab staff.

4. Contractor Personnel The Contractor shall propose qualified resources/labor categories commensurate with the requirements identified in Section 2.0, Tasks. The Contractor shall be responsible for managing and overseeing the activities of the Contractor personnel. The Contractor shall demonstrate that the proposed personnel and experience levels meet the Government's requirement.

5. Contract Information

This is a firm-fixed price contract.

Estimated Level of Effort Laboratory Support Services*: 1920 Hours per year *The contractor may propose their own labor category.

6. Period of Performance

The following period of performance is estimated:

Base Year: September 30, 2024, to September 29, 2025 Option Year One: September 30, 2025, to September 29, 2026 Option Year Two: September 30, 2026, to September 29, 2027

7. Place of Performance

Primary locations of operation: Buildings 52 / 72 and 75 10993 New Hampshire Ave.

Silver Spring, MD 20993.

8. Travel

The contractor personnel will report to the place of performance. Travel costs will not be reimbursed or provided.

9. GFP, GFM, GFE, or GFI

Government furnished property (materials, equipment, and/or information) may be provided in conjunction with required performance under this task order, as determined by mutual agreement between FDA and the contractor.

The Government may provide the laptop computers with FDA images for contractor staff that are performing work, which requires access to FDA systems (e.g. administrators, those needing access to FDA e-mail accounts etc.).

At the written request of the Government, the contractor shall immediately return any property (to include FDA laptops and badges) provided by FDA for the contractor. If not requested, the contractor will continue to abide by FAR Part 45 until completion of the contract.

A list of GFE will be developed and agreed to during the kickoff meetings. All materials contained on the agreed to list will be provided to the contractor within 14 calendar days of contractor badging.

10. Observance of Federal Holidays and Government Closures

The Government will not require support at the Government facility on Saturdays, Sundays, or the Federal holidays shown below, or days of government closure due to inclement weather:

1. New Year's Day 1 January

2. Martin Luther King's Birthday Third Monday in January

3. President's Day Third Monday in February

4. Memorial Day Last Monday in May

5. Juneteenth (Observed) 19 June

6. American Independence Day (Observed) 4 July

7. Labor Day First Monday in September

8. Columbus Day Second Monday in October

9. Veteran's Day 11 November

10. Thanksgiving Day Fourth Thursday in November

11. Christmas Day (Observed) 25 December

Note: 2025 will have an additional Federal Holiday, January 20, 2025, will be Inauguration Day.

Inclement Weather – The Vendor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather. In the event the Federal Government is closed by order of the President of the United States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Vendor shall follow directives issued by responsible officials concerning reporting for work.

11. Government Points of Contact

Contracting Officers Representative (COR): Ramakrishna Velicheti, Ph.D.

(Ramakrishna.velicheti@fda.hhs.gov) Contracting Officer (CO): James Jenrette (James.JenretteIII@fda.hhs.gov) Contracting Specialist (CS): Matthew Tran (matthew.tran@fda.hhs.gov)

12. Quotation Instructions

Please submit all required documents in PDF or native (Word/Excel) formats, however MS Word/Excel formats are preferred. The offeror shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror submits documents that contain macros, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation and will not be evaluated or considered for award. No additional time will be given to an offeror to correct the document submission, and the Government will not inform the offeror that their submission is non-responsive prior to award. It is the offeror’s responsibility to ensure all electronic documents are submitted without the use of macros.

All text in the proposal shall be single-spaced, and each paragraph shall be separated by at least one (1) blank line. The Offeror is encouraged to use Calibri 11-point font. However, a font of equivalent size may be used.

Tables and illustrations may use a reduced font size not less than 9-point and may be landscape. Offerors shall use the following page setup parameters: Page size – 8.5” x 11”, Margins (top, bottom, left and right) – 1”, Gutter – 0”, From edge (header and footer) – 0.5”.

mailto:(James.JenretteIII@fda.hhs.gov

The FDA is not responsible for any costs incurred in preparing the documents described in this RFQ. Offeror employees responsible for preparing material that may be proprietary information must mark each page that the Offeror believes contains proprietary information with the legend “Proprietary Information.”

The Technical Quotation and Business/Price Quotation must be kept separate from each other. Kept separate is defined as not including any cost/price information in the Technical Quotation. The Technical Quotation must not make reference to pricing data in order that the technical evaluation may be made strictly on the basis of technical merit. For submission purposes, it is acceptable for the Technical Quotation and Business/Price Quotation to be submitted together (along with the other required attachments), however, each attachment must be clearly marked with the Volume to which it belongs.

A complete quotation shall consist of 2 (two) volumes:

Volume I-Technical Quote, Volume II-Business/Price Quote

At a minimum, the following required documents must be submitted with the quote:

Volume I - Technical Quote, Page Limitation – 25 pages, not including resumes and commitment letters, cover pages, table of contents, dividers, or glossaries Volume II - Business/Price Quote, No Page Limitation

13. Evaluation and Basis for Award

The Government intends to issue a firm-fixed price contract as a result of this solicitation to the responsible offeror whose quote, conforming to the solicitation, represent the best value to the Government, technical, price, and other factors considered. Best value will be obtained using a trade-off process, which permits trade-offs among cost or price and non-cost factors and allows the Government to accept other than the lowest priced quote. The following evaluation factors, listed in descending order of importance, apply to this solicitation and when combined are equally important to price:

1. Technical Approach

2. Staffing Plan

14. Evaluation Factors

• Technical Factor 1: Technical Approach

• Technical Factor 2: Staffing Plan and Experience

• Price

Technical Approach

The Government will evaluate the degree to which the technical and management approach demonstrates a thorough understanding of the requirements and provides a viable plan and means for successful completion of the tasks described in the solicitation.

Quotes shall describe the Offeror’s proposed approach in conjunction with the tasks to be performed in achieving the requirement objectives. A work plan must be submitted indicating how each aspect of the statement of work is to be accomplished. The technical approach shall contain as much detail as necessary to fully explain the proposed technical approach. The technical quote must include information on how the project is to be organized, staffed, and managed. Information shall be provided which will demonstrate the Offeror’s understanding and management of tasks.

Staffing Plan

The Government will evaluate the extent and degree to which the composition of proposed personnel supports and is related to the requirement and the proposed personnel’s expertise and experience. Quotes shall include a list of names and proposed duties of the personnel proposed for the requirement. Resumes that clearly demonstrate the extent that the personnel meet or exceed the required qualifications and experience shall be included.

15. FAR 8.405-3 Procedures

Please note: This order will follow the procedures under FAR 8.405-3. The procedures in FAR Subpart

15.3 do not apply to this acquisition. In using FAR 8.405-3 procedures the Government is not obligated to determine a competitive range, conduct discussions with any vendors, solicit quotation revisions thereto, or use any other source selection techniques associated with subpart 15.3.

16. Submission Deadlines

Solicitation Questions and Comments

It shall be the obligation of the Quoter to exercise due diligence to discover and bring to the attention of the Contracting Officer (CO) at the earliest possible time, any ambiguities, discrepancies, inconsistencies, or conflicts between the statements of work and other documents attached hereto or incorporated by reference herein. The Government reserves the right not to answer all the questions received.

Questions shall be submitted to Matthew Tran at matthew.tran@fda.hhs.gov by Wednesday, September 18th, 2024, by 10 AM EST.

Quotes shall be submitted to Matthew Tran at matthew.tran@fda.hhs.gov by Thursday, September 19th, 2024, by 10 AM EST.

17. Invoicing

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) ([JAN 2022])

a. All Invoice submissions for goods and or services must be made electronically through the

U.S. Department of Treasury's Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov

1. The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 - 5 business days of the contract award for new contracts or date of modification for existing contracts.

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.

Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973- 3131.

3. The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within http://www.ipp.gov/vendors/index.htm https://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

4. If your company is already registered to use IPP, you will not be required to re-register.

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and

(2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

• Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

• Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

• Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

• Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

• Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

• Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

• Fee - amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. 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.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA 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.

18. PROCUREMENTS REQUIRING INFORMATION SECURITY AND/OR PHYSICAL

ACCESS

CONTRACTOR PERSONNEL SECURITY CLEARANCE STANDARDS AND RESIDENCY

REQUIREMENTS, DATED OCTOBER 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.

mailto:ERIC@fda.hhs.gov

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.

3. 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 Contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Employees who hold or have previously held a Government security clearance must advise the FDA Personnel Security Staff of the details of such clearance.

Note: Background investigations will be conducted by the Office of Personnel Management (OPM)

4. CONTRACT RISK DESIGNATION(S) - Contractor employees who will be in DHHS-owned or leased space for thirty (30) days or more must be able to obtain and shall obtain a PIV card pursuant to Homeland Security Presidential Directive-12 (HSPD-12) in order to access to DHHS-owned or leased property without an escort. (See Section 6 for details on the PIV Card process) However, in the event that work must commence before a security screening can be completed, contractor employees will be considered visitors, as described above, and allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation Processing system (e-Qip) system. The FDA Personnel Security Specialist will provide access to the e-Qip as well as guidance as to which forms will be required. The forms required vary with the position risk designations for the contract.

All standard forms submitted to the FDA will be forwarded to the Office of Personnel Management (OPM) to initiate background investigations. The assigned FDA Personnel Security Specialist will resolve with the contractor employee any issues arising out of inaccurate or incomplete forms.

The Risk Designation(s) for this contract is/are Tier(s): Tier 1

There are three (3) potential position risk designations, which are:

• Non-Sensitive Low Risk (Tier 1) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by the FDA Personnel Security Specialist are required for Non-Sensitive Low Risk Positions.

• Sensitive Moderate Risk (Tier 2) or Sensitive High Risk (Tier 4) - Public Trust Positions - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs.

In order to access the e-QIP system, Contractor employees must provide the appropriate FDA Personnel Security Specialist with the following information: (a) full name; (b) position title; (c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. This information will be provided on the e-Qip form that will be electronically sent to the employee. The FDA Personnel Security Specialist will use this information to enter each Contractor employee into the e-QIP system.

Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the background investigation.

A Contractor’s failure to comply with the e-QIP processing guidelines will result in that Contractor’s employees being denied access to FDA property until all security processing has been completed.

Furthermore, any such noncompliance may detrimentally impact Contractor performance, Contractor performance evaluations, rights and remedies available at law and equity retained by the Government.

5. PERSONAL IDENTITY VERIFICATION (PIV) CARDS - All PIV Cards (and any other type of Government-issued Access Card) shall remain the property of the Federal Government. At any time, if a Contractor employee is terminated or otherwise ceases work under the contract, or no longer requires a PIV Card for contract performance purposes, the Contractor must collect the individual’s PIV card and immediately notify FDA Personnel Security Staff in writing, with copies to the respective COR and Contracting Officer. The Contractor must immediately return the PIV Card(s) to the COR.

Because PIV Cards, like other Government-issued Access Cards are Government property, Contractors and Contractor Employees are hereby placed on notice that any abuse, destruction, defacement, unauthorized transfer or withholding (i.e., failure to return to the Government) may be punishable to the greatest extent at law.

Unauthorized possession of a PIV Card, or any other type of Government-issued Access Card, and/or willfully allowing any other person to have or to use your Access Card, is prohibited and can be criminally prosecuted under 18 U.S.C. §§ 499 and 70I, which prohibit photographing or otherwise reproducing or possessing HHS identification cards in an unauthorized manner, under penalty of fine, imprisonment, or both. Wrongdoers may also be held financially responsible for any/all civil and equitable remedies – to include, but not limited to, damages for any pecuniary loss suffered by the Government as a result of any of the above-listed actions or failure to act.

6. PIV CARD PROCESS - The COR will sponsor Contractor employees on the Form HHS 745 and HHS Smart Card Management System (SCMS) for the purpose of obtaining an FDA PIV Card. In order to obtain a PIV card, a Contractor employee must receive a favorable FBI fingerprint return and complete required security forms. The FDA Personnel Security Specialist will provide the Contractor employee(s) direction for scheduling fingerprinting appointments at the FDA location or other approved location.

During a fingerprint appointment, each contractor employee must present two (2) forms of identification in order to receive his or her PIV Card. One form of identification must be a government-issued photo identification document. Acceptable forms of identification are listed in

Appendix A, provided below. An individual who receives an unfavorable report may appeal that finding by submitting a written request to the FDA Personnel Security Specialist.

Required background investigations may include, but are not limited to:

• Review of prior Government/military personnel records;

• Review of FBI records and fingerprint files;

• Searches of credit bureaus;

• Personal interviews; and

• Written inquiries covering the subject's background.

7. RESIDENCY REQUIREMENTS FOR FOREIGN NATIONALS - Under the requirements for Homeland Security Presidential Directive-12 (HSPD-12), OPM can complete a background investigation only for persons who have resided in the U.S. for a total of at least three (3) of the past five (5). The residency requirements apply only to foreign nationals. If any prospective foreign national contractor/subcontractor employee does not meet the residency requirements, he/she cannot qualify for a PIV Card under HSPD-12.

8. NON-PUBLIC DATA PROTECTION - The Contractor must protect the privacy of all information reported by or about Contractor employees and protect against unauthorized disclosure.

*Upon a favorable fingerprint return, the Contractor will be notified to return to the Badging and Credentialing Office for their building pass.

*Food and Drug Administration Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m., Eastern Time 10903 New Hampshire Avenue

Building 32, Room 1205 Silver Spring, MD 20993 No appointment necessary Telephone: (301) 796-4000

19. FAR/HHS/FDA Clauses

FAR 52.204-27 Prohibition on a ByteDance Covered Application (Jun 2023)

(a) Definitions. As used in this clause—

Covered application means the social networking service TikTok or any successor application or service developed or provided by ByteDance Limited or an entity owned by ByteDance Limited.

Information technology, as defined in 40 U.S.C. 11101(6)—

(1) Means any equipment or interconnected system or subsystem of equipment, used in the automatic acquisition, storage, analysis, evaluation, manipulation, management, movement, control, display, switching, interchange, transmission, or reception of data or information by the executive agency, if the equipment is used by the executive agency directly or is used by a contractor under a contract with the executive agency that requires the use—

(i) Of that equipment; or

(ii) Of that equipment to a significant extent in the performance of a service or the furnishing of a product;

(2) Includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources; but

(3) Does not include any equipment acquired by a Federal contractor incidental to a Federal contract.

(b) Prohibition. Section 102 of Division R of the Consolidated Appropriations Act, 2023 (Pub. L. 117- 328), the No TikTok on Government Devices Act, and its implementing guidance under Office of Management and Budget (OMB) Memorandum M-23-13, dated February 27, 2023, “No TikTok on Government Devices” Implementation Guidance, collectively prohibit the presence or use of a covered application on executive agency information technology, including certain equipment used by Federal contractors. The Contractor is prohibited from having or using a covered application on any information technology owned or managed by the Government, or on any information technology used or provided by the Contractor under this contract, including equipment provided by the Contractor’s employees;

however, this prohibition does not apply if the Contracting Officer provides written notification to the Contractor that an exception has been granted in accordance with OMB Memorandum M-23-13.

(c) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (c), in all subcontracts, including subcontracts for the acquisition of commercial products or commercial services.

(End of clause) HHSAR Clauses incorporated in Full Text:

HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for BPA financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this BPA.

(b) Except as provided in paragraph (c) of this clause, the Vendor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Vendor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Vendor shall include a copy of the Contracting Officer's written authorization with each payment request.

http://www.ipp.gov/

FAR 52.217-9 Option to Extend the Term of the Contract ([MAR 2000])

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

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

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed the identified period of performance, inclusive of any options if exercised.

HHSAR 352.237-75 Key Personnel ([DEC 2015])

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

19. FAR/HHS/FDA Clauses