Sol Doc.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

DAO

See Schedule

CODE 16. ADMINISTERED BYCODE

X

X

541715

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAO

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

08/14/2024 1500 ET

08/05/2024

HILDA ARYEH

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBER a. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40124R00178

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 52 OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Silver Spring MD 20903 WO2/3rd Floor 10903 New Hampshire Ave.

ATTN:Hilda M. Aryeh

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

1,000

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

DHHS/FDA/OAGS/DAO

WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

ADMINISTERED BY:

DHHS/FDA/OAGS/DAO

ATTN:Hilda M. Aryeh 10903 New Hampshire Ave.

WO2/3rd Floor Silver Spring MD 20903 USA The US Food and Drug Administration hereby issues a solicitation for the delivery of 9 Pelvis with Proximal Femurs (L3/L4)- Intact Period of Performance: 09/01/2024 to 08/31/2025

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

IAN S. WEISS

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

52 2 of

FDA-24-RFQ- 75F40124R00178 Page 3 of 52

1. DESCRIPTION

This procurement is to support regulatory science tool development for novel sacroiliac joint fusion devices in the Orthopedics program area. The Office of Health Technologies – 6 (Orthopedic Devices) has noticed a substantial increase in submissions of in-line sacroiliac joint devices, which provide a minimally invasive posterior approach for implantation. However, this is an emerging technology with only five such devices cleared till date. The unique design approach of each of these devices has required applying non-standardized special controls during regulatory review (biomechanical evaluation via cadaver testing). However, lack of standardization of such techniques has resulted in lengthy regulatory reviews. Further, it remains unclear whether female SIJ biomechanics are considered during device design. The novel study design and methodologies employed in this study will provide an invaluable set of data which will substantially reduce the burden on innovators, manufacturers, and regulatory reviewers.

To satisfactorily solve these unknown regulatory review challenges, the Division of Applied Mechanics Orthopedics program area has proposed a study that will address these knowledge gaps investigating the biomechanical response of the female and male sacroiliac joints under a variety of physiologically relevant loading and boundary conditions to develop a female-specific cadaver testing protocol.

To develop a reliable cadaver testing protocol, we need to procure 9 female pelvic cadaver specimens. This will allow us to publish a validated cadaver testing protocol for novel sacroiliac joint devices. The regulatory science tools stemming from this work with directly support the Center of Devices and Radiological Health mission of protecting and promoting public health by using applied mechanics to investigate interactions between medical devices and the human body

1.1 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.

1.2 Notice Of FAC

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-06, effective July 30, 2024.

(https://www.acquisition.gov/browse/index/far)

1.3 Notice Of NAICS/Set Aside

This requirement is intended for full and open competition. The associated North American Industry Classification System (NAICS) code is 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), (1000 employees). It is advised that SAM be active when submitting the proposal. Offerors must have an active registration in SAM.gov (https://beta.sam.gov), with completed representations and https://www.acquisition.gov/browse/index/far https://beta.sam.gov/

FDA-24-RFQ- 75F40124R00178 Page 4 of 52 certifications, by the close date of the solicitation. Proposals submitted by offerors not registered in SAM.gov will not be considered.

2. CONTRACT TYPE AND MINUMUM/MAXIMUM AMOUNT

2.1 This is a Firm-Fixed Price Purchase Order.

2.2 Consideration And Payment

The Contractor shall provide the necessary personnel, equipment, supplies, and support services to perform as described in Section 4 of this document. In consideration for successful performance of these services, the Contractor shall be paid upon the presentation of a proper invoice in accordance with the applicable invoice clause with the Firm Fixed Price contract type specified.

3. PRICING AND ORDERING OF SERVICES

3.1 Description of Supplies & Services

Pricing Schedule:

Base Period September 1, 2024 – August 31, 2025

4. DESCRIPTION/SPECIFICATIONS

4.1 Objectives:

The overall objective of the requirement is to develop optimized female-specific cadaver testing protocols that can be used by medical device manufacturers to assess bone-implant interface integrity of sacroiliac joint fusion devices.

The expected goal is to identify the ideal mechanical protocol to thoroughly investigate any sacroiliac joint fusion device requesting marketing approval.

If the contract is successful, we will receive 9 female pelvic cadavers per the requirements

4.2 Task

The 9 female pelvic cadaver specimens must meet both general and specific requirements:

4.3 General Requirements

ITEM NAME (Model Number if possible)

Quantity Unit Price Total Cost

0001 Pelvis with Proximal Femurs (L3/L4)- Intact

0002 Shipping Total Price

FDA-24-RFQ- 75F40124R00178 Page 5 of 52

• All cadaveric donors, from which the specimens are extracted, must be tested at a minimum for Hepatitis B, Hepatitis C, Human Immunodeficiency Virus 1, Human Immunodeficiency Virus 2, Tuberculosis, and Covid-19. All donors must have negative results, and a written certificate of testing results must accompany each specimen.

• Shipping method must ensure that specimens arrive undamaged, in intact condition, and frozen with uncompromised tissue integrity.

• All specimens will be subject to inspection upon receipt. If they fail to meet requirements, they will not be counted towards the total number of required specimens.

• Any data provided about the cadaveric donors cannot include personally identifiable information.

• Support: Available during normal business hours

• Quotes must Include all Shipping and Handling costs.

4.4 Specific Requirements:

Pelvic Cadaver Specimens from Female Donors •Number of pelvic specimens required: 9

• Full pelvic cadaver specimens with both proximal femurs intact and lumbar spinal levels L4, and L5 intact. The proximal femurs are cut 6 inches distal to the inner groin.

•The pelvis specimens must come from a cadaveric donor born as female.

• All organs eviscerated.

•All supporting ligaments and joints left intact including hip joint. Muscle can be removed but ligaments cannot be damaged.

•No diagnosis/history of bone disease or any treatment history that would affect bone quality.

• no prior SI joint fusions or pelvic surgeries.

• Specimen should not be osteoporotic based on hip DEXA •Age range of cadaveric donor: 21-75 years •Specimen condition: Fresh frozen

5.DELIVERABLES

5.1 Deliverable(s)

The Contractor shall deliver 9 female pelvis cadaver per requirements within 120 days of award.

The contractor will ship three samples at a time resulting in a total of 3 shipments (total of 9 samples delivered). All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor’s name. The Contractor shall guarantee that all required materials shall be delivered in acceptable condition.

FDA-24-RFQ- 75F40124R00178 Page 6 of 52

5.2 Contractor Performance Assessment Report

In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration.

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 https://www.cpars.gov/. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor’s primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password.

Once a performance evaluation is issued, the Contractor’s primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 14 days from the date of performance evaluation issuance in which to review the evaluation. 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 the CPARS within 14 days from date the evaluation was issued by the FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final.

Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3-year period in the CPARS system.

Contractors may obtain CPARS training material and register for on-line training at https://www.cpars.gov/webtrain.htm. There is no fee for registration or use of the CPARS.

5.3. Reporting Matters Involving Fraud, Waste and Abuse

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in FDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll-free number is 1-800-HHS-TIPS (1-800- 447-8477). All telephone calls will be handled confidentially. The email address is HHStips@oig.hhs.gov and the mailing address is:

Office of Inspector General Department of Health and Human Services Attn: HOTLINE 330 Independence Avenue, S.W. Washington, D.C. 20201

5.4 Property, Equipment, Supplies, Facilities, Personnel and Services There shall be no Government furnished property, equipment, supplies, facilities and Government furnished information with this Contract.

6.CONTRACT ADMINISTRATION DATA

6.1 Period of Performance

https://www.cpars.gov/ https://www.cpars.gov/webtrain.htm

FDA-24-RFQ- 75F40124R00178 Page 7 of 52

It is requested that the specimens be delivered 3 at a time over a period of 4 months after award of contract. This will result in a total of 3 shipments and 9 specimens (9 female).

The work is expected to be completed in the 1st year after receiving of last shipment.

6.2 Place of Performance

SHIP TO:

US FDA CDRH

Division of Applied Mechanics Attention: Snehal Shetye 10903 New Hampshire Avenue

WO62 RM 2118

Silver Spring, Maryland 20993

PH: 240-402-0514

Email: Snehal.Shetye@fda.hhs.gov

6.3 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 In the event of inclement weather when the Federal government is closed, the Contractor is not required to provide on-site service. The Contractor is required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the Contract).

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.

6.4 Administrative Points of Contract

mailto:Snehal.Shetye@fda.hhs.gov

FDA-24-RFQ- 75F40124R00178 Page 8 of 52

6.4.1 Contracting Officer’s Representative’s

The Contracting Officer’s Representative (COR) will perform inspection and acceptance of equipment and services to be provided.

The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

6.4.2 The contact information for the Contract Specialist is the following:

Hilda M. Aryeh U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Rd.

Beltsville, MD 20705 Email: Hilda.Aryeh@fda.hhs.gov

6.4.3 The contact information for the Contracting Officer is the following:

Ian Weiss U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Rd.

Beltsville, MD 20705 Email: Ian.Weiss@fda.hhs.gov

6.4.4 The contact information for the Contracting Officer Representative:

Todd Johnston U.S. Food and Drug Administration

WO66 RM5107 HFA-500

10903 New Hampshire Ave Silver Spring MD 20993-0002 Email: Todd.Johnston@fda.hhs.gov

7. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022) mailto:Hilda.Aryeh@fda.hhs.gov mailto:Ian.Weiss@fda.hhs.gov mailto:Todd.Johnston@fda.hhs.gov

FDA-24-RFQ- 75F40124R00178 Page 9 of 52

(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 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.

(c) -----

(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 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).

(a) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

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

FDA-24-RFQ- 75F40124R00178 Page 10 of 52

(1) 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.

(b) 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:

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

- invoice number, amount, & date submitted

- corresponding payment amount & date received

- total amount of all payments received to date under the subject contract or order

- and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

(c) 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.

FDA-24-RFQ- 75F40124R00178 Page 11 of 52

(d) 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.

(e) 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.

(f) 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.

(g) 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.

8. SPECIAL CONTRACT REQUIREMENTS

8.1 Authority To Obligate The Government

The Contracting Officer is the only individual who can legally commit or obligate the Government to the expenditure of public funds. No cost chargeable to the proposed contract can be incurred before receipt of a fully executed contract, task order and/or modification or specific authorization from the Contracting Officer.

8.2. Conflict Of Interest And Confidentiality

(a) Purpose. The purpose of this clause is to ensure that the contractor and its subcontractors:

(1) Are not biased because of their financial, contractual, organizational, or other interests which relate to the work under this Contract,

(2) Do not obtain any unfair competitive advantage over other parties by virtue of their performance of this Contract.

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint venture, consultant, or in any similar capacity.

(c) Warrant and Disclosure. The warrant and disclosure requirements apply to both the contractor and all subcontractors. The contractor warrants that, to the best of the contractor's knowledge and belief, there are no relevant facts or circumstances which would give rise to an organizational

FDA-24-RFQ- 75F40124R00178 Page 12 of 52 conflict of interest, as defined in FAR Subpart 9.5, and that the contractor has disclosed all relevant information regarding any actual or potential conflicts. The contractor agrees it shall make an immediate and full disclosure, in writing, to the Contracting Officer of any potential or actual organizational conflict of interest or the existence of any facts that may cause a reasonably prudent person to question the contractor's impartiality because of the appearance or existence of bias or an unfair competitive advantage. Such disclosure shall include a description of the actions the contractor has taken or proposes to take in order to avoid, neutralize, or mitigate any resulting conflict of interest.

(d) Remedies. The Contracting Officer may terminate this award for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid, neutralize or mitigate an actual or apparent organizational conflict of interest. If the contractor fails to disclose facts pertaining to the existence of a potential or actual organizational conflict of interest or misrepresents relevant information to the Contracting Officer, the Government may terminate the award for default or cause; suspend or debar the contractor from Government contracting; or, pursue such other remedies as may be permitted at law or equity.

(e) Subcontracts. The contractor shall include a clause substantially similar to this clause, including paragraphs (f) and (g), in any subcontract or consultant agreement.

(f) Prime Contractor Responsibilities. The Contractor shall determine in writing whether the interests disclosed present an actual, or significant potential for, an organizational conflict of interest. The contractor shall identify and avoid, neutralize, or mitigate any subcontractor organizational conflict prior to award of the Contract or Task Order to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the contractor must obtain the written approval of the Contracting Officer prior to entering into the subcontract. If the contractor becomes aware of a subcontractor's potential or actual organizational conflict of interest after Contract or Task Order award, the contractor agrees that the Contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk. The contractor shall obtain from its subcontractors or consultants any disclosures identifying any potential organizational conflicts of interest.

(g) Waiver. The contractor may seek a waiver from the Head of the Contracting Activity by submitting such waiver request to the Contracting Officer, including a full written description of the requested waiver and the reasons in support thereof.

(h) All contractor personnel involved in this requirement shall abide by the FDA Commitment to Protect Non-Public Information Agreement.

8.3. Non-Personal Services and Inherently Governmental Functions Pursuant to FAR 37.1, no personal services shall be performed under this contract. Work requirements shall flow only from the Contracting Officer or the COR to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All employee assignments, and daily work direction, shall be given by the applicable Contractor 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.

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

FDA-24-RFQ- 75F40124R00178 Page 13 of 52 he or she is acting on behalf of the Government. In all communications 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 this contract and that if the other Contractor believes this communication to be a direction to change their contract, they shall 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 insure 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 this 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.

8.4 Briefings

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

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

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

8.5 Human Subjects Protection Review

For research exempt from the requirements of 45 CFR Part 46:

(a) The Contractor will submit to FDA a letter from their IRB or human subject protection entity that the proposed research is exempt (see 45 CFR 46.104).

(b) In accordance with SMG 9001.4, FDA will follow its procedures for exempt research determination. Data collection from human subjects cannot commence under this contract until the FDA COR provides the Contractor with the outcome of the FDA determination.

For nonexempt human subjects research:

(a) The Contractor agrees to protect the rights and welfare of human subjects involved in research under this contract by complying with 45 CFR Part 46 and the clause at HHSAR 352.270-4b.

(b) Initial proof of compliance with 45 CFR Part 46 shall consist of:

(1) A copy of a current Federal-wide Assurance on file with OHRP (https://www.hhs.gov/ohrp/ federalwide-assurances-fwas.html). The copy of a current Federal–wide Assurance shall be included with the Contractor’s proposal;

(2) A letter from the Contractor’s local IRB (the Institutional Review Board (IRB) specified in the Offeror’s Assurance of Compliance) stating that it has reviewed and approved the proposed

FDA-24-RFQ- 75F40124R00178 Page 14 of 52 research protocol. The letter from the local IRB shall be submitted to the Contracting Officer Representative (COR).

(3) In accordance with SMG 9001.4, the FDA will determine if FDA is considered engaged in the research for purposes of 45 CFR part 46. Data collection from human subjects cannot commence under this contract until the FDA COR provides the Contractor with the outcome of the FDA determination. When that determination is made, the FDA will confirm the extent to which the terms of “352.270-11 Protection of Human Subjects—Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required” apply.

9. CONTRACT PROVISIONS AND CLAUSES

9.1. FAR Clauses Incorporated by Reference

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer shall make their full text available. Also, the full text of a clause may be accessed electronically at:

www.acquisition.gov/far/index.html

52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) 52.212-4, Contract Terms and Conditions—Commercial Items (Nov 2023) 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023)

9.2 Solicitation Provisions Incorporated by Reference:

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

www.acquisition.gov/far/index.html

FAR 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sept 2007) FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.204-22, Alternative Line Item Proposal (Jan 2017) FAR 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony http://www.acquisition.gov/far/index.html http://www.acquisition.gov/far/index.html

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Conviction under any Federal Law (FEB 2016).

FAR 52.212-1, Instructions to Offerors- Commercial Items (Sep 2023) FAR 52.233-2, Service of Protest (Sept 2006) FAR 52.246-4 - Inspection of Services - Fixed-Price (AUG 1996)

9.3 HHSAR CLAUSES INCORPORATED BY REFERENCE

This contract incorporates one or more HHSAR clauses or provision by reference, with the same force and effect as if they were given in full text. HHSAR Clauses and Provisions can be viewed in full text at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

HHSAR Clause Clause Title HHSAR 352.203-70 Anti-Lobbying, (Dec 2015)

HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigation, ( Dec 2015) HHSAR 352.227-70 Publications and Publicity (Dec 2015)

HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice, (Dec 2015)

HHSAR 352.224-71 Confidential Information (Dec 2015)

9.4 HHSAR Clauses 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 contract 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 contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor 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 Contractor 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 Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

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

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(End of Clause)

352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(e) Respondents to this solicitation must identify any exception to Section 508 requirements.

If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

https://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.239-74 https://www.hhs.gov/web/508

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9.5 FAR Clauses Full Text.

FAR 52.212-5 - Contract Terms And Conditions Required To Implement Statutes Or Executive Orders—Commercial Products And Commercial Services (MAY 2024)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L.

115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[Contracting Officer check as appropriate.]

_X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) ( 41 U.S.C. 3509)).

https://www.acquisition.gov/far/52.203-19#FAR_52_203_19 https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://www.govinfo.gov/link/uscode/31/3903 https://www.govinfo.gov/link/uscode/10/3801 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.govinfo.gov/link/uscode/10/4655 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

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__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.203-17, Contractor Employee Whistleblower Rights (NOV 2023) ( 41 U.S.C.

4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

_X_ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (6) [Reserved].

_X_ (7) 52.204-14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111- 117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (9) 52.204-27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117-328).

__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (DEC 2023) ( Pub. L. 115–390, title II).

__ (11)

(i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders— Prohibition. (DEC 2023) ( Pub. L. 115–390, title II).

__ (ii) Alternate I (DEC 2023) of 52.204-30.

_X_ (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) ( 31 U.S.C. 6101 note).

__ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (OCT 2018) ( 41 U.S.C. 2313).

__ (14) [Reserved].

__ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) ( 15 U.S.C. 657a).

https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.203-17#FAR_52_203_17 https://www.govinfo.gov/link/uscode/41/4712 https://www.govinfo.gov/link/uscode/41/4712 https://www.acquisition.gov/far/3.900#FAR_3_900 https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.204-14#FAR_52_204_14 https://www.acquisition.gov/far/52.204-15#FAR_52_204_15 https://www.acquisition.gov/far/52.204-27#FAR_52_204_27 https://www.acquisition.gov/far/52.204-28#FAR_52_204_28 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/52.204-30#FAR_52_204_30 https://www.govinfo.gov/link/plaw/115/public/390 https://www.acquisition.gov/far/52.204-30#FAR_52_204_30 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.209-9#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/52.219-3#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim

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__ (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (17) [Reserved]

__ (18)

(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-6.

__ (19)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) ( 15 U.S.C. 644).

__ (ii) Alternate I (MAR 2020) of 52.219-7.

__ (20) 52.219-8, Utilization of Small Business Concerns (FEB 2024) ( 15 U.S.C. 637(d)(2) and (3)).

__ (21)

(i) 52.219-9, Small Business Subcontracting Plan (SEP 2023) ( 15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (NOV 2016) of 52.219-9.

__ (iii) Alternate II (NOV 2016) of 52.219-9.

__ (iv) Alternate III (JUN 2020) of 52.219-9.

__ (v) Alternate IV (SEP 2023) of 52.219-9.

__ (22)

(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) ( 15 U.S.C. 644(r)).

__ (ii) Alternate I (MAR 2020) of 52.219-13.

__ (23) 52.219-14, Limitations on Subcontracting (OCT 2022) ( 15 U.S.C. 637s).

__ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) ( 15 U.S.C.