75F40124Q00543 9-12-2024.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

WO64 CODE 16. ADMINISTERED BYCODE

X

X

X

333415

SIZE STANDARD:

100.00 % 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

09/18/2024 1400 ETKIMBERLY PENNIX

(No collect calls)

INFORMATION CALL:

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

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40124Q00543

5. SOLICITATION NUMBER

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

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

TELEPHONE NO.

17a. CONTRACTOR/

Silver Spring MD 20993 Building 64 10903 New Hampshire Avenue The US Food and Drug Administration

15. DELIVER TO

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

ATTN: Kimberly Pennix

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

1,250

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 SCHEDULEX

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: Kimberly Pennix 10903 New Hampshire Ave.

WO2/3rd Floor Silver Spring MD 20903 USA

DELIVER TO:

WO64

The US Food and Drug Administration 10903 New Hampshire Avenue Continued ...

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

HEREIN, IS ACCEPTED AS TO ITEMS:

XX

DATED

NICHOLAS C. BISHER

. 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.

Building 64

Silver Spring MD 20993 US

CDER Division of Applied Regulatory Sciences (DARS) Purchase of Cryopreservation

System

Period of Performance: 90 days post-award.

Delivery: 90 Days After Award

1 Base Effort: CDER Division of Applied Regulatory

Sciences (DARS) Purchase of Cryopreservation

System

Period of Performance: 09/26/2024 to 12/26/2024

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

30 2 of

Request for Quotations (RFQ) No. 75F40124Q00543 Purchase of Cryopreservation System

U.S. Food and Drug Administration (FDA)

Request for Quotations (RFQ) # 75F40124Q00543

CDER Division of Applied Regulatory Science’s (DARS)

Purchase of Cryopreservation System

NAICS Code: 333415

Air Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing

RFQ Issue Date: September 12, 2024

1. DESCRIPTION/COMMERICAL ITEM PROCUREMENT

This is a combined synopsis/solicitation for commercial products prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6- Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This is Request for Quotation (RFQ) no. 75F40124Q00543 for commercial products in accordance with the procedures of FAR Part 12- Acquisition of Commercial Products and Commercial Services, and FAR Part 13- Simplified Acquisition Procedures.

The associated North American Industry Classification System (NAICS) code is 333415- Air Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing. The associated small business size standard is 1,250 employees.

This is a total small business set-aside solicitation in accordance with FAR Subpart 19.5- Small Business Total Set-Asides, Partial Set-Asides, and Reserves.

2. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2023-04, effective August 29, 2024.

The FAR provisions and clauses referenced in this solicitation can be found on the following website: www.acquisition.gov

The Department of Health and Human Services (HHS) Acquisition Regulation (HHSAR) provisions and clauses referenced in this solicitation can be found on the following website: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

3. PURCHASE ORDER REQUIREMENTS

See Section 7, Statement of Work, for a full description of the services to be acquired.

4. ORDER TYPE

The Government anticipates awarding one (1) Firm-Fixed-Price (FFP) type Purchase Order.

5. PERIOD OF PERFORMANCE

The anticipated period of performance is delivery within 90 days of award.

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

6. PRICING

See Attachment A – Pricing Table

7. STATEMENT OF WORK

Purchase of Cyropreservation System

1.0. Background:

The safe cryogenic storage of biological materials such as cells is a primary component of the FDA CDER’s Division of Applied Regulatory Science’s (DARS) mission in support of drug metabolism, pharmacokinetics, and toxicology studies. Cryogenic freezers consist of steel vacuum tanks filled with liquid nitrogen as the refrigerant that can house biological samples and maintain them at a temperature of -190°C. Freezer electronics monitor the tank temperature and because nitrogen vaporizes over time and the level of liquid in the tank falls, auto-fill systems are employed to maintain the level of refrigerant. Construction and design of the vacuum tank determines how quickly refrigerant is consumed by vapor loss. High efficiency MVE Biological Solutions (MVE) systems employ design features to minimize refrigerant consumption such as an offset neck to minimize vapor loss while adding or removing samples from the vacuum tank. Other design feature such as a rotating interior tray and annular filling lines provide easy access to stored samples and reduce frost and ice formation near the access lid.

We are requesting to purchase an MVE high-performance cryogenic freezer for cryopreservation that will be compatible to with our existing older MVE systems in terms of temperature profile such that samples will be stored under identical conditions to our existing freezers while providing greater efficiency in terms of refrigerant consumption. The new freezer will provide a needed increase in storage capacity while maintaining the same storage conditions as our existing MVE freezers providing consistency and eliminating study to study variations related to cell storage conditions. All these advantages will increase laboratory productivity by providing reliable and reproducible cryogenic storage for cells and for biological samples collected in studies conducted across all DARS laboratories.

We have used MVE cryogenic freezers in our laboratories at FDA White Oak Building 64 for the past 6 years with no reliability or maintenance issues. Thirteen (13) MVE cryogenic freezers have been in operation at CBER’s Freezer Farm facility in FDA’s White Oak Building 75 since 2015. CBER’s Freezer Farm facility manager reported that their MVE cryogenic systems have been remarkably reliable requiring minimum maintenance.

Objective:

The objective of this project is the purchase of an additional high-performance cryopreservation freezer to complement our older existing MVE freezers thereby enhancing overall cryogenic storage capacity while reducing downtime caused by maintenance issues with older freezers. The new cryogenic freezer must be compatibility with our older existing cryogenic (MVE) systems in terms of storage conditions in order to minimize study to study variations.

The high-performance cryopreservation characteristics of MVE systems will provide multiple benefits over conventional systems including but not limited to holding temperatures stable from top to bottom of vacuum vessel sealing cork top for near 100% enclosure, keeping the samples and liquid nitrogen separate and ease of access so maintenance can be performed without moving samples. The new system’s benefits will ensure that samples collected from projects in DARS including drug metabolism, invitro drug testing, pharmacokinetic, pharmacodynamic and toxicology studies are stored safely and that storage conditions are identical between the new and existing cryogenic freezers.

2.0. Salient Characteristics / Requirements:

The instrument shall be a high-performance HeCO Vapor Series P-190 cryopreservation system and include the following components:

Description Part/Product

Quantity

MVE HECO 1536P-190AF-GB FULL

AUTO, GB cryopreservation freezer 20665511 1

V-13-2L Vertical Rack for 13 2'' boxes with locking rod V-13-2L 24

2'' 100 Cell Plastic Box P-100 312

Delivery, installation, and a minimum of 1-day on-site training shall be included.

3.0 Performance / Specifications: The instrument shall meet the following performance / specifications:

HeCO Vapor Series P-190 cryopreservation system

a. Compatibility with our older existing cryogenic (MVE Biological) systems in terms of storage conditions in order to minimize study to study variation.

b. Offset neck design to maintain -190°C in vapor storage and provide low liquid nitrogen consumption with standard racks.

c. Fully enclosed wiring and plumbing.

d. Capacity to store up to 36,400 1.2 and 2 ml vials, 24 racks for 100 cell boxes, 16 racks for 25 cell boxes and up to 13 stages per rack.

e. Minimum liquid nitrogen capacity of 730 liters, 115 liters under trays

f. Minimum Static hold time of 17 vapor days and 100 liquid full days

g. Durable metal lid vs plastic composite.

h. Rotating interior tray provides easy access to cryobiological samples.

i. Low maintenance, all stainless steel construction

j. Annular filling lines to reduce frost and ice formation near lid.

k. Rack Stand

l. Option battery backup for temperature monitor and refrigerant autofill system.

m. Low profile design for less lift-over height (37 inches) when adding and removing samples.

n. Available step-up platform available to allow easy access for shorter operators when adding or removing samples.

o. Minimum Two (2) Year Parts Warranty & Five (5) Year Vacuum Warranty

4.0. Delivery, Performance-Period Requirements, Place of Performance.

a. Period of Performance/Basis.

Delivery within 90 days of award

b. Reporting Requirements and Deliverables/Place of Performance.

DELIVER TO:

Sharron Stewart

US FOOD AND DRUG ADMINISTRATION

10903 NEW HAMPSHIRE AVE

WO BLDG 64 RM 2030

SILVER SPRING MD 20993

301-796-4265

Sharron.Stewart@fda.hhs.gov

5.0 Deliverables:

System shall include:

• MVE Biological Solutions HeCO Vapor Series P-190 cryopreservation system model 1536P-190AF-GB (Qty 1)

• V-13-2L Vertical Rack for 13 2'' boxes with locking rod (Qty 24)

• 2'' 100 Cell Plastic Box (Qty 312)

• Delivery, installation, and training

• Minimum five-year vacuum warranty and two year parts warranty

OCCUPATIONAL SAFETY AND HEALTH TERMS AND CONDITIONS

SECTION I – GENERAL OCCUPATIONAL SAFETY AND HEALTH TERMS AND CONDITIONS:

1. The contractor is responsible for ensuring contractor personnel comply with applicable OSHA requirements, report unsafe conditions or activities to the Contracting Officer’s Representative (COR), and avoid actions and conditions that may result in an accident.

2. The contractor shall submit to the COR a site-specific safety and accident prevention plan and OSHA 300A reports from the past three calendar years.

3. The contractor shall report all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than 24-hours after discovery of the incident, illness or injury, or near-miss.

4. The contractor shall provide an investigation report at no cost to the Government for all workplace incidents, accidents, injuries, and near-misses that occur within the scope of the acquisition (whether OSHA-recordable or not) to the COR by email as soon as possible, but no more than 24-hours after the conclusion of the investigation of the incident, illness or injury, or near-miss.

5. The contractor shall report all activities or conditions that pose imminent danger or harm to persons, animals, or Government property immediately upon discovery to FDA Security or directly to local emergency services, as appropriate. In addition, the contractor shall report the incident to the COR immediately thereafter.

6. The contractor shall be responsible for any and all costs, expenses, and other obligations paid or incurred, due to the contractor’s noncompliance with federal, state, and/or local laws or ordinances.

7. As applicable, the contractor shall provide personal protective equipment (e.g., hard hats, safety glasses, work gloves) for anticipated hazards and ensure that contractor personnel wear the prescribed safety and health equipment within the work area, as prescribed by 29 CFR part 1910, Subpart I. The contractor shall provide instructions to personnel on the proper wear, maintenance, and limitations of the personal protective equipment prior to commencement of any work under the acquisition.

8. Prior to bringing any hazardous material to an FDA facility, the contractor shall provide the COR copies of any Safety Data Sheets (SDS) to obtain advance, written authorization.

8.1. Unless otherwise specified in the acquisition, the contractor is responsible for removing any hazardous material, or any material with an SDS, that the contractor brought with them for use at an FDA facility before or during performance of the acquisition.

Contract Administration Data

Contracting Officer:

Nicholas Bisher

FDA/OO/OFBAP/OAGS/DAO/SCB

Nicholas.Bisher@fda.hhs.gov

Contract Specialist:

Kimberly Pennix

FDA/OO/OFBAP/OAGS/DAO/SCB

Kimberly.Pennix@fda.hhs.gov

Contracting Officer's Representative:

Robert J. Parker Robertj.parker@fda.hhs.gov

Contracting Officer’s Authority

The Contracting Officer (CO) has responsibility for safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this purchase order and is the only person authorized to approve changes to any of the requirements under this order, and notwithstanding any provision contained elsewhere in this purchase order, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this purchase order. 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 purchase order. The Government will not reimburse the Contractor for any work not authorized by the Contracting Officer, including work outside the scope of the purchase order.

Contracting Officer’s Representative (COR)

The Contracting Officer 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 purchase order. 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 purchase order. Such designation will not contain authority to sign contractual documents, purchase 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 purchase order.

The COR will provide the technical direction for the required work. The term “technical direction” is defined to include, without limitation, the following:

• Directions to the Contractor which redirect the purchase order 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 descriptions.

mailto:Nicholas.Bisher@fda.hhs.gov mailto:Kimberly.Pennix@fda.hhs.gov mailto:Roertj.parker@fda.hhs.gov

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

Technical direction must be within the general scope of work stated in this purchase order. The COR does not have the authority to and may not issue any technical direction which:

• Constitutes an assignment of additional work outside this purchase order.

• In any manner cause an increase or decrease in the total purchase order price or the time required for purchase order performance.

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

All technical direction shall be issued orally and/or in writing by the COR or shall be confirmed by him/her in writing within 5 working days after issuance.

The Contractor shall proceed promptly with the performance of technical direction duly issued by the COR in the manner prescribed by this article and within his/her authority under the provisions of this article.

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 issue a formal modification accordingly. Upon receiving such notification from the Contractor, the Contracting Officer shall issue an appropriate formal remedy or advise the Contractor in writing that, in his/her opinion, the technical direction is within the scope of the purchase order.

The Contractor shall immediately contact the Contracting Officer if there is any question regarding the authority of an individual to act on behalf of the Contracting Officer under this purchase order.

The Government may unilaterally change its COR designation.

The following person has been appointed as the purchase order COR:

Name: Robert J. Parker Telephone Number: 301.796.0117 Email Address: Robertj.parker@fda.hhs.gov

Offeror’s Certification – Organizational Conflicts of Interest

As a regulatory agency charged with protection of the public health, the Food and Drug Administration (FDA) must maintain public confidence in the integrity of its decisions. The FDA has various policies and procedures that safeguard against both actual and apparent conflict of interest (COI) on the part of its employees. It is additionally critical that the FDA be assured that there is no actual or apparent COI on the part of either the Contractor's organization or its individual employees in performance of this contract.

Offerors submitting quotes to perform work under this contract must assure the protection of the information and data they receive in performance or under this contract from unauthorized use or disclosure, and must avoid actions that would cause a reasonable person to question the impartiality of mailto:Roertj.parker@fda.hhs.gov the Contractor, its employees, or the Government in the performance of this immediate contract and potential participation in future contract actions. The Contractor will be held to the restrictions of the Organizational Conflict of Interest clause, unless an acceptable mitigation of risk plan is proposed, found to be acceptable by the Government, and enforced.

POTENTIAL CONFLICTS OF INTEREST SPECIFIC TO THIS PURCHASE ORDER – Offerors shall review the Statement of Work in detail to identify any particular aspects that may present organizational or individual COI, either actual or apparent.

DEFINITION OF CONFLICT OF INTEREST - Conflict of interest means that because of other activities or relationships with other persons or organizations, a person or organization is unable or potentially unable to render impartial assistance or advice to the Government, that the person's or organization's objectivity in performing the contract is or might be otherwise impaired, or that the person or organization has or might acquire an unfair competitive advantage (See FAR 9.501).

Conflicts of Interest (COI)

(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/blanket purchase agreement/order/call (hereafter referred to as contract), and

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

(b) Scope. This clause applies to performance or participation by the contractor, its parents, affiliates, divisions and subsidiaries, and successors in interest (hereinafter collectively referred to as “contractor”) in the performance of this contract as a prime contractor, subcontractor, co-sponsor, joint 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 a 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 contract, in whole or in part, or take any other lawful action deemed necessary to avoid, neutralize or mitigate an actual, apparent, or potential conflict of interest. If the contractor fails to disclose facts pertaining to the existence of actual, apparent, or potential conflicts of interest, or otherwise misrepresents relevant information to the Contracting Officer, the Government may terminate the contract 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 any relevant information disclosed by a subcontractor comprises an actual, apparent, or potential conflict of interest.

The prime contractor shall identify and avoid, neutralize, or mitigate any subcontractor conflict of interest prior to award of the subcontract to the satisfaction of the Contracting Officer. If the subcontractor's organizational conflict cannot be avoided, neutralized, or mitigated, the prime 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 actual, apparent, or potential conflict of interest after award, the prime contractor agrees that the prime contractor may be required to eliminate the subcontractor from its team, at the contractor's own risk.

(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.

(End of Clause)

Government Closures and Federal Holidays

Recognized Federal Holidays— The Contractor is not required to provide services on the following Federal holidays or on days designated as Federal holidays for the Washington D.C. area:

New Year’s Day Inauguration Day Martin Luther King’s Birthday President’s Day Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

Note: January 20th, 2025 and January 20th, 2029 will be additional Federal Holidays for Inauguration Day.

The Contractor shall not schedule training during federal holidays or Government closure. As necessary, training scheduled during unexpected Government closures may be rescheduled following coordination with the COR. The contractor shall not bill the Government for any training that the Contractor did not perform due to any Government closures.

Emergency or other specified closings: the Contractor is not required to provide service on days when the Federal Government is closed to non-essential personnel, i.e., storm emergency days and other specified emergencies as approved by the COR or designee.

Early closings will be at the discretion of the COR and will follow the policies of CDER.

Inclement Weather – The Contractor is not required to provide on-site service on days when the Federal Government is closed due to inclement weather.

In the event the Federal Government is closed by order of the President of the United States or the U.S.

Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

Non-Personal Services

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 order 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.

Inspection and Acceptance

All work and deliverables under this purchase order is subject to inspection and final acceptance by the Contracting Officer or the duly authorized representative of the Government. The Government’s Contracting Officer’s Representative (COR) is a duly authorized representative of the government and is responsible for inspection and acceptance of all items to be delivered under this order.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables.

The Contractor shall have three (5) business days to correct the rejected deliverable and return it per delivery instructions.

NOTICE TO THE GOVERNMENT OF DELAYS

Commented [PK1]: Program make sure this is updated too to sync with the days mentioned above.

In the event the Contractor encounters difficulty in meeting performance requirements, or when the Contractor anticipates difficulty in complying with the contract delivery schedule or completion date, or whenever the Contractor has knowledge that any actual or potential situation is delaying or threatens to delay the timely performance of this contract, the Contractor shall immediately notify the Contracting Officer and COR in writing, giving pertinent details. This data shall be informational only in character and this provision shall not be construed as a waiver by the Government of any delivery schedule or date, or any rights or remedies provided by law or under this contract.

FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) PROVISIONS:

NUMBER TITLE DATE

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT JAN 2017

REQUIRE CERTAIN INTERNAL CONFIDENTIALITY

AGREEMENTS OR STATEMENTS - REPRESENTATION

52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

REPORTING

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR AUG 2020

52.204-24 REPRESENTATION REGARDING CERTAIN NOV 2021

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE

SERVICES OR EQUIPMENT

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OCT 2020

OR SERVICES-REPRESENTATION

52.209-2 PROHIBITION ON CONTRACTING WITH INVERTED NOV 2015

DOMESTIC CORPORATIONS-REPRESENTATION

52-212-1 INSTRUCTIONS TO OFFERORS – COMMERCIAL PRODUCTS MAR 2023

AND SERVICES

FAR 52.212-3 Offeror Representations and Certifications-Commercial Items (Jun 2020) o This provision applies to this solicitation. Offerors shall provide the required data with their quotations in accordance with FAR 52.212-3. (Please include Completed representations and certifications, not already completed in SAM.gov.)

FAR PROVISIONS INCORPORATED BY FULL TEXT:

FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

http://www.acquisition.gov/comp/far/index.html.

The Government contemplates award of a Firm-Fixed-Price (FFP) type Purchase Order resulting from this solicitation.

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address:

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSES:

NUMBER TITLE DATE

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2019

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE AUG 2020

MAINTENANCE

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS DEC 2014

AND CERTIFICATIONS

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL DEC 2022

ITEMS

52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE NOV 2020

52.223-5 POLLUTION PREVENTION AND RIGHT-TO-KNOW MAY 2011

INFORMATION

52.226-7 DRUG-FREE WORKPLACE MAY 2024

52.226-8 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MAY 2024

MESSAGING WHILE DRIVING

52.232-1 PAYMENTS APR 1984

52.232-23 ASSIGNMENT OF CLAIMS MAY 2014

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS JUN 2013

52.232-40 PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS MAR 2023

CONTRACTORS

52.233-1 DISPUTES MAY 2014

52.233-4 APPLICABLE LAW FOR BREACH OF CONTRACT CLAIM OCT 2004

52.242-15 STOP-WORK ORDER AUG 1989

ALTERNATE I (APR 1984)

52.242-17 GOVERNMENT DELAY OF WORK APR 1984

52.243-1 CHANGES-FIXED-PRICE AUG 1987

52.243-1 CHANGES-FIXED-PRICE, ALT I APR 1984

52.246-4 INSPECTION OF SERVICES—FIXED-PRICE AUG 1996

52.246-25 LIMITATION OF LIABILITY-SERVICES FEB 1997

52.249-1 TERMINATION FOR CONVENIENCE OF THE GOVERNMENT APR 1984

(FIXED-PRICE) (SHORT FORM)

FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Items (June 2023) The additional FAR clauses cited in this clause that have an “X” next to them are applicable to this solicitation. Full text of this clause is provided in (Attachment B).

FAR CLAUSES IN FULL TEXT:

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

(a) Definitions. As used in this clause-

Internal confidentiality agreement or statement means a confidentiality agreement or any other written statement that the contractor requires any of its employees or subcontractors to sign regarding nondisclosure of contractor information, except that it does not include confidentiality agreements arising out of civil litigation or confidentiality agreements that contractor employees or subcontractors sign at the behest of a Federal agency.

Subcontract means any contract as defined in subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

Subcontractor means any supplier, distributor, vendor, or firm (including a consultant) that furnishes supplies or services to or for a prime contractor or another subcontractor.

(b) The Contractor shall not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(c) The Contractor shall notify current employees and subcontractors that prohibitions and restrictions of any preexisting internal confidentiality agreements or statements covered by this clause, to the extent that such prohibitions and restrictions are inconsistent with the prohibitions of this clause, are no longer in effect.

(d) The prohibition in paragraph (b) of this clause does not contravene requirements applicable to Standard Form 312 (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(e) In accordance with 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) use of funds appropriated (or otherwise made available) is prohibited, if the Government determines that the Contractor is not in compliance with the provisions of this clause.

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in subcontracts under such contracts.

(End of clause)

FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Nov 2021)

(a) Definitions. As used in this clause— Covered contractor information system means an information system that is owned or operated by a contractor that processes, stores, or transmits Federal contract information.

Federal contract information means information, not intended for public release, that is provided by or generated for the Government under a contract to develop or deliver a product or service to the Government, but not including information provided by the Government to the public (such as on public websites) or simple transactional information, such as necessary to process payments.

Information means any communication or representation of knowledge such as facts, data, or opinions, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on National Security Systems Instruction (CNSSI) 4009).

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information ( 44 U.S.C. 3502).

Safeguarding means measures or controls that are prescribed to protect information systems.

(b) Safeguarding requirements and procedures.

(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect covered contractor information systems. Requirements and procedures for basic safeguarding of covered contractor information systems shall include, at a minimum, the following security controls:

(i) Limit information system access to authorized users, processes acting on behalf of authorized users, or devices (including other information systems).

(ii) Limit information system access to the types of transactions and functions that authorized users are permitted to execute.

(iii) Verify and control/limit connections to and use of external information systems.

(iv) Control information posted or processed on publicly accessible information systems.

(v) Identify information system users, processes acting on behalf of users, or devices.

(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite to allowing access to organizational information systems.

(vii) Sanitize or destroy information system media containing Federal Contract Information before disposal or release for reuse.

(viii) Limit physical access to organizational information systems, equipment, and the respective operating environments to authorized individuals.

(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control and manage physical access devices.

(x) Monitor, control, and protect organizational communications (i.e., information transmitted or received by organizational information systems) at the external boundaries and key internal boundaries of the information systems.

(xi) Implement subnetworks for publicly accessible system components that are physically or logically separated from internal networks.

(xii) Identify, report, and correct information and information system flaws in a timely manner.

(xiii) Provide protection from malicious code at appropriate locations within organizational information systems.

(xiv) Update malicious code protection mechanisms when new releases are available.

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

(xv) Perform periodic scans of the information system and real-time scans of files from external sources as files are downloaded, opened, or executed.

(2) Other requirements. This clause does not relieve the Contractor of any other specific safeguarding requirements specified by Federal agencies and departments relating to covered contractor information systems generally or other Federal safeguarding requirements for controlled unclassified information (CUI) as established by Executive Order 13556.

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in subcontracts under this contract (including subcontracts for the acquisition of commercial products or commercial services, other than commercially available off-the-shelf items), in which the subcontractor may have Federal contract information residing in or transiting through its information system.

(End of clause)

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.

Health and Human Services Acquisition Regulation (HHSAR) Provisions and Clauses

DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR

CHAPTER 3) PROVISIONS AND CLAUSES IN FULL TEXT:

HHSAR Clauses can be viewed in full text at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

HHSAR Clauses incorporated by reference:

HHSAR 352.203-70 Anti-Lobbying (December 18, 2015) HHSAR 352.208-70 Printing and Duplication (December 18, 2015) HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.223-70 Safety and Health (December 18, 2015) HHSAR 352.224-71 Confidential Information (December 18, 2015) HHSAR 352.227-70 Publications and Publicity (December 18, 2015) HHSAR 352.231-70 Salary Rate Limitation (December 18, 2015) HHSAR 352.233-71 Litigation and Claims (December 18, 2015)

HHSAR Provisions 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 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.

(END OF CLAUSE)

HHSAR 352.239-73 Electronic and Information 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 https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html 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.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If an 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.

(End of provision)

HHSAR 352.239-74 Electronic and Information…