RFP_75F40124R00201.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

DAPFDA CODE 16. ADMINISTERED BYCODE

X

X

561210

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORDAP

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 1200 PT

08/28/2024

240-402-9672SHENEIL GREEN

(No collect calls)

INFORMATION CALL:

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

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75F40124R00201

5. SOLICITATION NUMBER

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

1 54 1275701OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

U.S Food and Drug Administration Los Angeles District Office Pacific Southwest Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612

15. DELIVER TO

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

ATTN: Sheneil Green

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$47

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/DAP

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.

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

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED . 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

DHHS/FDA/OAGS/DAP

ATTN: Sheneil Green 10903 New Hampshire Ave. WO2/3rd Floor Silver Spring MD 20903

The Government intends to award a firm fixed price contract under FAR 13.5 for laboratory vacuum pump replacement services to be performed at the Food and Drug Administration's Los Angeles District Office and Pacific Southwest Food and Feed Laboratory in Irvine, CA.

The anticipated period of performance shall not exceed 8 months.

Wage Determinations 2015-5645 and 1986-0879 are applicable to this solicitation.

x x

X

SHENEIL R. GREEN

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.

1 Supply and install the replacement of a vacuum pump system at the FDA Pacific Southwest

Laboratory and District Office in Irvine, CA.

In accordance with the Scope of Work

To include 12-month warranty for labor, equipment, and parts.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

54 2 of

75F40124R00201

This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) 12.6 as supplemented with additional information included in this notice. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. This combined solicitation is being issued as a Request for Proposal (RFP).

The solicitation is being issued in conjunction with FAR PART 13.106 and FAR 13.5 Simplified Procedures for Certain Commercial Items. The solicitation number for this acquisition is 75F40124R00201 for FDA Project OC-2024-123376.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05, May 22, 2024.

The associated NAICS for this solicitation is 561210 – Facilities Support Services. The business size standard is $47M. This requirement is being solicited as unrestricted – full and open competition.

Prospective offerors are responsible for downloading the solicitation and any amendments from SAM.gov.

The Government anticipates awarding a firm fixed price contract. The Government reserves the right to award the firm fixed price contract without discussions if the Contracting Officer determines that the initial offer provides the Best Value to the Government and discussions are not necessary.

The purpose of this solicitation is to perform replacement services for the end-of-life, obsolete laboratory vacuum pump system (currently AES-Dekker Laboratory Vacuum System Model AES-VMX0153MA2- 45-DS with capacity for each vacuum pump 23.3 SCFM @ 25 “HGVAC”) at the U.S. Food and Drug Administration’s Los Angeles District Office and Pacific Southwest Food and Feed Laboratory located in Irvine, California.

1. Mandatory Site Visit: All Offerors must attend at no cost to the Government, a Site Survey located at:

U.S Food and Drug Administration Los Angeles District Office Pacific Southwest Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612

Date: Thursday, September 5, 2024 Start Time: 8:30 AM PT

Offeror must electronically provide no later than Tuesday, September 2, 2024 at 8:00AM PT, the company name and attendees names to the Contracting Officer. Each attendee must possess and present a valid Government issued identification to enter the site. Please allow 1.5 hours for the site visit.

2. Question Deadline: Questions related to this procurement shall be submitted directly by email to

Contracting Officer (CO) Sheneil Green at: Sheneil.Green@fda.hhs.gov. No phone calls will be accepted. Questions not received by the question submission deadline of: Monday, September 9, 2024, at 12:00PM Pacific Time (PT) will not be considered.

3. Proposal Deadline: The deadline for receipt of Proposals for this requirement is Wednesday, September 18, 2024, at 12:00PM PT. Proposal submission shall be submitted electronically to the mailto:Sheneil

Contracting Officer using subject line “75F40124R00201 – Irvine Vacuum Pump Replacement”.

4. ADDENDUM to FAR 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services

(a) Offeror shall submit a signed SF 1449 signature page of the solicitation, along with signed SF- 30 solicitation amendment acknowledgements, as applicable.

(b) Offeror shall submit a firm-fixed price offer, including a recommended milestone/task completion schedule for payments. Pricing shall include itemized list of labor and material costs to satisfactorily complete the work; no charges presented after contract award will not be considered/accepted.

** Partial billing will be allowed per the negotiated milestone/task completion schedule submitted by the Offeror. If the Offeror fails to provide a milestone/task completion schedule, payment will only be rendered at project completion.**

(c) Offeror shall submit delivery date in its technical response.

(d) Offeror shall submit a completed FAR 52.212-3, Offeror Representations and Certification, FAR 52.204-24, Representation Regarding Certain telecommunications and Video Surveillance Services or Equipment.

(e) Offeror shall submit a listing of all proposed material and equipment, with country of origin denoted and ensure FAR 52.212-3(f) is properly completed.

(f) Offers shall also include the following, as shown below.

Volume 1: Technical. The Technical Volume shall include a Work Detail and Safety Plan, Materials List, and Past Performance references which clearly demonstrate recent (within the past 3 years), relevant, and documented experience providing the proposed service. Refer to the below Addendum to FAR 52.212-3 Evaluation – Commercial Products and Commercial Services for specifics.

Volume 2: Price. The Price Volume shall include a firm-fixed price offer, including a recommended milestone/task completion schedule for payments. Pricing shall also include itemized list of labor and material costs to satisfactorily complete the work; no charges presented after contract award will not be considered/accepted.

** Partial billing will be allowed per the negotiated milestone/task completion schedule submitted by the Offeror. If the Offeror fails to provide a milestone/task completion schedule, payment will only be rendered at project completion.**

(g) To be considered for award an Offeror shall be registered and active in SAM (www.sam.gov) by the date and time set forth for receipt of proposals.

(h) The Period for Acceptance of offerors: The Offeror agrees to hold the prices in its offer firm until September 30, 2024.

The Government is not responsible for locating or securing any information, which is not adequately identified in the proposal. Failure to submit a complete offer may result in a non-responsive determination.

(i) Offerors shall not submit electronic documents using Microsoft Office suite products that contain the use of “macros”. If the Offeror submits documents that contain macros the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an Offeror to correct the document submission and the Government will not inform the offeror that their submission is non-responsive prior to award. It is the Offeror’s responsibility to ensure all electronic documents are submitted without the use of macros.

(j) The solicitation does not commit the Government to pay any cost for the preparation and submission of an offer. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.

SCOPE OF WORK

VACUUM PUMP REPLACEMENT

FDA Project: OC-2024-120971

FDA Los Angeles District Office Pacific Southwest Food and Feed Laboratory

Irvine, CA 92612

1.0 Description of Work

1.1 Background Information

The U.S. Food and Drug Administration’s Los Angeles District Office and Pacific Southwest Food and Feed Laboratory, herein referred to as FDA Irvine, is an FDA owned facility located in Irvine, CA. Technical and support services for a replacement of an end-of-life, obsolete vacuum pump system (currently AES-Dekker Laboratory Vacuum System Model AES-VMX0153MA2-45-DS with capacity for each vacuum pump 23.3 SCFM @ 25 “HGVAC”) at the Irvine FDA facility is required. The existing system is nearly 23 years old, does not have replacement parts available on the market for repair, and represents a single-point failure risk to the facility's vacuum system.

Therefore, this critical system requires replacement.

1.2 Purpose and Scope of Work

The purpose of this Scope of Work (SOW) is to provide technical and support services for the vacuum pump system replacement at FDA Irvine.

2.0 Period of Performance

2.1 The work shall proceed promptly upon execution of the resultant contract and only after the issuance of the Notice to Proceed (NTP) by the Government for the activities indicated.

2.2 The actual performance of the work and delivery of the required documents shall be in accordance with the approved project schedule and shall be completed within 222 calendar days of the NTP unless otherwise agreed upon by the Contracting Officer’s Representative (COR) and Contracting Officer (CO).

3.0 Place of Performance

U.S Food and Drug Administration Los Angeles District Office Pacific Southwest Food and Feed Laboratory 19701 Fairchild Irvine, CA 92612

3.1 Normal Government business hours are 6:00am to 6:00pm. Any work that cannot be performed during normal business hours shall be coordinated with the COR.

3.2 Recognized Holidays: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial

Day, Juneteenth Day, Independence Day, Labor Day, Columbus Day, Veterans’ Day, Thanksgiving Day and Christmas. The Contractor is not permitted to work during these holidays or any days in which the federal building is closed, without written authorization from the COR.

3.3 The Contractor shall be responsible for all travel to and from the Government work site at no additional cost.

4.0 Specific Requirements

4.1 The Contractor shall perform all services described in this SOW in accordance with applicable requirements and provisions set forth in this SOW. The Contractor will be responsible for relocating any electrical, mechanical, or structural building system components necessary to perform this work. If so, this will be noted in this SOW and such work may only be performed after approval from FDA. The Contractor shall provide all necessary supervision, labor, material, insurance, training, and equipment to:

4.1.1 Contractor shall provide all necessary technical expert services (survey or study) to understand the existing conditions of the vacuum system at FDA Irvine. Contractor shall provide new equipment with matching capacity, or better. The necessary constraints shall include, but not limited to, vacuum pump HP and tank capacity.

4.1.2 Contractor shall provide equipment cutsheet submittals to FDA for review and approval before procurement of materials.

4.1.3 Contractor shall ensure N+1 redundancy integrated into new system for resilient facility operation.

4.1.4 Contractor shall assess and provide repairs or additions to any housekeeping pad intended to support new equipment, as needed.

4.1.5 Contractor shall provide new control panel, field located in an accessible area near the vacuum system. Control panel shall be integrated with existing Building Automation System (BAS) and include alarms both to BAS and readout local to the panel.

4.1.6 Contractor shall utilize power feed to existing vacuum system.

4.1.7 Contractor shall provide independent isolations valves and disconnect means to permit service of each vacuum pump while maintaining the system’s operation.

4.1.8 Contractor shall keep equipment shutdowns to a minimum and schedule/coordinate all shutdowns with FDA while providing adequate notice. Contractor shall provide temporary utilities for any shutdown lasting longer than three (3) calendar days. Weekend shutdowns are preferred.

4.1.9 Contractor shall provide all inspection and testing, except where required by code, specification, or detailed elsewhere in the requirements of this document.

4.1.10 The Contractor shall ensure compliance with National Institutes of Health (NIH)’s Design Requirements Manual (DRM). Section 12.4 is the most applicable to this project.

5.0 General Requirements

5.1 The Contractor shall:

5.1.1 Adhere to Project Management responsibilities as defined herein.

5.1.2 Appoint a Project Manager (PM) who shall be the Government’s primary point of contact and provide all necessary project representation for the successful accomplishment of the work contained herein. The PM shall be thoroughly familiar with all requirements and schedules. The PM shall be identified in the firm’s proposal prior to contract award.

5.1.3 Coordinate all project related activities including documentation through the COR for approval unless otherwise denoted.

5.1.4 Bring any questions and/or industry specification additions to the attention of the COR for direction.

5.1.5 Perform all work in a skillful and workmanlike manner as deemed applicable to this project.

5.1.6 Provide appropriate communication and coordination efforts with the facility department and the COR to avoid disruption of facility operations while performing contract work such as meetings, proposed phasing plans, outage notifications, etc. (where applicable).

5.1.7 Obtain necessary badges per FDA policies and guidelines (if applicable). FDA binding process is to be anticipated of 1 month. All badging must be completed prior to start of on-site work.

5.1.8 Provide (to the COR) a list of possible employees and sub-contractors who may require access to the FDA premises per the project being administered.

5.1.9 Provide utility outage notifications per facility department requirements (if applicable).

5.1.10 Perform all necessary measurements and sizing associated with the work assigned.

5.1.11 Confirm existing conditions of work assigned.

5.1.12 Perform all associated project work in accordance with FDA and NIH Guidelines; Executive orders, Energy Policy Act (EPACT), Energy Independence and Security Act (EISA), Sustainable design and Federal Regulations; Local City, County, and State building codes and regulations;

National Electrical Code (NEC), American Society of Mechanical Engineers (ASME), National Fire Protection Association (NFPA), Occupational Safety and Health Administration (OSHA), Underwriters Laboratories (UL), American National Standards Institute (ANSI), and Institute of Electrical and Electronics Engineers (IEEE) rules and regulations and standards; and all other applicable industry standards.

5.1.13 Restore all affected areas back to pre-project conditions or better by the completion of the specified project including necessary patching, repairing and/or replacing.

5.1.14 Provide all necessary drawings, documentation, and literature for all recommended items where applicable.

5.1.15 Provide all labor and equipment necessary to accomplish the above specified tasks.

5.1.16 Assume all risk and shall be liable for any damages to persons or property caused by the Contractor.

5.1.17 Be solely responsible for the quality of his/her work. Deficiencies and omissions shall be corrected prior to Government acceptance of work.

5.1.18 Be responsible for removing of all building and demolition debris daily from site. The Contractor shall provide the dumpster for the debris.

6.0 Government Furnished Material and Resources

6.1 The Government shall provide, but are not limited to, the following items:

• Site Utility Drawings (Upon request-PDF)

• Point(s) of contact at the FDA Site (Kickoff Meeting)

• Photographs of work-site conditions and others as needed

• Irvine Lab specification report volume 2 (Section 15486) (Upon request-PDF)

7.0 Submittals

7.1 General: Under the resultant contract, unless otherwise denoted, the Contractor shall provide all services necessary to perform the following activities as related to completing the FDA Irvine Vacuum Replacement mentioned above:

• Project Kick-Off Meeting

• Project Schedule (with earned value and loaded dollar values)

• Plan of action (Plan shall include names of Team members and PM – and phone/email)

• Point-of-contact, Project Manager

• Safety and Hazardous Material Plan

• Progress Meetings

• Meeting Minutes for review and approval by COR (within five business days)

7.2 Deliverables: The Contractor shall provide all deliverables in accordance with the project schedule and NIH DRM Appendix E, FDA Policy Guidelines, and compliant with Section 508 requirements.

7.2.1 Physical Deliverables (Format): The documentation process shall be compiled and provided per the following submission requirements unless otherwise denoted:

a) Two (2) copies of the Operations and Maintenance (O&M) Manuals shall be provided physically in binders and electronically per Compact Disc and Digital Versatile Disc (CD/DVDs) (if applicable).

b) Non-Stick, Locking Slant D-Style, three ring view binders, 8 1/2x 11 inches.

c) Title, FDA Logo, Contract and Project Number, Submission % (if applicable), etc.

shall be located on the front cover and spine of binder(s).

d) CD/DVDs shall contain electronic copies of any Reports, Calculations, Modeling(s), Drawings, Videos, Photos and O&M Manuals per final submission.

CD/DVDs shall have printed labels.

e) CD/DVDs shall be placed in CD/DVD page holders with slaps (like Avery 75263 or Avery 73721) when associated with a binder. Avery 75263 for multiple discs and Avery 73721 for a single disc.

f) Three (3) signed copies of all warranties shall be provided in binders and electronically per CD/DVDs. Warranty start date shall begin no earlier than the date of installation acceptance.

g) One (1) equipment submission.

h) Four (4) physical copies of as-built marked-up drawings, documentation, etc. for review and discussion. Also, provide electronic copies of the drawings, etc. All electronic drawings shall be provided in portable document format (PDF) and Computer-aided Design (CAD). Deliverables are to be submitted to the COR, unless otherwise stated.

i) Four (4) copies of Final Drawings shall be provided in PDF and CAD.

7.2.2 Electronic Deliverables (Format): Provide electronic deliverables in the below format using the latest version of software unless otherwise denoted or agreed upon. All FDA and Contractor collected, maintained, and delivered data files, reports, CAD or other documents developed in relation to this SOW are the sole property of the FDA and shall not be released to other parties in any form without the prior written consent of the COR and Contracting Officer (CO).

Reports: MS Word and Adobe PDF Presentation: MS PowerPoint Spreadsheets: MS Excel Schedule: MS Project (saved to PDF) with schedule of values Drawings: AutoCAD 2015 or later version and PDF Catalog Cut Sheets:

PDF

Modeling: PDF

7.2.3 Acceptance: Satisfactory performance of the Contract shall be deemed to occur upon performance of the work described in the Scope of Work (SOW) of this Contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the specified delivery items in accordance with the stated delivery schedule described in the Contract.

7.2.4 Marking Instructions for Deliverables: 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 immediate usable and acceptable condition.

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

8.0 Contract Administration

8.1 Contracting Officer’s Representative (COR): The COR is responsible for the acceptance of work provided hereunder and will be designated by separate correspondence and in the contract. The term “COR” means the person who monitors the technical aspects of the

Contract performance. The COR is not authorized to issue any instructions or directions which cause any increase or decrease in the scope of work which would result in the increase or decrease in the price of the Contract, or changes in the delivery schedule or period of performance of this contract. The COR is not authorized to receive or act upon any notification or revised price estimate provided by the Contractor of the contract.

8.2 The Contracting Officer (CO) is the only person with authority to act as agent of the

Government under the contract. Only the CO has authority to:

a) Direct or negotiate any changes in the contract;

b) Modify or extend the period of performance;

c) Change the delivery schedule;

d) Authorize reimbursement to the Contractor for any costs incurred during the performance of the contract; and

e) Otherwise change any terms and conditions of this contract.

Ms. Sheneil R. Green Contracting Officer FDA, Office of Acquisitions and Grants Services Division of Acquisition Programs, Facilities Support Branch Email: Sheneil.Green@fda.hhs.gov

9.0 Contractor Expectations

9.1 Employee Conduct: The Contractor shall be responsible for maintaining satisfactory standards of employee competency, conduct, appearance, and integrity at all times and shall be responsible for their employee’s performance and the quality of the employees’ services.

9.2 Smoke Free Environment: The Department of Health and Human Services is the Federal

Government’s principal agency for furthering the health of Americans and providing them with essential human services. The health risks of smoking and exposure to smoke are clearly documented by reports of the Surgeon General. It is essential that the Department, in the accomplishment of its mission, provide a smoke-free environment in all HHS owned and leased building space.

It is, therefore, the Departments policy to establish a smoke-free environment in all HHS building space. All HHS owned and leased building space is designated as no-smoking areas.

This policy applies to Government employees as well as Contractor employees who are assigned to work at HHS owned or leased building space.

9.3 Restriction on Employment of Unauthorized Alien Workers: The Contractor shall not use contract funds to employ workers described in section 274A(h)(3) of the Immigration and Nationality Act, which reads as follows:

"(3) Definition of unauthorized alien. - As used in this section, the term 'unauthorized alien' mailto:Sheneil.Green@fda.hhs.gov means, with respect to the employment of an alien at a particular time, that the alien is not at that time either (A) an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General.

9.4 Identification Badges: Contractor employees shall be required to always wear the required identification badges when working in Government facilities, which may vary based on the facility requirements.

10.0 FDA 1335 PERSONNEL SECURITY CLEARANCE REQUIREMENTS

Background

The Office of the Assistant Secretary for Management and Budget, Department of Health and Human Services (DHHS), requires that DHHS employees and contractor employees (including subcontractors) who will be working in a DHHS-owned or leased space and/or who will have access to DHHS equipment, and non-public privileged, proprietary, or trade secret information, undergo a background investigation of some type. Contractor employees who will be in DHHS-owned or lease space for less than thirty (30) days are exempted from the background investigation requirement. These contractor employees must be escorted at all times while in DHHS-owned or leased space.

General

The Contractor shall submit the following items to the Contracting Officer, ten (10) calendar days prior to commencement of work under this contract:

a. Certification that all required security form packets and a list of Contractor employees names for whom the requisite security information has been provided to Division of Security Operations, Policy and Planning, Personnel Security Staff.

b. "Contractor's Commitment to Protect Non-public Information Agreement" form assigned by each employee named in paragraph a. above.

With the exception of costs associated with fingerprinting Contractor employees outside of the FDA Personnel Security Office, the Government will conduct all required background investigations at no cost to the Contractor. The cost of fingerprinting Contractor employees at any location other than the FDA Personnel Security Office will be borne by the Contractor.

Contractor employees shall obtain security badges in order to access to DHHS-owned or leased property without an escort. (See Section 3 for details on the badging process) However, in the event that work must commence before security badges can be issued, Contractor employees will be allowed onto DHHS-owned or leased property, but must be escorted at all times.

All Contractor employees who undergo a background investigation are required to log onto the Office of Personnel Management’s (OPM’s) Electronic Questionnaire for Investigation

Processing (e-QIP) system to complete the forms necessary to initiate their background investigations. The forms required, vary with the position risk levels for the contract.

The position risk levels for this contract are Level 1.

There are two (2) potential position risk levels, which are:

Non-Sensitive Positions (Level 1) (SEE CHART A) - Positions which involve the lowest degree of adverse impact on the efficiency of the Agency. The forms set forth by CHART A are required for Non-Sensitive Positions (Level 1). Contractor employees assigned to Level 1 who receive a security badge will be required to provide additional security information for a background investigation as specified in Paragraph 5 below.

c. Public Trust Positions (Levels 5 or 6) (SEE CHART B) - Positions in which the incumbent's actions or inaction could diminish public confidence in the integrity, efficiency, or effectiveness of assigned Government activities, whether or not actual damage occurs. The forms set forth by CHART B are required for Public Trust Positions (Levels 5 or 6).

Contractor employees assigned Levels 5 or 6 must receive security badge as well as a background investigation.

CHART A

Mandatory for all on-site contract employees

NON-SENSITIVE

POSITIONS -

LEVEL 1

FORM NAME

OBTAIN

FROM

WHEN

REQUIRED

SUBMIT DATE

FDA Form 3391 -

FDA

Security Card Access Request

Contracting Officer’s Represen tative

(COR).

Sponsorship must be provided by FDA

COR.

All positions on DHHS property or leased space

Food and Drug Administration Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

**Form must be submitted by Security Rep.

Form must be received prior to making fingerprint appointment.

Contractor’s Commitment to Protect Non- Public Information (NPI) Agreement form

Contracting

Officer

All positions with access to non-public privileged, proprietary, or trade secret information

Officer for retention in contract file

Ten (10) calendar days prior to commencement of work

Listing of all Contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting Act Release generated

All positions, including intermittent, per diem or temporary

*Food and Drug Administration Attn: Badging and Credentialing Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

(301) 796-4592

Ten (10) calendar days prior to

SF 85 -

Questionnaire for Non-Sensitive Positions

Online via

OPM’s e-

QIP

system

Non- Sensitive Positions - Level 1 Clearance

*Submit to OPM online via the e- QIP system

Ten (10) calendar days upon request of the Contracting Officer

FD 258 -

Fingerprint Chart (2 Charts Required)

Fingerprinting services available by appointment only. Call (301) 827-9527

Non-Sensitive Positions - Level 1

*Food and Drug Administration Fingerprinting & Personnel Security Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

(301) 796-4607 prior to

*In addition to the submission of these forms, the Contractor shall provide a cover letter that includes: contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer.

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

*Food and Drug Administration Badging and Credentialing Office

8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.

10903 New Hampshire Avenue Building 1, Room 1201

Silver Spring, MD 20993 No appointment necessary

CHART B

Public Trust

Levels 5 or 6

FORM

NAME

OBTAIN

FROM

WHEN

REQUIRED

SUBMIT TO DATE

SF 85P -

Questionnair e for Public Trust Positions

Online via OPM’s e-

QIP

system

Level 5 or 6

*Submit to OPM online via the e- QIP system

Ten (10) calendar days prior to

FD 258 -

Fingerprint Chart (2 Charts Required) Fingerprintin g services available by appointment only.

Call (301) 827-9527

Level 5 or 6 Clearance

*Food and Drug Administration Fingerprinting & Personnel Security Office 10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

(301) 796-4607 prior to

FDA Form

3391 - FDA

Security Card Access Request

COR.

Sponsorship must be provided by

FDA

COR.

All positions on DHHS property or leased space

Food and Drug Administration Attn:

Badging and Credentialing Office 10903 New Hampshire

Avenue Building 1, Room 1201

Silver Spring, MD 20993 **Form must be submitted by Security Rep.

Form must be received prior to making fingerprinting appointment.

Contractor’s Commitment to Protect Non-Public Information

(NPI)

Agreement form

All positions with access to non-public privileged, proprietary, or trade secret information

Contracting Officer for retention in contract file

Ten (10) calendar days prior to

Listing of all contractor employee names, social security #s, gender, dates of birth, former names, and a completed Fair Credit Reporting

Act Release generated

All positions, including intermittent, per diem or temporary

*Food and Drug Administration

Attn: Badging and Credentialing

Office 10903 New

Hampshire Avenue Building 1, Room

1201 Silver Spring, MD 20993 prior to

*Upon favorable fingerprint return, contractor will be notified to respond to the badging office for their building pass.

*Food and Drug Administration

Badging and Credentialing Office 8:00 a.m. – 11:00 a.m. and 1:00 p.m. – 3:00 p.m.

10903 New Hampshire Avenue Building 1, Room 1201 Silver Spring, MD 20993

No appointment necessary

*In addition to the submission of these forms, the Contractor shall provide a cover letter that includes contractor’s name, contract number, contractor employees’ names, and name of Contracting Officer.

In order to access the e-QIP system, Contractor employees must provide the appropriate Personnel Security Specialist with the following information: (a) full name; (b) position title;

(c) social security number; (d) date of birth; (e) place of birth; (f) email address; and (g) phone number. The Personnel Security Specialist will use this information to initiate each Contractor employee into the e-QIP system. Once this is done, each Contractor employee will receive an email that contains a web link to access the e-QIP system, as well as instructions and additional forms needed to initiate the suitability background investigation. The Contracting Officer’s Representative (COR) for the contract will provide the name of the appropriate Personnel Security Specialist to the Contractor.

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

Badging Process The FDA identification badge (PIV) is a multi-purpose badge that includes a magnetic strip (for card access) and a barcode (for employee identification programs). The FDA has implemented the Monitor Dynamics, Inc. (MDI) Network Security System for access control at approximately 98 FDA facilities nation-wide. This system uses the magnetic strip badges and card readers to control access.

The purpose of the FDA badge is to ensure that only authorized personnel gain access to FDA facilities. The badges are encoded to limit an individual's access to designated security areas. Card readers are grouped into "classes" that define the areas that individuals have access to. The "class" is determined by your security representative.

If an individual is an FDA Headquarters or contract employee and need a security identification/access badge:

Complete HHS Form-745, HHS ID Badge Request. This form is available through the Contracting Officer’s Representative (COR), or in the FDA Badging Office at:

Food and Drug Administration, Fingerprinting and Personnel Security Office 10903 New Hampshire Avenue, Building 1, Room 1201 Silver Spring, MD 20993.

Contact the Contracting Officer’s Representative; have them assign the "class" and sign the HHS Form 745 in the designated blocks. Please, make sure that all appropriate information is completed before arriving at the badging office.

Hand carry the original (copies or faxes will not be accepted) HHS Form-745 and the old identification badge to the following location for photographing:

Food and Drug Administration, Fingerprinting and Personnel Security Office 10903 New Hampshire Avenue, Building 1, Room 1201, Silver Spring, MD 20993.

Hours of Service: Monday - Friday, 8 a.m. - 11 a.m. and 1 p.m. to 3 p.m.

You are required to wear your identification badge at all times while in FDA facilities. The badge must be displayed at or above the waist in plain view. If you do not have your badge when you attempt to enter an FDA facility a temporary visitor's badge will be issued to you on a daily basis.

If you lose your badge, immediately contact the Contracting Officer’s Representative (COR) so that it can be deactivated in the network security system to prevent unauthorized use. Before a replacement badge will be issued, you must wait three working days, and then submit a new completely signed off HHS-745 form, FDA Security Card Access Request. Hand-carry your HHS-745 form to the FDA Badging Office during normal hours of operation.

FDA Badges are issued for 5 years for employees and up to 1 year (contingent upon duration of contract) for contractors. To replace an expiring badge, complete an HHS- 745 form within 30 days of expiration. If you have any questions or problems, contact the Contracting Officer’s Representative (COR).

FDA Badges must not be given or loaned to any person other than the original recipient. Badges are used for security purposes only and must not be used as identification for personal or other business purposes. Badges must be surrendered to the issuing office when you retire, transfer, terminate FDA employment, etc. Lost or stolen badges must be immediately reported to the security office.

All non-FDA employees and contract employees who work on site or are required to have access to non-public information while working under an FDA contract for 30 calendar days or longer, must have a satisfactory preliminary check prior to being issued a security identification/access badge. Any questions or problems regarding these preliminary background checks should be directed to the Contracting Officer’s Representative (COR).

Background Investigations

The Government shall conduct an additional background investigation for those individuals named to risk Levels 1, 5 and 6 serving under the contract.

a. Required background investigations may include, but not be limited to:

b. Review of prior Government/Military personnel records;

c. Review of FBI records and fingerprint files;

d. Searches of credit bureaus;

e. Personal interviews; and

f. Written inquiries covering the subject’s background

Background investigations shall be conducted by the Office of Personnel Management

(OPM).

The Contractor is responsible for ensuring that the integrity of contract performance is maintained pending completion of all appropriate background investigations of contractor employees.

The Contractor shall submit the information required for e-QIP access and other requisite forms for the risk levels(s) specified. In addition, the Contractor shall provide a cover letter which includes: the Contractor’s name, the contract number, the name of the Contracting Officer administering the contract, the names of all Contractor employees for whom background check is required and those employees’ social security numbers, date of birth, and former names.

The Contractor shall advise its prospective employees that all standard forms submitted to the FDA shall be forwarded to the Office of Personnel Management (OPM) for scheduling background investigations.

Personnel Security Staff shall resolve with the contract employee any issues arising out of inaccurate or incomplete forms.

Employees who have been previously granted a Government security clearance shall advise Personnel Security Staff of the details of such clearances to determine if a previous clearance level is suitable for the current FDA position.

At any time, if a contractor employee for who security forms have been submitted is terminated or otherwise ceases work under the contract, the Contractor shall immediately notify Personnel Security Staff in writing, with copies to the respective FDA Contracting Officer’s Representative (COR) and Contracting Officers.

The OPM background investigation will take approximately 120 days. The Contracting Officer will notify the Contractor in writing if an employee is denied a clearance. Those individuals who have been cleared by Personnel Security Staff may continue to work under the contract. Those who are not cleared must cease work on the contract immediately.

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

In the event that a cleared individual is replaced, the Contractor shall notify the Contracting Officer and comply with all requirements of this clause, as specified herein, prior to the commencement of work by the replacement individual.

The Contractor shall be responsible for the return of any Government issued security badges to the Contracting Officer’s Representative (COR).

11.0 508 Reporting

11.1 Requirements: All reports required herein shall be submitted in electronic format. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under "Digital Accessibility @ HHS."

http://www.hhs.gov/web/508/index.html

Any paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

11.2 Reports: The Contractor shall submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information and Documents."

http://www.hhs.gov/web/508/contracting/technology/vendors.html

APPLICABLE CONTRACT CLAUSES

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 will make their full text available. Also, the full text of a clause may be accesses electronically at these addresses: www.acquisition.gov/far/ AND www.acquisition.gov/hhsar.

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS (NOV 2023)

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

52.204-18 COMMERCIAL AND GOVERNMENY ENTITY CODE MAINTENANCE

(AUG 2020)

52.204-19 INCORPORATION BY REFERENCE OF REPRESENTATIONS AND

CERTIFICATIONS (DEC 2014)

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR INFORMATION

SYSTEMS (NOV 2021)

52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

52.227-14 RIGHTS IN DATA – GENERAL (MAY 2014)

52.228-5 INSURANCE – WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

52.236-3 SITE INVESTIGATION AND CONDITIONS AFFECTING THE WORK (APR

1984)

52.236-5 MATERIAL AND WORKMANSHIP (APR 1984)

52.236-6 SUPERINTENDENCE BY THE CONTRACTOR (APR 1984)

52.237-2 PROTECTION OF GOVERNMENT BUILDINGS, EQUIPMENT, AND

VEGETATION (APR 1984)

352.208-70 PRINTING AND DUPLICATION (DEC 2015)

352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT

OPPORTUNITY INVESTIGATIONS (DEC 2015)

352.224-71 CONFIDENTIAL INFORMATION (DEC 2015)

352.233-71 LITIGATION AND CLAIMS (DEC 2015)

352.239-74 ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY

(DEC 2015)

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)).

http://www.acquisition.gov/ http://www.acquisition.gov/hhsar https://www.acquisition.gov/far/52.203-19#FAR_52_203_19

(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:

_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)).

__ (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/52.204-23#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 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.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…