FDA ORA-1264078 Hard Plates Ballistic Inserts Instruction Manual

The Food and Drug Administration, Office of Regulatory Affairs (FDA, ORA)
FDA/ORA OHAFO Division of Domestic Human and Animal Food Operations
Request for Quotation: FDA-ORA-1264078
Hard Plates Ballistic Inserts
March 2023

Response Date: Date: March 13, 2023 1:00 p.m. Eastern Time.
NOTE: Please indicate company’s SAM.gov Unique Entity ID on the quote or in the email.
The subject line shall read: FDA-23- FDA-ORA-2023-116601 Fully Automated Benchtop
Dissolution System
This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures.
This solicitation is issued as a Request for Quote (RFQ).
NAICS Code: 334516

Background

The U.S. Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Criminal Investigations (OCI) is comprised of Special Agents (SA) who are  responsible for conducting and coordinating criminal investigations of violations of the Federal Food, Drug, and Cosmetic Act (FDCA), the Federal Anti-Tampering Act  (FATA), other related acts, and applicable violations of Title 18 of the United States Code.
1.1 Objective
To perform the required job functions, SAs within the OCI require products to optimize their personal safety. A part of this aspect of the job involves SAs wearing protective gear, namely ballistic plates to be used with the agents’ body armor. The FDA-OCI has numerous existing body armor vests that require National Institute of Justice (NIJ)  compliant Level III+ ballistic plates to ensure SA safety.
The purpose of this delivery order is to procure ballistic plates for OCI SAs located at various OCI field offices nationwide. The Contractor shall provide Level III+ ballistic  lattes, as defined in the Requirements section below.

1.2 Line Item Pricing Table

| Desert ‘Hon| Annual Ouantitv
---|---|---
|
1| Ballistic Plates 10″ x 12″ Hesco 361IC
Item #: 361 IC-LE-MC-L| 42 plates (21 pairs)
2| Ballistic Plates 8″ x 10″ Hesco 361IC
Item #: 361 IC-LE-MC-S| 10 plates (5 pairs)

Requirements/Deliveries

The Contractor shall provide Hesco 3611C (or equivalent) NIJ Level III+ ballistic hard plates for FDA OCI. The ballistic panels shall meet the performance requirements  specified in NIJ 0101.06 Ballistic Level Protection III+.

MINIMUM SALIENT REQUIREMENTS
The ballistic hard plate shall meet the following specifications:

• NIJ 0101.06 Certified Standalone level III+ plate

• Ballistic plates must be “stand alone”. “In conjunction with” plates are not acceptable.

• Ballistic plates shall be available in the following nominal sizes: 8”x10”, and 10”x12”

• Special threat tested

• Multi-curve: ballistic plates shall have a multi-curve radius. Single curve radius is not acceptable.

• Shooter cut: ballistic plates shall have a “Shooter Cut” to maximize coverage while still allowing for a more comfortable shooting position. Elongated or exaggerated  “Swimmers Cut” is not acceptable. Chamfer width shall not exceed 3” and chamfer length (height) shall not exceed 4” on 10” x 12” plates. Chamfer radius shall be  consistent between 10” x 12” and 8” x 10” plates.

• Polyurea Coated: ballistic plates shall have a protective sprayed on, polyurea outer coating. Fabric coating or covering of any kind is not acceptable.

• Ballistic plate (10”x12”) weight shall not exceed 4.30 pounds per plate.

• Ballistic plate thickness shall not exceed 1.30 inches. Thickness shall be calculated using the average of 6 separate measurements, taken at each corner, 2” from each edge.

• Ballistic plate shall have a V50 velocity at or above 3010 (ft/s).

• Ballistic plate (10”x12”) shall be able to defeat six shots of each of the following additional rounds using a modified NIJ test protocol performed at 0.0° obliquity and ambient range temperature. NIJ back face deformation requirements shall also apply.
  Ammunition| Minimum Reference Velocity (ft/s)
  ---|---
  7.62×39 123 gr. Mild Steel Core| 2370
  5.56×45 M193| 3070
  5.56×45 M855| 3020
  7.62×39 PS Ball ammunition is acceptable.

• All plates shall be serialized

• Serial numbers shall be encrypted as barcodes on the NIJ certification labels
  o Barcodes shall use Code 3 of 9 barcode symbology (also known as Code 39)

• All plates shall have an Original Equipment Manufacturer’s (OEM’s) ballistic warranty of 10 years. Warranty commences at date of acceptance by the Government.
  o The vendor shall provide a letter or certificate of warranty issued by the plate manufacturer (for each make/model) indicating a 10 year ballistic warranty.
  o Ballistic plate labels shall also indicate a 10 year warranty period.
  o The vendor shall provide a return authorization number for all warranty claims.
  o Vendor shall acknowledge receipt of warranty claims to the government appointed COR within two business days of being notified.
  o Warranty claims shall be remedied at no expense to the government except for shipping to the factory.

Period of Performance

Delivery shall be made within 60 days of date of issuance of order.

Delivery/Place of Performance

The Contractor shall provide a shipping document to the COR (in Microsoft Excel format) containing the following information for all plates provided:

• Plate Make/Model: Hesco 3611C
• Plate size
• Alphanumeric plate serial number
• Contract and delivery order number

The document containing serial numbers shall be forwarded via email to all recipients designated by the COR within one business day of the associated shipment going out.  Shipment specific packing slips shall also contain a list of serial numbers included with that shipment.

deliver within 60 days after award

Shipping and Delivery
The Contractor shall ship the ordered items to OCI Headquarters located at: FDA/Office of Criminal Investigations
Delivery shall be completed within 60 days of date of issuance of order. All deliveries shall be made F.O.B. destination (IAW FAR 52.247-35). Upon shipment, the Contractor  shall provide the shipment tracking information to the FDA DO COR

Inspection and Acceptance

The government shall follow Federal Acquisition Requirement (FAR) 52.212-4, “Contract Terms and Conditions-Commercial Items” or 52.246-4, “Inspection of Services- Fixed Price” for a contractor’s failure to perform satisfactory services or failure to correct non-conforming services.
Government Holidays:
Unless otherwise specified, services shall be performed Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or  services scheduled for delivery on a Federal holiday shall be made the next business day.
Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather.

Contract Type

The anticipated contract type is firm-fixed price (FFP)

Government Points of Contacts

Contracting Specialist (CS):
Courtney Black
Courtney.Black@fda.hhs.gov

Contract Officer Representative (COR):
To be determined

Contracting Officer Authority

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions  contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the  CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO  shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.
The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any  changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with  the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

Order of Precedence

The Contractor shall follow the terms and conditions of this order. Should the Contractor include any additional terms and conditions resulting in conflicts between this  document and the Contractor’s document, the Order of Precedence shall be as specified in FAR Clause 52.212-4.
Any indemnification language indemnifying the Contractor of any liability and governing law language in the Contractor’s terms and conditions shall be null and void in this  order. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. Any additional terms and conditions identified with a web link and/or  incorporated by reference shall be null and void.

Language for Insertion in Acquisition Documentations Based on the Change to Disable Macros in Microsoft Office Documents from Outside Sources
The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the offeror or applicant 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 or applicant to correct the document submission and the Government will not inform the offeror or applicant that their  submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors.
ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL CONTRACTORS (OCT 2021) (DEVIATION)

(a) Definition. As used in this clause –
United States or its outlying areas means—

1. The fifty States;
2. The District of Columbia;
3. The commonwealths of Puerto Rico and the Northern Mariana Islands;
4. The territories of American Samoa, Guam, and the United States Virgin Islands; and
5. The minor outlying islands of Baker Island, Howland Island, Jarvis Island, Johnston Atoll, Kingman Reef, Midway Islands, Navassa Island, Palmyra Atoll, and Wake Atoll.

(b) Authority. This clause implements Executive Order 14042, Ensuring Adequate COVID Safety Protocols for Federal Contractors, dated September 9, 2021 (published in  the Federal Register on September 14, 2021, 86 FR 50985).
(c) Compliance. The Contractor shall comply with all guidance, including guidance conveyed through Frequently Asked Questions, as amended during the performance of this  contract, for contractor or subcontractor workplace locations published by the Safer Federal Workforce Task Force (Task Force Guidance) at https://www.saferfederalworkforce.gov/contractors/.
(d) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (d), in subcontracts at any tier that exceed the simplified acquisition  threshold, as defined in Federal Acquisition Regulation 2.101 on the date of subcontract award, and are for services, including construction, performed in whole or in part  within the United States or its outlying areas.

GOVERNMENT HOLIDAYS
a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

1. New Year’s Day
2. Martin Luther King’s Birthday
3. President’s Day
4. Memorial Day
5. Juneteenth
6. Independence Day
7. Labor Day
8. Columbus Day
9. Veterans’ Day
10. Thanksgiving Day
11. Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

1. Any other day designated by Federal Statute
2. Any other day designated by Executive Order
3. Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel shall not  be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor shall not charge any holiday as direct charge to the award.
d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an  additional period of performance, or entitlement of compensation except as set forth within the award.
e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

FDA THREE-WAY MATCH INVOICING PROCEDURES
352.232-71As prescribed in HHSAR 332.7003, use the following clause:
Electronic Submission of Payment Requests
(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 shall 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.
FDA Electronic Invoicing and Payment Requirements – Invoice Processing Platform (IPP) (Jan 2022)

a.  All Invoice submissions for goods and or services shall be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).
http://www.ipp.gov/vendors/index.htm
b.  Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor.  To constitute a proper invoice, the payment  request shall comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause  52.212-4 Contract Terms and Conditions Commercial Items included in commercial items contracts.  The IPP website address is: https://www.ipp.gov
c.

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

2. Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov.  Contractor
   assistance with enrollment can be obtained by contacting the IPP Production Helpdesk
   via email to IPPCustomerSupport@fiscal.treasury.gov or phone 866-973-3131.

3. The Contractor POC will receive two emails fromIPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You shall log in with the temporary password within 30 days.

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

5. If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request shall be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.
   d.  Invoices that include time and materials or labor hours Line Items shall include supporting documentation to (1) substantiate the number of labor hours invoiced for  each labor category, and (2) substantiate material costs incurred (when applicable).
   e.  Invoices that include cost-reimbursement Line Items shall be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.  At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.
   o Direct Labor – include all persons, listing the person’s name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;
   o Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;
   o Consultants (if applicable) – include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;
   o Travel – include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;
   o Subcontractors (if applicable) – include, for each subcontractor, the same data as required for the prime Contractor;

Section B: Contract Clauses and Provisions

FAR 52.252-2 Clauses Incorporated by Reference:
This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer shall make  their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/far/ and https://www.hhs.gov/policies/hhsar/subpart301-1.html.

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. The following provisions and clauses apply:

HHSAR Clauses
HHSAR 352.211-3 Paperwork Reduction Act
HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations
HHSAR 352.239-74 Electronic and Information Technology Accessibility
FAR Clauses
FAR 52.212-1 Instructions to Offerors—Commercial Items (Jul 2021)
FAR 52.212-4, Contract Terms and Conditions Commercial Item (Jun 2020)
FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive
Orders-Commercial Items. (JAN 2021)
(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 items:

1. 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and  Further Continuing Appropriations Act 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
2. 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)
3. 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).
4. 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 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 items:
_X (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).
_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (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) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).
(5) [Reserved] section 743 of Div. C).
(7) 52.204-15, Service Contract Reporting Requirements for Indefinite- Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).
x (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).
(9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).
(10) [Reserved] (11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).
(ii) Alternate I (Nov 2011) of 52.219-3.
(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so  indicate in its offer (15 U.S.C. 657a).
(ii) Alternate I (Jan 2011) of 52.219-4.
(13) [Reserved] (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).
(ii) Alternate I (Nov 2011).
(iii) Alternate II (Nov 2011).
(15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).
(ii) Alternate I (Oct 1995) of 52.219-7.
(iii) Alternate II (Mar 2004) of 52.219-7.
(16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).
(17) (i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637 (d)(4)).
(ii) Alternate I (Nov 2016) of 52.219-9.
(iii) Alternate II (Nov 2016) of 52.219-9.
(iv) Alternate III (Nov 2016) of 52.219-9.
(v) Alternate IV (Nov 2016) of 52.219-9.
(18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).
(19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a) (14)).
(20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).
(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657f).
(22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C. 632(a)(2)).
__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).
(24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women- Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).
_x__ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).
x (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O. 13126).

x (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
x (28) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).
_x (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
_x__ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).
_x (31) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).
x_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).
x (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).
_ (ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).
(34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the- shelf items or certain  other types of commercial items as prescribed in 22.1803.)
(35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA- Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the   acquisition of commercially available off-the-shelf items.)
(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)
(36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O.13693).
(37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).
(38) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514
(ii) Alternate I (Oct 2015) of 52.223-13.
(39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).
(ii) Alternate I (Jun 2014) of 52.223-14.
(40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).
(41) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s 13423 and 13514).
(ii) Alternate I (Jun 2014) of 52.223-16.
x (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513).
(43) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).
(44) 52.223-21, Foams (Jun 2016) (E.O. 13696).
(45) (i) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(ii) Alternate I (Jan 2017) of 52.224-3.
(46) 52.225-1, Buy American–Supplies (May 2014) (41 U.S.C. chapter 83).
(47) (i) 52.225-3, Buy American–Free Trade Agreements–Israeli Trade Act (May 2014) (41
U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169,  109-283, 110138, 112-41, 112-42, and 112-43).
(ii) Alternate I (May 2014) of 52.225-3.
(iii) Alternate II (May 2014) of 52.225-3.
(iv) Alternate III (May 2014) of 52.225-3.
(48) 52.225-5, Trade Agreements (Oct 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).
(49) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the
Department of the Treasury).
(50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).
(52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).
(53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).
_ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).
x (55) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).
(56) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).
_ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).
(58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).
(59) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) (15 U.S.C. 637(d)(12)).
(60) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631).
(ii) Alternate I (Apr 2003) of 52.247-64.
(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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 items:
(1) 52.222-17, Non-displacement of Qualified Workers (May 2014) (E.O. 13495)
(2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).
(3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards — Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and  41 U.S.C. chapter 67).
(5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards — Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).
(6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment– Requirements (May 2014) (41 U.S.C. chapter 67).

(7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to
Contracts for Certain Services–Requirements (May 2014) (41 U.S.C. chapter 67).
(8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O. 13658).
(9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).
(10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).
___ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed  bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records — Negotiation.

1. The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the  Contractor’s directly pertinent records involving transactions related to this contract.
2. The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years  after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this  contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination  settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.
3. As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not  require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.
   (e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause,  other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the  clause—
   (i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).
   (ii) 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).
   (iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the  subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor shall include  52.219-8 in lower tier subcontracts that offer subcontracting opportunities.
   (i) Within one business day from the date of such identification or notification: the contract number; the order number(s), if applicable; supplier name; supplier unique  entity identifier (if known); supplier Commercial and Government Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number,  manufacturer part number, or wholesaler number); item description; and any readily available information about mitigation actions undertaken or recommended.
   (ii) Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: any further available information about mitigation actions undertaken or recommended.
   In addition, the Contractor shall describe the efforts it undertook to prevent use or submission of covered telecommunications equipment or services, and any additional efforts that will be incorporated to prevent future use or submission of covered telecommunications equipment or services.

(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e) and excluding paragraph (b)(2), in all subcontracts and other  contractual instruments, including subcontracts for the acquisition of commercial items. (End of clause)
52.204-26 Covered Telecommunications Equipment or Services-Representation.
As prescribed in 4.2105(c), insert the following provision:
Covered Telecommunications Equipment or Services-Representation (Dec 2019)
(a) Definitions. As used in this provision, “covered telecommunications equipment or services” has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.
(b) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving  federal awards for “covered telecommunications equipment or services”.
(c) Representation. The Offeror represents that it □ does, □ does not provide covered telecommunications equipment or services as a part of its offered products or services  to the Government in the performance of any contract, subcontract, or other contractual instrument.
Section 508 Requirements
The following standards are applicable for this requirement:

• Shall meet WCAG 2.0 A and AA
• E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)
• E203 Access to Functionality (Appendix A, Application and Scoping Requirements)
• E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)
• E205 Electronic Content (Appendix A, Application and Scoping Requirements)
• E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)
• Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)
• 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements)

Electronic content shall be accessible to HHS acceptance criteria. Checklist for various formats are available at
https://www.hhs.gov/web/section-508/accessibility-checklists/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additionalresources/section-508-contacts/index.html.
Materials that are final items for delivery should be  accompanied by the appropriate checklist, except upon approval  of the Contracting Officer or Representative.

Offeror Instructions and Evaluation

Offeror Instructions
This is a single award acquisition. Please read these instructions carefully. All items required to be included in the quotation as delineated in these instructions shall be  provided in Quoter’s quotation.

1. Quoters shall submit one (1) copy of their quotation with pricing information using a Pricing Schedule. Quoters’ initial quote should contain the Quoters’ best terms  from a price standpoint.
   The firm fixed price proposed shall be inclusive of all delivery, shipping, and any other costs associated with meeting all the requirements in this solicitation. The  Government requests the Contractor to provide discounts off their established pricing for each line item. All Quoters providing quotations shall clearly state the overall  cost to the Government. All quotes shall be valid for 90 days.
   Quoters shall submit all applicable terms, conditions, and/or assumptions, if applicable in full text as attachments, appendix, or exhibits. Quoters are advised that  additional terms and conditions submitted with their quotations that are in conflict with the terms and conditions of this solicitation may be deemed as technically  unacceptable and as such not be considered for award.

2. The quote shall meet all the salient characteristics in order to be considered technically acceptable. If the part/s are different from the brand name part/s, Quoters shall  map their part/s to the brand name part/s. Quoters shall submit a separate Technical Quote with a detailed point-bypoint description of how the product meets all the salient characteristics of this SOW.

Evaluation Criteria
The Government intends to award a firm-fixed price purchase order resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation. Contractor selection will be based on the lowest price technically acceptable (LPTA) offer that can “meet or exceed” the requirements stated in this solicitation and is deemed  price reasonable. The Government reserves the right to award without exchanges with offerors. The Government may 1) reject any or all quotes if such action is in  the best interest of the Government; 2) accept other than the lowest offer; and 3) waive informalities and minor irregularities in offers received. The following factors shall be used to evaluate offers:

• Technical Acceptability: The Government will evaluate the degree to which the quote meets or exceeds the requirements and specifications described in this solicitation.  The Offeror’s quote shall demonstrate the ability to “meet or exceed” all requirements in this solicitation.
• Total price: Prices quoted shall be evaluated to ensure is the price is fair and reasonable to the Government. The sum of the offeror’s proposed prices for all items  (inclusive of any delivery, shipping, and any other costs associated) will be the total evaluated price.

Parties responding to this solicitation may submit their quote in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but  shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number;  4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall submit information to document that it meets  specifications as noted in the synopsis/solicitation and FAR 52.212-1.
Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall  be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov
All quotes shall be submitted via email to Courtney.Black@FDA.HHS.gov and Michael.Gemmill@fda.hhs.gov and be received by 1:00 PM (1300) on March 13, 2023 to the
attention of Courtney Black. Offerors shall ensure the RFQ number is visible in the header of the email.

References

• HHS Accessibility & Section 508 | HHS.gov
• SAM.gov | Home
• Front page | U.S. Department of the Treasury
• ipp.gov
• SAM.gov | Home
• FAR | Acquisition.GOV
• Accessibility Conformance Checklists | HHS.gov
• ipp.gov
• SAM.gov | Home

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