B08 W81XWH21Q0234-0001 Solicitation_KO FINAL.pdf

W81XWH21Q0234

COMBINED SYNOPSIS/SOLICITATION INSTRUCTIONS

1. Issue Date: 10 September 2021

2. Close Date: 17 September 2021

3. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA) located at 820 Chandler Street, Fort Detrick, MD 21702

4. Requiring Activity: The Telemedicine and Advanced Technology Research Center (TATRC), Fort Detrick, MD 21702

5. Subject: Medical Consumables and Supplies

6. Solicitation Number: W81XWH-21-Q-0234

7. Description of Requirement: The Telemedicine and Advanced Technology Research Center (TATRC), Fort Detrick, MD, requests a firm-fixed price contract for the purchase of medical consumables and supplies necessary for scenario testing on the National Emergency Tele-Critical Care Network (NETCCN) platform.

7.1 This is a combined synopsis/solicitation issued as a Request for Quote (RFQ) for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested.

7.2 This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06; 12 July 2021.

7.3 This acquisition is being procured as Brand Name or Equal and total small business set-aside solicitation.

The North American Industry Classification System (NAICS) code is 339113 – Surgical Appliance and Supplies Manufacturing with a size standard of 750 employees.

7.4 Contract award shall be made on a sole source basis using Lowest Price Technically Acceptable (LPTA) procedures.

7.5 The Contract Line Item Number (CLIN) numbers and items, quantities, units of measure and description are identified under the Supplies/Services Section of the RFQ.

7.6 The requested date of delivery is no later than 30 days after the date of contract.

7.7 Shipping shall be Free-On Board (FOB) Destination IAW FAR 52.247-34. The shipping location is:

JPC1

TELEMEDICINE AND ADVANCED TECHNOLOGY RESEARCH CENTER (TATRC)

1054 PATCHEL STREET

FORT DETRICK MD 21702

7.8 Offerors responding to this combined synopsis/solicitation shall include a completed copy of the provision at 52.212-3 ALT I, Offeror Representations and Certifications – Commercial Items, 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Service or Equipment, and 52.204-26 Covered Telecommunications Equipment or Services—Representation with its quote.

7.9 FAR provision 52.212-2 Evaluation – Commercial Items applies to this acquisition and the attached RFQ.

8. Point-of-Contact: The point-of-contact for this acquisition is Karyn Williams, Contract Specialist, karyn.m.williams2.civ@mail.mil. No telephone calls will be accepted.

9. Instructions for the Preparation and Submission of Quotes

9.1 Quotes shall be prepared in accordance with this solicitation and FAR provision 52.212-1 Instructions to Offeror-Commercial Items including the Addendum which is included with the attached RFQ.

9.2 All quotes shall be evaluated in accordance with the evaluation criteria identified in FAR 52.212-2 Evaluation-Commercial Items included with the attached RFQ.

9.3 FAR Clause 52.212-4 Contract Terms and Conditions – Commercial Items applies to this acquisition.

Additional contract requirements and terms and conditions are identified in the attached RFQ.

9.4 FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statue or Executive Order – Commercial Items, applies to this acquisition. See the clause for additional FAR clauses cited and market which are applicable to this acquisition.

9.5 The Government reserves the right to reject any or all quotes, and to award no contract at all, depending on the quality of the quote(s) submitted and the availability.

9.6 Questions: Questions shall be submitted via e-mail to Karyn Williams, Contract Specialist, karyn.m.williams2.civ@mail.mil no later than 14 September 2021 at 10:00 AM EST. Questions received after this date will not be accepted. An Amendment to this RFQ will be posted beta.sam.gov with responses to the questions received. No telephone calls will be accepted.

9.7 Quotes: Quotes in response to the RFQ are due via e-mail no later than 17 September 2021 at 10:00 AM EST to Karyn Williams, Contract Specialist, karyn.m.williams2.civ@mail.mil.

9.8 The Offeror shall agree to honor proposed prices for 60 days from the due date for receipt of quotes.

mailto:karyn.m.williams2.civ@mail.mil mailto:karyn.m.williams2.civ@mail.mil

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 3 Case

Primary IV Admin Set

FFP

Primary IV Admin Set with Pre-Pierced Y-Site, Sure-Lok Needle-Free Y-Site, 83in

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0002 10 Each

SAM Junctional Tourniquet

FFP

SAM Junctional Tourniquet, Deployment Module

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0003 10 Each

SAM Pelvic Sling II

FFP

SAM Pelvic Sling II, Medium, Olive Drab

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0004 1 Case

Bardia Closed System Foley Tray

FFP

Bardia Closed System Foley Tray, 16fr

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0005 1 Case

Argyle Salem Sump Stomach Tube

FFP

Argyle Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve, 16fr x 48in L

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0006 20 Each

Curaplex Deployable Chest Tube Kit

FFP

Curaplex Deployable Chest Tube Kit

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0007 3 Case

Curaplex Nasal Cannula

FFP

Curaplex Nasal Cannula, Green, Adult

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0008 100 Each

Tactical CricKit Cricothyroidotomy Kit

FFP

Tactical CricKit Cricothyroidotomy Kit

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0009 20 Each

Pro-series Utility/EMS Shear

FFP

Pro-series Utility/EMS Shear, 7.25in, Tactical All Black

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0010 2 Case

Non-rebreather Oxygen Mask

FFP

Curaplex Total Non-rebreather Oxygen Mask, Elongated Adult

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0011 1 Box

Endotracheal Tube with Stylet

FFP

Curaplex Select Endotracheal Tube with Stylet, Cuffed, 6.5mm Size

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0012 1 Box

Endotracheal Tube with Stylet

FFP

Curaplex Select Endotracheal Tube with Stylet, Cuffed, 7.5mm Size

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0013 1 Box

Endotracheal Tube with Stylet

FFP

Curaplex Select Endotracheal Tube with Stylet, Cuffed, 7mm Size

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0014 1 Box

Endotracheal Tube with Stylet

FFP

Curaplex Select Endotracheal Tube with Stylet, Cuffed, 8mm Size

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0015 1 Box

Curaplex Select Endotracheal Tube

FFP

Curaplex Select Endotracheal Tube with Stylet, Cuffed, 8.5mm Size

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0016 1 Each

Airway Intubation Kit

FFP

Airway Intubation Kit

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0017 1 Set

Pocket Otoscope/Ophthalmoscope Set

FFP

Pocket Otoscope/Ophthalmoscope Set with Case, Black

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0018 1 Box

Otoscope Specula, 4-1/4mm

FFP

Otoscope Specula, 4-1/4mm

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0019 1 Box

Otoscope Specula, 2-3/4mm

FFP

Otoscope Specula, 2-3/4mm

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0020 1 Package

Pulse Oximeter Fingertip Monitoring

FFP

Pulse Oximeter Portable Fingertip Spot-Check Monitoring

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0021 1 Case

Suturing Set, Sterile

FFP

Suturing Set, Sterile

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0022 1 Case

Suture Removal Kit

FFP

Suture Removal Kit, Sterile

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0023 2 Box

McKesson Non-Absorbable Surgical Suture

FFP

McKesson Non-Absorbable Surgical Suture, Nylon Suture 2-0

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0024 1 Case

AERO CHROME Surgical Gown

FFP

AERO CHROME Breathable Performance Surgical Gown, XL

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0025 2 Case

NitriDerm Surgical Gloves

FFP

NitriDerm Surgical Gloves, White, 7.5 Size

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0026 2 Case

Surgical Towel

FFP

Surgical Towel, Sterile, Blue

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0027 2 Case

Towel Drape

FFP

Towel Drape, 26in L x 18in W, Blue, Tissue/Poly

BRAND NAME OR EQUAL

FOB: Destination

PURCHASE REQUEST NUMBER: 0011658234

PSC CD: 6515

NET AMT

MECS

Simulation Consumable Resources and Supplies

Minimum Essential Characteristics

• Intravenous tubing must be designed to be used without an IV pump. It must not have a cassette that is inserted into an IV pump attached to it. It must be primary tubing with a clear drip chamber. It must have a roller clamp for fluid rate control. Must deliver approximately 15 drops per milliliter. It must have one (1) pre-pierced Y-site and one (1) luer-lock compatible Y-site. It must be 83 inches in length. The spike must be capped and sterile. The entire tubing must be sterile and individually packed.

• The SAM Junctional Tourniquet must be designed and FDA cleared for effective hemorrhage control in the inguinal or axilla areas of the human body and pelvic fracture stabilization. It must be compact, require four

(4) steps for use, and take approximately 25 seconds to apply. Must have two (2) inflatable target compression devices to be able to occlude flow bilaterally. Must have a buckle system that provides appropriate, correct force.

• The SAM Pelvic Sling must be designed to reduce and stabilize open-book pelvic ring fractures. Must come in one piece as force-controlled circumferential pelvic belt that utilizes a buckle to avoid under and over tightening. Must also have a Velcro securing strap. Must come individually packaged in colors black and olive green. Must be size medium.

• The foley-catheter system must be a completely closed, sterile system. The catheter must be 5cc silicone-elastomer coated latex connected to a 2000mL urine drainage bag. All supplies must come sterilely packaged together. Each sterile package must include the specific catheter and collection bag with a waterproof underpad, fenestrated drape, three (3) povidone iodine swabsticks, one (1) 10cc sterile water pre-filled syringe, lubricating jelly, 2 sterile latex free gloves in sterile wrapping, and a sterile specimen container with label.

• The gastric tube must be constructed clear PVC, be 48 inches long, and have double lumens to allow for suction/drainage and sump pump venting. The tube must be radiographically opaque and have multiple delivery ports. It must have a sump-pump irrigation funnel. It must come with a pre-attached anti-reflux valve. This tube must be designed for stomach suction, decompression, irrigation and delivery of medication. The anti-reflux valve must be designed for gastric reflux prevention. Must be able to accommodate to suction tubing and multiple feeding valves.

• The deployable chest tube kit must come in a vaccum-sealed, sterile kit. It must include (1) Chest Tube, 36 FR, (1) Heimlich Chest Drain Valve, (1) Rochester Pean Forceps, 8.5" Curved, Sterile, (1) Kelly Forceps, 6.25", Sterile, (1) #10 Scalpel, Sterile, (1) Nylon Double Needle Suture Kit, (2) Povidone Iodine Swab

Sticks, (8) 4" x 4" Sterile, 12 ply, (2) Petroleum Gauze, 5" x 9", (1) Pair Latex-Free Gloves, Sterile, Size Large, and (2) Drapes, Sterile

• The nasal cannulas with tubing must come in a flexible, clear green plastic. They must be appropriately sized for adults. The cannulas must offer over the ear functionality.

• The tactical cricothyroidotomy kit must come in a vacuum sealed, sterile package. It must contain all the necessary tools and components to perform a surgical cricothyroidotomy correctly. The tools must come in a lightweight, ruggedized pouch and be configured inside the pouch in a sequence of use, ideally for low-light, battlefield environments. The kit must include: (1) Bag (Pouch - Tactical CricKit), (1) Alcohol packet, (1) Povidone Iodine packet, (1) Gauze pad (4 in x 4 in), (1) Protected #10 Scalpel, (1) NAR Tracheal Hook, (1) 10 cc syringe, (1) Cric. tube with Obturator (Flexible, Cuffed, 6 mm), (1) Tube Securing Strap, (1) Plastic Vacuum Bag

• The shears must be designed for emergent situations and events. They must be 7.25 inches long with black plastic handles and black stainless steel blades.

• The endotracheal tube must be individually packaged and include a pre-inserted, low-friction coated stylet with each tube. The tubes must be sterile, latex-free, and include an inflatable cuff. The cuff sizes must be proportional to the tube size. The cuff must come connected to a pilot balloon for tactile feedback of cuff volume. The tube’s proximal connection must be 15mm with a Murphy tip while the distal tip must be soft and have a Murphy eye. The tubes must come in size 6.5mm, 7mm, 7.5mm, 8mm, and 8.5mm.

• The airway intubation kit must be an inclusive intubation kit that comes in a black bag, capable of being rolled or packaged. The kit must include: (1) Oral airway kit with Sizes: 60mm, 70mm, 80mm, 100mm, and 110mm; (1) Nasal airway kit with sizes: 20fr, 24fr, 26fr, 28fr, 32fr, and 36fr; (1) Miller laryngoscope blade kit with sizes: 0, 1, 2, 3, and 4; (1) Mac laryngoscope blade kit with sizes: 2, 3, and 4; (1) Pediatric laryngoscope handle, stainless; (1) Adult laryngoscope handle, stainless; (1) Fiberoptic halogen handle lamp; Forceps with sizes: Adult (9.75”) and child (8”); (2) “C” batteries; (2) “AA” batteries; (1) of each ET tube including uncuffed, sizes: 2.5mm, 3.0mm, 4.0mm and cuffed, sizes: 5.0mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 9.5mm; (2) Syringes, Luer-lock, 10mL; (1) ET tube introducer; (1) Adult stylette; (1) Neonatal stylette; (1) Carbon Dioxide detector; (1) ET tube holder, adult; (1) Roll tape, 1” x 10 yds; and (1) Intubation bag, black

• The otoscope and ophthalmoscope must come together as a set in a compact, portable case. Both instruments must be made of impact resistant plastic, use a fiber optic 2.5V halogen lamp and AA batteries.

The viewing lens must provide wide angle viewing and -20 to +20 diopters. The lens dial must be magnified and illuminated. The otoscope must have a rubber brow rest and both must have the option of being clipped to an article of clothing.

• The otoscope speculas must be constructed of black, disposable plastic. They must come in 4-1/4mm and

2-3/4mm.

• The pulse oximeter must be reusuable, use two (2) AAA batteries and accommodate finger circumference between 20-75mm. It must accurately measure and display oxygen saturation of arterial hemoglobin and pulse rate. It must have a large LCD display with a digital readout and low battery indicator.

• The suturing set must be packaged, sterile and disposable. The supplies must be contained inside a sterile, plastic tray with removable lid. The set must include: (1) one fenestrated drape, (1) one towel, (1) needle holder, (1) set of stainless steel curved scissors, (1) set of stainless steel forceps, (1) set of stainless steel Hemostat clamps, and sterile sponges or gauze.

• The suture removal kit must be packaged together, sterile and disposable. The supplies must be contained inside a sterile, plastic tray with removable lid. The set must include: (1) pair of stainless steel Littauer scissors, (1) set of stainless steel 4in metal forceps, and sterile gauze sponge.

• The surgical sutures must be sterile, single-use, and made of non-absorbable, monofilament nylon, size 2-0.

The sutures must not contain latex. The suture must be attached to a reverse cutting needle, type C-15.

• The surgical gowns must be disposable, sterile, and provide AAMI level 4 protection against fluids and pathogens. The fabric must be comfortable, breathable, and lightweight while maintaining a high-performing microbial barrier. The gown must offer an adjustable v-neck design and ties behind the back. It must also protection from possible ignition with surgical lasers.

• The surgical gloves must be disposable, sterile, white, and made of synthetic nitrile. They must be powder-free and latex-free with a textured finish. They must provide 6.7 elongation and 26MPa pre-aging and 6.2 elongation and 23Mpa post-aging. The finger thickness must be 7mil and palm thickness must be 6.3mil.

The total glove must be at least 12 inches in length. They must provide tactile sensitivity while maintaining a protective barrier.

• The surgical towels must be blue, disposable, sterile, and made of 100% cotton. They must be indicated for use in the operating room.

• The towel drapes must be designed for use in a minor surgical or procedure that requires a sterile field or drape. They must be sterile, disposable, latex-free, and have three-ply construction consisting of tissue/poly/tissue. They must be blue and measure 26in x 18 in.

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 0004 Destination Government Destination Government 0005 Destination Government Destination Government 0006 Destination Government Destination Government 0007 Destination Government Destination Government 0008 Destination Government Destination Government 0009 Destination Government Destination Government 0010 Destination Government Destination Government 0011 Destination Government Destination Government 0012 Destination Government Destination Government 0013 Destination Government Destination Government 0014 Destination Government Destination Government 0015 Destination Government Destination Government 0016 Destination Government Destination Government 0017 Destination Government Destination Government 0018 Destination Government Destination Government 0019 Destination Government Destination Government 0020 Destination Government Destination Government 0021 Destination Government Destination Government 0022 Destination Government Destination Government

0023 Destination Government Destination Government 0024 Destination Government Destination Government 0025 Destination Government Destination Government 0026 Destination Government Destination Government 0027 Destination Government Destination Government

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 30-OCT-2021 3 JPC1

TATRC

1054 PATCHEL STREET

FORT DETRICK MD 21702

FOB: Destination

W23RYX

0002 30-OCT-2021 10 (SAME AS PREVIOUS LOCATION)

0003 30-OCT-2021 10 (SAME AS PREVIOUS LOCATION)

0004 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0005 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0006 30-OCT-2021 20 (SAME AS PREVIOUS LOCATION)

0007 30-OCT-2021 3 (SAME AS PREVIOUS LOCATION)

0008 30-OCT-2021 100 (SAME AS PREVIOUS LOCATION)

0009 30-OCT-2021 20 (SAME AS PREVIOUS LOCATION)

0010 30-OCT-2021 2 (SAME AS PREVIOUS LOCATION)

0011 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0012 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0013 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0014 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0015 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0016 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0017 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0018 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0019 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0020 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0021 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0022 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0023 30-OCT-2021 2 (SAME AS PREVIOUS LOCATION)

0024 30-OCT-2021 1 (SAME AS PREVIOUS LOCATION)

0025 30-OCT-2021 2 (SAME AS PREVIOUS LOCATION)

0026 30-OCT-2021 2 (SAME AS PREVIOUS LOCATION)

0027 30-OCT-2021 2 (SAME AS PREVIOUS LOCATION)

CLAUSES INCORPORATED BY REFERENCE

52.204-7 System for Award Management OCT 2018 52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting AUG 2020 52.204-18 Commercial and Government Entity Code Maintenance AUG 2020

52.232-40 Providing Accelerated Payments to Small Business

Subcontractors

DEC 2013

52.247-34 F.O.B. Destination NOV 1991 52.252-5 Authorized Deviations In Provisions NOV 2020 52.252-6 Authorized Deviations In Clauses NOV 2020 252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013 252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7003 Control Of Government Personnel Work Product APR 1992 252.204-7008 Compliance With Safeguarding Covered Defense Information

Controls

OCT 2016

252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting

DEC 2019

252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support

MAY 2016

252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services

JAN 2021

252.211-7008 Use of Government-Assigned Serial Numbers SEP 2010 252.213-7000 Notice to Prospective Suppliers on Use of Supplier

Performance Risk System in Past Performance Evaluations

SEP 2019

252.223-7008 Prohibition of Hexavalent Chromium JUN 2013 252.225-7001 Buy American And Balance Of Payments Program-- Basic DEC 2017 252.225-7002 Qualifying Country Sources As Subcontractors DEC 2017 252.225-7012 Preference For Certain Domestic Commodities DEC 2017 252.225-7036 Buy American--Free Trade Agreements--Balance of

Payments Program--Basic

DEC 2017

252.225-7048 Export-Controlled Items JUN 2013 252.225-7974 (Dev) Representation Regarding Business Operations with the

Maduro Regime (DEVIATION 2020-O0005)

FEB 2020

252.232-7010 Levies on Contract Payments DEC 2006 252.232-7017 Accelerating Payments to Small Business Subcontractors--

Prohibition on Fees and Consideration

APR 2020

252.244-7000 Subcontracts for Commercial Items JAN 2021

252.246-7008 Sources of Electronic Parts MAY 2018 252.247-7023 Transportation of Supplies by Sea FEB 2019

CLAUSES INCORPORATED BY FULL TEXT

52.204-17 OWNERSHIP OR CONTROL OF OFFEROR (AUG 2020)

(a) Definitions. As used in this provision--

Commercial and Government Entity (CAGE) code means—

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror. Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

(b) The Offeror represents that it [ ___ ] has or [ ___ ] does not have an immediate owner. If the Offeror has more than one immediate owner (such as a joint venture), then the Offeror shall respond to paragraph (c) and if applicable, paragraph (d) of this provision for each participant in the joint venture.

(c) If the Offeror indicates ``has'' in paragraph (b) of this provision, enter the following information:

Immediate owner CAGE code:

Immediate owner legal name: ___

(Do not use a ``doing business as'' name)

Is the immediate owner owned or controlled by another entity?:

[ ___ ] Yes or [ ___ ] No.

(d) If the Offeror indicates ``yes'' in paragraph (c) of this provision, indicating that the immediate owner is owned or controlled by another entity, then enter the following information:

Highest-level owner CAGE code:

Highest-level owner legal name:

(Do not use a ``doing business as'' name)

(End of provision)

52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it "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" in paragraph (c)(1) in the provision at 52.204-26, Covered Telecommunications Equipment or Services-- Representation, or in paragraph (v)(2)(i) of the provision at 52.212-3, Offeror Representations and Certifications- Commercial Items. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it "does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services" in paragraph (c)(2) of the provision at 52.204-26, or in paragraph (v)(2)(ii) of the provision at 52.212-3.

(a) Definitions. As used in this provision-

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition.

(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.

115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to--

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) 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."

(d) Representations. The Offeror represents that--

(1) It [] will, [] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds "will" in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that--

It [] does, [] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds "does" in paragraph (d)(2) of this section.

(e) Disclosures.

(1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded "will" in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded "does" in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment--

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services--

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES--REPRESENTATION (OCT

2020)

(a) Definitions. As used in this provision, “covered telecommunications equipment or services” and "reasonable inquiry" have 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) Representations.

(1) 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.

(2) After conducting a reasonable inquiry for purposes of this representation, the offeror represents that it [ ___ ] does, [ ___ ] does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (JUN 2020)

** INCLUDES ADDENDUM STARTING AT SECTION (A) BELOW **

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the solicitation. However, the small business size standard for a concern which submits an offer in its own name, but which proposes to furnish an item which it did not itself manufacture, is 1500 employees.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show--

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

https://www.sam.gov/

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items for satisfying the requirements of this solicitation.

Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers:

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is “late” and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and--

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers.

Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation. (1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained for a fee by submitting a request to--GSA Federal Supply Service Specifications Section, Suite 8100, 470 East L'Enfant Plaza, SW, Washington, DC 20407, Telephone (202) 619-8925, Facsimile (202) 619-8978.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a single copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained free of charge by submitting a request to the addressee in paragraph (i)(1)(i) of this provision.

Additional copies will be issued for a fee.

(2) Most unclassified Defense specifications and standards may be downloaded from the following ASSIST websites:

(i) ASSIST (https://assist.dla.mil/online/start/).

(ii) Quick Search (http://quicksearch.dla.mil/).

(iii) ASSISTdocs.com (http://assistdocs.com).

(3) Documents not available from ASSIST may be ordered from the Department of Defense Single Stock Point (DoDSSP) by--

(i) Using the ASSIST Shopping Wizard (https://assist.dla.mil/wizard/index.cfm);

(ii) Phoning the DoDSSP Customer Service Desk (215) 697-2179, Mon-Fri, 0730 to 1600 EST; or

(iii) Ordering from DoDSSP, Building 4, Section D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, Telephone

(215) 697-2667/2179, Facsimile (215) 697-1462.

https://assist.dla.mil/online/start/ http://quicksearch.dla.mil/ http://assistdocs.com/ https://assist.dla.mil/wizard/index.cfm

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers that exceed the micro-purchase threshold, and offers at or below the micro-purchase threshold if the solicitation requires the Contractor to be registered in the System for Award Management (SAM).) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation "Unique Entity Identifier" followed by the unique entity identifier that identifies the Offeror's name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) Reserved.

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial items, the make and model of the item to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS

A.1. Instruction to Offerors - The Offerors response to this solicitation shall be legible and comprehensive to enable the Government to conduct the technical evaluation. The information shall be precise, factual, and complete.

Failure to submit all information concurrently and in accordance with these instructions shall render the Offeror’s offer “Unacceptable”.

Offers shall provide a minimum offer acceptance period of 60 days (including an agreement to hold the prices in offer firm) after the required date for receipt of quotes.

The quote shall include the following information:

Complete company name and address Company POC including title, email address and phone number Cage Code DUNS Number

In accordance with file submission requirements given in this section, the offeror shall submit the following:

A.1.1. Evaluation Factor I - Technical Approach - The offeror shall provide sufficient technical documentation http://www.sam.gov/ documenting the following:

The offeror shall demonstrate an understanding of and capability to meet all of the requirements of the Minimum Essential Characteristics (MECs). The MECs are identified in this RFQ.

The offeror shall provide a statement that they have a current registration in SAM (System for Award Management) and that the offeror is listed under the NAICS code utilized for this RFQ- 339113 – Surgical Appliance and Supplies Manufacturing.

The offeror shall complete the following provisions and return them as part of their quote:

-52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (NOV 2020)

ALTERNATE I (OCT 2014)

-52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

-52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES--REPRESENTATION (OCT

2020)

- 252.204-7016 COVERED DEFENSE TELECOMMUNICATIONS EQUIPMENT OR SERVICES—

REPRESENTATION (DEC 2019)

A.1.2 Evaluation Factor II – Price - The Offeror shall provide a unit price and total price for each Contract Line Item Number (CLIN) identified within this solicitation. Offerors shall use Section B of this solicitation to provide the unit price and total price for CLINs 0001 through 0027. The Government anticipates award of a Firm-Fixed Price (FFP) contract and the Offeror shall propose FFP pricing on all CLIN items.

All CLINs shall be priced.

A.2. The Offeror’s quote shall include the make and model of the products, manufacturer sales literature or other product literature which clearly documents the required Consumable Resources and Supplies identified in this RFQ.

A.3. The product offered must be new. Offerors offering used or remanufactured products are “Unacceptable”.

A.4. Shipping shall be Free-On Board (FOB) Destination IAW FAR 52.247-34. The shipping location is:

JPC1

TELEMEDICINE AND ADVANCED TECHNOLOGY RESEARCH CENTER (TATRC)

1054 PATCHEL STREET

FORT DETRICK MD 21702

A.5. The Government requests “best possible pricing available” equal or less than commercial preferred, or GSA/FSS, or other Government contract discount pricing.

*If the offeror possesses a Commercial Price List for the quoted Items, the offeror shall include a copy in their response to this RFQ.

A.6. Questions: All questions pertaining to the RFQ shall be submitted via e-mail to Karyn Williams, Contract Specialist, karyn.m.williams2.civ@mail.mil no later than 14 September 2021 at 10:00 AM EST.