36C25821Q0228_1.docx

Combined Synopsis-Solicitation for Commercial Items Contract Opportunity Combined Synopsis/Solicitation Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice F108 ABQ 501-21-3-257-0293 Pharmaceutical Incineration

(VA-21-00056205)

85014 36C25821Q0228 06-15-2021 N

SBA

562211 Department of Veterans Affairs NCO22-Gilbert Network Contracting 777 E. Missouri, Suite 300 Phoenix AZ 85014 Dawn White Dawn.White@va.gov Jeremy Seaton Jeremy.Seaton@va.gov Albuquerque NM VA Healthcare System 1501 San Pedro Dr. SE Albuquerque, NM

87108-5153

USA

Dawn.White@va.gov Jeremy.Seaton@va.gov Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2021-05 effective 03/10/2021.

This solicitation is an Open Market, small business, set-aside.

The associated North American Industrial Classification System (NAICS) code for this procurement is 562211, Hazardous Waste Treatment and Disposal, with a small business size standard of $41.5M.

The PSC is F108, Environmental Systems Protection/Remediation.

The Network Contracting Office 22 Gilbert is seeking to purchase a service for the incineration of pharmaceuticals, devices and clinical supplies.

All interested companies shall provide quotations for the following:

Services

STATEMENT OF WORK (SOW)

1. Contract Title

Incineration of Pharmaceuticals, Devices, and Clinical Supplies

2. Background The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) supports clinical trials by performing Drug Distribution Center functions (receiving, shipping, repackaging, and tracking of material). This material consists of non-controlled pharmaceuticals and non-controlled hazardous waste pharmaceuticals drugs; devices (i.e. FIT kits, glucose meter); and clinical supplies (i.e. Lancets, blood glucose test strip, alcohol swabs). Material is classified as investigational per 21 CFR Part 312 guidance and cannot be redistributed.

3. Scope

CSPCRPCC requires the services of a hazardous waste company licensed as required by Federal and State governments to pick up, transport, and dispose of by incineration hazardous waste consisting of pharmaceutical drugs, devices, clinical supplies, liquid drug products, and excipients/bulk active product ingredients used to manufacture pharmaceuticals. After disposal, the contractor will provide CSPCRPCC Certificate(s) of Destruction as required by law and this requirement.

CSPCRPCC will provide personnel and equipment (forklifts and/or pallet jacks) to load the contractor’s trailer(s).

CSPCRPCC will palletize, generate an itemized list of the materials to be destroyed, and contact the contractor to schedule pick up. Some of the material may actually be non-hazardous but still requires incineration since it was used to support clinical studies.

This requirement is for two separate shipments, the first within 3-months of contract award and the second between 6 and 9-months after contract award.

The first pick up is planned as a one-time pick up consisting of the following and this material has been collecting since April 2019.

NOTE: A small portion of the materials are considered HAZARDOUS, but all require incineration due to the previously mentioned Code of Federal Regulations guidelines.

The second shipment is estimated to be:

VA Focal Point to coordinate pickup:

Marty Nguyen, (505) 248-3273, marty.nguyen@va.gov

The contractor shall:

a. Provide proof of licensing allowing incineration of hazardous/non-hazardous pharmaceutical materials listed in the requirements.

b. Describe in proposal, your process for picking up, transporting, incinerating, and generating Certificates of Destruction.

4. Specific Tasks

4.1 Task 1 – Contractor will provide CSPCRPCC details on pallet material/configuration (height/weight) requirements so CSPCRPCC can ensure pallets are properly built for incineration.

4.2 Task 2 – After being notified of material availability, contractor will schedule transportation, inform CSPCRPCC on schedule, and have material picked up by properly licensed transporter.

4.3 Task 3 – Upon pickup (closing of transport vehicle and existing customer’s facility gates), contractor assumes all responsibility for shipment in the event of loss prior to incineration and will be liable for any violations of federal/state/local laws.

4.4 Task 4 - Material will be transported to a hazardous waste disposal site licensed to incineration the materials

4.5 Task 5 - Certificates of Destruction (COD): Within 45 days after incineration, contractor will provide Certificate(s) of Destruction to CSPCRPCC following standard industry procedures. One COD per pallet to include a list of pallet contents (manifest) will be provided.

Certificate(s) of Destruction in PDF format is acceptable and can be emailed to:

marty.nguyen@va.gov john.recio@va.gov

CSPCRPCC is responsible for notifying the contractor of any changes to names/addresses of focal points.

5. Pick up Location

VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue SE Albuquerque NM 87106 Place of Performance - Albuquerque NM VA Healthcare System

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items” (JUN 2020)

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” (FEB 2021)

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” (OCT 2018)

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders”(JAN 2021)

Please see Attachment A for complete listing of clauses, provisions, and statutes that apply to this RFQ.

All quoters shall submit the following: Please see Attachment A for instructions to offerors.

All quotes shall be sent to the NCO 22 Gilbert to dawn.white@va.gov. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contracting Specialist, Dawn White.

Award will be based upon a Lowest Price Technically Acceptable (LTPA) in accordance with the Simplified Acquisition Procedures of FAR 15.101-2. The LTPA source selection process is appropriate when best value is expected to result from selection of the technically acceptable proposal with the lowest evaluated price.

The following are the decision factors:

See “Section 3” on page 2 (Statement of work)

The award will be made to the response for the best value to the Government.

Responses should contain your best terms, conditions.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission of your response shall be received not later than 4:30 P.M. PDT on July 7, 2021 at dawn.white@va.gov and jeremy.seaton@va.gov

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Questions shall be due no later than June 30, 2021 by 4:30 P.M. PDT.

Point of Contact Dawn White, Contract Specialist, (602) 795-4315 or dawn.white@va.gov Jeremy Seaton, Contract Specialist, (602) 795- 4293 or jeremy.seaton@va.gov

See attached document: Attachment A_Contract Clauses 36C25821Q0228.

See attached document: Attachment B FMS Vendor File Update Request Form.

See attached document: Attachment C W-9 Form.

See attached document: Attachment D VA Form 10091.

Page 1 of

Page 1 of VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 9 of 9 Original Date: 10/12/17 Revision 04 Date: 06/10/20