Med Waste_Combined Synopsis Solicitation 75A50323R00003.pdf

NOTE: Due to the length of this combined synopsis/solicitation, a pdf copy to help provide easier readability is attached to this posting.

COMBINED SYNOPSIS SOLICITATION

i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; proposals are being requested and a written solicitation document will not be issued.

ii. The solicitation number is 75A50323R00003 which is being issued as a Request for Proposal (RFP).

The Government anticipates the award of a single Firm Fixed Price (FFP) contract for severable services.

iii. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2023-04, effective June 2, 2023.

iv. This acquisition is being posted as Full and Open and is not set aside for small businesses.

The associated NAICS Code is: 562211 (Hazardous Waste Treatment and Disposal).

The size standard is $47.0 (millions of dollars).

v. The Division of Strategic National Stockpile (SNS), of the U.S. Department of Health and Human

Services (HHS) Administration for Strategic Preparedness and Response (ASPR), has a requirement for medical material waste disposal services consisting of hazardous and nonhazardous medical supplies, pharmaceuticals, medical materials and equipment. See below for line-item numbers and description, quantities, and units of measure. The Government intends to evaluate offers and award a contract without discussions. However, the Government may, at its sole discretion, elect to conduct discussions if determined to be in the best interest of the Government.

vi. See below for description of requirements.

vii. The period of performance is anticipated to be 60 months, inclusive of a base period of 12 months with four

(4) one-year option periods. See below for place(s) of delivery and acceptance and FOB point(s).

viii. The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (MAR 2023) applies to this acquisition.

ix. The provision 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021), applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

x. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and

Certifications- Commercial Products and Commercial Services (DEC 2022), with its offer.

(Note, if offerors are registered within the System for Award Management (SAM) and certs and reps are up to date, make a statement to that affect in accordance with this clause).

xi. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (DEC 2022), applies to this acquisition.

xii. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Products and Commercial Services (JUN 2023), applies to this acquisition and FAR clauses applicable are 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225-5, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See below for details.

xiii. There are no special contract requirements or terms and conditions related to contract financing arrangements.

xiv. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

xv. Offers are due no later than 8 August 2023 on or before 5:00 PM Eastern Time. Offerors must submit an electronic copy of the Technical Proposal and Price/Business Proposal with Past Performance via email to DSNSsolicitations@cdc.gov with the subject line “SUBMISSION RFP 75A50323R00003,” and by email to Lawrence McCoy at gwg8@cdc.gov and Rebecca Washington at qvb1@cdc.gov. The offeror’s complete proposal (including all information required to be submitted as part of the offeror’s Volume I Technical Proposal and Volume II-Business Proposal with Past Performance) must be received by the date and time specified for receipt of offers. In accordance with FAR 52.212-1(f), proposals received after the deadline will not be accepted. See Section L for additional details.

Electronics submissions only will be accepted and shall be submitted via email to the email addresses specified above . Email submissions are limited to 10MB. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

o All questions regarding this RFP of contractual or technical nature, must be submitted electronically by email with the subject line “QUESTIONS RFP 75A50323R00003” to Lawrence McCoy at gwg8@cdc.gov and Rebecca Washington at qvb1@cdc.gov no later than 1:00 p.m., ET, 28 July 2023. The Government’s responses to questions will be posted as an amendment to the combined synopsis/solicitation posting.

xvi. The point of contact for information regarding this combined synopsis/solicitation is:

Contracting Officer Lawrence McCoy Office of Head of Contracting Activity (OHCA) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: gwg8@cdc.gov

Please note this requirement is subject to the availability of funds (FAR 52.232-18).

mailto:SNSsolicitations@cdc.gov mailto:gwg8@cdc.gov mailto:qvb1@cdc.gov mailto:gwg8@cdc.gov mailto:qvb1@cdc.gov mailto:gwg8@cdc.gov

SNS Medical Material Waste Disposal

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1

Base Year:

CLIN Description Quantity Unit Price

Extended Price

1001 Medical material waste disposal services consisting of nonhazardous medical supplies, pharmaceuticals, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

1002 Medical material waste disposal services consisting of hazardous medical supplies, pharmaceuticals, including controlled substances, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

1003 Hazardous waste generation management services in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item.

1 LOT

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 1001 through 1003: $

Option Period I:

CLIN Description Quantity

/UOM

Unit Price

Extended Price

2001 Medical material waste disposal services consisting of nonhazardous medical supplies, pharmaceuticals, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

2002 Medical material waste disposal services consisting of hazardous medical supplies, pharmaceuticals, including controlled substances, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

2003 Hazardous waste generation management services in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 2001 through 2003: $________________

Option Period II:

/UOM

Unit Price

Extended Price

3001 Medical material waste disposal services consisting of nonhazardous medical supplies, pharmaceuticals, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

3002 Medical material waste disposal services consisting of hazardous medical supplies, pharmaceuticals, including controlled substances, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

3003 Hazardous waste generation management services in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 3001 through 3003: $_________________

Option Period III:

/UOM

Unit Price

Extended Price

4001 Medical material waste disposal services consisting of nonhazardous medical supplies, pharmaceuticals, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

4002 Medical material waste disposal services consisting of hazardous medical supplies, pharmaceuticals, including controlled substances, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

4003 Hazardous waste generation management services in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 4001 through 4003: $______________

Option Period IV:

/UOM

Unit Price

Extended Price

5001 Medical material waste disposal services consisting of nonhazardous medical supplies, pharmaceuticals, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

5002 Medical material waste disposal services consisting of hazardous medical supplies, pharmaceuticals, including controlled substances, medical materials, and equipment in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

This is a severable Line Item

1 LOT

5003 Hazardous waste generation management services in accordance with Performance Work Statement (PWS) in Section C.

This is a Firm Fixed Price Line item.

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 5001 through 5003: $

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMs 1001 through 5003: $

B.2 CONTRACT TYPE:

This is a Firm Fixed Price (FFP) contract.

B.3 ESTIMATED NON-HAZARDOUS AND HAZARDOUS MATERIAL PICK-UP TABLE.

During the ASPR/SNS COVID-19 pandemic mission response SNS increased its inventory volume. The weights below are estimates for the total amount of weight for Non-hazardous and Hazardous over the current warehouse locations. The weights are not guarantees of actual requirements. There is no guarantee that each warehouse location will have a disposal. And thus, there are no minimum or maximum monthly weights per warehouse location. The Offeror shall provide the price per pound for non-hazardous and hazardous pickup. The estimated pound in the below chart is provided for pricing estimation inclusive of the current locations and additional waste material within the duration of this contract.

Contract year

Estimated Non- Hazardous weight per lbs.

Estimated Non- Hazardous price per pound

Estimated Hazardous weight per lbs.

Estimated Hazardous price per pound

Base Year (FY23) 62,676,000 2,000,000 Option Period I (FY24) 71,373,000 2,200,000 Option Period II (FY25) 81,435,000 2,500,000 Option Period III (FY26) 106,399,000 2,700,000 Option Period IV (FY27) 139,685,000 2,900,000

B.4 HAZARDOUS WASTE GENERATION MANAGEMENT SERVICES

The Performance Work Statement includes the requirement the Contractor to be registered as the waste co-generator on behalf of SNS warehouse facilities. Contractor shall demonstrate that they are registered with RCRA at RCRAInfo Sign In (epa.gov). The contractor shall register applicable SNS facilities in their name as the co-waste generator with the SNS Third Party Logistics company (3PL). Contract shall obtain the RCRA EPA Id number for each SNS warehouse. Contractor shall provide EPA Identification Number management and administration services for each CONUS and OCONUS SNS warehouse location that disposes of EPA deemed Hazardous waste and all other responsibilities to accomplish Task . The contractor shall document the experience they have in managing RCRA waste disposal as the waster generator on behalf of another company or organization at the size and scope listed in this Performance Work Statement. The contractor is responsible for all federal, state and local costs associated with licensing, certification, fees for hazardous waste disposal at each location, travel, training, and other direct costs (ODC) to accomplish this task.

*Travel will be billed at actual cost and in accordance with Federal Travel regulations located at http://www.gsa.gov/portal/content/104790 ” https://rcrainfo.epa.gov/rcrainfoprod/action/secured/login https://rcrainfo.epa.gov/rcrainfoprod/action/secured/login http://www.gsa.gov/portal/content/104790

Performance Work Statement (PWS) SNS Medical Material Disposal

A. Background and Need

The Strategic National Stockpile (SNS), of the Administration for Strategic Preparedness and Response (ASPR), is seeking the procurement of medical material waste disposal services. The mission of the SNS is to deliver critical medical assets to the site(s) of a national emergency. The SNS achieves this mission by operating and maintaining its Warehouse facilities at a high level of mission readiness by timely disposal of identified outdated or nonrequired medical material waste consisting of medical supplies, pharmaceuticals, and equipment.

The Strategic National Stockpile (SNS) of the Administration for Strategic Preparedness and Response (ASPR) requires medical material waste disposal services consisting of medical supplies, pharmaceuticals, and equipment.

The contract shall be a five-year Firm-Fixed Price (FFP) service contract to dispose of approximately 461.6 million pounds of nonhazardous and 12.3 million pounds of hazardous materials for pharmaceuticals and medical supplies.

The monthly disposals must be removed from each warehouse to ensure sufficient space will be available for newly procured other countermeasure medical supplies and equipment required to meet mission essential functions.

The contractor must have access to incinerators, landfills, or other processing facility resources to support the monthly disposal volume of the SNS. Based on historical and projected disposal volumes, each SNS warehouse location will have a disposal requirement and warehouse capacity of up to 10 (ten) tractor-trailer pickup's daily. Each truckload weight will range from 12,000 to 40,000 pending on type of material being disposed per pallet. The SNS disposal requirement is across the United States simultaneously each business day. All SNS warehouse disposals will require the contractor to contact each SNS warehouse location for an advance dock appointment of 48 hours in advance. SNS has determined that the warehouse requires 48 hours advance notice to schedule the daily work requirements of other incoming or outgoing tractor trailer loads. The contractor shall provide all plant, equipment, materials, personnel, necessary licenses, and certifications to process hazardous and nonhazardous waste disposal of designated pharmaceuticals, including Schedule II-V controlled substances.

The Contractor shall dispose of Medical Material waste and equipment on a monthly basis and provide all applicable forms, Shipping Manifests/BOL’s, labels, and placards required to transport designated products to the Contractor ’s processing facility from the SNS warehouses. Material to be transported is material that is still in manufacturers’ packaging but has been damaged, is unserviceable, or of such a state of quality that it cannot be disbursed to meet the need of a mission response, is expired, non-dated, or has not passed the Food and Drug Administration (FDA) Shelf-Life Extension Program (SLEP) pharmaceutical efficacy testing. The Contractor shall ensure conformance with practices and procedures of all existing and applicable laws and regulations of the United States including, but not limited to the Occupational Safety and Health Administration (OSHA) of the

U.S. Department of Labor at 29 CFR 1910 et. seq.; the U.S. Food and Drug Administration at 21 CFR Parts 1 through 1299; the U.S. Drug Enforcement Administration (DEA) at 21 CFR Parts 1300 through 1321; U.S.

Environmental Protection Agency (EPA) hazardous waste regulations in 40 CFR Parts 260 et. seq.; U.S.

Department of Transportation (DOT) hazardous materials regulations in 49 CFR Parts 100 et. seq. and the laws, ordinances, and regulations of any state, county, parish, township, or municipal subdivision thereof or other governmental agency which may be applicable to the management, handling, storage, removal, and disposal of medical material which consists of pharmaceuticals, biologics, non-pharmaceutical medical supplies, and equipment.

Waste pickups shall begin within seven (7) calendar days from COR notification unless informed otherwise by the Government Contracting Officer (CO) or Contracting Officer Representative (COR). The Contractor shall dispose of all materials slated for disposal within thirty (30) calendar days of 1st scheduled pickup. Exceptions can be made if (A) the SNS warehouse location is unable to support the amount of disposal truckloads each day/week to complete the total in one month, or (B) the volume of disposal trucks exceeds the maximum quantity of truckloads that the industry can support for disposal in one month. The Contractor must have the Incinerator, Landfill, or other processing facility resources to support a total of up to 10 Tractor Trailer pickup loads at each SNS warehouse facility across the United States simultaneously each day. The Contractor shall identify recyclable materials and recycle them appropriately. Facilities are located throughout the Continental United States (CONUS) and OCONUS

(Outside the Contiguous United States).

Disposals may include Schedule II – V controlled substance. The Contractor is required to verify the controlled substance product Lot counts and quantity of items slated for disposal one (1) to three (3) business days before the scheduled pickup at each applicable SNS warehouse facility. A Certificate of Destruction (COD) and/or Certificate of Recycling for all pharmaceutical and non-pharmaceutical waste shall be submitted to the COR within thirty (30) calendar days after the completion of the individual SNS warehouse facility destruction.

a) The Contractor ’s processing facilities shall be fully licensed by the DEA (Drug Enforcement Agency), Board of Pharmacy, EPA (Environmental Protection Agency), and other Federal, State, Local regulatory agencies. The Contractor and all subcontractors shall maintain all necessary licenses, permits and certifications required by the Resource Conservation and Recovery Act (RCRA), Clean Air Act, Clean Water Act and Occupational Safety and Health Administration (OSHA) as issued by Federal, and State Governments and all licenses and permits required by local agencies for reverse distribution operations. All vehicles shall have proper State and Federal Department of Transportation (DOT) licenses necessary to transport hazardous wastes for each jurisdiction in which they will be operating to fulfill this contract.

b) The Contractor shall be required to provide all plant, equipment, materials, and labor needed to process and/or arrange for proper disposal of designated pharmaceuticals, including Schedule II-V controlled substances. The Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs; Title 29 Hazardous Materials; Title 40 Protection of the Environment; Title 49 Department of Transportation; U.S. EPA; OSHA; FDA; DEA;

Department of Natural Resources (DNR); ASPR and the SNS. The Contractor shall also consult applicable state, local regulations and the regional office of the federal regulatory agency that has jurisdiction over their operation to assure compliance as well as laws and regulations. Accordingly, the Contractor shall arrange for, recommend, and/or advise the returning drug distribution point of the proper means of transporting the returned products to the Contractor 's central processing facility. The Contractor shall follow the Department of Defense (DoD), Veterans Affairs (VA) Guidelines for Reverse Distributors minimum Federal Regulatory Standards (Nov 1999 Edition) approved by the Returns Industry Association.

The Contractor is to follow these accepted standards of practice for reverse distributors with respect to regulatory compliance pursuant to CFR 1317.05 and 1317.55(a) and (c).

c) All necessary permits and licenses required by Federal, State, and Local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes any required permits and licenses for interstate transport, and storage/disposal of hazardous and non-hazardous, unserviceable, and non- returnable items or returns.

d) The Contractor shall be a licensed DEA registrant to handle Schedule II - V controlled substances. A copy of all renewals shall be forwarded to the COR and Contracting Officer for retention in the contract file. The Contractor shall have proper insurance coverage, including environmental remediation. The Contractor shall provide ARCOS (Automation of Reports and Consolidated Orders System) reporting to the DEA and EDI reporting to manufacturers as required by the Department of Justice (DOJ).

e) The Contractor shall be responsible for the SNS warehouse facilities RCRA Subtitle C administrative management services for all EPA Hazardous disposals. Contractor shall register each applicable SNS warehouse site on RCRA Info Sign In (epa.gov) for hazardous waste generation as the waste generator based on EPA and state regulations. The Contractor will register under their company name as the Hazardous waste Generator as defined by 40 CFR §261.2, §261.3 regulations governing the recycling and disposal of hazardous wastes found in §261.6 and Parts 266, 273, and 279. The Contractor will provide these EPA Identification Number services for each CONUS and OCONUS SNS warehouse location that disposes of EPA deemed Hazardous waste.

Task 1: Qualify Monthly Disposal Materials and complete Schedule of Shipments

The material disposal process begins with the SNS COR initiating the process for waste disposal each month per SNS location. The COR will provide the following information to the Contractor:

https://rcrainfo.epa.gov/rcrainfoprod/action/secured/login

1. Location where services will be performed

2. Total number of pallets

3. Total weight of the material

4. An excel spreadsheet with a detailed listing of the material. The minimum information required is as follows:

a. Description of the material

b. National Drug Code (NDC) Number

c. Unit of measure

d. Quantity

e. Lot number

f. Expiration date when applicable

g. Pallet configuration (i.e., double stacked) and quantity

h. Any helpful additional miscellaneous information (i.e., Blood Collection Kits are “unused / new”)

i. Requested pickup date range

5. Requested disposal processing priorities amongst multiple SNS warehouse sites.

6. The Contractor shall be required to provided up-to-date Hazardous and the multiple Nonhazardous classification listings via an excel data base. Listings may include but are not limited to a subcategory of Nonhazardous disposal items such as DEA, Batteries, Sharps, Vaccines, Iodine & Bromine. The data is to be based on historical and new material disposals. SNS COR will provide an example document at time of award.

a. SNS will provide a current copy of its existing inventory and its current waste categorizations as listed directly above.

Once the SNS COR approves and returns the approval of the Disposal Estimate to the Contractor, they will have four

(4) business days to develop and submit to the applicable warehouses a pickup schedule to initiate the start of the removal of disposal materials. The only exception will be if the Contractor requires further explanation of the materials SNS is disposing. For example, the Contractor may request a photo of the case label of the item, owner’s manual for the equipment, or any other information the Contractor requires in order to develop a disposal solution.

Task 2: Pickup and Disposal

The Contractor shall contact the SNS warehouse facilities directly to arrange for Contractor pickup dates. The Contractor shall provide all instructions, forms; labels and Shipping Manifests needed prior to the pickup and shipment of product from SNS facilities. The Contractor shall send a representative to quantify the DEA Controlled items one (1) to three (3) business days before the Controlled items are scheduled for pickup. The Contractor shall be responsible for all associated costs to pick up and ship product from SNS facilities and transport to the Contractor 's processing facility. The Contractor shall process all designated items by sorting, inventorying, and processing items through the disposal process in accordance with all applicable federal, state, and local regulations. The Contractor shall be required to dispose of all SNS products and materials.

All Contractor and Subcontractor personnel, including transportation partners must present a valid Federal, State, or Tribal Identification card to obtain admittance onto a SNS Warehouse property. Transportation partners must be available to present their vehicle for an inspection by SNS on-site security personnel. No exceptions will be made.

Due to location sensitivity, the Contractor understands that on-site service will primarily exist for shipments that contain DEA controlled items where a Contractor Account Representative will assist in the creation and completion of all proper transfer paperwork.

Task 3: Hazardous Waste Generation Management services

The Contractor shall be required to be registered on RCRAinfo.com as the waste generator on behalf of all SNS warehouse facilities per the RCRA Subtitle C as defined by 40 CFR §261.2, §261.3 regulations governing the recycling and disposal of hazardous wastes found in §261.6 and Parts 266, 273, and 279. The Contractor will provide these EPA Identification Number services for each CONUS and OCONUS SNS warehouse location that disposes of EPA deemed Hazardous waste. For each SNS site the requires EPA deemed Hazardous Waste disposal, the Contractor will register each site location per EPA and state requirements and will obtain EPA Identification Number for each SNS Site in their Contractor company name. The third-party logistics (3PL) provider that operates the SNS warehouse facility will be listed as physical location owner of the Site.

A. Hazardous Waste Generation Management Contractor Tasks and Responsibilities

1. Contractor is responsible for determining SNS hazardous classifications based on current EPA regulations.

2. Contractor shall designate specific Contractor employees to work with SNS Site employees and oversee management of any hazardous waste generated in the SNS warehouse facility site.

3. Contractor employees shall establish protocols (the “On-Site Management Standards”) for each

SNS warehouse Site generator location.

4. Contractor employees shall work with SNS Site and Third Partly Logistics (3PL) employees to establish and set-up a central accumulation area within each location as required by RCRA, state and local laws.

5. Contractor shall perform the follow tasks initially at each SNS warehouse facility:

a. Establish inventory processes for the SNS warehouse site to complete the following on a monthly basis:

a. To determine SNS warehouse location generator status VSQG, SQG, LQG (Very Small, Small and Large Quantality Generator) and

b. To determine accumulation time for shipments.

b. Establish physical weekly inspection documentation and process for tracking hazardous waste accumulation area as required by applicable regulations.

c. Establish container marking requirements:

a. Accumulation start date;

b. The words “Hazardous Waste”;

c. The composition and physical state of the waste;

d. The statement that calls attention to the hazard of the waste; and

e. The name and address of the generator (Contractor ).

6. Contractor will provide initial training on the On-Site Management Standards to SNS site employees and 3PL personnel as well as providing training materials and the ability to maintain training records onsite in accordance with the applicable regulations.

7. Contractor personnel will prepare contingency plans/release reporting as required to be maintained onsite for large-quantity generator (LQG) sites.

8. As the generator, Contractor will designate Contractor employees to visit the SNS Sites annually to ensure each location is ready for inspection:

a. LQG (Large Quantity Generator) sites - Twice annually.

b. SQG (Small Quantity Generator) or VSQG (Very Small Quantity Generator) - Once annually.

9. Contractor will perform all annual and biannual reporting, manifest tracking and record keeping requirements under the applicable federal and state regulations as the generator.

10. Contractor will establish on-site record maintenance at the SNS Sites. Contractor will establish a binder and processes whereby records may be provided to SNS Site/3PL designated representative(s) with records such as manifests for updating.

11. Contractor will pay any annual waste generation fees assessed by the operating state and/or region.

12. Contractor will assume the risk and responsibility for providing the On-Site Hazardous Waste Generation Management Services to the extent required by applicable laws and regulations.

13. The Contractor employees shall at all times remain under Contractor ’s exclusive control and direction and shall not be considered employees of SNS for any purpose whatsoever.

14. Contractor will be responsible for all Local and State agency EPA fees associated with licensing, registration, and data reporting.

B. SNS Hazardous Waste Generation Management Tasks and Responsibilities

1. SNS will provide Site facility access to Contractor employees designated by Contractor as required for onsite management.

2. SNS will guide the designated Contractor employee in each SNS Site to a central accumulation area within each SNS Site location.

3. SNS will provide to Contractor a designated contact for each SNS Site location, including email and telephone contact information. The designated SNS contact representative will coordinate SNS Site visits for Contractor and ensure daily compliance by the SNS Site with Hazardous Waste Generator requirements.

4. The SNS designated contact, along with other affected SNS Site and ASPR/3PL employees, will participate in all applicable training provided by Contractor .

5. SNS Site /3PL personnel will complete the following tasks on an ongoing basis after completion of training (“Ongoing Management Tasks”):

a. Complete monthly inventory.

b. Complete physical weekly inspection and documentation of hazardous waste accumulation area as required by applicable regulations.

c. Maintain container marking requirements:

1) Accumulation start date.

2) The words “Hazardous Waste”.

3) The composition and physical state of the waste.

4) The statement calls the attention to the hazard of the waste.

5) The name and address of the generator (Contractor).

6. SNS Site/3PL personnel will provide SNS Site access so that the third-party hazardous waste transporter can access the SNS Site facility to prepare the manifest and then load and sign the manifest. Alternatively, SNS Site/3PL trained employees may load the truck and the driver shall inspect the load prior to departure from the SNS warehouse.

Contractor required Work performed includes:

1. Estimates of disposal requests, and disposal service records.

2. Provide all instructions, applicable forms, labels, and placards needed to ship designated items to the Contractor's processing facility.

3. When applicable provide 24-hour operational access, secure data point input and retrieval of administrative access reports which break down the clients by facility highlighting the top 10 drugs that were returnable by quantity, return value and top 10 drugs non-returnable by quantity and reason code. Automated Reporting includes: the contract number, invoice number, product name, NDC or catalogue number, batch number, quantity, and actual return value.

4. Provide detailed report by manufacturer to each returning facility within 30 calendar days after processing has been completed.

5. Provide Monthly status reports of credit receipts listing the contract/order or invoice number, manufacturer, estimated return value, actual return value, and pending credits to the returning facility, status costs by each facility for each disposal, accumulative data regarding remaining available funds after each disposal quote and subsequent invoice in order to provide precise clear cost tracking.

6. Provide a Disposal Quote vs actual invoice cost tracker excel spreadsheet with every Disposal Quote, and invoice submitted to the contract by Year/Month summary page by Fiscal year to track remaining available funds per CLIN per contract year.

7. Maintain and provide up-to-date EPA deemed Hazardous classification lists of SNS inventory.

8. Provide ARCOS (The Automation of Reports and Consolidated Orders System) reporting to the DEA.

9. Certificate of Destructions (COD) shall be submitted to the COR within thirty (30) calendar days of each warehouse location pickup disposal completion.

a. The nonhazardous COD must contain the following information: Contractor name, address, phone 3, DEA Number, pickup date range (1st pick up date to completion date).

SNS warehouse location name, NDC Number . SNS item number, item description, Lot Number, expiration date, Unit of Measure (UoM) and quantity.

b. The hazardous COD must contain the above and the additional information: RCRA Identification Number, VAWD Number, Manifest number(s), authorizing Contractor name, title and date.

C: SPECIAL CONSIDERATIONS

Pursuant to Presidential Decision Directives 39 and 62 and Sections 311 and 319 of the Public Health Service Act, SNS warehouse storage locations shall not be disclosed. Non-Disclosure Agreements shall be signed by all Contractor personnel that are involved in administering this contract.

Period of Performance:

The anticipated Period of Performance (PoP) is as follows:

Base Period: September 1, 2023 - August 31, 2024 Option Period 1: September 1, 2024 - August 31, 2025 Option Period 2: September 1, 2025 - August 31, 2026 Option Period 3: September 1, 2026 - August 31, 2027 Option Period 4: September 1, 2027 - August 31, 2028

D: DELIVERY SCHEDULE

The Government shall provide delivery schedule after the contract award.

E. Place(s) of Performance

The Contractor shall perform all work under this contract at the SNS locations and off-site Contractor locations.

SNS pick-up locations are listed below and referenced to the nearest major airport within 35 miles of the actual SNS location. The Contracting Officer Representative (COR) shall provide warehouse location at the time of contract award. SNS State Pickup Locations are as follows:

STATE Airports within close proximity California (CA) Ontario International Airport, Los Angeles, California Connecticut (CT) Bradley International Airport, Windsor Locks, Connecticut Georgia (GA) Hartsfield-Jackson Atlanta International Airport, Georgia Guam (GU) A.B. Won Pat International Airport, Guam Hawaii (HI) Honolulu International Airport, Hawaii Indiana (IN) Indianapolis International Airport, Indianapolis, Indiana Kentucky (KY) Louisville International Airport, Louisville, Kentucky Maryland (MD) Baltimore-Washington International Airport, Maryland Mississippi (MS) Memphis International Airport Memphis, Tennessee Texas (TX) Dallas-Fort Worth International Airport, Texas Utah (UT) Salt Lake City International Airport, Salt Lake City, Utah Washington (WA) Seattle-Tacoma International Airport, Seattle, Washington

The Contractor may be required from time to time to pick up SNS disposal materials from other locations not stated above. Nine SNS warehouse facilities currently have RCRA regulated hazardous disposal materials that require Contractor management.

The SNS COR will update the Contractor if changes occur at a minimum of thirty (30) calendar days in advance of new or changing Hazardous SNS facility storage requirements that will require RCRA EPA Identification Number Contractor administrative management services.

E. DELIVERABLES

Task Description Quantity / Form Delivery Date

Task 1

Kickoff Meeting Notes

Electronic copy of Kick- Off Meeting Notes-COR

Within 5 business days of meeting being held.

Task 2

Disposal Pickup

Electronic Mail Confirmation-

COR

Within 7 calendar days of request

Task 3

Certificate of Destruction/Recycling

Electronic Mail PDF Certificate-

COR

30 calendar days after completion of disposal

Task 4 Monthly Report Electronic Mail Excel Formatted Report-COR

15 calendar days after each month completed

Task 5 Quality Control Plan Electronic Mail Confirmation-

COR

30 calendar days after contract award

(a) The Contractor shall provide a Monthly Disposal Report. Report shall reflect, at a minimum, call/order number, date of order, total dollar amount of each call/order number, total net costs, total amounts by weight and by pallet count. Reports shall be sent to the designated Contracting Officer s Representative (COR) by e-mail or as otherwise instructed by the Government s Contracting Officer. Reports are due fifteen (15) calendar days after the end of the month reporting on. The Annual Report submitted electronically shall reflect the same information as the monthly report broken down by months with ending yearly total. The report shall include the following:

1. List of items received from SNS and identify disposition

2. Address pickup

3. Date

4. Item description

5. NDC/Part Number

6. Unit of Measure

7. Lot Number

(b) The Contractor shall submit deliverables to the COR in electronic format unless directed to provide hard copies. All hard copy deliverables are to be transmitted on the Contractor ’s letterhead and requires review and acceptance by the COR. For Destination/Delivery Schedule/Dates any delivery delay will be reported to the SNS COR and the applicable warehouse within 24 hours. Controlled and Biologic material will be provided on a separate report with the same information as above. The Contractor will provide a Proof of Destruction Certificate within 30 calendar days of receipt for all material to the COR.

SECTION E – INSPECTION AND ACCEPTANCE

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://farsite.hill.af.mil/

FAR SOURCE TITLE AND DATE

52.246-2 Inspection of Supplies – Fixed Price (Aug 1996) 52.246-4 Inspection of Services – Fixed Price (Aug 1996)

E.2 Inspection and Acceptance (Jul 1999)

Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or a duly authorized representative (who for the purposes of this contract shall be the Project Officer or COR) at the destination of the articles, services or documentation. Final acceptance shall be based on the completion of each delivery.

(End of Clause) http://farsite.hill.af.mil/

SECTION F- DELIVERIES AND PERFORMANCE

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/

52.246-16 Responsibility for Supplies (April 1984) 52.247-34 F.o.b. Destination (NOV 1991) https://www.acquisition.gov/

SECTION G- CONTRACT ADMINSTRATION DATA

G.1 ADMINISTRATION

This contract will be administered by the following ASPR/SNS personnel:

Contracting Officer Team Lead Annette Wright

Office of Head of Contracting Activity (OHCA) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: owf8@cdc.gov Office: 404 498-0949

Contracting Officer (CO)

Office of Head of Contracting Activity (OHCA) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: gwg8@cdc.gov| Office: 770-488-2087

Contracting Officer’s Representative (COR) Scott Andrews Office of Logistics, Strategic National Stockpile (SNS) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: evl4@cdc.gov Office (404) 661-1838

G.2 HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of clause) mailto:owf8@cdc.gov mailto:gwg8@cdc.gov mailto:evl4@cdc.gov http://www.ipp.gov/

G.3 Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP)

a) All Invoice submissions for goods and or services delivered to facilitate payments must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP).

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 must comply with the requirements identified in the applicable Prompt Payment clause included in the contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services included in commercial items contracts. The IPP website address is https://www.ipp.gov.

c) The Agency will enroll the Contractors new to IPP. The Contractor must 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.

o 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.

1) The Contractor POC will receive two emails from IPP 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 must log in with the temporary password within 30 days.

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

e) 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 must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

2) Invoice Elements.

In accordance with FAR 32.905 Payment documentation and process, Contractor shall submit an electronic invoice to the email addresses designated in the contract to receive invoices. Payment will be based on receipt of a proper invoice and satisfactory contract performance.

(a) Content of invoices.

(1) A proper invoice must include the following items (except for interim payments on cost reimbursement contracts for services):

(i) Name and address of the contractor.

(ii) Invoice date and invoice number. (Contractors should date invoices as close as possible to the date of mailing or transmission.)

(iii) Contract number or other authorization for supplies delivered or services performed (including order number and line-item number).

(iv) Description, quantity, unit of measure, unit price, and extended price of supplies delivered, or services performed.

(v) Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading.

http://www.ipp.gov/ mailto:ipp.noreply@mail.eroc.twai.gov mailto:IPPCustomerSupport@fiscal.treasury.gov

(vi) Name and address of contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment).

(vii) Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

viii) Taxpayer Identification Number (TIN). The contractor must include its TIN on the invoice only if required by agency procedures. (See 4.9 TIN requirements.)

(ix) Electronic funds transfer (EFT) banking information.

(A) The contractor must include EFT banking information on the invoice only if required by agency procedures.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the contractor must have submitted correct EFT banking information in accordance with the applicable solicitation provision (e.g., 52.232-38, Submission of Electronic Funds Transfer Information with Offer), contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer-System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer-Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(x) Any other information or documentation required by the contract (e.g., evidence of shipment).

(2) An interim payment request under a cost-reimbursement contract for services constitutes a proper invoice for purposes of this subsection if it includes all of the information required by the contract.

(3) If the invoice does not comply with these requirements, the designated billing office must return it within 7 days after receipt (3 days on contracts for meat, meat food products, or fish; 5 days on contracts for perishable agricultural commodities, dairy products, edible fats or oils, and food products prepared from edible fats or oils), with the reasons why it is not a proper invoice. If such notice is not timely, then the designated billing office must adjust the due date for the purpose of determining an interest penalty, if any.

(b) Authorization to pay. All invoice payments, with the exception of interim payments on cost-reimbursement contracts for services, must be supported by a receiving report or other Government documentation authorizing payment (e.g., Government certified voucher). The agency receiving official should forward the receiving report or other Government documentation to the designated payment office by the 5th working day after Government acceptance or approval, unless other arrangements have been made.

This period of time does not extend the due dates prescribed in this section. Acceptance should be completed as expeditiously as possible. The receiving report or other Government documentation authorizing payment must, as a minimum, include the following:

(1) Contract number or other authorization for supplies delivered or services performed.

(2) Description of supplies delivered, or services performed.

(3) Quantities of supplies received and accepted, or services performed, if applicable.

(4) Date supplies delivered, or services performed.

(5) Date that the designated Government official-https://www.acquisition.gov/far/subpart-4.9#FAR_Subpart_4_9 https://www.acquisition.gov/far/52.232-38#FAR_52_232_38 https://www.acquisition.gov/far/52.232-33#FAR_52_232_33 https://www.acquisition.gov/far/52.232-34#FAR_52_232_34

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(i) Accepted the supplies or services; or

(ii) Approved the progress payment request, if the request is being made under the clause at 52.232-5, Payments Under Fixed-Price Construction Contracts, or the clause at 52.232-10, Payments Under Fixed-Price Architect-Engineer Contracts.

(6) Signature, printed name, title, mailing address, and telephone number of the designated Government official responsible for acceptance or approval functions.

(c) Billing office. The designated billing office must immediately annotate each invoice with the actual date it receives the invoice.

(d) Payment office. The designated payment office will annotate each invoice and receiving report with the actual date it receives the invoice.

The Administration for Strategic Preparedness and Response (ASPR) additional requirements:

(i) The contractor shall submit monthly invoices under this contract unless otherwise agreed upon by all parties. For indefinite delivery and blanket purchase agreement vehicles, separate invoices must be submitted for each order.

(ii) Invoices must break-out…