National Dry Ice RFI SOW.docx

Statement of Work for National Dry Ice contract

1.0 Background

The Food and Drug Administration (FDA) Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. As part of these duties, samples are obtained in the inspection process and need to be safeguarded for analysis at an FDA lab.

Collecting samples is a critical part of FDA's regulatory activities and proper sample collection is the keystone of effective enforcement action. Samples must be handled, identified, and sealed in such a manner as to maintain its integrity as evidence, with a clear record of its chain of custody. For frozen samples, the use of dry ice is important in maintaining sample integrity. FDA/ORA requires dry ice to accomplish its mission.

2.0 Objectives

The contractor to provide nationwide services that include the following:

a. Dry ice and other materials such as coolers and shipping material shall be available (delivered or picked up) within 24 hours notices of request.

b. Inspectors shall have dry ice and coolers/shipping containers for required inspections and samples as needed.

c. The ordering process for obtaining dry ice and coolers/shipping containers will be simplified and uniform across ORA.

3.0 Scope

This contract shall provide for the purchase and delivery of dry ice and coolers/shipping containers to FDA District Offices, Laboratories and Resident Posts as outlined in Section 8.

4.0 Tasks or Requirements

a. The contractor shall provide all necessary labor, materials, and transportation as necessary to deliver dry ice to each FDA/ORA location listed in Section 8 of this document.

b. Each location shall receive a regular delivery and have the ability to order dry ice on an as needed basis. The contractor shall have the dry ice requested on an as needed basis available for pickup or delivery within a 24 hours’ notice. Conversely, FDA shall have the ability to cancel any recurring dry ice delivery with 24 hours’ notice.

c. The contractor shall provide an online request system for use by ORA to request dry ice to be delivered, shipped or picked up.

d. Forms should include option to request pellets or block dry ice. Sizing will be determined by the sample size. Sizing will fluctuate in accordance with specimen being analyzed.

e. Coolers shall be provided for locations that request them for each order.

· The coolers shall be in various sizes to match the requirements for each order.

· The coolers shall have wheels for any orders over 20 pounds.

· The coolers shall ensure the dry ice remains in a stable form.

· Coolers will be disposed of at FDA facility unless options exist for vendor facility to dispose of coolers.

5.0 Deliverables

A report shall be provided each month to detail the amounts of dry ice provided to each location. This report can be included in the monthly invoice submission.

6.0 Other requirements

The contractor shall comply with all state and federal laws that are applicable to the safe handling of dry ice.

Deliveries shall be made once a week on Monday’s between 8:00 AM- 10:00AM, excluding holidays and any day declared an official federal holiday. If the government holiday falls on the scheduled delivery date, the delivery will be on the next business day. Holidays observed by the FDA are:

· New Year’s Day

· Martin Luther King Day

· President’s Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veteran’s Day

· Thanksgiving Day

· Christmas Day

7.0 Period of Performance

8.0 Place of Performance

The following FDA locations shall require dry ice delivery on a recurring basis:

The following FDA locations shall require dry ice to be picked up at a central vendor location on a recurring basis:

The following FDA locations shall require dry ice delivery on an as needed basis:

The following FDA locations shall require dry ice to be picked up at a central vendor location on a monthly or weekly basis:

The following FDA locations shall require dry ice to be picked up at a central vendor location on an as needed basis:

Baltimore, MD 21224

555 Winderley Pl Ste 200, Maitland, FL 32751

*The regions are defined below:

DNBI-Division of Northern Border Imports DNEI-Division of Northeast Imports DSEI-Division of Southeast Imports DSWI-Division of Southwest Imports DWCI-Division of West Coast Imports

9.0 Government Furnished Equipment or Information (GFE) or (GFI)

Badges, laptops will not be issued nor will access to WiFi be available. Contractor shall be escorted when on FDA property.

10.0 Security Requirements

See attachment 3 for location specific requirements

11.0 Staffing and Key Personnel

HHSAR 352.237-75 Key Personnel (December 18, 2015)

The key personnel specified in this contract are essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary.

The following individuals are considered to be essential to the work being performed and are designated as key personnel: