Questions_and_Answers.docx

In regards to Solicitation 16-233-SOL-00023, I request a response to the following questions and/or clarification of the proposal instructions.

1. Is the FDA currently performing these services? No, this is a new process.

2. Is this a new solicitation? Yes

3. If it is not a new solicitation, will the Government provide the contract number and contractor currently performing these services for the FDA? N/A

4. Will the Government provide the anticipated volume of waste that is currently stored, awaiting award of a contract? Yes this can be provided and discussed once the contract is awarded. If needed, we can provide an estimate of the articles currently awaiting destruction prior to award of a contract.

5. From Page 4, ¶1 under sub-heading Services: “The International Mail Facilities (IMF) expects to generate routinely two types of regulated wastes: (1) non-hazardous solid wastes and (2) various types of hazardous waste.”

a. Has “sharps” waste been a part of the hazardous waste collected from IMFs? No, FDA has the authority to destroy only Prescription medicines, “sharps” (i.e. needles) waste are considered medical devices. (in addition, currently combination products will not be destroyed under this authority)

b. Is liquid non-hazardous or hazardous waste collected from IMFs? On rare occasions we receive saline solution vials and unlabeled ampules.

c. Will the government provide any additional information as to the particular categories within non-hazardous solid wastes and various types of hazardous waste? FDA does not anticipate a significant volume of hazardous waste. Additional information can be found on EPA website: http://hwpharms.wikispaces.com/P-Listed and https://www.epa.gov/rcra

6. From Page 4, ¶2 under sub-heading Services: “FDA must be able to track these containers from the point of pick up by the contract through the disposal process.”; and Page 4 ¶4 under sub-heading Services: “The containers must be able to be tracked throughout the logistical process.”

a. How does the FDA currently track these type shipments? Currently this is not part of our process. We expect to maintain a chain of custody for the drums containing the products until destruction.

b. Does this contract require implementation of GPS or GIS in order for the contractor as well as the FDA to maintain continuous tracking of each shipment? No, this was not considered in the original contract concept. The purpose is to maintain a chain of custody of the products until destruction.

c. Is it the intention of the Government for all parties to maintain continuous tracking of each shipment through manifest documentation only? Yes, we are required to keep record of the products until the final disposition.

7. Page 33 ¶1 under PART 9: AWARD CRITERIA AND INFORMATION: “There will also be a firm fixed price portion of the contract to include tracking, manifest, containers and other administrative functions necessary to perform the pharmaceutical destruction.”

a. Will the Government amend its requirements to show that all tracking as well as travel, to and from each of the 9 IMF locations specified are reimbursable costs under this contract (reimbursable cost only, without markup)? The travel costs for this project should be built into the cost of disposal at each of the IMF locations. The rate that you provide should be a fully burdened rate.