DESCRIPTION: The Department of Veterans Affairs Consolidated Mail Outpatient Pharmacy program (CMOP) is in the process of obtaining and evaluating industry capability in developing Consumer Return Medication Envelopes (mailback envelopes). The Drug Enforcement Administration (DEA) recently published regulations to implement the 2010 Secure and Responsible Drug Disposal Act. Prior to publication of these regulations, ultimate users could return non-controlled medications but could not return controlled substance medications. This rule allows ultimate users to return both controlled and non-controlled medications per defined methods. One of the methods in the regulations allow for ultimate users (e.g. patients) to return their unused and unwanted medications to a DEA authorized "collector" for destruction using a mail-back envelope. A DEA distributor or reverse distributor authorized to conduct a mail-back program, may provide mail-back envelopes to a third party to distribute to ultimate users. Any interested Contractors must fully comply with the following regulations: 1. An Introductory Resource Guide for Implementing the Health Insurance Portability and Accountability Act (HIPPA) Security Rule, October 2008 2. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004 3. http://www.gpo.gov/fdsys/pkg/FR-2014-09-09/pdf/2014-20926.pdf Note: RFI responses will NOT be shared with other industry suppliers and will solely be used as part of the contract planning process. Disclaimer: The following requested information to be provided is for planning purposes only and does not constitute an Invitation for Bid, Request for Proposal, Request for Quotation, nor does it restrict the Government as to the ultimate acquisition approach. The government does not intend to award a contract based on this RFI nor is this an indication that the Government will contract for the items contained in this notice. Any contract that might be awarded based on information received or derived from this RFI will be the outcome of the competitive process. The Government will not reimburse respondents for any cost associated with the submission of the information being requested or reimburse expenses incurred to the interested parties for responses. SUBMISSION: Please answer the following questions in regards to your company's capability to provide the mailback envelopes: 1. Company Name, Company Address, Point of Contact, Telephone Number, e-mail Address, and Size of your Organization (i.e. Large Business, Small Business) using as the basis for your response. 2. Is your company registered with the DEA? Have you or do you plan to add the status of "collector" to your registration? If yes, please provide the registration/approval information. 3. Do you currently meet the requirements defined in the DEA regulations (see above) for operation of a mail-back program to include required storage and on-site destruction? 4. Responses should identify your organization's experience with and capability to manufacturer mailback envelopes (or similar items) and detail any experience in delivering large quantities to multiple locations. 5. Are these envelopes, or similar, currently in use by other government (Federal, State, or Local) organizations? If yes, please identify the agency, contract numbers, and a Point of Contact. 6. Is your company currently a GSA Federal Supply Schedule holder? If so, please provide your GSA contract number/s. 7. Responses should identify any current or potential future regulatory and/or security concerns. 8. Provide information on the size, material, enclosure depth and color of the envelope (attach a picture if possible). 9. Provide information on any wording that appears on the outside of the envelope. 10. Provide information on the type of destruction used and compliance with all applicable Federal, State, and Local regulations/laws. 11. Provide information on soonest date you would have envelopes available and what type of volume you would have available for purchase. 12. Provide information on which carrier (e.g. U.S. Postal Service, FedEx, UPS, etc.) you use for ultimate users to return the envelope Structure of Responses - should be provided in the order as presented in this RFI. All submissions must be in Microsoft Word or Adobe PDF 1-inch margins and 12 point Arial or Times New Roman font. Limit response to a maximum of 20 pages. The Point of Contact (POC) for this RFI is as follows: NAME: Ryan Collier Title: Contract Specialist Phone: (913)758-4728 Contractors should respond to this RFI by e-mail (only) to
[email protected] with the subject line reading "RFI Mailback Envelopes"