ID/IQ for Regulatory Consultant, Non-Personal Services   5

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 supplemented by FAR Subpart 13.5 with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued. The solicitation number is W911QY21R0007 and is issued as a Request for Proposal (RFP), unless otherwise indicated herein. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-09. The associated North American Industrial Classification System (NAICS) code for this procurement is 541714 with a small business size standard of 1,000 employees. This requirement is being solicited using full and open competition. Both small and other than small businesses may respond.

The Government requires the ability to engage senior regulatory experts to provide consultation and reporting on projects related to FDA regulations, quality auditing, FDA package submissions and other task areas. Please see the attached solicitation document and related attachments for the Performance Work Statement, ID/IQ CLIN schedule, response requirements, evaluation criteria and all terms and conditions.

All contractors must be actively registered in the System for Award Management without exclusions to be eligible for award.

The Contractor shall not be reimbursed for any costs incurred prior to the effective date of the contract.

Information contained in the successful or unsuccessful Offeror's Management or Price proposal must be released under the Freedom of Information Act (5 U.S.C. 552) upon request from the public after contract award, except to the extent it contains trade secrets and privileged or confidential commercial or financial information. If the Offeror's proposal contains material meeting this description which is customarily maintained in confidence in the course of the Offeror's business and is not otherwise publicly available, and if the Offeror does maintain this information in confidence and it is not otherwise publicly available, and if the Offeror does not want it disclosed to the public, the title page shall be marked with the legend that follows.

"This proposal, furnished in response to Solicitation No. W911QY-21-R-0007 contains trade secrets and/or privileged or confidential commercial or financial information. This information is maintained in confidence in the course of the Offeror's business and is not otherwise publicly available. The Offeror submits this information to the Government in confidence and understands that it is received with that intent. This information shall not be released or disclosed outside the Government under the Freedom of Information Act (5 U.S.C. 552) or under any other circumstances."

Proposals so marked will be accepted by the Government in confidence and will not be released provided that the Offeror and/or the Government can show, upon request under the Freedom of Information Act, that disclosure would either (1) impair the Government's ability to obtain necessary information in the future or (2) cause substantial harm to the competitive position of the Offeror.

Responses shall be submitted electronically to scott.i.hoffman2.civ@mail.mil, no later than the time and date specified in this notice. A courtesy copy shall be provided to susan.e.ruzicka2.civ@mail.mil no later than the time and date specified in this notice.

Questions regarding this solicitation shall be sent to scott.i.hoffman2.civ@mail.mil and a courtesy copy provided to susan.e.ruzicka2.civ@mail.mil, no later than 11:00 am Eastern time on 30 November 2020.

**Amendment 0001***

Amendment 0001 to this solicitation has been issued to extend the due date for responses from 07 December 2020 to 18 December 2020. See attachment for additional information.

***Amendment 0002***

Amendment 0002 to this solicitation has been issued to post responses to contractor questions, revise the terms of the solicitation, revise solicitation Attachments A and D and extend the due date for responses from 18 December 2020 to 28 December 2020. See attachments for additional information.