Regulatory Operations Support Services

This notice is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 "Streamlined Procedures for Evaluation and Solicitation for Commercial Items," as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Submit offers on NIAID-RFQ19-20197522. This solicitation is a request for quotes (RFQ). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-04, dated August 7, 2019. The associated North American Industry Classification System (NAICS) code for this procurement is 541715 with size standard of 1000 employees. The National Institute of Allergy and Infectious Diseases (NIAID), VRC (Vaccine Research Center) is in need of regulatory operations support services for Investigational New Drug Applications (IND) sponsored by the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, NIH. Regulatory activities will ensure IND Sponsor compliance with applicable federal regulations and guidelines, make sure that research is conducted ethically, human subjects are protected, and data integrity is preserved. Requirements are included in this solicitation and attached Statement of Work (SOW). An anticipated Period of Performance (POP) is as follows: Base is one (1) 12-month POP Includes three (3) 12-month option years. The Government intends to award a contract resulting from this solicitation to the responsible offeror(s) whose quotation represents the best value after evaluation in accordance with the factors and subfactors in the solicitation. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. The Government intends to make an award(s) to that offeror whose quotation provides the best overall value to the Government. Evaluation of past performance and price will only be conducted on those quotes found to be technically acceptable. Offerors are required to submit both a written technical quote and a price quote to Government officials for the purposes of assuring that the prospective Contractor is fully cognizant of the scope of this contract and has the capability to complete all the SOW requirements. Please see attached instructions. The Government intends to award without discussions but reserves the right to conduct discussions should it be deemed in the Government's best interest. The following FAR provisions apply to this acquisition: FAR 52.212-1 Instructions to Offerors Commercial Items (Oct 2018) - Addendum tailoring FAR 52.212-1 is attached to this RFQ FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (Oct 2018) Offerors must complete annual representations and certifications on-line at http://www.sam.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items The following contract clauses apply to this acquisition: FAR 52.204-7 System for Award Management (Oct 2018) FAR 52.212-4 Contract Terms and Conditions Commercial Items (Oct 2018) FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (Oct 2018) FAR 52.217-6 Option for Increased Quantity (Mar 1989) FAR 52.217-8 Option to Extend Services (Nov 1999) FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000) FAR 52.222-41 Service Contract Labor Standards (Aug 2018) FAR 52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) FAR 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards -- Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) FAR 52.222-55 Minimum Wages Under Executive Order 13658 (Dec 2013) FAR 52.222-62 Paid Sick Leave Under Executive Order 13706 (Jan 2017) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) HHSAR 352.203-70 Anti-Lobbying (Dec 2015) HHSAR 352.239-74 Electronic and Information Technology Accessibility (Dec 2015). HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) The applicable provisions of FAR52.212-5 are included in the attachment to this posting. Quoter must include the following provision in their quote and check the appropriate response. 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) (a) Definitions. "Inverted domestic corporation" and "subsidiary" have the meaning given in the clause of this contract entitled Prohibition on Contracting with Inverted Domestic Corporations (52.209-10). (b) Government agencies are not permitted to use appropriated (or otherwise made available) funds for contracts with either an inverted domestic corporation, or a subsidiary of an inverted domestic corporation, unless the exception at 9.108-2(b) applies or the requirement is waived in accordance with the procedures at 9.108-4. (c) Representation. By submission of its offer, the offeror represents that- (check one) ____(1) It is not an inverted domestic corporation: and ____(2) It is not a subsidiary of an inverted domestic corporation By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov). This is an open-market combined synopsis/solicitation for Regulatory Operations Support Services for Investigational New Drug Applications (IND) sponsored by the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, NIH. The government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award, process all quotes should include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" (Quoter shall list exception(s) and rationale for the exception(s).) Question and Answer session ends August 29, 2019. Questions must be submitted by email to chantal.guetat@nih.gov. Submission shall be received not later than the response date of this solicitation. Offers may be e-mailed to Chantal.guetat@nih.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). SPECIAL NOTICE TO OFFERORS Offerors are advised that the Government may share your information with non-government personnel who are assisting with the evaluation of quotes. The exclusive responsibility for source selection will reside with the Government. By submitting your offer, you will be consenting to disclosure of your offer to non-government personnel for purposes of evaluation.