Clinical Research Methodology

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, 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-RFQ-19-1966997.

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) 2019-03, dated July 12, 2019. The associated North American Industry Classification System (NAICS) code for this procurement is 541690 with a small business size standard of $15.0M.

The National Institute of Allergy and Infectious Diseases (NIAID), is seeking to procure Clinical Research Methodology. 1). Provide support in the development of standard operating procedures necessary to assure that FDA sponsor responsibilities are properly conducted or overseen, and for regulatory operations. 1.1). Shall assess the processes involved in conducting or overseeing FDA sponsor activities by the VRC, and regulatory operations: provide a revised list of additional SOPs required by a sponsor of FDA activities, and for regulatory operations to the VRC. Discuss processes with staff and provide suggestions for process improvement. Provide appropriate SOP training as requested, 1.2). Shall draft or revise and provide final SOPs (up to 15 SOPs) for conducting or overseeing FDA sponsor activities by the VRC, and regulatory operations, estimated hours 140 and 2). Reviews clinical trial site monitoring and audit reports for Zika Vaccine Study 705 and other studies as requested prior to Sponsor approval and reviews/develops other study-specific and program-wide essential documents and requirements to ensure compliance with sponsor responsibilities, 2.1). Oversight activity: Assist Sponsor with expansion of monitoring program, provide suggested staffing plan/division of tasks, develop tools to assist with tracking monitoring oversight, develop plans for escalation of critical issues and sponsor intervention, develop monitoring plans, assess clinical monitor's compliance with the clinical monitoring plan and provide suggestions for enhancing compliance when gaps are identified, 2.2). Shall review significance of the observations made by the monitor (i.e. critical vs. major vs. minor) and, based on industry standards, provide comments on the significance of the findings, 2.3) Shall review the status of investigations, and corrective actions and preventative actions (CAPA) proposed by the monitor. Provide assessment of the investigation, and comment on the suitability of the CAPA to address issues, 2.4). Shall provide solutions for disagreements regarding observations between the clinical trial site and monitor and 2.5). shall review and develop other study-specific essential documents to ensure compliance with Sponsor responsibilities, including but not limited to clinical monitoring plan templates, clinical monitoring plans, monitor qualifications, risk management plans, and data management plans, estimated 390 hours.

Please see attached Statement of Work (SOW).

Anticipated Period of Performance (POP)
8/15/19 to 8/14/20

The government will make an award based on a best value determination that includes factors of technical requirements, price and past performance. Only quotes that are technically acceptable will be evaluated for price and past performance. 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)
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 52.212-4 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 (Jan 2019)
FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)
(May 2014)
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)

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 a total Small business set aside combined synopsis/solicitation for Clinical Research Methodology as defined herein. The government intends to award a purchase orderas a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. All quotes shall include: price, technical capability, point of contact: name, phone number & email; DUNS #; and Cage Code. 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).)

Offers may be e-mailed to blandl@nih.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

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