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AMENDMENT 1 The purpose of this Amendment is to: (1) Inform interested vendors that answers to questions posed have been uploaded to SAM.gov. (2) The following document is hereby revised and supersede... AMENDMENT 1 The purpose of this Amendment is to: (1) Inform interested vendors that answers to questions posed have been uploaded to SAM.gov. (2) The following document is hereby revised and supersede the original version (revisions within this document are highlighted in yellow): NIMH23002448 COMBINED SYNOPSIS/SOLICITATION AMENDMENT 1 ALL OTHER TERMS AND CONDITIONS REMAIN UNCHANGED. COMPETITIVE COMBINED SYNOPSIS / SOLICITATION AMENDMENT 1 Title: Financial and Clinical Monitoring Activities Support for NIMH Studies (i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. (ii) The solicitation number is NIMH23002448 and the solicitation is issued as a request for proposal (RFP). This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) Number 2023-02, with effective date March 16, 2023. (iv) The associated NAICS code 541611 and the small business size standard is $21.5M. This requirement is full and open with no set-aside restrictions. (v) This requirement is for the following services: The National Institute of Mental Health (NIMH) is seeking support in reviewing and summarizing results from financial and clinical research site monitoring activities and preparing NIMH responses to reports from clinical research sites. (vi) The purpose of this acquisition is to acquire comprehensive services in reviewing for-cause clinical site study monitoring, continued review of research practices and audit reports as well as financial audit reports for studies funded by the National Institute of Mental Health (NIMH). (vii) The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance for this requirement is one (1) 12-month base period and four (4) 12-month option periods. (viii) The place of performance may be at the contractor’s location; however, travel to clinical sites may be necessary and will take place in the United States. (ix) The specific requirements for this acquisition are specified in the attached Statement of Work. (x) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of provision) The following provisions apply to this acquisition and are incorporated by reference: FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.212-1, Instructions to Offerors-Commercial Items (Nov 2021) FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022) HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015) HHSAR 337.103(f) Key Personnel (December 18, 2015) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html (End of clause) The following clauses apply to this acquisition and are incorporated by reference: FAR 52.204-13, System for Award Management Maintenance (Oct 2018) FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.212-4, Contract Terms and Conditions--Commercial Items (Nov 2021). Addendum to this FAR clause applies to this acquisition and is attached. FAR 52.217-7, Option for Increased Quantity-Separately Priced Line Item (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 52.222-49, Service Contract Labor Standards – Place of Performance Unknown (May 2014) HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (December 18, 2015) HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015) HHSAR 337.103(f) Key Personnel (December 18, 2015) The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their proposal. FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct 2020) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (Jan 2022) NIH Invoice and Payment Provisions (Feb 2021) (xi) The provision at FAR clause 52.212-2, Evaluation – Commercial Items (Nov 2021), applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical Approach; (ii) Key Personnel; and (iii) Past Performance See Technical Evaluation Criteria attachment for specific details. Technical factors when combined are more important than cost or price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.” (xii) The Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. (xiii) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (Nov 2021), applies to this acquisition. Addendum to this FAR clause applies to this acquisition and is attached. (xiv) There are no additional contract requirement(s) or terms and conditions applicable to this acquisition. (xv) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement. (xvi) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount. (xvii) The following is only an estimate. Offerors are advised to carefully review the requirement in deriving the level of effort they believe is necessary to provide their best value proposal. The offeror is not bound to propose using the below assumptions. Rather, offerors are expected to provide the best solution citing the labor mix and optional travel to accomplish this task. The estimated level of effort for this requirement is detailed below. This level of effort is estimated for the base period and subsequent option periods. The Government’s estimated level of effort was created using historical data obtained from previous acquisitions of similar work. LaborType Hours Per 12-Month Period of Performance Supervisory Program Manager 500 Clinical Study Audit Report Reviewers 2600 Psychiatrist Reviewer 300 Financial Audit Report Reviewers 1200 Optional Travel Each 12-Month Period To Clinical Sites $3,760 per trip not to exceed 12 trips per period The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All questions must be received by 1:00 p.m., Eastern Time, on March 28, 2023 and reference Solicitation Number NIMH23002448. Questions may be submitted electronically to Robin Knightly, Contracting Officer at Robin.Knightly@nih.gov. All offers must be received by 9:00 a.m., Eastern Time, on April 14, 2023, and reference Solicitation Number NIMH23004227. Responses must be submitted electronically to Robin Knightly, Contracting Officer at Robin.Knightly@nih.gov. Fax responses will not be accepted. ATTACHMENTS SOW; Technical Evaluation Criteria; FAR 52.204-24 (Nov 2021); FAR 52.204-26 (Oct 2020); FAR 52.212-3 (Nov 2021); FAR 52.212-5 (Mar 2023); and IPP Invoice Instructions

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SOURCES SOUGHT NOTICE Solicitation Number: NIMH23002448 Title: Financial and Clinical Monitoring Activities Support for NIMH Studies Classification Code: R499 Support-Professional: Other NAICS Code: 5... SOURCES SOUGHT NOTICE Solicitation Number: NIMH23002448 Title: Financial and Clinical Monitoring Activities Support for NIMH Studies Classification Code: R499 Support-Professional: Other NAICS Code: 541611 Management and Financial Consulting, Acquisition Size Standard: $21.5M Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; and (4) availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. For equipment/supply requirements, responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e. address Non-Manufacturer Rule). Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: As part of its oversight responsibilities, the National Institute of Mental Health (NIMH) is seeking support in reviewing and summarizing results from financial and clinical research site monitoring activities and preparing NIMH responses to reports from clinical research sites. Purpose and Objectives: The purpose of this acquisition is to acquire comprehensive services in reviewing for-cause clinical site study monitoring, continued review of research practices and audit reports as well as financial audit reports for studies funded by the National Institute of Mental Health (NIMH). Project requirements: Requirements are specified in the attached Statement of Work. Anticipated period of performance: The anticipated period of performance for this requirement is one (1) 12-month base period and four (4) 12-month option periods. Capability statement /information sought. Companies that believe they possess the capabilities to provide the required products or services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include 1) the total number of employees, 2) the professional qualifications of personnel as it relates to the requirements outlined, 3) any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, and 4) any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Interested companies are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2” x 11” paper size, with 1” top, bottom, left and right margins, and with single or double spacing. The information submitted must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses to this notice must be submitted electronically to the Contracting Officer. Facsimile responses are NOT accepted. The response must be submitted to Robin Knightly, Contracting Officer, at e-mail address Robin.Knightly@nih.gov. The response must be received on or before February 23, 2023 at 9:00 a.m. Eastern Standard Time. “Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).”