Clinical Site and Study Monitoring for NIMH Funded

Closed Pre-Solicitation Posted

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Solicitation number
75N95024R00008
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

This pre-solicitation notice seeks capability statements from small businesses to provide comprehensive clinical site and study monitoring services for research projects funded by the National Institute of Mental Health's Division of AIDS Research and Center for Global Mental Health Research. Interested parties must submit responses by November 17, 2023 demonstrating their technical qualifications, personnel qualifications as they relate to the requirements, applicable government contracts, opinions on feasibility, and NAICS code and size standards. Evaluation will be based on the respondent's ability to meet the requirements outlined in the statement of work.

The notice does not include any set-aside designations. Responses should include the company's NAICS code under Professional, Scientific, and Technical Services with applicable size standards. The base period of performance is one 12-month year with four 12-month option years. Monitoring will include initial site visits, interim monitoring visits at each site one to two times per year, closeouts, and specialized visits as required to ensure quality and compliance for research projects in locations globally.

Notice text

Title: Clinical Site and Study Monitoring for NIMH Funded Research in Global Settings

Description:

NOTE: This is NOT a solicitation for proposals, proposal abstracts, or quotations. There is no solicitation available at this time.

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; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. 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.

Background:

The Institute of Mental Health, Division of AIDS Research supports research to reduce the incidence of HIV/AIDS worldwide and to decrease the burden of living with HIV/AIDS. The Center for Global Mental Health Research (CGMHR) coordinates the NIMH¿s efforts to reduce mental health disparities beyond the United States. As part of the NIMH¿s Global Mental Health Research Strategy, the Center sponsors research that increases the body of evidence necessary to inform decisions concerning the adoption and scaling up of evidence-based interventions beyond the United States, particularly in low- and middle-income countries (LMICs).

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.

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.

Capability statements must also include the Company Name, Unique Entity ID (UEI) 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.

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 such as respondents¿ opinions about the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts any other information that may be helpful in developing or finalizing the requirement.
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 response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only.

Submission Instructions:

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 an 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 are not required.

The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses.

All responses must be submitted electronically to the Contracting Officer, Kristina Jenkins at Kristina.Jenkins@nih.gov by the closing date and time of this announcement. Facsimile responses will not be accepted, and all responses must reference the Notice ID.


Disclaimer and Important Notes. This notice does not oblige 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 pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. 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).


See Attachments for additional details.

Files

File Type Posted
Draft_SOW_75N95024R00008_1.pdf PDF
Sources_Sought_Notice_75N95024R00008_1.pdf PDF

Notice history

Notice Type Posted
Clinical Site and Study Monitoring for NIMH Funded Research in Global Settings Latest pre-solicitation Pre-Solicitation
Clinical Site and Study Monitoring for NIMH Funded Research in Global Settings Pre-Solicitation
This notice Original Pre-Solicitation

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