sources sought.docx

SMALL BUSINESS SOURCES SOUGHT NOTICE (NICHD-21-128)

Agency: The National Institutes of Health, National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK)

Title: Audit Support for the NIDDK Office of Clinical Research Support (OCRS)

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 consortium initially conducted a multi-center randomized clinical trial with a Coordinating Center and 20-some clinical centers and then transitioned to a long-term follow-up protocol. During the follow-up period, drug treatments were unmasked, the placebo was discontinued, and study-provided drug was continued in those initially randomized to it. All participants have been followed for long-term health outcomes and have two visits each year. Study-provided drug was distributed to participants in that treatment arm at these visits. The initial clinical trial operated under an FDA IND. The IND was withdrawn during the follow-up period, and then a new IND put in place later during that period when the study drug supplier was changed to a supplier that had not been inspected by the FDA. Study leadership with concurrence from the Data and Safety Monitoring Board (DSMB) subsequently discontinued study-provided drug therapy.

In mid-2020, the NIDDK learned that an IRB at one of the clinical centers had identified a potential issue of noncompliance and later in 2020 that IRB made a final determination that the issue was considered to be non-compliant with Federal regulations and GCP guidelines. Following this determination, NIDDK leadership and OCRS personnel consulted with relevant NIH offices and then decided that an independent ‘for cause’ assessment to address both funder and sponsor responsibilities should be conducted.

Purpose and Objectives:

The purpose of this requirement is to support the OCRS in the assessment of compliance with study protocol and procedures, Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable laws or regulations at awardee institutions or subaward/subcontract locations of an extramurally funded multi-center consortium. The objective is to complete the audits/assessments and identify any potential issues of non-compliance with the above regulations.

Project Requirements:

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below. Specifically, the Contractor shall:

Anticipated Period of Performance:

Base: 6 months Option Period 1: 6 months

Other Important Considerations:

N/A

Special Instructions:

If you or your firm/business has an interest and possess the required expertise we invite you to submit a corporate capability statement to assist the Government in determining in accordance with Federal Acquisition Regulation (FAR) 19.502-2(b) whether or not this procurement will be set-aside for any of the programs described above. The intended procurement will be classified under North American Industrial Classification (NAICS) code 541990 size standard of $16.6M. All respondents are requested to identify their firm's size and type of business.

Interested firms responding to this Small Business Sources Sought Notice should adhere to the following:

(a) Provide a capability statement demonstrating relevant experience, skills and ability to fulfill the Government's requirements for the above. The capability statement should contain sufficient detail for the Government to make an informed decision regarding your capabilities and at a minimum address the below:

a. 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;

b. information regarding respondents’: (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information

c. respondents’ DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code;

d. any other information that may be helpful in developing or finalizing the requirement.

(b) The capability statement should not exceed 15 pages using a font size 10 or larger and shall include:

a. respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses; and

b. the name, address, telephone number, and e-mail address of the Contract Specialist or Contracting Officer to whom the information should be sent.

(c) All capability statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via email) to the Kyle.Wisor@nih.gov in MS Word or Adobe Portable Document Format (PDF). The subject line must specify NICHD-21-128. Facsimile responses will not be accepted. Electronically submitted capability statements are due no later than 3:00 PM (Eastern Prevailing Time) on June 18th.

“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 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).”