Sources Sought Notice.pdf

Sources Sought Notice Information

Introduction

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

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical, and clinical research focusing on protective immune responses and immune-mediated diseases through a variety of research grants and contracts. This includes support for clinical research programs and individual research projects to 1) evaluate the safety and efficacy of therapeutic and preventive approaches and agents, and 2) elucidate the underlying mechanisms of such approaches and agents.

A critical component of DAIT’s awarded grants and contracts involves the design and conduct of clinical research studies, including Phase 1 through 4 clinical trials of investigational approaches, intended to lead to a functional state of immune tolerance in three main clinical areas:

autoimmune diseases; asthma and allergic diseases; and immune-mediated rejection of transplanted solid organs, tissues, and cells.

Purpose and Objectives

The purpose of this acquisition is to:

1. Provide an expanded, wide range of clinical site monitoring services for NIAID-funded clinical research/trials of immune-mediated diseases, including as examples the delivery of monitoring services for:

• the Immune Tolerance Network (ITN)

• Asthma and Allergic Diseases Clinical Research Programs:

o Asthma and Allergic Diseases Cooperative Research Centers (AADCRC) o Atopic Dermatitis Research Network (ADRN) o Consortium for Food Allergy Research (CoFAR) o Inner City Asthma Consortium (ICAC), which is to be replaced in 2021 by the

Childhood Asthma in Urban Settings Clinical Research Network (CAUSE CRN)

• Autoimmunity Centers of Excellence (ACE)

• Transplantation Clinical Research Programs:

o Clinical Trials in Organ Transplantation (CTOT) and in Children (CTOT-C), both of which will be replaced in Fiscal Year (FY) 2021 by the Clinical Trials in Organ Transplantation-Children and Adults (CTOT-CA)

• Non-network clinical research/trials on a limited, as-needed basis, and

• Unanticipated NIAID clinical research studies/trials that may be required in response to public health emergencies and/or emerging needs.

2. Advance the field of risk-based monitoring through innovation using novel and effective approaches, with the goal of ensuring participant safety, quality data, and greater site/study compliance.

Project requirements

The Contractor shall provide comprehensive clinical site and study monitoring services for a broad range of NIAID-sponsored and/or -funded clinical research (including but not limited to clinical trials) for both domestic and international research. The contractor will be responsible for:

1. Clinical Site Monitoring System: Maintain a system to monitor domestic and international clinical research sites with respect to ensuring their adherence to regulatory requirements governing human subjects research, ICH E6(R2) Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), country- and state-specific requirements governing human subjects research, protocol-specific requirements, and NIAID policies and procedures;

2. Training: Develop and implement training programs for clinical site personnel and site monitors;

3. CSMC Data Management and Reporting System: Manage, maintain and update, as necessary, a centralized 21 CFR Part 11 compliant CSMC Data Management and Reporting System, using commercially available software, for the storage, quality control and retrieval of contract-generated data, reports and other materials, and for reporting on contract activities and the findings of the clinical site assessment and monitoring functions performed;

4. Coordination and Collaboration with other NIAID Clinical Research Support Contractors and Grantees: At the direction of NIAID the Contractor shall collaborate and coordinate with NIAID contractors, grantees, and partners on an as needed basis, in order to carry out clinical site and study monitoring and reporting responsibilities;

5. Risk-Based Monitoring Innovation: At the direction of the COR, engage in the conduct of risk-based monitoring research that applies technological and effective solutions, with the goal of advancing strategic approaches that improve efficiencies in process and outcomes, with the outcome of increased participant safety, quality data and greater site/study compliance;

6. Quality Assurance and Quality Control: Develop and implement a Quality Assurance/Quality Control (QA/QC) Plan designed to: (i) standardize contract processes;

(ii) ensure that the conduct of all contract activities complies with domestic and country-specific regulations governing human subjects research, ICH GCP guidelines, and NIAID policies and procedures; and (iii) provide for the assessment of Contractor performance and the quality of clinical site monitoring activities conducted.

7. Clinical, Scientific and Technical Personnel: The Contractor shall provide a Principal Investigator (PI)/Project Director with responsibility for overall project management and communications, tracking performance and cost, and monitoring and reporting on project status and progress. The PI/Project Director will ensure that the clinical, scientific, and technical personnel have the relevant individual education, training, expertise, experience, and qualifications required for the successful completion of contract requirements.

8. Facilities, Equipment and Other Resources: The Contractor shall provide all facilities, equipment and other resources necessary to carry out the requirements of the contract.

Anticipated period of performance

The anticipated period of performance comprised of the base period plus optional periods is ten years and will start around November 2021.

Other important considerations

Capability statement / information sought

Interested respondents must submit a capability statement describing company’s experience and ability to perform the requirements that includes the following:

1. A summary list of similar work previously performed,

2. The professional qualifications and specific experience of staff who may be assigned to the requirement,

3. Resumes for proposed key personnel, including the Principal Investigator, that reflect

Education, and previous work relevant to the proposed requirement,

4. Documented adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity,

5. Documented adequacy and appropriateness of proposed organization and staffing to ensure efficient planning, initiation, implementation, conduct, and completion of all activities, including plans for communication and sharing of research resources,

6. Demonstrated ability to carry out the requirements.

Page Limitations:

Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such.

Required Business Information:

• DUNS.

• Company Name.

• Company Address.

• Company Point of Contact, Phone and Email address

• Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought.

• Do you have a Government approved accounting system? If so, please identify the agency that approved the system.

• Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov.

This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern’s name and address).

Number of Copies:

Please submit one (1) electronic copy of your response as follows:

All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to Debbie Blyveis, Contract Specialist, at blyveisd@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify 75N93020R00021. Facsimile responses will not be accepted.

https://www.sam.gov/

Common Cut-off Date:

Electronically submitted tailored capability statements are due no later than 3:00 PM ET on September 10, 2020. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME

WILL NOT BE CONSIDERED.

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).”