CLRS Sources Sought Notification.pdf

SOURCES SOUGHT/REQUEST FOR INFORMATION (RFI):

Clinical Research Support Services for National Institute of Environmental Health Sciences

1 INTRODUCTION

THIS IS A COMBINED REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT NOTICE ONLY. This Request for Information (“RFI”) is issued by the National Institutes of Health’s (“NIH”) National Institute of Environmental Health Sciences (“NIEHS” or “the Government”) in accordance with FAR Part 15.201(e) ‐ Exchanges with Industry. It is solely issued for market research information and planning purposes. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. This RFI does not commit the Government to contract for any supply or service whatsoever. Further, NIEHS is not at this time seeking proposals and will not accept unsolicited proposals. Responders are advised that NIEHS will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party’s expense. Not responding to this RFI does not preclude participation in any future RFP, if any is issued. If a solicitation is released, it may be synopsized on the SAM.gov website or issued through any number of existing Government contract vehicles determined by the Government to be the best procurement approach (e.g., GSA Federal Supply Schedule (FSS), Government Wide Acquisition Vehicles (GWACs), etc.). It is the responsibility of the potential offerors to monitor any related solicitation sites used by the Government for additional information pertaining to this requirement.

2 BACKGROUND

The National Institute of Environmental Health Sciences (NIEHS), located in the Research Triangle Park, North Carolina, is one of the 27 Institutes and Centers comprising the National Institutes of Health (NIH).

The NIEHS is a multidisciplinary research institution with the primary mission of conducting research to discover how the environment influences the development and progression of human disease in order to promote healthier lives. NIEHS focuses on basic science, disease‐oriented research, global environmental health, clinical research, and multidisciplinary training for researchers.

The Clinical Research Branch (CRB) conducts and oversees clinical research studies within the Division of Intramural Research (DIR), National Institute of Environmental Health Sciences (NIEHS). The objectives of these studies are to: 1) translate basic laboratory findings to clinical applications; 2) investigate the interaction between genetic susceptibility and environmental factors as they relate to complex traits and disease in human populations; and 3) intervene in disease development and/or progression by modifying these factors using preventative, therapeutic, and other techniques, or by altering environmental exposures, diet and lifestyles. In addition, the NIEHS conducts research on the potential health effects following natural disasters and will also collect time‐critical exposure and health information to address a wide variety of research questions about the health impacts of both natural (e.g., hurricanes, floods, drought and other severe weather events) and man‐made disasters (e.g., chemical spills, terrorist incidents).

The NIEHS is issuing this SS/RFI to accomplish five (5) goals:

1) Facilitate early (pre‐Request for Proposal [RFP]) engagement with industry, in accordance with FAR

15.201(e).

2) Improve NIEHS’s understanding of market capabilities and current vendor offerings for provision of the services as outlined in the Draft SOW (See Attachment 1).

3) Collect input and build knowledge on the vendors’ capabilities to provide the services outlined in the

Draft SOW.

4) Provide the specifications and set expectations with industry to support NIH’s commitment to fair competition, in accordance with FAR 5.401.

5) Determine if there are small businesses capable of fulfilling the requirement.

NAICS Code and Size Standard In the event that a Request for Proposal (RFP) is issued, North American Industry Classification System (NAICS) code 541715 ‐ Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) with a size standard of 1,000 employees is being considered.

Anticipated Period of Performance The anticipated Period of Performance is ten (10) years (a base year with nine (9) option years) with an estimated start date of May 2026.

Contract Type and Contractor’s Accounting System It is anticipated that the resultant contract will be a cost‐reimbursement type contract. Therefore, to be considered for an award under the resultant solicitation, the offeror’s accounting system and practices must be adequate and suitable for accumulating costs under government contracts. The offeror must further certify that the accounting system is currently in full operation.

2.1 CAPABILITIES SOUGHT

The NIEHS seeks information on contract support to provide scientific and technical expertise and support for activities including, but not limited to, those listed below and detailed in the Draft SOW

(Attachment 1). Award of a cost‐reimbursement, level of effort type contract is contemplated with the anticipated period of performance for ten (10) years. The total estimated level of effort is anticipated to be between 150,000 labor hours per year, including options, depending on the needs of NIEHS.

The NIEHS seeks contract support to provide medical, diagnostic, therapeutic, scientific, technical, data management, managerial, clerical, and statistical support to Principal Investigators (PIs) within the DIR, NIEHS and their collaborators. The Contractor shall assist the Government by identifying and enrolling subjects, and administering, managing, and conducting clinical studies designed and supervised by PIs alone or in collaboration with other scientists inside or outside of the NIEHS. Another purpose of this contract is to provide technical expertise and health care staff to the NIEHS Clinical Research Unit (CRU) in support of clinical studies conducted in that facility. The Contractor will also provide technical expertise and various staff members to the Environmental Autoimmunity Group (EAG) in support of the clinical studies conducted by them. The EAG is stationed at the National Institutes of Health in their

Clinical Center in Bethesda, Maryland. These staff will include research nurses, study coordinators, and other support personnel. The Contractor shall function in a purely supportive role carrying out specific task orders and shall not engage in independent research under this contract. The Contractor will also provide field research support to the NIEHS in response to natural or man‐made environmental disasters, or community outreach research. Thus, the NIEHS Clinical Support Services contractor must have the contractual ability to begin work at a short notice, the logistical ability to implement NIEHS research in a national scale, and the expertise to perform large‐scale field research as well as in‐house clinical research. The Contractor should also work with NIEHS to ensure that an appropriate level of funding is maintained to allow immediate response to a disaster without contractual modifications, and also that operational plans are in place for the rapid implementation of any pre‐approved research activities.

3 REQUESTED INFORMATION/RESPONSES

All interested parties are hereby invited to submit a capability statement in accordance with the following constraints:

Maximum of 15 pages in length submitted in Adobe Portable Document Format (.pdf), using the numbered format below (Items 1‐8).

Times New Roman font no smaller than 12‐point with one‐inch margins.

Electronic file submissions must be less than 30 megabytes in size.

Additionally, the Government will review each capability statement based on the interested party's demonstrated qualifications, capabilities, expertise, experience and past performance in each of the areas. More specifically, capability statements should provide the following information and address the following questions as appropriate and as applicable:

1. Company Information:

Company Name:

Point of Contact:

Address:

Phone #:

E‐mail address:

Cage Code:

UEI:

NAICS Code:

Small Business Status: (“8(a)” Program, Women‐Owned Small Business concern (WOSB), Economically Disadvantaged Women‐Owned Small Business concern (EDWOSB), HUBZone Small Business concern (HUBZoneSB), Veteran‐Owned Small Business concern (VOSB), Service‐ Disabled Veteran‐Owned Small Business concern (SDVOSB), Small Business, Large Business, Other)

2. Is your company currently capable of providing 100% of the requirements and objectives of the subject requirement? (Explain)

3. Please describe capabilities and experience on the following requirements:

(1) Provide expertise on, complete, and submit study design and planning for a wide array of single or multi‐center clinical studies and/or assist in the implementation of new clinical studies based on study designs provided by NIEHS Scientific Investigators.

(2) Draft, submit for review and finalize all study documents including IRB and OMB protocols, informed consent forms, letters, study pamphlets, recruitment and informational materials, posters, websites and others.

(3) Identify and recruit study populations either locally, nationally and/or internationally on short notice. For example, rapid response studies in the aftermath of a natural or man‐made disaster (e.g. Hurricane Katrina, Gulf oil spill) need to be on site within days of the disaster.

(4) Administer treatments, conduct examinations, and/or implement interventions in study subjects.

(5) Conduct diagnostic assessments or provide medical care to study subjects on an in‐ patient and/or out‐patient basis by providing medical personnel and facilities and/or interacting with medical personnel at other local or distant facilities including physicians' practices, clinics, hospitals and other research centers.

(6) Collect data and biologic materials from study subjects and coordinate data capture activities with various reference laboratories, medical clinics or other institutions.

(7) Store specimens collected during studies and maintain inventories.

(8) Isolate cellular, subcellular, and molecular fractions from biological samples and conduct biochemical, immunological, analytical, molecular and other types of laboratory assays. The Contractor shall furnish their own laboratory facilities and equipment for conducting specific laboratory assays or alternatively identify and select reference laboratories with relevant expertise.

(9) Develop study databases including the recording and summarizing of data and provide programming support for data analysis, perform scientific review and oversight, and conduct study management and analyses.

(10) Statistically analyze study data sets and develop reports, graphics, presentations and share in manuscript preparation.

(11) Document all the individual steps in a specific study, and establish and maintain orderly records of all relevant material so that any aspect of a study can be reviewed by the NIEHS at any point during its course,

(12) Convert all original questionnaires and other relevant study materials to a form suitable for efficient long‐term storage, e.g., microfilm, microfiche, CD ROM or optical disk storage,

(13) Submit and implement a Quality Control or Quality Assurance Plan for individual studies.

(14) Provide operational support (study coordinators, physicians, nurses, therapists, technicians, administrative and other types of personnel) and IT support (electronic patient registration and data management) for the NIEHS Clinical Research Unit (CRU) in RTP, NC and for certain NIEHS studies in the NIH Clinical Center (CC), Bethesda, MD. The CRU is an outpatient clinic on the NIEHS campus which sees up to 100 subjects per week. The CC is the nations’ largest clinical research unit with inpatient, out‐patient and day hospital services.

Staffing might be required full‐time, part‐time or be intermittent depending on the needs of the CRU and other facilities and the needs for individual studies. The Contractor shall also provide expertise to the CRU and other facilities for various aspects of running the facilities such as clinical monitoring, following Good Clinical Practices (GCP) and Good Laboratory Practices, and helping the CRU to obtain accreditation by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO).

(15) Provide operational support (study coordinators, physicians, nurses, therapists, technicians, administrative and other types of personnel) and IT support (electronic patient registration and data management) for multi‐site or off‐site studies. These could be either treatment trials or natural history studies in response to natural or man‐made disasters (see point 3), and they may be local, national or international in scope.

Rapidity of operational response is paramount.

(16) Conduct studies in compliance with pertinent federal guidelines and regulations.

The Contractor shall have and maintain up‐to‐date knowledge of and experience with all relevant guidelines and regulations for using human beings in research studies, e.g., 45

CFR46 or the DHHS Common Rule, and those regulations for patient confidentiality such as the Health Insurance Portability and Accountability Act of 1966 (HIPAA). Prior to contract award, the Contractor shall also have an up‐to‐date Federal Wide Assurance number issued through the HHS Office of Human Research Protections.

4. What is the feasibility of solutions to accomplish the requirements detailed in the Draft SOW?

Identify any barrier(s) that exist(s). Please include only items that are related to the requirement as described in the Draft SOW documents.

5. Describe your experience in a complex scientific research environment with respect to problem‐ solving and working with various stakeholders, such as Investigators, subcontractors, and community members.

6. Provide up to three examples of projects of similar scope, and complexity to the NIEHS requirement described herein—preferably with the Federal Government. Briefly describe the scope of work, solutions designed/implemented, project management methodology, and best practices/lessons learned. Please be sure to describe any commercial business practices that are unique to your industry (if applicable).

7. Vendors are invited to submit comments on the Draft SOW. The comments should identify any gaps in the SOW including areas requiring clarification, missing or ambiguous requirements, staffing considerations and any other general comments or concerns. Vendors may also provide specific comments and suggestions for refining the SOW to reflect clear guidance to industry and industry best practices, as well as provide additional information that they think is relevant for developing the acquisition strategy for this requirement.

8. Vendors are invited to submit comments on the anticipated NAICS code, period of performance and anticipated contract type.

Standard product brochures will not be considered a sufficient response to this RFI. Any additional comments that are not responsive to a particular RFI requirement/question should be separated labeled as “Additional Comments” and included at the end of the response.

NIEHS reserves the right to use any and all information submitted by, or obtained from, an interested party in any manner NIEHS determines is appropriate including, but not limited to, the creation of a competitive solicitation. An interested party should avoid including any business confidential and/or proprietary information in its response. However, if an interested party must submit such information, the information must be clearly marked accordingly, and the interested party must provide enough justification as to why such information is business confidential and/or proprietary.

NIEHS will review said information and safeguard it appropriately.

4 RESPONSE SUBMISSION INSTRUCTIONS

All capability statements/responses shall be submitted electronically no later than 2:00 p.m. Eastern Time (ET) on December 21, 2023 to Adam Muhsin, Contract Specialist, at the following e‐mail address:

adam.muhsin@nih.gov.

All questions in regard to this notice should be directed to Adam Muhsin at adam.muhsin@nih.gov.

NIEHS personnel may contact firms responding to this RFI to clarify a Responder’s capabilities and other matters as part of this market research process.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to Responders with respect to any information submitted.

THIS IS A REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE (SSN) ONLY to identify sources that can provide the services described herein. The information provided in the RFI/SSN is subject to change and is not binding on the Government.

NIEHS has not made a commitment to procure any of the equipment, commodities, and services listed herein, and release of this RFI/SSN shall not be construed as such a commitment or as authorization to incur cost for which reimbursement would be required or sought. All submissions become Government property and will not be returned.