Amendment 1_CLRS SB Sources Sought Notification.pdf

SMALL BUSINESS SOURCES SOUGHT NOTICE (SSN)

Clinical Research Support Services for National institute of Environmental Health Sciences

Agency: NIH/National Institute of Environmental Health Sciences (NIIEHS)

Office: Office of Acquisitions (OA)

SSN Document #: CLRS_RFI-SS_NIEHS_2023

1 PURPOSE

This announcement constitutes a Sources Sought Notice (SSN) in accordance with FAR Part 15.201(e) – Exchanges with Industry. THIS SSN DOES NOT CONSTITUTE A SOLICITATION (e.g., Invitation for Bids (IFB), Request for Proposal (RFP), Request for Quotation (RFQ), etc.) nor is it to be construed as a commitment by the Government. The information requested may be used as market research for planning purposes and to facilitate decision making (i.e., acquisition strategy determinations, availability of capable small business concerns, etc.). The information submitted will not be disclosed outside the Government. Proprietary information submitted shall be appropriately marked (see SSN Section 6 – Other SSN Administrative Information for additional information relating to Contractor proprietary information).

Despite being a Small Business Sources Sought / SSN, NIEHS does encourage responses from capable businesses of all sizes (i.e., small and large business concerns), to include all the socioeconomic categories.

NOTE: The Government will not be responsible for any costs incurred by interested parties in responding to this SSN (or any possible Government follow-up questions / meetings relating to this SSN).

Not responding to this SSN does not preclude participation in any potential future solicitation.

2 DESCRIPTION

The National Institutes of Health (NIH), National Institute of Environmental Health Sciences (NIEHS) is seeking sources that possess the capability to provide contract support for 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.

The DRAFT Statement of Work (SOW) has been attached for reference purposes and includes additional requirement details.

PLACE OF PERFORMANCE

NIEHS (main building and Clinical Research Unit), NIH Clinical Center (Bethesda, MD), and Contractor facilities.

ESTIMATED PERIODS OF PERFORMANCE

May 2026 – May 2036 with an Optional 6m extension IAW FAR 52.217-8 (May 2036 – Nov 2036)

3 BACKGROUND

3.1 PROGRAM INFORMATION

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).

3.2 CURRENT CONTRACT

Incumbent Contract Number: HHSN273201600002I

Incumbent Contractor: Social & Scientific Systems, Inc

Incumbent Contract Type: Research and Development, Cost-Plus-Fixed-Fee Level-of-Effort

Incumbent Award Value: $100,000,000

Incumbent Contract Acquisition Strategy: Competed, Unrestricted, Indefinite Delivery/Indefinite Quantity (IDIQ)

Incumbent Contract Period of Performance: May 2016 – May 2026

4 INFORMATION REQUESTED

Interested Parties in assisting NIEHS with this market research are requested to submit the following information in the format of a White Paper outlined below. The response should be concise (no more than 20 pages), 11 pt Calibri font, and address only the information requested below. Bulleted lists and summaries are acceptable. (Note: title pages, cover letters, etc., will not count against the total page limit).

Generic capability statements will not be provided to the requirements team for review.

Interested Parties shall provide the following information:

I. COMPANY INFORMATION

a. Company Name

b. CAGE Code

c. Point of Contract Name, Phone Number, and E-mail Address

d. Company Website

e. ALL government contract vehicles under which the Company holds contracts (e.g., GSA Federal Supply Schedule (FSS), NITAAC, OASIS, etc.)

II. BUSINESS SIZE

a. The anticipated NAICS for this effort is 541715 - Research and Development in the

Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology).

The Small Business Administration (SBA) small business size standard for this NAICS code is 1,000 employees.

b. Based on the NAICS 541715, identify your business size as Small or Large.

c. If a small business concern, identify which, if any, of the below small business socio-economic categories are applicable:

Small Disadvantaged Business (SDB

Woman-Owned Small Business (WOSB)

Economically Disadvantaged Woman-Owned Small Business (EDWOSB)

Veteran-Owned Small Business (VOSB)

Service-Disabled Veteran-Owned Small Business (SDVOSB)

HUBZone Small Business (HZ)

d. If your company is an Other Than Small Business (OTSB) concern (i.e., large business), have you partnered or subcontracted with small business concerns to provide the same or similar services as this requirement?

III. CAPABILITIES

a. Generally, describe your company’s capabilities in fulfilling the requirements of the attached draft Statement of Work.

b. Specifically, address the information in subparagraphs i. through iv. below:

i. Concisely describe your company’s ability to perform the work described in the below areas. Include supporting information which demonstrates your company’s knowledge / capability to meet the requirements of the DRAFT SOW tasks. Supporting information shall not reiterate the language of the tasks provided in the DRAFT SOW; rather it shall provide details regarding your company’s knowledge/capability to execute these tasks. NIEHS is not asking for disclosure of specific or detailed innovative solutions; however, specific examples would assist the Government with this SSN.

If your company does not have direct experience, please explain how you would perform tasks utilizing experienced subcontractors, through a proposed contract teaming arrangement (CTA) or hiring qualified personnel.

The specific areas are the following:

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.

15. Staffing might be required full-time, part-time or be intermittent depending on the needs of the CRU and

16. 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).

17. 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.

18. 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.

ii. Has your company performed work of the same or similar scope as this requirement within the last three (3) years? Please explain.

For any contracts or projects for the same or similar work performed by your company within the last three (3) years, please provide the following information relating (no more than three (3) examples; government or commercial contracts):

• Brief Description of the Contract/Project

• Contract Number

• Period of Performance

• Contract Type(s) (e.g., FFP, T&M, Labor-Hour (LH), etc.)

• Commercial or Non-Commercial Requirement?

• Was your company a prime or subcontractor?

• Contract/Project Dollar Value

• Scope of the portion of the effort your company supported

iii. Provide additional relevant experience/ information that demonstrate your company’s capabilities.

5 SSN SUBMISSION INSTRUCTIONS

5.1 QUESTIONS

Questions regarding this SSN shall be received no later than 2:00 PM Eastern Standard Time (EST) on 2 December 2024. Questions received by the due date/time will be answered and provided to all respondents in the form of an SSN Amendment. Questions received after the due date/time may not be answered.

Questions shall be submitted in writing via e-mail to Megan Bang at megan.bang@nih.gov, and shall reference this SSN.

5.2 SSN RESPONSES

Responses to this SSN shall be received no later than 4:00 PM EST on 9 December 2024 as identified the SSN’s online SAM.gov (formerly FBO) posting. (If there is a difference in SSN response date/time between this document and the online posting, the online posting shall take precedence.)

mailto:megan.bang@nih.gov

Responses shall be submitted electronically via e-mail to Megan Bang at megan.bang@nih.gov, and shall reference this SSN.

All SSN responses will be reviewed and utilized for market research.

5.3 SSN POINTS OF CONTACT

Contract Specialist: Megan Bang

Contracting Officer: Erica Kitzmiller

6 OTHER SSN ADMINISTRATIVE INFORMATION

All information received in response to this notice that is marked “Proprietary” will be handled accordingly. The Government reserves the right to use any non-proprietary information submitted by, or obtained from, a Respondent in any manner NIEHS determines is appropriate including, but not limited to, the creation of a competitive solicitation. Any proprietary data that is included in the response must be marked appropriately at the paragraph level (or at a more granular level as required; page level is acceptable for full page table, graphs, etc.). Any response marked proprietary at the document level will not be considered.

NIEHS personnel may contact any company responding to this SSN to clarify its capabilities/product/ other matters as part of its market research.

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. Responses to this notice will not be returned.

7 ATTACHMENT(S)

• Attachment 1: DRAFT Statement of Work (SOW)

8 FAR PROVISIONS

The following provision is applicable to this notice and is hereby incorporated by reference:

FAR 52.215-3: Request for Information or Solicitation for Planning Purposes (Oct 1997).

The full text of this provision is available at: https://www.acquisition.gov/far/52.215-3.

mailto:megan.bang@nih.gov https://www.acquisition.gov/far/52.215-3