11.23.2024 - SB Sources Sought Notice (EPI).docx

SMALL BUSINESS SOURCES SOUGHT NOTICE (SSN)

Epidemiology Support Services Contract

Agency: NIH/National Institute of Environmental Health Sciences (NIIEHS) Office: Office of Acquisitions (OA) SSN Document #: EPI_RFI-SS_NIEHS_2023 Purpose This announcement constitutes a Small Business 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).

This Small Business Sources Sought (SSN) encourages responses from capable small businesses, 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.

Description

Many Epidemiology Branch studies take advantage of biological and environmental samples to measure biomarkers of exposure, susceptibility, or effect. The research portfolio includes a mix of “big science” and more narrowly defined work. Large multi‐purpose cohorts and multi‐investigator pooling projects and research consortia address health effects of lifestyle and environmental exposures, gene-environment interactions, and genome‐ and epigenome‐wide associations. The portfolio also includes laboratory‐based observational and mechanistic studies. Cohorts developed and followed by the Branch facilitate multi‐disciplinary studies of health effects of environmental exposures and foster collaborations both within NIEHS and with the extramural community. There are five (5) requirement areas under this contract that support the Epidemiology Branch within NIEHS. These requirement areas include program and project management; development of research; management of biospecimens and environmental samples; statistical programming and management of data; and coordination and maintenance of the IT infrastructure. See the attached Draft Statement of Work (SOW; Attachment 1) for additional information. 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.

PLACE OF PERFORMANCE

At Contractor’s Facility

ESTIMATED PERIODS OF PERFORMANCE

The anticipated Period of Performance is ten (10) years with an estimated start date of June 2026. The contract will also include an optional 6‐month extension in accordance with FAR 52.217‐8.

Background 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 to promote healthier lives. NIEHS focuses on basic science, disease‐oriented research, global environmental health, clinical research, and multidisciplinary training for researchers.

The Epidemiology Branch addresses the mission of NIEHS by carrying out research on the effects of the environment on human health. Research conducted by the Epidemiology branch investigators covers a wide range of conditions with potential links to environmental exposures. Studies address health across the lifespan from pregnancy and child development to chronic diseases of aging.

Current Contract This is not a new requirement. The current contract (No. HHSN273201600003I) was awarded in 2016 to Social & Scientific Systems, Inc., now known as DLH Corp, as a R&D Cost Plus Fixed Fee Level of Effort Indefinite Quantity, Indefinite Delivery contract. This award includes a base period, multiple option periods, and an optional 6‐ month extension in accordance with FAR 52.217‐8, for a total contract period of performance of 10.5 years.

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 1000 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)

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) conduct pilot studies, literature reviews, computer searches, or other activities to determine capabilities of collaborating institutions, numbers of eligible study subjects, exposure information for study site selection; convene focus groups when appropriate; prepare, pretest, evaluate and produce data collection forms, including computer assisted telephone questionnaires, web‐based data collection platforms and capabilities, and in‐person questionnaires; ensure adequacy of inclusion of women, minorities, children and other under‐served groups in research projects, where applicable and appropriate;

(2) arrange and provide support for meetings of relevant individuals, collaborators, consultants, etc. to aid in study design, logistics, or analysis; arrange and provide support for monitoring, oversight, or advisory boards for specific studies;

(3) prepare training programs, procedure manuals, manuals of operation, and other required materials for abstractors, interviewers and other study personnel;

(4) provide commercial quality graphics support for field study print materials, study communications with participants, and public websites for recruitment, publicity, and general information dissemination;

(5) arrange, provide support, and prepare materials for IRB submissions and continuing reviews, OMB approvals (if applicable), and Certificates of Confidentiality;

(6) coordinate collection, handling, transport, storage and analysis of biological, clinical, agricultural, industrial, dietary, and environmental samples in field studies; arrange for shipping and delivery of samples to laboratories for analysis or to facilities for long term storage;

(7) assemble death certificates, medical records, industrial hygiene data, geocoding data, dietary/food frequency histories, reproductive histories, occupational histories, environmental monitoring data, etc. and have records evaluated and coded by appropriate nosologists, pathologists, industrial hygienists, clinicians, or other relevant experts and abstractors;

(8) depending on study design, recruit or trace study subjects, locate them, and obtain any necessary consent for interview and performance of relevant industrial or environmental measurements, biologic specimen collection, physical or other examination; conduct determination of vital status, assessment of disease status, exposures, genetic susceptibility or other information collection as necessary for the study;

(9) conduct study protocol training for abstractors, interviewers, coders, phlebotomists and others who will acquire and assemble data; abstract, photocopy, scan or obtain computer‐based (electronic) or paper records (clinical or office medical records, hospital charts, vital records, employment records, etc.);

(10) interview subjects or surrogates using mail, telephone, computer‐assisted, web based or in‐person interviews, evaluating the state‐of‐the‐art for technology dependent techniques where appropriate and cost‐effective, and arrange through licensing or subcontract to use the appropriate technique;

(11) arrange for clinical diagnostic studies, laboratory or other clinical evaluation of subjects, and for industrial, agricultural, dietary, or environmental measurements;

(12) staff and run a local contractor site laboratory for receipt, inventory, processing, aliquoting, bar‐code labelling, shipping, storage of frozen, refrigerated or ambient samples;

(13) staff and run a local contractor site laboratory facility for DNA extraction; identify quality facilities for DNA extraction in large scale studies and for genotyping and other omic" services (e.g. epigenomics, metabolomics, microbiomics);

(14) identify appropriate analysis laboratories, evaluate quality assurance/quality control of ongoing laboratory analyses, establish databases for the results of laboratory analyses, coordinate data processing needs for laboratory results for a wide range of studies;

(15) assist with monitoring the availability, and manage the use of stored biologic samples from previous historical Epidemiology Branch studies;

(16) enter coded information into suitable computer databases integrating quality assurance and quality control of all data collection systems;

(17) design, staff and run a FIPS 1 99 categorization 'Moderate' computing center under appropriate NIST, DHHS/NIH, FISMA, OMB, and IRB guidelines, with state‐of‐the‐art, secure on‐site, off‐site and/or cloud storage where appropriate, secure archival I backup storage and retrieval, software, hardware, high‐speed internet access, staff desktop computers, and technical IT staffing sufficient for management of a system incorporating existing Epidemiology Branch study data files, new studies, data management, freezer monitoring, laboratory inventory, telephone and web‐assisted interviewing, call center(s) and associated technologies, study management systems, archival data storage, analysis programming including genetic/bioinformatics programming, with protections for PII and PHI, and appropriate risk management and risk mitigation systems in place;

(18) design, develop, test, maintain, and host NIEHS EB study websites, adhering to relevant federal government policies and guidance regarding website design and management including but not limited to compliance with Section 508, local NIEHS policies, HHS guidance and standards, OMB guidance, and the Privacy Act;

(19) perform data linkages with National Death Index, vital statistics, cancer registries, Medicare data, and other national registries and databases;

(20) provide reproducible epidemiologic, statistical, genetic, bioinformatics, descriptive and other analyses specified by the EB investigator;

(21) produce publication‐quality graphics, tables, and figures as required for scientific publication of study analyses and findings;

(22) provide records management: document each step of a study and maintain, in an orderly and accessible manner, all relevant material so that any aspect of the study may be reviewed and evaluated by the EB staff with little or no prior notice;

(23) according to study protocols, provide professional communication materials and interactions with study participants, including letters, newsletters, reports of individual and summary results of tests performed, etc.;

(24) develop and maintain study websites for study data collection and transmission with data integrity and protection of personal identifiers;

(25) develop and maintain public, commercial quality study websites for study participants and the public for dissemination of study findings, vignettes, study contact information, study‐related resources, etc.;

(26) maintain staff or identify consultants with expertise in industrial hygiene/occupational exposure coding, medical record abstraction and coding, medication coding, language translation, etc.;

(27) develop and manage subcontracts for any clinical, data management, programming, field study operations, interviewing, laboratory analyses or other specialized procedures or knowledge not possessed by Contractor staff.

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.

SSN Submission Instructions Questions Questions regarding this SSN shall be received no later than Nov. 29th, at 5:00 PM Eastern Standard Time. 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 (Name of CO/CS) at adam.muhsin@nih.gov and shall reference this SSN.

SSN Responses Responses to this SSN shall be received no later than December 9th, at 2:00 PM EST 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.)

Responses shall be submitted electronically via e-mail to Adam Muhsin at adam.muhsin@nih.gov, and shall reference this SSN.

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

SSN Points of Contact

Contract Specialist: Adam Muhsin - adam.muhsin@nih.gov

Contracting Officer: Erica Kitzmiller - erica.kitzmiller@nih.gov 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.

Attachment(s)

· Attachment 1: DRAFT Statement of Work (SOW) 1 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.

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