EPI Sources Sought Notice.pdf

SOURCES SOUGHT/REQUEST FOR INFORMATION (RFI):

Epidemiology Support Services Contract

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 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.

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.

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 June 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 cost of the contract is anticipated to cost no more than $115,000,000.00, including options, depending on the needs of NIEHS.

It is estimated that the total level of effort required is approximately 114,000 direct labor hours per year.

The NIEHS seeks epidemiological, scientific, technical, data management, managerial, clerical, and statistical support to Principal Investigators (PIs) within the Epidemiology Branch, Division of Intramural

Research, NIEHS. The Contractor shall assist the Government by identifying and enrolling subjects, and administering, managing, and conducting epidemiological studies designed and conducted by

Epidemiology Branch PIs alone or in collaboration with other scientists inside or outside of the NIEHS.

The contractor shall function in a purely supportive role carrying out specific tasks as described in task orders, and shall not engage in independent research. The Contractor shall provide field research support for a range of studies in varied settings. The contractor shall provide oversight for sample collection, processing, and storage, assist in the management of a large biorepository, facilitate collaborative studies and data sharing, provide data management services, support or carry out data analysis, provide statistical support, coordinate or carry out a variety of laboratory assays, and arrange for a wide range of professional consultations as required to carry out specific task orders.

Epidemiology Branch studies are carried out throughout the US and in international settings. The

Contractor will be expected to provide oversight for projects in remote locations, conducting site visits as needed and maintaining close contact with research partners throughout the world. Access to bilingual staff may be required, depending on the specific research portfolio at any given time. On occasion, the Epidemiology Branch is required to respond to national disasters or other public health issues on short notice. Thus the contractor must have the resources to begin work on short notice. The workload is variable and the Contractor must have the ability to scale up or contract as required to meet needs that change over time and with the stage of ongoing research. Experience and expertise working with diverse and challenging populations is required as is experience working with community groups and awareness of best practices for sharing research results with community groups and study participants. Success in and knowledge of best practices for recruiting diverse populations and maintaining high retention rates in long‐term studies are mandatory.

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 in the following areas:

(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.

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, Scientific Collaborators, Institutional Review Boards, 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.

3 RESPONSE SUBMISSION INSTRUCTIONS

All capability statements/responses shall be submitted electronically no later than 2:00 p.m. Eastern Time (ET) on December 21st, 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.