Sources Sought PCA-NIEHS-00080.docx

Hospital and Laboratory Support Division Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM)

Title: DNA Sequencing Service

Sources Sought

Sources Sought No. PCA-NIEHS-00080

SYNOPSIS

General Information

Contracting Office Address

National Institutes of Health (NIH), Office of the Director (OD) Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM) Hospital and Laboratory Support Division 6701 Rockledge Drive Bethesda, MD 20892

Description This is a notice issued on behalf of the National Institutes of Health (NIH), Office of Acquisitions, OA Office of the Director, OD, DHHS, UNITED STATES. This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this Sources Sought is to seek the availability and capability of small business concerns, including 8(a) small business and/or small qualified small business concerns [including Small Disadvantaged Businesses (SDB), Woman-owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone) Small Businesses, Veteran-Owned Small Businesses (VOSB) and Service-Disabled Veteran-owned Small Businesses (SDVOSB] that are interested in and capable of performing the work described in the statement of work. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

GENERAL INFORMATION

Title: DNA Sequencing Service

1. Background

The National Institute of Environmental Health Sciences (NIEHS), located in Research Triangle Park (RTP), North Carolina, is seeking small businesses with the ability to provide a reliable, rapid, high-quality, and cost-effective contract for DNA sequencing services and associated support on an indefinite-delivery indefinite-quantity (IDIQ) basis. The period of performance for this requirement shall be five years from the effective date of award.

The NIEHS is one of the Institutes and Centers of the National Institutes of Health (NIH). The mission of NIEHS is to research how the environment affects biological systems across the lifespan and to translate this knowledge to reduce disease and promote human health. In support of this mission, NIEHS seeks to establish a reliable, rapid, high-quality, and cost-effective contract for DNA sequencing services to support investigators within the NIEHS Intramural Research Program and associated support on an indefinite-delivery indefinite-quantity (IDIQ) basis. Sequencing data generated under this contract will support research into the relationships among environmental exposures, biological systems, genetics, and disease, thereby advancing efforts to prevent disease and improve human health.

The Contractor shall provide DNA sequencing services for individual samples and associated technical and bioinformatics support as specified in this Statement of Work (SOW). Samples are expected to include, but are not limited to, yeast colonies, plasmid DNA, and PCR-generated samples from species including human and rodent, as well as recombinant DNA isolated from tissue sources and cell lines. Sanger sequencing will be the primary sequencing method required under this contract. A smaller number of plasmid DNA samples will require high-throughput whole-plasmid sequencing. The Contractor shall also provide sample receipt and tracking, appropriate storage and preservation, sequencing quality control, and secure delivery of sequencing results. The Government will provide information necessary for the Contractor to perform the requested sequencing services. Except for Contractor-provided processing, quality control, assembly, annotation, assay development, and other analyses expressly required by this SOW, scientific interpretation and downstream analysis of sequencing data shall be performed by NIEHS.

For purposes of this SOW, the term “user” means an authorized Government user, including an NIEHS investigator, the Contracting Officer’s Representative (COR), or other Government personnel authorized to use the contract.

2. Requirements/Specifications Independently and not as an agent of the Federal Government, the Contractor shall provide all qualified personnel, supervision, services, materials, supplies, equipment, software, facilities, transportation, and other resources necessary to perform the work described in this SOW, except for items expressly identified as Government-furnished. The Contractor shall maintain sufficient personnel, instrumentation, laboratory capacity, and operational capability throughout the period of performance to perform the work set forth below:

1. The Contractor shall have sufficient capacity to perform high-throughput Sanger DNA sequencing and whole-plasmid sequencing using appropriate automated laboratory processes and sample barcode or equivalent electronic tracking. The estimated average workload is approximately 2,000 to 3,000 samples per month. Actual quantities may vary according to the scientific requirements of NIEHS investigators. The Contractor shall maintain sufficient operational capacity to accommodate reasonable fluctuations in sample volume without materially affecting the turnaround-time requirements specified in this SOW.

2. The Contractor shall accept, as applicable to the requested service, user-provided agar plates containing yeast colonies, 96-well plates, or PCR strip tubes containing PCR-amplifiable material, which may be genomic DNA or plasmid DNA.

When PCR amplification is required prior to cycle sequencing, the requirement shall be specified by the user at the time of sample submission for each applicable sample. The Contractor shall perform the required PCR amplification and verify successful amplification by gel electrophoresis. Successful PCR amplification shall produce a single DNA band of the expected size. The Contractor shall perform PCR product purification when required or requested by the user prior to sequencing.

Samples requiring PCR amplification to produce the DNA template for sequencing may require additional processing time in accordance with the turnaround-time requirements of this SOW. The Contractor shall not be required to isolate genomic DNA from cells or tissues.

3. The Contractor shall normalize DNA templates for PCR amplification and/or sequencing when requested by the user.

4. The Contractor shall perform high-throughput Sanger DNA sequencing using appropriate automated sequencing instrumentation, sample tracking, quality-control procedures, and laboratory practices. Successful sequencing shall provide sequence coverage of the user-specified region for PCR products and plasmid DNA. Within the reportable region, sequencing quality shall meet a Phred-equivalent quality score greater than 20.

The Contractor shall maintain objective quality-control procedures sufficient to determine the cause of an unsuccessful sequencing result, including:

Contractor instrumentation or technical failure;

sequencing reaction failure;

PCR or template-generation failure;

inadequate or unsuitable sample material;

primer-related issues; or another documented cause.

Samples that fail to produce acceptable data because of capillary failure, instrument failure, sequencing reaction failure attributable to the Contractor, or another Contractor technical problem shall be repeated promptly at no additional cost to the Government.

5. The Contractor shall provide high-throughput whole-plasmid sequencing when requested by the user. The Contractor shall use sequencing and assembly methods appropriate for determining the complete plasmid sequence. Whole-plasmid sequencing deliverables shall include:

raw sequencing data in FASTQ format;

sequencing quality-control report;

consensus plasmid assembly; and annotation file(s).

The Contractor shall provide sufficient quality-control information to allow the user to evaluate the quality and completeness of the consensus plasmid sequence. If a complete and reliable consensus plasmid sequence cannot be generated, the Contractor shall notify the user and the COR and provide the reason for the limitation.

6. The Contractor shall provide personnel with appropriate education, training, and experience to perform primer design for new sequencing projects.

7. When requested by the user, the Contractor shall develop or optimize the necessary assays to determine the requested DNA sequence. Services may include:

primer design;

PCR optimization;

sequencing reaction optimization; and other technical optimization necessary to perform the requested sequencing.

The Government will provide applicable DNA reference sequences or accession numbers when necessary. The Government retains all rights to use assays developed in performance of this requirement. Upon written request from an authorized user or the COR, the Contractor shall provide technical information regarding the developed assay within 24 hours of receipt of the request, including, as applicable:

reagent formulations used in the assay;

instrumentation type;

relevant instrument settings;

relevant instrument calibrations;

primer sequences; and other technical information necessary to reproduce or evaluate the assay.

8. At the time of sample submission, the user shall provide the applicable plate key, tube label information, sample name, sample identifier, requested sequencing service, and other information necessary to process the sample. Multiple sequencing reactions or sequencing runs may be requested for an individual template when specified by the user.

9. The Contractor shall provide all necessary sample collection and shipping materials and associated instructions required for submission of samples under this contract, including, but not limited to:

· appropriate sample collection plates or vials;

· instructions for appropriate storage conditions prior to shipment;

· appropriate prepaid shipping containers and materials; and

· sample shipment tracking information.

10. The Contractor shall provide a reliable method for transporting samples between the NIEHS campus and the Contractor’s laboratory or facility. Transportation may include an in-house courier, contracted courier, FedEx, UPS, or another method acceptable under the contract. Routine sample pickup shall be available on Government business days from the NIEHS main campus at:

111 T.W. Alexander Drive Research Triangle Park, NC 27709 The Contractor shall coordinate routine pickup procedures and applicable cutoff times with the COR.

11. The Contractor shall provide and maintain a web-based ordering system that enables authorized Government users to efficiently order sequencing services and communicate with the Contractor. The system shall support, as applicable:

· sequencing service requests;

· submission of sample and plate information;

· sample/order identification;

· order-status tracking;

· communication regarding sample or sequencing issues;

· access to completed sequencing results; and

· retrieval of information necessary to administer sequencing orders.

The Contractor shall provide appropriate training and instructions to Government users regarding sample submission, use of the ordering system, and retrieval of sequencing data.

12. The Contractor shall deliver sequencing data to the Government user via the Internet or by email as attachments and shall deliver all data to the COR using a data transfer solution provided by the Government that meets the Government’s requirements for throughput, security, integrity, and reliability. For Sanger sequencing, data deliverables shall include .ab1, .seq, and qscrl files. Data deliverables for whole-plasmid sequencing shall include the files specified in Requirement 5 of this SOW. Electronic sequencing deliverables shall be generated in standard file formats that can be processed using Government-supported computing environments, as specified by the COR.

The Contractor shall deliver sequencing results within the following timeframes:

· within two (2) Government business days after receipt of plasmid DNA or PCR amplicon samples;

· within five (5) Government business days after receipt of genomic DNA requiring PCR amplification to generate the DNA template for sequencing.

Turnaround time shall begin upon receipt of the samples at the Contractor’s facility. The Contractor shall notify the user and the COR of receipt of samples on the same Government business day the samples are received.

13. Except as expressly authorized in writing by the COR or otherwise permitted by the contract, the Contractor shall maintain the confidentiality of sequencing data and associated information generated under this contract.

The Contractor shall not publish, disclose, distribute, reuse, analyze for unrelated purposes, or otherwise use sequencing data or results generated under this contract except as necessary to perform the requirements of the contract.

The Contractor shall have no access to, and shall not attempt to obtain access to, personal identifiers or other identifying information associated with human samples provided under this contract.

14. The Contractor shall maintain appropriate backup and protection of essential contract data, including:

· DNA sequencing data;

· sample tracking information;

· sample storage information;

· sequencing quality-control information; and

· other records necessary to support performance of the sequencing services.

The Contractor shall protect such information against unauthorized access, loss, corruption, or inappropriate disclosure in accordance with applicable contract requirements.

15. The Contractor shall provide a Monthly Status Report to the COR within five (5) Government business days after the end of each billing cycle.

The report shall summarize, at a minimum:

· total sequencing activity and number of samples sequenced;

· number of samples requiring PCR amplification;

· number of samples requiring PCR product purification;

· number of samples requiring modified sequencing protocols and the type of modification;

· number of samples requiring DNA normalization;

· number of assays developed;

· sequencing success and failure rates; and

· Contractor-attributable repeat rate.

The Government may provide a standard reporting template for use by the Contractor.

16. The Contractor shall submit invoices to the COR and Contracting Officer within ten (10) Government business days after the end of each billing cycle and in accordance with invoicing instructions contained elsewhere in the contract. When invoice revisions are requested, the Contractor shall submit a corrected invoice to the COR and Contracting Officer within two (2) Government business days after notification of the required revision.

17. The Contractor shall comply with applicable Section 508 accessibility requirements under the Rehabilitation Act of 1973 (29 U.S.C. 794d) for Information and Communication Technology and electronic deliverables required under this contract. Human-readable final electronic reports and other applicable electronic deliverables shall meet applicable Section 508 accessibility requirements. Data files intended primarily for machine processing rather than human reading shall be handled in accordance with applicable Section 508 requirements and the terms of the contract.

18. The Contractor shall notify the COR of significant concerns, barriers, outages, delays, or other circumstances that could adversely affect contract performance within 24 hours after identification.

For significant performance issues, the Contractor shall provide an initial assessment and proposed corrective action within 24 hours after notification or COR contact. The Contractor shall implement corrective actions as promptly as practicable and shall keep the COR informed of the status until the issue has been resolved.

The Contractor shall respond to requests for contract-performance information and to COR comments or questions within 24 hours unless the COR authorizes a different response period.

19. The Contractor shall appropriately preserve and store remaining DNA samples following completion of sequencing. Unless otherwise directed or approved by the COR, the Contractor shall retain remaining DNA for at least 180 days after completion of the applicable sequencing service. After the retention period, the Contractor shall return or destroy the remaining DNA as directed by the COR. Remaining unused primers, including primers produced or synthesized by the Contractor in performance of this contract, shall be returned to the COR for long-term storage. The Contractor shall maintain records documenting the disposition of DNA samples and primers.

Period of Performance: The anticipated period of performance for this requirement is January 01, 2027 – December 31, 2031. The first year will serve as the base year plus 4 additional ordering or pricing periods for a total period of performance of 5 years. This IDIQ will cover:

1. one base year (01/01/2027 – 12/31/2027),

2. option year 1 (01/01/2028 – 12/31/2028),

3. option year 2 (01/01/2029 – 12/31/2029),

4. option year 3 (01/01/2030 – 12/31/2030), and

5. option year 4 (01/01/2031 – 12/31/2031). In the event an extension is needed, in accordance with FAR 52.217-8 Option to Extend Services, the contract may be extended to an additional six months.

Delivery Location:

NIH/NIEHS

111 TW Alexander Drive Research Triangle Park, NC 27709

Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. The capability statement should include 1)Name and address of the vendor, 2) Size and type of business, 3) Point of contact with the name, title, phone, fax, and email, 4) UEI number, 5) the professional qualifications of experts, and technical personnel as it relates to the above outlined requirements, any other information considered relevant to this service. The capability statement must not exceed 7 pages. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. When submitting this information, please reference the solicitation notice number. Responses to this requirement must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as stated in this notice.

Point of Contact:

Luz Casey, Contract Specialist, Office of the Director, OD, Luz.Casey@nih.gov.

Department of Health and Human Services, National Institutes of Health, Office of Acquisition, Office of the Director, 6701 Rockledge Dr., Bethesda, MD 20892, USA

Submission Instructions:

Interested parties shall submit capability statements via email to Ms. Luz Casey, Contract Specialist, at Luz.Casey@nih.gov and must reference solicitation number PCA-NIEHS-00080 on all emails for this notice. Due Thursday, November 12, 2026 @ 8:00 a.m. EST. All responses must be received by the specified due date and time in order to be considered. Fax responses will not be accepted.

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 provide the item. 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. However, responses to this notice will not be considered adequate responses to a solicitation.

Responses must also include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”

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