RFQ 75N98B25Q00002 - DNAFeed Genetic Counseling Service (Sole Source).pdf

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Eye Institute, 31 Center Dr MSC 2510, Bethesda MD 20892-2510

Description:

1. This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and solicitation for commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested.

The Solicitation number is 75N98B25Q00002 and the solicitation is issued as a Request for Quotes (RFQ).

2. This acquisition will be awarded under FAR Part 13 Simplified Acquisition Procedures

(SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-04 January 19, 2021.

3. The North American Industry Classification System (NAICS) code for this procurement is

541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), with a small business size standard of 1,000 employees. The requirement is being competed as a total small business set-aside.

4. The National Eye Institute (NEI) has a requirement for a DNAFeed Genetic Counseling

Service (Sole Source). The vendor shall perform the following tasks as specified below.

Task 1. Provide Licensed Genetic Counseling Services

• Timely availability of licensed genetic counseling services in all 50 states, including pre- and post-test counseling. Counseling must include:

o Family history o Explanation of risks and benefits of genetic testing, including implications for family members o Summary letter to participant o Phone call/video call with participant that allows adequate time for counseling and all participant questions o Documentation of participant interaction

Task 2. Platform hosting and maintenance – The platform license is inclusive of platform hosting and maintenance as follows:

• Management of the solution, to include all necessary software and hardware maintenance

• Compliance with applicable standards, regulations and guidelines including those applicable to the federal government

• System training and platform user guides

• End user, site, and administration support

Task 3. Professional Service - Professional services in support of platform management, distribution and management, content management and reporting. Professional Service are to be billed as time and materials. Platform Support Package includes:

• Copyright and Creative Support

• Language translations

• Managed Services

• Solution Enhancements

• Training

Task 4. System Requirements - The list of requirements for the application functionality are as follows:

• 21 CFR Part 11 compliance

• WCAG 2/508 compliance

• Compatible with screen reading software (i.e. JAWS, ZoomText)

• On-demand access to participant status and download for Customer

• Participant structured data bulk download

• Long-term participant access to genetic counseling report

• Customer access to Participant interface for demo use and system testing

• Ensures appropriate government encryption, security, etc. for both archive and retrieval.

• Participant requirements for personal details to confirm their identity.

• The application will include a ‘More Information’ link which will direct users to eyegene.nih.gov in a new browser tab.

• The application will specify to contact program administration with any questions throughout. The application and all subsequent pages on the website will include contact info and links for the NIH Terms of Services, Privacy Policy, and Antispam Policy.

Search functionality by participant name minimally. Preferred search function to include status (complete, incomplete, not started).

5. Description:

Background:

The ability to detect disease-causing variants in individuals with inherited ophthalmic diseases offers several benefits for patients and their families. When eyeGENE® began in 2007, this type of molecular testing was not widely available. The eyeGENE® program helped overcome the challenge of providing genetic information to individuals who want to know the molecular basis for their condition, the chance of recurrence, and whether they could benefit from the treatments that were being developed. Clinical genetic testing has now become more readily available, and technologies have advanced to broaden testing and decrease costs.

Techniques such as whole exome sequencing (WES) or whole genome sequencing (WGS) allow researchers to look at thousands of genes. This new way of testing increases the chances of finding the genetic cause of an individual’s eye condition; however, it may also detect genetic changes related to other medical conditions distinct from the eye condition.

Pre- and post- genetic test counseling is a part of standard healthcare. Since the eyeGENE® research program is offering clinical genetic testing, the program is obligated to provide genetic counseling per the NIH IRB Guidance for the Return of Secondary Genomic Findings.

https://ohsrp.nih.gov/confluence/display/ohsrp/Genetic+and+Genomic+Research

General Requirements:

a. Only quotes for the DNAFeed Genetic Counseling Service (Sole Source) are being solicited and will be considered.

b. Vendors must provide their shipping lead time and any applicable delivery costs on their quote.

6. Provision 52.252-1 Solicitation Provisions Incorporated by Reference (Feb 1998)

This RFQ incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a solicitation provision may be accessed electronically at this address: www.acquisition.gov/far

7. Provision 52.212-1 Instructions to Offerors – Commercial Items (Nov 2021) is incorporated by reference.

8. Provision 52.212-2 Evaluation – Commercial Items (Nov 2021) is incorporated by reference.

The provision 52.212-2 incorporated above is completed as follows. Quotes received in response to this RFQ will be evaluated using the lowest-priced-technically-acceptable (LPTA) methodology. To be determined “Technically Acceptable” the offeror must provide the item listed under item 5. above.

9. Provision 52.212-3, Offeror Representations and Certifications – Commercial Items (Nov 2021) applies to this acquisition.

10. Clause at 52.212-4, Contract Terms and Conditions—Commercial Items (Nov 2021), applies to this acquisition and no addenda to the clause are included.

11. Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Jan 2022), applies to this acquisition.

12. Clause at 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) https://ohsrp.nih.gov/confluence/display/ohsrp/Genetic+and+Genomic+Research

13. HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

14. Questions are due no later than 3:00 p.m. EST on Tuesday, September 23, 2025. Send questions via email to Alexander Beraud, alexander.beraud@nih.gov.

15. Quotes are due no later than 12:00 p.m. EST on Wednesday, September 24, 2025. Send quotes via email in pdf format to Alexander Beraud, alexander.beraud@nih.gov.

Period of Performance: 09/26/2025 – 09/25/2026.

Place of Performance: 10 Center Dr, Bethesda, MD, 20892, United States. FOB: Destination

By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov).

Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax.