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This is a Request for Information (RFI)/Sources Sought notice. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regardin... This is a Request for Information (RFI)/Sources Sought notice. This is not a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the interest and capabilities of all qualified sources to provide services for a requirement for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to host, maintain and enhance its online Down Syndrome Patient Registry. As part of its market research, NICHD is issuing this notice to identify qualified vendors, (large and small businesses), capable of providing a hosting environment for development and maintenance of NICHD’s DS-Connect® Down Syndrome Patient Registry. The description of requirements provided on this notice indicates only the currently contemplated possible scope of services and may vary from the work described in the final statement of work (SOW) which will be included in any subsequent Request for Quotation (RFQ). At this time, Vendors are advised not to request a copy of the RFQ. This request is to SEEK SOURCES ONLY and does not constitute a Request for Quotations (RFQ). Please do not provide price quotes as this notice is only for market research purposes. Interested parties can submit a written response of their organization’s capabilities and expertise addressing the requirements specified under “Project Requirements” below. Responses to this Sources Sought are not quotes on which NICHD can issue any awards. Organizations are solely responsible for all expenses associated with responding to this notice. The Government will not pay for information received in response to this notice. There is no commitment by the Government to issue an RFQ, make an award or awards, or to be responsible for any monies expended by organizations in preparing responses to this notice. Project Requirements: The purpose of this request from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH), is to solicit input and feedback from vendors about their capabilities to host and maintain NICHD’s online Down syndrome patient registry. Vendors are requested to provide their capabilities/experience for the following: Non-proprietary software for hosting, maintaining, securing, and enhancing an online patient registry that serves the needs of participants, qualified researchers, and NIH program administrators. Strategies to migrate from a legacy platform to a non-proprietary platform/environment. Ability to fast-track and obtain an Authority to Operate (ATO). Background: NICHD’s Down Syndrome (DS)-Connect® and PregSource® online registries contract will end on August 27, 2023. The Prime contractor, Leidos, Inc., and its subcontractor, Invitae, Inc., through this contract have worked to establish and maintain a cloud-based System of Record (SOR) with Federal Information Security Management Act (FISMA)-moderate level of security controls. They host 2 patient registries that contain personally identifiable information (PII) on that platform. The first registry, DS-Connect®, was launched in September 2013, and it was planned for recompetition in FY2023; the second registry, PregSource®, was launched in September 2017 and will be ending at the end of the current period of performance (August 27, 2023), with a well-defined closeout process in place. There will be no need to continue the PregSource registry once the closeout occurs. Research Data Patient Registry (RDPR) The NICHD awarded a contract in September 2012 to create and maintain an online registry called DS-Connect®: The Down Syndrome Registry, which was subsequently housed in a SOR known as the Research Data Patient Registry (RDPR) that contained PII. This contract was recompeted in 2015 (adding in the creation and maintenance of the PregSource® registry) and again in 2018. The RDPR is currently hosted on the Amazon Web Services (AWS) cloud, and houses two online registries: • DS-Connect®: The Down Syndrome Registry (https://dsconnect.nih.gov/), and • PregSource®: Crowdsourcing to Understand Pregnancy (https://pregsource.nih.gov/). Each participant in these online registries is given a Global Unique Identifier (GUID) generated based on PII elements. This allows information to be combined between data sources or biospecimen repositories by matching to the GUID without revealing PII. DS-Connect®: The Down Syndrome Registry In September 2011, the NIH created the Down Syndrome Consortium to foster communication and idea-sharing among the NIH, individuals with Down syndrome and their families, national organizations interested in Down syndrome, and pediatric and other groups. Under the auspices of the Down Syndrome Consortium, NICHD supported development of a family-focused, web-based registry for individuals with Down syndrome, DS-Connect. DS-Connect facilitates contact and information sharing among families, individuals with Down syndrome, researchers, and parent groups. Down Syndrome Consortium members are involved in outreach efforts to the Down syndrome community to encourage families to sign up for DS-Connect. DS-Connect is composed of a demographic survey as well as an Initial Health Questionnaire that collects baseline information about the health status of the person with Down syndrome, with additional specialty surveys based on their age, sex, and specific medical issues. Participants can compare their survey answers to the aggregate, de-identified responses of other DS-Connect participants, as well as access resources such as healthcare provider lists, Down syndrome-specific growth charts, a medication tracker, and information about Down syndrome clinical trials. The DS-Connect registry, including the consenting process, health surveys, and most of the resources, is available in Spanish for participants for whom this is their primary language. There is also a professional portal for interested members of the Down syndrome community, including investigators, who can set up an account, review the aggregate de-identified data, and request recruitment support for their research projects. NIH registry program administrators facilitate outreach to eligible registry participants on behalf of approved researchers without revealing PII. In this way, DS-Connect® facilitates research opportunities for participants and connects them with researchers trying to recruit for Down syndrome studies, with the control decision to participate always resting with the participant and/or family members. Currently, the Contractor’s Team provides support services, project management, and audit and oversight functions for the FISMA-moderate security controls and working with NIH/NICHD staff, develops, implements, enhances, and maintains the online registries, including related responsive-template websites, all of which are Section 508 compliant in accordance with HHS regulations. DS Connect Registry is implemented using Invitae’s technology and a Joomla software platform. Recently, Invitae made a business decision to focus on a different market and exit the technology that is currently supporting the NICHD registries. It has indicated that it will not be able to participate in any potential recompetition of this current contract. Current specifications of the registry and the RDPR environment include the following application architecture based on a fully redundant system: access requests come through the NIH Domain Name Systems (DNS) and are directed to the redundant load balancers. The load balancers then direct requests to one of the redundant Apache web servers, and the request is processed, and the webpage rendered and presented to the end user via SSL. All PII for participants is stored in an encrypted MySQL database. The primary master database is mirrored in real time with a slave database. The slave database is backed up daily and hourly to the Amazon S3 Cloud Storage server. The users of the system include the following: Participants: Self-advocates and/or family members register and consent to share medical information and demographic data. The types of information collected include demographic information by answering surveys with radio button options and a few open data fields. Participants (account holders) can view their own detailed information as well as de-identified, aggregated data from other participants via charts and graphs available to registered users. Additional resources available to participants include Down syndrome-specific growth charts, age-specific healthcare recommendations, healthcare provider listings, trackers for medications, and information about Down syndrome clinical trials obtained from ClinicalTrials.gov. Currently, there are almost 5800 registered participants in the registry. Registry administrators and NIH program administrators: A select number of users authorized by the System Owner can access identifying participant information to verify data quality and to contact participants who may be qualified for a clinical trial or study. Qualified researchers: Researchers can request access to the de-identified data in the registry and sign up for an account themselves. If they wish to use the registry for recruitment for a research project, they can request assistance through a registry webform. After review and approval by the DS-Connect Research Review Committee, the NIH program administrator sends notices to eligible participants inviting them to participate on behalf of the researcher. PII is never shared directly with the researchers. Currently, there are almost 900 professional accounts registered on DS-Connect. The GUID is a way to streamline the data that will be potentially stored in external databases by associating multiple data records provided by investigators or registries for a single registry member without exposing or transferring the member’s PII. This capability provides two primary benefits. First, it allows data about a member to be accumulated across all registry participants over time, regardless of where and when those data were collected. Secondly, it enables access to ALL the program data without fear of violating the Terms & Conditions for each contributing participant with regard to their PII protections. The registry collects PII from registry members and stores those data in a local database that is not made available outside the managing institution; those data are only available to a limited number of individuals. The local data are used to generate GUIDs. This is made possible by using special software that runs at the registry on a computer managed by the registry. This software performs a one-way encryption, often called a one-way hash, which is sent to the GUIDWS (NDA GUID Service) to determine if the research subject hash codes have been seen in the receiving database before. The encrypted hash codes do not have information to recreate the PII. However, they do have enough information to determine if a registry member GUID already exists in the receiving database. In this way, each registry member retains a unique GUID without revealing PII. The DS-Connect Registry services are critical to support NICHD’s mission as well as for the improvement of the health of thousands of individuals with Down syndrome. It is also a critical component of the NIH-wide INCLUDE (INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE; https://www.nih.gov/include-project) Project, which is working to improve quality of life for people with Down syndrome at all ages and with a variety of co-occurring conditions. The registry has been used to support recruitment and data needs for over 100 projects over the past 9 years. Maintaining continuity of operations without any disruptions is critical to NICHD and to the individuals and family members who rely on this registry for access to research projects. De-identified data from DS-Connect are shared with the INCLUDE Data Coordinating Center data hub (https://includedcc.org) as part of its efforts to collate and share information about Down syndrome cohorts for secondary use by investigators and to design research projects. NICHD is committed to transitioning the current DS-Connect Registry to a non-proprietary environment. The Government intends to issue a solicitation after reviewing Vendors’ capability statements and subsequent identification of vendors who demonstrate potentially viable strategies, platforms, as well as the required expertise and experience in this area. Capability Statement Requirements: Capability statements submitted in response to this Notice should demonstrate the Offerors’ qualifications, expertise and experience, providing specific evidence of their capabilities to perform the work relevant to this requirement. Interested organizations that believe they possess the capabilities necessary to perform the work should submit electronic versions of their capability statements, addressing the needs described under Project Requirements as well as requirements stated below. Documents should be no more than 15 pages and use a font size of 12 points. Responses should also include the following business information: Company Name Company Address Unique Entity ID (UEI) Company Points of Contact, phone, and Email addresses Current GSA Schedule appropriate to this RFI/Sources Sought Notice Type of Company (i.e., large business, non-profit, educational institution, small business, 8(a), woman-owned, veteran owned, etc.), as validated in the System for Award Management (SAM). No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation. Interested Vendors may submit electronic copies of their capability statements via email to the Contracting Officer, Ms. Usha Raman @ ramanu2@mail.nih.gov by 4:00 PM Eastern Time on Wednesday, June 21, 2023. Any questions seeking clarifications related to this RFI/Sources Sought Notice should be sent via email to ramanu2@mail.nih.gov by 4:00 PM Eastern Monday, June 5, 2023. No phone calls will be accepted. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in the response. The Government reserves to 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 perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or to provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published in www.sam.gov or through GSA eBUY. Responses to this notice will not be considered adequate responses to any forthcoming solicitation.