Research Support Services for the Genetic and Rare Diseases (GARD) Information Center and Its Inter-Related Initiatives

THIS REQUEST FOR INFORMATION (RFI) IS NOT A REQUEST FOR PROPOSAL (RFP) OR AN OBLIGATION ON THE PART OF THE FEDERAL GOVERNMENT AND THE NIH. THE GOVERNMENT DOES NOT INTEND TO AWARD A CONTRACT BASED ON THIS RFI OR TO OTHERWISE PAY FOR THE INFORMATION SOLICITED. Key Date: All responses must be received on or before 10:00 a.m., Eastern Standard Time, February 14, 2019. This posting will remain open until further notice. Future deadlines to submit questions and comments may be added via an amendment to this posting. Issued By: National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), Office of Rare Diseases Research (ORDR) Purpose: This RFI is for market research only to formulate a procurement strategy to obtain research support services. NCATS wishes to continue operation of the Genetics and Rare Disease (GARD) information center and its inter-related initiatives including the provision of a variety of additional research-support services. The support services include providing the day-to-day management of GARD and its inter-related initiatives to include the NCATS Toolkit for Patient-Focused Therapy Development Project, the NCATS Rare Diseases Registry (RaDaR) Program, NIH-sponsored or co-sponsored scientific gatherings focusing on NCATS rare diseases initiatives, and other initiatives that will evolve as part of this requirement. Background: NIH is the nation's leading medical research agency and the primary federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability by supporting and making medical discoveries. NCATS is the only center at the NIH that focuses exclusively on all aspects of the translation of research with an innovative pipeline of treatment discoveries for all diseases. NCATS brings together a diverse group of scientists to translate basic science conducted elsewhere into products and services that help improve people's health and lives. NCATS' mission is to improve health through smarter science that results in better treatments faster for all diseases, rare or common. For the last 16 years, ORDR, a part of NCATS, jointly with the National Human Genome Research Institute (NHGRI), has funded the GARD information program. The program is meant to foster the generation and maintenance of information for and about research on rare diseases, and to stimulate vibrant partnerships with patient groups and other constituencies in the rare disease community. Currently, there are about 7,000 known rare diseases that affect people in the United States, yet only a few hundred (less than five percent) have a treatment, and even fewer a cure. A disease is characterized as rare when it affects fewer than 200,000 people. While developing treatments for any complex, chronic and severe disease is challenging, developing treatments for rare diseases presents additional difficulties and has many barriers in the translational development process aimed at treatments. To this day, accurate, comprehensive, timely, and easy to understand information about a rare disease is difficult to find and is hardly ever available in any one place. It is for these reasons that NCATS supports the GARD information program. ORDR acts as a convener to bring together the rare diseases community to develop a tools collection such as the NCATS Toolkit for Patient-focused Therapy Development ("Toolkit Project") and the NCATS RaDaR Program. The Toolkit Project brings together, on the GARD website, information on the process of developing a high-quality research program and data collections; and helps shepherd more efficiently and successfully projects through the treatment development process. The research support services for GARD include: - Developing, implementing, and maintaining an effective project planning and management process for the operation of the GARD information center and backside parts of the website including the portals for the Toolkit and link to RaDaR to ensure quality performance; - Maintaining an electronic inquiry tracking system to record and track all inquiries and responding to all inquiries, whether they are hand-written and mailed, e-mailed, sent via social media, by telephone or received directly or assigned to GARD by NCATS; - Updating the NCATS/GARD website: https://rarediseases.info.nih.gov/; - Providing support for scientific or otherwise rare diseases-related workshops, meetings, and relatively informal, small gatherings of experts at the National Institutes of Health, the Washington metropolitan area and outside of the Washington metro area including internationally. - Providing design, illustration, and typography, layout, production, printing and duplication services upon request by NCATS; - Conducting communications research in English or Spanish to better define GARD's priority audiences, determine their information needs, and determine effective strategies and channels for communicating with these audiences; - Supporting a comprehensive coordinated approach for NCATS to assist constituents of the rare disease community including researchers with information about standards to establish patient registries that are feasible, sustainable, and result in high quality data to advance clinical research and therapy development; - Assisting NCATS in bringing together members from multiple parts of the rare diseases research community, including researchers, patient groups, private sector and Federal entities and standards development organizations to harmonize and operationalize existing standards, and to develop guidance on registry design and conduct; and - Providing support for the identification and improvement of standards for use in the construction of registries for rare diseases, and development of guidance for how to design and conduct registries likely to yield interpretable data. Information Requested: This RFI seeks to obtain public comments regarding future contracts. NIH seeks comments on any or all-of, but not limited to, the following topics: - The availability and capability of any sources qualified to perform the research support services for GARD described above; - The availability and capability of qualified small business sources, including HUBzone small businesses, woman-owned small businesses, veteran-owned small businesses, service-disabled, veteran-owned small businesses, 8(a) small businesses, or small disadvantaged businesses; - DUNS number, organization name, address, point of contact, and size and type of business (e.g. 8(a), HUBZone, Small Business, etc.); - Description of organization, including information on staff expertise, availability, and experience; - Description of similar projects completed for both commercial and Government entities; - Suggested NAICS code and Product Service Code; - Preferred contract type (i.e. Fixed Price, Cost-Reimbursement, etc.-see FAR Part 16 for a complete list of contract types); - Suggested formats (tables, matrices, etc.) to provide information regarding scientific, and technical key personnel; - Suggested timeframe, milestones, and activities for transitioning into providing services; - Brief description of any procedures to manage conflict of interest issues, whether personal or organizational, and timeframe to complete conflict of interest checks; and - Additional services, skill sets, or feedback that may complement tasks not described above. Question/Answer Period: Interested parties are encouraged to submit questions for clarification, correction, or additional information on the RFI. Written questions should be submitted in writing via email to Mark McNally at mcnallyme@mail.nih.gov and Jeffrey Schmidt at schmidtjr@mail.nih.gov. The subject line should reference Federal Business Opportunities (FBO) notice number 75N95019R00031. All questions must be received on or before 10:00 a.m. February 11, 2019. A set of all questions and answers will be furnished simultaneously thereafter as an amendment to this announcement. Response Format: One copy of the response is required and must be in Microsoft Word or Adobe PDF format and using 11-point or 12-point font. The response is limited to ten pages. The ten-page limit does not include any applicable executive summary or references. Response Submission and Due Date: All responses to this notice must be submitted electronically to: Contract Specialist, Mark McNally, at mcnallyme@mail.nih.gov Contracting Officer, Jeffrey Schmidt, at schmidtjr@mail.nih.gov Responses must be received on or before 10:00 a.m., Eastern Standard Time, February 14, 2019. The subject line should reference Federal Business Opportunities (FBO) notice number 75N95019R00031. Disclaimer and Important Notices: This RFI is not an RFP or an obligation on the part of the Federal Government and the NIH. The Government does not intend to award a contract based on this RFI or to otherwise pay for the information solicited. All exchanges between the Government and outside entities including responses to this RFI, may guide the NIH in drafting future contracts at an undetermined time. There is no solicitation available at this time; no basis for claims against NIH shall arise as a result of this RFI, responses thereto, or the NIH's use of such information as either part of its evaluation process or in developing specifications for any subsequent requirement. Responses to this RFI are voluntary. This RFI is for planning purposes only and should not be construed as a solicitation for applications or an obligation on the part of the Federal Government, the National Institutes of Health, or individual NIH Institutes or Centers. The Government will not pay for the preparation of any information submitted or for the Government's use of that information. The information provided will not be considered confidential. The NIH will use the information submitted in response to this RFI at its discretion; the submitted information will be reviewed by the NIH and shared with the NIH Institutes and Centers that have an interest in this matter. 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(s), policies or procedures; responses to the RFI may be reflected in future funding opportunity announcements. Any solicitation resulting from the analysis of information obtained from this notice will be announced to the public in Federal Business Opportunities, at FBO.gov, in accordance with the FAR Part 5. However, responses to this notice will not be considered adequate responses to any resulting solicitation.