Development of Common Data Elements (CDEs) and Website Improvement under NINDS Center for Clinical Research Resources contract # HHSN271201700064C

THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO ADD ADDITIONAL HOURS AND FUNDING ON A SOLE-SOURCE BASIS FOR IN-SCOPE WORK ON AN ACTIVE CONTRACT WITH THE EMMES COMPANY, LLC. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. The NINDS Contracts Management Section of the National Institute on Drug Abuse (NIDA), intends to solicit on a sole-source basis to The Emmes Company, LLC to revise the Mitochondrial Diseases Common Data Elements (CDEs), perform NINDS CDE Website Improvements, and add level of effort hours to complete remaining in-scope activities under Option 2 expiring under Emmes Contract #HHSN271201700064C on 9/29/2020. Level of Effort was impacted due to covid-19 which caused certain tasks within the Statement of Work to incur more effort than originally anticipated and budgeted for. Current Statement of Work: The Scope of the Statement of Work of the subject contract indicates that - The contractor shall, in collaboration with the NINDS COR, oversee the maintenance and updating of the current CDE library, and maintain and updating any new diseases added to the library during the period of the contract. Additional Work: Accurate data collection is essential to maintaining the integrity of research. Both the selection of appropriate data collection instruments and clearly delineated instructions for their correct use reduce the likelihood of errors. Common Data Elements were developed to harmonize data collection across studies to ensure data integrity and data quality. These CDEs are used trans- NIH and many ICs encourage its use in their grants. NINDS is one of the NIH pioneers in developing CDEs and has experience managing a CDE project with CDEs in over 20 neurological diseases. Research in mitochondrial disorders has benefitted substantially from contributions by the North American Mitochondrial Diseases Consortium (NAMDC), supported by NINDS, NCATS, and the Office of Dietary Supplements via the NCATS-administered RDCRN. Specifically, NAMDC has provided key natural history and some genetic data that can be used in clinical trials. This information was not available when the mitochondrial disorder CDEs were first released back in 2015. The latest version of NAMDC includes at least one pilot clinical trial. All mitochondrial disorders would benefit from a revision of the CDEs. These are typically multisystemic disorders but many involve the central and peripheral nervous systems and muscle. Finally, NIH (NICHD, NINDS, NIGMS) has received two letters from the Senate and House specifically requesting an update of the Mitochondria CDEs. The NINDS CDE website was migrated to a new platform in 2019. However, the migration did not include improvements to the content and search features. One of the main goals of the website is to allow users to have a friendly environment in which they are able to easily locate the CDEs and Case Report Forms they need for their research studies. The current website search feature is not user-friendly and it needs some improvements. The EMMES Corporation is the only source capable of providing the aforementioned support activities without unacceptable delays and duplication of costs as they are the current Contractor charged with developing, updating and maintaining the NINDS CDEs. The main goal of this acquisition is to revise the Mitochondrial Diseases Common Data Elements (CDEs) and improvements to the NINDS CDE website in addition to effort needed to avoid disruption of current duties under the Statement of Work. The NINDS Center for Clinical Research Resources contract # HHSN271201700064C was awarded September 19, 2017. This requirement was competed via solicitation RFP-NIH-NINDS-17-03 on the basis of an unrestricted, full and open competition. Additional labor effort and associated funding are needed for the NINDS Center for Clinical Research Resources contract, HHSN271201700064C, to allow for the above referenced work. The NINDS Center for Clinical Research Resources contract # HHSN271201700064C was awarded September 19, 2017. This requirement was competed via solicitation RFP-NIH-NINDS-17-03 on the basis of an unrestricted, full and open competition. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The reasons for using the cited authority areas follow: Mitochondrial diseases are a group of disorders caused by genetic defects. Some mitochondrial disorders affect a single organ, but many involve multiple organ systems. Due to the marked variability of these diseases, conducting large?scale clinical trials is particularly challenging. Despite these constraints, some clinical trials have been conducted. However, these trials did not have a harmonized data collection system, making data sharing and meta-analysis complicated. The CDE project is an international collaborative effort involving many key stakeholders in mitochondrial medicine, including clinicians, translational and basic researchers, industry partners, patient advocacy groups, and the NIH. The breadth of the collaborators is a testament to the interest and need for these shared research tools to move the mitochondrial medicine field forward. Key findings have been reported since the release of the NINDS Mitochondrial CDES. Therefore, it is important and mission-critical to revise the existing CDEs to maintain their currency and encourage their use by the mitochondrial diseases research community. Due to the extensive revisions needed for these CDEs, it is necessary to treat this as a new disease. The time that will be spent in this revision will be as much as the time used to develop a new disease. At the last United Mitochondrial Disease Foundation (UMDF) annual meeting (June, 2019), one whole session was dedicated to reports from a number of industry-supported early-phase and - low N clinical trials, indicating interest from corporate and academic interests. Earlier this year, UMDF also conducted an Externally-led Patient-Focused Drug Development meeting with FDA. Therefore, the field is ready for this revision. In addition, NIH (NICHD, NINDS, NIGMS) has received two letters from the Senate and House specifically requesting an update of the Mitochondrial Diseases CDEs. NINDS CDE Website: Although our website was recently migrated to a new, modern and faster platform, these changes did not include update of the content and improvement of the search features. We propose to make the website more user-friendly and modernize the CDE and CRF search features. Finally, there is no practical alternative to revise the Mitochondrial CDEs and implement improvements to the NINDS CDE website. Not only does this Contractor have the trained and experienced personnel, but their contract, which was awarded on a competitive basis, clearly contains a Common Data Elements Development and Support performance area to cover such work as needs are identified within the period of performance of the contract award. Attempting to fulfill this need with any other contractor would result in a duplication of efforts, delay, increase costs, and reduced efficiency to the detriment of the Program and the Mitochondrial CDEs. Prior market research and soliciting under full and open competition has resulted in only The Emmes Company submitting a proposal. Using the same data across studies will streamline data analysis and potential important policy decisions. This will be possible with the revision of the Mito CDEs. The contractor, The Emmes Company, has an established experienced team that has worked with NINDS in over 20 CDE projects. Revising the Mito CDEs under this contract, will significantly reduce the timeline of the CDE developing process and will ultimately generate an excellent product. Additionally, adding effort to complete ongoing in-scope work for the current Option Period (expires 9/29/2020) is needed due to impact from covid-19 which resulted in extra effort coordinating and completing activities under the Statement of Work. Only one source is available: I hereby determine that the work to revise the Mitochondrial Diseases CDEs and improvements to the NINDS CDE website listed herein along with completing remaining activities under Option Period 2 impacted by covid-19 is available from only one source, and competition is precluded for the reasons indicated. There are no substitutes available. The intended source is: The Emmes Company, LLC 401 N. Washington Street, Suite 700 Rockville, MD 20850-1737 Period of Performance: The period of performance for this particular in-scope additional work under contract HHSN271201700064C will be as follows: Mitochonrial Disease is complete type, nonseverable and will have a performance period from date of contract funding action through the end of Option Period 3 - 9/29/2021 along with website improvement works which are completion type and nonseverable. Adding level of effort hours to current term option option 2 expiring 9/29/2020 will be severable and funding will expire for this work at that time. CLOSING STATEMENT THIS NOTICE OF INTENT TO ADD ADDITIONAL IN-SCOPE WORK TO AN EXISTING CONTRACT ON A SOLE-SOURCE BASIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice. A determination by the Government not to compete this proposed work based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the Comprehensive Service Agreement requirements contained in this notice and include your Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses must provide evidence that they can provide the requested screening services immediately upon order and in accordance with all Federal Information System Security requirements. All responses must be received by the closing date and time of this announcement and must reference the notice number, NIH-NINDS-NOI-20-008664. Responses must be submitted electronically to Danny Cohn, Contracting Officer, at danny.cohn@nih.gov. U.S. Mail and Fax responses will not be accepted.