Additional Hours for Development of Pain Common Data Elements (CDEs) under NINDS Center for Clinical Research Resources contract # HHSN271201700064C
INTRODUCTION
THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO ADD ADDITIONAL HOURS 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.
Additional labor effort and associated funding are needed for the NINDS Center for Clinical Research Resources contract, HHSN271201700064C, to allow for the development of Common Data Elements (CDEs) for Pain under the Early Phase Pain Investigation Clinical Network (EPPIC-Net). The EPPIC-Net serves as the cornerstone of the NIH's Helping to End Addiction Long-term (HEAL) Partnership. This project is a trans-NIH effort and it is mission critical.
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." The Pain CDE will be an addition to the library and is thus in-scope to the original statement of work.
The objectives of this added labor effort and funding are to: (1) plan and prepare Pain CDE development, (2) coordinate bimonthly HEAL CDE WG meetings over four months, and (3) provide ongoing maintenance of the Pain CDEs on website after posting.
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:
The opioid epidemic is a public health crisis and starting-up the study infrastructure is a time-sensitive issue. The most significant rationale for using the current NINDS Center for Clinical Research Resources contract is the fact most of the necessary infrastructure and expertise already exist at The Emmes Company, LLC. A fundamental piece of the infrastructure is ensuring that the data collection instruments are ready and harmonized across all the pain studies funded under the EPPIC-Net. Using the same data across studies will streamline data analysis and potential important policy decisions. This will be possible with the development of Pain CDEs. The contractor, The Emmes Company, has an established experienced team that has worked with NINDS in over 20 CDE projects. Developing the Pain CDEs under this contract, will significantly reduce the timeline of the CDE developing process
CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION
The determination by the Government to add this in-scope work to an existing contract without providing for full and open competition is based upon the following rationale:
The HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. The NIH HEAL Initiative℠ will bolster research across NIH to improve treatments for opioid misuse and addiction and enhance pain management. EPPIC-Net will manage early phase clinical trials of non-addictive pain therapeutics, including drugs and devices. The pain CDEs will be developed to harmonize the data collection of these trials to ensure data integrity.
Additionally, there is no practical alternative to developing the Pain CDEs. Not only does this Contractor have the trained and experienced personnel, but their contract, which was awarded on a competitive basis, contains 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 HEAL Initiative. Prior market research and soliciting under full and open competition has resulted in only The Emmes Company submitting a proposal.
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 limited to one year on or about (08/01/2019 - 07/31/2020).
Contract Type:
This additional in-scope work will be awarded a cost-reimbursement, level-of-effort basis consistent with the contract terms and conditions of contract HHSN271201700064C.
Specific Requirements:
The contractor will perform activities for pain CDE development under the NINDS contract # HHSN271201700064C. These activities include, but are not limited to the following:
1. Pain CDE development - initial planning:
a. Emmes will meet with NINDS to discuss plans for review process
2. Coordinate bimonthly HEAL CDE WG meetings over 4 months, approximately 6 hours of time spent per meeting: 48 hours
a. Prepare and distribute meeting materials to WG members. This will include providing resources (e.g., pain-related CDEs and CRFs recommended by other NINDS CDE diseases, CDEs from other sources) and research literature for review.
b. Prepare and distribute minutes and any follow-up materials
3. Provide progress updates outside of the monthly COR call as part of monthly meetings with NINDS
4. Internal Review: 2 months
a. Compile all draft recommendations made by the subgroups, which will include draft case report forms, guidelines documents, subgroup summary, and instrument Notice of Copyright (NOC) documents
b. Distribute these drafts to all WG members for review over a period of 2-4 weeks
c. Share recommendations or comments with the WG and schedule additional WG meetings to discuss comments if needed
5. Prepare/Post v1.0 CDEs on NINDS CDE website: 1 month
a. Curate CDEs
b. Finalize all CRFs and NOC documents
c. Post CDEs on NINDS CDE website, along with all CRFs, NOCs, subgroup summaries, WG roster
6. Maintenance of CDEs on website: ongoing, after posting
a. Updates as needed
b. Coordination of publication
c. Poster presentations on pain CDEs at conferences
d. Oversight Committee reviews
7. Pain CDE development deliverables:
a. Spreadsheets of all CDEs developed by the WG
b. All CRFs, NOC, WG summary, guidelines documents that will be posted to the NINDS CDE website
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-19-HHSN271201700064C. 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.
Danny Cohn, Contracting Officer, Phone 3014027111, Email danny.cohn@nih.gov
