SOURCES SOUGHT
R -- Data Processing
- Notice Date
- 2/6/2018
- Notice Type
- Sources Sought
- NAICS
- 518210
— Data Processing, Hosting, and Related Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Jefferson, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA_1194299
- Archive Date
- 3/8/2018
- Point of Contact
- ROOSEVELT D. WALKER, Phone: 8705437405
- E-Mail Address
-
roosevelt.walker@fda.hhs.gov
(roosevelt.walker@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the NCTR Division of Bioinformatics and Biostatistics (DBB) to require Data Service electronic medical record (EMR) database system to conduct research to assess the safety surveillance of the FDA adverse event reporting systems, with the pilot study working on the FDA Adverse Events Reporting System (FAERS) (CDER) database. The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is 518210- Data Processing, Hosting, and Related Services; $32.5 Small Business Size standard in millions of dollars. The FDA/NCTR/Division of Bioinformatics and Biostatistics (DBB) is conducting research that supports NCTR Research Support Program Acquisition Strategy. The Division of Bioinformatics and Biostatistics (DBB) requires Data Service electronic medical record (EMR) database system to conduct research to assess the safety surveillance of the FDA adverse event reporting systems, with the pilot study working on the FDA Adverse Events Reporting System (FAERS) (CDER) database. A novel data mining and data visualization method will be developed and evaluated by the large electronic medical record (EMR) system, such as VA databases. Identify patients who developed cardiovascular abnormalities (such as high blood pressure, stroke, QT prolongation, arrhythmia, etc.) after drug exposure. The specific aims of this study (project E0762001) as follows: i. A Bayesian approach known as topic modeling will be employed to identify the hidden un-recognized adverse events for products and characterize the significant safety signals in the FAERS, Vigibase and the VA EHR surveillance databases. ii. Broader and enrich medical lexicons in MedDRA ontology. iii. Apply Latent Dirichlet Allocation (LDA) algorithm on CDER FAERS database to identify the relationships between multi-drugs and multi-adverse events, therefore, providing a huge availability on data mining to study relationships between drugs and adverse events. Assess the disparities on drug-host interaction of drug-induced liver injury (DILI) reported in large electronic medical record (EMR) system using advanced methodologies for minority populations. The VA Cardio-related database (using drug-induced cardiovascular disease as a starting point) will be developed and used for this project. The database will be developed using the VA National EMR system at the VA Informatics and Computing Infrastructure (VINCI), including drugs, adverse events, lab data, etc. Due to the strict restriction on the permission to access the VA database and specific skill to retrieve and process the data, contractor shall have authority to access the VA database. Technical Requirements: The database shall be developed to include the following: 1) Create a drug dictionary populating all medications available at VA sites. The drug dictionary uses a unique drug identifier (drug ID) to organize all drugs that have been prescribed at the VA between 2000 and 2015. 2) Identify patients who developed cardiovascular abnormalities (such as high blood pressure, stroke, QT prolongation, arrhythmia, etc.) after drug exposure. Drugs that induce severe cardiovascular abnormal events will be identified in the system as "study drugs". 3) Create a drug dictionary populating all study drugs available at VA sites. The drug dictionary uses a unique drug identifier (drug ID) to organize all drugs that have been prescribed at the VA between 2000 and 2015. 4) Identify patients who developed cardiovascular abnormalities after drug exposure. Specifically, ECG, Blood pressure, and heart rates will be noted. 5) Select a medication-matched control population. Medication-matched control subjects will be identified as subjects who received the same agent for a similar duration but did not develop acute cardiovascular abnormalities. 6) Create a study population table and a cardio-event table. Combine the above cases and controls to create a study population table. 7) create a demographic table. Retrieve demographic information for the study population and create a demographic table. Age, gender and ethnicity information will be collected. 8) Create a table depicting comedications taken at the time of cardio-abnormalities. 9) Create a table identifying comorbidities at cardiovascular abnormalities. The study population needs to be linked to vital information, and an International Classification of Diseases (ICD-9) code table to examine. Creation of a database above using the VA National EMR system. Shall include data tables for the following: • Drug dictionary • Laboratory dictionary • ICD-9 dictionary • patients receiving any of the Study drugs • patients with Cardio • Exclude other cases of acute cardiovascular disease • medication-matched control population database • study population table and cardio event tables • patient demographic table • comedications taken at time-of cardio events • database of comorbidities at cardio events • model implementation 10) Provide aggregated data in the form of PDF, MS Word, MS Excel files, or text files as applicable Installation, Training and Additional System Requirements. The contractor shall have permission to access the VA database and specific skill to retrieve and process the data, to create electronic medical record (EMR) database system. The database will be developed using the VA National EMR system at the VA Informatics and Computing Infrastructure (VINCI), including drugs, adverse events, lab data, etc. The contractors shall have authority to access the VA database. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA's stated need. In addition, upon expiration of initial period of performance it is anticipated to include two (2) 1-Year option periods for date from 2016-2017 and option for 2018-2019.. The (EMR) system period of performance service shall include permission to access the VA database and specific skill to retrieve, process the data, and shall have authority to access the VA database, trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included. FOB Point Destination. All items shall include shipping, handling to the destination identified herein. FOB Point of Delivery for Services and Supplies will be the FDA NCTR facility located at 3900 NCTR RD, Jefferson, AR 72079. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address (Provide this same information if responding to provide a product manufactured by another firm); • Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. • Three (3) years of past performance information for the manufacture, installation and/or sale and maintenance support in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of the manufacturer (to include DUNS number and size status) if not the respondent. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement. • Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment. • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Standard commercial warranty and payment terms; and • Though this is not a request for quote, informational pricing is encouraged. The government is not responsible for locating or securing any information, not identified in the response. The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. Interested Parties shall respond with capability statements on or before February 21, 2018 by 13:00 hours (Central Time in Jefferson, Arkansas). Reference FDA1194299. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the 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 provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA_1194299/listing.html)
- Place of Performance
- Address: U.S Food and Drug Administration, NCTR/Division of Bioinformatics and Biostatistics (DBB), 3900 NCTR, RD, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN04811990-W 20180208/180206231448-21cd6633e9e3791f919c186838c30ec6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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