SPECIAL NOTICE
A -- Access to Inpatient Pediatric Drug Utilization Data - RFI 1149340
- Notice Date
- 5/12/2015
- Notice Type
- Special Notice
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- RFII-1149340
- Point of Contact
- Telisha Wilson, Phone: 2404027572
- E-Mail Address
-
telisha.wilson@fda.hhs.gov
(telisha.wilson@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Access to Inpatient Pediatric Drug Utilization Data Project Title: "Access to Inpatient Pediatric Drug Utilization Data" This Request for Information (RFI) is being issued in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers. The purpose of this RFI is to help the FDA understand the industry best practices, technical solutions, and sources capable of meeting the FDA's requirements. Specifically, the Government is seeking verification that its automated, auditable, quantitative data mining requirement is commercially available, determine if there are any questions about the FDA's requirements, determine if industry notes any omissions in the requirements, and information about sources available to meet the FDA's requirements. Background The FDA has access to multiple drug utilization databases, some of which contain pediatric use patterns, but gaps still remain in our ability to fully characterize pediatric drug use nationwide. In particular, information is lacking from stand-alone pediatric hospitals, where children may receive different therapeutic treatments compared to children treated in general hospitals or in outpatient settings. Identifying data sources to support an improved view of nationally representative inpatient pediatric drug utilization patterns could greatly improve our understanding of how drugs are being prescribed to children under real-world conditions to support FDA's mission. Objectives The Agency would like to determine sources available to provide continuous access to data containing pediatric inpatient drug utilization, including pediatric specialty hospitals and Emergency Departments (ED), and if available, treatment procedures and diagnostic information in pediatric patients. Instructions Interested parties should provide responses to the following questions (where available) regarding their data sources. Responses should be limited to 10 pages or less. 1) Timeframe - How many calendar years are captured and are there differences in the number of patients/institutions captured each year? How often is the data source updated? 2) Demographics - Number of hospitals captured, size and geographic distribution of hospitals, number of discharges per year by age, etc. 3) Data Type/Data Formation - How is clinical information captured from the healthcare system? Does it capture billing claims, and if so, in what format? Does it capture electronic medical records? 4) Location with hospital of care captured - From where are the data captured (i.e. inpatient and outpatient drug use, emergency departments, surgery units, neonatal/pediatric intensive care units)? 5) External linkable databases - What additional external databases can be or have been linked to the data source (e.g. National Death Index, survey data)? Are such linkages ever possible? 6) Patient capture - How many unique patients does the data source capture? Can patients hospitalized more than once at the same institution be distinguished? 7) Drug exposure - How are drug exposures captured (e.g. billing, patient interview, medical records)? Are data available to confirm the complete capture of prescribed treatments (e.g. a validation study)? Is there information regarding route of administration, dosage, or frequency? Are NDC codes available? 8) Health outcomes - Does the data source have the ability to capture health outcomes (e.g. adverse events, clinical data)? If so, how are they captured? Have any validation studies been conducted? Is discharge information available, including mortality? 9) Covariates - Does the data source have the ability to capture patient comorbidity (e.g. disease states other than the one that caused admission to hospital) or risk factors for disease (e.g. BMI, lifestyle factors, etc.)? If so, how are they captured? Is there information regarding indications for drugs administered/taken? 10) Data access - How customizable are data searches? Is direct access to the data possible? 11) Strengths - What are the particular strengths of the data source, with regard to ascertaining nationally representative information about pediatric inpatient drug exposures in stand-alone children's hospitals? 12) Limitations - What are the limitations of the data source with regard to ascertaining nationally representative information about pediatric inpatient drug exposures in stand-alone children's hospitals? Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this RFI with any interested parties. This request is not to be construed as a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this request. The Government will not reimburse respondents for any cost associated with submission of the information being requested or reimburse expenses incurred to interested parties for responses to this announcement. However, FDA reserves the right to contact one or more of the respondents if additional information is required or to request demonstrations of available systems. Responses to this announcement will not be returned, nor will there be any ensuing discussions or debriefings of any responses. However, information obtained as a result of this announcement may be reflected in the subsequent solicitation, if issued. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses. Capabilities and Technical Experience Provide a capability statement describing how your company would meet the requirements. Please provide the follow Business information: 1. DUNS Number 2. Company Name 3. Company Address. 4. Company Point of Contact, phone number and email address 5. Type of company under NAICS, as validated via the System for Award Management (SAM). Additional information on NAICS codes can be found at www.sba.gov. Any potential government contract must be registered on the SAM located at http://www.sam.gov/index.asp. 6. Corporate structure (corporation, LLC, sole proprietorship, partnership, limited liability partnership, professional corporation, etc.); 7. Current GSA Schedules appropriate to this Request for Information 8. Current Government Wide Agency Contracts (GWACs) 9. Point of Contact, phone number and email address of individuals who can verify the demonstrated capabilities identified in the responses. Interested parties having the capabilities necessary to provide the stated requirements may submit capability statements via email or regular mail to the point of contact listed below. Responses must be received not later than 3:00 PM EST, June 12, 2015. Capability statements will not be returned and will not be accepted after the due date. Documentation should be emailed to: Telisha.Wilson@fda.hhs.gov with subject line titled "Request for Information 1149340". 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/RFII-1149340/listing.html)
- Record
- SN03728833-W 20150514/150513000045-301fb94161cc71b8456fe7d9c0851eb7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |