SPECIAL NOTICE
B -- RFI-Patient Data-Exposure to Drugs and Infused Therepeutic Products
- Notice Date
- 4/3/2007
- Notice Type
- Special Notice
- NAICS
- 519190
— All Other Information 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, MD, 20857-0001, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- Reference-Number-CDER-RFI-DATA-Request
- Response Due
- 5/18/2007
- Archive Date
- 6/2/2007
- Description
- SUBJECT Hospital-Affiliated and Stand-Alone outpatient clinics and Infusion Centers in the United States for the characterization of drug and biologic usage and practice patterns of chemotherapeutics and other infused agents REQUEST FOR INFORMATION (RFI) This RFI is issued solely for information and planning purposes. It does not constitute a solicitation (Request for Proposal (RFP) or Request for Quotations (RFQ)) or a promise to issue a solicitation in the future. This RFI does not commit the Government to contract for any supply or service whatsoever. Furthermore, we are not at this time seeking proposals and will not accept unsolicited proposals. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI will be solely at the responding party?s expense. All information received in response to this RFI that is marked PROPRIETARY will be handled accordingly. The Government shall not be liable for or suffer any consequential damages for any proprietary information not properly identified. Proprietary information will be safeguarded in accordance with the applicable Government regulations. Proprietary information or trade secrets should be clearly identified. Responses to this RFI are welcome from all entities and organizations. However, the FDA is also requesting information from small businesses, which includes Small Disadvantaged Businesses, Women-Owned Small Businesses, HUBZone Small Businesses, and Service-Disabled Veteran-Owned Small Businesses. All small businesses are strongly encouraged to provide responses to this RFI. This will assist us in determining the potential levels of interest, competition, and technical capability to provide the required services within the Small Business community. In addition, this information may also be used to assist in establishing a baseline for developing any subsequent potential subcontracting plan small business goal percentages, as necessary. Responses to this notice are not offers and cannot be accepted by the U.S. Government to form a binding contract or agreement. FDA will not be obligated to pursue any particular acquisition alternative as a result of this RFI. Responses to the RFI will not be returned. Not responding to this RFI does not preclude participation in any future solicitation, if one is issued. BACKGROUND Hospital-Affiliated and Stand-Alone outpatient clinics and Infusion Centers in the United States for the characterization of drug and biologic usage and practice patterns of chemotherapeutics and other infused agents. The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products. FDA's authority to fund research projects is set out in section 301 of the Public Health Service Act (PHSA 42 U.S.C. 241). The Office of Surveillance and Epidemiology (OSE) contributes to this effort by evaluating drug risks and promoting the safe use of drugs by the American people ? a key component of FDA?s mission. In 1999, the Task Force on Risk Management?s ?Report to the FDA Commissioner? and the HHS Office of the Inspector General?s ?Report to the FDA Commissioner? both identified the need for greater postmarketing pharmacovigilance for prescription drugs. In response to these reports, FDA devoted greater resources to the area of postmarketing safety and has expanded the roles and responsibilities of OSE within CDER as well as FDA?s Center for Biologics to meet these needs for prescription drugs and biologic therapeutic products. FDA currently has several tools available to address postmarketing safety issues. These tools include a passive reporting system for adverse events related to drug and biologic therapy; several complementary drug utilization databases; and indirect access to US claims-based health encounter data for pharmacoepidemiology studies. To strengthen and complement these resources, FDA is interested in identifying existing commercially available data sources that capture data on patients exposed to drugs and infused therapeutic products that are administered outside of traditional retail and inpatient hospital pharmacy healthcare settings, e.g., outpatient clinics, infusion centers, or home infusion services in the US. At present, the FDA has the ability to estimate post-marketing drug exposure via access to data on outpatient prescription drug use including longitudinal patient-level data, healthcare practitioner prescribing patterns in office-based physician practices, and inpatient drug use based on hospital discharge billing data. However, no usage data are currently available to the FDA for drug products that are administered outside of these settings of care due to limitations in data collection with the available resources. FDA is interested in exploring existing commercially available database systems that capture data on patients exposed to drugs and infused therapeutic products that are administered outside of traditional retail and inpatient hospital pharmacy healthcare settings. FDA is not interested in database systems under development. Additionally, FDA is interested in organizations that own the data as well as a means to access data. Definition of Infused Therapeutic Products, Outpatient clinical practice settings Infused therapeutic products are defined as drug or biologic products that are administered parenterally. Outpatient clinical practice settings exist beyond the traditional retail and inpatient hospital pharmacy healthcare settings, e.g., outpatient clinics, and home infusion services. DESCRIPTION FDA is interested in identifying sources that capture data from, (1) hospital affiliated and stand-alone outpatient clinics and infusion centers that have existing data systems that will provide a denominator, or context, for understanding passive adverse events reported to FDA, (2) for modeling drug risk based on usage patterns, and (3) for calculating patient-based reporting rates for drugs and infused therapeutic products administered in these settings. In general, FDA is interested in, Systems that can provide any of the following information: Demographic usage information (age, gender) of patients, number of unique patients exposed; Indications for use; Strength and dosing information; Setting of administration, e.g., infusion centers, home infusion, oncology centers, hemophilia treatment centers, and dialysis centers; Concomitant medications or devices; Co-morbid conditions; Lot numbers for biologic products; Trade name and active ingredient name; Prescriber specialty; Systems that are nationally representative, or those including at least a multi-center or multi-state population or network. Systems that can provide HIPAA compliant data. INFORMATION REQUESTED Interested organizations that have relevant information are invited to submit a statement that describes their available product and its applicability to FDA?s needs. These submissions should contain cost estimates for FDA to access the data. Submitted information could include a discussion addressing some or all of the evaluation criteria (shown below), described in a comprehensive review of the currently available data resource product: Data Access Simplicity Flexibility Internet or network-based Data System Data Quality Timeliness of data availability Stability of data source Data Characteristics Drug and Biologic Products captured Data Elements captured, e.g., indications for use, patient demographic data (age, gender), product strength and dose Clinical Practice Setting Representativeness to nationwide use and trends Lot Numbers for Biologic Products Product Name Active Ingredient Name RESPONSES ALL RESPONSES SHALL BE SUBMITTED VIA EMAIL. Responses to this RFI should be submitted using MS Word (12 point font). Proprietary information should be identified as such. Responses to the RFI SHALL address the information requested above and include the following: Submitter?s Name Street Address, City, State, Zip code Point of Contact (POC), POC Telephone and facsimile numbers Status (e.g. women-owned small business or service-disabled veteran owned small business). If the company address includes a post office box, the complete street address must also be provided. North American Industry Classification System (NAICS) Code 519190 will be used for determining company size status. All information submitted to the FDA will be kept confidential as allowed by relevant federal law. All information submitted will be reviewed; however, FDA will not acknowledge or respond to any submissions. Information must be submitted by May 18, 2007. Responses are preferred in electronic format and can be e-mailed to the attention of Contracting Officer and Contract Specialist. Points of Contact: Ted Weitzman, Contracting Officer, 301.827.7178 or Ted.Weitzman@fda.hhs.gov Tamara Williams, Contract Specialist, 301.827.7154 or Tamara.Williams@fda.hhs.gov
- Record
- SN01264932-W 20070405/070403220258 (fbodaily.com)
- Source
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