SOURCES SOUGHT
B -- Epidemiologic Studies of Adverse Effects of Marketed Drugs
- Notice Date
- 1/11/2005
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-223-05-3001
- Response Due
- 1/26/2005
- Archive Date
- 2/10/2005
- Description
- This announcement is a Sources Sought Synopsis. Its purpose is to generate responses from qualified 8(a), HUBZONE, veteran owned, disabled veteran owned, or small business companies, which have the interest and ability to provide FDA access to data resources that can be used to conduct drug safety analyses to the benefit of the public?s health, to respond expeditiously to urgent public safety concerns, to provide a mechanism for collaborative pharmacoepidemiological research designed to test hypotheses, particularly those arising from suspected adverse reactions reported to FDA, and to enable rapid access to U.S. population-based data sources to ensure public health safety when necessary. Companies responding to this synopsis must indicate whether they are interested in this project as a prime contractor or as a possible subcontractor. Companies interested in this requirement as a subcontractor must indicate their areas of expertise that would support a prime contractor in the performance of the work described below. The NAICS code for this procurement is 541990. Contractors must submit a capability statement describing their company?s experience and ability to conduct as the prime contractor or support as a subcontractor epidemiologic studies of adverse effects of marketed drugs. FDA is not interested in developing a database as a part of any resultant contract and expects any qualified organization to own the data as well as the means to access the data. A one (1) year base contract with four (4), one (1) year options is intended. The evaluation process of Offerors submitting capability statements as a prime contractor will consist of an assessment of the minimum mandatory data resource requirements. If a database does not meet the minimum mandatory requirements outlined below, the Offeror shall be deemed nonresponsive. The Minimum Mandatory Data Resource Requirements are that the Offeror provide documentation that its data resource contains a minimum of 2 million currently enrolled patients or covered lives within the US as of July 1, 2004 and that the Offeror provide documentation of its ability to retrieve inpatient medical records. The FDA will use the minimum requirements and the written capability statement to determine whether Offerors are able to meet the following data resource requirements: ability to provide US health encounter data for pharmacoepidemiology studies through collaboration with FDA; availability of a computerized system for linking each patient to all relevant medical care data including enrollment status, drug exposure data, coded medical outcomes, vital records (desired, but not required), cancer registries (desired, but not required), and birth defect registries (desired, but not required); capability of providing a patient population with low turnover, thereby permitting long-term longitudinal follow-up of most patients for acute or delayed adverse effects from drugs or other medical products; ability to capture all outpatient prescription drug exposures and health provider encounters, linked longitudinally to each patient; ability to capture all health provider encounters whether in the ambulatory, emergency, chronic care, or acute care setting in sufficient detail so that FDA has the ability to estimate the contribution of various risk factors (e.g., age, gender, dose, co-existing disease, disease severity, concomitant medications) associated with the occurrence of medical events of interest; demonstrated (post HIPAA) ability to access and retrieve complete, primary medical records as required for completion and validation of studies; ability to provide exposure data on new molecular entities (those approved within the last 5 years in the United States) and identify adverse drug events that occur infrequently (i.e., at rates lower than can be detected in clinical trials); ability to provide data and preliminary analyses to determine the feasibility of formal studies within 4 weeks of a data request; capability to form groups (i.e., cohorts) of patients exposed to one or more drug or biologic products and to follow them for the occurrence of one or more medical outcomes; full disclosure of data collection, coding, and configuration methods to allow FDA to appropriately interpret findings; and it shall be solely the Offeror?s responsibility to de-identify the data for FDA use. FDA will require no patient-, provider-, or health plan-specific identifiers. In providing access to longitudinal, population-based data, the Offeror shall ensure that the following criteria are met. At a minimum, the database description shall include: number of people (active and inactive) in the database, distribution of person time by calendar year in the database, extent of geographic diversity, demographics, size of special populations of interest (including children, women of childbearing age, and elderly patients); turnover rate, and enrollment data (if applicable) for participating individuals. In addition, the following information shall be provided to FDA: the number of years of data available overall; the lag time between the health encounter date and availability of the data; the mean, median, and range of observation time for patients in the database; and data collection and management procedures. These longitudinal data shall have the capability to follow uniquely identifiable individuals (using encrypted patient identifiers). Demographic information including but not limited to age and gender, health history, diagnoses and procedures, and hospitalizations shall be provided. Information on race/ethnicity shall be included if available, accompanied by documentation of the origin of this information. In addition, for each patient these data shall contain prescription drug and biologic utilization information, including the generic and brand name of the product, strength, dosage form, days supply, all dates dispensed, initial/continuing therapy indicator, quantity dispensed, instructions for use (if available), and prescriber specialty. The evaluation process of Offerors submitting capability statements as a subcontractor will consist of a subjective assessment of the Offeror?s expertise and experience in supporting the work described above. Interested Offerors shall provide (1) a summary list of similar work previously performed or being performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; resumes for proposed key personnel should be included; (3) any other specific and pertinent information as pertains to this Sources Sought Notice that would enhance FDA?s consideration and evaluation of the information submitted. Responses must reference Request for Information (RFI) number 223-05-3001 and include the following: (1) name and address of firm, (2) type of business (i.e.: small business, small disadvantaged 8(a) certified, HUBZONE, woman-owned small business, small disadvantaged business (not 8(a) certified), veteran-owned small business, disabled veteran owned business, etc.) (3) two points of contact: name, title, phone, fax and e-mail, (4) DUNS number, (5) NAICS codes, (6) contractor?s capabilities statement which provides the information stated above, (7) list of customers covering the past 5 years including a summary of similar work performed, contract number, contract type, dollar value for each customer, reference and customer point of contact with phone number, and identify your role as either the Prime or Subcontractor. THIS SYNOPSIS IS FOR INFORMATION AND PLANNING PURPOSES AND IS NOT TO BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT. THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT AND ANY FOLLOW-UP INFORMATION REQUESTS. RESPONDENTS WILL NOT BE NOTIFIED OF THE RESULTS OF THE EVALUATION. ALL INFORMATION SUBMITTED IN RESPONSE TO THIS ANNOUNCEMENT MUST ARRIVE ON OR BEFORE THE CLOSING DATE. Glossary concomitant medications ? One or more therapies that appear to be used in conjunction with each other at any point in time (i.e., overlapping days supply, same date of fill, by a specified number of days elapsed, etc.) demographic ? The age and gender of the patient shall be required. Information on race/ethnicity shall be included if available, accompanied by documentation of the origin of these data. full disclosure of data collection, coding and configuration ? detailed information on how the database sample is selected, how data are obtained and cleaned/edited for analysis, how the data resource was built, how variables are defined, and the relationship between variables within the data structure. geographic diversity ? The extent to which patients are broadly distributed throughout the database?s country of origin. (The patients whose information is in the data resource shall not be concentrated in any single geographic area.). health encounter ? any interaction that an individual has with the health care system. This includes, but may not be limited to the outpatient setting (e.g., doctor?s office, hospital or outpatient clinic visits), inpatient hospitalizations, or visits to a pharmacy for receipt of prescription drugs or medical products. longitudinal ? The capability of tracking a single individual (e.g. patient A) across multiple encounters over time and of differentiating that individual from another individual (e.g. patient B). new molecular entity?A medication containing an active substance that has never before been approved for marketing in any form in the United States.
- Place of Performance
- Address: Contractor site
- Record
- SN00732858-W 20050113/050111211629 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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