SOURCES SOUGHT
B -- Scientific Program to Support Epidemiologic Investigation of Safety Related Issues of Marketed Drugs, and Evaluations of Risk Management Programs and Tools
- Notice Date
- 6/18/2008
- 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, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA1041506
- Archive Date
- 7/8/2008
- Point of Contact
- Patricia Wright,, Phone: 301-827-7217
- E-Mail Address
-
patricia.wright@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of potential small businesses to provide services for the project titled: Scientific Program to Support Epidemiologic Investigations of Safety Released Issues of Marketed Drugs, and Evaluations of Risk Management Programs and Tools. The NAICS Code is 541990. Interested small business potential offerors are encouraged to respond to this notice. However, be advised that generic capability statements are not sufficient for effective evaluation of respondents’ capacity and capability to provide the required services. The primary objectives to be accomplished under these contracts are to provide FDA with: 1) Conduct drug safety analyses of importance to FDA using both retrospective and prospective methods, as appropriate; 2) Establish a collaborative arrangement with existing pharmacoepidemiologic research programs for the purpose of conducting epidemiologic studies of drug safety issues using databases containing electronic health information; 3) Establish a collaborative arrangement with existing pharmacoepidemiologic research programs for the purpose of evaluating the effectiveness of risk management programs and tools using databases containing electronic health information; 4) Obtain technical assistance or consultative support on methods and the use of electronic healthcare data resources for conducting pharmacoepidemiologic research, and; 5) Enable timely access to US and Canadian population-based data sources to ensure public safety when necessary. Data Requirements: Successful Contractors will have continuous access to an updated electronic healthcare data resource containing patient-level health encounter data from the U.S. or Canada. The data resource shall be a computerized system able to link each patient to all relevant medical care data including enrollment status, drug exposure data, and coded medical outcomes. This data resource will meet the criteria specified in the minimum mandatory criteria throughout the length of the contract. Linkage of this data resource to additional information, including vital records, chronic disease and/or cancer registries, and birth defect registries, if available, is also of interest. It shall be solely the Contractor’s responsibility to insure that the data are HIPAA-compliant, and to de-identify the data for FDA use. FDA will require no patient-, provider-, or health plan-specific identifiers. All research performed by the FDA PRP centers must comply with standards for privacy of individually identifiable health information and protect the rights of human subjects in research. For the purpose of this requirement, the data resource shall be sufficient to meet FDA’s need to access patient-level data describing health encounters and prescription drug use by individuals over time. The data resource shall have longitudinal data that shall be capable of following uniquely identifiable individuals (using encrypted patient identifiers) over time. Demographic information (e.g. 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. The data resource shall also have the ability to identify pregnancies and pregnancy outcomes as well as have the ability to subsequently link maternal and child records after birth. 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), indication for use (if available) and prescriber specialty. The resource shall employ the use of a generally accepted, granular coding system for drugs and medical products, as well as for diagnoses and procedures. In addition, the contractor shall have the ability to determine that the drug or biologic was dispensed to the patient, rather than just prescribed to the patient. All patient medical diagnostic information shall be represented in the data resource, including diagnoses and procedures associated with all ambulatory, emergency, chronic or acute care setting visits and their dates, diagnoses and procedures associated with all related hospitalizations and their dates, and all laboratory tests and results (if available) and their dates. Other health measures (such as family health history, height, weight, body mass index, smoking status, alcohol use, blood pressure measurements, etc.), are of interest if available. The successful Contractors shall have the capability of accessing inpatient medical records for validating coded diagnostic data; access to outpatient medical records is also of interest if available. The ability to contact a sample of physicians and/or a sample of patients/caregivers on an ad hoc basis for information beyond what is available in the data source (e.g., survey to determine reasons for prescribing decisions, use of informed consent, use of nonprescription drugs and/or medical products, comprehension of consumer medication information) is also of interest. Responses to this notice shall be limited to 15 pages, and must include: 1.Company name, mailing address, e-mail address, telephone and FAX numbers, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. 2.Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. 3.Business size for NAICS xxxxxx (size standard $ or number of employees) and status, if qualified as an 8(a) firm (must be certified by SBA), Small Disadvantaged Business (must be certified by SBA), Woman-Owned Small Business, HUBZone firm (must be certified by SBA), and/or Service-Disabled Veteran-Owned Small Business (must be listed in the VetBiz Vendor Information Pages). 4.DUNS number, CAGE Code, Tax Identification Number, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in the Central Contractor Registry (CCR, at www.ccr.gov) to be considered as potential sources. 5.Identification of the firm's GSA Schedule contract(s) by Schedule number and contract number and SINs that are applicable to this potential requirement are also requested. 6.If the company has a Government approved accounting system, please identify the agency that approved the system. Please submit copies of any documentation such as letters or certificates to indicate the firm’s status (see item #3, above). Teaming arrangements are acceptable, and the information required above on the company responding to this announcement, should also be provided for each entity expected to be teammates of the respondent for performance of this work. To the maximum extent possible, please submit non-proprietary information. Any proprietary information submitted should be identified as such and will be properly protected from disclosure. This notice is for planning purposes only, and does not constitute an Invitation for Bids, a Request for Proposals, a Solicitation, a Request for Quotes, or an indication the Government will contract for the items contained in this announcement. 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. Responses to this notice must be received to the attention: Patricia Wright, email: patricia.wright@fda.hhs.gov not later than 12:00 PM Eastern Standard time on June 23, 2008 for consideration. 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, and FDA may contact one or more respondents for clarifications and to enhance the Government’s understanding. This announcement is Government market research, and may result in revisions in both its requirements and its acquisition strategy based on industry responses.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=a69c54b93bfc417dd4a23921d7e3a97f&tab=core&_cview=1)
- Record
- SN01595765-W 20080620/080618215418-a69c54b93bfc417dd4a23921d7e3a97f (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 |