SOURCES SOUGHT
R -- Access to Outpatient Prescription and Patient Level Drug Utilization Data - DRAFT SOW
- Notice Date
- 2/25/2011
- 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
- 11-223-SOL-00053
- Archive Date
- 3/19/2011
- Point of Contact
- Sherry Solodkova, Phone: 301-827-7165
- E-Mail Address
-
sherry.solodkova@fda.hhs.gov
(sherry.solodkova@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Draft SOW This is a SOURCES SOUGHT NOTICE to determine the availability and capability of small businesses (including certified 8(a), Small Disadvantaged, and HUBZone firms; veteran and service-disabled veteran-owned small businesses, and women-owned small businesses) to provide Access to Outpatient Prescription and Patient Level Drug Utilization Data. 1. Project Title: "Access to Outpatient Prescription and Patient Level Drug Utilization Data" 2. Background A vital part of FDA and CDER's mission is to protect the public health. In early 2005, FDA commissioned the Institute of Medicine (IOM) to conduct a study to examine the US drug safety system. In September 2006, the Institute of Medicine Report entitled, "The Future of Drug Safety: Promoting and Protecting the Health of the Public" was released and outlined numerous ongoing and future activities designed to continue to strengthen the FDA's drug safety program. 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. Specific recommendations in the IOM report addressed modernizing the drug safety program and outlined activities designed to modernize the process of pharmacovigilance, including activities for the expansion of database resources. In furtherance of this effort and in conjunction with the recommendations in the IOM report, FDA seeks to continue to access drug utilization data in an outpatient setting at the national level in the US. The ability of FDA to respond expeditiously to the increasing number of postmarketing issues is of paramount importance to the overall public safety. Continued access to these data complement and strengthen the utility of the passive reporting system currently in place by providing estimates of the numbers of patients exposed to drugs and the numbers of prescriptions dispensed nationwide in the outpatient setting. These data provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the outpatient setting. Access to these data also increase the FDA's ability to perform regulatory impact studies; in particular, those studies that assess the impact of risk managements plans and labeling changes on prescribing habits and usage patterns for prescription drugs. Finally, direct access to these data in real time enhances and accelerates the pace of FDA's regulatory decision-making process. 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. The funding of "Access to Outpatient Prescription and Patient Level Drug Utilization Data" would serve as a mechanism for FDA to respond expeditiously to serious public health or regulatory issues. FDA is not interested in developing this database and expects any qualified organization to own the data as well as have the means to access and manage the data. 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). 3. Objectives Program Research Goals: A. Provide FDA personnel with real-time, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level counts of outpatient prescriptions over time. B. Provide FDA personnel with real-time, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level counts of unique patients utilizing prescription drug products in an outpatient setting over time. C. Provide prescription-medical claims and patient-level information, in either the same or separate, linked resources. If separate linked data resources are proposed, all individuals in the patient-level data resource shall link directly to their prescription data. D. Provide FDA personnel with the ability to use these data to characterize the duration of exposure to prescription drug products at the patient level and to examine concomitant use of multiple drug products at the patient level over the same time period. E. Provide FDA personnel with the ability to use these data to describe national patterns of drug utilization in the outpatient setting through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel. F. Provide FDA personnel with direct, unlimited, Internet or network-based access to all HIPAA-compliant data in a multi-user environment and in real time. G. Provide FDA personnel with the ability to download (or obtain in a timely manner using other means) large datasets as needed, for the purpose of conducting epidemiological drug safety studies. Please see the attached draft SOW for additional information. 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 perform the specific work as required. Responses must directly demonstrate the company's capability, experience, and/or ability to marshal resources to effectively and efficiently perform each of the tasks described above at a sufficient level of detail to allow definitive evaluation; and evidence that the contractor can satisfy the minimum requirements listed above while in compliance with FAR 52.219-14 ("Limitations on Subcontracting"). Failure to definitively specifically address these requirements will result in a finding that respondent lacks capability to perform the work. Responses to this notice shall be limited to 5 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 541990 (size standard $7 Million) 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 by the Contracting Officer named in this announcement not later than 11:00 a.m. ET on Friday, March 4, 2011 for consideration. E-Mail is the only acceptable method of delivery for this sources sought notice. 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. Thank you.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/11-223-SOL-00053/listing.html)
- Place of Performance
- Address: Contractor-Site, United States
- Record
- SN02388470-W 20110227/110225234827-5a8509a746538e6f8c0e80679062297e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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