SOURCES SOUGHT
70 -- Access to data on Pharmaceutial Sales
- Notice Date
- 11/4/2008
- 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
- 1051583
- Response Due
- 12/15/2008
- Archive Date
- 12/30/2008
- Point of Contact
- Linda Giles,, Phone: 301-827-7048, Ted Weitzman,, Phone: 301-827-7178
- E-Mail Address
-
linda.alexander-giles@fda.hhs.gov, ted.weitzman@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- This is a SOURCES SOUGHT NOTICE to determine the availability and capability of qualified small businesses that can provide access to global and national pharmaceutical sales data to estimate and forecast trends in pharmaceutical sales, pricing and volume of distribution throughout various settings of care as well as to identify international sources of critical drug products. Continued access to these data allows the FDA to respond expeditiously to questions relating to drug safety, the impact of regulatory policies and to potential drug shortage situations as well as strengthen the FDA’s position in the following critical areas. Access to these data enhances and accelerates the pace of FDA's regulatory decision-making process and FDA’s responses to requests from Health and Human Services (HHS) and Congress. The contractor shall provide the following: Provide FDA personnel with real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, data with the capability of providing global and national-level estimates of pharmaceutical sales, and to identify international sources of critical drug products. Data concerning pharmaceutical sales information shall include current data on product- and substance- specific pharmaceutical sales to health care institutions by channels of distribution. Updated information on sales shall be available on a monthly and yearly basis. Historical sales data shall also be available for trending and forecasting. Provide FDA personnel with the ability to use these data to analyze and describe global and national patterns of pharmaceutical sales through the use of projection or other appropriate methodologies that are scientifically sound and transparent to FDA personnel. 1) Pharmaceutical Sales Data Requirements. The Contractor shall have continuous access to current global and national-level pharmaceutical sales data resources, and have the ability to identify international sources of critical drug products. These data resources shall meet the criteria specified in the minimum mandatory criteria throughout the length of the contract. These data resources shall be accessible via a secure Internet or network-based method permitting simultaneous, multi-user access through a user friendly data query tool(s). The data resource(s) shall be sufficient to meet FDA’s need to access global and national-level pharmaceutical sales data. These data resource(s) shall provide sales data broken down by channels of distribution (e.g., retail, mail-order, long-term care, for-profit and non-profit, federal and non-federal, clinics, institutional/non-institutional, specialty pharmacies, etc.), U.S. geographic regions, and international sources of critical drug products. These data resource(s) shall include the unit of measure(s) for the volume of pharmaceutical product sales (dollars, units, SKU, etc.), the number of manufacturers included in the sample, and the ability to search on raw/sample numbers, as well as projected numbers. These data resource(s) shall have basic data elements at the product level, product package level, and ingredient level. These data shall also be available in monthly and annual increments for all prescription and non-prescription, generic and OTC drugs and biologics. This data resource shall have raw/sample and projected numbers throughout the length of the contract. The company specific data elements shall include (but are not limited to): name of corporation (parent company); name of manufacturer/distributor (marketing company); nationality or country identifier; and company size indicators (e.g., total products, sales, gross profit, revenue, etc.). The drug specific data elements shall include for all prescription, generic and OTC drugs and biologic products: product names (international and national proprietary, and generic); volume measures (e.g., packages, units, extended units, SKU, etc.); name of corporation/manufacturer; originator status (e.g., originator, repackager, branded or private label, etc.); molecule; active ingredient; chemical family; composition (e.g., single-ingredient or combination product); therapeutic class identifier; NDC Code or drug coding system used; dosage form; strength; molecular salt (if applicable); package details (e.g., form, strength, size or volume); product age (e.g., date and location first marketed); and patent details (e.g., date first patent granted, date of patent expiry) if available. The pricing specific data elements shall include for all prescription, generic and OTC drugs and biologic products: exit manufacturer price; wholesale price (price paid by pharmacy to wholesaler); retail price (high, low and/or average along with method of computation); and average retail markup (along with methodology/calculation details). Price data for foreign countries should be expressed in units of both Local/Domestic Currency and in US Dollars. Price data shall include relevant period exchange rates to facilitate currency conversion. The Contractor shall provide the following information relating to an existing projection methodology: distribution of types of facilities and sales channels (to include numbers and percents) compared to the national coverage by regions (Northeast, Midwest, South, West); and distribution of sales data characteristics by geography (e.g., urban, rural, etc.), sales volume, type (independent, chain, etc.), and four census regions 2) Technical Requirements and Capabilities. The pharmaceutical sales data shall be a currently existing, commercially available, product that shall provide immediate automated access with the capability of providing characterization of current product- and substance-specific drug and biologic sales data to health care settings and facilities. The data shall be a currently existing, commercially available product that shall provide immediate automated access with the capability of providing both current and historical global and national-level pharmaceutical sales data. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Access shall include all upgrades, enhancements, and modifications to software and data. Access shall be via secure Internet or network-based methods and shall be in a multi-user environment. The network-based methods shall not necessitate any additions to the FDA communications infrastructure. Preferred methods for access (in order of preference) are: 1) secure Internet access, and 2) firewall-to-firewall virtual private network (VPN). FDA shall not support modem-based or dial-up access. The NAICS Code is 541990; size standard is 23M. Interested small business must provide a capability statement demonstrating their experience, skills and capability to fulfill the Government requirement that is stated above. However, be advised that generic capability statements are not sufficient to evaluate your capability statement effectively. Information submitted must be in sufficient detail to permit the government to determine whether your organization meets the government requirement. This notice is for planning purposes only, and does not constitute a Request for Quotation. This request is not to be construed as a commitment on the part of the Government to award a purchase order or 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. Interested small business organizations that believe they possess the capabilities necessary to undertake this project should submit information via email copies of their capability statement, addressing the areas above. NO CALLS WILL BE ACCEPTED. RESPONDENTS MUST SUBMIT CAPABILITY STATEMENT VIA E-MAIL to Linda Alexander-Giles at linda.alexander-giles@fda.hhs.gov, no later than December 15, 2008 at 3:00 PM Eastern Time for consideration.
- Web Link
-
FedBizOpps Complete View
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- Place of Performance
- Address: Food and Drug Administration, Cener for Drug Evaluation and Research, Office of Surveillance Epidemiology, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN01700398-W 20081106/081104214814-759747148f8f6b2e12161851f4ed4079 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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