SOLICITATION NOTICE
R -- Professional Services
- Notice Date
- 8/28/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541611
— Administrative Management and General Management Consulting 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
- 1004667
- Response Due
- 9/12/2005
- Archive Date
- 9/27/2005
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, identified as No. 1004667, is to notify contractors of the government?s intent to award a purchase order to Karen H. Hass Enterprise Inc. under the simplified acquisition procedures. The FDA intends to issue a purchase order on a sole source basis to Karen H. Hass Enterprise Inc., 2120 Golf Course Drive, Reston, VA 20191, as in accordance with FAR Part 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements due to the following reasons: Ed Hass of Karen H. Hass Enterprise Inc. is an expert analyst with knowledge and experience in the definition of drugs and the identification of drug classes, definition of drug prices using IMS data, and statistical methods appropriate for the proper characterization of the effects of new drugs on drug prices. Mr. Hass is uniquely qualified for this work for several reasons. While at FDA he began, but did not complete, the construction of a database containing: 1) all new active substances approved for marketing in the U.S. since 1999 and 2) all drugs with both chemical structure and therapeutic effect similar to each of these new active substances. This set of drugs is more comprehensive and more up-to-date than those used in other recent papers including those published in Pharmacoeconomics and Regulation. In addition, Mr. Hass has extensive experience and deep familiarity with the various measures of revenue and units (standard units, extended units and kilograms) available in proprietary data from IMS, a private company with which FDA has an existing contract. Familiarity with these data is essential to defining the measure of drug price that is appropriate for this study. Finally, Mr. Hass has extensive practical experience applying appropriate statistical analyses to drug price data derived from IMS data. While at FDA he conducted studies comparing U.S. drug prices with those in Canada and Australia, and was a key senior analyst in the development of the international drug price comparisons underlying important chapters in the 2004 HHS Task Force Report on Drug Importation of the Surgeon General. Looking for an alternative contractor other than Mr. Hass would delay this project beyond the time horizon desired by ASPE, which is asking for our help completing this project. These reasons, considered in their entirety, uniquely position Karen Hass Enterprise, Inc. to do the required work with a dramatically reduced ramp-up period. FDA anticipates a sole source award to Karen H. Hass Enterprises, however, other sources may submit descriptive literature that fully demonstrates their capabilities and they will be reviewed to determine if they are considered qualified. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular(FAC) 2001-27. The associated NAICS code is 541611 ? Administrative Management and General Management Consulting Services and the small business size standard is $6M. The following is background information and the services Karen H. Hass Enterprise will be requested to provide: Analytic Support for Research - The Impact on Prescription Drug Spending of Follow-On and Generic Drugs. The rapid rise in prescription drug spending and the implementation of Medicare Part D have intensified the interest in methodologies for making drug-spending projections. The Office of the Actuary of CMS has principal responsibility for tracking and projecting all aspects of health spending in the U.S. Their projection model and methods have been subject to increased scrutiny since the passage of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and they have publicly stated they will be updating and modifying the model. The impact on past drug spending of key factors such as market entrance of breakthrough drugs, follow-on drugs, and generic competitor, as well as switches from prescription to over-the-counter (OTC) drug status, may provide important information for updating projection models. Indeed, there is significant potential for increased generic competition and OTC switches in the near future as patents for many top-selling drugs are due to expire. New estimates and modeling are required to estimate the potential impacts of these factors. Moreover, the evidence concerning the price and spending impact of follow-on drugs has not been conclusive with regard to the magnitude and direction of impact. For example, some studies suggest the entrance of follow-on or ?me too? drugs moderate price increases while other studies suggest the opposite. The purpose of this request for services is to support research concerning the market impacts of follow-on and generic drugss. The project will use IMS and other data sources to examine these impacts in the past and build capacity for projecting future impacts and analyzing policy proposals. Staff from the Office of the Assistant Secretary of Planning and Evaluation (ASPE), HHS and the Office of Policy andPlanning (OPPl), FDA will conduct the majority of the research. However, contract support is required for certain data analysis and programming necessary to conduct a statistical analysis of alternative methods of measuring results. Scope of work: In consultation with the project officer and other staff from OPPl and ASPE, the contractor will conduct the following tasks: 1. Develop an Excel database that identifies all new active substances (NAS) approved for marketing by FDA since 1999 including marketed NAS which are similar in chemical structure and therapeutic effect. This database will also include defined daily doses (DDDs) as specified below. (a). Identify and list generic names for all NAS approved for marketing by FDA since 1999 and all NAS which have been marketed in the U.S. during or after 1999 and which are similar in chemical structure and therapeutic effect. (b). For each NAS listed in 1a, list defined daily doses (DDDs) for which DDDs have been published either by the World Health Organization (WHO) or by an equivalent organization. 2. Prepare a report containing the analysis and findings for evaluating the statistical merit of alternative approaches to comparing the prices of me-too drugs to the prices of incumbent products, taking into account differences across drug classes and time. The contractor will provide all necessary programming support for analyzing data, including IMS data as provided by the FDA, and other required databases, and will provide all necessary statistical and other analytic support required to complete the project tasks. There will be draft databases and a final database as deliverables with scheduled due dates. The period of performance is one year. The provision at FAR 52.212-1, Instructions to Offerors?Commercial Items applies to this solicitation. The following agenda have been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications?Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions?Commercial Items applies to this acquisition. The following agenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders?Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, FAR 52.225-3, FAR 52.225-15, FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. The FDA intends to make award immediately following the response date on this notice. All responsible sources that intend to submit descriptive literature shall submit it by COB on the due date referenced above to the following address or e-mail: Food and Drug Administration, 5630 Fishers Lane, Room 2083, HFA-500, Rockville, Maryland 20857-0001 or Lforgosh@oc.fda.gov. The Government will award a firm-fixed-price purchase order using Simplified Acquisition procedures in accordance with FAR 13.5. For information regarding this solicitation, please contact Lori Forgosh at 301-827-7044, fax 301-827-7106 or e-mail Lforgosh@oc.fda.gov.
- Place of Performance
- Address: Karen H. Hass Enterprises Inc. (primary), 2120 Golf Course Drive, Reston, VA, and, FDA (secondary), 5600 Fishers Lane, Rockville, MD 20857
- Zip Code: 20191
- Zip Code: 20191
- Record
- SN00881423-W 20050830/050828211537 (fbodaily.com)
- Source
-
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