SOURCES SOUGHT
B -- Monitor National Plasma Supply Data
- Notice Date
- 3/27/2002
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, Program Support Center, Division of Acquisition Management, Parklawn Building Room 5-101 5600 Fishers Lane, Rockville, MD, 20857
- ZIP Code
- 20857
- Solicitation Number
- Reference-Number-02T690127
- Response Due
- 4/9/2002
- Archive Date
- 4/24/2002
- Point of Contact
- Nickie McKenna, Contract Specialist, Phone 301-443-7078, Fax 301-443-2761, - Nickie McKenna, Contract Specialist, Phone 301-443-7078, Fax 301-443-2761,
- E-Mail Address
-
nmckenna@psc.gov, nmckenna@psc.gov
- Description
- The Office of Public Health and Science (OPHS), through the Program Support Center (PSC), is seeking sources to provide monitoring of national plasma supply data. The contractor shall monitor the capacity of the supply of plasma derivatives and their recombinant analogs to meet demand. Background: Because of unanticipated shortages of plasma derivatives, and their recombinant analogs, members of affected patient communities and their advocates have repeatedly requested the Department of Health and Human Services (DHHS) to monitor the supply of plasma derivatives. DHHS anticipates that this monitoring effort it will provide both producers and consumers of plasma derivatives with information that will be useful in anticipating and preventing product shortages, in addition to providing post marketing surveillance for the occurrence of adverse events associated with the use/overuse/ underuse of these products. DHHS hopes that this monitoring effort will promote additional Phase IV studies of the efficacy, and also the comparative efficacy of various treatments for these various diseases. Specific Scientific Need: The contractor shall recruit no less than 500 but no more than 2,000 individuals with diagnosed common variable or X-linked hypogammaglobulinemia whose physician has prescribed a plasma derivative or its recombinant analog on at least a fortnightly (14-day) basis. Due to the orphan disease status of Alpha-1 Antitrypsin Deficiency, the contractor shall maintain a disease specific patient registry which will allow patients to be recruited in a timely manner. Individual participants must be willing to report daily by internet, or by a telephone link to the internet, and provide the following information: 1 the amount, in milligrams or units, infused on that day; 2 the amount prescribed by a physician to take on that day; 3 the amount of product in their own possession; and 4 a list of up to ten predetermined symptoms. The symptoms to be reported will be determined, and to the extent possible justified, by a Medical Advisory Board of the contractor?s choice. The contractor shall collect basic demographic information and baseline clinical information (which shall be updated every six months) on each study participant. The contractor shall obtain prior approval and ongoing review of this human subject research activity from a qualified Institutional Review Board in conformity with 21 CFR 50 (found at http://www.valimation.com/Part 50_Downloads.html). Individuals recruited by the contractor shall sign an informed consent form which has been approved by the contractor?s Institutional Review Board. This form shall be held by the contractor and made available for inspection by the Project Officer during regular business hours for a period of up to 2 years after the termination of this contract. Data shall be entered directly by the study participants into a central server to be provided by the contractor. No data shall be stored on a computer which is not in the possession or control of either the contractor the government. The contractor shall limit access to any computers as necessary to insure patient confidentiality. Data shall be accessible in real time to the Project Officer and/or her/his designated staff. The contractor shall employ a Study Coordinator who shall assist in the recruitment and retention of study participants. This Study Coordinator shall also review on each business day, the date that each study participant provided data for this study. Software for this program will not be provided. If the date is more than seven days prior to the date of review, the Study Coordinator shall attempt to make direct voice contact with the study participant on each of five subsequent business days. If no response is received after such attempts, the Study Coordinator shall contact a third party individual (e.g. physician, parent or friend specified by the study participant) to determine why the participant is not reporting in a timely manner, and to take such steps as are possible or necessary to obtain resumed compliance. The anticipated period of performance is a Basic period of September 30, 2002 through September 29, 2003, and four twelve month Option periods. The closing date is April 9, 2002. Interested concerns may identify their interest and submit a capability statement which demonstrates the ability to provide the specified services by the closing date, referencing 02T690127, attn: Nickie McKenna, Contract Specialist. This notice is not a request for competitive proposals. No solicitation document is available at this time; therefore, requests for such document will be considered invalid responses.
- Place of Performance
- Address: 200 Independence Avenue, SW, Washington, DC 20201
- Record
- SN00049054-W 20020329/020327213147 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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