SOLICITATION NOTICE
R -- Data Entry for ADE Reports
- Notice Date
- 3/3/2007
- Notice Type
- Solicitation Notice
- NAICS
- 561410
— Document Preparation 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, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- 1027270gh
- Response Due
- 3/9/2007
- Archive Date
- 3/24/2007
- Description
- The Food and Drug Administration intends to procure on a sole source basis professional services from Sonya Barbee, Rockville, MD 20857. PERIOD OF PERFORMANCE: Beginning May 1, 2007 and NTE 1368 hours. The FDA/Office of Surveillance and Compliance, Division of Surveillance is tasked with the technical review of Drug Experience Reports consisting of adverse drug events (ADEs), labeling and advertising. The Division of Surveillance is responsible for monitoring the safety and effectiveness of animal health drugs under the authority of the Federal Food, Drug, and Cosmetic Act, regulations, guidance?s and regulatory actions. During the past 14 years, Surveillance has developed an adverse drug event system that is paper based with manual entry of data. Surveillance is presently developing an automated adverse drug event system by converting from a paper-based system to an electronic system. The system is unique to the Agency?s mission in regards to public and animal health. SCOPE OF WORK: (1) Enter adverse drug event data from the paper ADE reports to allow more efficient retrieval and evaluation. The paper reports must be entered during 2007 in preparation for the conversion to a fully electronic processing system for ADEs. (2) Review reports and enter data into the STARS program in detail in a timely manner with the information accurately identified for data retrieval by Veterinary Medical Officers using the information to complete urgent and mission critical work. (3) Conduct DER M Package Label Reviews using the Corporate Data Portal (CDP). (4) Navigate the CDP using multiple modules to perform M package reviews, which include: DER History, SubList, Document Overview, and the M package reviewer screen. (5) Perform duties and responsibilities as a Consumer Safety Officer as needed. (6) Monitor ADE Hotline daily, which requires handling consumer complaints and directing the inquiries to the appropriate personnel. Record and respond to incoming messages from consumers whose animals have experienced adverse effects to various drugs. Handle inquiries and process complaints, or refer to appropriate personnel. (7) Create and maintain an electronic log book to track the flow of documents. (8) Serve as the main point of contact to prepare travel for the Division. She has the expertise to perform necessary task using the customized ADE reporting system. She is qualified to analyze the adverse drug events and to assist with reducing the backlog. This acquisition will be conducted under simplified acquisition procedures. The NAICS code classification is 561410. This notice is not a request for proposals and no solicitation documents exists for this requirement. However, anyone interested in responding to this notice will need to submit technical data, including cost, sufficient to determine capability in providing the same products and services. All capability statements received by 2:00 p.m., EST, March 9, 2007 will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Inquiries must be submitted in writing by facsimile on (301) 827-7106 or email. No telephone inquiries will be accepted.
- Place of Performance
- Address: Rockville, MD
- Zip Code: 20857
- Country: UNITED STATES
- Zip Code: 20857
- Record
- SN01243378-W 20070305/070303220209 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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