SOLICITATION NOTICE
H -- AVRP Quality Assurance Monitoring
- Notice Date
- 9/3/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2004-N-01474
- Response Due
- 10/3/2004
- Point of Contact
- Peter Penny, Contract Specialist, Phone 770-488-1115, Fax 770-488-2777, - Lorenzo Falgiano, Contract Specialist, Phone (770) 488-2629, Fax (770) 488-2670,
- E-Mail Address
-
pmp7@cdc.gov, ljf5@cdc.gov
- Description
- The Centers for Disease Control and Prevention, CDC, is sponsoring a study of Anthrax Vaccine Adsorbed (AVA, BioPort Corporation, Lansing MI). This includes a human clinical trial conducted under an FDA Investigational New Drug (IND) application. The study is designed to evaluate the feasibility of changing the route of AVA administration and dose reduction of AVA. Based on feedback from several Good Laboratory Practices and data management audits, CDC now requires independent oversight for the development and documentation of a quality systems initiative governing the CDC Anthrax Vaccine Research Program (AVRP). The successful offeror should have proven quality assurance system development expertise as well as demonstrated experience and success in Q/A monitoring and auditing of laboratories that are conducting analytical testing under Good Laboratory Practice guidelines or compliance. It will be advantageous for offerors to have an established network of subject matter expertise pertaining to FDA regulated vaccine clinical trials that can be applied to this project. Only written requests, directly from the requestor, will be accepted. Email requests will be accepted. No telephone requests will be accepted. Requests should reference the solicitation number, state the name of the firm, name of the requestor, mailing address, telephone number, fax number, and email address. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (03-SEP-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 30-SEP-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/CDCP/PGOA/2004-N-01474/listing.html)
- Record
- SN00907863-F 20051002/050930213723 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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