SOURCES SOUGHT
B -- Quality Assurance Unit For The HPV Type 16 Vaccine Trial in Costa Rica
- Notice Date
- 11/18/2003
- Notice Type
- Sources Sought
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-N02-CP-21003
- Response Due
- 1/2/2004
- Archive Date
- 1/17/2004
- Point of Contact
- Karen McFarlane, Contracting Officer, Phone (301)435-3782, Fax (301) 480-0241, - Sharon Miller, Contracting Officer, Phone (301) 435-3783, Fax (301) 480-0241,
- E-Mail Address
-
km63k@nih.gov, sm103r@nih.gov
- Description
- The National Cancer Institute (NCI), Division of Cancer Epidemiology & Genetics (DCEG), Hormonal and Reproductive Epidemiology Branch (HREB) intends to negotiate on a sole source basis with Westat, Inc. for an increase/expansion of services currently being performed under Contract No. N02-CP-21003, entitled ?Quality Assurance Unit For The HPV Type 16 Vaccine Trial in Costa Rica?. The proposed action will include an increase/expansion of services currently being performed under the contract as follows: 1) to conduct record reviews for 100% of critical fields (e.g., informed consent) and fields related to study outcomes (e.g., CIN 2+), and for 20% of all other fields on case reporting forms will be monitored by an outside reviewer; 2) monitors will verify that field, clinical, and laboratory activities and equipment used in the trial comply with Standard Operating Procedures; 3) external audits will be conducted periodically, with greatest frequency during the initial year of enrollment and vaccination and at closeout of the trial to assure compliance with protocol and procedures of the HPV vaccine trial; 4) training of personnel, preparation of forms, and submission of documents to NCI following audits will be increased as required; 5) adverse event reports will be tracked to assure that all source documents for serious adverse events are reported in an expedited manner; and 6) case reporting forms, procedure manuals, and SOPs that will be used in the trial will be developed and translated into both English and Spanish. Authority: 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1(a)(2) (ii). See numbered Note 22. Numbered Note 22 applies as follows: The proposed contract action is for supplies and services for which the Government intends to solicit and negotiate with only one source under FAR 6.302. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within forty-five days after date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon 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. No collect calls will be accepted.
- Place of Performance
- Address: 1650 Research Boulevard, Rockville, Maryland
- Zip Code: 20850
- Country: USA
- Zip Code: 20850
- Record
- SN00471934-W 20031120/031118211923 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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