SOLICITATION NOTICE
B -- Clinical Study Data and Research Services
- Notice Date
- 7/27/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy & Infectious Diseases/AMOB, 10401 Fernwood Drive, Suite 2NE70, MSC 4811, Bethesda, MD, 20817
- ZIP Code
- 20817
- Solicitation Number
- NOI6061
- Response Due
- 8/10/2006
- Archive Date
- 8/25/2006
- Description
- This is a combined/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are not being requested and a written solicitation will not be issued. The solicitation number for this acquisition is NOI6061 and the solicitation is being issued as a notice of intent. This solicitation document and its incorporated provisions are those in effect through the Federal Acquisition Circular (FAC 2005-11). This acquisition will be processed under Simplified Acquisition Procedures and is not a Small Business Set-Aside. The National Institute of Allergy and Infectious Disease (NIAID) intend to procure from International TB Research Center Clinical Study Data and Research Services. We must maintain continuity of the Multidrug Resistant Mycobacterium Tuberculosis (MDR-TB) Study. The purpose of this requirement is focused on clinical research in infectious disease. Scientific areas include all infectious diseases (e.g., HIV, TB, malaria, STDs, diarrhea diseases, respiratory diseases, and vector-borne diseases). The Contractor will participate in developing the protocol, patient consent forms, and case report forms (CRFs) used in studies. The Contractor will provide comments on these documents on electronic versions of these documents in the NIAID-compatible format. The contractor will maintain the patient consent forms and patient records at the hospital in a secured room or cabinet. Contractor will maintain an Institutional Review Board (IRB) to review proposed research protocols that involve human subjects. The IRB must meet the standards set out in US 21 CFR part 56. The contractor will maintain registration of the IRB and provide documentation of IRB members training, by-laws and other documents in order to be awarded a Federal Wide Assurance certification. The contractor will implement at least monthly basis, data entry into the web-based SQL database provided by NIAID. The contractor will arrange for at least quarterly shipping of samples to NIAID or more frequently as requested. The contractor will aid the preparation of F-PET studies of drug penetration into tubercular lung tissue protocol. The contractor will assist in the preparation of tissue according to scanning ionization mass spectrometry study of drug penetration into tubercular lung tissue protocol. The contractor will provide Genotype/Phenotyping of MDR strains. Contractor will collect and process lung resection specimens including dissection, tissue preservation and mycobacterial culture of sputum, and BAL. The contractor will process blood from patient samples to isolate leukocytes, DNA, and RNA. The contractor will support database development and implementation. The contractor will submit an electronic copy of the progress reports on the conduct of the clinical studies including protocols, CRFs, reviews of these documents, reports of data collected from the medical, microbiological, molecular and radiology data collected. The contractor will submit this report every six (6) months and thereafter. The North American Industry Classification System (NIACS) Code for this acquisition is 541380, and the small-business size standard is $11.0 million dollars. This is a firm fixed-price contract and the FOB terms are ?Destination? and Net 30. FAR provisions and clauses that apply to this acquisition: FAR 52.212-1, Instructions to Offerors, Commercial Items; FAR 52.212-3, Offeror Representations and Certifications-Commercial Items; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders, Commercial Items; FAR 52.225-1, Buy American Act-Supplies; FAR 52.204-7, Central Contractor Registration; and FAR 32.703-2, Availability of Funds, FAR 52.232-34, Payment by Electronic Funds Transfer-Other than Central Contractor Registration. In order to be considered for an award, an offeror must have completed the online electronic Representations and Certifications located at http://orca.bpn.gov/ in accordance with FAR 4.1201(a). By submission of an offer, the offeror acknowledges the requirement that a prospective awardee will be registered in the CCR at www.ccr.gov/ prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation [Note: Lack of registration in the Central Contractor Registration will make an offeror ineligible for award.] Offers must be submitted no later than 5:00 P.M. Eastern Daylight Time on Thursday, August 10, 2006.For delivery of responses through the Postal Service, the address is NIH/NIAID/OA, 10401 Fernwood Drive, Suite 2NE70, Room 2NE38E, MSC/2811 Bethesda, Maryland 20892-4812. E-mail and Fax submissions are not authorized. Requests for information concerning this requirement will be submitted in writing, and can be faxed to 301-480-0469, or e-mailed to whitear@niaid.nih.gov. It is the vendor?s responsibility to confirm receipt of all quotations and/or questions by the closing date of this announcement by contacting Arlene White at 301-402-5770. Collect calls will not be accepted.
- Place of Performance
- Address: National Institutes of Health NIAID, Bethesda, MD
- Zip Code: 20892
- Country: UNITED STATES
- Zip Code: 20892
- Record
- SN01099281-W 20060729/060727220455 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |