RFP Announcement: International Clinical Sciences Support - NIH-NIAID-DMID-05-07
Notice Number:NOT-AI-04-053
Key Dates Release Date: September 3, 2004 Receipt Date: November 15, 2004
Issued by National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)Description
The Division of Microbiology and Infectious Diseases (DMID), of the National
Institute of Allergy and Infectious Diseases (NIAID), of the National
Institutes of Health (NIH), intends to compete a requirement currently being
performed by Family Health International (FHI) under Contract No.
N01-AI-05403. This solicitation is being issued under full and open competitive
procedures. DMID supports extramural research to diagnose, treat, and
prevent diseases caused by virtually all human infectious agents except HIV.
DMID supports projects spanning the entire spectrum of biomedical research
from early basic research through phase III clinical trials. Through the
contemplated contract, DMID intends to establish and maintain an
International Clinical Studies Support Center (ICSSC). The primary goal of
the ICSSC is to enhance the capacity of international clinical sites to
perform clinical research in accordance with international standards, such as
the International Conference on Harmonization’s (ICH) Good Clinical Practices
(GCP), and to facilitate the planning and conduct of clinical evaluations of
interventions against infectious disease. Studies that require support
include epidemiologic studies and clinical trials that range from small,
early phase trials to large multi-center efficacy trials. These studies are
conducted throughout the world, primarily in Africa, South and Central
America, and Asia. The primary focus of this solicitation is assistance and
site development activities rather than regulatory compliance or monitoring
activities as these services are provided under other DMID-funded contracts.
The activities of all concerned contractors will be coordinated by DMID
staff. Work to be performed will include: assessment of the readiness of
sites to conduct clinical studies; development and design of clinical
protocols; training in clinical research design and conduct, including GCP
and ethical issues, data management, statistical analysis, and safety
monitoring and; logistical/operational aspects of managing the DMID
international clinical research portfolio. It is anticipated that the
resultant contract will require an estimated 4 FTEs with expertise consistent
with the operations of a project of this size and complexity. Any responsible
offeror may submit a proposal that will be considered by the Government. This
notice does not commit the Government to award of a contract. No collect
calls will be accepted. No facsimile transmissions will be accepted. See
Government-Wide Numbered Note 26.
It is anticipated that up to one award for a cost reimbursement, completion
type contract will be awarded for a period of seven (7) years, beginning
approximately July 20, 2005. RFP NIH-NIAID-DMID-05-07 will be available
electronically on or about September 15, 2004, and may be accessed at
http://www.niaid.nih.gov/contract/rfps.htm or http://www.fedbizopps.gov/.
Only electronic copies of the solicitation will be available. All
information required for the submission of an offer will be contained in the
solicitation. Responses to this RFP will be due on/before November 11, 2004.
Any responsible offeror may submit a proposal that will be considered by the
Government, however, this notice does not commit the Government to the award
of a contract. No collect calls will be accepted.
Contracting Office Address
Department of Health and Human Services
National Institutes of Health
National Institute of Allergy and Infectious Diseases
Division of Extramural Activities
Contract Management Program
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD 20892-7612
Point of Contact
David Lisle, Contract Specialist, Phone 301-451-2617, Fax 301-402-0972,
Email [email protected]
Barbara Shadrick, Contracting Officer, Phone 301-496-7288, Fax 301-402-0972,
Email [email protected]
