RFP Announcement: Pilot and Feasibility Trials for Osteoporosis, RFP NIH-NIAMS-BAA-05-02

Notice Number: NOT-AR-05-003

Key Dates
Release Date: January 7, 2005

Issued by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) , (http://www.niams.nih.gov/)

The National Institute of Arthritis and Musculoskeletal and Skin Diseases announces the availability of a Broad Agency Announcement (BAA) which describes in general terms a research topic and outlines proposal preparation requirements. The purpose is to solicit proposals for small, pilot, and feasibility clinical trials and to encourage the adequate testing of novel and innovative potential therapies for osteoporosis. Projects supported would be early phase human trials to test basic safety and efficacy of treatments that would not be otherwise developed and pursued by private industry. The objectives of this initiative are to: 1) Identify and begin clinical testing of potential bone active agents; and 2) Perform initial dosing trials; and 3) select appropriate populations and endpoints for larger scale testing in appropriately powered clinical intervention trials. To achieve the main goal of this BAA, the NIAMS seeks to support small, pilot and feasibility trials. The trials should be designed so that the preliminary data obtained would be sufficient to design the next phase (for example, Phase II/III), for which the investigators will have to seek separate funding or obtain evidence of efficacy where a large, double-blind, placebo-controlled trial is not feasible.

It is anticipated that two to three cost reimbursement contract awards will be made for a period of three years beginning on or about September 30, 2005. This acquisition has been designated as full and open competition under the North American Industrial Classification System (NAICS) code 541710. The solicitation will be available electronically on or about January 14, 2005. RFP NIH-NIAMS-BAA-05-02 will be available at the FedBizOpps Website: http://www.fedbizopps.gov and at the NIAMS Website: http://www.niams.nih.gov/rtac/funding/grants/rfp/wwwrfp.htm. Proposals will be due on or about March 25, 2005. Offerors are responsible for downloading their own copy of the solicitation and amendments and for routinely checking the Internet site for any possible solicitation amendments that may be issued by the Government. All responsible sources may submit proposals which will be considered by the Government. This advertisement does not commit the Government to award a contract.


Inquiries may be directed to:

Dean Guidi
Contract Specialist, Contracts Management Branch, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Boulevard
Democracy One, Suite 800, MSC 4872
Bethesda, Maryland 20892-4872
Telephone: 301-594-2543
FAX: 301-480-5996
Email: guidid@mail.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

H H S Department of Health
and Human Services

  N I H National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892