Solicitation Number:

RFP-BARDA-08-12

Notice Type:

Solicitation

Synopsis:

The Biomedical Advanced Research and Development Authority(BARDA) intends to purchase the following.Following the 2001 anthrax mail attacks, concerns were raised about the availability of pediatric formulations of ciprofloxacin and doxycycline should another anthrax attack occur. Therefore the development of emergency home preparation instructions for pediatric use of these antibiotic drugs began. It was recognized early in the instruction development process that stability, dose uniformity, and palatability data were crucial to the effectiveness of home preparation instructions. For that reason several studies were conducted in support of emergency home preparation instructions. The data from solid oral dosage formulations of doxycycline and ciprofloxacin when mixed with various household food and drinks were tested and evaluated. Each drug mixed with food/drink was rated for palatability; however, absolute palatability for each mixture was not measured. As a result of these initial studies, there is also interest in determining how home preparation instructions could be a viable component of a home MedKit for personal stockpiling purposes.
In light of these laboratory studies, CDER posted doxycycline emergency home preparation instructions for anthrax prophylaxis on its external website in 2002. These instructions were intended to assist the layperson during an emergency in taking solid oral dosage forms of doxycycline and converting them to child-friendly, liquid oral dosage forms using commonly-available household materials. In 2005, it was decided by the CDC working group that the instructions that were developed from this 2001 initiative were to be included as a component of the Medkits.

The purpose of this acquisition is to identify commercial entities capable of designing and performing food palatability studies to mask the bitter taste of doxycycline and ciprofloxacin, and capable of evaluating home preparation instructions acceptability of these drugs, in terms of delivery of dose. The final objective of the palatability studies should be the identification of foods, pharmaceutical flavoring additives and/or instruction procedures that will most successfully mask the unpleasant taste of ciprofloxacin and doxycycline solid oral dosage forms intended to be used in pediatric, dysphagic, and elderly populations.
The final objective for the home preparation studies should be to evaluate performance of the home preparation instructions when performed in a household by laypersons.

The Government intends to acquire a commercial item/service using FAR Part 12.

It is anticipated that one contract for food palatability studies to mask the bitter taste of doxycycline and ciprofloxacin and for studies evaluating home preparation instructions will be awarded. However, the Government reserves the right to make multiple awards. RFP-BARDA-08-12 will be available electronically through the FedBizOpps on or about February 8, 2008. Responses will be due on or about March 8, 2008. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to the award of a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26. All responses should be identified with RFP-BARDA-08-12 and should be submitted to the Contracting Office Address identified in this notice.

Contracting Office Address:

Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority 330 Independence Avenue, SW, Rm G640, Washington, DC, 20201, UNITED STATES

Primary Point of Contact.:

Secondary Point of Contact:

Point of Contact(s):

Leon Snyder, Contract Specialist, Phone 202-260-1720, Fax 202-205-4520, Email leon.snyder@hhs.gov - Darrick Early, Contracting Officer, Phone 202-260-0293, Fax 202-205-4520, Email darrick.early@hhs.gov