SOLICITATION NOTICE
R -- Capacity-building activities in Latin America and the Caribbean Basin.
- Notice Date
- 1/6/2009
- Notice Type
- Presolicitation
- NAICS
- 928120
— International Affairs
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-2009-GMI
- Response Due
- 1/23/2009
- Archive Date
- 2/7/2009
- Point of Contact
- Lee Cohen,,
- E-Mail Address
-
lee.cohen@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration (FDA) intends under the authority of FAR 6.302-1 to negotiate on a sole source basis with the Regional Health-Care Training Center, Gorgas Memorial Institute for Health Studies (GMI), Panamá City, Republic of Panamá for services, facilities and evaluation reports on capacity-building activities in Latin America and the Caribbean Basin. The FDA requires a single source capable of hosting, within a single, centralized, well-equipped Latin American location, capacity-building seminars and workshops, and evaluation reports of those and other training activities, related to HHS/FDA expertise in the regulation of foods, drugs, animal feed and medical devices. HHS/FDA requires that the entity be widely reputed among Latin American and Caribbean Basin government, academic, and private circles as being of independent judgment, scientifically sound, and capable of culturally adapting HHS/FDA regulatory curricula and training to local economies within Latin America and the Caribbean Basin. HHS/FDA also requires that the entity have strong relationships with the national Health Ministries of the countries of the region, and the ability to perform rigorous evaluations of training activities. The source will have existing experience with regulatory issues of a public health nature that will permit it to tailor presentations to local conditions, and in the Spanish and Portuguese languages. Specific tasks include the following: Using pre-existing contacts and relationships, the source will be expected to recruit knowledgeable, independent, and experienced regulatory experts to work with HHS/FDA experts to develop curricula for a series of public-health workshops and seminars related FDA-regulated products exported to the United States. Using pre-existing contacts and relationships, the source will be expected to recruit participants for the seminars and workshops who are in Governmental, academic, and industry positions to apply the information learned to take regulatory, manufacturing, or other actions to improve compliance of HHS/FDA-regulated products with HHS/FDA requirements. Strengthening HHS/FDA’s resources and expertise in capacity-building in Latin America and the Caribbean basin, by providing formal assessments to improve the effectiveness and reach of HHS/FDA training activities. Providing conference facilities in an easily accessed, centralized location that can handle up to 50 participants for week-long events in which participants will have constant access to computers and other electronic teaching methods for the duration of the seminar. Providing presentation, audio, and related conference services for facilitation of the events. Providing culturally appropriate translation and interpretation services for participants, including Spanish- and Portuguese-speaking participants. GMI is the only entity that has the facilities, the central location, the established scientific, academic, and regulatory reputation for excellence and independence, and the staff to perform these services. As part of the Panamanian Ministry of Health, GMI has a unique set of relationships with institutions across the region, especially units of other national Governments; this affiliation is critical for assembling and evaluating effective capacity-building activities on behalf of HHS/FDA in Latin America and the Caribbean Basin. GMI has workers that include trainers, physicians, scientists, technical staff and administrative staff. GMI scientific and technical expertise resides in its excellent professional staff members including Ph.D.s, and M.D.s including veterinary physicians with Ph.Ds, and many technicians with Master’s degrees in science. GMI has a specialist in geo-reference, and a group trained in the field isolation of dangerous organisms from animal tissues. GMI has well-established laboratories of virology, parasitology, immunology, genomics, entomology and food and water chemistry. GMI is the national Public Health Laboratory of Panamá, and this makes it the national reference laboratory for malaria, tuberculosis and all viral and bacterial diseases; GMI is also a regional reference laboratory for several pathogens. GMI has departments of epidemiology and biostatistics, chronic-disease studies, health policy, and health and human-reproduction studies. In addition to all these areas of expertise, GMI is also the locus of the Panamanian national committee on human-subjects protection (National Institutional Review Board). A new BLS-3 laboratory currently under construction, along with the expansion and improvement of existing laboratory space, is part of a modernization plan that will significantly enhance the capability of GMI laboratories to provide training in the role that laboratory services play in the regulation of foods and drugs and the delivery of community health care. The unique geographic characteristics of Panama and its transportation (air, sea and land) infrastructure make it an extremely central and accessible location for people from Central and South America and the Caribbean who would attend for training. GMI also has a unique, formalized relationship with HHS that reflects the cooperation between the two organizations that is deeper and more varied than with any other organization in Latin America or the Caribbean Basin. In April 2006, HHS and the Gorgas Memorial Institute concluded a Memorandum of Understanding (MoU) that provides for joint projects “ to improve our preparedness for and response to infectious disease, with particular regard to influenza and other respiratory diseases. Projects could take the form of joint meetings, conferences, training, exchanges of scientists and public health experts….” In October 2007, the Governments of Republic of Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panamá, and the United States of America, created the RHCTC at GMI through an MoU. That MOU provided the RHCTC would work, among other things, to do the following: to serve as a resource for training to build individual and collective capacity to improve the health and health care of the populations of the Participating Countries and better monitor, respond to, and prevent potential, critical infectious-disease threats, actual and potential; improve the skills and abilities of health-care workers to provide basic health care, including preventive care, to populations at-risk and/or in need, with an initial emphasis on situations related to infectious and respiratory diseases, including potential emerging threats; to work collectively to enhance the public health expertise of health-care workers from the Participating Countries,, through an increased knowledge base and competency about the similarities and difference of populations and their health-risks, including cultural barriers to access and delivery of care; and to facilitate the international exchange of information and expertise on surveillance, prevention and control of, and research on, communicable and non-communicable diseases; and detection and response The NAICS code is 928120. This notice is not a request for competitive quotes; no solicitation document is available and telephone requests will not be accepted. However, sources may submit descriptive literature, fully documenting their capability to perform these services, which will be considered by the Agency. A determination to compete this procurement based on response(s) to this notice is solely within the discretion of the Government. A solicitation will be issued to GMI no less than 15 days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement. All inquiries must be received by 10:00 AM (1000) EST on 23 January 2008 to the attention of Lee Cohen, lee.cohen@fda.hhs.gov.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=f855220207972b14bcffa1860ce5edbb&tab=core&_cview=1)
- Place of Performance
- Address: Regional Health-Care Training Center, Gorgas Memorial Institute for Health Studies (GMI), Panamá City, Republic of Panamá, Panama
- Record
- SN01727528-W 20090108/090106220528-f855220207972b14bcffa1860ce5edbb (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 |