Justification and Approval for Germany Cohort HIV Study

1.0 GENERAL INFORMATION: The following notice constitutes a Request for Information (RFI). The government is seeking responses from potential sources to meet this requirement, however, if no other capable sources are identified, it is the Government's intent to award a sole source contract to the Institut f'r HIV Forschung (Institute for HIV Research) Universit'tsklinikum Essen (A'R) Universit't Duisburg-Essen (University of Duisburg-Essen), Virchowstr.171, D-45147 Essen, for the requirement outlined in this notice. The US Army Medical Research Acquisition Activity (USAMRAA) in support of the US Army Medical Materiel Development Activity (USAMMDA) intends to award a sole source contract under statutory authority 10 U.S.C. 2304(c)(1) as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy the Agency Requirements. The associated North American Industry Classification System (NAICS) code for this procurement is 541712 with a size standard of 1,000 employees. 2.0 DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this notice. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding. All information received in response to this notice that is marked proprietary will be handled accordingly. Responses will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained. 3.0 SUBJECT: In support of the USAMMDA's mission to develop a subtype B HIV vaccine, it is executing an observational study entitled "Longitudinal incidence study in subtype B-prevalent region among men who have sex with men at risk for HIV infection to determine feasibility of HIV vaccine efficacy trials". This study will be executed in Germany at preselected clinical sites with support from several research laboratories. 4.0 DESCRIPTION: The US Army is pursuing development of a subtype B HIV vaccine and is interested in developing potential clinical sites for future efficacy studies. The HIV epidemic in Germany is predominantly subtype B, similar to the epidemic in US military personnel and in the general US population. The establishment of new sites in Germany will augment those already available in the US, and will ensure that the Army has sufficient numbers of clinical sites with access to a high-risk population for future HIV vaccine efficacy trials. In order to develop new sites and train staff to conduct HIV vaccine trials, an observational cohort study in the target population will be executed. The University of Duisberg-Essen has recruited investigators throughout Germany to conduct the cohort study, which will enroll 1000 men who have sex with men and transgender women to determine the incidence of HIV infection and their willingness to participate in a vaccine trial. The University of Duisberg-Essens' Institute for HIV Research has established a collaboration with the German government Robert Koch Institute (equivalent to the US CDC), the Center for Infectious Disease Research (DZIF), the University of Cologne, and other non-governmental organizations to develop co-funding mechanisms to support the objectives of the cohort study. The University of Duisberg-Essen has been instrumental in bringing together academic, government and nongovernmental organizations to support this study, resulting in cost-sharing agreements for multiple diagnostic assays, research assays, and site costs. This co-funding is available only with the collaborations achieved by the University of Duisberg-Essen; otherwise, the government would be required to bear the full cost of the study. The University has written a final clinical protocol that has been reviewed by the local IRB. It has also prepared a manual of procedures to ensure the sites are consistent in their execution of the study, and study staff has received training on both the protocol and procedures. In addition to holding proprietary information, the University has recruited investigators in each city, who have agreed to collaborate on this study, saving an estimated 6 to 12 months for site recruitment. The University of Duisberg-Essen is uniquely positioned to support the US Military in its development of a subtype B vaccine because of the Institute led by Dr. Streeck, and the collaborations already established within Germany. 5.0 SUBMISSION INSTRUCTIONS: All responses to this notice shall be via e-mail to the point of contact below. Telephone questions or inquiries will not be answered or accepted. Entities interested in submitting a response must furnish in writing, a 2-3 page (not including cover page, index or list of references) synopsis of their capability to perform the requirement described above, a Rough Order of Magnitude estimate of the cost to perform the services, and a separate estimate of the cost and lead time required to achieve the necessary collaborations with the parties identified to perform the work. Companies responding to this notice must provide complete contact information (Company name, Address, Point of Contact, telephone, email address, CAGE Code and DUNS number). Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUB zone, woman owned, service disabled veteran owned). Please also include information regarding any prior experience with U.S. Government contracts and favorable experience working with the FDA. Responders must have an active profile in in the System for Award Management (SAM) and must have current representations and certifications uploaded into their active SAM profile. See https://www.sam.gov for details/instructions. Responses must be sent to later than 4:30PM Eastern Time on 22 Sept, 2017. 6.0 SUBMISSION POINT OF CONTACT: Interested entities shall forward submissions to Dana Kavitski, Contract Specialist, at dana.kavitski.civ@mail.mil.