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Surveillance for Antimicrobial Susceptibility of Gonorrhoeae in Transgender Women (TGW) in the Vicinity of Pattaya, Thailand


Maryland, United States
Government : Military
RFI
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This is a notice of intent to issue an award on the basis of other than full and open competition in accordance with the Federal Acquisition Regulation (FAR) 6.302-1 only one responsible source and no other supplies of services will satisfy agency requirements.

The US Army Medical Research Acquisition Activity (USAMRAA) The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to issue a single source award to Sisters Foundation (SISTERS) Pattaya, Chonburi, Thailand. The total award amount is estimated to be $103,000.00. This new requirement is for the contractor to provide support services for the surveillance for antimicrobial susceptibility of Gonorrhoeae in transgender women (TGW) in Pattaya area, Thailand. This support will include filed advertisement. Additionally, this support will include the rental site infrastructure for sample enrollment, sample compensation, sample collection, and sample storage before transporting the samples to perform laboratory testing at AFRIMS.
Objectives: The objective of this requirement is to provide support services for the surveillance for antimicrobial susceptibility of Gonorrhoeae in transgender women (TGW) in Pattaya area, Thailand. This support will include filed advertisement. Additionally, this support will include the rental site infrastructure for sample enrollment, sample compensation, sample collection, and sample storage before transporting the samples to perform laboratory testing at AFRIMS.

Specific Task/Requirement:
1. Projects shall be conducted in accordance with the prescribed protocols, current or amended as may be available and approved by international and local regulatory authorities.


2. The conduct of the study shall be based on the applicable portions of the US Code of Federal Regulations (CFRs) for clinical studies, including but not limited to Good Clinical Practice Regulations (Title 21 CFR Parts 11, 50, 54, 56), the Health Insurance Portability and Accountability Act (HIPPA) of 1996 (Pub L. 104-191, 110 Stat. 1936, enacted August 21, 1996), and International Conference on Harmonization Guidelines for Good Clinical Practices (GCPs) (ICH Guidelines for Good Clinical Practice (E6), Published May 9, 1997).


3. Execution of the protocol shall collaborate with the USAMRDC, local Regulatory Authorities, USAMD-AFRIMS, and local collaborators, stakeholders and communities.


4. The contractor shall apply the principles of Good Clinical Laboratory Practice (GCLP) in all aspect of the studies, meeting quality and management standards to ensure laboratory data integrity, accuracy, and completeness. The contractor will coordinate with AFRIMS and the study teams in the execution of the projects and laboratory operations, to include, but not limited to: organization and personnel, facilities, equipment use and maintenance, maintain adequate supply of materials and reagents, standard operating procedures in sample management encompassing sample collection, transport and chain of custody, sample storage/retention of samples, proper record keeping/reporting as well as ensure reports are available for quality control/quality audits.


5. Sample Enrollment Support. The contractor shall:
a. Identify potentially eligible subjects using study inclusion criteria.
b. Generate subject identification code list (Deliverable 1)
c. Obtain written informed consent forms form participants (Deliverable 2)


6. Sample Compensation Support. The contractor shall distribute the sample compensation to the participants who comply with all study inclusion criteria.


7. The contractor shall administer management, field advertisement and social communication for understanding the research aim, scope and community advantages, as appropriate


8. Sample Collection Support. The contractor shall:
a. Support participant samples collection and storage
b. Identify best possible shipping methods and ship/deliver these samples to AFRIMS (Deliverable 3)


9. Required Reporting. The contractor shall:


a. Report protocol deviations to the WRAIR IRB and Thai MoPH (Deliverable 4)
b. Report all unanticipated problems involving risks to subjects or others to the WRAIR IRB and Thai MoPH (Deliverable 5)


10. Site Infrastructure. The contractor shall provide management support for the use of physical sites for biomedical research such as clinics, health centers, laboratories, office space, and/or hospitals that are appropriate to the scientific requirements of the research project. Infrastructure costs may include site rental, utilities, and facility upgrades as necessary to meet regulatory requirements. (Deliverable 6)


This is not a formal solicitation or request for quote. This synopsis of intent is to give notice of the Government's intent to make a sole source award. Contractors who can provide USAMRAA with the required services are invited to electronically submit an affirmative, written response indicating a bona fide ability to meet this specific requirement. Responses should appear on company letterhead and include, at minimum, affirmation of active registration in the System for Award Management (SAM), your Data Universal qualifications, and any applicable pricing data or information. All responses should include a point of contact, telephone number, and electronic mail address. Additionally, respondents should indicate whether they are a large business, small business, small disadvantaged business, 8(a) concern, women-owned small business, HUBZone, service disabled veteran-owned small business, or qualify as socially or economically disadvantaged and whether they are U.S. or foreign owned. Responses to this notice will be used to determine the availability of this type of service. All responsible sources may respond to this synopsis and all responses will be considered by the agency.


Responses should be furnished electronically to flodean.p.billings.civ@mail.mil no later than 9:00AM Eastern Standard Time, 02 August 2019.


 


Flodean Billings, Contract Specialist, Phone 3016192648, Email flodean.p.billings.civ@mail.mil

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