B01-Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Date: 12/16/2020

Contracting Office Address – US Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014

Subject: Notice of Intent to Sole Source –Assessment on the Effects of Exercising under Non-heat Acclimatized and Heat Acclimatized Conditions

Solicitation Number: W81XWH21R0114

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis IAW FAR 6.302-1 with University of Birmingham

This contract is a non-personal services contract for Clinical trials to assess the effects of exercising under non-heat acclimatized and heat acclimatized conditions on exogenous glucose oxidation and glucose turnover in human volunteers. The contractor shall provide intellectual assistance in research design and conduct, to include all data collected and a comprehensive final report that could be in the form of a peer-reviewed scientific publication or multiple publications with detailed appendices separate from quarterly reports.

The Analysis Services will include the following tasks:

3.1.1. Task 1: Clinical Development/Clinical Study Support

3.1.1.1: Clinical Protocol Support. The Contractor shall provide scientific/expert and administrative support in order to develop clinical protocols and related documents. The Contractor shall support coordination of scientific and human use review of all clinical study protocols by the Institutional Review Board (IRB) of record and by the Office of Research Protections (ORP) of the US Army Medical Research and Development Command (USAMRDC), Fort Detrick, MD. The contractor shall be responsible for the electronic Trial Master File.

3.1.1.2.: Clinical Supplies and Equipment. The Contractor shall obtain supplies and equipment essential to the mission of conducting the clinical trial in a cost effective and timely manner. The contractor shall:

• Provide exercise intervention design, supplies and equipment costs.

3.1.1.3: Clinical Recruitment Support. The Contractor shall provide scientific/technical and administrative support for the recruitment of study volunteers. Work in this task includes, but is not limited to: developing recruitment strategy (ies), and developing marketing materials (e.g.:

advertisements, fliers, commercials, etc.) as needed to achieve the recruitment goals of the study. The Contractor shall:

• Provide volunteer recruitment, marketing, communication, and advertising services.

• Recruit, 20 volunteers to complete the clinical trial.

• Enroll, retain, and provide Volunteer stipend for 16 volunteers.

3.1.1.4: Perform study and site management activities. The contractor shall provide clinical site/facilities and associated personnel capable of performing clinical studies. The contractor shall provide medical, scientific, technical and administrative support necessary to manage clinical sites and/or activities associated with the study and to conduct the study. Activities include:

• Provide qualified and experienced site staff at adequate levels to support clinical studies.

• Provide Medical Oversight, Project Management and Intervention Oversight service to execute clinical study protocol.

• Implement and/or validate computer-related systems (i.e. data management systems) and equipment necessary for conduct of the clinical study.

• Provide Principal Investigator (PI) support to collaborate with USARIEM on human clinical project study designs during protocol development and project progress once initiated via conference calls, emails, written documentation, and face-to-face meetings, and with analysis of the data collected as part of the study. Obtain approval for conducting human research from the local Institutional Review Board (IRB) and the appropriate Human Research Protection Office (HRPO) of the U.S. Army Medical Research and Development Command. Complete data collection on 16 volunteers. Conduct comprehensive statistically-appropriate analyses of collected data.

• Complete medical screening procedures, consisting of a medical history questionnaire, medication use/adverse event assessment, physical exam, physical activity assessment.

• Perform the exercise intervention in under temperate/dry (20°C, 20% RH) and hot/dry (40°C, 20% RH) conditions

• Perform 16.1 km time trial performance test, which includes familiarization tests and 3 criterion tests per volunteer, for 20 volunteers.

• Perform 3 stable-isotope protocols and analysis to assess exogenous glucose oxidation and glucose turnover per volunteer, for 20 volunteers, which include intravenous blood draws, muscle biopsies, and bolus intravenous administration of stable isotopically labeled glucose per test.

• Provide medical screening failures, serious adverse event collection and management services.

3.1.1.5: Clinical Data Management. The Contractor shall provide full clinical data management services, using electronic systems. Use of paper systems will be limited and only accepted on a case by case basis, such as a site location with limited access to electricity. Clinical data management services include, but are not limited to: protocol review, Case Report Form (CRF) or electronic Case Report Form (eCRF) creation and modification, CRF or eCRF completion instructions, clinical database development, programming, testing and validation, end user training, data tracking, data entry, data query generation and resolution, medical coding (using MedDRA and WHO-DD dictionaries), database locking or unlocking, data transfer, data reconciliation, and reporting. The contractor shall:

• Perform data entry services and data collection, oversight, software management, and transfer services.

3.1.1.6: Final Clinical Study Report. The Contractor shall provide scientific/expert and administrative support for development of the final clinical study report.

3.1.2 Task 2 Regulatory Support

3.1.2.1.: Regulatory Document Support. Provide scientific/technical, financial, regulatory, and administrative support for development, review, and/or submission of product regulatory documents to regulatory bodies. All regulatory documents shall be developed in collaboration with the Sponsor, in accordance with eCTD format. Examples of regulatory documents include, but are not limited to:

Non-clinical protocols and reports Clinical Synopsis, Protocols and Reports Case Report Forms Source documents Validation packages for assays, software, or medical devices Investigator Brochures Chemistry, Manufacturing, and Controls Sections Letters of Cross Reference Import/Export Request Letters Annual Reports, Safety Reports, Protocol/Information Amendments 513(g)

3.1.2.2.: Regulatory Meeting Support. The Contractor shall provide scientific, technical, regulatory, and administrative support for the conduct of regulatory meetings to include preparation of read-ahead packages and meeting minutes.

3.1.3. Task 3 Research Involving Human Subjects: The Contractor shall oversee the execution of the research to ensure compliance with this section. The Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 USC 980 and, when applicable, FDA policies and regulations.

The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph (c)(1) or (c)(2) have been met:

(1) The Contractor furnishes to the ORP, with a copy to the KO and COR, an assurance of compliance and IRB approval and receives notification from the KO that the ORP has approved the assurance as appropriate for the research under the Statement of Work and also that the ORP has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor may furnish evidence of an existing assurance of compliance for acceptance by the ORP, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the KO immediately of any suspensions or terminations of the assurance.

(2) The Contractor furnishes to the ORP, with a copy to the KO and COR, a determination that the human research proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the KO that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR 219.101(b) and a rationale statement.

In the event of a disagreement regarding the Contractor’s furnished exemption determination, the ORP retains final judgment on what research activities or classes of research are covered or are exempt under the contract.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS. Responsible, interested parties may identify their interest by submitting capability information, in writing, by 2:00 p.m. est.

30 December 2020 to Mr. Nathaniel Reus at Nathaniel.a.reus.civ@mail.mil. Supporting evidence must be furnished in sufficient detail to demonstrate the firm’s ability to provide the stated capability.

Responses will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. If no responses are received, USAMRAA will proceed with the sole source contract.

mailto:Nathaniel.a.reus.civ@mail.mil