A02 RFI Sources Sought.pdf

Subject: Clinical Trial Assessment Based on Exercising Under Non-heat and Heat acclimatized Conditions, U.S. Army Research Institute of Environmental Medicine (USARIEM)

THIS IS NOT A REQUEST FOR PROPOSALS (RFP) OR A REQUEST FOR QUOTATIONS (RFQ);

IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS

NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO

CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.

1.0 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 RFI. 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 to this RFI. All information received in response to this RFI that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

2.0 SUBJECT: The purpose of this requirement is to conduct a clinical trial assessing the effects of heat acclimatization on exogenous glucose oxidation and glucose turnover during exercise, and subsequent impact on physical performance. To achieve this need, USARIEM requires a study be conducted in human volunteers taking part in three experiments trials each involving 90 minutes of steady-state aerobic exercise followed by a performance test. The trials will need to be conducted under: 1) non-heat acclimatized, temperate/dry (20°C, 20% humidity); 2) non-heat acclimatized, hot/dry (40°C, 20% humidity) and; 3) heat acclimatized, hot/dry (40°C, 20% humidity). Isothermic heat acclimatization to exercise-heat stress will need to take place over nine consecutive days. Within each experimental trial stable isotope methodologies and muscle biopsies will be used to assess changes in glucose oxidation and turnover, glycogen content, and molecular regulation of carbohydrate metabolism. The Contractor shall provide this study and intellectual services to support the USARIEM Military Nutrition Division research programs that conducts research on substrate oxidation and physical performance.

3.0 BACKGROUND: The Military Nutrition Division is one of four research divisions within the U.S.

Army Research Institute of Environmental Medicine (USARIEM). USARIEM's mission is to optimize Warfighter health and performance through medical research. USARIEM is internationally recognized as the premiere DoD laboratory for Warfighter health and performance research and focuses on environmental medicine, physiology, physical and cognitive performance, and nutrition research. USARIEM publishes guidance for DoD operations in hot weather, cold weather, and high-altitude environments, and nutrition for health and performance.

The mission of the Military Nutrition Division is to conduct research that provides the biomedical science basis for developing new rations, menus, policies and programs that enable Warfighter health-readiness and optimal performance. Its focus areas include Recovery Nutrition, Healthy Eating, Dietary Supplements, and Biomedical Performance Enhancement.

4.0 RESPONSE INSTRUCTIONS: Respondents should address the following in their capabilities statement:

Task 1: Clinical Development/Clinical Study Support

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.

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.

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.

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.

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.

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

2.1. Task 2 Regulatory Support

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)

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 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.

5.0 CONTACT INFORMATION: All information regarding Capabilities Statements or any other proprietary information relative to this RFI shall be submitted via email to nathaniel.a.reus.civ@mail.mil no later than 2:00 p.m. E.S.T. on Monday, 4 January 2021.