Medical Product Research and Development (MPRD) Indefinite Delivery Indefinite Quantity Contract

**Amendment 0011 to this presolicitation notice is to notify interested parties that the estimated release date for the solicitation is currently on or before 13 Aug 2014. A more specific date is not available at this time.

There is no response required for this presolicitation notice and questions will not be accepted at this time either by telephone or e-mail.


_____________

This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation will be released via FedBizOpps (www.fbo.gov) to the vendor community sometime in the future but is currently 'to be determined' and cannot be accurately estimated at this time. This notice will be modified to reflect an accurate release date as more information becomes available. When posted, the solicitation will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Joint Project Manager (JPM) Medical Countermeasure Systems (MCS) (formerly Chemical Biological Medical Systems (CBMS)) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0010 to this presolicitation notice is to notify interested parties that the estimated release date for the solicitation is currently between mid-June and 30 July 2014. A more specific date is not available at this time.

There is no response required for this presolicitation notice and questions will not be accepted at this time either by telephone or e-mail.


_____________

This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation will be released via FedBizOpps (www.fbo.gov) to the vendor community sometime in the future but is currently 'to be determined' and cannot be accurately estimated at this time. This notice will be modified to reflect an accurate release date as more information becomes available. When posted, the solicitation will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Joint Project Manager (JPM) Medical Countermeasure Systems (MCS) (formerly Chemical Biological Medical Systems (CBMS)) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0009 to this presolicitation notice is to notify interested parties that the estimated release date for the solicitation is currently 3rd quarter FY14 (April - June 2014). A more specific date is not available at this time. Additionally, the title of this requirement has changed from 'Medical Product Development Support' to 'Medical Product Research and Development (MPRD)'. There is no response required for this presolicitation notice and questions will not be accepted at this time either by telephone or e-mail.


_____________

This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation will be released via FedBizOpps (www.fbo.gov) to the vendor community sometime in the future but is currently 'to be determined' and cannot be accurately estimated at this time. This notice will be modified to reflect an accurate release date as more information becomes available. When posted, the solicitation will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Joint Project Manager (JPM) Medical Countermeasure Systems (MCS) (formerly Chemical Biological Medical Systems (CBMS)) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0008 to this presolicitation notice is to notify interested parties that the estimated release date for the solicitation is currently 3rd quarter FY14. A more specific date is not available at this time. Additionally, the title of this requirement has changed from 'Medical Product Development Support' to 'Medical Product Research and Development (MPRD)'. There is no response required for this presolicitation notice and questions will not be accepted at this time either by telephone or e-mail.


_____________

This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation will be released via FedBizOpps (www.fbo.gov) to the vendor community sometime in the future but is currently 'to be determined' and cannot be accurately estimated at this time. This notice will be modified to reflect an accurate release date as more information becomes available. When posted, the solicitation will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Joint Project Manager (JPM) Medical Countermeasure Systems (MCS) (formerly Chemical Biological Medical Systems (CBMS)) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0007 to this presolicitation notice is to notify interested parties that the estimated release date for the solicitation is currently 'to be determined.' Any updates to the estimated release date or any other information contained in this announcement will be communicated by way of modification to this notice. There is no response required for this presolicitation notice and questions will not be accepted at this time either by telephone or e-mail.

NOTE: The modified Response Date of 9/30/14 above is an arbitrary date which is only established to keep this notice open for an extended period of time to allow for subsequent posts. This date is not related to the solicitation in any way and a response date for the actual solicitation will be posted with the solicitation. There is no response required for this presolicitation notice.

_____________

This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation will be released via FedBizOpps (www.fbo.gov) to the vendor community sometime in the future but is currently 'to be determined' and cannot be accurately estimated at this time. This notice will be modified to reflect an accurate release date as more information becomes available. When posted, the solicitation will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Joint Project Manager (JPM) Medical Countermeasure Systems (MCS) (formerly Chemical Biological Medical Systems (CBMS)) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0006 to this presolicitation notice is to update the estimated release date for the solicitation. There is no response required for this presolicitation notice and questions will not be accepted at this time either by telephone or e-mail.


This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOpps (www.fbo.gov) to the vendor community on or about January 6, 2014 which will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Joint Project Manager (JPM) Medical Countermeasure Systems (MCS) (formerly Chemical Biological Medical Systems (CBMS)) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0005 to this presolicitation notice is to update the estimated release date for the solicitation. There is no response required for this presolicitation notice and questions will not be accepted at this time either by telephone or e-mail.


This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOpps (www.fbo.gov) to the vendor community on or about December 18, 2013 which will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Joint Project Manager (JPM) Medical Countermeasure Systems (MCS) (formerly Chemical Biological Medical Systems (CBMS)) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0004 to this presolicitation notice is to update the estimated release date for the solicitation. There is no response required for this presolicitation notice and questions will not be accepted at this time.


This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOpps (www.fbo.gov) to the vendor community on or about November 14, 2013 which will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Chemical Biological Medical Systems (CBMS) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0003 to this presolicitation notice is to update the estimated release date for the solicitation. There is no response required for this presolicitation notice and questions will not be accepted at this time.


This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOpps (www.fbo.gov) to the vendor community on or about October 14, 2013 which will be available for 45 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Chemical Biological Medical Systems (CBMS) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

**Amendment 0002 to this presolicitation notice is to update the estimated release date for the solicitation. There is no response required for this presolicitation notice and questions will not be accepted at this time.


This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOpps (www.fbo.gov) to the vendor community on or about September 16, 2013 which will be available for 60 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Chemical Biological Medical Systems (CBMS) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

** Amendment 0001 to this presolicitation notice is to inform potential offerors that the Response Date of 4/18/14 is an arbitrary date which is only established to keep this notice open for an extended period of time to allow for subsequent posts. This date is not related to the solicitation in any way and a response date for the solicitation will be posted with the solicitation. There is no response required for this presolicitation notice.


This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOpps (www.fbo.gov) to the vendor community on or about August 12, 2013 which will be available for 60 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Chemical Biological Medical Systems (CBMS) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.

Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.

This synopsis is not a request for quotes or proposals. This is a pre-solicitation notice that a solicitation has been scheduled to be released via FedBizOpps (www.fbo.gov) to the vendor community on or about August 12, 2013 which will be available for 60 days. Specifications of this requirement shall be provided in the solicitation under Solicitation Number W81XWH-13-R-0038.

This presolicitation notice follows a Request for Information which was released as RFI Number RFIPRODDEVP on January 11, 2013.

The solicitation will be unrestricted and will allow for full and open competition. The North American Industry Classification System (NAICS) code is 541712 and the size standard is 500 employees.

Requirement Description:

This requirement is for all medical product development services required to support the U.S. Army Medical Materiel Development Activity (USAMMDA), the U.S. Army Medical Materiel Agency (USAMMA), other U.S. Army Medical Research and Materiel Command (USAMRMC) subordinate commands, and Chemical Biological Medical Systems (CBMS) in their missions to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. This acquisition will provide multiple awards of Indefinite Delivery Indefinite Quantity (IDIQ) contracts for services to support their missions. Support services include support in the following areas, intended to support all aspects of product development: Technical/Administrative, Meeting and Informational Products, Clinical Development, Non-Clinical Development, Medical Product Manufacturing, Regulatory, Training, Protocol, and Information Technology. This is a new requirement integrating and standardizing a multitude of different requirements into a comprehensive, efficient and economical approach to providing contract support for medical advanced development. This contract vehicle may be used by other activities of the Defense Health Agency when/if the USAMRMC is incorporated thereunder.

Background:

The USAMMDA and USAMMA, both subordinate commands of USAMRMC, are the Department of Defense's (DoD) advanced development organizations for medical products designed to protect and preserve the lives of Service Members. The USAMMDA and USAMMA develop new drugs, vaccines, devices and medical support equipment that enhance readiness, ensure the provision of the highest quality medical and preventative care to the DoD, and maximize survival of medical casualties on the battlefield. The USAMMDA and USAMMA direct, control, manage, and focus the development of medical materiel systems to meet Service-unique and joint Service performance, schedule, and cost requirements.

The USAMMDA and USAMMA Project Managers develop and field medical products for the US Armed Forces in conjunction with the Army Medical Department Center and School (the combat developer) and other service inputs (external partners). Project Manager assigns product development to individual product managers and the product managers (PdMs), with support from the Division of Regulated Activities and Compliance (DRAC) and Clinical Support Services Division (CSSD), take promising new concepts and technologies developed in the USAMRMC laboratories and in the academic and commercial sectors, manage the development and testing of prototypes of these products (as necessary), and manage the products through the development lifecycle, ultimately to achieve US Food and Drug Administration (FDA) approval, licensure and /or clearance, Environmental Protection Agency (EPA) registration, and/or approval of the developed product, to include post marketing commitments, for use by our Service Members through the requirements defined in the DoD and Army acquisitions processes (DoD 5000 series). Thus, the USAMMDA and USAMMA product managers are responsible for the success (including cost/schedule/ performance) of the product development effort and must manage Integrated Product Teams (IPTs) through the development and implementation of development plans (and other acquisition requirements, as applicable), to develop and field medical materiel. The USAMMDA and USAMMA accomplish their respective missions by exercising four core capabilities: (1) Defense Acquisition and Program Management; (2) Regulatory Affairs (FDA or EPA regulated products); (3) Medical Product Development; and, (4) Coordination of The Surgeon General's Executive Agent management of Force Health Protection's IND products.

Depending on the product development strategy, the Office of the Surgeon General (OTSG), Department of the Army, may be the regulatory sponsor. For these product development efforts, DRAC and CSSD are the regulatory elements responsible for ensuring compliance with applicable regulations. In these cases, DRAC and CSSD may execute FDA regulated sponsor responsibilities or delegate some or all of these responsibilities to the Prime or its subcontractor and only provide oversight of these activities. In other cases, the product development effort will include industry or academia partners who hold the regulatory Sponsorship, which may also include foreign government marketing strategies. The DRAC and CSSD may provide oversight of regulated activities sponsored by partners, depending on the capabilities or requests of the partner. Specific requirements will be variable and included in detail at the task order level.

Additionally, DRAC and CSSD provide regulatory affairs and medical product development support for other organizations outside of USAMMDA and USAMMA, including USAMRMC subordinate commands, and the Chemical and Biological Defense Program. These organizations may utilize this contract vehicle to conduct product development activities, which are being sponsored by OTSG and supported by USAMMDA DRAC and CSSD.

The CBMS Joint Project Management Office is responsible for research, development, acquisition, fielding, and life cycle management of FDA-approved medical systems for protection, treatment, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) threat agents. All CBRN medical countermeasures are approved by and regulated through the FDA. The CBMS continues to aggressively explore opportunities to partner with other government agencies, industry, academia, and allied countries for all CBRN medical countermeasure efforts. The CBMS product portfolio includes products spanning the entire acquisition life cycle.
Objective:

The objective of this requirement is to facilitate the timely and efficient execution of the US Army's medical materiel development program by providing a mechanism for all aspects of medical product/device development and life cycle support, including project management, technical expertise/assistance, strategic planning, market analysis, training, administrative activities, and pharmaceutical manufacturing and testing, assay validation, validated storage and shipment, non-clinical testing, clinical research (to include monitoring, safety pharmacovigilance and surveillance, full data management, and biostatistical support), regulatory writing and submission support, regulatory strategy and consultation, quality, integrated logistics support, equipment maintenance support and information technology in support of each task order. For example: a task order may specify that a contractor will conduct clinical trials worldwide (inclusive of pre-trial activities, trial activities and post trial activities), provide product managers with support services to assist/provide technical guidance and provide independent and objective reviews, site feasibility assessments, prepare and assemble both generic and product-specific US FDA and EPA related documentation, take meeting minutes, provide complete clinical monitoring support including compilation of Sponsor trial master files, provide a data management system , preferably an electronic data capture (EDC) system, compliant with FDA/ICH regulations and guidance, data management, biostatistical evaluation and data analysis, safety pharmacovigilance and surveillance, and complete a final clinical study report compliant with International Conference on Harmonization (ICH) and/or FDA regulations and guidance.

Period of Performance:

The Period of Performance for this contract will be a five year base period with five one-year option periods.

Response:

This notice is for informational purposes only. No response is required for this presolicitation notice. Telephone requests in response to this presolicitation notice will not be honored. Additional information is not available at this time. Potential offerors are directed to respond to the Solicitation when it is released on this website under Solicitation Number W81XWH-13-R-0038.