SRCSGT | A | Validation of Image Premarket Evaluation and Regulation "VIPER"

FBO DAILY ISSUE OF JULY 14, 2011 FBO #3519
SOURCES SOUGHT

A -- Validation of Image Premarket Evaluation and Regulation "VIPER"

Notice Date: 7/12/2011
Notice Type: Sources Sought
NAICS: 541990 — All Other Professional, Scientific, and Technical Services
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
ZIP Code: 72079
Solicitation Number: 1085822
Archive Date: 8/9/2011
Point of Contact: Marcia O Park, Phone: (870) 543-7405
E-Mail Address: marcia.park@fda.hhs.gov
(marcia.park@fda.hhs.gov)
Small Business Set-Aside: N/A
Description: This notice is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the services described below. Many innovative Imaging and computer assist devices under development with a purpose of improving a clinician's diagnosis. The Food and Drug's (FDA) Center for Devices and Radiological Health (CHRH) has responsibility for protecting public health through the appropriate regulation of these new and emerging technologies. Recent CDRH experience with new digital mammography systems and 3D breast imaging systems are examples, and many more are on the horizon for a wide variety of applications across disease, organ systems, and imaging modality. The evaluation of the performance of imaging technologies in terms of the impact on a clinician's diagnostic ability given the image or computer assist is challenging. Prospective clinical trials can be burdensome for two significant reasons: disease prevalence is very low in some settings, and reader variability is usually substantial. The services under this study require that the contractor make use of a unique resource of images and reader data; the digital and screen/film (S/F) mammograms acquired during the Digital Mammography Imaging Screening Trial (DMIST) and the clinical interpretations that were also obtained as part of DMIST. The tasks required will develop tools for displaying tools for displaying a subset of thee same images, so that new interpretations can be acquired from the images from trained mammographers, with the goal of validating less burdensome approaches to the premarket evaluation of imaging devices. The DMIST image data and reader interpretations are from a study that was conducted in 2005. The use of these data for the current work will be for retrospective image reading and validation of statistical endpoints. No patient identifiers will be provided to the FDA for the readers to participate in this work. The images and the interpretations are owned by the Principal Investigator of the DMIST study, Dr Etta Pisano, who is currently the Vice President for Medical Affairs and the Dean of the College of Medicine, Medical University of South Carolina. This work will perform tasks required to design, set up, conduct and analyze a set of investigations involving the interpretation of digital and S/F mammograms to investigate the effect of prevalence and enrichment on reader performance as measured by the statistical quantities known as area under the Reader Operating Characteristic Curve (AUC), sensitivity, and specificity in premarket image evaluation studies. Description of Work 1. The Contractor will be required to provide FDA with raw DMIST image interpretation data (line data). 2. The Contractor shall obtain Institutional Review Board (IRB) approval at Medical University of South Carolina (MUSC) and FDA for the purpose of performing new reader studies involving retrospective interpretation of DMIST images 3. The Contractor shall collect together full-field digital mammography (FFDM) and SFM images in the number and according to patient characteristics specified by the FDA based on the analysis of DMIT study results. 4. The contractor shall develop study interpretation tools, including display hardware and software, and interpretation capture software for the purpose of collection of reader interpretations of FFDM and SFM images. 5. The contractor shall develop training materials for the readers who will participate in this work 6. The contractor shall recruit and train readers in the number specified by the FDA with qualifications necessary to perform the statement of work 7. The contractor will collect reader data during the performance of case interpretation, where the number of reader and the number and types of cases is to be specified by the FDA. The contractor is responsible for all tasks related to travel management and arranging for reader compensation. 8. The Contractor shall develop and maintain a data base of data containing the results of reader interpretations on each case's modality combination with associated case characteristics as specified by the FDA 9. The contractor shall provide results and reports of reader interpretations in increments of five (5) completed collections of reader interpretation data across both modalities (FFDM and SFM) within each investigation for the purpose of data monitoring recalculating of study size estimates of possible subsequent investigations and/or analyses. The associated North American Industry Classification System (NAICS) code is 541990 - Other Professional, Scientific and Technical Services. The small business size standard is $7.0 million. Potential contractors must provide: 1. Company contact information to include at a minimum company name, company physical and mailing addresses, company point of contact with phone number, fax number and email address; 2. Company DUNS number and Cage Code; 3. Socioeconomic size status under the aforementioned NAICS/size standard, i.e., large business, small business, veteran-owned small business, service-disabled veteran owned-small business, HUBzone small business, small disadvantaged small business, woman-owned small business, 8(a)small business (the Government will verify against annual certifications at https://orca.bpn.gov/ and as such respondents should make sure their representations and certifications are current); 4. GSA Schedule or other Federal Contract Vehicles under which this technology may be acquired; and 5. Capability statement identifying core competencies relating to this requirement, a detailed description of recent prior experience with same or similar technology to include client name and current contact information sufficient for the Government to verify the work performed, and any other information which clearly demonstrates the capabilities of the contractor to meet this specific requirement. Responses are due in person, by postal mail or by email to the point of contact listed below on or before July 25, 2011 by 1:00 P.M. CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502. Reference 1085822. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in a resultant solicitation that may result from this market survey. For information regarding this notice contact, Marcia Park, 870/543-7405, FAX 870/543-7990 or email to marcia.park@fda.hhs.gov. This notice is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the services described below. Many innovative Imaging and computer assist devices under development with a purpose of improving a clinician's diagnosis. The Food and Drug's (FDA) Center for Devices and Radiological Health (CHRH) has responsibility for protecting public health through the appropriate regulation of these new and emerging technologies. Recent CDRH experience with new digital mammography systems and 3D breast imaging systems are examples, and many more are on the horizon for a wide variety of applications across disease, organ systems, and imaging modality. The evaluation of the performance of imaging technologies in terms of the impact on a clinician's diagnostic ability given the image or computer assist is challenging. Prospective clinical trials can be burdensome for two significant reasons: disease prevalence is very low in some settings, and reader variability is usually substantial. The services under this study require that the contractor make use of a unique resource of images and reader data; the digital and screen/film (S/F) mammograms acquired during the Digital Mammography Imaging Screening Trial (DMIST) and the clinical interpretations that were also obtained as part of DMIST. The tasks required will develop tools for displaying tools for displaying a subset of thee same images, so that new interpretations can be acquired from the images from trained mammographers, with the goal of validating less burdensome approaches to the premarket evaluation of imaging devices. The DMIST image data and reader interpretations are from a study that was conducted in 2005. The use of these data for the current work will be for retrospective image reading and validation of statistical endpoints. No patient identifiers will be provided to the FDA for the readers to participate in this work. The images and the interpretations are owned by the Principal Investigator of the DMIST study, Dr Etta Pisano, who is currently the Vice President for Medical Affairs and the Dean of the College of Medicine, Medical University of South Carolina. This work will perform tasks required to design, set up, conduct and analyze a set of investigations involving the interpretation of digital and S/F mammograms to investigate the effect of prevalence and enrichment on reader performance as measured by the statistical quantities known as area under the Reader Operating Characteristic Curve (AUC), sensitivity, and specificity in premarket image evaluation studies. Description of Work 1. The Contractor will be required to provide FDA with raw DMIST image interpretation data (line data). 2. The Contractor shall obtain Institutional Review Board (IRB) approval at Medical University of South Carolina (MUSC) and FDA for the purpose of performing new reader studies involving retrospective interpretation of DMIST images 3. The Contractor shall collect together full-field digital mammography (FFDM) and SFM images in the number and according to patient characteristics specified by the FDA based on the analysis of DMIT study results. 4. The contractor shall develop study interpretation tools, including display hardware and software, and interpretation capture software for the purpose of collection of reader interpretations of FFDM and SFM images. 5. The contractor shall develop training materials for the readers who will participate in this work 6. The contractor shall recruit and train readers in the number specified by the FDA with qualifications necessary to perform the statement of work 7. The contractor will collect reader data during the performance of case interpretation, where the number of reader and the number and types of cases is to be specified by the FDA. The contractor is responsible for all tasks related to travel management and arranging for reader compensation. 8. The Contractor shall develop and maintain a data base of data containing the results of reader interpretations on each case's modality combination with associated case characteristics as specified by the FDA 9. The contractor shall provide results and reports of reader interpretations in increments of five (5) completed collections of reader interpretation data across both modalities (FFDM and SFM) within each investigation for the purpose of data monitoring recalculating of study size estimates of possible subsequent investigations and/or analyses. The associated North American Industry Classification System (NAICS) code is 541990 - Other Professional, Scientific and Technical Services. The small business size standard is $7.0 million. Potential contractors must provide: 1. Company contact information to include at a minimum company name, company physical and mailing addresses, company point of contact with phone number, fax number and email address; 2. Company DUNS number and Cage Code; 3. Socioeconomic size status under the aforementioned NAICS/size standard, i.e., large business, small business, veteran-owned small business, service-disabled veteran owned-small business, HUBzone small business, small disadvantaged small business, woman-owned small business, 8(a)small business (the Government will verify against annual certifications at https://orca.bpn.gov/ and as such respondents should make sure their representations and certifications are current); 4. GSA Schedule or other Federal Contract Vehicles under which this technology may be acquired; and 5. Capability statement identifying core competencies relating to this requirement, a detailed description of recent prior experience with same or similar technology to include client name and current contact information sufficient for the Government to verify the work performed, and any other information which clearly demonstrates the capabilities of the contractor to meet this specific requirement. Responses are due in person, by postal mail or by email to the point of contact listed below on or before July 25, 2011 by 1:00 P.M. CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502. Reference 1085822. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in a resultant solicitation that may result from this market survey. For information regarding this notice contact, Marcia Park, 870/543-7405, FAX 870/543-7990 or email to marcia.park@fda.hhs.gov. This notice is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the services described below. Many innovative Imaging and computer assist devices under development with a purpose of improving a clinician's diagnosis. The Food and Drug's (FDA) Center for Devices and Radiological Health (CHRH) has responsibility for protecting public health through the appropriate regulation of these new and emerging technologies. Recent CDRH experience with new digital mammography systems and 3D breast imaging systems are examples, and many more are on the horizon for a wide variety of applications across disease, organ systems, and imaging modality. The evaluation of the performance of imaging technologies in terms of the impact on a clinician's diagnostic ability given the image or computer assist is challenging. Prospective clinical trials can be burdensome for two significant reasons: disease prevalence is very low in some settings, and reader variability is usually substantial. The services under this study require that the contractor make use of a unique resource of images and reader data; the digital and screen/film (S/F) mammograms acquired during the Digital Mammography Imaging Screening Trial (DMIST) and the clinical interpretations that were also obtained as part of DMIST. The tasks required will develop tools for displaying tools for displaying a subset of thee same images, so that new interpretations can be acquired from the images from trained mammographers, with the goal of validating less burdensome approaches to the premarket evaluation of imaging devices. The DMIST image data and reader interpretations are from a study that was conducted in 2005. The use of these data for the current work will be for retrospective image reading and validation of statistical endpoints. No patient identifiers will be provided to the FDA for the readers to participate in this work. The images and the interpretations are owned by the Principal Investigator of the DMIST study, Dr Etta Pisano, who is currently the Vice President for Medical Affairs and the Dean of the College of Medicine, Medical University of South Carolina. This work will perform tasks required to design, set up, conduct and analyze a set of investigations involving the interpretation of digital and S/F mammograms to investigate the effect of prevalence and enrichment on reader performance as measured by the statistical quantities known as area under the Reader Operating Characteristic Curve (AUC), sensitivity, and specificity in premarket image evaluation studies. Description of Work 1. The Contractor will be required to provide FDA with raw DMIST image interpretation data (line data). 2. The Contractor shall obtain Institutional Review Board (IRB) approval at Medical University of South Carolina (MUSC) and FDA for the purpose of performing new reader studies involving retrospective interpretation of DMIST images 3. The Contractor shall collect together full-field digital mammography (FFDM) and SFM images in the number and according to patient characteristics specified by the FDA based on the analysis of DMIT study results. 4. The contractor shall develop study interpretation tools, including display hardware and software, and interpretation capture software for the purpose of collection of reader interpretations of FFDM and SFM images. 5. The contractor shall develop training materials for the readers who will participate in this work 6. The contractor shall recruit and train readers in the number specified by the FDA with qualifications necessary to perform the statement of work 7. The contractor will collect reader data during the performance of case interpretation, where the number of reader and the number and types of cases is to be specified by the FDA. The contractor is responsible for all tasks related to travel management and arranging for reader compensation. 8. The Contractor shall develop and maintain a data base of data containing the results of reader interpretations on each case's modality combination with associated case characteristics as specified by the FDA 9. The contractor shall provide results and reports of reader interpretations in increments of five (5) completed collections of reader interpretation data across both modalities (FFDM and SFM) within each investigation for the purpose of data monitoring recalculating of study size estimates of possible subsequent investigations and/or analyses. The associated North American Industry Classification System (NAICS) code is 541990 - Other Professional, Scientific and Technical Services. The small business size standard is $7.0 million. Potential contractors must provide: 1. Company contact information to include at a minimum company name, company physical and mailing addresses, company point of contact with phone number, fax number and email address; 2. Company DUNS number and Cage Code; 3. Socioeconomic size status under the aforementioned NAICS/size standard, i.e., large business, small business, veteran-owned small business, service-disabled veteran owned-small business, HUBzone small business, small disadvantaged small business, woman-owned small business, 8(a)small business (the Government will verify against annual certifications at https://orca.bpn.gov/ and as such respondents should make sure their representations and certifications are current); 4. GSA Schedule or other Federal Contract Vehicles under which this technology may be acquired; and 5. Capability statement identifying core competencies relating to this requirement, a detailed description of recent prior experience with same or similar technology to include client name and current contact information sufficient for the Government to verify the work performed, and any other information which clearly demonstrates the capabilities of the contractor to meet this specific requirement. Responses are due in person, by postal mail or by email to the point of contact listed below on or before July 25, 2011 by 1:00 P.M. CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502. Reference 1085822. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in a resultant solicitation that may result from this market survey. For information regarding this notice contact, Marcia Park, 870/543-7405, FAX 870/543-7990 or email to marcia.park@fda.hhs.gov. This notice is for Market Research purposes only, not a request for proposal or solicitation. The Food and Drug Administration (FDA) is seeking sources, including service-disabled veteran-owned small businesses, HUBzone small businesses, 8(a) certified businesses as well as small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for providing the services described below. Many innovative Imaging and computer assist devices under development with a purpose of improving a clinician's diagnosis. The Food and Drug's (FDA) Center for Devices and Radiological Health (CHRH) has responsibility for protecting public health through the appropriate regulation of these new and emerging technologies. Recent CDRH experience with new digital mammography systems and 3D breast imaging systems are examples, and many more are on the horizon for a wide variety of applications across disease, organ systems, and imaging modality. The evaluation of the performance of imaging technologies in terms of the impact on a clinician's diagnostic ability given the image or computer assist is challenging. Prospective clinical trials can be burdensome for two significant reasons: disease prevalence is very low in some settings, and reader variability is usually substantial. The services under this study require that the contractor make use of a unique resource of images and reader data; the digital and screen/film (S/F) mammograms acquired during the Digital Mammography Imaging Screening Trial (DMIST) and the clinical interpretations that were also obtained as part of DMIST. The tasks required will develop tools for displaying tools for displaying a subset of thee same images, so that new interpretations can be acquired from the images from trained mammographers, with the goal of validating less burdensome approaches to the premarket evaluation of imaging devices. The DMIST image data and reader interpretations are from a study that was conducted in 2005. The use of these data for the current work will be for retrospective image reading and validation of statistical endpoints. No patient identifiers will be provided to the FDA for the readers to participate in this work. The images and the interpretations are owned by the Principal Investigator of the DMIST study, Dr Etta Pisano, who is currently the Vice President for Medical Affairs and the Dean of the College of Medicine, Medical University of South Carolina. This work will perform tasks required to design, set up, conduct and analyze a set of investigations involving the interpretation of digital and S/F mammograms to investigate the effect of prevalence and enrichment on reader performance as measured by the statistical quantities known as area under the Reader Operating Characteristic Curve (AUC), sensitivity, and specificity in premarket image evaluation studies. Description of Work 1. The Contractor will be required to provide FDA with raw DMIST image interpretation data (line data). 2. The Contractor shall obtain Institutional Review Board (IRB) approval at Medical University of South Carolina (MUSC) and FDA for the purpose of performing new reader studies involving retrospective interpretation of DMIST images 3. The Contractor shall collect together full-field digital mammography (FFDM) and SFM images in the number and according to patient characteristics specified by the FDA based on the analysis of DMIT study results. 4. The contractor shall develop study interpretation tools, including display hardware and software, and interpretation capture software for the purpose of collection of reader interpretations of FFDM and SFM images. 5. The contractor shall develop training materials for the readers who will participate in this work 6. The contractor shall recruit and train readers in the number specified by the FDA with qualifications necessary to perform the statement of work 7. The contractor will collect reader data during the performance of case interpretation, where the number of reader and the number and types of cases is to be specified by the FDA. The contractor is responsible for all tasks related to travel management and arranging for reader compensation. 8. The Contractor shall develop and maintain a data base of data containing the results of reader interpretations on each case's modality combination with associated case characteristics as specified by the FDA 9. The contractor shall provide results and reports of reader interpretations in increments of five (5) completed collections of reader interpretation data across both modalities (FFDM and SFM) within each investigation for the purpose of data monitoring recalculating of study size estimates of possible subsequent investigations and/or analyses. The associated North American Industry Classification System (NAICS) code is 541990 - Other Professional, Scientific and Technical Services. The small business size standard is $7.0 million. Potential contractors must provide: 1. Company contact information to include at a minimum company name, company physical and mailing addresses, company point of contact with phone number, fax number and email address; 2. Company DUNS number and Cage Code; 3. Socioeconomic size status under the aforementioned NAICS/size standard, i.e., large business, small business, veteran-owned small business, service-disabled veteran owned-small business, HUBzone small business, small disadvantaged small business, woman-owned small business, 8(a)small business (the Government will verify against annual certifications at https://orca.bpn.gov/ and as such respondents should make sure their representations and certifications are current); 4. GSA Schedule or other Federal Contract Vehicles under which this technology may be acquired; and 5. Capability statement identifying core competencies relating to this requirement, a detailed description of recent prior experience with same or similar technology to include client name and current contact information sufficient for the Government to verify the work performed, and any other information which clearly demonstrates the capabilities of the contractor to meet this specific requirement. Responses are due in person, by postal mail or by email to the point of contact listed below on or before July 25, 2011 by 1:00 P.M. CDT at the Food and Drug Administration, OC/OA/OAGS, Attn: Marcia Park, 3900 NCTR Road, HFT-322, Jefferson, AR 72079-9502. Reference 1085822. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by the respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a solicitation may be published in the Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. No proprietary, classified, confidential or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in a resultant solicitation that may result from this market survey. For information regarding this notice contact, Marcia Park, 870/543-7405, FAX 870/543-7990 or email to marcia.park@fda.hhs.gov.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/1085822/listing.html)
Place of Performance: Address: FDA, White Oak Campus, Building 62, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States; Zip Code: 20993
Record: SN02496011-W 20110714/110712234902-652bf92dcd27db92cdfb74f0241ed80a (fbodaily.com)
Source: FedBizOpps Link to This Notice
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A -- Validation of Image Premarket Evaluation and Regulation "VIPER"