and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Institute of Biomedical Imaging and Bioengineering (NIBIB) |
|
Funding Opportunity Title |
NIBIB Biomedical Technology Service Centers (P30) |
Activity Code |
P30 Center Core Grants |
Announcement Type |
Reissue of PAR-13-249 |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
PAR-14-145 |
Companion Funding Opportunity |
None |
An individual applicant may not submit more than one NIBIB P30 Center application. However, there is no limit on the number of applications an institution may submit provided that each application is scientifically distinct. See Section III. 3. Additional Information on Eligibility. |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.286 |
Funding Opportunity Purpose |
This Funding Opportunity Announcement (FOA) encourages grant applications for Biomedical Technology Service Centers (P30 Centers) that support infrastructure and resources that are needed by a diverse group of funded NIH researchers, but are not widely available. Consistent with this function, NIBIB P30 Centers should engage in dissemination activities and may engage in training activities. Infrastructure and resources in an NIBIB P30 Center could range from shared biomedical instrumentation to open bioinformatics systems. |
NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) supports Biomedical Technology Service Centers (NIBIB P30 Centers) to ensure that independently funded investigators working in a targeted area have access to biomedical technologies and expertise currently not available. These Centers are expected to have a regional or national scope, serving a significant number of investigators from multiple institutions outside the applicant institution. Further, projects that receive service from the NIBIB P30 Center should be highly regarded in their respective fields of research.
Specifically, a NIBIB P30 Center must have a sufficient number of matured technologies or tools that can be deployed directly or, if needed, requiring very limited development, to serve their user communities. These technologies or tools must be unique and cutting edge, thus providing important capabilities to their user communities that cannot be obtained in other ways, including through commercial products or other institutions, both domestic and international. Resources available in a typical NIBIB P30 Center could include, but are not limited to, specialized shared instrumentation, customized algorithms, novel tissue/organ engineering platforms, or open bioinformatics systems.
The following exclusions apply: (1) NIBIB P30 Centers will not support independent scientific research or unfunded pilot studies, except for very limited development of novel technologies that support the NIBIB P30 Center service mission (see "Technology Service Cores" section). (2) NIBIB will not support P30 Centers focusing on a specific disease, or involve clinical trials or patient services. (3) NIBIB will not support P30 Centers that overlap with pre-existing facilities at the host institution.
NIBIB P30 Centers shall consist of one Administrative Core, one or more Technology Service Cores, associated Research Base Projects, and a Dissemination Core. If appropriate, NIBIB P30 Centers may also engage in training activities; in this case, a Technology Training Component should be included.
The Administrative Core coordinates the different components and activities of the NIBIB P30 Center including dissemination (and training, if relevant).
Technology Service Cores provide a needed service to investigators outside of the NIBIB P30 Center, supporting work that could not be conducted, or could be conducted more efficiently and effectively, with the resources of the P30 Center.
Each Technology Service Core shall have an associated Research Base component consisting of projects that will utilize the Technology Service Core. Investigators using the Technology Service Cores (i.e., the "Research Base") are expected to have highly regarded existing biomedical research programs funded by NIH Institutes or Centers, other Federal Agencies, or other nationally or internationally recognized funding sources.
Consistent with their function to help the community gain access to these resources, NIBIB P30 Centers must engage in dissemination activities.
Finally, a NIBIB P30 Center must have an External Advisory Committee (EAC) that advises the Program Director/Principal Investigator on current operating procedures and future directions for the NIBIB P30 Center.
Because extensive planning is required in preparing NIBIB P30 applications, prospective new applicants are strongly encouraged to discuss their plans with the relevant NIBIB Program Directors (refer to www.nibib.nih.gov/Research/ProgramAreas) well before the application is prepared.
Funding Instrument |
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. |
Application Types Allowed |
New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. |
Award Budget |
Application budgets are not limited but it is strongly recommended that applicants not request a budget of more than $600,000 in direct costs per year. In addition to the direct costs, a total cost for equipment up to $500,000 can be requested for the duration of the five-year project period. |
Award Project Period |
Support may be requested for up to five years. |
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to
apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always encouraged
to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:
Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Christina H Liu, Ph.D. P.E.
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering
6707 Democracy Boulevard, Suite 200
Bethesda, MD 20892 (20817 for courier service)
Telephone: 301-451-7638
Fax: 301-480-1614
Email: [email protected]
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
6 |
Admin Core (Use this component for Administration) |
6 |
Core(s) (Use this component for each Technology Service Core. Note: cores will appear in the application in the order in which they were entered in ASSIST) |
12 |
Dissemination Core |
6 |
Technology Training |
6 |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed. For this FOA, there are page limitations for the Research Base Section to be included in the Research & Related Other Project Information form of the corresponding Technology Service Core:
Introduction for the Research Base Section (resubmissions only): may not exceed 1 page
Summary of Research Base Projects: may not exceed 1 page
Description of Research Base Project: may not exceed 1 page per Project for up to 10 Projects total excluding references.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
* Note: Different from PAR-13-249, which requested the Research Base Section to be included in the Appendix, the Research Base Section must be included as Other Attachments under Research & Related Other Project Information of the corresponding Technology Service Core Component. Applications without Research Base(s) relevant to proposed Technology Service Core(s) will be considered incomplete and will not undergo peer review.
When preparing your application in ASSIST, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Overall)
Complete entire form.
PHS 398 Cover Page Supplement (Overall)
Follow the instructions in the SF 424 (R&R) Application Guide.
Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Research & Related Other Project Information (Overall)
Follow standard instructions.
Project Summary/Abstract: The application should include a succinct project summary of the proposed work. State the proposed Center's broad, long-term objective, specific aims, and the significance to the field of Biomedical Imaging and/or Bioengineering. Define the relevance of each proposed Technology Service Cores to the overall theme and goals of the program.
Project Narrative: Provide the Project Narrative of the entire P30 application.
Project/Performance Site Location(s) (Overall)
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Research & Related Senior/Key Person Profile (Overall)
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
Budget (Overall)
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
PHS 398 Research Plan (Overall)
Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.
Specific Aims: State concisely the goals of the proposed P30 Center.
Research Strategy: Describe the overall objectives of the P30 Center, and discuss what makes this particular P30 Center unique.
Give a brief overview of the Technology Service Cores, and evaluate the regional and national need for the Technology Service Cores.
Describe the qualifications of the PD(s)/PI(s). He/she should be a highly experienced and respected scientist with demonstrated administrative capabilities and a proven track record for obtaining NIH and/or other relevant funding, as well as a track record of providing technical service to the scientific community.
For New Applications, describe the factors and events contributing to the decision to create the P30 Center.
For Renewal Applications, highlight major accomplishments from the previous funding period, and point out major changes from the original P30 Center design.
Letters of Support: Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as senior/key personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services.
Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a leadership plan must be attached. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other contributors. If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award (NoA).
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Admin Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Administration)
Complete only the following fields:
PHS 398 Cover Page Supplement (Administration)
Follow the instructions in the SF 424 (R&R) Application Guide.
Research & Related Other Project Information (Administration)
Human Subjects: Answer No to the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer No to the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Administration)
List all performance sites that apply to the Administration component, which should be the same as the primary performance site(s).
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Administration)
ASSIST will default to Project Lead . If you would like to use a different category, then replace Project Lead below with a different Category (e.g., Core Lead).
The PD/PI (or one of the PD(s)/PI(s)) of the P30 Center must be the Director of the Administrative Core.
In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Administration)
Budget forms appropriate for the Administrative Core will be included in the application package.
Personnel: The budget should include a detailed justification for key personnel. The PD/PI or each of the PD(s)/PI(s) is expected to devote at least 3 calendar months of his/her efforts to the P30 Center, with a minimum of 1.2 calendar months being devoted to the Administrative Core. Salaries for support positions in the P30 Center are permitted. No overlap of time and effort between the P30 Center and other funded projects is permitted.
Supplies: Consumable supplies related to the operation of the P30 Center such as office materials are permitted.
Equipment: Major equipment requests should be justified. Price quotes should be included for equipment costing more than $25,000. General purpose laboratory equipment and supply requests should be included only when necessary to support visiting Research Base investigators.
Service Contracts: Service Contracts for major equipment items are allowed.
Travel: Domestic and foreign travel for P30 Center personnel is permitted, if the travel is directly related to the activities of the P30 Center.
Consultants: Consultants (including External Advisory Committee members) and any associated costs are permitted.
Consortium/Contractual agreements: Funds may be requested for domestic subcontracts. In general, funds may not be requested for foreign subcontracts. Foreign subcontracts may be allowed if a written waiver is provided by the NIBIB Associate Director.
Note: Funds may not be requested for alteration and renovation, rental space, staff retreats, direct support for individual research projects, or direct support for pilot studies.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Administration)
Introduction to Application: For Resubmission applications, an Introduction to Application is required for each component
Specific Aims: State concisely the goals of the proposed Administrative Core.
Research Strategy: Describe the roles and contributions of other staff who will be involved in the Administrative Core. Do not repeat information that is included in the biosketches.
Describe the P30 Center organizational structure. Discuss the relationship of the P30 Center to the administrative structure of the grantee institution.
Describe the P30 Center operating procedures. Discuss procedures to review requests for use of the equipment and facilities, and to schedule use.
If a charge-back system that results in Center income is planned, a description of how costs are to be shared by the users should be included. Additionally, special administrative requirements that apply to Center income must be observed.
The External Advisory Committee (EAC) is appointed by the Director of the Administrative Core. External Advisory Committee members and the chair should be from outside the host institution, and should be rotated periodically.
Describe the role of the External Advisory Committee. The External Advisory Committee chair should be knowledgeable about the P30 Center technology and the science it serves, but should not be a member of the P30 Center staff or a major user of the P30 Center. Other committee members should be balanced among scientists knowledgeable about the P30 Center technologies, experts in the application of P30 Center technologies to biomedical research problems, and users of the technology.
For new P30 grant applications, the External Advisory Committee should not be constituted prior to or during the review of the application, and potential candidates should not be approached or discussed.
For existing P30 Centers, list the current members of the External Advisory Committee, and briefly describe their qualifications.
The External Advisory Committee must meet at least annually and prepare a written report, addressed to the Director of the Administrative Core, of its recommendations. This report must be supplied as part of the P30 Center Annual Progress Report.
Describe the role of any local executive committees that are proposed as adjuncts to the External Advisory Committee.
Letters of Support: Do not include any letter of support here.
Resource Sharing Plan: Not Applicable
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
External Advisory Committee Report: For Renewal applications, include a copy of the most recent EAC Report in the Appendix.
Planned Enrollment Report (Administration)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Administration)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Core for each Technology Service Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted. NIBIB P30 Centers must have a minimum number of one Technology Service Core. However, if there is more than one Technology Service Core, each Technology Service Core should be considered as a separate Component and described separately.
SF424 (R&R) Cover (Technology Service Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Technology Service Core)
Follow the instructions in the SF424 (R&R) Application Guide.
Research & Related Other Project Information (Technology Service Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Other Attachments:
Research Base Projects (required): 10 representative projects, 1 page per project excluding references.
There must be a Research Base for each Technology Service Core. This attachment must include a description of the Research Base. In addition, provide a Table of all projects including the 10 representative projects described in the Research Base. Each entry in the Table should include:
References and overall Tables are not included in the page limitations.
For Renewal applications, projects from the previous funding period that are not being continued should be listed in a separate Table.
In the body of the text for this section, begin the section with a heading indicating "Research Base" followed by the name of the Technology Service Core. Note: the max number of characters for filenames is 50. Save the entire section in a single file named, "Research Base-name of the Technology Service Core" and upload this file under Other Attachments.
Project /Performance Site Location(s) (Technology Service Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Technology Service Core)
Technology Service Core leaders should be acknowledged experts in the technology provided by their respective Technology Service Core (s). The PD(s)/PI(s) of the P30 Center may be the leader(s) of one (or more) of the Technology Service Cores
In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Technology Service Core)
Budget forms appropriate for the Technology Service Core will be included in the application package.
Personnel: The P30 Center can cover salaries for individual Technology Service Core leaders to the extent that they provide an essential P30 Center function. Salaries for technical or support positions in the P30 Center can also be requested. No overlap of time or effort between the P30 Center and other funded projects is permitted. The resources in the Technology Service Cores should be equitably distributed: the maximum effort that a single Technology Service Core can spend on projects directed by a single investigator is 25%.
The Technology Service Cores may support technicians and engineers that have the appropriate scientific or engineering skills. Examples of appropriate skills could be operation and maintenance of the specialized shared instrumentation, implementation/support of customized algorithms, assembly of existing components (without extensive modifications) for research platforms and implementation/support of open bioinformatics systems. Where appropriate, an established expert in the Technical Service Core activities could also be included as a consultant.
Equipment: Without overlapping what is requested under other components, major equipment requests should be justified. Price quotes should be included for equipment costing more than $25,000. General purpose laboratory equipment and supply requests should be included only when necessary to support visiting Research Base investigators.
Note: Funds may not be requested for alteration and renovation, rental space, staff retreats, direct support for individual research projects, or direct support for pilot studies.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Technology Service Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is required for each component
Specific Aims: State concisely the goals of the proposed Technology Service Core.
Research Strategy: Discuss the role and contributions of the leader(s) of each Technology Service Core. Do not repeat information that is included in the biosketches.
Describe the hardware, software and other specialized facilities available to the Technology Service Core. Technology Service Cores are expected to implement and maintain appropriate commercial equipment and off-the-shelf software, and may also utilize specially designed equipment and software. Finally, very limited developmental research is appropriate if it directly enhances the utility of the Technology Service Cores. Whenever possible, open-source software should be utilized. If an element of the support provided by the P30 Center involves software or algorithm development, it should be disseminated in open-source platforms and details regarding the plan for software maintenance and documentation should be provided.
A Technology Service Core should serve at least ten independently-funded projects (Research Base). Briefly discuss how the technologies or tools provided by this Technology Service Core are unique and cutting edge and how they deliver important capabilities to their Research Base that cannot be obtained in other ways.
Projects using a particular Technology Service Core form a "Research Base" for that Technology Service Core. Each Research Base must be described in detail in the Other Attachments section of the relevant Technology Service Core.
For New Applications, each Technology Service Core should include information on preliminary studies.
For Renewal Applications, each Technology Service Core should include a Progress Report.
Letters of Support: Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as senior/key personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services. Letters of support from PDs/PIs of Research Base projects are NOT required and should not be included.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Technology Service Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Technology Service Core)
When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Dissemination Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Dissemination Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Dissemination Core)
Follow the instructions in the SF 424 (R&R) Application Guide.
Research & Related Other Project Information (Dissemination Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Dissemination Core)
List all performance sites that apply to the Dissemination Core.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Dissemination Core)
In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Dissemination Core)
Budget forms appropriate for the Dissemination Core will be included in the application package.
Personnel: The budget should include a detailed justification for key personnel under this component. The person months for each member of the P30 Center staff related to this component should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100% under the entire P30 Center.
Web Site: Cost is allowed for the development and maintenance of a web site.
Note: Funds to support courses given for academic or other types of credit are not allowed. Funds may not be requested for alteration and renovation, rental space, staff retreats, direct support for individual research projects, or direct support for pilot studies.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Dissemination Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is required for each component
Specific Aims: State concisely the goals of the proposed Dissemination Core.
Research Strategy: A fundamental motivation for the NIBIB P30 Center program is to apply cutting-edge technology to important biomedical research problems. The realization of this goal depends on an effective Dissemination Program. Researchers are encouraged to share data obtained using the facilities of the P30 Center. Scientific and technical staffs are encouraged to share information on the technologies available at the P30 Center.
Describe the details of the Dissemination Program. Dissemination activities should inform the scientific community about the technical capabilities of the P30 Center, and promote and enable a broader use of the technologies.
A variety of approaches can be proposed to promote dissemination. These approaches include, but are not limited to: publishing book chapters, patents, newsletters, or annual reports; conducting workshops; distributing software products; transferring technologies to other laboratories; and licensing technologies to industry.
Website Requirement: All P30s are expected to have a robust web presence that clearly acknowledges support from the NIBIB. The website should provide information about:
For Renewal applications, include a link to a list of all publications that have resulted from the center's efforts since its inception.
Letters of Support: Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as senior/key personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Dissemination Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Dissemination Core)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Technology Training.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Technology Training)
Complete only the following fields:
PHS 398 Cover Page Supplement (Technology Training)
Follow the instructions in the SF 424 (R&R) Application Guide.
Research & Related Other Project Information (Technology Training)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete.
Project /Performance Site Location(s) (Technology Training)
List all performance sites that apply to the Training Core.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Technology Training)
In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
Budget (Technology Training)
Budget forms appropriate for the Technology Training Core will be included in the application package.
Personnel: The budget should include a detailed justification for key personnel under this component. The person months for each member of the P30 Center staff related to this component should be included here. It is possible to have overlapped personnel under different components, as long as their total efforts do not exceed 100% under the entire P30 Center.
Note: Individuals benefiting from the training experience may not be paid a stipend nor may the training experience be a requirement for receipt of an academic degree. Trainee-related costs such as stipends, fringe benefit, travel, and room and board are not allowed.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Technology Training)
Introduction to Application: For Resubmission applications, an Introduction to Application is required for each component
Specific Aims: State concisely the goals of the proposed Technology Training.
Research Strategy: The Technology Training Program (if present and appropriate for the P30 Center) should create a cadre of biomedical researchers that are trained in the P30 Center technologies, and can effectively apply them to their own research. Participants may range from graduate students, to faculty members and practicing physicians, to researchers from industry as is appropriate for the P30 Center's technology.
The choice of approaches should be informed by the special constraints and opportunities presented by the individual P30 Center. A defining feature of technology training activities is the potential for onsite and/or direct interaction between P30 Center personnel and the users or students. Note that activities such as web-based self-service tutorials would fall under Dissemination, since there is no direct interaction between P30 Center personnel and the users or students.
Examples of successful approaches include hands-on laboratory experience such as residencies in the P30 Center laboratories, seminars and lectures, and short courses or symposia offered independently or in conjunction with society meetings attended by the user community. Another example would be workshops that bring together researchers from academic institutions, hospitals, and industry for discussions on the P30 Center's technology. Because of the increasing importance of translational and clinical research, plans for technology training for researchers involved in those efforts are encouraged.
Letters of Support: Attach all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as senior/key personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services.
Resource Sharing Plan: Not Applicable
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Planned Enrollment Report (Training)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
PHS 398 Cumulative Inclusion Enrollment Report (Training)
When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential field of the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIBIB program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the P30 Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the P30 Center proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a P30 Center that by its nature is not innovative may be essential to advance a field.
Significance
Does the P30 Center address an important problem or a critical barrier to progress in the field? If the aims of the P30 Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Additional review criteria for NIBIB P30 Centers: Will the P30 Center have a significant influence on the biomedical research output of the funded investigators in the Research Base in ways that would not be feasible for individual research projects?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the P30 Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Additional review criteria for NIBIB P30 Centers: Are the PD(s)/PI(s) well qualified to effectively administer the P30 Center? Are the PD(s)/PI(s), the Technology Service Core leaders and other key personnel appropriately trained for their respective roles? Are they able to devote adequate effort to the P30 Center activities? Do they have a history of performing services for their colleagues or the scientific community at large, outside of the needs of their own research?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
For NIBIB P30 Centers "Innovation" is defined as a coherent plan to ensure that independently funded investigators have access to biomedical technologies and expertise that are not widely available and will substantially increase the capabilities of other funded research.
Approach
Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the P30 Center?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?
If the P30 Center involves human subjects and/or NIH-defined clinical research,
are the plans to address 1) the protection of human subjects from research risks,
and 2) inclusion (or exclusion) of individuals on the basis of sex/gender,
race, and ethnicity, as well as the inclusion or exclusion of children,
justified in terms of the scientific goals and research strategy proposed?
Additional review criteria for NIBIB P30 Centers: Do the Technology Service Cores provide advanced technologies and services that are not easily available to investigators in the Research Base? Are they appropriate for the anticipated research needs of PD/PIs in the Research Base? Do the PD/PIs using the Technology Service Cores (i.e., the Research Base) have highly-regarded existing biomedical research programs funded by NIH Institutes or Centers, other Federal Agencies, or other nationally or internationally-recognized funding sources? Does the Research Base have a regional and/or national geographic distribution?
Are plans for the administration of the P30 Center appropriate?
For New applications, are the plans for the External Advisory Committee appropriate?
For Renewal applications, is the role of the External Advisory Committee appropriate? Do the members of the External Advisory Committee have sufficient breadth and ability to take an effective role in the review and guidance of P30 operations? Is there evidence that the External Advisory Committee is active?
Are plans to provide dissemination appropriate? Are sufficient activities planned that inform the scientific community about the technical capabilities of the P30 Center, and promote and enable a broader use of the technologies? Does the Dissemination Plan assure that appropriate users will have fair access to the facilities and service?
Is there a robust web presence, or is one planned?
For P30s that are developing software, is the software portable when appropriate, well-documented, user-friendly, and readily available to the user community?
When applicable, does the Technology Training Plan ensure that a cadre of trained biomedical Researchers can apply the P30 Center technologies effectively in their own research?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
As applicable for the P30 Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.
Inclusion of Women, Minorities, and Children
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
Renewals
For Renewals, the committee will consider the progress made in the last funding period.
Revisions
Not Applicable
As applicable for the P30 Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Biomedical Imaging and Bioengineering, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council of the NIBIB. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS, SAM
Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Cooperative Agreement Terms and Conditions of Award
Not Applicable
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Telephone: 301-710-0267
TTY: 301-451-5936
Email: [email protected]
Christina H. Liu, Ph.D., P.E.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-7638
Email: [email protected]
David T. George, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8633
Email: [email protected]
Angela Eldridge
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4793
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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