Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (http://commonfund.nih.gov) through the NIH Office of the NIH Director, Office of Strategic Coordination (http://dpcpsi.nih.gov/osc/).  The FOA will be administered by the National Institute of Diabetes and Digestive and Kidney Diseases  (www.niddk.nih.gov) on behalf of the NIH.

Funding Opportunity Title

Regional Comprehensive Metabolomics Resource Cores (RCMRC) (U24)

Activity Code

U24 Resource-Related Research Projects – Cooperative Agreements

Announcement Type

New

Related Notices

  • November 7, 2012 - See Notice NOT-RM-13-002. Notice of Clarification of Award Budget and Application and Submission Instructions.
  • January 10, 2012 - See Notice NOT-RM-12-009. This Notice is to inform potential applicants that the National Institutes of Health Common Fund is correcting and clarifying information relating to the “P&F Program” and required personnel effort.

Funding Opportunity Announcement (FOA) Number

RFA-RM-11-016

Companion FOA

RFA-RM-11-020, U01 Research Project – Cooperative Agreements

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.310

FOA Purpose

This FOA invites cooperative agreement applications to establish Regional Comprehensive Metablomics Resource Cores (RCMRC) to increase the national capacity for utilizing metabolomics in biomedical research.  To facilitate the biological and clinical application of metabolomics, technology service cores, pilot/feasibility projects, training activities, and outreach activities will be supported.

Key Dates
Posted Date

December 2, 2011

Letter of Intent Due Date

January 13, 2012; January 15, 2013

Application Due Date(s)

February 15, 2012; February 15, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2012; June, 2013

Advisory Council Review

August 2012; August 2013

Earliest Start Date(s)

September, 2012; September, 2013

Expiration Date

February 16, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose/Overall Description of Program

This initiative is funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress. 

The purpose of this funding opportunity announcement (FOA) is to increase the national capacity to provide metabolomics profiling and data analysis services to basic, translational, and clinical investigators through support for high quality metabolomics core facilities and associated personnel.  The Regional Comprehensive Metabolomics Resource Cores (RCMRC) (U24) are intended to facilitate institutional development of pioneering research, metabolomics training, and outreach programs in this emerging area.  This initiative is expected to support the creation of 5-6 RCMRCs that will serve as regional and/or national resources for metabolomics profiling and augment the current national capacity for translational research requiring a metabolomics approach. Important goals of the RCMRCs are to expand the use of sophisticated metabolomics technologies and augment metabolomics research leadership. An RCMRC should serve the research community beyond their institution and foster collaborative efforts that will advance translational research using metabolomics approaches. Consistent with these goals, where appropriate, RCMRCs may employ various activities such as pilot grant programs, training, dissemination, and other collaborative activities. While the Common Fund will provide funds to establish the RCMRCs, successful cores must provide plans for transition to a self–sustaining financial structure by the end of the five year project period.

The RCMRCs are expected to address the need for increasing metabolomics research capacity by providing national leadership in metabolomics research, training, and knowledge dissemination.  Individual RCMRCs can be structured to maximize the strengths of the institution(s) involved but are expected to have the following key components: an administrative core; one or more technology service core(s); and a promotion/outreach core encompassing pilot/feasibility projects, training of researchers in metabolomics, and/or outreach activities (e.g. dissemination of knowledge to the broad scientific community). While building unique expertise in a specific scientific area utilizing metabolomics is desirable, it is expected that each RCMRC will have expertise and resources supporting a broad range of metabolomics research. Since training of both junior and senior investigators is needed to realize the full potential of metabolomics in translational and clinical research, metabolomics training and education are desirable, but not required, outreach activities for the RCMRCs.  Pilot and feasibility projects that leverage core services to apply metabolomics technologies to biological questions will also be supported. It is expected that RCMRCs will need to acquire additional infrastructure to support a range of metabolomics technologies, laboratories, bioinformatics and statistical analyses, as well as data quality control and management, in the initial phase of the cooperative agreement. This infrastructure could include equipment for nuclear magnetic resonance (NMR), mass spectrometry (MS), gas/liquid high pressure chromatography (GLC, HPLC), and other relevant technologies, as well as personnel with appropriate expertise.

In order to achieve a comprehensive facility such as an RCMRC, applicants may wish to leverage existing institutional and regional metabolomics resources and expertise by integrating such resources, thereby developing a shared research infrastructure. For example, two metabolomics cores at an institution may work together to support one RCMRC, or two institutions in the region may collaborate by providing complementary technical platforms and expertise. It should be made clear in the application how such an RCMRC would provide seamless metabolomics services to the greater research community. Industrial partnerships are permitted, but not required. While institutional co-funding is not necessary, a letter of support indicating how an institution plans to position itself as a regional and/or national comprehensive metabolomics resource is highly desirable. Ultimately, the RCMRC should aim for the widespread and routine application of the proposed technologies.

Background

Metabolomics is the study of low molecular weight molecules or metabolites found within cells and biological systems and the metabolome is a measure of the functional output of biological pathways.  Metabolites are conserved across various animal species, facilitating the extrapolation of research findings in laboratory animals to humans and thus clinical and translational research.  Common technologies for measuring the metabolome include mass spectrometry (MS) and nuclear magnetic resonance spectroscopy (NMR), which can measure hundreds to thousands of unique chemical entities (UCE).

Despite the early promise of metabolomics, challenges remain in the application of this approach to biomedical research. The complexity and heterogeneity of metabolites are considerably greater than those seen with genes or proteins; normal physiological levels of many metabolites are not known and likely vary under different conditions; and there is a lack of comprehensive databases and standards against which the data can be accurately analyzed.  In addition, comprehensive, high quality metabolomics investigations require access to specialized equipment and highly trained personnel with interdisciplinary expertise in bioinformatics, biochemistry, physiology, and spectrometry in order to analyze the multidimensional and high throughput data arising from such studies.  Such specialized resources and expertise are difficult to establish through investigator initiated or singular institutional efforts. Few institutions are equipped to handle the volume of analyses required to undertake comprehensive studies and fewer still have personnel with appropriate metabolomics expertise.  The field is also expanding with a variety of novel and promising technological platforms, making it virtually impossible for a single academic facility to support the whole range of technical platforms and necessary technical expertise.

Currently, the need for metabolomics analyses of biological sample sets within individual investigators’ projects far outweighs the ability of the few existing comprehensive metabolomics facilities to provide suitable profiling and data analysis services.  Therefore a critical need exists across the biomedical research community to expand metabolomics profiling capacity by increasing the number of high quality metabolomics core facilities and trained investigators. To address this need, the NIH Common Fund has developed a comprehensive program with the collective goal of increasing metabolomics research capacity (http://commonfund.nih.gov/Metabolomics/).

RCMRC Organizational Structure

Each RCMRC should include an administrative core, one or more technology service cores, and a promotion/outreach core.  Each core has well-defined and distinct functions as described below.

Administrative Core

The Administrative Core will be responsible for the overall management of the RCMRC and for coordination with the Metabolomics Data Repository and Coordinating Center (DRCC; see RFA-RM-11-020). The Administrative Core will work closely with the DRCC to ensure that metabolomics data are deposited in accordance with the guidelines determined by the Executive Committee (see Governance Structure). The PD/PI of the RCMRC will serve as the director of the Administrative Core and will assume the overall leadership of the RCMRC. S/he should be assisted by a program coordinator who will oversee day-to-day operations of the RCMRC. The program coordinator should have broad knowledge of metabolomics technologies and the ability to support and manage core resources. The Administrative Core of each RCMRC will oversee the overall budget, including workflow records, collaborative activities, technical services, outreach activities, and travel to annual program meetings. The Administrative Core will also ensure that necessary agreements for external collaborative activities are in place, and will establish a reasonable cost-recovery fee schedule for such activities, in accordance with guidelines determined by the Executive Committee. The Administrative Core will provide an overall management plan for the RCMRC, including detailed plans and a timeline for transition to a self-sustaining financial structure by the end of the five year project period (see “RCMRC Implementation Phases” below and Section IV.2, Content and Form of Application Submission).

The Administrative Core will maintain a website for the RCMRC that links to the NIH Common Fund website for the Metabolomics Program.  Website content should include, but not be limited to, descriptions of the individual RCMRC cores, contact information for key RCMRC personnel, and descriptions of metabolomics technologies supported, including assays, protocols, and fees. The Administrative Core will update the RCMRC website in a timely fashion and communicate changes to the DRCC.

Technology Service Cores

Each RCMRC will have one or more Technology Service Cores. These cores will provide technology related consultation, metabolomics profiling services on biological or clinical samples, and bioinformatics and statistical analyses of the resulting data. The Technology Cores will also develop standard operating procedures to be shared with other RCMRCs. Technical methodology specific training curricula that would address the training goals of the Common Fund Metabolomics Program are also highly desirable. Collaborations with investigators participating in NIH Clinical and Translational Science Awards (CTSAs; http://www.ctsaweb.org/) are encouraged, but not required.  It is expected that each core will be adequately supported by the necessary scientific, technical, and bioinformatics expertise. Technology Core personnel should possess appropriate experience and expertise in metabolomics, including backgrounds in biochemistry, physiology, spectrometry, and bioinformatics. All of the technology cores will work in a coordinated fashion within the RCMRC.

Promotion/Outreach Core

The Promotion/Outreach Core will plan and facilitate various promotional, collaborative activities for the RCMRC. To accomplish this goal, the Promotion/Outreach Core may undertake one or more of the following activities: pilot and feasibility (P&F) projects, training activities, workshops, and/or courses to disseminate current metabolomics approaches to the broad scientific community. Examples of training programs may include, but are not limited to, a formal week-long class in a given technology with classroom and practical components; a visiting scientist program at the RCMRC laboratories; and/or synergy with existing institutional training programs.

Within the Promotion/Outreach Core, an RCMRC will request funds for P&F projects to enhance collaborative research activities and to promote the application of core services for biological and clinical research. These funds are not intended to support the ongoing, funded research of an investigator and are not renewable. The RCMRC will establish a process to solicit applications for this program. Review and selection of P&F projects will be accomplished by the Executive Committee of the Metabolomics Program (see Governance Structure). It is expected that each RCMRC will support 3-5 P&F projects  and, consistent with being a regional resource, at least half would include investigators outside the RCMRC institution.  By FY2015 inclusion of clinical collaborations is expected.  Descriptions of the goals and progress of supported P&F projects should be included in the annual RCMRC progress report.

RCMRC Implementation Phases                                        

This initiative anticipates two phases in the establishment of the RCMRCs. During the first three years of Common Fund support, RCMRC institutions will expand their metabolomics capacities by complementing existing facilities with additional instrumentation, hiring additional staff trained in the areas required for comprehensive metabolomics analyses, and developing plans for future sustainability and research collaboration to become a regional and/or national comprehensive metabolomics resource. Accordingly, the Common Funds available anticipate higher budget requests in years 1-3 for equipment purchase and other start-up costs. The RCMRCs will also serve as training and/or dissemination centers for building a technical workforce of metabolomics researchers.

During the last two years of Common Fund support, the RCMRCs will continue to build a nationwide clientele of metabolomics research collaborators and will transition to a self-sustaining business model. After the five year award period, the RCMRCs should be able to maintain their status as national resources on a self-sustaining financial structure, such as fee for service basis.

Governance Structure

In order to facilitate the management of the Common Fund Metabolomics Program, two administrative bodies will be created: the Executive Committee (EC) and the External Evaluation Committee (EEC).

The EC will consist of the PD(s)/PI(s) of the DRCC, the PD(s)/PI(s) of each RCMRC, and the NIH Project Scientists for each RCMRC and the DRCC. The DRCC PD(s)/PI(s) and each RCMRC PD(s)/PI(s) will be voting members. The NIH will have one vote on the EC. The chair of the EC will be selected by the EC membership with the approval of NIH staff. The EC will be the principal governing body of the Metabolomics DRCC and will provide scientific management, leadership, and overall governance of the operations of the Common Fund Metabolomics Program. An important purpose of the EC will be to develop data repository policy, including data sharing standards for the associated Common Fund Metabolomics Program awards. The EC will also evaluate operational concerns of each RCMRC, discuss important issues relevant to the general metabolomics community, help with the planning of major events (e.g., annual program meeting), evaluate collaborative activities, and provide feedback to NIH program staff. The EC will also discuss the implementation of recommendations or suggestions from the NIH or the EEC and then plan a timely implementation strategy.

The EEC will assist NIH staff in its task of administering the Common Fund Metabolomics Program. It will be composed of 5-7 highly regarded scientists, selected by NIH, who will evaluate progress and provide oversight and recommendations to the NIH regarding ongoing activities and future directions of the various Metabolomics Program components.

Annual Metabolomics Program meetings, including EC and EEC members, will be held in order to facilitate collaborative activities and dissemination of scientific advances across all components of the Metabolomics Program. RCMRC budget requests should include plans for the PD(s)/PI(s) and program coordinator to attend these meetings. EC and EEC meetings will be held in conjunction with the Annual Metabolomics Program meeting.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Resubmission

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The total amount of funds available for these awards is approximately $53 million for FY2012-2017, contingent upon receiving scientifically meritorious applications. Three awards are anticipated in FY2012 and an additional three awards are anticipated in FY2013.

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project. Budgets are expected to be higher in the initial years due to the need for equipment purchase.

Prior to funding, proposed budgets will be scrutinized with care.  Components or specific activities that are not as meritorious may be deleted, and a project may not be funded for the full number of years requested if, for example, that duration of support is not deemed critical to achieving essential goals or if progress needs to be formally evaluated after fewer years.

Award Project Period

The total project period for applications submitted in response to this FOA may not exceed 5 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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

Foreign Institutions

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 allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

Project Director(s)/Principal Investigator(s)

The PD(s)/PI(s) of the RCMRC must be an established expert in metabolomics research. The PD(s)/PI(s) is responsible for the overall scientific direction and development of the RCMRC to support metabolomics research within and across institutions. The PD(s)/PI(s) will resolve disputes arising in the priority of core usage and will be responsible for final budget decisions with the assistance of the program coordinator. The PD(s)/PI(s) must devote at least 2.4 calendar months annually to the RCMRC. 

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. 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.

Letter of Intent

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:

Padma Maruvada, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
6707 Democracy Blvd., Room 663
Bethesda, MD  20892-5450 (20817 for express mail)
Telephone: 301-594-8884
Email: Padma.maruvada@nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Page Limitations

All page limitations described in the PHS398 Application Guide must be followed, with the following additional requirements:

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instruction:

In addition, RCMRC applications should be structured according to the following instructions.

Overall RCMRC

Face page

Information provided here should pertain to the overall RCMRC.

Description, Performance Sites, and Key Personnel (Form Page 2)

Information provided here should pertain to the overall RCMRC. Key Personnel should include the PD/PI, the Program Coordinator, and individual core leaders. Others should be listed under Other Significant Contributors.

Table of Contents (Form Page 3)

Budget Information (Form Pages 4 and 5)

Categorical figures should be provided to reflect the budget of the overall RCMRC. Since detailed budget justification will be provided separately for each core (as described below), only items for which justification is not provided elsewhere should be presented in narrative form here.

Biographical Sketch of the RCMRC PD(s)/PI(s) (not to exceed 4 pages)

A biographical sketch should be provided for the RCMRC PD(s)/PI(s) (use the PHS 398 Biographical Sketch form).  The biographical sketch should include a personal statement describing why the scientific qualifications and leadership experience of the proposed RCMRC PD(s)/PI(s) make him/her particularly well suited for leading the RCMRC, a chronological list of previous positions, honors, and a list of 15 selected, peer-reviewed publications. 

Biographical Sketch of the RCMRC Program Coordinator (not to exceed 4 pages)

A biographical sketch should be provided for the RCMRC Program Coordinator (use the PHS 398 Biographical Sketch form).  The biographical sketch should include a personal statement describing why the scientific and administrative qualifications of the proposed RCMRC Program Coordinator make him/her particularly well suited for leading the day-to-day operations of the RCMRC, a chronological list of previous positions, honors, and a list of 15 selected, peer-reviewed publications. 

Resources

Resources described here should be restricted to those not described separately for the individual cores (as described below).

Research Strategy for the overall RCMRC (not to exceed 12 pages):

The Research Strategy should include:

1.  An overview of the entire proposed RCMRC and the scientific objectives to be achieved, relevant background and significance, and a description of the impact of the RCMRC in relation to the state-of-the-art of the field. This statement should also include an explanation of how the work proposed is innovative. Additionally, the overview section should describe how the proposed individual cores will work together to achieve the overall RCMRC objectives and create synergy among the various components.

2.  A description of the current capabilities of the institutional resources to conduct metabolomics research and a description of the proposed expanded capabilities. This description should specifically include the rationale and intent for any additional infrastructure/equipment that will be purchased.

3. Representative preliminary studies that demonstrate the current capabilities of the institution to undertake metabolomics analyses, including evidence of feasibility and successful research collaboration. This section should also present very clear evidence that the RCMRC personnel has been/will be able to work together effectively to accomplish the goals of the RCMRC.

4. A resource design that describes the working scientific and logistical design, the Laboratory Information Management System (LIMS) and data analysis capability, as well as the resource support necessary to achieve the goal of becoming a regional comprehensive metabolomics resource. When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included (documentation of these arrangements should be included in the Letters of Support section).  Cost sharing or institutional support, if any, should be described in this section.

5.  If a core activity involves risk, applicants should explain how the degree of risk will be counterbalanced by the benefits to be gained and how these benefits will impact the science in relation to the state-of-the-art of the field.

The following items, which are not included in the 12-page limit, should be included after the Overall RCMRC Research Strategy:

a.  Literature cited

b.  Letters of support

Administrative Core

Cover Page (use continuation page, not PHS398 face page)

Please include a separate Title and Number and the name of the leader for the core.

Description, Performance Sites, and Key Personnel (Form Page 2)

This information needs to be supplied for each core. The list of key personnel should include individuals who, in addition to the core leader, contribute in a substantive, measurable way to the functions provided by the core.

Budget Information (Form Pages 4 and 5)

Detailed budget information should be provided for each core, with a narrative justification given for all budget items. In addition, the administrative core must include a budget for:

a.  Data and resource sharing
b.  Travel of the PD/PI and the program coordinator to the annual Metabolomics Program meeting
c.  Website development and maintenance

Biographical Sketches of Key Personnel

Biographical sketches should be provided for key personnel of each core using the PHS 398 Biographical Sketch form (limit 4 pages).  The biographical sketch should include a personal statement describing why the experience and qualifications of the proposed key personnel for each core make them particularly well suited for contributing to that core and to the RCMRC, a chronological list of previous positions, honors, and 15 selected, peer-reviewed publications. 

Resources

Resources should be described for each core.

Specific Aims for the Administrative Core should not exceed 1 page

Research Strategy for the Administrative Core (not to exceed 6 pages)

The description of the administrative  core should include a brief overview and indicate how the core will contribute to the overall goal of the RCMRC to become a regional comprehensive metabolomics resource. The description of the core should clearly indicate the facilities, resources, services, and professional skills that the facility will provide to the proposed RCMRC.

Special requirements for the Administrative Core Research Strategy

a. Management Plan (required): This should include a clearly described operational plan for the overall management of the RCMRC, including plans for oversight of services provided by the RCMRC; monitoring of pilot and feasibility projects; training; outreach activities; and the incorporation of new technologies. Applicants should address how program income will be spent and provide plans on cost recovery approaches that allow for continued growth and evolution of the RCMRC. A plan for regular and systematic review of the overall workflow and core utilization, as well as recommended performance measures, should be provided. The Administrative Core management plan should also describe how the RCMRC will transition to a self-sustaining, fee for service financial structure by the end of the five year project period. A timeline with milestones for this transition should be provided.

b. Resource and Data Sharing (required): This should be included in the administrative core and should describe plans for the sharing of research data and research resources. RCMRCs will also be subject to data sharing standards developed by the Executive Committee of the Metabolomics Program (see Governance Structure).

c.  Website (required):  Plans for establishing and maintaining a RCMRC website targeted to a broad audience that describes the RCMRC and the implications of research supported by the RCMRC should be described here.

The following information should be provided consecutively after the Research Strategy:

a.  Human Subjects

b.  Vertebrate Animals

c.  Literature cited

d.  Letters of support

e.  Letters documenting interest/commitment for collaborations

Technology Service Cores and Promotion/Outreach Core

Cover Page (use continuation page, not PHS398 face page)

Please include a separate Title and Number and the name of the leader for the core.

Description, Performance Sites, and Key Personnel (Form Page 2)

This information needs to be supplied for each core. The list of key personnel should include individuals who, in addition to the core leader, contribute in a substantive, measurable way to the functions provided by the core.

Budget Information (Form Pages 4 and 5)

Detailed budget information should be provided for each core, with a narrative justification given for all budget items.

Within the Promotion/Outreach Core, P&F programs may be proposed for up to 5% of the total cost of a RCMRC and must be included within the total cost request for the entire RCMRC.  Each P&F award must be limited to 1 year in duration and $50,000 in total costs.  Cost-sharing of proposed P&F programs with applicant institutions is encouraged. 

Biographical Sketches of Key Personnel

Biographical sketches should be provided for key personnel of each core using the PHS 398 Biographical Sketch form (limit 4 pages).  The biographical sketch should include a personal statement describing why the experience and qualifications of the proposed key personnel for each core make them particularly well suited for contributing to that core and to the RCMRC, a chronological list of previous positions, honors, and 15 selected, peer-reviewed publications. 

Resources

Resources should be described for each core.

Special requirements for each Technology Service Core Research Strategy (not to exceed 6 pages):

The proposed metabolomics technologies to be offered and the tools to be used for bioinformatics and statistical data analyses should be fully detailed. Capacity estimates for annual metabolomics services, with a clear plan for prioritization of service requests, should also be provided. It is appropriate to request equipment, hardware, software, and associated personnel in this core. Plans to incorporate any new equipment into the core services should be fully justified.

Each technology core should also describe proposed approaches to the analysis of primary metabolomics data generated (e.g., spectrographic and chromatographic traces). Proposed approaches for the presentation of raw and analyzed data to the user should also be described.  Additionally, plans for coordination with the Metabolomics Data Repository and Coordinating Center (DRCC) and with other technology cores within other RCMRCs to develop data standards and common analytical platforms for data sharing and integration should be described.

Special requirements for the Promotion and Outreach Core Research Strategy (not to exceed 6 pages):

a. Promotion/Outreach Plan (required):  This section of the application will describe a clear plan for achieving the promotional and outreach goals of the RCMRC. Promotion and outreach activities may include, but are not limited to, research collaborations, visiting scientist opportunities, workshops, and/or courses to disseminate current metabolomics approaches to the broad scientific community.

b. Training activities: Where training activities are included, a description of the plans for developing curricula and the target trainee population is expected. The training plan should include the manner in which the proposed RCMRC relates to and will synergize with existing institutional training programs to strengthen metabolomics training efforts at the participating institution(s) and/or plans to build the pipeline of future investigators

c. Pilot and Feasibility (P&F) program:  P&F programs should describe the internal procedures for solicitation of applications, evaluation of progress, and IRB/IACUC compliance for these projects.  Review and selection of pilot projects will be accomplished by the Executive Committee of the Metabolomics Program (see Governance Structure in Section I, Funding Opportunity Description).  Copies of P&F applications that were successful, associated IACUC/IRB approvals, and any special provisions that are being made for these projects to move forward will be reported to the Common Fund Metabolomics Program at the time the P&F award is made.  Progress reports on funded P&F awards will be required each year as part of the overall RCMRC progress report. 

The following information should be provided for each core, consecutively, after the Research Strategy section:

a.  Human Subjects

b.  Vertebrate Animals

c.  Literature cited

d.  Letters of support

e.  Letters documenting interest/commitment for collaborations

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 PHS398 Application Guide, with the following modifications:

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

PRE-APPLICATION CONFERENCE CALL

The NIH Common Fund Metabolomics Program has scheduled a pre-application conference call in which all interested prospective applicants are invited to participate.  Program and review staff will explain the goals and objectives of the funding opportunity announcement (FOA) for the Regional Comprehensive Metabolomics Resource Cores (RCMRC), discuss the application peer review process and answer questions.  The conference call is scheduled for January 4, 2012 at 1:00 pm Eastern time.  Teleconference updates and access information will be posted on the Common Fund Metabolomics Program website (http://commonfund.nih.gov/metabolomics/index.aspx) before January 4, 2012. 

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation.   As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs).  These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses.  Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits. 

If selected, appropriate funding will be provided by the NIH Intramural Program.  NIH intramural scientists will participate in this program as PD/PIs in accord with the Terms and Conditions provided in this FOA.  Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights. 

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application.  The intramural scientist may submit a separate request for intramural funding as described above.

Section V. Application Review Information

1. Criteria

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.

For this particular announcement, note the following:

RCMRCs are intended to expand and enhance the national capacity to apply metabolomics to translational research.  It is expected that these cores will serve as regional resources for metabolomics profiling and together serve as a national resource for metabolomics research. The Administrative Core, Technology Service Cores and Promotion/Outreach Core are each required components of the RCMRC and should function in an integrated manner to achieve the RCMRC goals.

Overall Impact - Overall

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the RCMRC 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 RCMRC proposed).

Scored Review Criteria - Overall

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 RCMRC that by its nature is not innovative may be essential to advance a field.

Significance

Does the RCMRC address an important problem or a critical barrier to progress in the field? If the aims of the RCMRC 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? Is the proposed RCMRC well positioned to pioneer and deliver metabolomics technology services to a wide research community?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the RCMRCt? 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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

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?    

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the RCMRCt? 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 RCMRC involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are the administrative and managerial plans adequate for coordinating activities within the RCMRC and with the DRCC? Is appropriate operational oversight proposed within the RCMRC?  Are plans for sharing costs with the users, including fee for service systems, appropriate?  Is the technological infrastructure requested for technology service cores necessary and adequate for the RCMRC? Has the applicant chosen the most cost effective and appropriate infrastructure?  Will proposed promotional and outreach activities reach a broad group and establish a continuing customer base for the RCMRC?  Are the plans to manage pilot and feasibility programs adequately described?  Are training opportunties likely to expand the cadre of expert metabolomics researchers?

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? Is the institutional commitment to the RCMRC appropriate and adequate?

Additional Review Criteria - Overall

As applicable for the RCMRC proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority 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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed RCMRC involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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

Not Applicable.

Revisions

Not Applicable.

Additional Review Considerations - Overall

As applicable for the RCMRC 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/priority 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.   

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.


As part of the scientific peer review, all applications:

Appeals of initial peer review will not be accepted for applications submitted response to this FOA.

Applications will be assigned  to the appropriate NIH Institute or Center and 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 appropriate National Advisory Council or Boardl. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

Section VI. Award Administration Information

1. Award Notices

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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

The PD(s)/PI(s) and Program Coordinator Effort Requirements:

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The NIH Project Scientist will serve as the contact point for all facets of the scientific interaction with the awardee (s). As required for the coordination of activities and to expedite progress, NIH may designate additional NIH staff to provide advice to the awardee on specific scientific and/or analytic issues. Such staff may include another Project Scientist(s) or Analyst, who will provide direct technical assistance to the awardees to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.

The NIH Project Scientist:

In addition, a separate NIH Program Official identified in the Notice of Award will be responsible for the normal stewardship and monitoring of the award including review and approval of all progress reports and all budgetary decisions. Monitoring may include: regular communications with the principal investigator and staff, periodic site visits, fiscal review, and other relevant activities.

Areas of Joint Responsibility

In order to facilitate the management of the Common Fund Metabolomics Program, two administrative bodies will be created: the Executive Committee (EC) and the External Evaluation Committee (EEC).

The EC will consist of the PD(s)/PI(s) of the Metbolomics Data Respository and Coordinating Center (DRCC), the PD(s)/PI(s) of each RCMRC, and the NIH Project Scientists for each RCMRC and the DRCC. The DRCC PD(s)/PI(s) and each RCMRC PD(s)/PI(s) will be voting members. The NIH will have one vote on the EC. The chair of the EC will be selected by the EC membership with the approval of NIH staff. The EC will be the principal governing body of the Metabolomics DRCC and will provide scientific management, leadership, and overall governance of the operations of the Common Fund Metabolomics Program. The purpose of the EC will be to develop data repository policy, including data sharing standards for the associated Common Fund Metabolomics Program awards. The EC will also evaluate operational concerns of each RCMRC, discuss important issues relevant to the general metabolomics community, help with the planning of major events (e.g.,annual program meeting), evaluate collaborative activities, and provide feedback to NIH program staff. The EC will also discuss the implementation of recommendations or suggestions from the NIH or the EEC and then plan a timely implementation strategy.

The EEC will assist NIH staff in its task of administering the Common Fund Metabolomics Program. It will be composed of 5-7 highly regarded scientists, selected by NIH, who will evaluate progress and provide oversight and recommendations to the NIH regarding ongoing activities and future directions of the various Metabolomics Program components.

Annual Common Fund Metabolomics Program meetings, including EC and EEC members, will be held in order to facilitate collaborative activities and dissemination of scientific advances across all components of the Metabolomics Program. RCMRC budget requests should include plans for the PD(s)/PI(s) and program coordinator to attend these meetings. EC and EEC meetings will be held in conjunction with the Annual Metabolomics Program meeting.

Upon award the NIH will constitute a "kick-off" meeting the Fall 2012 where RCMRC PD(s)/PI(s) so that a series of milestones can be developed along with timelines for their completion. PD(s)/PI(s) are responsible for the travel costs associated with this meeting.

Data and Resource Sharing:

RCMRCs must include  sharing plans for both data and unique research resources that are generated by the projects in concordance with NIH policies on the sharing of data and resources.  It is expected that resources developed by the RCMRC will be made available to the broader scientific community, after a proprietary period, at no charge other than the cost of reproduction and distribution during the project period.  In addition the metabolomics data generated through various research activities of the RCMRCs are expected to be transferred to the Metabolomics DRCC in accordance with guidelines developed by the EC.  Therefore, the RCMRCs must comply with the data base standards of  the EC and ensure timely data transfer to the DRCC.  The grant application must also include a statement indicating the applicant’s willingness to abide by the Cooperative Agreement Terms of Award.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) 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. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Padma Maruvada Ph.D.
Program Director
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8884
E-mail: Padma.maruvada@nih.gov

Peer Review Contact(s)

J. Thomas Peterson, Ph.D.
Chief - Bioengineering Sciences and Technologies
Center for Scientific Review
Telephone: 301-408-9694
E-mail: petersonjt@csr.nih.gov

Financial/Grants Management Contact(s)

Christina Coriz
Grants Management Specialist
Grants Management Branch
Division of Extramural Affairs
National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
Telephone:301-594- 8848
E-mail: corizc@niddk.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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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