Administrative Supplements for Collaborative Projects in Metabolomics Research (Admin Supp)

Administrative Supplements for Collaborative Projects in Metabolomics Research (Admin Supp) is sponsored by National Institutes of Health (NIH). This funding opportunity supports supplemental funds to current NIH-funded research projects for new interactive collaborations between basic or clinical researchers and metabolomics experts.

Expired PA-14-003: Collaborative Activities to Promote Metabolomics Research (Admin Supp) This notice has expired. Check the NIH Guide for active opportunities and notices. of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations Office of Strategic Coordination ( Common Fund ) This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative ( http://commonfund. nih.

gov/ ) through the Office of Strategic Coordination, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the NIH Director ( http://dpcpsi. nih. gov/osc/ ).

This FOA will be administered by the National Cancer Institute ( NCI ) on behalf of the NIH.

Funding Opportunity Title Collaborative Activities to Promote Metabolomics Research (Admin Supp) Administrative Supplement Additional funds may be awarded as supplements to parent awards using the following Activity Code(s): Administrative supplement requests must be submitted on paper for the following activity codes: P01 Research Program Projects Administrative supplement requests may be submitted electronically for the following activity codes: DP2 NIH Director’s New Innovator Awards DP3 Type 1 Diabetes Targeted Research Award R00 Research Transition Award R01 Research Project Grant R37 Method to Extend Research in Time (MERIT) Award U01 Research Project Cooperative Agreements November 5, 2014 - This PA has been reissued as PA-15-030 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose This administrative supplement funding opportunity is part of the Common Fund Metabolomics Program created to increase and improve the nation’s ability to undertake metabolomics analyses in translational and clinical research.

Metabolomics has great potential to advance our understanding of human diseases, but requires specialized expertise in metabolomics study design, technology, and data analysis and interpretation. This FOA supports supplemental funds to current NIH-funded research projects for new interactive collaborations between basic or clinical researchers and metabolomics experts to add biomedical studies requiring a metabolomics approach.

In addition to enhancing the parent grant by adding metabolomics analyses, collaborative projects must include activities to increase the expertise of the biomedical research group in key aspects of metabolomics study design, analysis, and data interpretation. All applicants are strongly encouraged to discuss potential requests with the awarding IC and with the Common Fund Metabolomics Scientific/Research contact listed below.

Additionally, prior to submission, applicants must review the awarding IC's web site to ensure they meet the Open Date (Earliest Submission Date) Letter of Intent Due Date(s) February 14, 2014, by 5:00 PM local time of applicant Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in the Application Guide ( SF424 (R&R) Application Guide or PHS 398 Application Guide , as appropriate) 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. 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 Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description This Funding Opportunity Announcement (FOA) 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.

This FOA is specifically part of the Common Fund Metabolomics Program, the overall goal of which is to increase and improve the nation’s ability to undertake metabolomics analyses in translational and clinical research. Metabolomics has great potential to advance our understanding of human diseases, but requires specialized expertise in metabolomics study design, technology, and data analysis and interpretation.

This initiative supports supplemental funds to current NIH-funded research projects for new, interactive collaborations between basic or clinical researchers and metabolomics experts to pursue biomedical studies requiring a metabolomics approach and increase metabolomics expertise in the biomedical research 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).

Metabolomic profiling in basic, epidemiological, clinical and translational studies has revealed potential new biomarkers of disease and therapeutic outcome and led to novel mechanistic understanding of pathogenesis. Comprehensive, high quality metabolomics investigations require access to specialized equipment and highly trained personnel with expertise in bioinformatics, biochemistry, physiology, and spectrometry.

Proper metabolomics study design, particularly for studies involving clinical samples, is critical for translationally relevant outcomes and interpretation of metabolomics results requires an in-depth understanding of metabolism and physiology. Few institutions are equipped to handle the intricacy of analyses required to undertake comprehensive studies and fewer still have personnel with metabolomics expertise.

An investment in training investigators in the disciplines required to undertake metabolomics analyses is expected to help increase the capacity to apply this powerful approach to translational questions. This initiative will support new, highly interactive collaborations that exploit metabolomics approaches to move basic and clinical research towards translational goals.

In doing so, it will also increase the number of investigators cross-trained in metabolomics, methodology, bioinformatics analysis, biochemistry, and physiology. Fee-for-service only arrangements where samples are analyzed without an extensive interactive collaboration are not eligible as they will not increase the pool of investigators with direct experience in metabolomics analysis.

Similarly, groups which have collaborated before in the area of metabolomics are not eligible, as collaborations are intended to expand the community of scientists using metabolomics. Criteria for Funding Consideration The collaborations must be new and composed of at least one biomedical research investigator and an investigator with documented experience in comprehensive metabolomics analyses.

There can be no history of prior collaboration on metabolomics between the components (including, but not limited to, publications) within the The collaborative study must propose a metabolomics study consistent with the general scope of the parent research grant. Analysis of a small number of known metabolites is not eligible. Pilot projects in preparation for an extensive study are allowed.

The parent grant must be funded through June 30, 2015, exclusive of no cost extensions, to allow sufficient time to achieve training goals. Interactive collaboration between the biomedical researcher and the metabolomics personnel must be integral to the research plan so as to increase the metabolomics expertise of the biomedical researcher.

If the parent grant already contains metabolomics analyses, the application must clearly state the added value of the new collaboration and how the new collaboration will meet the goals of increasing metabolomics knowledge and expertise in the biomedical research community.

Support for fee-for-service only arrangements where samples are analyzed without an extensive interactive collaboration are not eligible as they will not increase the pool of investigators with direct experience in metabolomics analysis. The application must describe how the collaboration will enhance the expertise of the biomedical researcher in metabolomics.

The proposed study cannot be duplicative of any active or previously funded research for any of the collaboration members. The PD/PI or metabolomics collaborator must be available to attend the annual Common Fund Metabolomics Program meeting, which will be held Section II.

Award Information The funding instrument will be the same as the parent Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement.

Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. Application Types Allowed Non-competing Administrative Supplements 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.

NIH intends to commit approximately $2 million in FY2014 to fund 12-14 awards.

Application budgets are limited to no more than $100,000 direct costs, exclusive of consortium/contractual Facilities and Administrative (F&A) costs, and must reflect the actual needs of the The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives, as long as the research objectives are within the original scope of the project, or the cost increases are for unanticipated expenses within the original scope of the project.

Any cost increases need to result from making modifications to the project that would increase or preserve the overall impact of the project consistent with its originally approved objectives and purposes. The project and budget periods must be within the currently approved project period for the existing parent award. Parent awards must be funded through June 30, 2015, exclusive of any no cost extension.

Supplemental funding is limited to a maximum of 12 months. described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. All organizations administering an eligible parent award may apply for a supplement under this announcement.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Black Colleges and Universities (HBCUs) Controlled Colleges and Universities (TCCUs) Native and Native Hawaiian Serving Institutions American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) This announcement is for supplements to existing projects.

To be eligible, the parent award must be active and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be to provide for an increase in costs due to unforeseen circumstances. All additional costs must be within the scope of the peer reviewed and approved project.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

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.

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 Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.

gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the 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. Eligible Individuals (Program Director/Principal Individual(s) must hold an active grant or cooperative agreement, and the research proposed in the supplement must be accomplished within the competitive segment of the active award.

Individuals are invited to work with their organizations to develop applications for support. For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.

Do not use this administrative supplement application to add, delete, or change the PDs/PIs listed on the parent award. Visit the Multiple Program Director/Principal Investigator Policy in the SF424 (R&R) Application Guide for more This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute applications to this announcement will only receive administrative review by the awarding Institute or Center, and will not receive a peer review, the NIH policy on resubmissions will not apply.

However, applications not accepted by the Institute or Center for review, or not funded by the Institute or Center, should not be submitted again without either responding to any written concerns or contacting the awarding Institute or Center for instructions first. Only one application per parent award is allowed. Section IV.

Application and Applicants are required to prepare applications according to the current application forms in accordance with the Application Guide. For electronic submissions, applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this announcement, or use the eRA Commons streamlined submission process. 2.

Content and Form of Application Submission All forms should be completed for the supplemental activities only and should not reflect funding or activities for the previously awarded parent award. It is critical that applicants follow the instructions in the Application Guide (R&R) Application Guide or PHS 398 Application Guide , as appropriate) 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 For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant All page limitations described in the Application Guide and of Page Limits must be followed, with the following exceptions or additional The Research Strategy (including description of collaborative benefits) cannot exceed six pages.

Electronic submission of request for administrative supplements is only available for single-project activity codes for which competing applications are submitted electronically. Visit the list of Codes Processed Electronically by eRA to determine if the single-project activity code of the parent award has transitioned to electronic submission.

Submission of requests for administrative supplements is for all other activity codes must If the administrative supplement may be submitted electronically, then you may either (A) submit using the SF424 (R&R) Application Forms and Grants. gov/Apply, (B) submit using the streamlined submission process of eRA Commons, or (C) submit using the paper-based PHS 398 Application forms and the PHS 398 Application Guide.

Applicants must use the PHS 398 Application Forms and the PHS 398 Application Guide. Instructions for Submissions using Grants. gov/Apply for electronic-based submissions For single project grants with activity codes that have transitioned to electronic submission using the SF424 (R&R) application forms, administrative supplement requests may be submitted electronically as a Revision application type on the R&R Cover Component.

Prepare applications using the SF424 (R&R) application forms associated with this announcement. Please note that some components marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional components.

Special Instructions for Streamlined Submissions using the eRA Commons for electronic-based submissions NIH now offers a streamlined system through the eRA Commons for submitting administrative supplements. Login to the eRA Commons , identify the parent award, and prepare an administrative supplement request. A User s Guide for submitting through this system is available.

Include the Research Strategy and any other required documentation (described below) as a PDF file using the Add Other Attachments function. Budget information should be entered for the grantee institution in the fields provided.

There is no template or form available for subaward information; instead, all subaward information should be included as a separate attachment showing the funds requested (by budget period) using the same categories provided for the grantee institution. Also include a budget justification for the subawardee institution in the same file.

Instructions for Submissions using the PHS 398 Application Forms (for paper-based submissions) Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. The grantee institution, on behalf of the PD/PI of the parent award, must submit the request for supplemental funds directly to the awarding component that supports the parent award.

Submit a signed, typewritten original of the application, including the checklist, and two signed photocopies in one Chief, Office of Grants Management National Cancer Institute (NCI) 9609 Medical Center Drive On the face page of the application form, note that your application is in response to a specific program announcement, and enter the title and number of this announcement.

Research Plan (Research Plan) All instructions in the Application Guide must be followed for all Research Plan sections applicable to the proposed supplement activities. At a minimum, the Research Strategy section should be completed and must include a summary or abstract of the funded parent award or project.

Other sections should also be included if they are being changed by the proposed Aims : This section is not required and will not be evaluated. Strategy: The research strategy should address, in separate sections, the 5 bulleted items below. the scope of the overall project on which the supplemental request is based.

the rationale for the proposed metabolomics component and how this activity will benefit achieving the goal of the parent grant. the supplement's specific aims, metabolomics research design and methods.

Include information on the technology platform and method of analysis that will be used, as well as the available bioinformatics support and data storage the interactions between collaborators, anticipated information and technology exchange, and how the collaborative study is expected to enhance the expertise of the biomedical collaborator in metabolomics. any technical or conceptual innovations central to this application.

of Support: In addition to the required elements listed above, the application should include a letter from the leader of each collaborating group that briefly describes his/her commitment to the project and lists his/her active research grant support, including the annual direct costs. The letter should be countersigned by the authorized organizational representative/institutional official of the collaborators institution.

Sharing Plan: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan that includes deposition of metabolomics data and appropriate metadata in the Common Fund Metabolomics Program Data Repository and Coordinating Center (DRCC).

Governance of this repository will provide for appropriate proprietary Project/Performance Site Locations (Project/Performance All instructions in the Application Guide must be followed, with the following additional instructions: Include the primary site where the proposed supplement activities If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided.

Senior/Key Personnel Form All instructions in the Application Guide must be followed, with the following additional instructions: List the PD/PI as the first person (regardless of their role on the supplement activities). List any other Senior/Key Personnel who are being added through this supplement, or for whom additional funds are being requested through this supplement; include a biographical sketch for each.

Clearly identify the collaborator serving as the metabolomics expert. R&R Detailed Budget Form (for use with electronic All budgets should be submitted using the R&R Detailed Budget form, regardless of the form used for the parent award, and should only include funds requested for the additional supplement activities.

Include travel budget for the biomedical researcher or metabolics collaborator to attend the annual Common Fund Metabolomics Program meeting, held domestically. Do not include travel to additional scientific meetings, except where vital to establish or maintain collaboration. Budgets should not include equipment, service contracts, or publication costs.

Provide justification that details the Budget for the Entire Proposed Period of Support (for use with paper-based submissions) A proposed budget should be submitted using the PHS 398 budget forms, in accordance with the PHS 398 Application Guide, and should only include funds requested for the additional supplement activities.

Include travel budget for the biomedical researcher or metabolics collaborator to attend the annual Common Fund Metabolomics Program meeting, held domestically. Do not include travel to additional scientific meetings, except where vital to establish or maintain collaboration. Budgets should not include equipment, service contracts, or publication costs.

Provide justification that details the Other Project Information (for use with electronic submissions); Appendix (use with paper-based All instructions in the Application Guide must be followed, with the following additional instructions: IACUC Documentation and IRB Documentation (Uploaded via the Other Attachments Section for electronic If applicable, include documentation that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution.

Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects involvement is planned for the supplement component.

The filename provided for each Other Attachment will be the name used for the bookmark in the electronic application in eRA Planned Enrollment Report (for use with electronic submissions) research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies Grants Policy Statemen t , and procedures for foreign institutions described throughout the 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 as described above.

Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH’s electronic system for grants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

For electronic application submission, information on the submission process and a definition of on-time submission are provided in the SF424(R&R) For paper-based application submission, iinformation on the process of receipt and determining if your application is considered on-time is described in detail in the PHS 398 Application Guide. 4.

Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Pre-award costs are allowable only as described in the NIH Grants Requirements and Information Applications must be submitted using the instructions 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 For applications submitted electronically on the SF424 (R&R) Application forms, all PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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 Application Guide. tips for avoiding common errors. Upon receipt, applications will be evaluated for completeness and/or responsiveness by the awarding Institute or Center.

Applications that are incomplete and/or nonresponsive will not be reviewed. Post Submission Materials Section V. Application Review Information Administrative Supplements do not receive peer review.

Instead, the administrative criteria described below will be considered in the administrative The staff of the NIH awarding component will evaluate requests for a supplement to determine its overall merit.

The following general NIH Staff will consider whether the budget and the requested period of support are fully justified and reasonable in relation to NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award: Will the administrative supplement increase or preserve the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved?

Is the use of metabolomics integral to accomplish the proposed Does the collaborative team have documented expertise in metabolomics to conduct and achieve the goals the supplemental study? Are the analytical platforms appropriate for the supplement goals and is the metabolomics study design well-rationalized?

Is the sample collection for the study appropriate for Are power calculations and statistical analyses appropriate for Will the proposed activities enhance metabolomics knowledge of the biomedical investigator leading to increased metabolomics expertise in the biomedical research community?

Is the requested timeframe adequate to accomplish scientific goals and enhance the expertise of the biomedical researcher in metabolomics Is there an adequate data sharing plan, including deposition of data in the Common Fund Metabolomics Program Data Repository and Coordinating Is there adequate progress on the parent grant appropriate to the current stage of the project? Is there a current estimated unobligated balance?

In addition, each of the following criteria will be evaluated as applicable for the proposed supplement.

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, NIH staff 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, NIH staff 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 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 .

NIH Staff 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 for Review of the Vertebrate Animal Section . NIH Staff will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if