NICHD Resource Program Grants in Bioinformatics (P41 Clinical Trial Not Allowed)

NICHD Resource Program Grants in Bioinformatics (P41 Clinical Trial Not Allowed) is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), NIH. This opportunity supports the continued operation, enhancement, and broad dissemination of major bioinformatics resources that are critical to the research community using animal models to study embryonic developmental processes.

Expired PA-08-180: Resource Program Grants in Bioformatics (P41) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services of Health (NIH) ( http://www.

nih. gov ) Components of Participating Organizations Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ( http://www. nichd.

nih. gov ) Title: Resource Program Grants in Bioformatics (P41) Update: The following update relating to this announcement has been issued: December 1, 2009 - This FOA has been updated to reflect the new requirements from NIH’s Enhancing Peer Review Initiative. The new requirements are effective for submissions intended for due dates January 25, 2010 and beyond.

If submitting an application intended for a due date of January 25, 2010 and beyond, follow the guidance below and be sure to use the 06/2009 version of the PHS 398 application forms and instructions. If applying for a due date before January 25, 2010, follow the guidance in the archived version of this FOA and be sure to use the 11/2007 version of the PHS 398 application forms and instructions.

of the Department of Health and Human Services' implementation of e-Government the NIH will gradually transition each research grant mechanism to electronic submission through Grants. gov and the use of the SF 424 Research and Related (R&R) forms. For more information and an initial timeline, see http://grants.

nih. gov/grants/guide/notice-files/NOT-OD-06-035. html .

NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts ( http://grants. nih. gov/grants/guide/index.

html ). Program Announcement (PA) Number: PA-08-180 Catalog of Federal Domestic Assistance Letters of Intent Receipt Date(s): Not applicable Application Submission Date (s): Standard dates apply; please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward AIDS Application Submission Date(s): Standard dates apply; please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#AIDS Peer Review Date(s): Standard dates apply; please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward Council Review Date(s): Standard dates apply; please see http://grants1. nih.

gov/grants/funding/submissionschedule. htm#reviewandaward Earliest Anticipated Start Date(s): Standard dates apply; please see http://grants1. nih.

gov/grants/funding/submissionschedule.

htm#reviewandaward Additional Information to Be Available Date (Url Expiration Date: September 8, Kennedy Shriver National Institute of Child Health and Human Development (NICHD) solicits Resource Program Grants in Bioinformatics for supporting the continued operation, improvement, and dissemination of databases, digital information, or software tools that are unique, and of special importance to research using animal models of embryonic developmental processes.

Applicants are strongly encouraged to consult with the Scientific/Research Contact listed below in Section VII to ensure that the proposed project reflects the objectives of this FOA and the programmatic interests of the NICHD. of Support. This FOA will utilize the P41 grant mechanism .

Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received.

and Project Period. Budgets for direct costs of up to $1,750,000 per year and a project duration of up to five years may be requested for a maximum of $8,750,000 direct costs over a five-year project period. Eligible Institutions/Organizations.

Institutions/organizations in Section III, 1. A. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). I ndividuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/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 Number of PDs/PIs.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application. Number of Applications. Applicants may submit more than one application, provided that each application is scientifically distinct.

Resubmissions. Resubmission applications will be accepted. Such applications must include an Introduction addressing the previous peer review critique (Summary may submit a renewal application.

Special Date (s). See Receipt, Review and Anticipated Start Dates . Application Research Strategy Length : The P41 application Research Strategy section of the PHS398 may not exceed 12 pages, including tables, graphs, figures, diagrams, and charts.

IV. 1 for application materials. All applications, including resubmission, revision and renewal, submitted for due dates January 25, 2010 and beyond, must utilize the current forms and instructions.

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY 301-451-5936 Part II Full Text of Announcement Section I. Funding Opportunity Section II.

Award Information 2. Cost Sharing or Matching 3. Other - Special Eligibility Criteria IV.

Application and Submission Information 1. Address to Request Application Information 2. Content and Form of Application Submission 3.

Submission Dates and Times A. Receipt and Review and B. Sending an Application to C.

Application Processing 4. Intergovernmental Review 6. Other Submission Requirements and Information V.

Application Review Information 2. Review and Selection Process A. Additional Review Criteria C.

Resource Sharing Plan(s) Anticipated Announcement and Award Dates VI. Award Administration Information 2. Administrative and National Policy Requirements 1.

Scientific/Research Contact(s) 2. Peer Review Contact(s) 3. Financial/ Grants Management Contact(s) VIII.

Other Information - Required Federal Citations - Full Text of Announcement Section I.

Funding Opportunity Description This FOA announces the Eunice Kennedy Shriver National Institute for Child Health and Human Developments Resource Program Grants in Bioinformatics supporting the continued operation, enhancement, and dissemination of databases or software tools that are unique, and of major importance to research using animal models of embryonic developmental processes.

The NICHD Biomedical Informatics Resource Program grant will support ongoing research, maintenance, and enhancement, of the tool or resource, user training and services, and wide dissemination of the tool or The emergence and rapid evolution of detection and sequencing technologies has generated unprecedented quantities of data from the analyses of biological systems at a molecular level.

This rapid progress has been particularly significant with regard to genomic and proteomic technologies. This exponential increase of information has been paralleled and facilitated by the increased ability of computers to digitally record, store, and analyze this cascade of data.

However, for the ever-increasing quantities of information to be maximally useful to biomedical scientists requires the establishment and maintenance of data base resources to provide for the compilation, annotation, storage, and dissemination of the data.

Additionally, resources are required to develop and supply tools for analysis, to provide for input of new data, and to provide the necessary technical advice and training required to utilize the database resources.

These Resource Program Grants in Bioinformatics are intended to support continued operation, improvement and maintenance of bioinformatics tools or resources, user training and services, and wide dissemination of the tools or resources.

To qualify for support, bioinformatics resources software, algorithms, or knowledge resources must be of demonstrable value toward advancing research utilizing animal model systems in the biomedical sciences and must also be of particular importance to those seeking to understand the biological basis of human and animal development and the etiology of structural birth defects.

The resources must be sufficiently mature to have verifiable support and utility for users within the developmental biology research community. Examples of activities that Resource Program Grants in Bioinformatics are intended to support include but are not Efforts to curate and annotate unique collections of data, information or knowledge that support learning and research utilizing animal model systems.

Software for information and knowledge processing, including information extraction, integration of data from heterogeneous sources, event detection, and feature recognition within these Tools for analyzing and/or storing large datasets, including genomic and proteomic data, data regarding gene and protein expression in relation to cellular, anatomical, and/or developmental Data sets and tools for analysis of gene regulatory networks, protein-protein interaction networks, epigenetic regulatory mechanism, systems biological approaches, and other tools for understanding normal and abnormal biological function and/or development.

Other unique data sets or information tools of demonstrable utility for biomedical research using animal models of Systems for knowledge representation, including vocabularies, ontologies, simulations and virtual reality, retrieval tools and intelligent agents for scientific information related to Resource Program Grants in Bioinformatics are not intended to support: Research and development intended as proof of concept, to ascertain feasibility, or to underwrite the initial development Projects that utilize a tool or database being supported through these resource program grants.

Such projects should seek funding through customary NIH research grant mechanisms.

Applicants who wish to undertake biomedical informatics research, to develop and test novel information technologies, or to perform feasibility or proof-of-concept studies, should use other research Tools and resources that duplicate activities of the National Library of Medicine or existing resources supported by other Institutes of the National Institutes of Health.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review . Incomplete applications will not be reviewed. Applicants are strongly encouraged to consult with the Scientific/Research Contact listed below in Section VII to ensure that the proposed project reflects the objectives of this FOA and the programmatic interests of the NICHD.

VIII, Other Information - Required Federal Citations , for policies related to this announcement. opportunity announcement (FOA) will use the P41 award mechanism. The applicant will be solely responsible for planning, directing, and executing the FOA uses Just-in-Time information concepts.

It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants. nih. gov/grants/funding/phs398/phs398.

html ). Requested direct costs are expected to range from $500,000 up to 1,750,000 per year [see Section IV 6 for special the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the and administrative costs requested by consortium participants are not included in the direct cost limitation see NOT-OD-05-004 . grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA . III.

Eligibility Information organizations/institutions are eligible to apply: Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Hispanic-serving Institutions Historically Black Colleges and Tribally Controlled Colleges and Native Hawaiian Serving Institutions Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) Indian/Native American Tribal Governments (Federally Indian/Native American Tribally Designated Organizations City or Township Governments Special District Governments Independent School Districts Public Housing Authorities/Indian Housing Authorities U.S. Territory or Possession American Tribal Governments (Other than Federally Recognized) Agencies of the Federal Government or Community-based Organizations 1.

B. Eligible Individuals skills, knowledge, and resources necessary to carry out the proposed research is invited to work with his/her institution 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.

than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants. nih.

gov/grants/multi_pi . All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era. nih.

gov/ElectronicReceipt/preparing. htm for instructions). decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project.

Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.

Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.

nih. gov/grants/multi_pi . 2.

Cost Sharing or Matching require cost sharing as defined in the current NIH Grants Policy Statement . 3. Other-Special Eligibility Criteria may submit a resubmission application, but such applications must include an Introduction addressing the previous peer review critique (Summary Statement) .

Applicants may submit a renewal application. submit more than one application, provided that each application is Section IV. Application and Submission Information 1.

Address to Request Application instructions are available at http://grants. nih. gov/grants/funding/phs398/phs398.

html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected] .

the hearing impaired: TTY 301-451-5936. 2. Content and Form of Application Submission prepared using the most current PHS 398 research grant application instructions and forms.

Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www. dnb.

com/us/ . The D&B number should be entered on line 11 of the face page of the PHS 398 this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked. proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs.

NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period.

The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al.

The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution. All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project. PD/PI Leadership Plan : For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described.

The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award. information is available in the PHS 398 grant application instructions .

3. Submission Dates and Times See Section IV. 3.

A. for details. Submission, Review and Anticipated Start Dates Receipt Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm AIDS Application Submission Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm Review Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm Anticipated Start Date(s): Standard dates apply, please see http://grants.

nih. gov/grants/funding/submissionschedule. htm letter of intent is not required for the funding opportunity.

Sending an Application to the NIH must be prepared using the research grant application forms found in the PHS 398 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: National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 (U.S. Postal Service Express Bethesda, MD 20817 (for express/courier service; deliveries of applications are no longer permitted (see http://grants. nih. gov/grants/guide/notice-files/NOT-OD-03-040.

html ). At the time of submission, two additional copies of the application and all copies of the appendix materials must be sent to: Director, Division of Scientific Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Rockville , MD 20852-7510 (for express mail or courier service) Telephone: (301) 496-1485 3. C.

Application Processing Applications must be submitted on or before the application receipt/submission dates described above ( Section IV. 3. A.

) and at http://grants. nih. gov/grants/dates.

htm . applications will be evaluated for completeness by CSR. Incomplete applications accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application.

The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review. status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.

era. nih. gov/commons/ .

4. Intergovernmental Review subject to intergovernmental subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants are allowable.

A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval.

If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or renewal award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred.

NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants. nih. gov/grants/policy/nihgps_2003/NIHGPS_Part6.

htm .)

Requirements and Information Instructions for Applications Requesting $500,000 (direct costs) or More per $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps: IC program staff at least 6 weeks before submitting the application, i.e., as plans are being developed for the study; from the IC staff that the IC will accept the application for consideration for 3) Include a cover letter with the application that identifies the staff member and IC who agreed to accept assignment of the applies to all new, renewal, revision, or resubmission applications.

See NOT-OD-02-004 , October 16, 2001. All paper PHS 398 applications must provide appendix material on CDs only. Include five identical CDs in the same package with the application.

(See http://grants. nih. gov/grants/guide/notice-files/NOT-OD-08-031.

html .) Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may be delayed in the review process.

considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance, research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community.

If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants. nih.

gov/grants/policy/data_sharing/data_sharing_faqs. htm . (a) Data Sharing Plan : Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible.

Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants. nih.

gov/grants/guide/notice-files/NOT-OD-03-032. html .

(b) Sharing Model Organisms : Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not Model Organisms Policy , and NIH (c) Genome-Wide Association Studies ( G WAS ): Regardless of the amount requested, applicants seeking funding for a genome- w ide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.

A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088 , and http://grants. nih.

gov/grants/gwas/ . V. Application Review Information Criteria ( Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025 ).

described below will be considered in the review process. Review and Selection Process Applications submitted for this funding opportunity will be assigned on the basis of established PHS referral guidelines to the ICs for funding consideration. complete will be evaluated for scientific and technical merit by (an) appropriate scientific review group(s) in accordance with NIH peer review procedures ( http://grants1.

nih. gov/grants/peer/) using the review criteria stated below. part of the scientific peer review, all applications will: selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned an impact/priority score.

Receive a second level of review by the appropriate national advisory council or board. submitted in response to this funding opportunity will compete for available funds with all other recommended applications . The following will be considered in making funding decisions: merit of the proposed project as determined by scientific peer review.

of the proposed project to program priorities. goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.

Each of these criteria will be addressed and considered in assigning the overall score, and weighted as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious impact/priority score.

For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Overall Impact .

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five core review criteria, and additional review criteria (as applicable for the project proposed). Core Review Criteria .

Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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 project that by its nature is not innovative may be essential to advance a field.

Significance: Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project 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?

Investigator(s): Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? 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 project?

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 project involves clinical research, are the plans for 1) Protections for Human Subjects, 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?

For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? 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?

Additional Review Criteria As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate 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 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 Inclusion of Women, Minorities, and Children.

When the proposed project 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. 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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), 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. Renewal Applications.

When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period. Revision Applications. When reviewing a Revision application (formerly called a competing supplement application), the committee will consider the appropriateness of the proposed expansion of the scope of the project.

If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident. 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 Additional Review Considerations project proposed, reviewers will address 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. Budget and Period Support.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be