Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Center for Research Resources (NCRR)
Funding Opportunity Title	National Gene Vector Biorepository and Coordinating Center (P40)
Activity Code	P40 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Material Resource Grants
Announcement Type	New
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-RR-10-010
Companion FOA
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestics Assistance (CFDA) Number(s)	93.389
FOA Purpose	The purpose of this FOA is to solicit grant applications to provide a resource to support authorized investigators in gene transfer research. The resources sought include laboratory services and a repository of data and materials of use to the research community with an interest in gene transfer. The applications are also expected to include one or more proposals for original research in areas related to the resource and the services it provides.

Posted Date	October 28, 2010
Letter of Intent Due Date	December 28, 2010
Application Due Date	January 27, 2011 by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	N/A.
Scientific Merit Review	June-July 2011
Advisory Council Review	October 2011
Earliest Start Date(s)	April, 2012
Expiration Date	January 28, 2011
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.

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

This FOA issued by National Center for Research Resources, National Institutes of Health, solicits grant applications to provide a resource to support authorized investigators in gene transfer research. The resources sought include laboratory services and a repository of data and materials of use to the research community with an interest in gene transfer. The applications are also expected to include one or more proposals for original research in areas related to the resource and the services it provides.

The specific goals of the award are to

• To develop and maintain a resource for specific needs of NIH-supported gene transfer investigators and gene-transfer investigators supported by other agencies of the Federal Government, elsewhere designated in this FOA as "authorized investigators".
• To perform core laboratory services related to gene transfer products in order to support authorized investigators.
• To create a biologic storage facility for materials related to gene transfer products.
• To create a biologic storage facility for materials related to human exposure to gene transfer studies.
• To create a pharmacology-toxicology database and repository.
• To develop and maintain a coordinating center to facilitate access to materials and information in the field of gene therapy.
• To conduct independent research regarding the properties, assessment and pharmacology and toxicology of gene therapy. The research could include studies related to sequencing, insertion site analysis, novel or improved assays for persistence of replication competent vector, or other similar issues related to the genes, vectors, reagents, and other products used in gene transfer research. The research should be used to improve understanding related to the generation, analysis, storage, retrieval, and/or replication of the products used in gene transfer research and/or clinical applications.

Background: Support for Gene Therapy Research

The NIH supports a broad array of investigations that make use of vectors as transport vehicles of genetic material for use in laboratory-based, translational, and/or clinical studies of gene transfer. The genetic material has defined functions, including the following:

• The potential to generate a specific gene product such as a cytokine, a hormone, an antigen, or an enzyme
• The potential to perform a genetic function inside a target cell as a replacement for a defective or inactive gene, a suppressor of an abnormally active host gene, or an activator of an abnormally silent host gene.
• The potential to transform a cell to induce a property in a host cell that will result in a beneficial biologic effect or to induce a property in a malignant cell that will result in the inactivation or death of the cell or to change its response to external agents such as cytokines, chemotherapeutic agents, stimulants, or inhibitors.

Establishment of National Gene Vector Biorepository and Coordinating Center (NGVBCC): In an FOA released in 2007, http://grants.nih.gov/grants/guide/rfa-files/rfa-rr-07-002.html#SectionII, the NCRR announced its intention to establish the NGVBCC as a resource for authorized investigators in gene transfer research to store, retrieve, test, and study vectors, tissues, and other products related to gene transfer. In addition, NCRR asked the NGVBCC to develop a pharmacology/toxicology database to include acceptable data from relevant NIH-supported studies. Having pharmacology/toxicology data available in a centralized database could inform plans for studies involving vector-related toxicities; spare investigators the unnecessary expense of repeating pharmacology-studies; avoid unintentional exposure to unacceptable toxicities; and obviate additional studies that are unlikely to yield new or useful information. A single award was made to create the NGVBCC to develop a resource. NCRR now seeks applications to continue to support an NGVBCC.

Gene transfer technology creates unique technical requirements for serving investigators' needs and providing storage facilities for relevant biologic materials. To serve the investigators' needs the NGVBCC must maintain a specialized facility that (1) meets cGMP http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211 and cGLP http://www.21cfrpart11.com/files/library/pred_rules/mcdowall_glp_annotate.pdf as defined in the Code of Federal Regulations; (2) provides no cost storage to not-for-profit and government agencies that qualify for NIH funding and are capable of performing scientific studies for up to 15 years for gene transfer clinical trial samples; (3) supplies web-based access to a fully automated information and accession system; (4) banks back up storage for clinical grade vector and master cell banks; (5) performs insertion site analysis (clonal analysis L M/LAM PCR); (6) publicizes informational and educational materials; and (7) distributes a variety of AAV, Adenovirus, HSV, Lentivirus, and Retrovirus antibodies, cell lines, plasmids, and vectors for use in gene transfer research. It must maintain a website with public and password protected sectors that includes information about its services, a governance document, and a policy and procedure manual. It must provide storage and access to the public to pharmacology/toxicology data on pre-clinical gene transfer studies. It must be governed by a policy and procedure manual that defines the characteristics of the NGVBCC, describes all of the related procedures for access, storage, and utilization of services and resources, provides tools to obtain authorization as an investigator and rules for validating authorization, describes procedures to protect specimens, the environment, and privacy of access, and all necessary infrastructure for developing and protecting the resource. It must deliver reports to and regularly seek advice from an External Advisory Board that includes qualified authorized investigators, relevant regulatory representation, and other experts the principal investigator considers qualified to assist in meeting the standards set forth in this proposal. The facility must develop policies and procedures for terminating storage, either by return or disposal of stored materials.

In offering to continue support for an NGVBCC, the NCRR seeks to maintain and expand upon the services and research resources the NGVBCC currently provides. Applicants are referred to information at the NGVBCC interactive website at https://www.ngvbcc.org/Home.action. NCRR seeks applications that will provide support for archiving services, insertion site analysis, pharmacology/toxicology resources, a reagent repository, and educational resources. The website should serve in excess of 400 unique visitors and 1,200 visits per month. It stores data on 35 pharmacology/toxicology gene transfer studies in its Pharmacology/Toxicology Database and 11,000 samples from 8 pharmacology/toxicology studies. In future years, NCRR expects the NGVBCC to plan for greatly expanded demand for storage of information and samples. The current reagent repository houses 70 gene therapy reagents with a focus on retroviral, lentiviral, and AAV reagents; the core laboratory analyzed 200 clinical samples for replication-competent virus and provided letters of support to the investigators for their FDA submissions. The NGVBCC should continue to serve intramural NIH investigators and extramural investigators in the field of gene therapy/transfer who are supported by awards from NIH institutes and centers.

The FDA's Biologic Response Modifiers Advisory Committee suggested that all participants in clinical studies in which they are exposed to gene vectors be followed for fifteen years for the delayed appearance of adverse events. Accordingly, the NGVBCC is expected to accommodate the needs of investigators and the participants in their studies by providing primary or back up storage facilities for materials and biological specimens resulting from relevant clinical studies that include gene vectors in accordance with FDA Guidelines for long-term follow up.

Human studies that include exposure to new gene therapy products are contingent upon demonstration of safety in preclinical test models. Pharmacologic data, including acute toxicity associated with gene therapy, have been shown to be more likely attributable to the chosen vector than the gene it carries. Thus, studies demonstrating that a particular vector is relatively free of acute toxicity have broad implications for other test products that employ the same vector. Likewise, vectors shown to be associated with acute toxicities might be avoided if relevant information is available before the vectors are incorporated into new products. In addition, pharmacokinetic and pharmacodynamic data on specific vectors may have general implications for similar or related vectors. For these reasons, investigators may profit by searching for studies on gene therapy products for which the NGVBCC currently has data from toxicology and biodistribution studies. For these reasons, the NGVBCC should plan to house all relevant pharmacology/toxicology data relevant to potential gene vectors.

The intent of this FOA is to continue to provide a gene transfer resource for investigators who are authorized to use the facility by the NGVBCC based on the current or previous status as NIH-funded investigators in the field of gene therapy/transfer. Specifically, the award is intended to provide an adequate and sufficient resource to provide:

• Access of authorized investigators to repository resources that allow for storage and re-accessioning of master cell banks, plasmids, or other vector-related products for potential laboratory, pre-clinical, and clinical investigation.
• Services such as insertion site, LAM-PCR, and LM-PCR, analysis on gene therapy materials and analyses on biological specimens for replication-competent vectors. The resource must also host a bioinformatics tool for identifying viral integration sites from LAM-PCR and LM-PCR analysis equivalent to SeqMap.
• Access of investigators to pharmacology/toxicology related materials such as aliquots of stored products and study data stored in a database. To provide access the applicant must create a database and repository for research results stemming from pharmacology-toxicology studies on gene transfer products. The database and repository must provide centralized, generally accessible storage of vector related information. The data storage facility must provide authorized investigators in the field of gene therapy with access to information relevant to the use of vectors and/or genetic material in pre-clinical settings. Because acute toxicities associated with gene therapy often relate to vector exposure, the investigators would benefit from the shared information.
• An archival storage system for clinical specimens related to exposure to gene transfer projects. The system must permit retention of preserved biological materials from human subjects who may be at risk of delayed adverse events associated with exposure to gene therapy products. The materials stored potentially include cellular, tissue, and other biological materials donated by study participants. The stored materials could be used to support investigations of delayed adverse events following exposure to gene therapy products. The archive could provide a back-up storage facility for specimens in the event that a clinical investigator of gene therapy or an institution is unable to continue storage of the biological materials.
• A coordinating center that will educate and report to members of the gene transfer community information regarding emerging knowledge of the pharmacology and toxicology of gene vectors and the assessment of delayed adverse events following exposure to gene therapy. Education could be in the form of tutorials provided through the NGVBCC website, in hard copy, or presentation at nationally advertised scientific meetings. Reports could be in the form of publications in peer-reviewed scientific journals or presentations at related scientific meetings.
• Protection of the materials, data, and related communications from risks so as to insure their security, safety, and stability. To do this the application must include a plan to protect the resource against access by unauthorized personnel. It must also be protected against potential physical hazards such as electrical failure, fire, and flood by the installation of alarms, back-up memory and auxiliary storage facilities.
• A plan for disposing of materials for cause such as contamination, degradation, or loss of scientific value. To be acceptable the plan should be subject to approval by the External Advisory Board, include permission from relevant parties such as donors and investigators, and conform to the handling of materials with the potential for risks of biohazards.
• Assurance to the NIH, authorized investigators, donors of stored material, and the public that the policies, procedures, services, software, and equipment are regularly reviewed on no less than an annual basis by an External Advisory Board that includes four qualified experts in the field of gene transfer and permits attendance by non-voting members from NIH, FDA, and Office of Biotechnology Activities.
• A plan for performing an original research project that addresses an issue of importance to the gene transfer research community with respect to any of the following: (1) archiving, storing, or retrieving materials or data; (2) testing products for insertion site, sequencing information, persistence of replication competent virus, or other information germane to gene transfer research.

In the annual progress report, the applicant must plan to document usage and activity data documenting the provision of services and the volume of materials stored in the biorepository to help the NIH to determine the ongoing need for services and storage and the required capacity of the NGVBCC.

Funding Instrument	Grant
Application Types Allowed	New The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	NCRR intends to commit $600,000 for 1 award in FY 2012.
Award Budget	Application budgets are not limited, but need to reflect actual needs of proposed project.
Award Project Period	The total project period for an application submitted in response to this funding opportunity 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.

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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• 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

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• 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
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (PD/PIs) 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 least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.

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

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

NIH will not accept any application 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.

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

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.

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:

Descriptive title of proposed research
Name, address, and telephone number of the PI
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent to:

Daniel Rosenblum, MD
Division of Clinical Research Resources
6701 Democracy Blvd, Room 918
Bethesda, MD 20892
rosenblumd@mail.nih.gov
Telephone: 301-435-4051
Email: rosenblumd@mail.nih.gov

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 three 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)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

Mohan Viswanathan, PhD
National Center for Research Resources/NCRR
6701 Democracy Blvd MSC 4874
Room Number 1066
Bethesda, MD 20892-4874 (20817 for express mail)
Telephone: (301) 435-0824
FAX: (301) 480-3660
e-mail: ViswanaM@mail.nih.gov

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• Research Strategy section is limited to 12 pages.

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

• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts is limited to 12 pages. See Table of Page Limits.

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.

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, with the following modifications:

The appendix must contain a statement that the biorepository will not accept materials for storage from any human subject unless that subject has given signed, explicit informed consent for his/her materials to be stored in a biorepository.

The biorepository will not distribute human materials to any scientific investigator(s) unless the donor of those materials has given signed, explicit informed consent for this purpose.

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.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be 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.

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

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.

Overall Impact - Overall

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 review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a 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? Does the proposed research project address an issue of importance to the gene transfer research community with respect to any of the following: (1) archiving, storing, or retrieving materials or data; (2) testing products for insertion site, sequencing information, persistence of replication competent virus, or other information germane to gene transfer research? Are the proposed biorepository, pharmacology-toxicology database, and evaluation laboratory designed to have a substantial effect on gene transfer research?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Has the investigator provided sufficient evidence of his/her ability to provide the specific services described in this FOA and to operate and maintain a biorepository, biomaterials archive, pharmacology-toxicology database, data retrieval system, interactive website, and tracking system?

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) 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? Does the biorepository meet cGMP and cGLP standards? Does it provide no-cost storage for authorized NIH-supported gene transfer investigators and gene-transfer investigators for materials from clinical study participants exposed to gene vectors? Does it provide password protected web-based access to services and resources for authorized investigators? Does it provide back up storage for clinical grade vector and master cell banks? Does it publicize informational and educational materials? Does it distribute AAV, Adenovirus, HSV, Lentivirus, and Retrovirus antibodies, cell lines, plasmids, and vectors for use in gene transfer research? Does it have a governance system and a policy and procedure manual? Is the proposed biorepository, pharmacology-toxicology database, and evaluation laboratory designed to have a substantial impact on gene transfer research? Does the proposed resource include a plan to provide NIH with data reflecting the use of services and the volume of materials stored in the biorepository? Does it have an External Advisory Board of experts in gene transfer research to review policies procedures, services, and equipment? Does it provide a biobank and access to qualified individuals for archiving of pharmacology/toxicology data and access by the public to the data? Does it have the capacity to provide investigators in gene transfer access, safety, security, and dependability to store gene vector materials such as master cell banks, plasmids, and other gene vector products, materials from subjects in human trials, and specimens from pharmacology-toxicology studies? Does the proposed research project address an issue of importance to the gene transfer research community with respect to any of the following: (1) archiving, storing, or retrieving materials or data; (2) testing products for insertion site, sequencing information, persistence of replication competent virus, or other information germane to gene transfer research? Does the applicant have an acceptable plan for disposing of materials for cause such as contamination, degradation, or loss of scientific value? Does the proposal include a plan for disposing of materials for cause such as contamination, degradation, or loss of scientific value? Has the applicant provided a plan for providing the NIH with an ongoing assessment of the use of services and storage space in the biorepository? Has the applicant developed an adequate plan to protect the resource against access by unauthorized personnel and to ensure alarms and back up arrangements to protect against physical hazards?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

As applicable for the project 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.

The application must also contain a section labeled Policy and Procedures for Disposal of Materials Stored in Biorepository. The section must include the following:

A plan for disposing of materials for cause such as contamination, degradation, or loss of scientific value. Disposal could be interpreted in any of the following ways (1) the return of materials to the investigator or institution that deposited the material, (2) delivery of materials to an investigator or institution acceptable to the PI and the donor/investigator, or (3) the destruction of the materials. The PI will make a reasonable effort to obtain explicit permission from relevant parties such as donors and investigators. To be acceptable the plan should be subject to approval by the External Advisory Board, include permission from relevant parties including donors, investigators, and institutions acting on behalf of investigators, and conform to the handling of materials with the potential for risks of biohazards.

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. 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

Not Applicable.

Renewals

Not Applicable.

Revisions

Not Applicable.

As applicable for the project 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

Foreign are not applicable to this FOA.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

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

As part of the scientific peer review, all applications will:

• Undergo a 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 overall impact/priority score.
• Receive a written critique.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Research Resources Council . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee 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.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NGA. 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.

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 Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.FSRS.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
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

Daniel Rosenblum, MD
National Center for Research Resources (NCRR)
Telephone: 301-435 4051
Email: rosenblumd@mail.nih.gov

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Amy McGuire, Grants Management Specialist
National Center for Research Resources (NCRR)
Telephone: 301-435-0853  
Email: mcguirear@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.