Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Office of Research Infrastructure Programs (ORIP), Division of Program Coordination, Planning and Strategic Initiatives Programs (ORIP)

National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Funding Opportunity Title

Research Resource for Human Organs and Tissues (U42)

Activity Code

U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements

Announcement Type

Reissue of RFA-RR-07-006

Related Notices

Funding Opportunity Announcement (FOA) Number

RFA-OD-12-002

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.351

Funding Opportunity Purpose

The purpose of this FOA is for the support of a Research Resource for Human Organs and Tissues for the continued availability of human tissues and organs to biomedical researchers in the United States previously funded under the auspices of RFA-RR-07-006 (http://grants.nih.gov/grants/guide/rfa-files/rfa-rr-07-006.html ). The research resource is expected to facilitate procurement, preservation, and distribution of human tissue and organs to qualified biomedical researchers.

Key Dates
Posted Date

June 13, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

October 23, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2013

Advisory Council Review

May2013

Earliest Start Date(s)

July 1, 2013

Expiration Date

October 24, 2012

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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The Office of Research Infrastructure Programs (ORIP), Division of Program Coordination, Planning, and Strategic Initiatives, invites applications for the continued support and advancement of human organ and tissue research resource. The overarching purpose of the research funded by ORIP is to reduce the burden on the society of morbidity and mortality of diverse conditions and diseases and understand normal human tissue and organ function. The resource described by this FOA focuses on access and providing a resource for biomedical research.  The research resource for human organs and tissues provide a wide variety of human tissues and organs,  both diseased and normal, to researchers for laboratory studies.  Such samples include tissues from the nervous system, pulmonary system, cardiovascular system, endocrine system, eyes, skin, bone, and cartilage.

The resource is currently funded as a cooperative agreement (U42) to provide normal and diseased human tissues and organs for biomedical research. The research resource for human organs and tissues support the procurement, preservation, and distribution of human tissue and organs for basic and clinical research at research centers, academic institutions, the NIH, and other federal agencies.

Section II. Award Information
Funding Instrument

Cooperative Agreement

Application Types Allowed

New
Renewal

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

Funds Available and Anticipated Number of Awards

NIH intends to fund an estimate of one (1) award. Issuing IC and partner components intend to commit an estimated total of up to $1.5M for fiscal year 2013. Future year amounts will depend on annual appropriations..

Award Budget

Application budgets are not limited, but need to reflect actual needs of the proposed project.

Award Project Period

Costs appropriate for the project and a project duration of up to five years may be requested.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Required Registrations

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

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

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

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

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Application Submission

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

Sheri Hild, Ph.D.
Scientific Review Officer
Office of Grants Management and Scientific Review
National Center for Advancing Translational Sciences
National Institutes of Health
6701 Democracy Blvd., Room 1082
Bethesda, MD 20892-4874
Courier service zip code 20817
301-435-0810 (direct line)
301-435-0811 (Office of Review)
301-480-3660 (fax)
Email: hildsa@mail.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed.

Research Plan

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

The Research Plan must be organized in the following sections:

A.  Overall Aims, Background, and Significance

B.  Administrative Structure

C.  Research Resource Design and Plan

D.  Research Resource Infrastructure

E.  Human Subjects

F.  Literature Cited

G.  Consortium/Contractual Arrangements

H.  Budget and Supplementary Documentation

A.  Overall Aims, Background and Significance

The overall goal of the research resource for human organs and tissues is to provide a wide variety of human tissues and organs, both diseased and normal, to researchers for laboratory studies. The  successful applicant/organization must have a demonstrated track record of running an established human tissue and organ research resource that includes recognized expertise, knowledge of managing such a resource, including a customer service component.  Applicants must provide an overall description of the proposed resource and organizational structure, its specimens, and the topics of research. (For the current holder of human organ and tissue research resource, plans must address recommendations of an advisory board - including external advisors). Plans must also include the following key areas:

i.  Enhancing the capacity and evaluating processes of the human organ and tissue resource to engage biomedical researchers and address the tissue and organ requests.

ii.  Evaluating and continually improving service delivery and communication with the biomedical research community.

iii.  Increasing the role of tissue and organ banks, hospitals, research facilities, and tissue and organ procurement organizations affiliated with the applicant’s human tissue and organ research resource in the formulation and continued development of the research resource for human organs and tissues.

iv.  Enhancing the capacity to utilize technologies and improving the quality of the resource’s procurement, preservation, storage, and distribution of specimens.

v.  Evaluating and continually maintaining biohazard safety.

vi. Evaluating and maintaining adherence to Health and Human Services and NIH guidelines and regulations on informed consent and research resources, and the implications of the Health Insurance Portability and Accountability Act (HIPAA) regulations Privacy Rule.

vii. Communicating with the government and public on current research and research advancements from the research community it serves.

Briefly describe the purpose and history of human organ and tissue resource and the research communities that it serves.

Describe record of running a human organ and tissue resource, including a description of the interactions that occurred among tissue and organ banks, hospitals, research facilities, and organ and tissue repositories, and with the researchers served.

B. Administrative Structure.

This section should describe the proposed administrative structure of the project, e.g., PD(s)/PI(s), co-investigators, the Steering Committee, other functional committees or special interest groups, other research support resources, and how these units function to support and maintain the research resource plan of the human organ and tissue resource, and to maintain communication across tissue and organ banks, hospitals, research facilities, and organ and tissue repositories, participating Federal agencies (i.e., ORIP/NIH and other NIH Institutes and Centers), and the biomedical research community. A list of key personnel, titles, and organization affiliation should also be included. Appropriate structures that would oversee procurement, protocols for collection and storage, distribution procedures, and quality control of specimens should be described. Also, the applicant should decribe an appropriate structure for advisory and steering panels.

C.  Research Resource Design and Plan.

i.  Structure and Approach:

The applicant must propose detailed plans describing the design and development of the resource for human organs and tissues, to include current capacities of the research resource, procedures for the procurement, shipping, preparation, preservation, confidentiality and informed consent, biohazards and pathogen screening, tissue and organ request application and fulfillment, and distribution of all types of specimens that will be handled by the resource center. The applicant must describe the design of the quality control, data collection and analysis, and diagnostic verification. The design and development of the database should be such that it provides a user-friendly accounting of the resource’s holdings, including all human tissue and organ specimens for human subject research, and ensure data integrity, accuracy and security. The applicant must maintain a core of remote site collection centers.

ii.  Customer Service

The applicant must describe the current status and future plans of the customer service and public relations. The applicant must describe plans for a user-friendly customer service interface.  This plan needs to provide access for biomedical researchers who search for tissue and organ specimens, who have technical questions regarding the search or specification of tissue or organ specimens, or who need assistance with decisions on ordering or obtaining tissue and organ specimens. Moreover, the applicant must outline current status and plans on communication and enhancement of public relations of the research resource with government, and private research facilities.

iii.  Milestones

The application must present specific milestones that will need to be met in order to accomplish the work set out above in a five-year time frame.

iv.  Program Director(s)/Principal Investigstor(s)

The effective management of a research resource requires a significant commitment by the PD(s)/PI(s).  The PD(s)/PI(s) of a research resource under this FOA must devote at least 1.2 (CY) person months effort to the project.  The applicant should have direct experience, knowledge, and hands-on involvement in daily operations.  It is expected that this individual will be an established scientist with a fitting level of seniority within the applicant organization, and with appropriate authority.

v.  Management of Integration plans

The applicant must describe the management plan for the proposed project, and how it will support achievement of the proposed goals and milestones.  The application should describe the organization of the proposed research resource effort and its management structure, including integration of the separate components to form an efficient pipeline from request of specimens to the specimens’ distribution to biomedical researchers, key personnel, expert advisory committee, and reporting relationships.  Recruitment and training of personnel should be discussed.  The plan should also describe how the various components of the proposed research resource effort will be integrated, and how collaborations or subcontracts, if proposed, will be managed.  Coordination of the proposed awardee’s activities with those of the other components of the human tissue and organ research resources, as well as with other national and international programs aimed at producing human tissue and organ specimens, must be described.

D. Evaluation

Procedures should be described for the evaluation of core functioning (e.g., by an advisory board) and for implementing recommendations resulting from such evaluations.

E.  Human Subjects and Biohazards

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score: Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398). Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

F.  Literature Cited

While this section is not included in the page limitation, it is important to be concise and to select only those literature references pertinent to the research resource. List complete literature citations as directed in the PHS 398 Instructions.

G.  Budget and Consortium/Contractual Arrangements

Costs should be budgeted for attendance at scientific meetings, and other key administrative functions.  The applicant must outline an overall cost-recovery program that provides a stepwise plan for a charge-back fee for procurement, distribution and restocking that will result in eventual self-sufficiency of the research resource.  All proposed costs and projected cost reductions asked for above must be given in terms of the direct, indirect, and total costs, i.e. the fully loaded costs (including overhead).  The calculated costs must take into account all of the expenses associated with each component activity including those attributable to informatics infrastructure, quality control, management, and data release. The applicant must present a fully justified budget for the work described above.

If multiple institutions are involved, the project will be administered through a traditional consortium/contractual arrangement, and the usual documentation is required.

H.  Supplementary Documentation

Only statements of Institutional Commitment, Letters of Support, letters of collaborations, and other similar documents, if appropriate, should be included in this section.  In addition, a letter from the applicant should be included and titled “Procedures Related to Materials Obtained from Human Subject” and that provides documentation of the following:

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

Appendix materials will not be allowed. Applications that are submitted containing Appendix material will not be accepted for review.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be postmarked on or before the due dates in Part I. Overview Information.

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.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the resource? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the applicant/organization have a demonstrated track record of running an established human tissue and organ research resource that includes recognized expertise, knowledge of managing such a resource, including a customer service component? Does the PD/PI have the effective scientific and administrative leadership, as demonstrated by program development, and by promotion of effective interactions and relationships with researchers, tissue and organ banks, hospitals, research facilities, and tissue and organ repositories? Does the PD/PI devote at least 1.2 (CY) person monthsto the project? Does the management plan for the proposed project support achievement of the proposed goals and milestones?  Are recruitment and training of personnel adequate?

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? Does the human organ and tissue resource utilize new technologies to improve the quality of the resource’s procurement, preservation, storage, and distribution of specimens?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the resource? 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 resource 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 Administrative Structure function to support and maintain the research resource plan of the human organ and tissue resource, and to maintain communication across tissue and organ banks, hospitals, research facilities, and organ and tissue repositories, participating Federal agencies, and the biomedical research community? Are confidentiality and informed consent, biohazards and pathogen screening adequately addressed? Are the design of the quality control, data collection and analysis, and diagnostic verification systems adequate? Does the proposed database provide a user-friendly accounting of the resource’s holdings, including all human tissue and organ specimens for human subject research, and ensure data integrity, accuracy and security? Does the applicant maintain a core of remote site collection centers?

Are the plans to access, procure, preserve, and distribute specimens well developed?  Does the application address evaluation of mechanisms, a continuous process to improve programs, and implementation of improvement plans of the Resource's procedures and programs? Does the application provide specific milestones that will need to be met in order to accomplish the work set out above in a five-year time frame? Has the applicant considered the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule  and its implication on the resource’s operations? Has the applicant institution human subjects' policies and procedures been reviewed and approved by their Institutional Review Board ?

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? Does the application describe plans of the customer service and public relations with government, public, and private research facilities? Does the applicant address shared commitment and linkages with organ and tissue banks, hospital surgical and pathology offices, and organ and tissue procurement organizations?  Are there detailed plans describing the design and development of the human organ and tissue resource, including current capacities of the research resource as described in the Research Plan?

Additional Review Criteria - Overall

As applicable for the resource proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.   

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed resource 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

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable

Additional Review Considerations - Overall

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

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the NIH Council of Councils. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the  NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

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

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

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

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

Areas of Joint Responsibility include:

Dispute Resolution:

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

Scientific/Research Contact(s)

Michael Chang, Ph.D.
Division of Comparative Medicine
Office of Research Infrastructure Programs,OD, NIH
6701 Democracy Boulevard
Room 942, MSC4874
Bethesda, MD 20892-4874
Phone: 301-435-0744
FAX: 301-480-3819
Email: changmic@mail.nih.gov

Jerome R. Wujek, Ph.D.
Division of Extramural Research
National Eye Institute
Suite 1300
5635 Fishers Lane, MSC 9300
Bethesda, MD 20892-9300
Telephone: 301-451-2020
Fax: 301-496-2297
Email: wujekjer@nei.nih.gov

Dennis A. Przywara, Ph.D.
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8182
Bethesda, MD 20892-7956
Telephone: 301-435-0504
Email: przywarad@nhlbi.nih.gov

Paul Black Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
6700B Rockledge Dr, MSC 7626
Bethesda, MD 20892
Phone: 301-496-2970
Fax: 301-402-3210
Email: pblack@niaid.nih.gov

Carl C. Baker M.D. Ph.D.
Division of Skin and Rheumatic Diseases
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892-4872
Phone: 301-594-5017 Fax: 301-480-4543
Email: ccb@nih.gov

Michael C. Appel, Ph.D.
Director, Islet Biology and Transplantation Research Program
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes & Digestive & Kidney Diseases
Democracy II, Room 792
6707 Democracy Blvd, MSC 5460
Bethesda, MD 20892-5460
Telephone: (301) 594-4740
Fax: (301) 480-0475
E-mail: appelm@niddk.nih.gov

Peer Review Contact(s)

Sheri Hild, Ph.D.
Scientific Review Officer
Office of Grants Management and Scientific Review
National Center for Advancing Translational Sciences
National Institutes of Health
6701 Democracy Blvd., Room 1082
Bethesda, MD 20892-4874
Courier service zip code 20817
301-435-0810 (direct line)
301-435-0811 (Office of Review)
301-480-3660 (fax)
Email: hildsa@mail.nih.gov

Financial/Grants Management Contact(s)

Jean Richelsen
Office of Grants Management and Scientific Review
National Center for Advancing Translational Sciences
National Institutes of Health
6701 Democracy Blvd., Room 1052
Bethesda, MD 20892-4874
Courier service zip code 20817
301-435-0844
301-480-3777 (fax)
Email: richelsj@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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