Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

Components of Participating Organizations

Center for Drug Evaluation and Research (CDER)

Funding Opportunity Title

Pediatric Anesthesia Safety Initiative (PASI) (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-11-005

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.103

FOA Purpose

The award is intended to provide support to establish an administrative infrastructure to facilitate scientific collaboration among multiple stakeholders within a public-private partnership (PPP) framework, and to support the conduct of non-clinical and clinical studies to answer unknown questions regarding the effects of anesthetics and sedatives in the pediatric population under FDA's Pediatric Anesthesia Safety Initiative (PASI).    

Key Dates
Posted Date

April 6, 2011

Open Date (Earliest Submission Date)

April 6, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

May 5, 2011, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May, 2011

Advisory Council Review

Not Applicable

Earliest Start Date(s)

July 14, 2011

Expiration Date

May 6, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the FDA Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission 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

PEDIATRIC ANESTHESIA SAFETY INITIATIVE (PASI)

BACKGROUND

Non-clinical studies in juvenile animal models have shown that exposure to some anesthetics and

sedatives is associated with neurodegenerative changes in the central nervous system, as well as

memory and learning deficits. Anesthetic agents that have been specifically implicated are NMDA

receptor antagonists, such as ketamine, and GABA agonists, such as sevoflurane. The anesthesia

community and the FDA acknowledge that there are insufficient human data to either support or refute the clinical relevance of these findings for pediatric patients. Therefore, numerous non-clinical and clinical studies are needed to assess the effect of anesthetics and sedatives on the developing human brain, including long-term studies in neonates and young children.  However, the planning and performance of the numerous studies needed to address the aforementioned issues will involve enormous challenges in terms of design, assurance of validity and reliability of the outcome measures, and ethical considerations. It is unlikely that any one entity will possess the necessary expertise and resources to accomplish all the work needed to address the issues in an expeditious manner.  FDA seeks under its Pediatric Anesthesia Safety Initiative (PASI), to encourage and facilitate scientific collaboration among multiple stakeholders within a public-private partnership (PPP) framework, and to support the conduct of non-clinical and clinical studies to answer unknown questions regarding the effects of anesthetics and sedatives in the pediatric population.

OBJECTIVES

PROJECT MANAGEMENT of the PASI Public-Private Partnership (PPP)

The Pediatric Anesthesia Safety Initiative (PASI) aims to bridge the scientific and clinical gaps in the field of pediatrics to ensure the safe use of anesthetic and sedative agents in children. Specific activities to be funded through this announcement include, but are not limited to:

SPECIAL REQUIREMENTS

The Grantee(s) are expected to provide the necessary support to assist the FDA and its stakeholders in achieving the goals of PASI.  This support would include, but not be limited to the following activities:

Applications should include a plan that defines the overall governance and organizational structure of the proposed PPP. A plan to manage and, where necessary, reassign, institutional resources and PPP resources among the schools, departments, specialties, affiliated hospitals, and affiliated independent research institutions that participate in the PPP; and between the PPP and outside foundations and/or industry should be described. Administrative policies and procedures should be described, including an evaluation component that will assess the administrative and scientific functioning and accomplishments of the PPP.

The clinical research experience of the Principal Investigator(s) (PI(s)), who is/are the Program Director(s) (PD(s)), should be described, together with his/her/their involvement in the daily activities of the PPP. It is expected that PI(s) would be an established clinician scientist and that the PI(s) have the ultimate responsibility for the implementation and function of the PPP. The PI(s) may be assisted by co-PI(s) from the same institution or an affiliated institution. Co-PI(s) should also be experienced investigators who have administrative skills and backgrounds that complement those of the PI(s). The amount of effort for the PI and co-PI(s) should be commensurate with the requirements of the position(s), and not less than two person-months each and preferably sum to not less than 6 person-months per year. This level of effort is required whether or not salary is requested.

The Directors of the key functions of the PPP should, in general, be senior faculty members who possess the stature, knowledge, authority, leadership, and administrative skills and capabilities necessary to direct the resource and to speak for their institution in national forums. Applicants should explain how their clinical and translational science communities would contribute to the selection and allocation of key resources, the implementation and self-evaluation of key functions, and the prioritization of use.

More than one PI, or multiple PIs, may be designated on the application for projects that require a team science approach that clearly does not fit the single-PI model. Additional information on the implementation plans and policies and procedures to formally allow more than one PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PIs must be registered in the NIH eRA Commons prior to the submission of the application (see https://commons.era.nih.gov/commons/).

Applications designating multiple PIs should include a section of the research plan, entitled Multiple PI Leadership Plan (Section 12 of the Research Plan in the PHS 398). A rationale for choosing a multiple PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including 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 PIs and other collaborators.

If budget allocation is proposed, the distribution of resources to specific components of the project or the individual PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations will be identified in the Notice of Award (NoA).

Applicants should consider both internal, intra-institution communication platform(s) and external interoperability to allow for communication among PPP members and the research partners of clinical and translational investigators (e.g., government, clinical research networks, pharmaceutical companies, commercial vendors, laboratories, and equipment manufacturers). This informatics support is expected to be flexible and innovative. Interoperability, security, workflow, usability, and standards are essential areas of work. To facilitate the conduct of research in health care settings and to transfer research findings into routine care, clinical and translational research must employ applicable standards (e.g., identifiers, vocabularies, transactions, security measures) that are consistent with those adopted by the Department of Health and Human Services for use in U.S. health care and public health operations. All human subjects data must be handled securely to ensure privacy and confidentiality. Biomedical informatics research activity should be innovative in the development of new tools, methods, and algorithms.

Applicants are responsible for a strategy to identify and establish relationships with key experts in the field, including stakeholders from industry, professional organizations, academia, and other Government agencies.

Applications should include detailed plans to form, populate, and convene an Executive Committee to include a scientific and administrative infrastructure   Applicants should also include detailed plans to form, populate, and convene an independent scientific oversight body to coordinate the overall scientific mission of the PASI PPP.  Members of this group should include, but not be limited to, scientific experts in the fields of anesthesia, neuroscience, neurology/development, epidemiology and other scientific disciplines necessary to carry out the work of the scientific oversight body. Members of scientific oversight body will report to the aforementioned Executive Committee.

Applicants should identify other committees and their responsibilities as necessary to accomplish the scientific mission of the PPP.

For all committees implemented under the PASI PPP, seats allocated to FDA will be filled in accordance with FDA’s Federal Liaison Policy.

Applicants should include a method (e.g., Gantt chart) to plan and track progress toward specific projects under this award for the purpose of reporting the status to the FDA and its stakeholders.  At a minimum, information reported should include a listing of interim steps necessary to complete a given project, the timeline for completing those tasks, and a report of any issues in meeting those established deadlines.  Quarterly updates and meetings with the FDA working group are recommended.

Upon award, the PI and associated personnel will be required to sign confidentiality disclosure agreements and comply with applicable Government data and personnel security guidelines.

Applicants should include plans for annual public workshops to discuss the PASI Initiative, PPP, associated projects, and related public health needs/goals. 

RESEARCH PROJECTS

Grantee(s) will be responsible for conducting research projects designed to determine whether or not the findings from animal data discussed above are applicable to children.  Applicants should address at least one (1) of three (3) general types of studies to be conducted in children: clinical, observational and epidemiologic studies.

Overall study design processes should include the following elements:

The clinical research experience of the Principal Investigator(s) (PI(s)), should be described, together with his/her/their involvement in the daily activities of the research studies. It is expected that PI(s) would be an established clinician scientist.  The PI(s) may be assisted by co-PI(s) from the same institution or an affiliated institution. Co-PI(s) should also be experienced investigators who have administrative skills and backgrounds that complement those of the PI(s). The amount of effort for the PI and co-PI(s) should be commensurate with the requirements of the position(s), and not less than two person-months each and preferably sum to not less than 6 person-months per year. This level of effort is required whether or not salary is requested.

The PI(s) and co-PI(s), in general, be senior faculty members who possess the stature, knowledge, authority, leadership, and administrative skills and capabilities necessary to direct the research study and to speak for their institution in national forums. Applicants should explain how their clinical and translational science communities would contribute to the selection and allocation of key resources, the implementation and self-evaluation of key functions, and the prioritization of use.

More than one PI may be designated on the application for research projects that require a team science approach.  Additional information on the implementation plans and policies and procedures to formally allow more than one PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PIs must be registered in the NIH eRA Commons prior to the submission of the application (see https://commons.era.nih.gov/commons/).

Applications designating multiple PIs should include a section of the research plan, entitled Multiple PI Leadership Plan (Section 12 of the Research Plan in the PHS 398). A rationale for choosing a multiple PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including 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 PIs and other collaborators.

If budget allocation is proposed, the distribution of resources to specific components of the project or the individual PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations will be identified in the Notice of Award (NoA).

To facilitate the conduct of research in health care settings and to transfer research findings into routine care, clinical and translational research must employ applicable standards (e.g., identifiers, vocabularies, transactions, security measures) that are consistent with those adopted by the Department of Health and Human Services for use in U.S. health care and public health operations. All human subjects' data must be handled securely to ensure privacy and confidentiality. Biomedical informatics research activity should be innovative in the development of new tools, methods, and algorithms.

Applicants should include a method (e.g., Gantt chart) to plan and track progress toward specific projects under this award for the purpose of reporting the status to the FDA and its stakeholders.  At a minimum, information reported should include a listing of interim steps necessary to complete a given project, the timeline for completing those tasks, and a report of any issues in meeting those established deadlines.  Quarterly updates and meetings with the FDA working group are recommended.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Center for Drug Evaluation and Research (CDER), intends to commit and estimated total of $1,000,000 for one or more awards.

Award Budget

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

Award Project Period

Scope of the proposed project(s) should determine the project period. The maximum period is 5 years.   

FDA grants policies as described in the HHS 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 FDA support as Public or Private Institutions of Higher Education:

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Other

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.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) 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 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program 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 FDA 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 SF 424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the HHS 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.

FDA 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. FDA will not accept any application that is essentially the same as one already reviewed.    

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Not Applicable

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide must be followed, with the following exceptions or additional requirements:

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

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 SF424 (R&R) Application Guide, with the following modifications:.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the FDA Review Team and responsiveness by components of participating organizations. 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

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 review criteria and additional review criteria (as applicable for the project 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 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, 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?   

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?  

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 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 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

Additional Review Considerations

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 Review Group(s) convened, in accordance with HHS  peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the review, all applications:

Applications will be assigned to the appropriate Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA.  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/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 HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS 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.

2. Administrative and National Policy Requirements

The following Terms and Conditions will be incorporated into .the award statement and will be provided to the Principal Investigator as well as to the appropriate Institutional official, at the time of award.

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 FDA 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 FDA programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the FDA 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 of 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 FDA as defined below.

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

The Principal Investigator/Program Director (PD/PI) will have the primary responsibility for and dominant role in planning, directing, and executing the proposed project, with the FDA staff being substantially involved as a partner with the PI.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies.

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

An FDA Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Project Scientist will monitor the project-related activities of the grantee periodically. The monitoring may be in the form of telephone conversations, emails, or written correspondence between the Project Scientist and the PD/PI.  Periodic site visits with the PD/PI and other officials of the grantee organization may also occur.  The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request, consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the grant, including those that state that future funding will depend on recommendations from the Project Scientits.  In addition,

a.  FDA will have prior approval of the appointment of all key administrative and scientific personnel proposed by the grantee.

b.  FDA will be directly involved in the guidance and development of the program. 

The FDA Project Scientist will participate, with the grantee, in determining and carrying out scientific and technical activities. Collaboration will also include data analysis, interpretation of findings and, where appropriate, co-authorship of publications.

In addition to the Project Scientist, an FDA Program Official will be responsible for normal stewardship of the cooperative agreement, and will be named in the Notice of Award.

Areas of Joint Responsibility include:

None

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 FDA staff voting, one FDA 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 HHS 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 FDA 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 HHS 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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding FDA grant resources)
Telephone 301-827-7177
TTY: 301-480-0434
Email: vieda.hubbard@fda.hhs.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)

ShaAvhree Buckman, M.D.
Director, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
10903 New Hampshire Avenue, WO 21, Room 4554
Silver Spring, MD  20993
Telephone: 301-796-1653
Email: Shaavhree.buckman@fda.hhs.gov

Peer Review Contact(s)

ShaAvhree Buckman, M.D.
Director, Office of Translational Sciences
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
10903 New Hampshire Avenue, WO 21, Room 4554
Silver Spring, MD  20993
Telephone: 301-796-1653
Email: Shaavhree.buckman@fda.hhs.gov

Financial/Grants Management Contact(s)

Vieda Hubbard
Grants Management Specialist
Food and Drug Administration (FDA)
Office of Acquisitions and Grant Services (OAGS)
5630 Fishers Lane, Room 2141
Rockville, MD  20857
Telephone: 301-827-7177
Email: vieda.hubbard@fda.hhs.gov

Section VIII. Other Information

All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS 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.

Required Federal Citations

1.A.  Clinical Trials Data Bank

The Food and Drug Administration Amendments Act of 2007 (FDAAA) contains provisions that expand the current database known as ClinicalTrials.gov to include additional requirements for individuals and entities, including grantees, who are involved in conducting clinical trials that involve products regulated by FDA or that are funded by the Department of Health and Human Services (HHS), including FDA.  These additional requirements include mandatory registration of certain types of clinical trials, as well as reporting of results for certain trials for inclusion in the ClinicalTrials.gov database.  ClinicalTrials.gov, which was created after the Food and Drug Administration Modernization Act of 1997, provides patients, family members, healthcare providers, researchers, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions. The U.S. National Library of Medicine (NLM) has developed this site in collaboration with NIH and FDA. ClinicalTrials.gov is available to the public through the Internet at http://clinicaltrials.gov

ClinicalTrials.gov contains information about certain clinical trials, both federally and privately funded, of drugs (including biological products) and medical devices.  The types of trials that are required to be registered, and for which results must be reported, are known as "applicable clinical trials."  FDAAA defines the types of clinical trials that are "applicable clinical trials" and, therefore, are subject to the registration and results reporting requirements.  The registry listing for each trial includes information such as descriptive information about the trial, patient eligibility criteria, recruitment status, location information on the clinical trial sites, and points of contact for those wanting to enroll in the trial.  The database also contains information on the results of clinical trials.  More detailed information on the definition of "applicable clinical trial" and the registry and results reporting requirements can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html and http://prsinfo.clinicaltrials.gov/fdaaa.html

FDAAA also added new requirements concerning clinical trials supported by grants from HHS, including FDA.  Under these provisions, any grant or progress report forms required under a grant from any part of HHS, including FDA, must include a certification that the person responsible for entering information into ClinicalTrials.gov (the "responsible party") has submitted all required information to the database.  There are also provisions regarding when agencies within HHS, including FDA, are required to verify compliance with the database requirements before releasing funding to grantees.  Program staff will be providing additional information on these requirements, including the appropriate means by which to certify that a grantee has complied with the database requirements.

1.B.  Data and Safety Monitoring Plan

Data and Safety monitoring may be required for certain types of clinical trials.  The establishment of Data and Safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase 3 clinical trials. Although Phase 1 and Phase 2 clinical trials may also use DSMBs, smaller clinical trials may not require this oversight format, and alternative monitoring plans may be appropriate.

1.C.  Access to Research Data through the Freedom of Information Act (FOIA)

The Freedom of Information Act (FOIA), 5 U.S.C. 552, provides individuals with a right to access certain records in the possession of the Federal government, subject to certain exemptions. The government may withhold information pursuant to the exemptions and exclusions contained in the FOIA. The exact language of the exemptions can be found in the FOIA. Additional guidance on the exemptions and how they apply to certain documents can be found in the HHS regulations implementing the FOIA (45 CFR part 5) and FDA regulations implementing the FOIA (21 CFR part 20). Also, see the HHS Web site http://www.hhs.gov/foia/ and FDA Web site at http://www.fda.gov/RegulatoryInformation/FOI/default.htm

Data included in the application may be considered trade secret or confidential commercial information within the meaning of relevant statutes and implementing regulations. FDA will protect trade secret or confidential commercial information to the extent allowed under applicable law.

1.D.  Use of Animals in Research

Recipients of PHS support for activities involving live vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals as applicable http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf as mandated by the Health Research Extension Act of 1985 http://grants.nih.gov/grants/olaw/references/hrea1985.htm and the USDA Animal Welfare Regulations http://www.nal.usda.gov/awic/legislat/usdaleg1.htm

1.E.  Human Subjects Protection

Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

1.F.  Inclusion of Women And Minorities in Clinical Research

It is the policy of the DHHS that women and members of minority groups and their sub-populations must be included in clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH/DHHS staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

1.G.  Inclusion of Children as Participants in Clinical Research

The DHHS maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research conducted unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

1.H.  Required Education on the Protection of Human Subject Participants

DHHS policy requires education on the protection of human subject participants for all investigators submitting FDA applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

1.I.  Standards for Privacy of Individually Identifiable Health Information

HHS issued final modification to the Standards for Privacy of Individually Identifiable Health Information, the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR Web site http://www.hhs.gov/ocr/ provides information on the Privacy Rule.

1.J.  Healthy People 2020

PHS is committed to achieving the health promotion and disease prevention objectives of Healthy People 2020, a PHS-led national activity for setting priority areas. This Funding Opportunity Announcement is related to one or more of the priority areas. Potential applicants may obtain a copy of Healthy People 2020 at http://www.health.gov/healthypeople.

1.K.  Smoke-Free Workplace

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

1.L.  Authority and Regulation

This program is not subject to the intergovernmental review requirements of Executive Order 12372. FDA's research program is described in the Catalog of Federal Domestic Assistance (CFDA), No. 93.103 http://www.cfda.gov/

FDA will support the clinical studies covered by this notice under the authority of section 301 of the PHS Act as amended (42 U.S.C. 241) and under applicable regulations at 42 CFR Part 52 and 45 CFR Parts 74 and 92. All grant awards are subject to applicable requirements for clinical investigations imposed by sections 505, 512, and 515 of the act (21 U.S.C. 355, or 360e) or safety, purity, and potency for licensing under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262), section 351 of the PHS Act, including regulations issued under any of these sections.

All human subject research regulated by FDA is also subject to FDA's regulations regarding the protection of human subjects (21 CFR Parts 50 and 56). Applicants are encouraged to review the regulations, guidance, and information sheets on human subject protection and Good Clinical Practice available on the Internet at http://www.fda.gov/oc/gcp/

The applicant is referred to HHS regulations at 45 CFR 46.116 and 21 CFR 50.25 for details regarding the required elements of informed consent.

All awards will be subject to all policies and requirements that govern the research grant programs of the PHS as incorporated in the HHS Grants Policy Statement, dated January 1, 2007 http://www.hhs.gov/grantsnet/adminis/gpd/index.htm


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