Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Cancer Institute (NCI)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)

Funding Opportunity Title

Developmental Pharmacology (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-07-416.

Related Notices

  • August 7, 2013 - This PAR has been reissued as PAR-13-306.
  • May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013.

Funding Opportunity Announcement (FOA) Number

PAR-11-057

Companion FOA

PAR-11-058 , R03 Small Grant Program

PAR-11-059, R21 Exploratory/Developmental Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.865, 93.853, 93.859, 93.242, 93.113

FOA Purpose

This FOA issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS), National Institute of Mental Health (NIMH), and National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), encourages Research Project Grant (R01) applications from institutions/ organizations that propose to encourage multidisciplinary, investigator-initiated basic and translational research in developmental pharmacology with particular emphasis on the role of ontogeny on drug metabolizing enzymes, transporters, receptors and signaling pathways activity across developmental periods from fetal life to adolescence.

Key Dates
Posted Date
Open Date (Earliest Submission Date)

January 5, 2011 (Previously: February 5, 2011)

Letter of Intent Due Date

30 days prior to the application due date

Application Due Date(s)

Standard dates apply or Month Day, Year, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard dates apply or Month Day, Year, by 5:00 PM local time of applicant organization.

Scientific Merit Review

Standard dates apply

Advisory Council Review

Standard dates apply

Earliest Start Date(s)

Standard dates apply

Expiration Date

August 8, 2013 reissued as PAR-13-306

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 NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Purpose

This FOA issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Cancer Institute (NCI), National Institute of General Medical Sciences (NIGMS), National Institute of Mental Health (NIMH), and National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), encourages Research Project Grant (R01) applications from institutions/ organizations that propose to encourage multidisciplinary, investigator-initiated basic and translational research in developmental pharmacology with particular emphasis on the role of ontogeny on drug metabolizing enzymes, transporters, receptors and signaling pathways activity across developmental periods from fetal life to adolescence.

This initiative is aimed at unraveling the effects of development on mechanisms of drug action/ pharmacodynamics and biotransformation, prenatally and from birth through adolescence. In addition, because drugs are now being developed to target specific receptors or modulators, it is imperative to determine their functional expression over time in the pediatric population. Applications should be designed around a central theme of ontogeny of processes that have pharmacologic relevance, with emphasis on the interaction and/or relationships between these processes (e.g., drug metabolism and drug transport, receptors and ion channels, or receptors and pharmacologic ligands).
Knowledge accrued in developmental biology studies need to be applied to the study of the pharmacology of drugs used in children in an integrated manner.

Background

It is known that developmental pharmacology is both organ-specific as well as biological process -specific. In recent years the ontogeny of Phase I drug metabolizing enzymes, (DMEs) has been characterized, but limited information is available on Phase II DMEs, ontogeny of drug metabolic pathways and functional interaction between transporters and DMEs during development. Insights gleaned from developmental biology need to be applied to understand the pharmacology of drugs used across the course of development in an integrated manner. Development and organ maturation involve the completion of a series of complex and interlocking events that proceed as a continuum but at uneven rates. Drugs are juxtaposed at different stages of the developmental continuum.

For the rational use of drugs across development, a systems biology framework needs to be established based on the developmental stage of the processes involved in drug disposition and action. Progress in this area can only be realized by cross-disciplinary research that integrates related processes. Isolated studies of a particular DME can be misleading without consideration of the functional integrity of the whole pathway. There is also a need to determine existence of developmental shifts in activity between different enzymes, transporters and pharmacologic targets. The characterization of the disposition and effect of drugs across the course of development will ultimately allow the use of developmental guideposts to replace the current system of allocating children in drug trials and clinical studies on the basis of chronological age.

Research Objectives

This initiative seeks to stimulate interdisciplinary collaboration of clinical, translational and basic researchers working in complementary areas of research in developmental therapeutics. Knowledge accrued in developmental biology studies needs to be applied to the study of the pharmacology of drugs used across the course of development in an integrated manner. Incorporation of genomics, pharmacogenomics, proteomics, cell biology and metabolomics in developmental pharmacologic research is encouraged. The long term goal of this initiative is to provide the scientific basis for the rational use of drugs in children of all ages. Proposals developed as a result of this initiative must be patient oriented and designed to answer research questions of clinical significance.

The following topics and study areas are not intended to be comprehensive or exhaustive. Synergistic studies that reach across two or more of these areas are welcomed and interdisciplinary and multidisciplinary research is especially encouraged.

The use of appropriate established and innovative techniques for the study of ontogeny from a pharmacological perspective is encouraged (e.g., knockout animals and drug applications in vivo, gene expression over time in living animals; in vitro-in silico-in vivo correlations). An overriding consideration in the proposed research must be the appropriateness of testing models and extrapolation of animal data to humans.

NIGMS Statement of Interest . The NIGMS is interested in tools or data that will enhance the preclinical evaluation of drug candidates, especially for ADME-Tox information in children. Metabolic pathways and a systems biology approach to understanding drug actions need to be identified, such as modeling the interactions of Phase I, II and III enzymes. NIGMS is also interested in the development of novel approaches to correlating pharmacokinetic and pharmacodynamic data in order to better understand the underlying biochemical and molecular processes. In children and adults, identification of relevant biomarkers to indicate toxic or therapeutic effects is of interest, including anesthetic agents that may exert unique effects on neuronal activities in children at different stages of brain development.

NIEHS Statement of Interest: The NIEHS is interested in understanding the role of exposure to environmental chemicals on the ontogeny of drug metabolizing enzymes, transporters and pharmacologic receptors and signaling pathways and in vitro in vivo interactions. For example, the effect of environmental chemicals on: developmental patterns of the diverse Phase I and Phase II enzymes, inducibility and imprinting of genes involved in pharmacokinetics or pharmacodynamics, short and long term alterations of genes involved in pharmacokinetics or pharmacodynamics, ontogeny of expression and functional characteristics of tissue receptors, ion channels, and their pharmacological significance in different tissues. NIEHS is also interested in the effect of environmental chemicals on the analysis and comparison of cell, tissue, organ-specific effects of drug responses across various developmental stages including the environmental influence on DMEs, transporters and receptors during development and during aging. The NIEHS wants to understand the difference in pharmacokinetics and pharmacodynamics of environmental chemicals during development and throughout life.

NIMH Statement of Interest: The NIMH has interest in supporting studies aimed at identifying developmental mechanisms contributing to differential efficacy and adverse effects of drugs used to treat psychiatric conditions in children as well as predictors of differential effects. Potential applicants are encouraged to review the NIMH Strategic Plan http://www.nimh.nih.gov/about/strategic-planning-reports/index.shtml and to contact NIMH program listed on this FOA prior to submitting an application.

NCI Statement of Interest: NCI is interested in basic and translational research in developmental pharmacology that has the potential for providing insights that address the optimal use of anticancer agents across the entire pediatric age spectrum. NCI is additionally interested in the development and utilization of preclinical models that address the potential effects of molecularly targeted agents that inhibit or modulate key developmental pathways. Many such agents are now being brought forward for evaluation against adult cancers, and the introduction of these agents into the childhood cancer setting may benefit from access to relevant preclinical data demonstrating the impact of pathway inhibition in juvenile animal model systems. Examples of pathways of interest as anticancer therapeutic targets include the hedgehog, Notch, and Wnt signaling pathways.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New
Renewal
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

Award Budget

Applications for an R01 award are limited to a total direct cost of $499,999 dollars. For applications requesting $500,000 or more in direct costs, see Section IV.6.

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

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

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

Foreign (non-U.S.) components of U.S. Organizations are 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 (Project Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) 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. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the SF 424 (R&R) Application Guide.

Renewal applications may be submitted.

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be sent to:

George P. Giacoia, M.D.
Obstetric and Pediatric Pharmacology Branch
Center for Research for Mothers and Children

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
6100 Executive Boulevard, Room 4AO1C
Bethesda, Maryland 20892-7510
(Rockville, Maryland 20852 for non USPS/courier service)
Telephone: 301-496-5589
Email: gg65m@nih.gov

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 and the Table of Page Limits must be followed.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide must be followed.

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.

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.

Foreign Organizations

Foreign (non-US) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout 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 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 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 Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Annual Meeting of Principal Investigators

The principal investigator for each grant awarded under this FOA should plan to attend annual NIH-sponsored two-day meetings in Bethesda, MD. The meetings will provide an opportunity for all the investigators to communicate, discuss the progress of their research, exchange ideas and information, share resources, and foster collaborations that are relevant to the research goals of this FOA. This plan is designed to establish an interactive network of investigators who are interested in advancing this area of research.

All applications should include a request for funds to support attendance of the project principal investigators at the annual meetings, as well as a statement of agreement to participate in these meetings and to cooperate with other investigators.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF 424 (R&R) Application Guide.

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 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

RFA/PAR only: Additional Questions may be added.

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? If animal models and/or in-vitro systems are proposed what is the relevance of the results to humans?

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 Center for Scientific Review (assignments will be shown in the eRA Commons), in accordance with NIH peer review policy and procedures, using the stated review criteria.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board . 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 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 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

Not Applicable.

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

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

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 NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: GrantsInfo@nih.gov

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

Scientific/Research Contact(s)

George P. Giacoia, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-5589
Email: gg65m@nih.gov

Laurie Nadler, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Blvd, Room 7184, MSC 9641
Bethesda, MD 20892-9641
Telephone: (301) 443-5288
FAX: (301) 402-4740
Email: lnadler@mail.nih.gov

Margaret Grabb, Ph.D.
Division of Developmental Translational Research and Treatment Development
National Institute of Mental Health
6001 Executive Boulevard, Room 7201, MSC 9645
Bethesda, MD 20892-9645
Telephone: (301) 443-3563
FAX: (301) 443-1731
Email: mgrabb@mail.nih.gov

Richard T. Okita, Ph.D.
Program Director, PPBC (MSC - 6200)
Division of Pharmacology, Physiology, & Biological Chemistry
National Institute of General Medical Sciences (NIGMS)
National Institutes of Health, Department of Health and Human Services
45 Center Drive, Room 2AS-49A
Bethesda, MD 20892-6200
Telephone: (301) 594-3827
Fax: (301) 480-2802
Email: okitar@nigms.nih.gov

Jerrold (Jerry) Heindel, Ph.D.
Scientific Program Administrator
National Institute of Environmental Health Sciences
Division of Extramural Research and Training
Cellular, Organ and Systems Pathobiology Branch
POB 12233
Research Triangle Park, NC, 27709
For express mail: 79 T.W. Alexander Drive, 4401 Bldg, 3rd Floor
Telephone: (919) 541-0781
FAX: (919)541-5064
Email: heindelj@niehs.nih.gov

William C. Timmer, Ph.D.
National Cancer Institute (NCI)
Telephone: 301- 594-9796
Email: timmerw@mail.nih.gov

Peer Review Contact(s)

Not applicable

Financial/Grants Management Contact(s)

Bryan S. Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-0915
Email: clarkb1@mail.nih.gov

Wanda Boggs
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-316-4638
Email: boggsw@niehs.nih.gov

Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: lm236j@nih.gov

Rebecca Claycamp, CRA
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: rclaycam@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.


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