Research Project Grant (R01) applications from institutions/organizations addressing preclinical research in model organisms of neurodevelopmental disorders

Research Project Grant (R01) applications from institutions/organizations addressing preclinical research in model organisms of neurodevelopmental disorders is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and National Institute of Mental Health (NIMH). This funding opportunity encourages Research Project Grant (R01) applications for preclinical research in model organisms of neurodevelopmental disorders.

Expired PAR-11-038: Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01) This notice has expired. Check the NIH Guide for active opportunities and notices.

Department of Health and Human Services Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and Stroke ( NINDS ) Funding Opportunity Title Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01) R01 Research Project Grant April 25, 2013 - This PAR has been expired and reissued as PAR-13-195.

Funding Opportunity Announcement (FOA) Number Additional Information on Eligibility .

Catalog of Federal Domestics Assistance (CFDA) Number(s) This FOA issued by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health, encourages Research Project Grant (R01) applications from institutions/ organizations addressing preclinical research in model organisms of neurodevelopmental disorders.

Applications responsive to this FOA will propose to develop, validate, and/or calibrate outcome measures, surrogate markers, and biomarkers in model organisms that can inform and effectively translate to human clinical trials for individuals with intellectual and developmental disabilities (IDD).

In addition, applications may propose to conduct rigorous, controlled and standardized preclinical animal trials designed for safety, toxicity, and efficacy prediction or to perform an independent validation of efficacy in animals prior to human clinical trials.

The goal of this FOA is to accelerate and improve the preclinical testing of candidate treatments and therapeutic compounds in order to move promising new drug therapies into clinical trials.

Potential applicants may be interested in the FOA Outcome measures for use in treatment trials of individuals with intellectual and developmental disabilities issued simultaneously with this Open Date (Earliest Submission Date) Letter of Intent Due Date dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s) (Now Expired April 26, 2013 per issuance of PAR-13-195 ), Originally May 8, 2013 Required Application Instructions It is critical that applicants follow the instructions in 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. 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 Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement This Program Announcement with Referral (PAR) seeks investigator-initiated R01 applications that propose to identify, validate and/or calibrate physiologic and/or behavioral measures in preclinical animal models of disorders associated with intellectual and developmental disabilities (IDD), particularly in the pediatric population.

The announcement specifically targets the development of outcome measures or biomarkers that can serve as informative endpoints in preclinical trials of therapeutic compounds and will predict the safety and efficacy of interventions in human clinical trials for these disorders. This solicitation will focus ongoing clinical and translational research on a neglected area essential for therapy and pharmacological treatment development.

Potential applicants may be interested Outcome Measures for Use in Treatment Trials of Individuals with Intellectual and Developmental Disabilities issued simultaneously with this FOA. Over the past several decades, major advances have been made in finding the genetic and environmental causes of many forms if IDD in children and adults. Historically, treatment has focused on alleviating symptoms in affected individuals.

More recently, however, a great deal has been learned about the mechanisms and pathways that underlie disorders such as Down, Fragile X, Rett, Angelman and Prader-Willi syndromes and hypoxic/ischemic injuries leading to IDD.

Researchers have created and characterized mice, flies and other organisms with genetic mutations that model human neurodevelopmental disorders (e.g., Fmr1 and MeCP2 knockout mouse models of Fragile X syndrome and Rett syndrome, respectively). Animal models of environmental insults are available that mimic IDDs in humans (e.g., Rice-Vannucci rat model of hypoxia/ischemia).

Further, investigators have studied these and other "model animals" to understand the biological bases of the syndromes. (For a discussion of the use of model animals in psychiatric research, see Insel TR [2007], Biol. Psychiatry 62:1337-1339.)

A 40-year investment in this research has resulted in greater mechanistic knowledge of the syndromes and yielded a target-rich environment for developing promising new rationale-based treatments and pharmacological interventions. Investigators have begun testing biologic and pharmacologic agents in model animals and cell lines that permit an understanding of the mechanisms of their action.

Scientists working on several IDD including Fragile X syndrome and Rett syndrome are actively engaged in therapy development efforts ranging from early translational studies to human clinical trials.

As promising candidate therapeutics move to preclinical (animal) testing, there is a critical need for sensitive, reliable and valid outcome measures and/or surrogate markers in model organisms, particularly measures that can predict safety, toxicity and efficacy in human trials. Consensus outcome measures that successfully bridge pre-clinical and clinical studies are lacking for the IDDs.

Consequently, there is a compelling need to develop endpoints and biomarkers in model organisms that can inform and reliably predict outcomes in human clinical trials. This Funding Opportunity Announcement (FOA) addresses a significant need in the field: the identification of sensitive, reliable, and valid endpoints that can be used in preclinical animal testing and human clinical trials of therapeutic compounds for IDD.

One of the goals of the proposed FOA is to align and validate outcome measures and biomarkers developed for preclinical animal testing with endpoints currently or potentially used in human trials; this FOA focuses on preclinical measures that will predict safety and efficacy of interventions in humans with developmental disabilities.

Responsive applications may also propose preclinical animal trials or replication studies conducted in a rigorous, controlled and standardized manner. This solicitation is designed to stimulate and accelerate ongoing clinical and translational research in the IDDs.

Potential areas of research include but are not limited to: Identification of sensitive, reliable, and relevant outcome measures and/or biomarkers in model organisms that address key domains of function impacted in neurodevelopmental disorders, ideally with knowledge of their neural and physiological substrates and developmental progression.

Examples include cognitive function (e.g., memory, learning, executive function, attention), behavior and emotion (e.g., anxiety, aggression, and social interactions), communication, sensory impairment, auditory processing, ocular function, seizures, sleep architecture, respiratory function, endocrine regulation, and biochemical, molecular or other physiologic indices that can inform and predict outcomes in human clinical trials for IDD.

Studies in juvenile animal models of pediatric IDD using more than one mammalian species (e.g., rodents and non-human primates) in parallel experiments in order to validate a set of measures. Studies of non-invasive biological and/or physiological measures of neural circuits underlying treatment response that can be evaluated in both model animals and pediatric patients.

Investigations of biomarkers or surrogate markers of disease progression and amelioration that measure treatment response in animals and can predict outcomes in human clinical trials.

Studies of in vivo, cellular and/or molecular measures in model organisms that are predictive of safety, efficacy, and toxicity of novel therapeutics in infants, children and adults with IDD, particularly projects that focus on neurologic, behavioral, growth and developmental outcomes in pediatric patient populations.

Development of measures that predict specific adverse effects and toxicities of pharmacological treatments in IDD patient populations will be considered responsive. Investigators should identify the outcomes to be assessed in preclinical studies and provide a means for determining the predictive value for the human clinical outcomes.

The measures developed via this initiative may also be relevant to neurodevelopmental conditions other than the IDD syndromes listed.

Preclinical animal trials of therapeutic compounds for IDD conducted in a rigorous, controlled and standardized manner; responsive applications may also propose replication trials of a compound or treatment to allow an independent validation of efficacy or to address a discrepancy reported in published studies prior to launching a large scale translational project or human clinical trial.

It is important to note that biomarker discovery is rapidly advancing in other disease conditions such as epilepsy and muscular dystrophy. Thus, prospective applicants may benefit from lessons learned in other, similar endeavors.

Investigators may find it beneficial to establish a multidisciplinary team that includes, for example, expertise in biochemistry, physiology, and pharmacology; behavioral and cognitive studies in animals; the design of clinical trials; clinical aspects of IDD; and other fields as statement of interest: The NIMH is interested in applications proposing to develop and/or validate novel measures in model systems and/or clinical populations with predictive validity for therapeutics development for neuropsychiatric disorders with developmental etiologies.

Potential applicants Section II. Award Information Application Types Allowed Glossary and the SF 424 (R&R) Application Guide provide details on 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. Expected annual direct cost amount for individual awards is between $100,000 and $499,999.

Budgets for direct costs of up to $500,000 per year may be requested for a maximum of $2,499,996 direct costs over a five-year project The total project period for an application submitted in response to this funding opportunity may not exceed 5 years. described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. III.

Eligibility Information Higher Education Institutions: Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Foreign (non-U.S.) components of U.S. Organizations are allowed.

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 Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually 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 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.

This FOA does not require cost sharing as defined in the NIH Grants 3. Additional Information on 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. Section IV.

Application and 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 (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 are encouraged to specify in the Data Sharing Plan ways of validating putative outcome measures, biomarkers and surrogate markers that they discover by sharing them with the research community prior to publication.

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.

All page limitations described in the SF424 Application Page Limits must be followed Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Model Organism Sharing Plan, and Genome Wide Association Studies (GWAS) Sharing Plan) as provided in the SF424 PHS 398 Research Plan Component All instructions in the SF424 (R&R) Application Guide Do not use the appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) 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 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 All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Pre-award costs are allowable only as described in the NIH Grants 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 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. 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. 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 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 Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

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?

Will the proposed specific aims generate and validate outcome measures or biomarkers for use in preclinical testing that are likely to be informative for human clinical trials in IDD? Is the proposed project likely to lead to the development of treatments and/or therapeutics for 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?

Do Senior/Key Personnel constitute a team and if so, how appropriate is the team for the proposed 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? 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 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?

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 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 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 .

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 for Review of the Vertebrate Animal Section . 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.

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

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).

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 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 review policy and procedures , using the stated review As part of the scientific peer review, all applications Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review), will be discussed and assigned an overall impact/priority Receive a written critique.

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: Scientific and technical merit of the proposed project as determined by scientific peer review. Relevance of the proposed project to program priorities. Compliance with resource sharing policies and team strength.

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) Information regarding the disposition of applications is available in the NIH Grants Award Administration Information If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants 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 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 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 Conditions and Information for NIH Grants .

Cooperative Agreement Terms and Conditions of Award 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 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 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 We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Application Submission Contacts Customer Support (Questions regarding Grants.

gov registration and submission, downloading or navigating forms) GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources) 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) Scientific/Research Contact(s) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) Financial/Grants Management Contact(s) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke (NINDS) 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... Turning Discovery Into Health ®