Research Project Grant (R01) applications from institutions/organizations that propose to develop, validate, and/or calibrate informative outcome measures for use in clinical trials for individuals with intellectual and developmental disabilities (IDD)

Research Project Grant (R01) applications from institutions/organizations that propose to develop, validate, and/or calibrate informative outcome measures for use in clinical trials for individuals with intellectual and developmental disabilities (IDD) 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 focused on developing, validating, or calibrating informative outcome measures for use in clinical trials for individuals with intellectual and developmental disabilities (IDD).

Expired PAR-11-045: Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information 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 Outcome Measures for Use in Treatment Trials for Individuals with Intellectual and Developmental Disabilities (R01) R01 Research Project Grant April 25, 2013 - This PAR has been expired and reissued as PAR-13-213.

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 (NIH), encourages Research Project Grant (R01) applications from institutions/organizations that propose to develop, validate, and/or calibrate informative outcome measures for use in clinical trials for individuals with intellectual and developmental disabilities (IDD).

This funding opportunity will address a significant need in the field, one that is especially apparent in efforts to develop pharmacological treatments for these populations. 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 in FOA ( PAR-11-038 ) Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01) issued simultaneously with this FOA. 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) dates apply, by 5:00 PM local time of applicant organization. (Now Expired April 25, 2013 per issuance of PAR-13-213 ), 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 I.

Funding Opportunity Description 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 (NIH), encourages Research Project Grant (R01) applications from institutions/organizations that propose to develop, validate, and/or calibrate informative outcome measures for use in clinical trials for individuals with intellectual and developmental disabilities (IDD).

This Funding opportunity will address a significant need in the field, one that is especially apparent in efforts to develop pharmacological treatments for these populations. Potential applicants may be interested in FOA ( PAR-11-038 ) Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01) issued simultaneously with this FOA.

Clinical trials are being formulated that seek to alleviate the debilitating cognitive, behavioral, and comorbid medical symptoms associated with disorders such as Down syndrome, Fragile X syndrome, Rett syndrome, Angelman syndrome, Prader-Willi syndrome, and autism spectrum disorders.

Individuals with IDD are heterogeneous, with a broad range of cognitive abilities and a variety of behaviors that can vary across the lifespan, making assessment difficult. There is an urgent need to identify outcome measures that are adequately sensitive, specific, reliable and valid to demonstrate treatment benefit for pharmacologic interventions or behavioral trials developed for use in these disorders, particularly in children.

The purpose of this solicitation is to facilitate identification of endpoints that can be utilized in clinical trials for therapies in IDD that may include but Objective tests, which may include laboratory measurements or device measurements that are performance-based Patient-reported outcome (PRO) measures that may be self-administered or interviewer-administered (see FDA guidance on PRO measures that support labeling claims based on a conceptual framework at http://www.

fda. gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.

pdf ) Caregiver-reported outcome measures that may be based on observations or proxy report, which may be of particular relevance for some IDD populations with limited ability to provide self-reports Clinician-reported outcome measures that may be based on observations during examination or interview Composite instruments that utilize a variety of the above Types of research responsive to this FOA may include: Research that identifies and demonstrates the efficacy of measures and instruments that currently exist and that can be used to effectively assess treatments for IDD population(s).

Development of clinical rating scales for specific disorders or for combinations of phenotypes commonly observed in multiple disorders across Development of sensitive and validated novel outcome measures (cognitive, clinical, and/or behavioral) to assess efficacy in different domains of function/dysfunction in individuals with IDD.

Outcome measures must be shown to exhibit content validity, i.e., the instrument must sufficiently measure all of the important concerns in the target population and IDD disorder for the treatment being proposed. The measures should have a broad dynamic range, be sensitive to different levels of ability, and have test-retest reliability and validity.

These measures could potentially apply to specific or multiple developmentally-based disorders. Investigators may propose to develop, validate and/or calibrate outcomes common to patients and begin clinical testing, or alternatively, test and validate these measures in larger populations via a clinical trial.

These measures could apply to children and/or adults with IDD, and may reflect different cognitive, behavioral, and functional levels.

Outcome measures may focus on the following targets and include but are not limited to: Cognition (e.g., executive function, visuospatial skills, memory, learning, inhibition, attention), Behavior and emotion (e.g., anxiety, arousal, stress response, irritability, sociability), Physical/medical (e.g., motor symptoms, sleep disorders, sensory alterations such as ocular or auditory function, seizures, endocrine or immune regulation, respiratory or autonomic dysregulation).

Adaptive behavior (e.g. functional abilities in a variety of living situations, such as home or community settings). Clinically relevant and psychometrically robust, health-related quality of life assessment tools for children and adults (see: http://www. neuroqol.

org/Web%20Pages/overview. aspx ).

We strongly encourage applications from multidisciplinary teams that may consist of clinicians who treat individuals with IDD; researchers experienced in the design of successful clinical trials, psychometric and/or medical assessments, and in the conduct of behavioral and cognitive studies of children with IDD; and basic scientists with knowledge of the molecular, neurological, and/or physiological basis of the disorder(s).

These teams may focus predominantly but not exclusively on one condition or syndrome or group of related syndromes. Investigators may wish to formally define and characterize clinical outcome assessments that are informative for the condition(s) of interest, a process that may involve the organization of planning conference(s) and production of a consensus document.

The measures should be informative for both progression or deterioration and improvement or stabilization of outcomes of clinical interest and value, should be calibrated across relevant population(s), and should support characterization of the stage or status of a condition. Multi-site collaborations are also acceptable.

We also strongly encourage the use of the Common Data Elements (CDE) format in developing standardized outcome measures for IDD (for example, see: www. commondataelements. ninds.

nih. gov ). Additional resources that may be of value to investigators include the NIH Toolbox for Assessment of Neurological and Behavioral Function (see: http://www.

nihtoolbox. org ) and the Patient-Reported Outcomes Measurement Information System (PROMIS, see: http://commonfund. nih.

gov/clinicalresearch/overview-dynamicoutcomes. asp ). 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. Budgets for direct costs of up to $499,999 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. Section 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 Additional Information on Eligibility 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 Submission 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 .

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 the methods that will be used to validate putative outcome measure(s) and how they will share 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.

PHS 398 Research Plan Component All instructions in the SF424 (R&R) Application Guide 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).. 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 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 incompletewill not be reviewed.

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 . V. Application Review Information 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?

How will successful completion of the specific aims generate and validate outcomes for patients with IDD? How likely are the proposed outcome measures to lead to development of treatments and/or therapeutics for the proposed IDD condition(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? Do the senior/key personnel constitute a multidisciplinary team with experience in measurement development and clinical trials? How appropriate is the team for the proposed development of outcome measures?

How will the proposed personnel synergize with others in a consortium, if this is 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?

Do the outcome measures proposed effectively utilize an endpoint model and are they likely to have adequate content validity? Do the outcome measures allow for evaluation of clinically meaningful effects? 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. Outcome Measures.

The use of the Common Data Elements (CDE) format is strongly encouraged. Applicants should provide a plan for using CDEs or CDE compatible data elements in their study case report forms and include a specific data sharing plan in the application (See: www. commondataelements.

ninds. nih. gov ).

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 are 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: May 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 Will 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.

Strength of the team/consortium, if proposed. 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 Section VI.

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 noted on the Award Conditions and Information for NIH Grants website. 2.

Administrative and National Policy 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 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 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) Melissa A.

Parisi, MD, PhD Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Andrea Beckel-Mitchener, PhD National Institute of Mental Health (NIMH) National Institute of Mental Health (NIMH) National Institute of Neurological Disorders and Stroke 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) Section VIII.

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

Authority and Regulations Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. Weekly TOC for this Announcement NIH... Turning Discovery Into Health ®