NIH Brain Development Cohorts (NBDC) and Population Assessment of Tobacco and Health (PATH) Study Biospecimen Access

NIH Brain Development Cohorts (NBDC) and Population Assessment of Tobacco and Health (PATH) Study Biospecimen Access is sponsored by National Institutes of Health (NIH) / National Institute of Neurological Disorders and Stroke (NINDS). Supports targeted research access to biospecimens from major brain development and pediatric cohorts to advance neurological and cognitive evaluation, aligning with broad neurodevelopmental and brain injury research goals.

PAR-27-051: NIH Brain Development Cohorts (NBDC) and Population Assessment of Tobacco and Health (PATH) Study Biospecimen Access (X01 Clinical Trial Not Allowed) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Drug Abuse ( NIDA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute of Mental Health ( NIMH ) National Institute of Neurological Disorders and Stroke ( NINDS ) National Cancer Institute ( NCI ) Note: Not all NIH Institutes, Centers, and Offices (ICOs) participate in Announcements.

Applicants should carefully note which ICOs participate in this announcement and view their respective areas of research interest at the ICO-Specific Scientific Interests website . ICOs that do not participate in this announcement will not consider applications for funding.

Funding Opportunity Title NIH Brain Development Cohorts (NBDC) and Population Assessment of Tobacco and Health (PATH) Study Biospecimen Access (X01 Clinical Trial Not Allowed) X01 Resource Access Award Check for any recent Notices of NIH Policy Changes that may impact application requirements. Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 279, 93.

121, 93. 242, 93. 273, 93.

399, 93.

853 Funding Opportunity Purpose The National Institutes of Health seek to advance their mission by providing the scientific community with the opportunity to request access to biospecimens from the Adolescent Brain Cognitive Development SM (ABCD) Study, the HEALthy Brain and Child Development (HBCD) Study, and the Population Assessment of Tobacco and Health (PATH) Study to conduct research consistent with the respective study objectives that will maximize the scientific utility of these limited samples.

Applications should expand the knowledge gained from these studies and advance our understanding of the multiple genetic and environmental factors, such as exposure to substances, that affect health and disease over the course of a lifetime. Funding Opportunity Goal(s) To support basic, clinical, translational, and implementation research in the field of substance use.

To develop new knowledge and approaches for the prevention, diagnosis, and treatment of drug use, misuse, and addiction, drug overdose, and related health outcomes, including HIV/AIDS. Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide , follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants. gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of 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.

Notice of Funding Opportunity Description This Resource Access Program allows investigators to apply for access to biospecimens from the Adolescent Brain Cognitive Development SM (ABCD) Study , the HEALthy Brain and Child Development (HBCD) Study - collectively known as the NIH Brain Development Cohorts (NBDC) - and the Population Assessment of Tobacco and Health (PATH) Study for use in conducting research consistent with study objectives.

These biospecimens are stored in a temperature-controlled facility for subsequent analyses. The HBCD Study is the largest long-term study of early brain and child development, tracking children from the perinatal period through 9-10 years of age. It is a nationwide study with 27 research sites across the country.

The goal of HBCD is to examine how prenatal substance exposures (alcohol, marijuana, opioids, etc.), as well as other environmental exposures impact child development. The HBCD Study includes neuroimaging, toxicology, behavioral and cognitive development assessments, and the collection of a wide range of biospecimens. The HBCD Study enrollment is planned through July 2027 with a goal of ~5000 participants.

For more information on the HBCD protocol, please visit HBCDStudy. org . Specimen collection for both studies is ongoing.

Available specimens include: ABCD Study: oral fluid, whole blood, serum, deciduous teeth, and DNA from either saliva or blood. HBCD Study: plasma, serum, whole blood, blood spot cards, urine, and DNA from either saliva or buffy coat from birth parents; urine, stool, and DNA from saliva from children. The ABCD and HBCD Studies release data to the scientific community through the NBDC Data Hub .

Annual releases include curated data from neuroimaging and all assessment domains, including some data from biosamples, but not the biosamples themselves. In addition, residential history derived socio-environmental data is available to contextualize primary data collected. Please visit nbdc-datahub.

org for more information on the data releases. The Family Smoking Prevention and Tobacco Control Act (FSPTCA), signed in June 2009, created the U.S. Food and Drug Administration (FDA) Center for Tobacco Products (CTP) and granted it the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco in order to protect public health.

In 2016, CTP's authority was extended through a "deeming" rule to include all tobacco products, including electronic cigarettes or electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, hookah tobacco, and other tobacco products such as nicotine gels. A full description of the FSPTCA can be found on FDA's website (https://www. govinfo.

gov/content/pkg/PLAW-111publ31/pdf/PLAW-111publ31. pdf). The PATH Study is a collaboration between the National Institute on Drug Abuse (NIDA), NIH, and the CTP and was launched in 2011 to inform FDA's regulatory activities under the FSPTCA.

This ongoing longitudinal cohort study follows a nationally representative sample of approximately 46,000 participants, including youth (ages 12 to 17) and adults (ages 18+) who currently or formerly use nicotine and tobacco products as well as those who have never used these products.

The goal of the study is to generate epidemiologic data on tobacco use behaviors including patterns of use, attitudes, beliefs, exposures, and related health outcomes.

Starting in 2013, the study consists of annual and biennial primary waves of data collection with the multi-wave design allowing for longitudinal assessment of participants' patterns of nicotine and tobacco product use, nicotine and tobacco exposures, health, and disease risks. The study is planned to continue through 2030. Stored biospecimens available to researchers include urine, serum, plasma, and genomic DNA.

Applicants should review the Study Biospecimen Access Program information before completing the X01 application. More information on the PATH Study data and biospecimen collection can be found here: Population Assessment of Tobacco and Health (PATH) Study Series .

Detailed information on the policies for obtaining PATH Study biospecimens, types of biospecimens available, and the application and review processes may be found on the PATH Study Biospecimen Access Program web page at the University of Michigan's National Addiction & HIV Data Archive Program (NAHDAP), part of the Inter-University Consortium for Political and Social Research's (ICPSR).

Applicants should review this information before applying for access to the PATH Study biospecimens. Specific Areas of Research Interest Applications should expand the knowledge gained from these studies and advance our understanding of the multiple genetic and environmental factors that affect health and disease over the course of a lifetime.

Access to samples will be limited to investigators proposing meritorious and feasible studies consistent with study objectives.

Additionally, research areas of interest include, but are not limited to, those listed below: NBDC: Genomics, including epigenetics, substance exposure, inflammation and stress, proteomics, neurotoxicants and environmental exposures, microbiome, and nutriture will be given the highest priority for access to ABCD or HBCD Study biospecimens.

Studies that expand the knowledge of child and adolescent health more broadly, but not exploratory or pilot studies, will also be considered. PATH Study: Research priorities for tobacco regulatory science will be given the highest priority for access to PATH Study biospecimens. Studies that address other objectives that expand the knowledge of tobacco use and/or tobacco related health outcomes will also be considered.

Specific Requirements and Expectations for this Opportunity NHLBI TOPMed: Omics Phenotypes of Heart, Lung, and Blood Disorders (X01 - Clinical Trial Not Allowed) Recipients who are granted access to NBDC or PATH Study biospecimens will be required to adhere to terms in the Data Use Certification and applicable reporting and data sharing requirements.

See the Requesting Biospecimens page of the NBDC Biobank or the PATH Study BAP Overview and application guide for more information. Interested applicants are strongly encouraged to explore available biospecimens and review the key steps in applying for biospecimens via the NBDC Biobank portal or contact the NBDC team at nbdc_biobank@mail. nih.

gov . Interested applicants are strongly encouraged to explore available biospecimens and review the key steps in applying for biospecimens as described here: How to Apply for Biospecimens | NAHDAP . For further information on special considerations for NIDA applicants, please see the Resources section on the NIDA Grants and Funding page .

See Section VIII. Other Information for award authorities and regulations. Section II.

Award Information Other: A financial assistance mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications. Application Types Allowed The OER Glossary and the How to Apply - Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Not Allowed: Only accepting applications that do not propose clinical trials. Note: Applications may propose activities involving human subjects that are not deemed clinical trials.

Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The total number of projects granted access to biospecimens is dependent on the number of meritorious applications and the availability of biospecimens. Not Applicable; funds are not awarded via the X01 mechanism.

The scope of the proposed project should determine the project period. The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III.

Eligibility Information Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) 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 Recognized) 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 Organizations/Foreign Collaborations Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards .

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.

Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications for additional information System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Foreign organizations must obtain a NATO Commercial and Government Entity (NCAGE) Code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants.

gov – Applicants must have an active SAM registration in order to complete the Grants. gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. Obtaining an eRA Commons account can take up to 2 weeks. All PD(s)/PI(s) must be registered with ORCID .

The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

Eligible Individuals (Program Director/Principal Investigator) Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for 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 How to Apply - Application Guide . This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1. 2 Definition of Terms.

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ).

Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed.

Please follow these additional instructions as this is not an application for funding: Total Federal Funds Requested : Enter $0 Total Federal and Non Federal Funds : Enter $0 Estimated Program Income : Enter $0. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. Describe facilities where laboratory analyses will be done in Facilities and Other Resources. Describe instrumentation that will be used to conduct laboratory analyses in Equipment .

Availability of Biospecimens (required): Include the Resource Availability and Impact Report (NBDC Studies)/letter about the proposed study or written confirmation from the PATH Study team indicating the availability of sufficient numbers of biospecimens .

To obtain this documentation: NBDC Studies: Interested applicants are strongly encouraged to explore available biospecimens and submit a Biospecimen Availability Inquiry via the NBDC Biobank portal at least 4 weeks prior to the submission deadline to determine whether there is a sufficient quantity of samples required for the proposed study and to determine whether the proposed use of samples is consistent with the limitations of the participant's informed consents.

Applicants may apply for access to samples from multiple time-points if they are proposing a feasible longitudinal design and can demonstrate adequate storage capabilities.

In response to the Biospecimen Availability Inquiry, a Resource Availability and Impact Report will be generated and uploaded to the Inquiry Dashboard, documenting if there is a sufficient quantity of the samples required for the proposed study, which will serve as supportive information for the application.

PATH Study: Interested applicants are strongly encouraged to explore available biospecimens and review the key steps in applying for biospecimens as described here: How to Apply for Biospecimens | NAHDAP . Briefly, applicants should review the PATH Study Biospecimen Access Program guidelines and submit a concept statement outlining the biospecimens of interest and a short description of the proposed study.

The PATH Study Biospecimen Access Committee (BAC) will review the concept statement and evaluate the proposed study for feasibility, scope, and consistency with PATH Study objectives, and/or research priorities for tobacco regulatory science. If the proposed study is approved, the notification e-mail will include a letter which indicates that the requested biospecimens are available.

Funding Source (required): NBDC: Applicants must identify the funding source and secured budget to be used for the proposed studies and include relevant documentation (e.g., Notice of Award).

Include this as a PDF file labeled Funding Source PATH Study: Applicants must identify the proposed funding source to be used for the research project (currently available or application in process), and include relevant documentation once available (e.g., Notice of Award). Include this as a PDF file labeled Funding Source SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Significance: Explain how the proposed use of biospecimens relates to NBDC or PATH Study objectives, and how results will inform the scientific community, public health policy, child and adolescent health and/or tobacco regulation.

The application must address the following: Explain how the proposed project will improve scientific knowledge of child, adolescent, or young adult health, tobacco control, and/or tobacco regulatory science. Describe how the study aims make use of the unique nature of the NBDC or PATH Study design and biospecimens. Describe how the amount of sample requested is justified by the significance and objectives of the proposed project.

Approach: Describe how your overall research strategy and use of specific methods and analyses will accomplish the specific aims of the study. The application must address the following: Describe how the choice of participant variables, biospecimens, assays, and statistical analyses will answer the research questions.

List challenges, and potential confounders and biases that might be encountered in conducting the proposed study and what measures will be taken to minimize these issues.

Biospecimen Information: Briefly describe participant characteristics (variables) to define participant groups for source of biospecimens, as well as the type(s), numbers and volumes of samples being requested, and the collection timeframe for samples being requested, including a clear justification for each. This should match what was entered in the Biospecimen Availability Inquiry (NBDC) or PATH Study Concept Proposal.

NBDC and/or PATH Study biospecimens may be used to validate previous studies or used in combination with biospecimens from other studies to increase sample size and study power. If the biospecimens are used to validate previous studies or are used in combination with biospecimens from other studies, how comparable are those biospecimens from these other studies to the NBDC and/or PATH Study biospecimens?

List each laboratory assay planned for the biospecimens. Provide the following information for each assay: Describe to what extent the proposed assays have been validated for use with the specific types of biospecimens requested.

Provide preliminary data if available; Describe numbers, types and volume of biospecimen required (including justification for volume requested, and both dead and assay volumes); multiplex assay approaches that minimize volume requirements are preferred; methodologies and instrumentation (including assay kit name if commercial kit); Analyte stability and assay validation for the type of biospecimen requested; Assay performance (precision, specificity, accuracy, linearity of range, limits of detection); Quality control (QC) plan (proportion of QC samples, estimated batch size, use of a pooled sample or individual replicates, plan for evaluating assay performance, and the source of QC samples); Competency of laboratories conducting the analyses and laboratory quality control plan; Relevant preliminary data demonstrating experience with the assay.

Provide power calculations and anticipated size of a detectable effect for each aim. Include details on the statistical approach used to calculate power calculations and/or study size. For the PATH Study only: If submitting an application for exploratory or pilot analyses, power analyses and directional hypotheses are not required, but can be included if effect sizes from related research are available.

Provide a detailed statistical analysis plan including the following: enumeration of all exposure and outcome variables (primary and secondary) and covariates; statistical models and assumptions; plans for evaluating assumptions required by the models; and other statistical issues germane to the proposed research such as measurement error, multiple comparison testing, bias, interactions, and data adjustments.

Provide a proposed timeline for each step of the process from the receipt of biospecimens until the completion of statistical analysis of the data. Please include details that will allow evaluation of the feasibility of the timeline. Individuals conducting data analyses should include their biosketches with the application, even if they are not senior/key personnel on the project.

Biosketches should include information related to the expertise and experience with the specific statistical analyses proposed. Protection of Human Subjects : Applicants must consult with their local IRB to determine whether the proposed research constitutes human subjects research or is exempt. Applicants must provide documentation of the IRB's determination if their application is approved.

Note: the use of de-identified biospecimens from the NBDC or PATH Study does not meet the NIH definition of human subjects research. If these data are combined with data from other human subjects, consult with your local IRB to determine the IRB exemption status. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide .

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan is not applicable for this NOFO. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide , with the following additional instructions: If you answered "Yes" to the question "Are Human Subjects Involved?"

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record. Study Record: PHS Human Subjects and Clinical Trials Information All instructions in the How to Apply - Application Guide must be followed.

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply - Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply - Application Guide must be followed.

Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply Application Guide. 3. Unique Entity Identifier and System for Award Management (SAM) See Part 2.

Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants. gov 4.

Submission Dates and Times Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next business day. Organizations must submit applications to 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. NIH and Grants. gov systems check the application against many of the application instructions upon submission.

Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2. 3. 9.

2 Electronically Submitted Applications . Applicants are responsible for viewing their application before the due date 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 How to Apply – Application Guide .

5. Intergovernmental Review (E. O.

12372) This initiative is not subject to intergovernmental review. 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 Section 7.

9. 1 Selected Items of Cost . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply – Application Guide .

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII. All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form .

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. See Section III of this NOFO for information on registration requirements. The applicant organization must ensure that the unique entity identifier provided on the application is the