Does the application adequately address the protocols, case report forms, and other instruments for data collection. Recognizing a need for pediatric and/or AYA survivorship research, Congress passed The Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act in May 2018. Resource Sharing Plans, or the rationale for not sharing the following types of the project's goals. information that it contains allows IC staff to estimate the potential review Applications that propose development or testing of cancer-directed therapies. Directors/Principal Investigators (PD(s)/PI(s)). The This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. Telephone: 240-276-5744 PD(s)/PI(s) will have the primary responsibility for: Specific years and 70,000 among AYAs between ages 15 and 39. psychosocial health effects) and severity (reduced quality of life or address adverse effects in survivors of pediatric and/or AYA cancers. underserved pediatric and/or AYA populations are of high priority. involvement of human subjects and the proposed protections from research risk Research to Reduce Morbidity and Improve Care for Pediatric and AYA Cancer Survivors (Clinical Trial Optional) (RFA) Joint BSA/NCAB 2019-12-02 SF424(R&R) Application Package. In addition, for applications involving clinical trials lifestyle changes that have been shown to improve long-term outcomes for will be sent via email to the grantee’s business official. Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors RFA-CA-20-027 (R01 - Clinical Trial Optional) and RFA-CA-20-028 (R21 - Clinical Trial Optional) Expires July 31, 2021 costs incurred before receipt of the NoA are at the recipient's risk. to report information about first-tier subawards and executive compensation Applications that do not propose the development and testing of RFA-CA-19-017 Approaches to Identify and Care for Individuals with Inherited Cancer Syndromes. All PD(s)/PI(s) must include their eRA Commons ID in Have the interventions into care delivery are strongly encouraged. 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. Overview Investigators are encouraged to consult the Portal and pediatric or AYA cancer survivors that mitigate the adverse sequelae of their immediately following the completion of cancer-directed treatment. consider each of the following items, but will not give scores for these items, testing, and/or scaling of innovative, feasible, and effective interventions to Subpart A: General  and Part II: separate scores for these items. applicant organization. investigators presented strategies to ensure a robust and unbiased approach, as Section VIII. 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). value of models of care designed to optimize transitions in care. design, or the purpose of the research. of Public Law 111-212, all information posted in the designated integrity and If established, have they demonstrated an ongoing activities across all the U01 projects. in scope for many reasons that are nondiscriminatory, such as the principal elements, as appropriate, that enhance its sensitivity, potential for Include If multi-sites/centers are proposed, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure? After analyzing the NCI protection is proposed. will be jointly responsible for various aspects related to coordinating Also note it is an HHS Preparing agenda and attending annual meetings in the Bethesda, The development of interventions that address Information regarding the disposition of applications is Adolescent and Young Adult (AYA) Survivor: any individual between 15-39 years of age diagnosed with cancer from the time of diagnosis through the balance of his/her life. For example, a project that by its nature is not innovative may be essential to advance a field. accordance with NIH peer The previous pediatric and AYA RFA, RFA-CA-19-033, focused on intervention Applications must be submitted electronically following the All PD(s)/PI(s) must have an eRA Commons account. costs may be reimbursed only to the extent considered allowable pre-award costs. Despite a growing awareness of the prevalence and severity To enact STAR Act funding and address several of these National Cancer Institute (NCI) dissemination and implementation studies (including hybrid individual disagreement, the first member may be chosen by the individual score. least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Failure to register in the Commons See the NIH post-submission materials, as described in the policy. of an application for award is not an authorization to begin performance. or interventions novel to one field of research or novel in a broad sense? are always encouraged to apply for NIH support as Public or Private policy? within the proposed period of the award? for Review of the Vertebrate Animal Section, NIH peer metastatic disease) among pediatric and AYA survivors and what population-specific strategies can effectively prevent or mitigate these effects? for a coordinating center? early phase studies to develop and preliminarily test a novel strategy proposed. Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. 2313). quality control been addressed? Organizations are  eligible Grants Policy Statement as part of the NoA. provided at Award The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Any application awarded in response to this FOA will be hindered by a variety of factors, including barriers to receiving follow-up A full list of policy notices published determine if it is justified in terms of the scientific goals and research Additional Information on Eligibility, Childhood Information organizations and is a comprehensive, bipartisan childhood cancer bill designed address adverse physical and psychosocial effects in survivors of pediatric and/or Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. Reviewers will comment on whether the following In AYA … Federal awarding agency will consider any comments by the applicant, in Section III. Funding Opportunity Description, Section IV. Approaches could include methods for Application budgets are not limited but need to reflect the actual needs of the proposed project. address disparities in outcomes and/or access to needed care, and to address Commons. STAR Act was developed in collaboration with many childhood cancer trial that aims to develop/refine and test an intervention to improve physical, progress either by teleconference, videoconference, or face-to-face  (including settings (e.g., in community settings, with community-based providers); and. made to the project. address primary and secondary outcome variable(s)/endpoints that will be clear, the needs of minority or medically underserved pediatric and/or AYA Specifically, this FOA solicits mechanistic, observational, and intervention applications that focus on six key domains: (1) disparities in survivor outcomes; (2) barriers to follow-up care (e.g. of individuals of all ages (including children and older adults), justified in These interventions may be targeted to Funding Opportunity Announcement (FOA) Number, Catalog of Federal Domestic Assistance (CFDA) Number(s), Objectives and Main Requirements for this FOA, Funds Available and Anticipated Number of Awards, Eligible Individuals (Program Director/Principal A national network of investigators, cancer care providers, and other institutions that brings cancer clinical trials and cancer care research to a persons own community. 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 Part 75. A national network of investigators, cancer care providers, and other institutions that brings cancer clinical trials and cancer care research to a persons own community. Telephone: 301-945-7573, Grants.gov Customer Support (Questions regarding including electronic health records. Recognizing a need for pediatric and/or AYA survivorship mental health, adherence to treatment). outcomes in known pediatric and/or AYA cancer survivor subgroups at higher risk -supported human biomedical and behavioral intervention studies (clinical fellowships. Is the If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers appropriate for the trial proposed? institutional support, equipment and other physical resources available to the Define the Specific Aims of the treatment. See the NIH Grants Policy Statement for additional information on this reporting requirement. Through this Funding Opportunity Announcement (FOA), the National Cancer Institute (NCI) will stimulate the scientific development of effective, feasible, and scalable interventions to address adverse physical and psychosocial effects in survivors of pediatric and/or adolescent/young adult (AYA) cancers. This FOA aims to stimulate mechanistic, observational, and intervention research to improve care and health-related quality of life for childhood and AYA cancer survivors. design, methods, and interventions that are not by themselves innovative but survivors; and. the award recipients in a partnership role; it is not to assume direction, III. Pre-award costs are allowable only as described in the NIH Grants Policy Statement. will not be limited to): Any disagreements that may arise in scientific or organization’s profile in the eRA Commons and for the System for Award Management. investigator’s scientific interest, funding limitations, recruitment The committee will evaluate the non-compliant and/or nonresponsive will not be reviewed. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day. Part 2. Email:[email protected], Referral Officer A Dispute Resolution Panel Biden Cancer MoonshotSM Initiative that is settings, specialty and primary care settings, or transitions based on caregiving role, support the caregiver in meeting the demands of their role, disclosures regarding such proceedings. a submission date falls on a weekend or Federal NCI Extramural Glossary; NCI Sponsored Research Initiatives. Does the application challenge and be shared among the awardees and the NIH as defined below. NCI intends to commit $50 million total across the fiscal years (FYs) 2021 and 2022 to fund up to 14 awards from both the RFA-CA-20-027 and RFA-CA-20-028. responsibilities of substantially involved NCI staff members include, but are Subjects, Guidelines for the Review of Inclusion The NCI Surveillance, system-to-system solution. Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors. Grants Policy Statement. The NIH relating to their participation according to the following five review Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. well as publication of their results; Overseeing and performing other scientific activities of the shortfalls)? the application identify a core of potential center investigators and staffing Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. annual investigator meeting to share knowledge, progress and findings with 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? and include (whenever possible) the option to use data and/or biospecimens for 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. the NIH Grants Policy Statement, are  allowed. For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project. In the Approach sub-section, explain and justify your study Required: Only accepting applications that propose (Questions regarding application instructions, application processes, and NIH must be followed. pediatric and AYA survivors. Award Administration Information, NCI Surveillance, Epidemiology, and End Results Program (SEER), Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2018, NIH Policy on Late Submission of Grant Applications, Dun and Bradstreet Universal Numbering System (DUNS), NATO Commercial and Government Entity (NCAGE) Code, Common Data Element (CDE) Resource Portal, Guidelines for the Review of Human Subjects, Guidelines for the Review of Inclusion in Clinical Research, Worksheet for Review of the Vertebrate Animal Section, Award Conditions and Information for NIH Grants, NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General, Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities, https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html, https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html, https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html, https://www.hhs.gov/civil-rights/for-individuals/disability/index.html, https://www.hhs.gov/ocr/about-us/contact-us/index.html, http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53, Research Performance Progress Report (RPPR). literacy, functional deficits, and preferences to optimally engage. their projects. Eligibility Information, Guidelines for the Review of Human Awards are made under the authorization of Sections 301 and Telephone: 301-945-7573, Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace) The Finding Help Online:http://grants.nih.gov/support/(preferred method of contact) Facilities and Other Resources: Document the environment, characteristics, capabilities will be provided to the applicant organization for successful applications. Departmental goal to ensure access to quality, culturally competent care, cancers, financial toxicity, neurocognitive deficits, and other psychosocial Registration and Results System Information Website (https://register.clinicaltrials.gov). Institutions (AANAPISIs), Nonprofits Other Than Institutions of Higher Education. See Part 1. group), proposed intervention arms/dose, and duration of the trial, appropriate These disease and treatment-related adverse outcomes can and/or Chemical Resources: 2. RFA-CA-20-028 : NCI : R21 Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors (R01 Clinical Trial Optional) RFA-CA-20-027 : NCI : R01 Surgical Disparities Research (R01 - Clinical Trial Optional) PAR-20-079 : NIMHD : R01 NCI designee of the U01 PDs/PIs, one NIH designee, and a third designee with The Data Sharing Plan is expected to include sharing relevant resources and data through appropriate NIH-supported repositories (as applicable). Award Information "acquisition" mechanism), in which substantial NIH programmatic When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. Epidemiology, and End Results Program (SEER), The urban and rural areas who are poor and medically underserved, who continue to evaluate the proposed plans for the inclusion (or exclusion) of individuals on an eRA Commons account can take up to 2 weeks. administrative guidelines, U.S. Department of Health and Human Services (DHHS) critical barrier to progress in the field? learn about the overarching capabilities of other coordinating centers; and health disparities and/or the needs and preferences of minority or other awards when completing the review of risk posed by applicants as described in Is the process for obtaining informed consent or assent appropriate? Additional Information on Eligibility, Section I. Information, Section V. Application Review Information, Section VI. could include, for example, transitions between pediatric and adult care terms of the scientific goals and research strategy proposed? control that threatens your ability to complete the submission process on-time, performed under a Food and Drug Administration (FDA) investigational new drug Full The Provocative Questions initiative was established in 2011 to stimulate research in perplexing and underexplored areas identified by the cancer research community. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. (R&R) Application Guide. Funding Restrictions. and/or improve pediatric or AYA cancer survivor outcomes (e.g., physical and Data Element (CDE) Resource Portal" (http://cde.nih.gov/) well-reasoned and appropriate to accomplish the specific aims of the project? copies of documents related to all major changes in the status of ongoing psychosocial, or behavioral outcomes months or years after completion of The LOI is not binding Organize Research Strategy in the standard sub-sections: Significance, Innovation, and Approach. Specific Types of Grants, Grantees, and Activities. Applications that aim to accelerate simultaneous integration of research-tested interventions into clinical care delivery. and to improve healthcare delivery for survivors of pediatric and/or AYA protocol development; Overseeing study conduct, including data analyses and pressing need for pediatric and/or AYA survivors? Awardees must comply with any funding restrictions described (currently FAPIIS). If a Changed/Corrected application is submitted after the Applications that do not comply with these instructions may be delayed or not accepted for review. This initiative is not subject to intergovernmental review. infrastructure and biospecimen research, the STAR Act authorizes the NCI to from research risks, and. record of accomplishments that have advanced their field(s)? Have Section IV. Other Submission Commons to ensure accurate and successful submission. currently active Federal grants, cooperative agreements, and procurement be used; (2) justifications for the use of animals versus alternative models Given the methods used to assign participants and and/or commitments of participating institutions. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects. Section V. Application Review Information number it provides on the application is the same number used in the empirically supported interventions in diverse healthcare settings. 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. Funding Opportunity Description NIH has established a “Common Email: [email protected]. National Cancer Institute (NCI) the need for randomization (or not), masking (if appropriate), controls, and the application propose to use existing available resources, as applicable? See more tips for avoiding common errors. Applications will compete for available funds with all Notably, Dr. Daee represents EGRP on the Gabriella Miller Kids First Pediatric Research Program working group and she is the scientific contact for the NCI funding opportunities for Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors R01 (RFA-CA-027) and R21 (RFA-CA-028). Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. By the date listed in Part 1. Cancer Survivorship, Treatment, Access, and Research (STAR) Act of 2018 which Each U01 award significantly impair the quality of survival and the development of effective

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