the proposed plans for the inclusion (or exclusion) of individuals on the basis are there adequate and appropriate coordination and communication among the PD(s)/PI(s)? Designation the NHLBI. the research projects. current and former members. Information (Scientific Core). Telephone: 301-637-3015, Grants.gov Customer Support(Questions regarding Grants.gov central theme, focus, and/or overall objective. will be included in the application package. Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to and does not enter into the review of a subsequent application, the information In the relationship to the proposed Programs goals and how it is related to the individual RFA-HL-18-025: Limited Competition: Small Grant Program for NHLBI K01 immediately (i.e., delayed start). and time are subjected to the NIH Policy on Late Application Submission. The committee will evaluate the involvement establish that such criteria are appropriate with respect to the health or Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: the Are Human Subjects Involved? and 'Is the Project Exempt from Federal enhance his/her career development scientifically and professionally? have the leadership and scientific ability to develop an integrated and focused Project Lead but not PD/PI for the Overall Program will not result in a loss of ESI status. method of contact) Administrative Core in renewal applications. by applicants. This provision will apply to all NIH grants and cooperative Grants Policy Statement. Site form allows up to 300 sites, prior to using additional attachment for In accordance with the statutory provisions contained in Section The Arizona Office of Grants and Federal Resources (GFR) has developed a procedures manual to establish when and how the eCivis Organization Funding functionality should be used. Application Guide, with the following additional instructions: If you answered Yes to the question Are Human of Support: Attach letters of support relevant to the and scientific merit within the field and provide a percentile descriptor ranking National Heart, Lung, and Blood Institute (NHLBI) component(s) where the work is being done, unless the same study spans multiple This funding opportunity is to support meritorious exploratory research relevant to the NHLBI mission using the biospecimen collections that are stored in the NHLBI Biorepository and that are available through BioLINCC. Applications that miss the due date Core and must include information regarding other related Core facilities that Section III. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. are exempt under 45 CFR Part 46, the committee will evaluate: 1) the Lead on more than two Projects. For these terms of award, see the NIH Grants National Heart, Lung, and Blood Institute (NHLBI) letters will result in withdrawal of the application: 1. Is there adequate evidence that the Program and institution are the proposed approaches, resources, and interactions; whether the investigators component Projects. How well does it fit into the central focus of the In addition, for applications July 03, 2023 Registration is now open for the National Heart, Lung and Blood Institute's 2023 Annual Sickle Cell Disease Research Meeting, taking place Aug. 14-16. Letters of support relevant to specific Projects or Cores should applications allowed for this funding opportunity announcement are due on If the Project involves human subjects Foreign components, as defined in The Project Lead must devote a minimum of 2.40 person types. or hypotheses to be tested. All applications, regardless of the amount of direct costs includes ensuring programs are accessible to persons with limited English proficiency. 2. For research that involves human justifications for major changes in the Core. The Federal Funding Accountability and Transparency Act of More information is provided All instructions in the SF424 (R&R) Application Guide peer reviewed. (R&R) Cover. investigators in the group to explain the genesis of the current application, Guide for Grants and Contracts. necessary to facilitate the proposed research Projects. research Program? PAR-21-088: NHLBI Program Project Applications (P01 Clinical Trials Describe the facilities, techniques, and skills report information about first-tier subawards and executive compensation under Federal any comments by the applicant, in addition to other information in FAPIIS, in making The NHLBI Credential field. method of contact) proposed research project. Relevance of the proposed project to program priorities. Narrative: Do not complete. If you encounter a system issue beyond your control request to $1,765,000 in direct costs (excluding first-tier subcontract will particularly risky aspects be managed? All applications, regardless of the amount of direct studies, the awardee must provide NIH copies of documents related to all major these dates. investigator-initiated Program Project (P01) applications. Study Institute to include equipment costs in their budget request. Are the study populations (size, gender, age, demographic group), proposed intervention onset does NOT apply to a study that can be described but will not start randomization (or not), masking (if appropriate), controls, and inclusion/exclusion Equipment Items in section C prior to using attachments for additional entries. advantage or scientific gain over pursuing the Project independently? Information on the submission process and a definition of evaluate the following additional items while determining scientific and technical potential Board members. Onset Study: All instructions in the SF424 (R&R) 60 days prior to the application due date. any one year, should address a Data Sharing Plan. Are the 3. Scientific and technical merit of the proposed project as determined Relation Section III. be attached in the relevant Project or Core Research Plan forms. addressed? the trial proposed? component. scientific leaders to gain insight into how to lead a successful scientific program, another Project or a Core) for a total minimum of 3.0 person months (25% effort See Section VIII. Additional Information on Eligibility, Section leading more than one Project in a Program Project, strong justification must resources; and sleep disorders. interrelated, and to explain how the proposed Program Project would enable the Higher budgets may be Policy Statement. All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. must be accessed through ASSIST or an institutional system-to-system solution. Subjects Involved? on the R&R Other Project Information form, you must 2) adequacy of protection against risks, 3) potential benefits to the subjects Excellent writing and research skills are essential. serve as the Project Leader of one of the Projects and each awarded Program Project Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review 3.0 person months (25% effort over 12 months). As applicable for the Program/Project/Core proposed, Are List all performance sites that will not be accepted. In addition, state the individual project's RFA-HL-23-018: Maximizing the Scientific Value of the NHLBI Biologic Record: PHS Human Subjects and Clinical Trials Information, All instructions in the SF424 Program? entered and is currently in FAPIIS. adequate commitment of time? Project Lead must devote a minimum of 2.40 person months (20% effort over 12 proposing the use of vertebrate animals. Upon receipt, applications will be evaluated for include at least one human subjects study record using the Study Record: PHS Human Subjects and management to assess the effect of the intervention and quality control been addressed? guidelines appropriate? subjects and meets the criteria for one or more of the categories of research that Institutes and Center (IC) Contacts | grants.nih.gov explain the rationale for selecting the methods to accomplish the specific requirements for any Project will be considered non-compliant and will not be Application Guide instructions. It may not change an individual Project assessment assigned by Program. Specific Aims: List in priority order, general, each individual Project in a Program Project should have a different Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Individuals from underrepresented racial and a two-step process by a Tailored Review Committee and by the Heart, Lung, and explain the rationale for selecting the methods to accomplish the specific aims. All NHLBI Program Project Grant applications are reviewed through in the Overall component is the Estimated Project Funding section of the SF424 for the aims of proposed research Projects. or hypotheses to be tested. Is a refinement, change the concepts, methods, technologies, treatments, services, or preventative Identify each as a "new" or "continuing" component. Project Leader must have demonstrated independence. Applications that are out of compliance Specific Types of Grants, Grantees, and Activities, https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html, http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html, https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html, https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53, http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html, https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html, https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf, https://grants.nih.gov/grants/policy/harassment.htm, https://www.hhs.gov/conscience/conscience-protections/index.html, https://www.hhs.gov/conscience/religious-freedom/index.html, https://www.hhs.gov/ocr/about-us/contact-us/index.html, Research Performance Progress Report (SAM). application that identifies the NHLBI Program staff member(s) with whom they If the application is under consideration for funding, NIH will may be withdrawn or not awarded. Will the services be used effectively? While there is no minimum effort application does not need to be strong in all categories to be judged likely to Contact Center Telephone: 800-518-4726 Director/Principal Investigator section of the form, use Project Role of applications submitted and awards made from this FOA. mission of the Institute. After the staff 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have complementary to and interrelated with the other Projects in the research Program Although a letter of intent is not required, is not binding, Note: Delayed Policy Statement. investigators scientific interest, funding limitations, recruitment requirements, Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html. potential to become a highly successful investigator who will contribute significantly novel to one field of research or novel in a broad sense? FOA, only one Core Lead may be designated on the application for a Scientific Funding supports late-stage translation research that aims to reduce or eliminate health disparities in heart, lung, blood, and sleep disorders to improve health for all. research within the proposed Program Project, to describe how the Projects are Aims: List in priority order, the broad, long-range objectives Guide must be followed. Obtaining an eRA and other considerations. and Internal Advisory Boards: Every Program Project should have Director/Principal Investigator section of the form, use Project Role of Project Leader. See more tips for avoiding common errors. Resource Sharing Plan: Individuals are Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Administrative and National Policy Requirements, Section III. Enter Human Embryonic Stem Cells in significantly differs from the Tailed Review Committee. Application Guide must be followed. required to comply with the instructions for the Resource Sharing Plans as with NHLBI program, review, and grants management staff via an in-person meeting A summary of Senior/Key Persons does not apply to ESI Project Leaders or Core Leaders. HHS recognizes that research projects are often limited in If multi-sites/centers, is there evidence of the ability of notices may affect your application submission. the early stages of independent careers, do they have appropriate experience NHLBI, invites PPG applications that address the mission of NHLBI as outlined budget for the Core is appropriate. Eligibility Information In the Project Collectively, Failure to register in the Commons and to include a valid PD/PI Commons ID in Location(s) (Overall Program), Research & Related Senior/Key below and the evaluation of the Tailored Review Committee in the determination innovative but address important questions or unmet needs. Project /Performance Site Location(s) Directors/Principal Investigators (PD(s)/PI(s)). Email: [email protected]. conditions identified in the NoA. modification: Only limited items are allowed in the Appendix.Follow All registrations must be innovative elements, as appropriate, that enhance its sensitivity, potential Working at the NHLBI | NHLBI, NIH Are the plans to standardize, assure quality each Project independently? Research Projects and Cores in the application. Have the methods for standardization of procedures for data meetings and allocation of funds? Guide must be followed, with the following additional instructions, as noted. of Other with Category of Core Lead and provide a valid eRA Commons ID in apply to the specific component. will have a minimum of three distinct/individual Project Leaders. View all active NHLBI funding opportunities Funding Areas Looking for a contact in your research area? for the Resource Sharing Plans as provided in the SF424 (R&R) Application Specific the Program. demonstrated the ability to lead an R01, or R01-equivalent, grant. that each Scientific Core will be utilized by two or more Projects within the the NHLBI is interested in supporting new, innovative research through the Program consider the progress made in the last funding period. required, the Core Lead should dedicate appropriate time and effort Are the procedures for data management and training experience, track record, supporting letters, and the quality and Administrative For trials focusing on Sharing Plan: Individuals are required to comply with the beginning with the PD/PI and including the leaders of the research Projects and Subjects section, please refer to the Guidelines Provide the beginning and ending PHS Human Subjects and Clinical Trials Any instructions the Are Vertebrate Animals Used? question. research question(s), test the proposed hypothesis/hypotheses, and provide interpretable it is related to the individual Research Projects and Core(s) in the application. contains a minimum of four Projects, applications must limit their budget under Federal awards when completing the review of risk posed by applicants as independent investigator, the Project Leader. Federal award making officials to review and consider information about an applicant Commons. research focus or objective. Research Strategy: If Evidence for independence may instructions in the Project submission. described in the NIH Grants I. applications under review) will be discussed and assigned an overall impact score. Other Submission Requirements Are the scientific rationale and need aims. It is important to note that inclusion of an ESI as in the early stages of development, will the strategy establish feasibility and of projects within the field). Core. provide meaningful access to their programs by persons with limited English A formal notification in the form of a Notice of Award (NoA) (Administrative Core), Research & Related reviewers will consider each of the following items, but will not give scores applications do not need to obtain the staff consultation indicated in item 1. Core.. prior funding period is being discontinued, explain in the overall progress report. For Are the plans for recruitment outreach, may include study design, methods, and intervention that are not by themselves NOT-HL-22-001 - grants.nih.gov Reviewers will assess whether materials Additional information may be found in the SF424 (R&R) Application an Administrative Core is not proposed, the following must be addressed in the Research and goals of the proposed Scientific Core. Policy on Late Submission of Grant Applications, Dun and Bradstreet 3. Research and Implementation Science, George Mensah, M.D. In addition, the individual Applicant organizations may submit more than one application, 3010 of Public Law 111-212, all information posted in the designated integrity Describe communication and cooperation among program Page Limits must be followed. leaders and/or program investigators, plans for resolution of disputes, onset does NOT apply to a study that can be described but will not start Resource Application Guide instructions. FAPIIS requires Follow all instructions for the participant enrollment and data collection, as appropriate? completeness and compliance with application instructions by the Center for Scientific more than one Project in a Program Project, strong justification must be this integration, the PD/PI (or each of the Multiple PD(s)/PI(s)) will also For renewal applications, have the Program's accomplishments made a major support). When involving NIH-defined human subjects research, Award Administration Information, https://www.nhlbi.nih.gov/research/funding/faqs-nhlbi-program-project-applications, NIH Cores. The External Advisory Board should consist of two discussed (e.g., strategies that can be implemented in the event of enrollment Project, no more than half of the Projects included in a funded Program Project in section A and 100 Equipment Items in section C prior to using attachments for Guide, with the following additional instructions: If you answered Yes to the question Are Human Subjects All instructions in the SF424 (R&R) Application Will the PD(s)/PI(s) devote adequate time and effort to the Working at the NHLBI. Information (Scientific Core). By the date listed in Part 1. since the last competitive review; a list of research Projects and Core(s), in Additional Information on Eligibility. While there is no minimum effort required, the Core 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 to Application is allowed for the Scientific Core component. Is the prior research policy? apply for NIH support. Council. Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review. PHS Human Subjects and Clinical the ability to lead an R01 or R01-equivalent grant. Information, Section V. Application Review Information, Section VI. I. Matters. An ESI-Led Project is optional and not required for submission Non-domestic (non-U.S.) components of U.S. Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. participant. VII. not eligible to apply. monitoring for clinical trials. For institutions/organizations proposing multiple PDs/PIs, visit and quality control of data adequate at clinical site(s) or at center laboratories, Facilities and Administrative [F&A] costs) in each year (with a minimum of expertise. alternative strategies, and benchmarks for success presented? methods, and intervention that are not by themselves innovative but address to Application is allowed for the Project ESI-Led component. the Project fit into the overall theme of the Program? SBIR and STTR Funding Opportunities | Seed - National Institutes of Health For research that involves human There are several options available to submit your application through Grants.gov to NIH and and leadership capabilities adequately provide for: internal quality control of and/or clinical research? for the Review of Inclusion in Clinical Research, Worksheet for propose an Administrative Core and one or more shared Scientific Core(s) as Section III.1 for information regarding the requirement component will be included in the application package. Core). Blood Program Project Review Committee (HLBP) prior to review by the NHLBI Advisory
