I. OVERVIEW OF THE FUNDING OPPORTUNITY
I.OVERVIEW OF THE FUNDING OPPORTUNITYProgram Announcement for the Department of DefenseDefense Health ProgramCongressionally Directed Medical Research ProgramsAutism Research ProgramClinical Translational Research AwardAnnouncement Type: InitialFunding Opportunity Number: W81XWH-21-ARP-CTRACatalog of Federal Domestic Assistance Number: 12.420 Military MedicalResearch and DevelopmentSUBMISSION AND REVIEW DATES AND TIMES Pre-Application Submission Deadline: 5:00 p.m. Eastern time (ET), May 3, 2021 Invitation to Submit an Application: June 2021 Application Submission Deadline: 11:59 p.m. ET, August 5, 2021 End of Application Verification Period: 5:00 p.m. ET, August 10, 2021 Peer Review: September 2021 Programmatic Review: November/December 2021This program announcement must be read in conjunction with the General ApplicationInstructions, version 603. The General Application Instructions document is available fordownloading from the Grants.gov funding opportunity announcement by selecting the“Package” tab, clicking “Preview,” and then selecting “Download Instructions.”DOD FY21 Autism Clinical Translational Research Award1
TABLE OF CONTENTSI.OVERVIEW OF THE FUNDING OPPORTUNITY. 1II.DETAILED INFORMATION ABOUT THE FUNDING OPPORTUNITY . 3II.A. Program Description. 3II.A.1. FY21 ARP Clinical Translational Research Award Areas of Interest . 3II.A.2. Award History . 4II.B. Award Information . 4II.C. Eligibility Information . 8II.C.1. Eligible Applicants . 8II.C.2. Cost Sharing. 8II.C.3. Other . 8II.D. Application and Submission Information. 9II.D.1. Address to Request Application Package . 9II.D.2. Content and Form of the Application Submission . 9II.D.3. Dun and Bradstreet Data Universal Numbering System (DUNS) Number andSystem for Award Management (SAM) . 26II.D.4. Submission Dates and Times . 26II.D.5. Funding Restrictions . 27II.D.6. Other Submission Requirements . 28II.E. Application Review Information . 28II.E.1. Criteria . 28II.E.2. Application Review and Selection Process . 31II.E.3. Integrity and Performance Information. 32II.E.4. Anticipated Announcement and Federal Award Dates . 32II.F. Federal Award Administration Information . 33II.F.1. Federal Award Notices . 33II.F.2. Administrative and National Policy Requirements . 34II.F.3. Reporting . 34II.G. Federal Awarding Agency Contacts. 35II.G.1. CDMRP Help Desk . 35II.G.2. Grants.gov Contact Center . 35II.H. Other Information . 35II.H.1. Program Announcement and General Application Instructions Versions. 35II.H.2. Administrative Actions . 35II.H.3. Application Submission Checklist . 38APPENDIX 1: ACRONYM LIST . 40DOD FY21 Autism Clinical Translational Research Award2
II. DETAILED INFORMATION ABOUT THE FUNDINGOPPORTUNITYII.A. Program DescriptionApplications to the Fiscal Year 2021 (FY21) Autism Research Program (ARP) are beingsolicited for the Defense Health Agency (DHA) J9, Research and Development Directorate, bythe U.S. Army Medical Research Acquisition Activity (USAMRAA) using delegated authorityprovided by United States Code, Title 10, Section 2358 (10 USC 2358). As directed by theOffice of the Assistant Secretary of Defense for Health Affairs (OASD[HA]), the DHA managesthe Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E)appropriation. The execution management agent for this program announcement is theCongressionally Directed Medical Research Programs (CDMRP). The ARP was initiated in2007 to provide support for research of exceptional scientific merit and innovation with highimpact that focuses on autism spectrum disorder (ASD). Appropriations for the ARP from FY07through FY21 totaled 104.4 million (M). The FY21 appropriation is 15M.The ARP’s vision is to improve the lives of individuals with ASD now, and its mission is topromote innovative research that advances the understanding of ASD and leads to improvedoutcomes.The proposed research must be relevant to active-duty Service Members, Veterans, militarybeneficiaries, and/or the American public.II.A.1. FY21 ARP Clinical Translational Research Award Areas of InterestThe FY21 ARP Clinical Translational Research Award seeks applications for early-phaseclinical research. The ARP encourages applications that address the critical needs of the ASDcommunity in one or more of the following areas: Dissemination/implementation of clinically validated interventions Behavioral, cognitive, and other non-pharmacological therapies for ASD core symptoms orto alleviate co-occurring conditions Pharmacological, genetic, and other biological treatments for ASD core symptoms or toalleviate co-occurring conditions Improve diagnosis and access to services across the life span Interventions promoting success in key transitions to adulthood for individuals living withASD Healthcare provider-focused training or tools to improve healthcare delivery for individualswith ASD across the life span and the continuum of care (i.e., primary care, urgent/emergentcare, and disaster relief)DOD FY21 Autism Clinical Translational Research Award3
Cultural, socioeconomic, and gender factors in diagnosis, treatment efficacy, delivery, andaccess to services Understanding heterogeneity in treatment response Pragmatic trialsII.A.2. Award HistoryThe ARP Clinical Translational Research Award mechanism was first offered in FY17. Sincethen, 55 Clinical Translational Research Award applications have been received, and 8 havebeen recommended for funding.II.B. Award InformationThe ARP Clinical Translational Research Award is intended to support early-phase, proof-ofprinciple translational studies that will examine hypothesis-based, innovative interventions/clinical research that has the potential to address current clinical deficits for ASD. Applicationsare strongly encouraged to address one of the FY21 ARP Clinical Translational ResearchAward Areas of Interest. If the proposed project does not address any of the FY21 ARP ClinicalTranslational Research Award Areas of Interest, the application should describe how the projectwill nevertheless address another critical problem or issue in ASD. Outcomes from studiesfunded by this award are anticipated to provide scientific rationale for subsequent developmentof larger, efficacy-based clinical trials of interventions that will transform ASD clinical care.A clinical trial is defined as a research study in which one or more human subjects areprospectively assigned to one or more interventions (which may include placebo or othercontrol) to evaluate the effects of the interventions on biomedical or behavioral health-relatedoutcomes. Funded trials are required to post a copy of the Institutional Review Board (IRB)approved informed consent form used to enroll subjects on a publicly available federal website inaccordance with federal requirements described in the Code of Federal Regulations, Title 32,Part 219 (32 CFR 219). For more information, a Human Subject Resource Document isprovided %20Resource%20Document.pdf.Clinical research is defined as: (1) patient-oriented research. Research conducted with humansubjects (or on material of human origin such as tissues, specimens and cognitive phenomena)for which an investigator (or colleague) directly interacts with human subjects. Excluded fromthis definition are in vitro studies that utilize human tissues that cannot be linked to a livingindividual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeuticinterventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic andbehavioral studies; and (3) outcomes research and health services research. Note: Studies thatmeet the requirements for IRB Exemption 4 are not considered CDMRP-defined clinicalresearch. IRB Exemption 4 refers to research involving the collection or study of existing deidentified specimens or data, if these sources are publicly available.DOD FY21 Autism Clinical Translational Research Award4
Principal Investigators (PIs) seeking funding for a larger clinical trial should consider theARP Clinical Trial Award (Funding Opportunity Number W81XWH-21-ARP-CTA).Similarly, PIs seeking funding for a preclinical research project should consider the ARP IdeaDevelopment Award (Funding Opportunity Number W81XWH-21-ARP-IDA).For applications that include a clinical trial, the Investigational New Drug (IND)/InvestigationalDevice Exemption (IDE) Documentation (Attachment 11) should be included. If the proposedclinical trial involves the use of a drug that has not been approved by the U.S. Food and DrugAdministration (FDA) for the proposed investigational use, then an Investigational New Drug(IND) application to the FDA that meets all requirements under the 21 CFR 312 may berequired. It is the responsibility of the applicant to provide evidence from the IRB of record orthe FDA if an IND is not required. If an IND is required, the IND application must be submittedto the FDA by the Clinical Translational Research Award application submission deadline.The IND should be specific for the product (i.e., the product should not represent a derivative oralternate version of the investigational agent described in the IND application) and indication tobe tested in the proposed clinical trial. For more information on IND applications, the FDA hasprovided guidance at .htm.If the investigational product is a device, then an IDE application to the FDA that meets allrequirements under 21 CFR 812 may be required. It is the responsibility of the applicant toprovide evidence from the IRB of record or the FDA if an IDE is not required or if the devicequalifies for an abbreviated IDE. If an IDE is required, the IDE application must be submitted tothe FDA by the Clinical Translational Research Award application submission deadline. TheIDE should be specific for the device (i.e., should not represent a derivative or modified versionof the device described in the IDE application) and indication to be tested in the proposedclinical trial.If the clinical trial of an investigational product will be conducted at international sites, evidencethat an application to the relevant national regulatory agency of the host country(ies) has beensubmitted by the Clinical Translational Research Award application submission deadline isrequired.Research must be based on preliminary data. Although the proposed research must havedirect relevance to ASD, the required preliminary data, which may include unpublished resultsfrom the laboratory of the PI, research team, or collaborators named on this application, may befrom outside the ASD research field.The following are important aspects of the research to be funded by the Clinical TranslationalResearch Award: The research should include clearly defined and appropriate endpoints. The research should include a statistical analysis plan that will support the objectives of thestudy. Robust statistically powered efficacy studies are not expected at this stage of researchand development.DOD FY21 Autism Clinical Translational Research Award5
A transition plan (including potential funding and resources) must be included showing howthe research findings or intervention will progress to the next level of development (e.g.,future clinical trials) after the completion of the FY21 ARP Clinical Translational ResearchAward. The proposed clinical research must be based on sound scientific rationale that is establishedthrough logical reasoning and critical review and analysis of the literature.The types of awards made under the program announcement will be assistance agreements. Anassistance agreement is appropriate when the federal government transfers a “thing of value” to a“state, local government,” or “other recipient” to carry out a public purpose of support orstimulation authorized by a law of the United States instead of acquiring property or service forthe direct benefit and use of the U.S. government. An assistance agreement can take the form ofa grant or cooperative agreement. The level of involvement on the part of the Department ofDefense (DOD) during project performance is the key factor in determining whether to award agrant or cooperative agreement. If “no substantial involvement” on the part of the fundingagency is anticipated, a grant award will be made (31 USC 6304). Conversely, if substantialinvolvement on the part of the funding agency is anticipated, a cooperative agreement will bemade (31 USC 6305), and the award will identify the specific substantial involvement.Substantial involvement may include, but is not limited to, collaboration, participation, orintervention in the research to be performed under the award. The award type, along with thestart date, will be determined during the negotiation process.The anticipated direct costs budgeted for the entire period of performance for an FY21 ARPClinical Translational Research Award will not exceed 600,000. Refer to Section II.D.5,Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2022. For additional information refer toSection II.F.1, Federal Award Notices.The CDMRP expects to allot approximately 1.92M to fund approximately two ClinicalTranslational Research Award applications. Funding of applications received is contingentupon the availability of federal funds for this program as well as the number of applicationsreceived, the quality and merit of the applications as evaluated by scientific and programmaticreview, and the requirements of the government. Funds to be obligated on any awardresulting from this funding opportunity will be available for use for a limited time periodbased on the fiscal year of the funds. It is anticipated that awards made from this FY21funding opportunity will be funded with FY21 funds, which will expire for use on September30, 2027.Research Involving Human Anatomical Substances, Human Subjects, or HumanCadavers: All DOD-funded research involving new and ongoing research with humananatomical substances, human subjects, or human cadavers must be reviewed and approved bythe U.S. Army Medical Research and Development Command (USAMRDC) Office of ResearchProtections (ORP), Human Research Protection Office (HRPO), prior to researchimplementation. This administrative review requirement is in addition to the local IRB or EthicsCommittee (EC) review. Local IRB/EC approval at the time of submission is not required.DOD FY21 Autism Clinical Translational Research Award6
Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes.Refer to the General Application Instructions, Appendix 1, and the Human Research ProtectionsOffice Resources and Overview document available on the electronic Biomedical ResearchApplication Portal (eBRAP) “Funding Opportunities & Forms” web page(https://ebrap.org/eBRAP/public/Program.htm) for additional information.If the proposed research is cooperative (i.e., involving more than one institution), plans for themulti-institutional structure governing the research protocol(s) should be outlined.A written plan for single IRB review arrangements must be provided for cooperative researchconducted in the United States. The lead institution responsible for developing the masterprotocol and master consent form should be identified and should be the single point of contactfor regulatory submissions and requirements. The master protocol and consent form must bereviewed by the HRPO prior to distribution to the additional sites for IRB/EC review.Communication and data transfer between or among the collaborating institutions, as well ashow specimens and/or imaging products obtained during the study will be handled, should beincluded in the appropriate sections of the application. A separate intellectual and materialproperty plan agreed upon by all participating institutions is also required for multi-institutionalclinical trials.Research Involving Animals: All DOD-funded research involving new and ongoing researchwith animals must be reviewed and approved by the USAMRDC ORP Animal Care and UseReview Office (ACURO), in addition to the local Institutional Animal Care and Use Committee(IACUC) of record. IACUC approval at the time of submission is not required. Allow at least 3to 4 months for ACURO regulatory review and approval processes for animal studies. Refer tothe General Application Instructions, Appendix 1, for additional information.Rigor of Experimental Design: All projects should adhere to accepted standards for rigorousstudy design and reporting to maximize the reproducibility and translational potential ofpreclinical research. Core standards are described in Landis, S.C., et al., A call for transparentreporting to optimize the predictive value of preclinical research, Nature 2012, v490/n7419/full/nature11556.html). While thesestandards were written for preclinical studies, the basic principles of randomization, blinding,sample-size estimation, and data handling derive from well-established best practices in researchand should be applied consistently across basic and translational studies. Applicants shouldconsult the
II.B. Award Information . (ies) has been submitted by the Clinical Translational Research Award application submission deadline. is . Human Subjects, or Human Cadavers: All DOD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by .
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