IATCI InterAirline Through Check-In (IATCI) Implementation Group is an industry interest group including airlines, system/software providers and handling agents/operators involved in development, implementation and usage of interairline through check-in functionality. Currently, it has more than 60 members. The Group closely co-operates with the International Air Transport Association (IATA) and its Passenger and Airport Data Interchange Standards (PADIS) organisation by providing guidelines for the ATA/IATA EDIFACT Message Standards Document regarding InterAirline Through Check-In (Scenario 1) messages as well as InterAirline Local Check-In and Flight Management (Scenario 2) messages.

1. Sdtm Implementation Guide
2. Padis Reservations Implementation Guide

IATCI maintains and distributes the IATCI Group Message Implementation Guide document. The Group also facilitates multilateral agreements and assists in bilateral agreements in connection with the interairline through check-in by maintaining a standard set of documented rules and recommendations. Procedural issues in direct relation to interairline through check-in may be addressed in the meetings as well.

A minimum of one regular meeting per 18 months is foreseen. Meetings are hosted by one of the members varying among the three IATA Traffic Areas. The membership in the Group may be regular, associate or observable. Between the meetings, the members provide the assistance in running Documentation, Administration and Research centres. They are also active in different IATCI ad-hoc activities. The meetings and other activities are co-ordinated by the Group's chairperson and/or vice-chairperson who are elected for a two year period.

This Funding Opportunity Announcement (FOA) is associated with the that is intended to accelerate cancer research. The purpose of this Funding Opportunity Announcement (FOA) is to create a U24 Coordinating Center that will integrate and facilitate trans-disciplinary research across the Drug Resistance and Sensitivity Centers (DRSCs), established under an earlier released RFA-CA-17-009 for U54 specialized centers.

The DRSCs are designed to target the following area designated as a scientific priority by the Blue Ribbon Panel (BRP): Establish a network of multi-disciplinary research teams to study mechanisms of tumor resistance and sensitivity and develop innovative anti-cancer therapy strategies. The Coordinating Center to be established under this FOA will facilitate the activities of the DRSCs and help integrate the results of their studies.

Required Application Instructions It is critical that applicants follow the Research (R) Instructions in the, except where instructed to do otherwise (in this FOA or in a Notice from the ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review. Funding Opportunity Description The purpose of this Funding Opportunity Announcement (FOA) is to create a U24 Coordinating Center that will integrate and facilitate trans-disciplinary research across the Drug Resistance and Sensitivity Centers (DRSCs) U54s established under; and to the extent possible coordinate its activities with other Cancer Moonshot coordinating centers and NCI programs.

The DRSC U54s will conduct basic and preclinical research focused on investigating the mechanisms of tumor resistance (intrinsic or acquired) and sensitivity and on developing new therapeutic strategies that either combat tumor resistance or exploit its sensitivity. These strategies will explore genetic and other molecular characteristics of the cancer underlying sensitivity/resistance to anticancer treatments.

Each DRSC has 2-3 interrelated research projects. DRSC applicants have proposed collaborative arrangements (within one institution and/or with partnering institutions) to ensure all capabilities are met that might be necessary to fulfill the need for highly specialized multidisciplinary expertise. The proposed projects have a clear translational potential to inform the development of novel therapeutic strategies based on mechanistic understanding of resistance and/or sensitivity to anticancer agents as mono or combination therapeutics.

Collectively, the DRSC U54s will act as a network (DRSN) with the U24 as its Coordinating Center to serve as a critical basic and preclinical part to NCI’s clinical therapeutics development. Basic and preclinical discoveries resulting from research performed by DRSCs should enable future clinical application of concepts to prevent and/or overcome cancer drug resistance within the NCI Cancer Therapy Evaluation Program clinical trials networks. Applications that propose to conduct a clinical trial is beyond the scope of this FOA and of RFA-CA-17-009. The U24 Coordinating Center will facilitate the DRSN activities, manage and harmonize data generated across the DRSN, and maximize the optimal utilization of resources within the network and - to the extent possible - with other Cancer Moonshot coordinating centers. In collaboration with investigators across the NCI intramural program and the extramural Divisions portfolios, the U24 will also promote exchange of scientific findings and potential collaborations between the network investigator teams across the NCI portfolio, including NCI Precision Medicine Initiatives. Formal meetings of the DSRN network participants, invited outside experts and Experimental Therapeutics Clinical Trials Network (ETCTN) investigators and trans-Divisional NCI extramural staff will be held twice each year, with at least one of these meetings being a face-to-face discussion at the NCI. The U24 Coordinating Center will also facilitate interactions between investigators at the U54 DRSCs and other NCI-funded resources/centers, including Frederick National Laboratory for Cancer Research (FNLCR) and its Pharmacodynamic Assay Development & Implementation Section (PADIS) laboratories staff.

The U24 Coordinating Center will also facilitate the access of CTEP IND investigational agents and use of the NCI formulary for basic and preclinical studies by the DRSN investigators. Background The DRSCs funded under “Mechanisms of Cancer Drug Resistance and Sensitivity' RFA-CA-17-009 were developed in response to the joint recommendation from the Pediatric Cancers and Tumor Evolution and Progression Working Groups of the National Cancer Institute (NCI) Moonshot Blue Ribbon Panel (BRP). Each DRSC is based on 2-3 interrelated research projects that conduct basic and preclinical research focused on innovative strategies to understand and combat mechanisms of tumor resistance (intrinsic or acquired) and/or to exploit tumor sensitivity to anti-cancer therapies. These strategies explore genetic and other molecular characteristics of cancers' underlying sensitivity/ resistance to anticancer treatments. The specialized centers are pursuing distinct areas of cancer drug sensitivity and/or resistance research within the following disease platforms: acute myelogenous leukemia, multiple myeloma, non-small cell lung cancer, prostate cancer, colorectal cancer, and melanoma. This FOA proposes to further implement this NCI BRP recommendation by adding a U24 Coordinating Center to help integrate and manage the activities of the DRSCs.

The DRSCs, together with the Coordinating Center will not only guide the development of the NCI’s Investigational New Drug (NCI-IND agents) portfolio through the NCI Experimental Therapeutics (NExT) program for single agents or combinations with genotoxic agents already in clinical trials , but also encourage the introduction of new therapeutics that may be under development but not yet part of ongoing NCI-sponsored programs. Key Requirements of the DRSC Coordinating Center The Coordinating Center will function as a crucial scientific and logistic infrastructure part of the DRSN. The main responsibilities of the U24 will be to provide:.

Logistical and administrative support and coordination of DRSN meetings and conferences;. Statistical support and computational analysis as needed by the DRSN; and. Data harmonization and management. The Coordinating Center must have expertise and capabilities in biostatistics, information technology, study design, data management, protocol development, and logistical support. Areas under consideration for this Coordinating Center include expertise in: A.

Network support infrastructure. Required Registrations Applicant Organizations Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The states that failure to complete registrations in advance of a due date is not a valid reason for a late submission. All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations.

The same DUNS number must be used for all registrations, as well as on the grant application. (formerly CCR) – 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 an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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. – Applicants must have an active DUNS number and 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. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role.

Obtaining an eRA Commons account can take up to 2 weeks. 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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide. Number of Applications 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. 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 ). Letter of Intent Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in, prospective applicants are asked to submit a letter of intent that includes the following information:. Descriptive title of proposed activity.

Name(s), address(es), and telephone number(s) of the PD(s)/PI(s). Names of other key personnel. Participating institution(s). Number and title of this funding opportunity The letter of intent should be sent to: Laurence (Austin) Doyle, M.D. National Cancer Institute (NCI) Telephone: 240-276-6112 Email. PHS 398 Research Plan All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Specific Aims: List Specific Aims for the proposed Coordinating Center Research Strategy: Instead of standard sub-sections, Research Strategy must consist of the following sub-sections A, B, C, D, and E. Sub-section A.

Submission Dates and Times 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, the application deadline is automatically extended to the next business day. Organizations must submit applications to (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, 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 Policy on Late Application Submission. 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 SF424 (R&R) Application Guide. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.

Paper applications will not be accepted. Applicants must complete all required registrations before the application due date.

Contains information about registration. For assistance with your electronic application or for more information on the electronic submission process, visit.

If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the. For assistance with application submission, contact the Application Submission Contacts in.

Important reminders: All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See of this FOA for information on registration requirements. The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See for avoiding common errors. Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NCI, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Use of Common Data Elements in NIH-funded Research Many NIH ICs encourage the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records.

NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g. Genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a “Common Data Element (CDE) Resource Portal' to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects. For NCI-relevant CDEs, please visit CDE (Common Data Element) Browser. Investigator(s) Are the PD(s)/PI(s) and other personnel well suited to their roles in the Coordinating Center?

Do they have appropriate experience and training and have they demonstrated experience and an ongoing record of accomplishments in managing multi-institutional research? Do the investigators demonstrate significant experience with coordinating collaborative trans-disciplinary research? If the Coordinating Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approaches, governance, plans for conflict resolution, and organizational structure appropriate for the Coordinating Center? Specific to this FOA: Does the applicant team have experience overseeing selection and management of sub-awards, if needed? Approach Are potential problems, alternative strategies, and benchmarks for success presented? If the network is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the network?

Is an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed? Specific to this FOA: Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research network the Coordinating Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the DRSN research network, as appropriate for the work proposed? Leadership and Administration Unit Are the research infrastructure, programs, and collaborations adequate to support the DRSN Research Centers?

Is there adequate evidence for the managerial and collaborative capabilities of the proposed Coordinating Center leadership? How appropriate is the leadership structure of the proposed Coordinating Center in terms of (a) the overall goals of the DRSN program; (b) the coordination of multiple institutions participating in the DRSN Research Centers; and (c) understanding and familiarity with the state of the science in this field of research? Will the Coordinating Center have the appropriate capabilities to support proposed projects and data sharing among all DRSN participating sites?

How adequate are the plans to achieve compatibility with the DRSN Research Centers to facilitate data and resource sharing across the DRSN Research Network? Does the administration infrastructure demonstrate the capacity of the DRSN Coordinating Center to collaborate with the DRSN Research Centers and NCI program staff on scientific progress, peer-reviewed publications, web sites, evidence-based dissemination, or new collaborations and partnerships? Virtual Resource Repository Unit How appropriate and balanced are the proposed plans to create the Virtual Resource Repository?

Does the Coordinating Center have the capacity for setting-up a database that collects information on all available non-standard tools, reagents, protocols and technologies, along with clinical, demographic, and molecular information of all patients samples to be used in the studies conducted by the DRSN program, including information on the availability of biological specimens at all participating sites? Are the plans well justified and include appropriate safeguards for privacy and confidentiality protections of identifiable data? Does the plan describe a program that will efficiently support the sharing of unique tools, technologies, specimens and information across the DRSN as well as access by extramural collaborating investigators as appropriate and consistent with achieving the goals of the program? Does the plan enable the tracking and distribution of available non-standard materials, protocols, technologies, reagents and new and/or archived specimens to investigators, consistent with achieving the goals of the program? Environment Will the institutional environment in which the Coordinating Center will operate contribute to the probability of success in facilitating the DRSN research network it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the Center proposed? Will the Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel?

Are resources available within the scientific environment to support electronic information handling? Protections for Human Subjects For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

For additional information on review of the Human Subjects section, please refer to the. Inclusion of Women, Minorities, and Children 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 children to determine if it is justified in terms of the scientific goals and research strategy proposed.

For additional information on review of the Inclusion section, please refer to the. Vertebrate Animals The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the. Review and Selection Process Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NCI, in accordance with, using the stated. Assignment to a Scientific Review Group will be shown in the eRA Commons. As part of the scientific peer review, all applications:.

Sdtm Implementation Guide

May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score. Will receive a written critique. Of initial peer review will not be accepted for applications submitted in response to this FOA. Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Cancer Advisory Board. The following will be considered in making funding decisions:.

Padis Reservations Implementation Guide

Scientific and technical merit of the proposed project as determined by scientific peer review. Availability of funds. Relevance of the proposed project to program priorities. Award Notices If the application is under consideration for funding, NIH will request 'just-in-time' information from the applicant as described in the.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official. Awardees must comply with any funding restrictions described in. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the website. This includes any recent legislation and policy applicable to awards that is highlighted on this website. Administrative and National Policy Requirements All NIH grant and cooperative agreement awards include the as part of the NoA. For these terms of award, see the and. More information is provided.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency.

Please see The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see; and. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at or call 1-800-368-1019 or TDD 1-800-537-7697.

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. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care. In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement, an 'assistance' mechanism (rather than an 'acquisition' mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. Reporting When multiple years are involved, awardees will be required to submit the annually and financial statements as required in the A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at on all subawards over $25,000. See the for additional information on this reporting requirement.