U41 Cooperative Agreement for Resource-Related Research Projects

U41 Cooperative Agreement for Resource-Related Research Projects is sponsored by NIH. Supports the development and operation of resources that are essential to the research community.

Expired PAR-14-191: Genomic Resource Grants for Community Resource Projects (U41) This notice has expired. Check the NIH Guide for active opportunities and notices. Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) National Cancer Institute ( NCI ) Components of Participating National Human Genome Research Institute ( NHGRI ) Funding Opportunity Title Genomic Resource Grants for Community Resource Projects U41 Biotechnology Resource Cooperative Agreements May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018.

See NOT-OD-17-062 . May 8, 2017 - This PAR has been reissued as PAR-17-273 . NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals supersedes instructions in Section III.

3 regarding applications that are essentially the same. May 5, 2014 - Notice of National Cancer Institute (NCI) Participation in PAR 14-191. See Notice NOT-CA-14-034.

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose Genomic research has had substantial impact on biomedical research, in large part because of the open sharing of data (often prior to publication) and resources with the greater research community.

To facilitate genomic research and the dissemination of its products, NHGRI supports resources that are crucial for disease studies, model organism studies, and other biomedical research. Awards under this FOA will support the development and distribution of genomic resources that will be available to and valuable for the broad research community, using cost-effective approaches.

Such resources include (but are not limited to) informatics resources (such as human and model organism databases, ontologies, and coordinated sets of analysis tools), comprehensive identification and collections of genomic features (such as structural variants or functional genomic elements), and standard data types produced for central sets of samples (such as 1000 Genomes or GTEx samples).

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days before the application due date June 30, 2014; September 25, 2014; January 25, 2015; May 25, 2015; September 25, 2015; January 25, 2016; May 25, 2016; September 25, 2016; January 25, 2017 by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s) ** ELECTRONIC APPLICATION SUBMISSION REQUIRED** NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants. gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted.

ASSIST replaces the Grants. gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

Required Application Instructions It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ) and where instructions in the Application Guide are directly related to the Grants. gov downloadable forms currently used with most NIH opportunities.

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 Section IV . 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. Part 1. Overview Information Part 2.

Full Text of the Announcement Section I. Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information I.

Funding Opportunity Description Genomics has had substantial impact on biomedical research, in large part because of the open sharing of data (often prior to publication) and resources with the greater research community.

The widespread availability of genomics resources provides the entire community with comprehensive sets of data and materials of defined and uniform high quality, allows researchers to compare methods and results with the same sets of samples or reagents, allows researchers to use integrated and documented sets of analysis tools and frameworks, allows the integration of multiple data types through use of the same sets of samples or other resources, and promotes the efficient use of funds by not supporting redundant efforts.

NHGRI currently supports a number of genomics resources. Examples include model organism databases (MODs), the Genome Ontology (GO), PhenX, and collections of structural variants. The resource projects that NHGRI has funded share several key characteristics: 1.

They fill a demonstrable need and have a wide impact, well beyond the field of genomics itself. 2. They are comprehensive in scope, covering, for example, the entire genome or all genes of an organism.

3. They make data or materials broadly available to all researchers in a user-friendly manner. 4.

They use established, state-of-the-art, cost-efficient, and robust production methods to generate and distribute high-quality products 5. They are unique, and do not duplicate resources that are otherwise available. Awards under this FOA will support genomic resource projects, either for the continued support of genomic resources of broad value to the research community or for the development of new ones.

A major goal of this FOA is to provide access to these genomic resources by the research community. Generally this will require awardees to actively disseminate the data and resources supported under these awards.

Resources for which applications will be accepted under this FOA include (but are not limited to): Genome informatics resources: A genome informatics resource is a project that collects, curates, integrates, and distributes information related to genes, sequences, phenotypes, and other genetic and genomic information. Awards may support the development, maintenance, and distribution of genomic informatics resources.

Microbial and microbiome databases are generally not appropriate for NHGRI support. Applicants are encouraged to consult Scientific/Research staff about all such resources.

Collections of coordinated tools and frameworks for analysis: NHGRI will support the development and implementation of sets of related analysis tools or frameworks that can be applied to particular types of genomic data, to allow users to work with those data types and integrate them with related data types to provide a deeper understanding of biological phenomena.

The coordination of the analysis tools allows users of all experience levels to use many of the tools together efficiently. Community data standards and ontologies: These resources are needed to describe data in standard ways so that they can be compared and integrated across studies. Awards may be made to support groups to work with the community to develop consensus standards and ontologies that will be widely used by researchers.

Collections of genomic data: NHGRI will support the comprehensive collection, production, and distribution of data about specific genomic features, such as structural variants, functional genomic elements, or protein interactions, and the collection of standard data types in central sets of samples, such as the 1000 Genomes samples or GTEx samples.

The data production approaches should be well established and thus may be considered not innovative enough for regular R01 awards, but should be justified on the basis of the value of the data produced, especially when multiple data types are to be produced on central sample sets. This FOA will support awards for the discovery of comprehensive data about features not currently addressed by existing programs.

When possible, these data should be submitted to central databases such as dbSNP or GEO.

Some existing NHGRI programs, such as ENCODE, the large-scale genome sequencing program, and KOMP, coordinate the collection of data about certain types of features; applications in these areas are not appropriate for this FOA and should be directed to those Collections of samples or other biological materials: Awards may be made for the collection or generation of comprehensive sets such as cell lines, DNA clones, and gene or regulatory region knockout resources for functional analyses.

When possible, the materials generated should be deposited in a standard repository, such as DNA clones in the appropriate clone repository or blood samples in the Coriell Institute for Medical Research. If an appropriate repository is not available, the application should include a plan for continued maintenance and distribution of the materials during the award period and after it ends.

Applications proposing to collect samples restricted to research on particular diseases are more likely to be appropriate for the Institute or Center supporting research on those diseases, rather than NHGRI. Sets of samples that are characterized for many phenotypes are generally not appropriate for NHGRI support; they would need to have unusual general usefulness and strong programmatic need.

Generally, samples or reagents would be supported only if they are part of a well-defined NHGRI program; it is essential to check with program staff.

Competitions or cooperative activities for genomic analysis tools: Such activities may be appropriate if they support analysis goals that are of high programmatic priority, involve many participants, and distribute the results broadly; applicants are encouraged to consult Scientific/Research staff. Awards for support of resources differ from typical research grants.

Many genomic resources, such as data resources, fulfill an ongoing community need and support must be provided as long as that need exists and remains a priority to the community. This means that NHGRI is able to support only a limited number of resources, and that the long-term effects of funding a new resource must be carefully considered. The cost efficiency of the resource is important in consideration for support.

Many of the awards made under this FOA will be for ongoing support of existing resources that continue to have value across the entire biological and biomedical research community. NHGRI’s interest is to meet the community needs, not necessarily to continue support for a specific resource; thus applications are accepted from new providers to meet current needs.

As the choice of which resources to support will be determined in large part by NHGRI-defined programmatic needs, all applicants are strongly encouraged, in the early planning stages of applications, to contact the relevant Scientific/Review staff, who can provide advice about whether the proposed resources address programmatic priorities.

To ensure that the awards continue to meet programmatic needs, NHGRI will use the U41 cooperative agreement mechanism for support of resources. Under this mechanism, program staff will have significant programmatic involvement in the form of assistance and guidance, although the awardees will have primary responsibility for designing the project and doing the work.

Program staff will monitor progress on achieving the aims, particularly how well the resource is meeting the community needs for which it was created. Program staff will work with the awardee on any modifications of the aims as technologies and scientific needs change.

Program staff will also assist the coordination of the work with related resources and Frequently, the resources will integrate other data sets and help develop or use data and metadata standards. Applications for resources that support only particular diseases or other specific biological issues should be directed to the appropriate Institute or Center.

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets are not limited, but should reflect the needs of the proposed project. Applications may request project periods of up to 5 years.

The duration must be justified by the proposed work. Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government Native American Tribal Organizations (other than Federally recognized tribal governments) Non-domestic (non-U.S.) Entities (Foreign Institutions) Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to Foreign components, as defined in the NIH Grants Policy Statement , are allowed. 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 Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - 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. System for Award Management (SAM) (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. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

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 must have an active DUNS number and SAM registration in order to complete the 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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described Grants Policy Statement ), except for submission: To an RFA of an application that was submitted previously as an investigator-initiated application but not paid; Of an investigator-initiated application that was originally submitted to an RFA but not paid; or Of an application with a changed grant activity code.

IV. Application and Submission Information 1. Requesting an Application Package Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.

gov . Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants. gov to NIH.

Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants. gov will also be accepted. Form of Application Submission It is critical that applicants follow the instructions in (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.

gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant 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 Institute staff to estimate the potential review workload and plan the review.

By the date listed in Part 1.

Overview Information , 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 e-mailed to: National Human Genome Research Institute (NHGRI) Types Available in ASSIST Strategy/Program Plan Page Limits Project (use for Resource Project) Core (Use for Resource Informatics or Production Core) Admin Core (Use for Management, Dissemination, and Additional page limits described in the SF424 Application Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components: Resource Project: one required Resource Informatics or Production Core: one required Management, Dissemination, and Training Core: one required When preparing your application in ASSIST, use Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall) PHS 398 Cover Page Supplement (Overall) Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component. Research & Related Other Project Information Follow standard instructions.

Project/Performance Site Location(s) (Overall) summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research & Related Senior/Key Person Profile (Overall) Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall) to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component. Aims: Provide aims that address the overall goals of the project, including all the components (Resource Project; Resource Informatics or Production; Management, Dissemination, and Training).

Strategy: The overview should explain the rationale for the community resource, describe the resource to be generated, document community support for the proposed resource, and explain the anticipated impact of the resource widely across biomedical research. The overview should also include the project's elements, including the technologies that will be used to produce the resource.

Applications proposing to develop new databases, repositories, or other resources should clearly explain why there is a need or why the current resources are not adequate. of Support: Include letters of support from any person or group that is supposed to provide the proposed project with resources, such as materials, data, or software.

Applicants are encouraged to include letters only from those offering specific resources rather than many letters of general support, to avoid unnecessarily limiting the pool of non-conflicted reviewers.

Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, if appropriate for the resources proposed, with the following modifications. These plans should cover all the components of the application, and should be included only in the Overall Component.

All applications, regardless of the amount of direct costs requested for any one year, should provide a Data Sharing Plan. Specific Plan for Sharing Software: A software dissemination plan, with appropriate timelines, is expected in the application.

There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. A dissemination plan guided by the following principles is thought to promote the largest impact: 1.

The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of education, research institutions, and government 2. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software 3.

To preserve utility to the community, the software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling 4. The terms of software availability should include the ability of researchers outside the Center and its collaborating projects to modify the source code and to share modifications with other colleagues as well as with the Center.

An applicant should take responsibility for creating the original and subsequent official versions of a piece of software. 5. Given the long-term goals of this initiative to create software and tools for data science research that will serve as a resource to biomedical researchers across the nation, applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others.

This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. Any software dissemination plans represent a commitment by the institution (and its subcontractors as applicable) to support Appendix: Do not use the Appendix to circumvent page limits.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. When preparing your application in ASSIST, use Component All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Resource Project) Complete only the following fields: Type of Applicant (optional) Descriptive Title of Applicant’s Project Proposed Project Start/Ending Dates PHS 398 Cover Page Supplement (Resource Project) Enter Human Embryonic Stem Cells in each relevant Research & Related Other Project Information (Resource Subjects: Answer only the Are Human Subjects Involved?

and 'Is the Project Exempt from Federal regulations? questions. Animals: Answer only the Are Vertebrate Animals Used?

Narrative: Do not complete . Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Resource Project) List all performance sites that apply to the specific Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Resource In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field. In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component. If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Resource Project) Budget forms appropriate for the specific component will be included in the application package. The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries.

All other SF424 (R&R) PHS 398 Research Plan (Resource Project) to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component. Aims: Provide specific aims for the production of the overall resource. Strategy: The central focus of the project should be the generation of a research resource that is broadly useful.

This component should describe the resource in more detail than the Overview Component, how it will be produced, and how it will be integrated or coordinated with related Complex applications for large awards should include all the elements below. Applications that are less complex will likely require fewer pages and may skip elements below that are not relevant.

The application should include preliminary data that support the technological approach, if appropriate. Renewal applications should include a progress report. Other guidance may apply to some, but not all, types of resource applications: Training about the use of the resource is a common feature of NHGRI community resource awards.

For the types of resources where this would be useful, such as informatics tools and data resources, the application should include information on how training in use of the resource If appropriate, the application may have an applied research component to improve the methods used to develop the resource. (Note that hypothesis-driven R21- or R01-like research is not considered applied research).

This research component may comprise up to 10 percent of the direct costs of the award. The resources that NHGRI will support must represent work in genomics that is broadly applicable to many diseases and research questions. If appropriate, applications may include plans for obtaining additional support and co-funding for the resource.

requirements for informatics community resource projects These projects include human or model organism databases and other informatics resources that involve curation of data from the literature and integration with other genomic or genetic data. Applications for these resources should also address the following issues: 1.

The data types to be included in the resource: The application should present a rationale for including or excluding particular data types (incorporating community priorities), and should provide a plan for adding new data types as they arise.

In addition to the main data types that are the focus of the resource, the resource should also include types of evidence, measures of data quality, descriptions of curation methods and associated metadata, and attribution of data sources, for both experimental and computational data. 2. The curation processes to be used: These should be described and justified.

Processes addressed should include high-quality manual and computational methods as well as extraction of information from the literature. The application should describe the plans to present the curated data and descriptions of the curation process to users. The application should outline the controlled vocabularies that will be used to describe the data.

The application should list the amounts of the various data types to be curated. 3. Any plans to leverage and integrate data from other genomics data resources: The application should explain which resources were chosen and why the data are appropriate for inclusion in the proposed resource.

If data from existing resources that provide similar or overlapping information are included, the application should justify their value and how unnecessary duplication will be avoided. Applications should discuss how the resource will clearly attribute data to other resources. 4.

Any plans to coordinate with related data resources: This may include playing an active role in securing agreement on controlled vocabularies and common data exchange formats where necessary. Applicants should discuss their track record in coordinating with other resources.

Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 The resource sharing plans should be provided only in Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Applications that involve human subjects, such as ones proposing to collect samples from people, must provide a template of the consent form to be used. Consent forms that allow broad sharing of de-identified data are strongly preferred; justification must be provided for projects that propose anything less than broad sharing.

Similarly, any other restrictions on use of the data (such as for the study of particular diseases) must be stated and justified; such conditions lower the general value and thus programmatic interest in these samples Planned Enrollment Report (Resource Project) When conducting clinical research, follow all instructions for completing Planned