(See NIH Guide Notice NOT-OD-11-010)

Background

What is a multi-year funded (MYF) award?
A multi-year funded (MYF) award is one in which the project period and budget period are the same and are longer than one year, and the award is funded from a single appropriation. A no-cost extension of an existing grant does not constitute multi-year funding. NIH has traditionally used multi-year funding for programs such as:

• C06:Research Facilities Construction Grant
• DP2: NIH Director's New Innovator Award
• DP3: Type 1 Diabetes Targeted Research Award
• R15: AREA

The American Recovery and Reinvestment Act (ARRA) provided opportunities for additional programs to use multi-year funding such as:

• DP4: NIH Director's Pathfinder Award
• KM1: Institutional Career Enhancement Awards (MYF equivalent to K12)
• RC3: Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Program

The following instructions and submission process apply to any NIH multi-year funded program, regardless of the funding source.

Many ARRA Supplements were awarded with budget/project periods greater than 12 months. Are these considered multi-year funded awards that require this separate progress report?
No. The progress report for any ARRA Administrative supplement or competing revision is incorporated into the annual progress report of the parent grant (see NIH NOT-OD-10-066). A separate progress report using these instructions is not required.

Some of the other HHS agencies that use the PHS2590 (e.g., AHRQ) also awarded ARRA grants using multi-year funding authority. Do these instructions and process apply to those grants too?
No. These instructions and submission process are for NIH grants only. Contact the funding agency for specifics about any progress reporting requirements and submission process.

Due Dates, Reporting Period, and How to Submit

When are Progress Reports for MYF awards due?
Progress Reports for MYF awards are due annually on or before the anniversary of the budget/project period start date of the award. NIH will send an email notification to the PD/PI two months before the anniversary of the award requesting that the MYF progress be submitted. These instructions may represent a change from previous instructions (e.g., in the Funding Opportunity Announcement); these instructions supersede any previous instructions.

What is the reporting period for a MYF award progress report?
The reporting period for a MYF progress report is the calendar year preceding the anniversary date of the award. For example, if an award is made on 04/01/2010, the MYF progress report is due on or before 04/01/2011, and should report on the activities performed under the award between 04/01/2010 and 03/31/2011. The subsequent year the MYF progress report would be due 04/01/2012, and should report on the activities performed under the award between 04/01/2011 and 03/31/2012.

How do I submit a progress report for a MYF award?
Once you have completed the instructions below, convert the document to a PDF file format. The PDF must be uploaded through the eRA Commons. To locate the upload site, log in to the eRA Commons and navigate to the Status search page. Select the link “List of Applications/Grants” and locate the grant number. In the “Action” column you will find a hyperlink “ MYPR.” Click the hyperlink to navigate to the Upload Annual Progress Report for Multi-year Funded Award screen. At the Upload Annual Progress Report screen, the PD/PI may route the progress report to the Signing Official (SO) for review, who may submit the progress report to the NIH.

The report must be submitted by a Signing Official (SO), or a PD/PI with delegated authority from the SO to submit a progress report. Information about SO delegation of authority to a PD/PI to submit a progress report appears in the eSNAP User Guide under Section 2. Delegating Authority (http://era.nih.gov/docs/eSNAP_UG_v2.25.0.0_041210.pdf). Note that the eSNAP module is not used for submission of a MYF progress report.

Content of MYF Progress Report*

What information is required in the progress report for a MYF award?
To prepare a MYF progress report, complete the PHS 2590 Form Page 5 - Progress Report Summary, and Form Page 7 - All Personnel Report, following the instructions below. These instructions are excerpted from the non-competing continuation award progress report, PHS 2590 (OMB No. 0925-0001; approved through 6/30/2012). Include, as necessary, other PHS 2590 form pages provided in the table below (e.g., Continuation Page, Targeted/Planned Enrollment Format Page, Inclusion Enrollment Format Page, and Other Support Format Page). Other PHS 2590 forms that do not appear below (e.g., Face page, Project Performance Site, Checklist, etc.) are not required.

Identifying information about the grant (grant number, PD/PI, grantee (applicant) organization, and title of funded project ) should be completed on Form Page 5. The reporting period, as described above, should be entered on the form under “Period Covered by this Report.”

* These instructions should be followed unless the funding IC provides different instructions for the content of the report (e.g., for research facilities construction grant awards).

Post Submission of Progress Report

What will happen after a progress report is submitted?
Upon submission through the eRA Commons, the awarding IC will be notified of the progress report submission via e-mail. The IC Program and Grants Management Officials will review the report and request any additional information as appropriate.

Will there be any communication back to the grantee or PD/PI that the progress report has been accepted?
Not routinely. As noted above, there may be some follow-up communication if additional information is needed. However, unless follow-up is needed for additional information, the progress report is considered complete and accepted.

PHS 2590 Forms and Instructions for MYF Progress Reports - 06/2009 Revision

Complete Form Pages 5 and 7 following the instructions below. As necessary, use the Continuation Page, the Targeted/Planned Enrollment Format Page, Inclusion Enrollment Report Format Page, and the Other Support Format Page. Convert the document to a PDF file before uploading the report in the eRA Commons using the Multi-Year PR link for the award found on the Status screen.

Instructions for Form page 5 - Progress Report Summary

Well-planned Progress Reports can be of great value by providing records of accomplishments that serve as a basis for continued support of the project. Furthermore, Progress Reports provide information to awarding component staff that is essential in the assessment of changes in scope or research objectives (as defined in the NIH Grants Policy Statement) from those actually funded. They are also an important information source for the awarding component staff in preparing annual reports, in planning programs, and in communicating scientific accomplishments to the public and to Congress.

The Progress Report should be a brief presentation of the accomplishments on the research project during the reporting period, in language understandable to a biomedical scientist who may not be a specialist in the project's research field. The style used in Scientific American articles would be appropriate. Abbreviations and language that may not be known to the broader scientific community should be avoided unless clearly defined.

When submitting Progress Reports for program project grants, center grants, education grants, or other large multicomponent grants, contact the program official of the awarding agency for specific instructions.

The entire Progress Report for regular projects, exclusive of the list of publications and the “Inclusion Enrollment Report,” should not exceed two pages. The report should follow the outline and numbering system shown below. Continuation pages may be used as necessary. Tables and figures that summarize key accomplishments are not counted in the two-page limit.

Using the following headings, provide the information requested below:

A. Specific Aims

The aims, as actually funded, may differ in scope from those stated in the original, competing application, because of Scientific Review Group (SRG) and Council recommendations and/or budgetary modifications made by the awarding component. If the aims have not been modified, state this. If they have been modified, give the revised aims and the reason for the modification.

B. Studies and Results

Describe the studies directed toward specific aims during the reporting period and the positive and negative results obtained. If applicable, address any changes to the innovative potential of the project. If technical problems were encountered in carrying out this project, describe how your approach was modified.

Revisions (formerly Supplements): If applicable, include a separate section(s) describing the results obtained by individuals supported on this grant through various revisions. Examples include Research Supplements to Promote Diversity in Health-Related Research, supplements to enhance diversity and Re-entry and/or other similar supplements to support addition of an individual or a discrete project.

C. Significance

Emphasize the significance of the findings to the scientific field and their potential impact on health.

D. Plans

Summarize plans to address the Specific Aims during the next year of the award. Include any important modifications to the original plans.

Human Subjects
If the protocols planned for the coming year are different from those proposed in the previous competing submission, or if a new applicable clinical trial is proposed, include an explanation of how they differ and provide a new or revised Protection of Human Subjects section as described in Part II.3 of the competing application instructions. Include designated headings, as appropriate, for Exempt Human Subjects Research, Non Exempt Human Subjects Research, Clinical Trial, or NIH Defined Phase III Clinical Trial, Data and Safety Monitoring, Inclusion of Women and Minorities, and Inclusion of Children. New protocols or protocol changes will require IRB approval, in accord with the DHHS regulations for protection of human subjects. Provide a protocol only upon request.

If human subject studies planned for the coming year were identified in the Research Plan of the competing application, but were not adequately described because they were planned for a later time within the project period, provide a Protection of the Human Subjects section as instructed in Part II of the competing application instructions.

If studies involving human subjects are planned, and they were not part of the originally proposed research design, provide a Protection of Human Subjects section as instructed in Part II of the competing application instructions, and also provide the following information: whether all of the research is exempt under 45 CFR Part 46, and if so, the exemption number, the Federalwide Assurance number, whether the research is a Clinical Trail and whether the research is an NIH defined Clinical Trial (see definitions in Part III of the competing application instructions).

Public Law 110-85, also known as the Food and Drug Administration Amendments Act (FDAAA) of 2007, mandates registration and results reporting of certain “applicable clinical trials” in ClinicalTrials.gov.

When submitting a progress report for a project that includes applicable clinical trial(s):
If a new applicable clinical trial is proposed -OR- if the progress report includes an applicable clinical trial that is on-going but not yet required to register under FDAAA (e.g. less than 21 days have passed since enrollment of the first subject), the Human Subjects section of the progress report must include a clear statement, under a heading entitled “ClinicalTrials.gov”, that the project includes an applicable clinical trial which will require registration in ClinicalTrials.gov. Applicable clinical trials must be registered in ClinicalTrials.gov no later than 21 days after the first subject is enrolled.

If the progress report includes an applicable clinical trial that is registered in ClinicalTrials.gov, then the Human Subjects section of the progress report must include, under a heading entitled “ClinicalTrials.gov”, the ClinicalTrials.gov registry number (“NCT” followed by an 8-digit number, e.g. NCT00000418), the Brief Title (protocol title intended for the lay public), and the identity (name, organization) of the responsible party and their contact information (e-mail address-required for internal administrative use only).

In submitting the progress report to NIH, the Authorized Organization Representative of the grantee organization certifies that if the research is an applicable clinical trial under Public Law 110-85, the applicant organization will be in compliance with the registration and reporting requirements of Public Law 110-85 (Part III, Section 2.1.6 of the competing application instructions). See the NIH Office of Extramural Research ClinicalTrials.gov web site (http://grants.nih.gov/ClinicalTrials_fdaaa) for additional information.

Women and Minority Inclusion in Clinical Research:
Reporting Data on Inclusion to NIH - If you are conducting clinical research as defined in the application instructions, you must report the cumulative enrollment of subjects and their distribution by sex/gender and ethnicity/race on the Inclusion Enrollment Report, unless otherwise notified by your program official. See detailed instructions and frequently asked questions in http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html.

Reporting data on inclusion is not included in the two-page limit. If there is more than one study, provide a separate table for each study. Information about ethnic/racial subpopulations included in the study should be provided as an attachment to the table.

Changes to Targeted/Planned Enrollment - If there are changes from the Targeted/Planned Enrollment originally approved for funding, you should submit a revised Targeted/Planned Enrollment Table and an Inclusion Enrollment Report describing data collected to-date. Explain the changes in a footnote or attachment to the report. The NIH Policy on Reporting Race and Ethnicity Data for Subjects in Clinical Research is described and referenced in Part II, Section 5.8 of the competing application instructions.

NIH-defined Phase III Clinical Trial:
If you are conducting an NIH-defined Phase III Clinical Trial as defined in Part III of the competing application instructions, you must report on the cumulative enrollment (as described above) and indicate if data analysis has begun for the trial. If analysis has begun, report on progress made in conducting valid analyses for sex/gender and ethnic/racial differences.

Foreign Populations:
If you are conducting clinical research outside of the US, you should design culturally sensitive and appropriate data collection instruments that allow participants to self-identify their ethnic and racial affiliation. These items, however, should be designed in a way that allows the information to be aggregated into the OMB minimally required ethnic and racial categories and complete the Inclusion Enrollment report. When completing the Inclusion Enrollment report, you should add an asterisk and footnote the report to indicate that data is from foreign participants. If your study includes both domestic and foreign participants, we suggest submitting two separate reports - one for domestic data and one for foreign data, with an asterisk and footnote explaining the foreign data.

The enrollment data by race may be lower than the Targeted/Planned enrollment by race because some individuals may designate that they belong to more than one race and will report under "More Than One Race" category. In this case, you may discuss these discrepancies in an attachment to the Inclusion Enrollment report.

Standards for Collecting Data from Study Participants:
When you are planning collection of data on ethnicity and race, as well as sex/gender, you should use the categories listed below to obtain the data from individuals. The collection of greater detail is encouraged, e.g., on ethnic/racial subpopulations; however, any collection that uses more detail shall be organized in such a way that the additional categories can be aggregated into these minimum categories for reporting data on ethnicity and race. Using self-report or self-identification to collect this information, you should use two separate questions, with ethnicity information collected first followed by the option to select more than one racial designation. When reporting these data in the aggregate, you should report:

(a) the number of subjects in each ethnic category;
(b) the number of subjects who selected only one category for each of the five racial categories;
(c) the total number of subjects who selected multiple racial categories reported as the “number selecting more than one race”; and,
(d) the number of subjects in each racial category who are Hispanic or Latino.

NIH is required to use these definitions to allow comparisons to other federal databases, especially the census and national health databases. Federal agencies shall not present data on detailed categories if doing so would compromise data quality or confidentiality standards (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-053.html).

The Inclusion Enrollment Report format is not designed for use as a data collection instrument. You should collect the data using instruments prepared for the study and use the information from the study database to fill out the enrollment report. Study participants who select two or more racial categories should be reported in the aggregate in the "More Than One Race" category.

The Office of Management and Budget (OMB) Directive No. 15 defines minimum standards for maintaining, collecting and presenting data on ethnicity and race for all Federal (including NIH) reporting purposes. The categories in this classification are social-political constructs and should not be interpreted as being anthropological in nature. The standards were revised in 1997 and now include two ethnic categories: Hispanic or Latino, and Not Hispanic or Latino. There are five racial categories: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Other Pacific Islander, and White. Reports of data on ethnicity and race should use these categories. The following definitions apply for the ethnic and racial categories.

Ethnic Categories:

Hispanic or Latino: A person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race. The term, “Spanish origin,” can be used in addition to “Hispanic or Latino”.

Not Hispanic or Latino

Racial Categories:

American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America and maintains tribal affiliation or community.

Asian: A person having origins in any if the original peoples of the Far East, Southern Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam.

Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as “Haitian” or “Negro” can be used in addition to “Black or African American.”

Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands.

White: A person having origins in any of the original peoples of Europe, North Africa, or the Middle East.

Ethnic/racial subpopulations. In addition to the OMB ethnic and racial categories, NIH uses the following definition for ethnic/racial subpopulations: Subpopulations. Each ethnic/racial group contains subpopulations that are delimited by geographic origins, national origins, and/or cultural differences. It is recognized that there are different ways of defining and reporting racial and ethnic subpopulation data. The subpopulation to which an individual is assigned depends on self-reporting of specific origins and/or cultural heritage. Attention to subpopulations also applies to individuals who self identify with more than one ethnicity or race. These ethnic/racial combinations may have biomedical, behavioral, and/or social-cultural implications related to the scientific question under study. (http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm).

Human Subjects Education Requirement:
If there are any new senior/key personnel or other significant contributors involved in the design or conduct of research involving human subjects, provide certification that they have completed an educational program in the protection of human subjects.

Vertebrate Animals:
If vertebrate animals were not involved in the last application but are now to be included, or if significant changes regarding the use of animals are now proposed, provide a description of the intended involvement of animals in accord with the PHS Policy on Humane Care and Use of Laboratory Animals. Examples of changes considered to be significant include, but are not limited to, changing animal species, changing from noninvasive to invasive procedures, new project/performance site(s) where animals will be used, etc. If studies involving live vertebrate animals are planned, and they were not part of the originally proposed research design, you must comply with the requirements of the Research Plan, Item 5.5.10, “Vertebrate Animals,” described in the competing application instructions, and provide the required information. Before activities with live vertebrate animals begin, the applicant must provide a valid Animal Welfare Assurance number and certification of current IACUC approval.

Select Agent Research:
If there are any changes involving use of Select Agents, include an explanation of how research plans differ and provide a new or revised Section 5.5 Select Agent Research of the Research Plan following the competing application instructions, reflecting the changes.

If Select Agent Research planned for the coming year was described in the Research Plan of the competing application, but had not been approved by regulatory authorities, provide the Select Agent Research information requested in the competing application instructions.

If studies involving Select Agents are planned, but were not part of the originally proposed research design, provide Section 5.5 Select Agent Research of the Research Plan following the competing application instructions.

Multiple PD/PI Leadership Plan:
This section is only applicable if Multiple PD/PIs are part of the NIH approved project.

If there has been any change in the governance and/or organizational structure of the Multiple PD/PI Leadership Plan, provide a description, including communication plans and procedures for resolving conflicts, any changes to the administrative, technical, and scientific responsibilities for the PD/PIs.

If the progress report submission includes a change in the contact PD/PI, address this change and the impact, if any, the change has on the administrative, technical, and scientific responsibilities for the PD/PIs.

Human Embryonic Stem Cell Line(s) Used:
This section is only applicable if hESCs are part of the approved project.

If the research involving hESCs planned for the coming year is different from that proposed in the previous submission, including use of a different cell line, include an explanation of how research plans differ, and if different cell lines are to be used, provide the cell line number(s). Only cell lines listed on the NIH hESC Registry as approved for use in NIH funded research may be used.

E. Publications

Report publications resulting directly from this grant that you have not previously reported, including manuscripts submitted or accepted for publication. Provide the complete citation (author(s), title, journal or book, volume, page number, year). If available electronically provide a url or PMCID number. If not available electronically you may provide one copy with the progress report. State if there have been no publications.

For each publication that falls under the Public Access Policy, provide the NIH Manuscript Submission reference number (e.g., NIHMS97531) or the PubMed Central (PMC) reference number (e.g., PMCID234567), at the end of the citation. If the PMCID is not yet available because the Journal submits articles directly to PMC on behalf of their authors, indicate "PMC Journal - In Process." A list of these Journals is posted at: http://publicaccess.nih.gov/submit_process_journals.htm.

A citation management tool “My Bibliography” is now integrated with eRA Commons and allows users to manage their publication citations through their Person Profile. My Bibliography will display the correct text format, and if available, include the appropriate reference number (PMID, PMCID, or NIHMSID). For addition information about “My Bibliography”, see NIH Guide Notice NOT-OD-10-103.

For additional information on compliance with the Public Access Policy see NIH Guide Notice NOT-OD-08-119 and NOT-OD-09-136.

F. Project-Generated Resources

If the research supported by this grant resulted in data, research materials (such as cell lines, DNA probes, animal models), protocols, software, or other information available to be shared with other investigators, describe the resource and how it may be accessed.

If any inventions were conceived or reduced to practice during the course of work under this project during the past year, you must promptly report all inventions as specified in 37 CFR 401.14 and described at http://www.iedison.gov. In this section of the progress report, stated whether any inventions were conceived or reduced to practice and indicate whether this information has or has not been reported to the PHS or to the official responsible for patent matters at the grantee organization.

If the initial research plan included a formal plan for sharing final research data, describe progress in implementing that plan. A final statement on data sharing should be included in the final progress report or earlier, if the plan is implemented prior to closeout.

If the initial research plan included specifics for sharing model organisms, include information on the progress of that plan as well as information on the number of requests received and fulfilled.

If the initial research plan includes Genome Wide Association Studies and a plan to share data with the NIH centralized data repository, describe progress in implementing that plan. A final statement on submitting data to the repository should be included in the final progress report or earlier, if the plan is implemented prior to closeout (see NOTICE OD-08-023 and NOTICE OD-07-088).

G. Changes in Other Support or Effort of Senior/Key Personnel

Indicate whether there has been a change in the active other support for any Senior/Key Personnel. If a previously active grant has terminated and/or if a previously pending grant is not active, submit complete Other Support information using the suggested format and instructions found in the competing application instructions. Annotate this information so it is clear what has changed from the previous submission. Submission of other support information is not necessary if support is pending or for changes in the level of effort for active support reported previously.

Indicate whether, during the next year, if there will be a significant change in the level of effort from what was approved for this project for the PD/PI and any Senior/Key Personnel specifically named in the Notice of Award. A significant change in level of effort is defined in Federal regulations as a 25% reduction in time devoted to the project from what was approved at the time of award. For example, if a NoA specified individual on the project is expected to reduce his/her effort from 4.8 calendar year (CY) months to 3.6 CY months, which represents a 25% reduction in the level of effort, an explanation must be provided.

Instructions for Form page 7 - All Personnel Report

Always list the PD/PI(s). In addition, list all other personnel (salaried and unsalaried) for the current budget period at the applicant organization or elsewhere, who participated in the project during the current budget period for at least one person month or more, regardless of the source of compensation. A person month equals approximately 160 hours or 8.3% of annualized effort. Include the Commons ID (when applicable) names of individuals, all degrees, the last four digits of the Social Security number, role on project, date of birth (MM/YY), and number of person months devoted to the project (indicate academic, calendar, and/or summer).

When requesting the last four digits of the Social Security numbers from personnel, explain that provision of the Social Security number is voluntary, and the information will be used only for program management purposes. The Commons ID is required for all PD/PIs and all individuals with a postdoctoral role; it is optional for all other personnel.

Use the following categories for describing Role on Project:

PD/PI
Co-Investigator
Faculty Collaborator
Staff scientist (doctoral level)
Postdoctoral Scholar, Fellow, or Other Postdoctoral Position
Graduate Research Assistant
Undergraduate Research Assistant
Research Assistant/Coordinator
Technician
Consultant
Other (please specify)

If personnel are supported by a Reentry or Diversity Supplement or American Recovery and Reinvestment Act (ARRA) funding, please indicate such after the Role on Project, using the following abbreviations:

RS - Reentry Supplement
DS - Diversity Supplement
AF - General ARRA Supplement
ASE - ARRA Summer Experience funding.

Individuals designated as “Other Significant Contributors,” (e.g., those that may contribute to the scientific development or execution of the project, but are not committing any specified measurable effort to the project), should not be included in this report unless their involvement has changed so that they are now participating in the project during the current budget period for at least one person month or more.

Grantees should not report personnel if they have submitted a 2271 Appointment form for those individuals (e.g., participants on R25 or R90 awards).

NIH STAFF ONLY