NIH and Grants.gov Manual University of Maryland User Guide

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1 NIH and Grants.gov Manual University of Maryland User Guide This user guide is adapted for use at UM from the complete User Guide offered by Grants.gov. You can use this online document or print it as needed. 1

2 Table of Contents Tips for Submitting to Grants.gov....3 NIH Terminology NIH Formatting Specifics.. 5 Downloading & Installing Adobe Reader Finding Grants using Grants.gov...8 Locating & Downloading Funding Opportunities from NIH.. 9 Completing the Application Package. 12 Cover Page R&R Form.. 15 Attaching Documents Completing other Forms in NIH Application Packages..20 R&R Senior/Key Person Profile. 21 R&R Other Project Information...23 R&R Project/Performance Site Locations PHS 398 Cover Page Supplement PHS 398 Research Plan. 30 PHS 398 Checklist...37 PHS 398 Cover Letter File.. 39 Budget Forms...40 PHS 398 Modular Budget.. 40 R&R Budget..42 R&R Subawards.. 51 Saving the Application...53 Printing the Application..53 Uploading the Application to ORAA..54 Viewing the Application in NIH era Commons

3 General Tips for Submitting Applications via Grants.gov Have the necessary software installed on your machine. 1. Download and install Adobe Reader 9.4 Each machine that will access the application package needs to have this software. 2. Use Internet Explorer, Firefox, Mozilla, or Safari as your Internet browser to download application packages and upload them to ORAA. 3. Enable cookies and pop-ups in your Internet browser when downloading for Grants.gov. 4. Most agencies require attachments to be in PDF format. ORAA and OIT recommend using Adobe Professional to create these PDFs rather than using free converter software that may cause issues. Registration to Submit Applications to Grants.gov 1. An individual researcher does not need to register with CCR and get a DUNS number to have their application submitted to the agency via Grants.gov. The University of Maryland is already registered. 2. Individuals do need to register with NIH Commons if submitting to NIH. Completing the Forms in that Application Package 1. Read the directions for the specific funding announcement for how the agency wants the forms to be completed. The directions for any specific funding announcement take precedence over any general guidelines, including these materials. 2. All forms must be completed in the application package; pre-populated forms can not be added to replace any existing forms. 3. Complete the SF 424 R&R form or the 424 form first as this form will fill in some information in other forms in the package. Saving the Application Package 1. Save the application package onto your machine before beginning to complete it. 2. Save the application package often while working on it as there is no auto-save feature. 3. Do not save the application on a shared drive as this can introduce version control issues. Name Files and the Application Package 1. Do not use space or special characters in naming the application file or any files that are attached to the package. Capital letters and underscores (_) are acceptable to use. 2. ORAA suggests the following convention for naming the application package file: LastName_agencyname_duedate.pdf 3. File names of attachments should follow this convention, unless otherwise stated in the instructions: LastName_OneOrTwoWordDescription.pdf Routing Procedures 1. One hard copy of the proposal must be submitted to ORAA with the completed Routing Form at least 6 business days prior to the deadline. This must contain the final budget, budget justification, abstract, and signed routing form at the minimum. 2. The final electronic copy must be uploaded to ORAA no later than 48 hours prior to the submission deadline. 3. NIH proposals that are submitted electronically must have the hard copy and the electronic copy to ORAA at least 6 business days prior to the deadline.

4 NIH Terminology In an effort to remain consistent with other funding agencies using Grants.gov, NIH has elected to alter some vocabulary commonly seen on applications, in funding announcements, and in application instructions. New Terminology New Resubmission Renewal Continuation Revision FOA (Funding Opportunity Announcement) PI/PD AOR (Authorize Organizational Representative) Current and Pending Support Bibliography and References Cited (located in the R&R Other Project Information form) Subaward Budget Old Terminology New Revision (revised or amended application) Competing Continuation Equivalent to the Progress Report, NIH will not use Grants.gov for the submission of Progress Reports. Equivalent to a Competing Supplement PA and RFA (Program Announcement and Research Funding Announcement) PI AOO and SO (Authorized Organizational Official and Signing Official) Other Support Literature Cited Part G. of the Research Plan Consortium Budget 4

5 NIH Formatting Specifics for Attached Documents Unless specifically stated otherwise in the Program Announcement or Research Funding Announcement, the following formatting guidelines apply to all NIH applications submitted via Grants.gov PDF Attachments: NIH and other PHS agencies require all text attachments to the forms be submitted as PDFs. PDFs may not have security features enabled, nor may then have fillable fields. Font: Use an Arial or Helvetica font in black font color and a font size of 11 points or higher. Type density, including characters and spaces, must be no more than 15 characters per inch. Type may be no more than six lines per inch. A Symbol font may be used to insert Greek letters or special characters but the font size requirements still apply. Page Margins: Use standard paper size 8 ½ x 11. Use at least one-half inch margins (top, bottom, left, right) for all pages. Page Format: Applicants are strongly encouraged to use only a standard, single-column format for the text. Two column formats can cause difficulties for the reviewers viewing the electronic version. Headers/Footers: Do not include any headers or footers, including page numbers, on any of the pages. The system will generate a header that references the name of the PI and a footer that includes the page number. Additionally, a table of contents is not required as this, too, will be system generated. Figures, Graphs, Diagrams, Charts, Tables, Legends, and Footnotes: These may use a smaller typeface, but it must be black in color, use Arial or Helvetica font, and readily legible. Page Limits: Although many of the sections of the application require separate PDF files to be attached to the application file, all page limits must still be followed, and this will be validated. NIH and ORAA recommend completing the Research Plan as one document to determine that the page limits are met. After determining this, then the Research Plan should be separated into the necessary sections and each section individually converted to PDF. The complete Research Plan, together as one document, should be uploaded to ORAA when the final application package is uploaded. 5

6 The following table gives general page and content guidelines. NOTE: Page limits in the PAs and RFAs always take precedence over the limits in the table below. Section Page Limit Content Introduction New Applications Not to be submitted Resubmissions 3 pages See Instructions Revisions 1 page Research Plan Sections pages Text including all figures, charts, tables, and diagrams Biographical Sketches 4 No more than 4 pages for each person listed as Senior/Key Person Appendix None New requirements effective 1/3/2007. Refer to the Funding Opportunity Announcements for the specifications regarding the appendix. Generally, limited publications are allowed now only in certain situations. Only questionnaires and other materials are allowed. Refer to the Funding opportunity announcement. 6

7 Download and Install Adobe Reader 9.4 In order to access and complete applications you will need to download and install the Adobe Reader 9.4, a free program. Adobe Reader 9.4 will need to be set as the default program to open.pdf files. Do not use Adobe Professional, or any other version of Adobe Reader to view, complete or save these applications from Grants.gov unless if ORAA has communicated that updated versions are acceptable. To download the Adobe Reader 9.4: 1. Remove older versions of Adobe Reader from your machine. a. Open the Control Panel under the Start Menu (for PCs) and select Add or Remove Programs. b. Browse through the list of programs and remove prior versions of Adobe Reader. 2. Navigate your web browser to 3. Select your operating system version and language and then click Continue. 4. Follow the instructions on the download page. 5. When given the option to Run or Save the installer, click Save and enter in the location to save the file. 6. Once the file has save to your computer, double click on the icon to begin the installation process. 7. When asked if you would like to make Adobe Reader 9.4 your default application to open.pdf files, select yes. It is very important to make Adobe Reader 9.4 your default application for.pdf files as if Grants.gov Adobe Forms packages are opened with any other version they can become corrupt and will not be accepted by Grants.gov. It is not possible for ORAA to determine if an application has become corrupt until it is submitted to Grants.gov

8 Finding Funding Opportunities in Grants.gov Grants.gov provides you with the ability to search for Federal government-wide grant opportunities and to sign up to receive grant opportunity notifications. To find grant opportunities or to sign up to receive grant opportunity notifications, click the Find Grant Opportunities tab at the top of any screen within Grants.gov. or go to This will take you to the Find Grant Opportunities screen. You can learn how to find grant opportunities in the following sections: Search Grant Opportunities - Grants.gov provides you with the ability to search for Federal government-wide grant opportunities. Four search options are available from the Search Grant Opportunities page; Basic Search, Browse by Category, Browse by Agency and Advanced Search. Receive Grant Opportunity s - Sign up to receive grants announcements from the Federal Grants Opportunities (FGO) site. You can receive grant announcements based on the options listed below: Register to receive all notices for selected notices based on funding opportunity number. Register to receive all notices from selected agencies and categories of funding activities. Register to receive all notices from selected interest and eligibility groups. Register to receive all grants notices. Subscribe to RSS feed You can subscribe to the RSS feed by either category of announcement, or by particular agency and have announcements, and modifications, sent to your RSS reader.

9 Locating and Downloading Funding Opportunities from NIH Since NIH uses multiple CFDA numbers, it is easier to use the NIH OER Home Page to locate Funding Opportunity Announcements. NOTE: For NIH Application Packages go to NIH s Office of Extramural Research Home Page and select Funding Opportunities and Application Packages Then click on the Program Announcement link or the Request for Application link depending on the Funding Opportunity you are looking for. If you are looking for Parent Announcements or unsolicited applications, click on the link provided. If searching for a particular Program Announcement, enter information into the search box. You can sort the columns by clicking on the hyperlink at the top of each one. To sort by Activity Code click on the hyperlink entitled Activity Code(s). Locate the program that you wish to apply for and click on the Announcement number (ex. PA ). Once you open the Announcement, you will see program specific instructions. You are advised to print out this document and follow all program specific instructions. To download the application package from the Announcement, scroll down the page until you see the Program Announcement number again. You will see a button that says Apply for Grant Electronically. 9

10 Clicking on the Apply for Grant Electronically button will take you directly to Grants.gov and the location where you can download the package and instructions for the opportunity. In some cases, there will be more than one application package available for download from Grants.gov, in order to accommodate recent form changes. In that event, you should only download the application package with the highest version number (usually Version B1) will be listed in the Competition ID field. The other application package (without this designation) has expired and is invalid for future submissions. Click on download to access application package and instructions. To receive updates in the event that forms change, fill in your current address and click SUBMIT. To download instructions click on the Download Application Instructions. This takes you to a resource page with information about NIH submissions. To download the most current NIH R&R 424 Application Guide, go to and select the version (GENERAL or SBIR/STTR) of the guide that you need. To download the package, click on Download Application Package. If the application package opens in an Internet Browser window, be sure to save the application package to your hard drive. 10

11 If the application package does not open in an Internet Browser window, it may open directly in Adobe 9.4 Reader or it may be saved to your designated directory. Be sure to rename the application package and save it in a location that you will remember. Directions on saving the application are in the previous section. 11

12 Completing Forms in NIH Application Packages NIH application packages have a number of specific forms, each of which contain specific information that is necessary to complete. Like many other agencies, NIH includes directions for completing these forms. NIH specific instructions can be found in the Funding Opportunity Announcement and in the SF424 R&R Manual, for more general instructions, is available at If the guidelines differ, follow the guidelines contained in the Funding Opportunity Announcement. Some general guidelines regarding attaching documents to NIH Application Packages are: 1. All attachments, other than the R&R SubAward, must be in PDF format. Free PDF converter software should not be used as it may result in some security issues. 2. Font size is limited to size 11 or greater. 3. Allowable font styles are limited. Do not use Times New Roman Font. Arial and Helvetica are acceptable fonts. 4. PDF file names may not contain any spaces, special characters, or hyphens. Capital letters, numbers, and underscores (_) are acceptable. 5. No headers, footers, or page numbers should be included in files attached to NIH Application Packages. NIH will generate headers, footer, page numbers, and a table of contents when the package is received. 6. PDFs should not have any security settings or fillable forms. 12

13 Completing the Cover Page Enter a name for the application in the Application Filing Name field. NOTE: There is 43 character limit for this field. Enter as much of the title as you can. You will be able to enter the entire title on the 424 or the 424 (R&R). You can save your application at any time by clicking the Save button at the top of your screen. The Submit button will not be functional until the application is complete and saved. Only ORAA is authorized to submit the application. Move all of the documents that you need to complete over to the right hand side of the screen. To do this, click the form/document name to select it, and then click the =>> button. This will move the form/document to the Mandatory Completed Documents or Optional Completed Documents box for submission. To remove a form/document from the Completed Documents box, click the form/document name to select it, and then click the <<= button Open and complete all of the documents listed in the Mandatory Documents box and Optional Documents box. The documents listed in the Mandatory Documents box and Optional Documents may be predefined forms, such as SF-424 or SF-424 R&R, or documents that need to be attached, such as a program background statement. 13

14 Mandatory Documents are required for this application. Optional Documents can be used to provide additional support for this application or may be required for specific types of grant activity. Reference the application package instructions for more information regarding Optional Documents. When you open a required form, the fields which must be completed are noted by a *, and on some computers (depending on your settings) highlighted in yellow/red. Optional fields and completed fields are displayed in white. If you enter invalid or incomplete information in a field, you will receive an error message once you have the field. Refer to the application package instructions for details about completing the application and to verify that all required information is included in the application. Be sure to follow the steps below: Complete the 424 or the 424 R&R forms first, as these forms populate some data in other forms. All mandatory fields in all mandatory forms have been completed and moved to the Mandatory Completed Documents for Submission box. The Save button has been clicked after all documents have been moved to the Mandatory Completed Documents for Submission box. All mandatory fields in all optional forms that have been moved to the Optional Completed Documents for Submission box have been completed. 14

15 Completing 424 R&R Form Forms, such as SF-424 and SF-424 R&R, are predefined and will require you to enter information into fields. For specific information on completing the 424 R&R fields, see the NIH Checklist. Note the DUNS number that is entered within the application package must be the same DUNS number registered with the AOR who logins to submit the application. In the case of University of Maryland, the DUNS number is Optional fields and completed fields are displayed in white. However, some fields that are required will also be displayed in white and sometimes do not have an asterisk. Please refer to the instructions to make sure that all required information is completed. You can click any field to enter the necessary information or you can also use the TAB button on your keyboard to move from field to field. If you enter invalid or incomplete information in a field, you will receive an error message upon leaving the field. On the above form, only 5 digits were entered in the Zip Code, but 9 digits are required. 15

16 Once the box has been corrected, it will turn blue. Continue filling out the form using the information from the NIH Checkliest and the Grants.gov FAQ page (both available on the ORAA website under esubmissions-> esystems). Save the file any time by clicking on the Save button at the top of the form. 16

17 APPLICATION FOR FEDERAL ASSISTANCE SF 424 (R&R) 1. * TYPE OF SUBMISSION Pre-application Application Changed/Corrected Application 2. DATE SUBMITTED 3. DATE RECEIVED BY STATE 4. Federal Identifier Applicant Identifier State Application Identifier 5. APPLICANT INFORMATION * Organizational DUNS: * Legal Name: University of Maryland Department: Research Admin & Advancement Division: Research * Street1: 3112 Lee Building Street2: * City: College Park County: Prince George's * State: MD: Maryla Province: * Country: UNITED ST * ZIP / Postal Code: Person to be contacted on matters involving this application Prefix: * First Name: Middle Name: * Last Name: Suffix: Contract Administrator Contract Administrator * Phone Number: Fax Number: oraa@umd.edu 6. * EMPLOYER IDENTIFICATION (EIN) or (TIN): 7. * TYPE OF APPLICANT: H: Public/State Controlled Institution of Higher Education 8. * TYPE OF APPLICATION: New Other (Specify): Small Business Organization Type Resubmission Renewal Continuation Revision Women Owned Socially and Economically Disadvantaged If Revision, mark appropriate box(es). A. Increase Award B. Decrease Award C. Increase Duration D. Decrease Duration E. Other (specify): 9. * NAME OF FEDERAL AGENCY: National Institutes of Health 10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: * Is this application being submitted to other agencies? Yes No What other Agencies? TITLE: 11. * DESCRIPTIVE TITLE OF APPLICANT'S PROJECT: Enter in complete title of application 12. * AREAS AFFECTED BY PROJECT (cities, counties, states, etc.) enter impact area 13. PROPOSED PROJECT: 14. CONGRESSIONAL DISTRICTS OF: * Start Date * Ending Date a. * Applicant b. * Project 02/01/ /31/2012 MD PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION Prefix: * First Name: Middle Name: * Last Name: Suffix: PI's Name PI's Name Position/Title: PI's title as in Commons * Organization Name: University of Maryland Department: Division: * Street1: Street2: * City: College Park County: Prince George's * State: MD: Maryla Province: * Country: UNITED ST * ZIP / Postal Code: * Phone Number: Fax Number: * OMB Number: Expiration Date: 04/30/2008

18 SF 424 (R&R) APPLICATION FOR FEDERAL ASSISTANCE Page ESTIMATED PROJECT FUNDING 17. * IS APPLICATION SUBJECT TO REVIEW BY STATE EXECUTIVE ORDER PROCESS? a. * Total Estimated Project Funding b. * Total Federal & Non-Federal Funds c. * Estimated Program Income a. YES THIS PREAPPLICATION/APPLICATION WAS MADE AVAILABLE TO THE STATE EXECUTIVE ORDER PROCESS FOR REVIEW ON: DATE: b. NO PROGRAM IS NOT COVERED BY E.O ; OR Assistant Director PROGRAM HAS NOT BEEN SELECTED BY STATE FOR REVIEW 18.By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein are true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with any resulting terms if I accept an award. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. (U.S. Code, Title 18, Section 1001) * I agree * The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions. 19. Authorized Representative Prefix: * First Name: Middle Name: * Last Name: Suffix: Assistant Director * Position/Title: Assistant Director * Organization: University of Maryland Department: Research Admin & Advancement Division: Research * Street1: 3112 Lee Building Street2: * City: College Park County: Prince George's * State: MD: Maryla Province: * Country: UNITED ST * ZIP / Postal Code: * Phone Number: Fax Number: * oraa@umd.edu * Signature of Authorized Representative * Date Signed Completed on submission to Grants.gov Completed on submission to Grants.gov 20. Pre-application Add Attachment Delete Attachment View Attachment 21. Attach an additional list of Project Congressional Districts if needed. Add Attachment Delete Attachment View Attachment OMB Number: Expiration Date: 04/30/2008

19 Attaching Documents In addition to forms, application packages may also require that you submit specific documentation, such as a program background statement. NOTE: Some agencies have specific directions for attachments (name of file, type of file, formatting of the document, etc.) Be sure to read the solicitation carefully. NIH requires all documents to be in PDF format. The Pure Edge file will not reject file formats that the agency will not accept. It is very important that you read and follow all agency instructions. Files submitted that are not in the correct format may not be accepted by the agency for review. To open a form that requires you to attach a document, simply click on the form name to select it and click the Open Form button which appears below the appropriate box. When you have completed a form, you will need to move it to the appropriate Completed Documents for Submission box. When you open a form, you will be able to attach documents from your computer to it. Depending on the form, you may be able to attach a PDF, Text Document, Word Document or other type of documents. Consult the application package instructions for details on file type and file naming conventions. Attaching a Document To upload a document, simply click the Add button. This will open an Attachment window. Attachment window Click the Attach button. This will open a Browse window which will allow you to select the document on your computer which you want to upload. Browse window When you have selected the document you want to attach, click the Open button. You will return to the Attach window. Repeat this process until you have attached all of the necessary documents. When you have selected all of the documents you want to include for this requirement, click the Done button. If multiple files are attached to the field, the box next to Attachment will be checked. If only one file is attached, the name of the file will be displayed in the box next to Attachment. 19

20 Deleting a Document To delete a document which you have uploaded, to the form, open the form, click the Delete button. If multiple documents are attached, the Delete Attachment window will open. Delete Attachment window On the Delete Attachment window, select the document or documents which you want to delete and click the Remove button. Click the Done button when you are finished deleting the documents. Once all the attached documents have been removed, the check mark after the attachment will be removed. If there is only one attachment, press the Delete button. The Remove Attachment window will appear. Click Yes to delete or No to return back to the form. The file name will be removed from the display box on the form. Viewing a Document To view a document which you have uploaded, simply click the View button. You must have Internet Explorer selected as your default Internet browser. The attachment will open in an IE window. If only one document was attached the document will open. If multiple documents are attached, the View Attachment window will open. View Attachment window If you have uploaded more than one document you will need to select the document which you want to view and click the Display button. Click the Done button to return back to the form without displaying the attachment. Closing the open document, returns you back to the form. To exit the mandatory documents page, click the Close button. To make changes to an already attached document, you must save the document from the Internet Explorer window and make the changes to the document. Then, you must delete the original from the Pure Edge application and attach the modified document. 20

21 RESEARCH & RELATED Senior/Key Person Profile (Expanded) PROFILE - Project Director/Principal Investigator Prefix * First Name Middle Name * Last Name PI's Name PI's Name Suffix Position/Title: PI's title as in Commons Department: Organization Name: University of Maryland Division: * Street1: Street2: * City: College Park County: Prince George's * State: D: Maryla Province: * Country: UNITED STA * Zip / Postal Code: * Phone Number Fax Number * Credential, e.g., agency login: PI's NIH Commons user ID * Project Role: PD/PI Other Project Role Category: *Attach Biographical Sketch Attach Current & Pending Support Add Attachment Delete Attachment View Attachment Add Attachment Delete Attachment View Attachment PROFILE - Senior/Key Person 1 Prefix * First Name Middle Name * Last Name Suffix Position/Title: Organization Name: Department: Division: * Street1: Street2: * City: County: * State: Province: * Country: UNITED STA * Zip / Postal Code: * Phone Number Fax Number * Credential, e.g., agency login: * Project Role: Other Project Role Category: *Attach Biographical Sketch Add Attachment Delete Attachment View Attachment Attach Current & Pending Support Add Attachment Delete Attachment View Attachment Reset Entry Select to attach additional Senior/Key Person Forms Next Person OMB Number: Expiration Date: 04/30/2008

22 Tips for Completing the Senior/Key Person Profile Form for NIH Applications Much of the information for the PD/PI is automatically populated from the SF 424 R&R form. The Credential, e.g. agency login is the assigned Commons User Name in all capital letters. This field is required for the PD/PI for NIH applications, and applications will not pass agency validations requirements without this field correctly completed. Current and Pending support information is not required at time of application submission, unless specifically required in the FOA. This information may be requested later in the pre-award cycle. Biographical Sketches for NIH are limited to 4 pages per person. NIH will ask for Current and Pending support in a JIT (Just In Time) format if required. To add more individuals, click on the Next Person button. Biographical Sketch Provide a biographical sketch for the PD/PI. Recommended information includes: Education and Training, Research and Professional Experience, Collaborators and Affiliations (for conflicts of interest), Publications and Synergistic Activities. Save the information in a single file. The biographical sketch should follow this format: Use the sample format on the Biographical Sketch Format Page to prepare this section for all (modular and other) grant applications. Include biographical sketches of all Senior/Key Personnel and Other Significant Contributors. The Biographical Sketch may not exceed four pages per person. This 4-page limit includes the table at the top of the first page. If the individual is registered in the era Commons, include the assigned Commons User Name. This data item is currently optional. Complete the educational block at the top of the format page, and complete Sections A, B, and C. A. Positions and Honors. List in chronological order previous positions, concluding with your present position. List any honors. Include present membership on any Federal Government public advisory committee. B. Selected peer-reviewed publications or manuscripts in press (in chronological order). Do not include manuscripts submitted or in preparation. C. Research Support. List both selected ongoing and completed (during the last three years) research projects (Federal or non-federal support). Begin with the projects that are most relevant to the research proposed in this application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs. Current & Pending Support Don t confuse Research Support with Other Support. Though they sound similar, these parts of the application are very different. As part of the biosketch section of the application, Research Support highlights your accomplishments, and those of your colleagues, as scientists. This information will be used by the reviewers in the assessment of each individual s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. In contrast, Other Support information is required for all applications that are selected to receive grant awards. NIH staff will request complete and up-to-date other support information from you after peer review. This information will be used to check that the proposed research has not already been Federally-funded. Unless otherwise required in a specific FOA, do not use this attachment upload for NIH and other PHS agency submissions. This information is no longer required at the time of application submission. This information may be requested later in the pre-award cycle. 22

23 RESEARCH & RELATED Other Project Information 1. * Are Human Subjects Involved? 1.a If YES to Human Subjects Yes No Is the IRB review Pending? IRB Approval Date: Yes No Exemption Number: Human Subject Assurance Number: 2. * Are Vertebrate Animals Used? Yes No 2.a. If YES to Vertebrate Animals Is the IACUC review Pending? IACUC Approval Date: Animal Welfare Assurance Number Yes No 3. * Is proprietary/privileged information included in the application? Yes No 4.a. * Does this project have an actual or potential impact on the environment? 4.b. If yes, please explain: Yes No 4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an environmental assessment (EA) or environmental impact statement (EIS) been performed? 4.d. If yes, please explain: Yes No 5.a. * Does this project involve activities outside the U.S. or partnership with International Collaborators? 5.b. If yes, identify countries: 5.c. Optional Explanation: Yes No 6. * Project Summary/Abstract 7. * Project Narrative 8. Bibliography & References Cited 9. Facilities & Other Resources 10. Equipment Add Attachment Delete Attachment View Attachment Add Attachment Delete Attachment View Attachment Add Attachment Delete Attachment View Attachment Add Attachment Delete Attachment View Attachment Add Attachment Delete Attachment View Attachment 11. Other Attachments Add Attachments Delete Attachments View Attachments OMB Number: Expiration Date: 04/30/2008

24 Tips for completing the Other Project Information Form for NIH Applications Field 1: Are Human Subjects Involved? Field 2: Are Vertebrate Animals Used? Are Human Subjects Involved? Field 1.a.: Is the IRB review Pending? IRB Approval Date Exemption Number Human Subject Assurance Number Are Vertebrate Animals Used? Field 2.a.: If YES to Vertebrate Animals, Is the IACUC review Pending? IACUC Approval Date Animal Welfare Assurance Number If activities involving human subjects are planned at any time during the proposed project at an performance site, check the Yes box. Check this box even if the proposed project is exempt from Regulations for the Protection of Human Subjects. If no activities involving human subjects are planned, check the No box. If the IRB review is pending, check the Yes box, otherwise check the No box. In the IRB Approval Date field, enter the latest approval date if available, leave the date blank if Pending. Applicants should check the Yes box to the question Is the IRB review Pending? even if the IRB process has not begun at the time of submission. Note that an IRB Approval Date is not required at the time of submission. This may be requested later as a Just-In-Time requirement. If human subjects activities are exempt form Federal regulations, provide the exemption numbers corresponding to one or more of the exemption categories. Regulations can be found at cfr46.htm Do not insert the human subjects assurance number of any collaborating institution. The UM assurance number is If activities involving vertebrate animals are planned at any time during the proposed project at any performance site, check the Yes box. If the IACUC review is pending, check the Yes box, otherwise check the No box. In the IACUC Approval Date field, enter the latest approval date if available, leave the date blank if Pending. Applicants should check the Yes box to the question Is the IACUC review Pending? even if the process has not begun at the time of submission. Note that an IACUC Approval Date is not required at the time of submission. This may be requested later as a Just-In-Time requirement. The UM assurance number is A

25 Tips for completing the Other Project Information Form Field 3: Is proprietary/ privileged information included in the application Field 4: Environmental Questions Field 5: Activities Outside US or with International Collaborators Field 6: Project Summary/Abstract Field 7: Project Narrative If the application contains such information, check the Yes box and clearly mark each line or paragraph on the pages containing the proprietary/privileged information with an asterisk (*) and with the legend similar to: The following contains proprietary/privileged information that (name of applicant) requests not be released to persons outside the Government, except for purposed of review and evaluation. Unless a specific FOA indicates that the National Environmental Policy Act (NEPA) applies, applicants should check No. If the applicant organization is a foreign institution or if the project includes a foreign component, the applicants must check yes. The Project Summary must contain a summary of the proposed activity suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate lay reader. This Summary must not include any proprietary/confidential information. The first and major component of the Project Summary/Abstract (i. e., Description ) is a Project Summary. It is meant to serve as a succinct and accurate description of the proposed work when separated from the application. State the application s broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Describe concisely the research design and methods for achieving the stated goals. This section should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate reader. Avoid describing past accomplishments and the use of the first person. Finally, please make every effort to be succinct. This section must be no longer than 30 lines of text, and follow the required font and margin specifications. An abstract which exceeds this allowable length may be flagged as an error by the agency upon submission. This would require a corrective action before the application will be accepted. For NIH and other PHS agencies applications, this attachment will reflect the second component of the Project Summary. The second component of the Project Summary/Abstract (i.e., Description ) is Relevance. Using no more than two or three sentences, describe the relevance of this research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience. A separate Research Plan component is required for NIH applications. 25

26 Tips for completing the Other Project Information Form Field 8: Bibliography & Literature Cited Field 9: Facilities and Other Resources Field 10: Equipment Field 11: Other Attachments Provide a bibliography of any references cited in the Project Narrative. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations. Be especially careful to follow scholarly practices in providing citations for source materials relied upon when preparing any section of the application. Note this section (formerly Literature Cited ) should include any references cited in the PHS 398 Research Plan component. The reference should be limited to relevant and current literature. While there is not a page limitation, it is important to be concise and to select only those literature references pertinent to the proposed research. This information is used to assess the capability of the organizational resources available to perform the effort proposed. Identify the facilities to be used (Laboratory, Animal, Computer, Office, Clinical and Other). If appropriate, indicate their capacities, pertinent capabilities, relative proximity and extent of availability to the project. Describe only those resources that are directly applicable to the proposed work. Provide any information describing the Other Resources available to the project (e.g., machine shop, electronic shop) and the extent to which they would be available to the project. If there are multiple performance sites, then resources available at each site should be described. In describing the scientific environment in which the work will be done, discuss ways in which the proposed studies will benefit from unique features of the scientific environment, or subject populations or employ useful collaborative arrangements. If research involving Select Agent(s) will occur at any performance site(s), the biocontainment resources available at each site should be described. List major items of equipment already available for this project and, if appropriate identify location and pertinent capabilities. Attach a file to provide any other project information not provided above or in accordance with the announcement and/or agency-specific instruction. Reminder: All attachments need to be in PDF format, and must not contain headers, footers, pager numbers, fillable forms, or security features. 26

27 RESEARCH & RELATED Project/Performance Site Location(s) Project/Performance Site Primary Location Organization Name: University of Maryland * Street1: PI's lab/office address * City: Province: County: * Country: UNITED S Street2: * State: * ZIP / Postal Code: Project/Performance Site Location 1 Organization Name: * Street1: Street2: * City: County: * State: Province: * Country: UNITED S * ZIP / Postal Code: Reset Entry Next Site Additional Location(s) Add Attachment Delete Attachment View Attachment OMB Number: Expiration Date: 04/30/2008

28 PHS 398 Cover Page Supplement OMB Number: Expiration Date: 9/30/ Project Director / Principal Investigator (PD/PI) Prefix: Middle Name: * Last Name: PI's Name Suffix: * First Name: PI's Name * New Investigator? No Yes Degrees: 2. Human Subjects Clinical Trial? No Yes * Agency-Defined Phase III Clinical Trial? No Yes 3. Applicant Organization Contact Person to be contacted on matters involving this application Prefix: Middle Name: * Last Name: Contract Administrator Suffix: * First Name: Contract Administrator * Phone Number: Fax Number: oraa@umd.edu * Title: Contract Administrator * Street1: 3112 Lee Building Street2: * City: College Park County: * State: MD: Maryland Province: * Country: UNITED ST * Zip / Postal Code: 20742

29 PHS 398 Cover Page Supplement OMB Number: Expiration Date: 9/30/ Human Embryonic Stem Cells * Does the proposed project involve human embryonic stem cells? No Yes If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list: Or, if a specific stem cell line cannot be referenced at this time, please check the box indicating that one from the registry will be used: Cell Line(s): Specific stem cell line cannot be referenced at this time. One from the registry will be used.

30 PHS 398 Research Plan OMB Number: Expiration Date: 9/30/ Application Type: From SF 424 (R&R) Cover Page and PHS398 Checklist. The responses provided on these pages, regarding the type of application being submitted, are repeated for your reference, as you attach the appropriate sections of the research plan. *Type of Application: New Resubmission Renewal Continuation Revision 2. Research Plan Attachments: Please attach applicable sections of the research plan, below. 1. Introduction to Application Add Attachment Delete Attachment View Attachment (for RESUBMISSION or REVISION only) 2. Specific Aims Add Attachment Delete Attachment View Attachment 3. Background and Significance Add Attachment Delete Attachment View Attachment 4. Preliminary Studies / Progress Report Add Attachment Delete Attachment View Attachment 5. Research Design and Methods Add Attachment Delete Attachment View Attachment 6. Inclusion Enrollment Report Add Attachment Delete Attachment View Attachment 7. Progress Report Publication List Add Attachment Delete Attachment View Attachment Human Subjects Sections Attachments 8-11 apply only when you have answered "yes" to the question "are human subjects involved" on the R&R Other Project Information Form. In this case, attachments 8-11 may be required, and you are encouraged to consult the Application guide instructions and/or the specific Funding Opportunity Announcement to determine which sections must be submitted with this application. 8. Protection of Human Subjects Add Attachment Delete Attachment View Attachment 9. Inclusion of Women and Minorities Add Attachment Delete Attachment View Attachment 10. Targeted/Planned Enrollment Add Attachment Delete Attachment View Attachment 11. Inclusion of Children Add Attachment Delete Attachment View Attachment Other Research Plan Sections 12. Vertebrate Animals Add Attachment Delete Attachment View Attachment 13. Select Agent Research 14. Multiple PI Leadership Plan Add Attachment Delete Attachment View Attachment Add Attachment Delete Attachment View Attachment 15. Consortium/Contractual Arrangements Add Attachment Delete Attachment View Attachment 16. Letters of Support Add Attachment Delete Attachment View Attachment 17. Resource Sharing Plan(s) Add Attachment Delete Attachment View Attachment 18. Appendix Add Attachments Remove Attachments View Attachments

31 Tips for Completing the PHS 398 Research Plan Applications found not to comply with the requirements may be delayed in the review process. Application Type Research Plan Attachments Separate Attachments Page Limitations Inclusion of URLs Notice of Proprietary Information This information is automatically populated form the SF 424 (R&R) Cover Page. Even though there are separate PDF attachments, the total research plan must follow the page limit referenced in the instructions or FOA. NIH will validate that page limits are adhered to, along with checking the other formatting restrictions. Reviewers will review the application as an electronic document. Therefore, applicants are encouraged to use only a standard, singlecolumn format for the text. Full-sized glossary photographs of materials may be included in the Appendix; however, an image of each, which may be in reduced size, must also be included within the page limits of the Research Plan. The separate attachments will allow for increased efficiency in the automatic validations conducted by the NIH era system. The Research Plan sections will be concatenated in the appropriate order so reviewers and agency staff will see a single cohesive Research Plan. When validating for page limits, the era Commons will not count the white space created by breaking the text into separate files for uploading. Do not exceed 25 pages for Items 2 5. Some FOAs will include further limitations. If there are limitations included in the FOA, always follow those limitations. All tables, graphs, figures, diagrams, and charts must be included within the 25-page limit. Be succinct and remember that there is no requirement to use all 25 pages allotted to items 2 5 of the Research Plan. Unless otherwise specified in an NIH solicitation, Internet website addresses may not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that they should not directly access an Internet site as it could compromise their anonymity. Applicants are discouraged from submitting information considered proprietary unless it is deemed essential for proper evaluation of the application. If the information is essential, applicants should mark Yes to question 3 on the Other Project Information page. Then, all pages in the application that contain proprietary information should be marked with an asterisk (*) in the left-hand margin. A legend should be included at the beginning of Section 2, similar to The following sections marked with an asterisk contain proprietary/privileged information that (name of Applicant) requests not be released to persons outside the Government, expect for purposed of review and evaluation. 31

32 Begin each text section of the Research Plan with a section title (e.g., Introduction, specific Aims, Background & Significance, etc). The page length guidelines assume that the FOA states that the research plan may be up to 25 pages. Review your FOA to the required page limit for your application. 1. Introduction to Application (for Resubmission or Revision only) Use only if you are submitting an R&R Resubmission or Revision. The Introduction may not exceed 1-3 pages for resubmissions or one page for revisions. Page limits for the Introduction vary for specialized mechanisms. Applicants must follow the page limits that are outlined in the specific announcement. 2. Specific Aims List the broad, long-term objectives and the goal of the specific research proposed, for example, to test a stated hypothesis, create a novel design, solve a specific problem, challenge an existing paradigm or clinical practice, address a critical barrier to progress in the field, or develop new technology. One page is recommended. 3. Background and Significance 4. Preliminary Studies/Progress Report Briefly sketch the background leading to the present application, critically evaluate existing knowledge, and specifically identify the gaps that the project is intended to fill. State concisely the importance and health relevance of the research described in this application by relating the specific aims to the broad, long-term objectives. If the aims of the application are achieved, state how scientific knowledge or clinical practice will be advanced. Describe the effect of these studies on the concepts, methods, technologies, treatments, services or preventative interventions that drive this field. Two to three pages are recommended. Preliminary Studies. For new applications, use this section to provide an account of the PD/PI s preliminary studies pertinent to this application, including his/her preliminary experience with and outreach to the proposed racial/ethnic group members. This information will also help to establish the experience and competence of the investigator to pursue the proposed project. Except for Exploratory/Development Grants (R21/R33), Small Research Grants (R03), and Phase I Small Business Research Grants (R41/R43), peer review committees generally view preliminary data as an essential part of a research grant application. Preliminary data often aid the reviewers in assessing the likelihood of the success of the proposed project. Progress Report for Renewal (previously known as Competing Continuation) and Revision (previously known as Supplemental) Applications. A Progress Report must be provided for renewal and revision applications. Provide the beginning and ending dates for the period covered since the project was last reviewed competitively. Summarize the previous application s specific aims and the importance of the findings. Provide a succinct account of published and unpublished results, indicating progress toward their achievement. Discuss any changes in the specific aims as a result of budget reductions. A list of publications, manuscripts accepted for publication, patents, and other printed materials will be included in Section 7; do not include that information here. Six to eight pages are recommended for the narrative portion of this section. 32

33 5. Research Design and Methods 6. Inclusion Enrollment Report 7. Progress Report Publication List Describe the research design conceptual or clinical framework, procedures, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 17, include how the data will be collected, analyzed, and interpreted as well as the data-sharing plan as appropriate. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project. Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised. Although no specific number of pages is recommended for the Research Design and Methods section, be as succinct as possible. There is no requirement that all 25 pages allotted for items 2-5 be used. If the renewal or revision application involves clinical research, then you must report on the enrollment of research subjects and their distribution by ethnicity/race and sex/gender. More detail can be found in the NIH SF 424 (R&R) Application Guide. List the titles and complete references to all appropriate publications, manuscripts accepted for publication, patents, and other printed materials that have resulted from the project since it was last reviewed competitively. For publicly available citations, URLs or PMC submission identification numbers may accompany the full reference. Note copies of these publications are no longer accepted as appendix material. As part of the Appendix material you may include only up to 3 of the following types of publications: Manuscripts and/or abstracts accepted for publication but not yet published: The entire article should be submitted as a PDF attachment. Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available: The entire article should be submitted as a PDF attachment. Patents directly relevant to the project: The entire document should be submitted as a PDF attachment. (Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.) Note, publications and/or abstracts in press should no longer be included in the appendix material. Include the URL or PMC submission identification numbers along with the full reference in the Bibliography and References cited section, the Progress Report Publication List section, and/or the Biographical Sketch section. 33

34 8. Protection of Human Subjects This section covers only the initial information regarding the Protection of Human Subjects. Refer to the SF 424 (R&R) Application Guide for more detailed instructions. See separate sections below for other human subjects related sections that may apply. 9. Inclusion of Women and Minorities To determine if Inclusion of Women and Minorities applies to this application, refer to the SF 424 (R&R) Application Guide. 10. Targeted/Planned Enrollment Table If this application involves the Inclusion of Women and Minorities, complete the Targeted/Planned Enrollment Table. 11. Inclusion of Children To determine if Inclusion of Children applies to this application, refer to the SF 424 (R&R) Application Guide. 12. Vertebrate Animals If you indicated that Vertebrate Animals are involved in this project, address the following five key points. In addition, when research involving vertebrate animals will take place at collaborating site(s) or other performance site(s), provide this information before discussing the five points. Although no specific page limitation applies to this section of the application, be succinct. Refer to the SF 424 (R&R) Application Guide for more detailed instructions. For those applicants familiar with the PHS398, please note that the Literature Cited section of the Research Plan is now captured as Bibliography & References Cited. Refer to Item 8 in the Other Project Information Component for instructions. 13. Select Agents If any of the activities proposed in your application involve the use of Select Agents at any time during the proposed project period, either at the applicant organization or at any other performance site, address the following three points for each site at which Select Agent research will take place. Although no specific page limitation applies to this section, be succinct. Refer to the SF 424 (R&R) Application Guide for more detailed instructions. 14. Multiple PD/PI Leadership Plan For applications designating multiple PDs/PIs, a leadership plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Grant Award. 34

35 15. Consortium/Contractual Arrangements Explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee. The signature of the authorized organizational official on the SF424 (R&R) cover component (Item 18) signifies that the applicant and all proposed consortium participants understand and agree to the following statement: The appropriate programmatic and administrative personnel of each organization involved in this grant application are aware of the agency s consortium agreement policy and are prepared to establish the necessary inter-organizational agreement(s) consistent with that policy. A separate statement is no longer required. 16. Letters of Support Attach appropriate letters here from all individuals confirming their roles in the project and rate/charge for consulting services. 17. Resource Sharing Plan(s) This section includes Data Sharing Plan, when applicable, and Sharing Model Organisms. 1) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Specific funding opportunity announcements may also require that all applications include this information regardless of the dollar level. (2) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are to include a description of a specific plan for sharing and distributing unique model organism research resources or state appropriate reasons why such sharing is restricted or not possible. Note unlike the data sharing requirement above, this requirement is for all applications where the development of model organisms is anticipated. 35

36 18. Appendix Only one copy of appendix material is necessary. Use filenames for these attachments that are descriptive of the content. Use the add attachments button to the right of this field to complete this entry. A maximum of 10 PDF attachments is allowed. If more than 10 are needed, combine the remaining information into attachment #10. A summary sheet listing all of the items included in the appendix is encouraged, but not required. When including a summary sheet, it should be included as the first appendix attachment. New, resubmission, renewal, and revision applications may include the following materials in the Appendix: Publications No longer allowed as appendix materials except in the circumstances noted below. Applicants may submit up to 3 of the following types of publications: o o Manuscripts and/or abstracts accepted for publication but not yet published: The entire article should be submitted as a PDF attachment. Manuscripts and/or abstracts published, but a free, online, publicly available journal link is not available: The entire article should be submitted as a PDF attachment. o Patents directly relevant to the project: The entire document should be submitted as a PDF attachment. Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication. Note, publications and/or abstracts in press should no longer be included in the appendix material. Include the URL or PMC submission identification numbers along with the full reference in the Bibliography and References cited section, the Progress Report Publication List section, and/or the Biographical Sketch section. Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. Photographs or color images of gels, micrographs, etc., are no longer accepted as Appendix material. These images must be included in the Research Plan PDF. However, images embedded in publications are allowed. For materials that cannot be submitted electronically or materials that cannot be converted to PDF format (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Administrator for instructions following notification of assignment of the application to a study section. Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application. Do not use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe these limitations will be withdrawn from review. These Appendix limitations may not apply to specialized grant applications. Request and follow the additional instructions for those applications. Specific appendix requirements may also be listed in a specific funding opportunity announcement. The Appendix will be sent only to certain members of the Scientific Review Group who will serve as the primary reviewers of the application. 36

37 OMB Number Expiration Date: 9/30/ * Program Income Is program income anticipated during the periods for which the grant support is requested? Yes No If you checked "yes" above (indicating that program income is anticipated), then use the format below to reflect the amount and source(s). Otherwise, leave this section blank. *Budget Period *Anticipated Amount ($) *Source(s) 5. Assurances/Certifications (see instructions) In agreeing to the assurances/certification section 18 on the SF424 (R&R) form, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the agency's application guide, when applicable. Descriptions of individual assurances/certifications are provided at: If unable to certify compliance, where applicable, provide an explanation and attach below. Explanation: Add Attachment Delete Attachment View Attachment

38 PHS 398 Cover Letter OMB Number: Expiration Date: 9/30/2007 *Mandatory Cover Letter Filename: Add Cover Letter File Delete Cover Letter File View Cover Letter File

39 Completing the Budget Forms Grants.gov has several different budget format pages that agencies may choose to include in their application. Applicants must complete the budget that is included in the package. The notable exception is that NIH includes two budget forms in their packages. Applicants must read the Instructions to determine which budget form is required. Modular Budget Guidelines: Modular budgets are applicable to certain research grant applications requesting $250,000 or less per year in direct costs. Consortium/contractual F&A costs are not factored into the direct cost limit. Consortium F&A costs may be requested in addition to the $250,000 limit. Modular budgets are simplified; therefore, detailed categorical information is not to be submitted with the application. The modular budget is applicable only to R01, R03, R15, R21, and R34 submissions. The fields are the same for budget periods 1 through 5, the instructions following the diagram can be used to complete each. Start Date for Period 1 is populated from the SF424R&R form. 40

40 Tips for Completing the PHS 398 Modular Budget Budget Period Start Date Enter the requested/proposed start date of the budget period using MM/DD/YYYY format. End Date Enter the requested/proposed end date of the budget period using MM/DD/YYYY format. A. Direct Costs Direct Costs Enter the amount of the direct costs, less the actual consortium F&A costs for this less budget period. This figure must be in $25,000 increments, and it may not exceed Consortium $250,000. F&A Consortium If this project involves a consortium, enter the actual consortium F&A costs for F&A Total Direct Costs this budget period. If this project does not involve a consortium, leave blank. This field auto-calculates. Requested Cognizant agency Indirect Cost Rate Agreement Date Total Indirect Costs B. Indirect Costs Indirect Cost Indicate the type of base: for example, Salary & Wages, Modified Total Direct Type Costs (MTDC), Other (with explanation), and indicate if the project is off-site. Indirect Cost Indicate the most recent Indirect Cost (F&A) rate established with the cognizant Rate Federal Office. If the project takes place on-campus use UM s MTDC rate of 50%. Indirect Cost Enter in the amount of the base for each indirect cost type. Base Funds Enter in the funds requested for each indirect cost type, this field does not autocalculate. Enter in the name of agency, name, and phone of the individual responsible for negotiating your rate. DHHS Office of Audit, Region III 150 South Independence Mall West, Suite 316 Philadelphia, PA Brian Caudill (202) If you have a negotiated rate agreement, enter in the agreement date. Currently, this is 03/02/2007. The total funds requested for indirect costs. This field auto-calculates. C. Total Direct and Indirect Costs Funds The total funds requested, this field auto-calculates. Requested 41

41 PHS 398 Modular Budget, Cumulative All values for Cumulative Budget Information 1. Total Costs, Entire Project are calculated automatically from the completed Budget Periods 1 5. If any of the amounts displayed in this section of the form appear incorrect, you may correct it by adjusting one or more of the vales that contributed to that total. To make such adjustments, you will need to revisit the appropriate budget period form(s) to enter the correct value. Modular Budget Justifications Personnel Justification List all personnel, including names, number of person months devoted to the project (indicate academic, calendar, and/or summer) and roles on the project. Do not provide salary information. Since the modules should be a reasonable estimate of costs allowable, allocable, and appropriate for the proposed project, you must use the current legislatively imposed salary limitation when estimating the number of modules. Contact your Contract Administrator for guidance on current salary limitations. Consortium Justification Provide an estimate of total costs (direct plus indirect) for each year, rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, along with all personnel, including percent effort and roles on the project. Do not provide individual salary information. Indicate whether the collaborating institution is foreign or domestic. While only the direct cost for a consortium/contractual arrangement is factored into eligibility for using the modular budget format, the total consortium/contractual costs must be included in the overall requested modular direct cost amount. Additional Narrative Justification If the requested budget requires any additional justification, such as variations in the number of modules requested, add the attachment to this section. R&R Budget The Research and Related Budget is made of Sections A K, which is spread over 3 pages in Pure Edge File. For each budget period, all sections A K must be completed individually. Section K, the budget justification, allows for a file to be attached to the form. Attach one budget justification file here, this justification should cover the entire life of the budget. The R&R Budget requires effort to be expressed in person months, either calendar, academic or summer. To convert percent effort to person months, use the interactive conversion table that is accessible from Tips for completing the R&R Budget may be found after the sample pages. 42

42 RESEARCH & RELATED BUDGET - SECTION A & B, BUDGET PERIOD 1 * ORGANIZATIONAL DUNS: * Budget Type: Project Enter name of Organization: Subaward/Consortium University of Maryland Reset Entries * Start Date: 02/01/2009 * End Date: Budget Period: (If the Reset Entries button is pressed, please navigate to previous year to enable the submission of the form.) A. Senior/Key Person Prefix * First Name Middle Name * Last Name Suffix PI's Name PI's Name PD/PI * Project Role Base Salary ($) Cal. Months Acad. Months Sum. Months * Requested Salary ($) * Fringe Benefits ($) * Funds Requested ($) 9. Total Funds requested for all Senior Key Persons in the attached file Total Senior/Key Person Additional Senior Key Persons: Add Attachment Delete Attachment View Attachment B. Other Personnel * Number of Personnel * Project Role Cal. Months Acad. Months Sum. Months * Requested Salary ($) * Fringe Benefits ($) * Funds Requested ($) Post Doctoral Associates Graduate Students Undergraduate Students Secretarial/Clerical Total Number Other Personnel Total Other Personnel Total Salary, Wages and Fringe Benefits (A+B) RESEARCH & RELATED Budget {A-B} (Funds Requested) OMB Number: Expiration Date: 04/30/2008

43 * ORGANIZATIONAL DUNS: RESEARCH & RELATED BUDGET - SECTION C, D, & E, BUDGET PERIOD 1 * Budget Type: Project Enter name of Organization: Subaward/Consortium University of Maryland Reset Entries * Start Date: 02/01/2009 * End Date: Budget Period: 1 (If the Reset Entries button is pressed, please navigate to previous year to enable the submission of the C. Equipment Description List items and dollar amount for each item exceeding $5,000 Equipment item * Funds Requested ($) Total funds requested for all equipment listed in the attached file Total Equipment Additional Equipment: Add Attachment Delete Attachment View Attachment D. Travel Funds Requested ($) Domestic Travel Costs ( Incl. Canada, Mexico and U.S. Possessions) Foreign Travel Costs Total Travel Cost E. Participant/Trainee Support Costs Funds Requested ($) Tuition/Fees/Health Insurance Stipends Travel Subsistence Other Number of Participants/Trainees Total Participant/Trainee Support Costs RESEARCH & RELATED Budget {C-E} (Funds Requested) OMB Number: Expiration Date: 04/30/2008

44 RESEARCH & RELATED BUDGET - SECTION F-K, BUDGET PERIOD 1 Next Period * ORGANIZATIONAL DUNS: * Budget Type: Project Enter name of Organization: Subaward/Consortium University of Maryland Reset Entries * Start Date: 02/01/2009 * End Date: Budget Period: 1 (If the Reset Entries button is pressed, please navigate to previous year to enable the submission of the F. Other Direct Costs Funds Requested ($) Materials and Supplies Publication Costs Consultant Services ADP/Computer Services Subawards/Consortium/Contractual Costs Equipment or Facility Rental/User Fees Alterations and Renovations Total Other Direct Costs G. Direct Costs Total Direct Costs (A thru F) Funds Requested ($) H. Indirect Costs Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) * Funds Requested ($) Total Indirect Costs Cognizant Federal Agency (Agency Name, POC Name, and POC Phone Number) I. Total Direct and Indirect Costs Total Direct and Indirect Institutional Costs (G + H) Funds Requested ($) J. Fee Funds Requested ($) K. * Budget Justification (Only attach one file.) Add Attachment Delete Attachment View Attachment RESEARCH & RELATED Budget {F-K} (Funds Requested) OMB Number: Expiration Date: 04/30/2008

45 Tips for Completing the R&R budget Budget Type Enter name of Organization Start Date End Date Budget Period A. Senior/Key Person Prefix, First Name, Middle Name, Last Name, and Suffix Project Role Base Salary Cal. Months Months of effort may be listed as partial months, with up to two decimal places. Acad. Months Months of effort may be listed as partial months, with up to two decimal places. Sum. Months Months of effort may be listed as partial months, with up to two decimal places. Check the appropriate block. Check Project if the budget requested is for the primary applicant organization. Check Subaward/Consortium if the budget requested is for subawardee/consortium organization(s). Note: Separate budgets are required only for subawardee/consortium organizations that perform a substantive portion of the project. If creating a Subaward Budget, use the R&R Subaward Budget Attachment and attach as a separate file on the R&R Budget Attachment(s) form. Pre-populated from the R&R SF424. Enter the name of your organization. Enter the requested/proposed start date of each budget period. Use the following format: MM/DD/YYYY. Enter the requested/proposed end date of each budget period. Use the following format: MM/DD/YYYY. Identify the specific budget period (for example, 1, 2, 3, 4, 5). If submitting through Grants.gov, the system will automatically generate a cumulative budget for the total project period. Enter in the information for each Senior/Key Person. Only the first and last name are required. Enter the project role of the Senior/Key person. This field could also include such roles as Co-PD/PI, Postdoctoral Associates, and Other Professionals. The first individual is always the PD/PI indicated on the SF (424) R&R, this information is automatically populated. Enter the annual compensation paid by the employer for each Senior/Key person. This includes all activities such as research, teaching, patient care, or other. You may choose to leave this column blank, and the PHS staff will request this information prior to award. Enter the number of months devoted to the project for each Senior/Key person (for example, calendar, academic, summer). If effort does not change throughout the year, use the calendar months column. If effort varies between academic and summer months, leave the calendar months column blank and use only the academic and summer months columns. Enter the number of months devoted to the project for each Senior/Key person (for example, calendar, academic, summer). If your institution does not use a 9-month academic year, indicate your institution s definition of academic year in the budget justification. Enter the number of months devoted to the project for each Senior/Key person (for example, calendar, academic, summer). If your institution does not use a 3-month summer period, indicate your institution s definition of summer in the budget justification. 46

46 A. Senior Key Person Continued Requested Salary Fringe Benefits Funds Requested Total Funds requested for all Senior Key Persons in the attached file Total Senior/Key Person Additional Senior Key Persons Regardless of the number of months being devoted to the project, indicate only the amount of salary being requested for this budget period for each Senior/Key person. Enter applicable fringe benefits, if any, for each Senior/Key person. Enter the requested salary and fringe benefits for each Senior/Key person. Enter the total funds requested for all Senior/Key persons listed in the attached file. The total funds requested for all Senior/Key persons. If funds are requested for more than eight Senior/Key persons, include all pertinent budget information and attach as a file here. Enter the total funds requested for all additional senior/key persons in line 9 of Section A. Use the same format as the budget component and include all required information. B. Other Personnel Number of Personnel For each project role category identify the number of personnel proposed. Note, for Secretarial/Clerical Personnel, in most circumstances the salaries of administrative or clerical staff at educational institutions and nonprofit organizations are included as part of indirect costs. The circumstances for requiring direct charging of these services must be clearly described in the budget justification. For all Postdoctoral Associates and Graduate Students not already named in Section A. Senior/Key Person, individually list names, roles (e.g., PostDoc or Graduate Student), associated months, and salary & fringe benefits requested in the Budget Justification. Project Role If Project Role is other than Post Doctoral Associates, Graduate Students, Undergraduate Students, or Secretarial/Clerical, enter the appropriate project role (for example, Engineer, IT Professional, etc.) in the blanks. Do not include consultants in this section. Consultants are included below in Section F. Other Direct Costs. For the remaining fields refer to instructions provided in the Senior/Key Person section To navigate to the next page (Sections C through E), click the Next button at the top of the form. 47

47 C. Equipment Description Equipment item Funds Requested Total funds requested for all equipment listed in the attached file Total Equipment Additional Equipment Equipment is defined as an item of property that has an acquisition cost of $5,000 or more and an expected service life of more than one year. List each item of equipment separately and justify each in the budget justification section. Enter the estimated cost of each item of equipment including shipping and any maintenance costs and agreements. Dollar amount for item should exceed $5000. Enter the total funds requested for all equipment listed in the attached file. Total Funds requested for all equipment. If the space provided cannot accommodate all the equipment proposed, attach a file by clicking Add Attachment. List each additional item and the funds requested. For all additional items in the attached file, list the total funds requested on line 11 of this section. D. Travel Domestic Travel Costs (Incl. Canada, Mexico, and US Possessions) Foreign Travel Costs Total Travel Cost Enter the total funds requested for domestic travel. Domestic travel includes Canada, Mexico, and US possessions. In the budget justification section, include the purpose, destination, dates of travel (if known), and number of individuals for each trip. If the dates of travel are not known, specify estimated length of trip. Enter the total funds requested for foreign travel. Foreign travel includes any travel outside of North America and/or US possessions. In the budget justification section, include the purpose, destination, dates of travel (if known) and number of individuals for each trip. If the dates of travel are not known, specify estimated length of trip. The total funds requested for all travel. E. Participant/Trainee Support Costs Unless specifically stated otherwise in an announcement, NIH and other PHS agencies applicants should leave blank Section E. Note: Tuition remission for graduate students should continue to be included in Section F. Other Direct Costs when applicable. 48

48 F. Other Direct Costs 1. Materials and Supplies Enter the total funds requested for materials and supplies. In the budget justification, indicate general categories such as glassware, chemicals, animal costs, including an amount for each category. Categories less than $1,000 do not have to be itemized. 2. Publication Costs Enter the total publication funds requested. In the budget justification, include supporting information. 3. Consultant Services Enter the total costs for all consultant services. In the budget justification, identify each consultant, the services he or she will perform, total number of days, travel costs, and the total estimated costs. 4. ADP/Computer Services Enter total funds requested for ADP/computer services. In the budget justification, include the established computer service rates at the proposing organization if applicable. 5. Subawards/Consortium/ Contractual Costs 6. Equipment or Facility Rental/User Fees 7. Alterations and Renovations Enter the total funds requested for 1) all subaward/consortium organization(s) proposed for the project and 2) any other contractual costs proposed for the project. Enter the total funds requested for equipment or facility rental/use fees. In the budget justification, identify each rental user fee and justify. Enter the total funds requested for alterations and renovations. In the budget justification, itemize by category and justify the costs of alterations and renovations including repairs, painting, removal or installation of partitions, shielding, or air conditioning. Where applicable, provide the square footage and costs Other Add text to describe any other direct costs not requested above. Use the budget justification to further itemize and justify. Use lines 8-10 for such costs as patient care and tuition remission. If requesting patient care costs, request inpatient and outpatient costs separately using lines 8 and 9. If line space is an issue, combine all remaining other direct costs together on the last line and include details in the budget justification (description and funds requested). Total Other Direct Costs The total funds requested for all other direct costs. G. Total Direct Costs (A through F) The total funds requested for all direct costs. 49

49 H. Indirect Costs Indirect Cost Type Indirect Cost Rate Indirect Cost Base Funds Requested Total Indirect Costs Cognizant Federal Agency Indicate the type of cost for example: Salary & Wages, Modified Total Direct Costs, or Other (explain). Also indicate if Off-site. Use the budget justification if additional space is needed. Indicate the most recent indirect cost rate established with the cognizant Federal office, or in the case of for-profit organizations, the rate(s) established with the appropriate agency. If this field does not allow a figure greater than 100% to be entered, use two lines to show the entire calculation. This field should be entered using a rate such as 50. Enter the amount of the base for each indirect cost type. Enter the funds requested for each indirect cost type. The total funds requested for indirect costs. Enter in the name of agency, name, and phone of the individual responsible for negotiating your rate. DHHS Office of Audit, Region III 150 South Independence Mall West, Suite 316 Philadelphia, PA Brian Caudill (202) I. Total Direct and Indirect Institutional Costs (G + H) The total funds requested for direct and indirect costs. J. Fee Generally, a fee is not allowed on a grant or cooperative agreement. Do not include a fee in your budget, unless the program announcement specifically allows the inclusion of a fee (for example, NIH s SBIR/STTR). If a fee is allowable, enter the requested fee. K. Budget Justification Use the budget justification to provide the additional information requested in each budget category identified above and any other information you wish to submit to support your budget request. Note this is a single justification for all budget years so include all justification information for all years in the same file. Click Add Attachment to attach the file. Use this section to also list the names, role (e.g., PostDoc or Graduate Student), associated months, salary and fringe benefits for all Postdoctoral Associates and Graduate Students included in Budget Section B. Other Personnel. If the application includes a subaward/consortium budget, a separate budget justification is submitted for that budget. See the next section about Subaward/Consortium budgets. Completing Budget Periods 2-5 If funds are being requested for more than one budget period, you must complete a separate detailed budget for each year of support requested. To navigate to screens for the next budget period, click the Next Period button at the top of the 3 rd budget screen (Sections F through K). You must complete all the required information (i.e., those fields that are highlighted and noted with an * ) before the Next Period button is activated. If no funds are requested for a required field, enter 0. Note that the Budget Justification is also a required item and must be attached before the Next Period button is activated. 50

50 Preparing Applications with a Subaward/Consortium A complete subaward/consortium budget component (including the budget justification section) should be completed by each consortium grantee organization. Separate budgets are required only for subawardee/consortium organizations that perform a substantive portion of the project. Note that a complete subaward/consortium budget component is only required when the prime grantee is submitting a detailed budget using the R&R Budget Component. Do not use this subaward/consortium budget component for applications using the PHS398 Modular Budget Component. To start the process, the applicant organization should: Select the Subaward Budget Attachment Form from the Optional Documents in the Grant Application Package. Open the form, and click the Click here to extract the R&R Subaward Budget Attachment button in the middle of the form. Save the file using the first 10 letters of the consortium organization s name as the file name and leave.xfd as the file extension. (The extracted file is a PureEdge document.) the form to the consortium grantee. Note: consortium grantees must have installed the PureEdge Viewer before they can complete the form. The consortium grantee should 51

51 complete all the budget information as instructed in the R&R Budget component instructions. Note: Organizational DUNS and Name of Organization fields must reflect that of the subaward/consortium grantee. The consortium grantee must complete the budget component and it back to the applicant organization. Return to the Subaward Budget Attachment Form and attach the consortium grantee s budget to one of the blocks provided on the form. Do not convert this attachment to PDF. Only text attachments must be converted to PDFs. Attachments generated from PureEdge forms, such as the R&R SubAward Budget Attachment Form, should not be converted to PDFs. Instructions for the subaward process can be found at: grantsgov_docs/424rr_subaward_budget_form_instruction.pdf. 52

52 Saving Your Application To save your application, simply click the Save button at the top of your screen. Do not save your application to a shared drive as it may cause some technical difficulties. If it necessary that have the application on a shared drive, save the application on your hard drive, then copy the saved application to the shared drive. When opening an application that has been saved to a shared drive, first copy the application to your hard drive, then open the application. Printing Your Application To print your application, simply click the Print button at the top of your screen on the face page of the grant application. NOTE: There are some real issues with printing-especially budget pages and Key Personnel pages. Go to the Budget form and print each page. It is recommended that you print your application to a PDF, and then remove all of the pages of the nonsense fields before printing a hard copy. All attachments will need to be printed individually from either in the program that created them, or by selecting View Attachment, and then selecting print in the popup window. Finalizing Your Application You can save your application at any time by clicking the Save button at the top of your screen. Once you have properly completed and saved the application, you need to upload it to ORAA s upload site at 53

53 Uploading Application File to ORAA 1. Save and close your application file. Name the file PIlastname_agency_duedate_final.xfd 2. Open Internet Explorer, Firefox, Mozilla or Safari and locate ORAA s upload website. Do not use Netscape Enter your Directory username and password. Click the LOG IN button. If you are unsure what these are, then click on the links provided on the page to locate that information. 4. Required fields are marked by an asterisk. To upload your application, go to File 1 and click the BROWSE button. A window appears. Locate the file on your computer and click on it and then click on the word OPEN. This will attach the file in the FILE 1 area. 5. For NIH applications, upload the entire Research Plan document as a Word (.doc) file into filed There is a comment box that you can type in information for ORAA if you wish. Click the SUBMIT button. 7. You will then get a confirmation message stating that the file has been successfully uploaded. Click on the LOGOUT button. An is automatically sent to ORAA staff notifying them that a file has been uploaded. 54

54 Viewing Submitted Applications in NIH era Commons Once you have received the from NIH stating that application is ready for you to view go to NIH era Commons at and log in with your user name and password. From the top tool bar, select Status.

55 In the Status Window, select the Recent/Pending esubmissions link. This will bring up your list of recent submissions, including the application that was just submitted by ORAA. Select the Application ID link to view the application and any errors or warnings. GRANT Title of Proposal PI Name

56 Any errors or warnings will be displayed on the top of the page. Errors will need to be addressed and ORAA will need to resubmit the applications. Warnings may or may not need to be addressed. Contact the ORAA era team member for further information. To view the complete application, select the e-application link. This will allow you to open or save the application in PDF format. This is the version the reviewers will access. Review the PDF of the application, paying special attention that all diagrams and figures appear correctly. If there are any issues, contact the ORAA era team member who sent you the submission confirmation . Any errors or warnings will appear here. Contact the ORAA era team member who sent your the submission confirmation with and questions.

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