5

Additional information

Include a statement in the cover letter if the proposed studies will generate large-scale human or non-human genomic data as detailed in the NIH Genomic Data Sharing Policy (see the NIH Grants Policy Statement, Section 2.3.7.10: NIH Genomic Data Sharing and Section 8.2.3.3: Genomic Data Sharing (GDS) Policy/Policy for Genome-Wide Association Studies (GWAS)). 3.2 Number of Copies Submit the original and two identical, legible, single-sided photocopies of each application. The original must be signed by an Authorized Organization Representative. 3.3 Bindings and Packaging Submit the following materials in one package: cover letter (original only); original application; two copies of the application, made after the original has been signed and not including the cover letter; Appendix materials – two identical CDs of all appendix material in PDF format. PHS 398 12 Do not include more than one application (original plus two copies and appendices) in each mailing envelope. Cover letter. Place the original cover letter at the beginning of the original application. It should not be duplicated. The original application. The original application must be single-sided, with the required signature on the Face Page. Do not staple or otherwise bind the original application. Rubber bands or clips are acceptable. Assemble the pages in the order specified in the table of contents. Two identical, single-sided copies of the original application. Make the copies after an Authorized Organization Representative has signed the Face Page so that the official’s signature is present on the copies. Do not include the cover letter in the copies. Do not staple or otherwise bind the five copies of the original application. Rubber bands or clips are acceptable. Two identical CDs containing all appendix material. When preparing CDs: • Use PDF format. Label each disk with the PD/PI name and application title. If burning CD-ROM disks on a Mac, select the ISO 9660 format. • Do not use compression techniques for the electronic files. • Do not use password protection, encryption, digital signature and/or digital certification in the PDF files. Appendix materials submitted in paper are not accepted and may lead to a delay in the review process. 3.4 Application Mailing Address For applications to NIH, use the mailing label provided at the end of the forms. Send the application to the following address, making sure to use the correct ZIP code: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Suite 1040 MSC 7710 Bethesda, MD 20892-7710 (United States Postal Service (USPS) Express or Regular mail) or Bethesda, MD 20817 (Express/Courier Non-USPS Service) C.O.D. applications will not be accepted. All applications and other deliveries to the Center for Scientific Review must come either via courier delivery (e.g., Federal Express, DHL, UPS) or via the USPS. Applications delivered by individuals to the Center for Scientific Review will not be accepted. For additional information, see the NIH Grants Policy Statement, Section 2.3.9.1 Paper Applications. There may be additional instructions for submission of responses to RFAs; check the FOA for details. For applications to other (non-NIH) PHS agencies, refer to the FOA for submission instructions and mailing addresses. PHS 398 13 Completing the PHS 398 Forms and Format Pages Prepare the application using the PHS 398 MS Word or PDF form pages and format pages as provided at the PHS 398 Grant Application page. • Form pages must be identical to those provided. You may substitute computer-generated facsimiles for government-provided forms; however, they must maintain the exact wording and format of the government forms, including all captions and spacing. Format pages are intended to assist you in the development of specific sections of the application. Alternatively, you may create a page similar to any format provided as long as all the requisite information is included. Shading/colors may not be used in any text portions, including the face page. Font sizes on some PHS 398 form pages vary due to field or space limitations. The PHS 398 Microsoft Word (MS Word) and Portable Document File (PDF) Form Pages as provided are acceptable to NIH. All other sections of the application (e.g., Biographical Sketch; Introduction, if necessary; and the Research Plan) must conform to the font requirements stated in Section 2.6 Format Specifications above. • Some fields on the PDF Form Pages are pre-set to auto calculate. In these cases, a zero will appear until actual data are entered. 4.1 Face Page The first part of the Face Page (Form Page 1) must be printed on a single page. The Face Page must not have any shading or colors. Form Page 1-continued is only for multi-PD/PI applications; if used, it should be printed as a separate page. The information provided on the Face Page of the application and the fiscal information, including the calculation of F&A costs, must be verified by the official signing for the applicant organization. 1. Title of Project Do not exceed 81 characters, including spaces and punctuation. Choose a descriptive title that is specifically appropriate. A new application must have a different title from any other PHS project with the same PD/PI. A Renewal or Resubmission application should normally have the same title as the previous grant or application. If the specific aims of the project have significantly changed, choose a new title. A Revision application must have the same title as the currently funded grant. 2. Response to Specific Request for Applications or Program Announcement or Solicitation Check “Yes” and insert the appropriate announcement number (e.g., PA-16-287) and title of the announcement if the application is submitted in response to an RFA or a PA issued through the NIH Guide for Grants and Contracts. 3. Program Director/Principal Investigator 3a. Name (Last, first, middle) Name the one person responsible to the applicant organization for the scientific and technical direction of the project. PHS staff conduct official business only with the named PD/PI and institutional officials. A Revision application must have the same PD/PI as the currently funded grant. PHS 398 14 When multiple PD/PIs are proposed, use the Face Page-Continued page to provide 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution. All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include his/her respective eRA Commons ID in the eRA Commons User Name field. 3b. Degree(s) Indicate up to three academic and professional degrees or other credentials, such as licenses (e.g., R.N.). 3c. Position Title Provide the academic or professional title of the PD/PI. If more than one title, indicate the one most relevant to the proposed project (e.g., Professor of Biochemistry, Chief of Surgical Service, or Group Leader). 3d. Mailing Address Provide complete information (including room number, building, and street address) necessary for postal delivery. All written communications with the PD/PI will use this address. For electronic mail, enter the appropriate e-mail address (not a website URL). 3e. Department, Service, Laboratory, or Equivalent Indicate organizational affiliation, such as Department of Medicine, Materials Research Laboratory, or Social Sciences Institute. 3f. Major Subdivision Indicate school, college, or other major subdivision, such as medical, dental, engineering, graduate, nursing, or public health. If there is no such subdivision, enter “None.” 3g. Telephone and Fax Provide a daytime telephone number and, if available, a fax number. 3h. eRA Commons User Name The Commons User Name is the ID assigned to and used by the individual to access the eRA Commons. All PD/PIs are required to be registered in the eRA Commons and must provide their Commons User Name. The PD/PI must enter the date of his/her terminal research degree, or end date of medical residency, to receive consideration as an Early Stage Investigator. All data must contain the most recent information in order for the application to be processed accurately. 4. Human Subjects Research No (Human Subjects Involved) Check “No” if activities involving human subjects are not planned at any time during the proposed project period. The remaining parts of “Section 4: Human Subjects Research” are then not applicable. PHS 398 15 Yes (Human Subjects Involved) Check “Yes” if activities involving human subjects are planned at any time during the proposed project period, either at the applicant organization or at any other Project/Performance Site or collaborating institution. Check “Yes” if the research is exempt from HHS regulatory requirements for the protection of human subjects (see the Frequently Asked Questions from Applicants section on Exemptions for more information). If you plan to conduct research involving human subjects, but do not have definite plans at the time of application, you will need to include 6 of the Research Plan. Certification of IRB review and approval must be provided and accepted by the awarding component before the research may occur. An IRB approval date is not required at the time of submission when IRB review is pending. This may be requested later in the pre-award cycle as a Just-In-Time requirement. See the NIH Grants Policy Statement, Section 2.5.1: Just- in-Time Procedures for more information. See the definition of a human subject. To help determine whether research that involves the use of human data or biological specimens is human subjects research, refer to the Research Involving Human Subjects website. Additional information is available at: • OHRP Decision Charts • OHRP Guidance on Repositories • OHRP Memo on Engagement 4a. Research Exempt Check “Yes” if the activities proposed are exempt from the regulations at 45 CFR Part 46. Insert the exemption number(s) corresponding to one or more of the exemption categories listed at the Research Involving Human Subjects website. OHRP guidance states that appropriate use of Exemptions described in 45 CFR 46 should be determined by an authority independent from the investigators (see OHRP’s FAQs on Exempt Research Determination). Institutions often designate their IRB to make this determination. Because NIH does not require IRB approval at the time of application, the exemptions designated in 4a often represent the opinion of the PD/PI, and the justification provided for the exemption by the PD/PI is evaluated during peer review. Proposed research may include more than one research project; thus the application may include individual projects that meet the requirements for non-exempt or exempt human subjects research, or are not defined as human subjects research. Human subjects research should be designated as exempt if all of the proposed research meets the criteria for one or more of the six exemptions. Check “No” if any of the planned activities involving human subjects are not exempt, and complete the remaining parts of 4. 4b. Federal-Wide Assurance No. Enter the approved Federal Wide Assurance (FWA) number that the applicant has on file with the Office for Human Research Protections. Enter the 8-digit number. Do not, enter FWA before. Enter “None” in 4b if the applicant organization does not have an approved FWA on file with OHRP. In this case, the signature on the Face Page is a declaration that the applicant organization will comply with 45 CFR Part 46 and proceed to obtain a FWA (see the OHRP Federalwide Assurance (FWA) for the Protection of Human Subjects page. PHS 398 16 Do not enter the human subjects assurance number of any Project/Performance Site or collaborating institution in the space provided. 4c. Clinical Trial Check “Yes” or “No” to indicate whether the project includes a clinical trial. Refer to the OER glossary’s definition of “clinical trial.” All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals submitted on or after 1/18/2017. See the Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov for more information. 4d. NIH-Defined Phase III Clinical Trial Check “Yes” or “No” to indicate whether the project is an NIH-Defined Phase III Clinical Trial. Refer to the definition of "NIH-Defined Phase III Clinical Trial." 5. Vertebrate Animals Check “No” if activities involving vertebrate animals are not planned at any time during the proposed project period, and leave 5a blank. Note that the generation of custom antibodies constitutes an activity involving vertebrate animals. Check “Yes” if activities involving vertebrate animals are planned at any time during the proposed project period. If animal involvement is anticipated within the period of award but plans are indefinite, check "Yes" and in the Research Plan, Section 5.5: Vertebrate Animals, provide an explanation and indicate when it is anticipated that animals will be used. If an award is made prior to the involvement of animals, the grantee must provide all of the information required by 5.5 (Research Plan, Section 5.5: Vertebrate Animals), and verification of IACUC approval to the awarding component. IACUC approval must have been granted within three years to be valid. NIH does not require verification of review and approval of the proposed research by the IACUC before peer review of the application. However, this information is required under Just-in-Time policy (see NIH Grants Policy Statement, Section 2.5.1: Just-in-Time Procedures). 5a. Animal Welfare Assurance Enter the OLAW approved Animal Welfare Assurance number of the applicant organization in 5a. To determine whether the organization holds an Animal Welfare Assurance, see the lists of Domestic and Foreign Assured institutions. Enter “None” in 5a if the applicant organization does not have an OLAW-approved Animal Welfare Assurance. Do not enter the Animal Welfare Assurance number of any Project/Performance Site or collaborating institution. When an applicant organization does not have an Animal Welfare Assurance, the Authorized Organization Representative’s signature constitutes declaration that the applicant organization will submit an Animal Welfare Assurance when requested by OLAW. 6. Dates of Proposed Period of Support Request no more than 5 years of support, unless specifically authorized in the FOA. Note that some programs specify fewer years. New application. Consult the schedule on the Due Dates page for an appropriate beginning date. Refer to the FOA for beginning dates for PHS agencies other than NIH. Renewal application. Choose a beginning date immediately following the termination date of the current period of support. PHS 398 17 Revision application. Submit a Revision application only for a period within the current period of the active grant. At the time of submission, the Revision request must be within the time period of the original (parent) award period, and any extension must be done before submission. Make the ending date of the Revision’s first budget period coincide with the ending date of the budget period that is to be supplemented, regardless of the Revision’s beginning date. If requesting supplemental funds for the future years of a currently funded grant, make the future years’ budget periods coincide with those of the currently funded grant. Budget Request All amounts requested in 7 and 8 and on the budget pages must be in U.S. dollars. 7. Costs Requested for Initial Budget Period 7a. Direct Costs ($) From Form Page 4, enter the "Subtotal Direct Costs for Initial Budget Period." 7b. Total Costs ($) Enter the sum of: 1) the "Total Direct Costs for Initial Budget Period" from Form Page 4 and 2) the Facilities and Administrative costs for the initial budget period, as calculated on the Checklist Form Page. Note the "Total Direct Costs" used to calculate 7b includes any consortium F&A costs. 8. Costs Requested for Proposed Period of Support 8a. Direct Costs ($) From Form Page 5, enter the sum of "Subtotal Direct Costs" for all years. 8b. Total Costs ($) Enter the sum of: 1) "Total Direct Costs for Entire Proposed Project Period" from Form Page 5; and, 2) the total Facilities and Administrative costs for all years calculated on the Checklist Form Page. Note the "Total Direct Costs" used to calculate 8b includes any consortium F&A costs. Please ensure number(s) complies with application requirements. 9. Applicant Organization Name the one organization that will be legally and financially responsible for the conduct of activities supported by the award. Provide a complete address of that organization. 10. Type of Organization Check the appropriate box. See definitions of Applicant Organization Types in the OER glossary. 11. Entity Identification Number, DUNS Number, Cong. District Entity Identification Number. Enter the 12-digit Entity Identification Number (EIN) assigned to the applicant organization by the Department of Health and Human Services Payment Management System for payment and accounting purposes. This number is an expansion of the 9-digit EIN assigned by the IRS. If the institution has not yet been assigned a number, enter either (1) the organization’s Internal Revenue Service employer identification number (nine digits) or (2) the words “Applied for” to indicate that the organization does not have an EIN but has applied to the local office of the IRS for one. Do not enter the PD/PI's social security number; it is not appropriate for this. PHS 398 18 Data Universal Numbering System (DUNS) number. Enter the DUNS number. Applicant organizations must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual PD/PIs do not need to register for a DUNS number. Congressional District. Enter the number of the Congressional District of the applicant organization. If you do not know the Congressional District: Go to the United States House of Representatives website and search for the Congressional District by entering the ZIP+4. If you do not know the ZIP+4, look it up on the USPS Look Up Zip Code website. 12. Administrative Official to be Notified if Award is Made Name the applicant organization administrative official to be notified if an award is made. Provide a complete address for postal delivery and the telephone, fax, and e-mail address for the administrative official. 13. Official Signing for Applicant Organization Name an individual authorized to act for the applicant organization and to assume the obligations imposed by the Federal laws, requirements, and conditions for a grant or grant application, including the applicable Federal regulations. Provide a complete address for postal delivery and the telephone, fax, and e-mail address for the signing official. 14. Applicant Organization Certification and Acceptance An original signature, in ink, is required. Only an institutional official with formal designated or delegated authority to sign on behalf of the organization may sign the form. The signature must be dated. In signing the application Face Page, the Authorized Organization Representative of the applicant organization certifies that the applicant organization will comply with all applicable policies, assurances and/or certifications referenced in the application. The applicant organization is responsible for verifying its eligibility and the accuracy, validity, and conformity with the most current institutional guidelines of all the administrative, fiscal, and scientific information in the application, including the Facilities and Administrative rate. Deliberate withholding, falsification, or misrepresentation of information could result in administrative actions, such as withdrawal of an application, suspension and/or termination of an award, debarment of individuals, as well as possible criminal penalties. The signer further certifies that the applicant organization will be accountable both for the appropriate use of any funds awarded and for the performance of the grant- supported project or activities resulting from this application. The grantee institution may be liable for the reimbursement of funds associated with any inappropriate or fraudulent conduct of the project activity. Assurances and Certifications The list of assurances, certifications, and other policies that apply to applications submitted to NIH and other PHS agencies is found in the NIH Grants Policy Statement, Section 4: Public Policy Requirements, Objectives and Other Appropriation Mandates. PHS 398 19 4.2 Summary, Relevance, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells FORM PAGE 2 and 2-continued Do NOT insert additional pages between Form Page 1 and Form Page 2. Project Summary and Relevance The first and major section of the 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. The second section of the 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. DO NOT EXCEED THE SPACE PROVIDED. Use text only (no figures or other information not in standard text). Do not include proprietary, confidential information or trade secrets in the description section. If the application is funded, the project description will be entered into an NIH database and will become public information. Project/Performance Site(s) Indicate where the work described in the Research Plan will be conducted. If there are more than two Project/Performance Sites, use the Project/Performance Site Format Page to list all the sites, including Department of Veterans Affairs (VA) facilities and foreign sites. Provide an explanation on the Resources Format Page of the application, and state whether a consortium/contractual arrangement is involved with one or more collaborating organizations for the conduct of a portion of the work described in the Research Plan. One of the sites indicated must be the applicant organization or be identified as off-site in accordance with the conditions of the applicant organization’s negotiated Facilities and Administrative (F&A) agreement. This information must agree with the F&A information provided in the rest of the application. If a Project/Performance Site is engaged in research involving human subjects, the applicant organization is responsible for ensuring that the Project/Performance Site operates under an appropriate Federal Wide Assurance for the protection of human subjects and complies with 45 CFR Part 46 and other NIH human subject related policies described in the PHS 398 and the NIH Grants Policy Statement, Section 4.1.15.1: Federalwide Assurance Requirements. For research involving live vertebrate animals, the applicant organization must ensure that all Project/Performance Sites hold an OLAW-approved Animal Welfare Assurance. If the applicant organization has neither an animal care and use program, facilities to house animals and conduct research on site, nor an IACUC, and the animal work will be conducted at an institution with an Animal Welfare Assurance, the applicant must obtain an Inter-institutional Assurance from OLAW prior to an award. PHS 398 20 Senior/Key Personnel In addition to the PD/PI, Senior/key Personnel are defined as individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries are requested. Typically, these individuals have doctoral or other professional degrees, although individuals at the masters or baccalaureate level should be included if their involvement meets the definition of Senior/key Personnel. Consultants and those with a postdoctoral role should also be included if they meet the same definition. Senior/key Personnel must devote measurable effort (described in person months) to the project, whether or not salaries are requested. "Effort of zero person months” or “as needed” are not acceptable levels of involvement for those designated as Senior/key Personnel. Start with the PD/PI(s). List the PD/PI’s last name first. When multiple PIs are proposed, list the contact PI first, then all additional PIs in alphabetical order. Then list all other Senior/key Personnel in alphabetical order, last name first. For each individual provide name, eRA Commons User Name (if known), organization name (their institutional affiliation), and role on the project. Under role on the project, indicate how the individual will function on the proposed project. Use additional consecutively numbered pages as necessary. Other Significant Contributors This category identifies individuals who have committed to contribute to the scientific development or execution of the project, but are not committing any specified measurable effort (i.e., person months) to the project. These individuals are typically presented at "effort of zero person months” or "as needed." Individuals with measurable effort may not be listed as Other Significant Contributors (OSCs). Consultants should be included if they meet this definition. A biosketch, including Research Support information, will be required for Senior/key Personnel and OSCs, as this highlights their relevant accomplishments. Reviewers use these pages to address the "investigator(s)" review criterion (see Research Project Evaluation Criteria in Section 6. The Peer Review Process). However, if an award is to be made, Other Support information will not be required or accepted for OSCs since considerations of overlap do not apply to these individuals. Should the level of involvement for an individual listed as an OSC increase to measurable effort, he/she must be redesignated as Senior/key Personnel. This change must be made before any compensation is charged to the project. Human Embryonic Stem Cells If the proposed project involves human embryonic stem cells, in this section list the registration number of the specific cell line(s) from the NIH Human Embryonic Stem Cell Registry. Use continuation pages as needed. If a specific line cannot be referenced at the time of application submission, include a statement that one from the registry will be used. 4.3 Research Grant Table of Contents FORM PAGE 3 Provide the page number for each category listed on the Table of Contents. Throughout your application, place page numbers at the bottom of each page, and consecutively number pages. Do not include unnumbered pages, and do not use suffixes, such as 5a, 5b. PHS 398 21 4.4 Budget Instructions FORM PAGE 4 DETAILED BUDGET FOR INITIAL BUDGET PERIOD Each element listed on Form Page 4 must be clearly justified on Form Page 5. List only the direct costs requested in this application. Do not include any items that are treated by the applicant organization as Facilities and Administrative (F&A) costs according to a Federal rate negotiation agreement, except for those F&A costs included in consortium/contractual costs. Applications from foreign organizations must request budgets in U.S. dollars. Foreign organizations may not include any charge-back of customs and import fees, such as consular fees, customs surtax, value-added taxes (VAT) and other related charges. Note: If you are requesting a budget of $500,000 direct costs or more for any year, you must obtain prior approval from Institute/Center staff. This limit is exclusive of any consortium F&A costs. If the subtotal Direct Costs on Form Page 5 equals or exceeds $500,000 in any year, prior approval is required. (See the NIH Grants Policy Statement, Section 2.3.7.2: Acceptance for Review of Unsolicited Applications Requesting $500,000 or More in Direct Costs.) The following items pertain to the completion of Form Page 4 (Detailed Budget for Initial Budget Period – Direct Costs Only). Personnel Name. Starting with the PD/PI(s), list the names of all applicant organization employees who are involved on the project during the initial budget period, regardless of whether a salary is requested. Include all collaborating investigators, individuals in training, and support staff. Role on Project. Identify the role of each individual listed on the project. Describe their specific functions under Justification on Form Page 5. Provide budget narrative for ALL personnel by position, role, and level of effort using person months (calendar, academic and/or summer). This includes any “to-be-appointed” positions. Cal/Acad/Summer Months Devoted to Project. Enter the number of months devoted to the project. Three columns are provided depending on the type of appointment being reflected: academic, calendar, and/or summer months. Individuals may have consecutive appointments within a calendar year, for example for an academic period and a summer period. In this case, each appointment should be identified separately using the corresponding column. If effort does not change throughout the year, use only 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. In cases where no contractual appointment exists with the applicant organization and salary is requested, enter the number of months for the requested period. Institutional Base Salary. An applicant organization may choose to leave this column blank. However, PHS staff will require this information prior to award. See the definition of “Institutional Base Salary.” Salary Requested. 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 individual listed. Some PHS grant programs are currently subject to a legislatively imposed salary limitation. Any adjustment for salary limits will be made at the time of award. For guidance on current salary limits see the Salary Cap Summary on the NIH grants website or contact the organization’s office of sponsored programs. NIH grants also limit the compensation for graduate students. Compensation includes salary or wages, fringe benefits and tuition remission. While actual institutional-based compensation should be PHS 398 22 requested and justified, this may be adjusted at the time of the award. For more guidance on this policy, see NIH Grants Policy Statement, Section 2.3.7.9 Graduate Student Compensation Fringe Benefits. Fringe benefits may be requested in accordance with institutional guidelines for each position, provided the costs are treated consistently by the applicant organization as a direct cost to all sponsors. Totals. Calculate the totals for each position and enter the subtotals in each column where indicated. The applicant organization and its consortium/contractor(s) may omit salaries and fringe benefits for individuals from copies of the application that are available to non-Federal reviewers. In such cases, replace the numbers with asterisks. You must show the subtotals. Provide one copy, for use only by PHS staff, with the asterisks replaced by the salaries and fringe benefits. Special Instructions for Joint University and Department of Veterans Affairs (VA) Appointments Individuals with joint university and VA appointments may request the university’s share of their salary in proportion to the effort devoted to the research project. The individual’s salary with the university determines the base for computing that request. Signature by the institutional official on the application certifies that: (1) the individual is applying as part of a joint appointment specified by a formal Memorandum of Understanding between the university and the VA; and (2) there is no possibility of dual compensation for the same work, or of an actual or apparent conflict of interest regarding such work. Additional information may be requested by the awarding components. Consultant Costs Whether or not costs are involved, provide the names and organizational affiliations of all consultants (see definition of “Consultant”), other than those involved in consortium/contractual arrangements. Include consultant physicians in connection with patient care and persons who are confirmed to serve on external monitoring or advisory committees. Describe the services to be performed on Form Page 5 under “Justification.” Include the number of days of anticipated consultation, the expected rate of compensation, travel, per diem, and other related costs. Equipment List each item of equipment (see definition of “Equipment”) with amount requested separately and justify each purchase on Form Page 5. Supplies Itemize supplies in separate categories, such as glassware, chemicals, radioisotopes, etc. Categories in amounts less than $1,000 do not have to be itemized. If animals are to be purchased, state the species and the number to be used. Travel Itemize travel requests and justify on Form Page 5. Provide the purpose and destination of each trip and the number of individuals for whom funds are requested. Inpatient and Outpatient Care Costs If inpatient and/or outpatient costs are requested for research with human subjects, provide the names of any hospitals and/or clinics and the amounts requested for each on Form Page 5. State whether each hospital or clinic has a currently effective HHS-negotiated research patient care rate agreement and, if not, what basis is used for calculating costs. If an applicant does not have a HHS-negotiated rate, the PHS awarding component can approve a provisional rate. Indicate, in detail, PHS 398 23 the basis for estimating costs in this category, including the number of patient days, estimated cost per day, and cost per test or treatment. If both inpatient and outpatient costs are requested, provide information for each separately. If multiple sites are to be used, provide detailed information by site. Include information regarding projected patient accrual for the project/budget periods and relate this information to the budget request for patient care costs. If patient accrual is anticipated to be lower at the start or during the course of the project, plan budget(s) accordingly. Provide specific information regarding anticipated sources of Other Support for patient care costs, e.g., third party recovery or pharmaceutical companies. Include any potential or expected utilization of