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«Forms Approved Through 08/31/2018 Instructions for PHS 2590 Revised 03/2016 OMB No. 0925-0002 TABLE OF CONTENTS Notable and Upcoming Changes 1. ...»

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Assurances/Certifications Each progress report to the PHS requires that the following policies, assurances, and/or certifications be verified by the signature of the Authorized Organization Representative (AOR) on the Face Page of the progress report. The list of assurances, certifications, and other policies that apply to progress reports submitted to NIH and other PHS agencies is found in Part III of the Supplemental Grant Instructions for All Competing Application and Progress Reports. Applicants and recipients must comply with a number of additional public policy requirements. Contact the institution’s research grant administrative office or refer to the NIH Grants Policy Statement for additional information.

The policies, assurances and certifications listed in Part III may or may not be applicable to certain projects, programs, or types of applicant organizations. If unable to certify compliance, provide an explanation and place it after the All Personnel Report Form Page 7 (4.1.7).

PHS 2590 7

2.2 Detailed Budget for Next Budget Period (Not Applicable to SBIR/STTR Fast-Track Phase II Applications) FORM PAGE 2 Itemize the direct costs requested for the next budget period by budget categories. Use the recommended direct cost shown on the spreadsheet included with the Notice of Award issued in the competitive year as the guide for developing the line item annual budget. Use Form Page 3 and continuation pages as necessary to provide required explanation of budget items.

For multi-project grants where individual projects are budgeted separately, additional copies of Form Page 2 should be prepared for each project or core in the program. Number these pages consecutively.

Do not use suffixes such as 2a, 2b. On the individual budget pages for each specific project, clearly identify the name of the project leader and the title of the project.

Certain conditions may change the funding requirements for a budget period from those originally recommended. Such proposed funding changes, particularly increases over the recommended level, must be explained and fully justified for PHS awarding component consideration.

Name and Role on Project Starting with the PD/PI(s), list all employees of the applicant organization who will be involved on the project for at least one person month or more, regardless of whether or not salaries are requested.

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, identify each appointment 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 devoted to the project period.

If a change in the level of effort for the PD/PI(s) or other Senior/Key Personnel designated on the NoA is proposed from what was approved in the competing year award of this project, a detailed justification must be provided under Section 2.3 Budget Justification.

Salary Requested Regardless of the number of months being devoted to the project, enter the dollar amounts for each position for which funds are requested. The salary requested may not proportionally exceed any imposed salary limitation. Recipients are encouraged to check the NIH Guide for Grants and Contracts for the salary limitation each year (http://grants.nih.gov/grants/policy/salcap_summary.htm).

Fringe Benefits Fringe benefits may be requested in accordance with the 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.

Special Instructions for Individuals with Joint University and Department of Veterans Affairs (V.A.) Appointments PHS 2590 8 Individuals with joint university and V.A. 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 V.A.; 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, other than those involved in consortium/contractual arrangements. Include consultant physicians in connection with patient care and persons who serve on external monitoring boards or advisory committees to the project. Briefly describe on Form Page 3 any changes in services to be performed.





Include the number of days of anticipated consultation, the expected rate of compensation, travel, per diem, and other related costs.

Equipment List separately each item of equipment and justify the purchase on Form Page 3, if not previously approved.

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, strain(s), ages, sex, and the number of animals to be used.

Travel Itemize travel requests and justify on Form Page 3. Provide the purpose and destination of each trip and the number of individuals for whom funds are requested.

Patient Care Costs Indicate the basis for estimating costs in this category in detail, 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, and if multiple sites are to be used, provide the information in detail for each site.

Include information regarding projected patient accrual for the budget period and relate this information to the budget request for patient care costs.

Provide specific information regarding anticipated sources of other support for patient care costs, e.g., third party recovery or pharmaceutical companies. Include potential or expected utilization of General Clinical Research Centers.

Patient care costs do not include travel, lodging, and subsistence or donor/volunteer fees. Request these costs in the Other Expenses category. Request the costs for consultant physician fees in the Consultant Costs category. Patient care costs will be provided to foreign organizations only in exceptional circumstances.

Alterations and Renovation Itemize by category and justify on Form Page 3 the costs of essential alterations and renovations, including repairs, painting, removal or installation of partitions, shielding, or air conditioning. When applicable, indicate the square footage involved, giving the basis for the costs, such as an architect's or contractor's detailed estimate as outlined in the NIH Grants Policy Statement. Line drawings of the proposed alterations should be submitted with the progress report where required by the NIH Grants Policy Statement. Note, costs for any Alterations and Renovations (A&R) were previously unallowable from foreign institutions, international organizations and domestic applications with foreign subawards.

PHS 2590 9 However an HHS policy change now allows for minor A&R ($500,000) on these applications. When requesting minor A&R costs under this policy, provide detailed information on the planned A&R in the budget justification.

Other Expenses Itemize any other expenses by category and unit cost. These might include animal maintenance (unit care costs and number of days), patient travel, donor fees, publication costs, computer charges, rentals and leases, equipment maintenance, service contracts, and tuition remission when budgeted separately from salary/fringe benefits.

Consortium/Contractual Costs Each participating consortium/contractual organization must submit a separate detailed budget (Form Page 2) and budget justification (Form Page 3) for the next budget period. If a new consortium is added, follow the guidelines in the competing application instructions.

List the Facilities and Administrative (F&A) costs, if any, and provide the basis for the rate in the Consortium/Contractual Costs category. Insert the page(s) for each consortium/contractual organization after Form Page 3 and number them consecutively.

The sum of all consortium/contractual costs (direct and F&A) must be entered in the Consortium/Contractual Costs category of the applicant organization's budget.

2.3 Budget Justification (Not Applicable to SBIR/STTR FastTrack Phase II Applications) FORM PAGE 3 Budget Justification Provide detailed justification for those line items and amounts that represent a significant change from previously recommended levels (e.g., total rebudgeting greater than 25 percent of the total award amount for this budget period).

If there has been a significant change in the level of effort devoted to the project from what was approved in the competing year award for the PD/PI or other Senior/Key Personnel designated on the NoA, provide a justification of the reduction for those individuals. (A significant change in level of effort is defined in Federal regulations as a 25 percent reduction in time devoted to the project.) Current Budget Period In the space provided, or on additional pages, explain any estimated unobligated balance of total costs (including prior year funds carried over) that is greater than 25 percent of the current year's total approved budget. Explain why there is a significant balance and how it will be spent if carried forward into the next budget period. The “total approved budget” equals the current fiscal year award authorization plus any carryover of funds from a prior year. The numerator equals the total amount available for carryover and the denominator equals the current year’s total approved budget.

2.4 Biographical Sketch

BIOGRAPHICAL SKETCH FORMAT PAGE

Complete a Biographical Sketch for all new senior/key personnel since the previous submission. Follow the biosketch instructions in the competing application guide.

PHS 2590 10

2.5 Other Support For the purposes of the continuation progress report, other support information is only required on active support for all senior/key personnel. Include other active support for all senior/key personnel whose support has changed and indicate what the change has been. Refer to the competing application instructions, definitions, policy, and format pertaining to other support. Do not include other supporting information for individuals designated as other significant contributors unless their involvement has changed so that they now meet the definition of senior/key personnel.

2.6 Progress Report Summary FORM PAGE 5 Well-planned Progress Reports can be of great value by providing records of accomplishments that serve as a basis for continued support of the project. Furthermore, Progress Reports provide information to awarding component staff that is essential in the assessment of changes in scope or research objectives (as defined in the NIH Grants Policy Statement) from those actually funded. They are also an important information source for the awarding component staff in preparing annual reports, in planning programs, and in communicating scientific accomplishments to the public and to Congress.

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



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