Reviewing & ProcessingNational Institutes of Health

Grant Applications on the PHS-398

A Guide For Pre-Award Staff:Research & Sponsored ProgramsUniversity of Wisconsin-Madison

May 31, 2006

Stephanie GrayPreAward Supervisor

Table Of Contents

Understanding the NIH PHS-398 Application Kit: When It’s Used & How It’s Submitted

Processing Practice Differences Between Federal & Non-Federal Pre-Award Sections

Reviewing the T-Form

Reviewing & Processing NIH Applications on the PHS-398 Forms: Current RSP Practices

Coding the NIH Proposal in ESIS

Understanding the NIH PHS-398 Application Kit: When It’s Used & How It’s Submitted

When The PHS-398 is Used

The PHS-398 is required by NIH for submission of New, Revised and Competing Renewal Proposals for the following types of grants:

Research Project Grants (R-series), Career Development Awards (K-series), Program Project Grants (P-series) and Institutional NRSA Training Grants (T-series).

NIH is transitioning to Grants.gov and many of the programs that previously required use of the 398 are now on the SF424R&R. Please be sure the applicant is completing the correct form set by checking the NIH Ramp Up schedule at: http://era.nih.gov/ElectronicReceipt/files/Electronic_receipt_timeline_Ext.pdf

So Many Application Kits, So Little Time… Which NIH Application Should the PI Use?

PHS-398 New, Revised and Competing Renewals of Research

Project Grants (R-series), Program Project Grants (P-series), Career Development Awards (K-series) and Institutional NRSA Training Grants (T-series).

PHS-2590 Non-competing continuations of all the above grant series.

PHS-416-1 New and Revised Individual NRSA Fellowships (F-series)

PHS-416-9 Non-competing continuations of F-series grants.

NIH Grant Vocabulary

Competitive Segment: The initial project period recommended for support (up to 5 years) or each extension of a project period resulting from a competing continuation award that establishes a new competitive segment for the project.

Budget Period: The intervals of time, usually 12 months each, into which a project period is divided for budgetary and funding purposes.

Project Period: The total time for which NIH approves support of a project. The total project period is comprised of the initial competitive segment, any subsequent competitive segment resulting from competing continuation awards, and non-competing extensions.

New Application: A grant application for a new project that has not previously been submitted to NIH for funding consideration.

Revised Application: An application which was previously not funded by NIH and which the PI has revised to address the concerns of peer reviewers. NIH will only accept up to 2 revisions of the same application.

Competing Continuation/Renewal: An application that requests funding of an additional several years for a project that was previously funded for a period of several years by NIH. The renewal application must compete with all other new, revised and competing continuation applications, i.e., it receives no special consideration for funding.

Non-competing Continuation: An application that must be submitted each year within the competitive segment in order to receive the next budget year of funding. This application includes the PI’s annual progress report on the science of the project. This application does not compete with others for funding, since the funding was already committed by NIH at the beginning of the competitive segment.

Competing Supplement: A request by the PI for additional funds to cover unforeseen costs on an existing research grant, usually as a result of some unexpected scientific opportunity.

“R01’s and K08’s and T32’s, Oh My!” So What Do All Those Letters Mean?

NIH uses a variety of funding mechanisms, including: grants, cooperative agreements & contracts.

Grants & Cooperative Agreements are classified by “Activity Codes” that indicate the kind of activity that will be conducted under the project:

The R-series indicates Research Project Grants, e.g., R01, R03, R21.

The P-series indicates Program Project Grants, e.g., P01, P30, P50.

The T-series indicates institutional NRSA training grants.

The K-series indicates career development awards.

The F-series indicates individual NRSA fellowships.The IMPAC Manual contains complete explanations

of all activity codes and other arcane NIH classification codes. It may be found at: http://grants1.nih.gov/grants/funding/funding.htm

Locating the NIH PHS-398 Application Kit

The PHS-398 Face Page with UW-Madison institutional information pre-completed is available on the NIH page of the RSP website at: http://www.rsp.wisc.edu/fednih.html

The NIH Office of Extramural Research (OER) website contains all the NIH grant application forms and instructions at: http://grants1.nih.gov/grants/forms.htm You also can find on the OER website:

NIH Guide for Grants & Contracts containing Notices, PA’s/RFA’s/RFP’s Supplemental Guidelines Policies Peer Review Information

PHS-398 SUBMISSION REQUIREMENTS

Cover Letter from PI (optional) Original, single-sided application

w/RSP signature 5 exact single sided copies (made

after signature of original), DO NOT STAPLE

5 collated sets of appendix materials

PHS-398 Submission Requirements

Mailing Address*: Center for Scientific Review

National Institutes of Health6701 Rockledge Drive, Room 1040-MSC 7710Bethesda, MD 20892-7710

When Shipping Via FedEx and other Express Couriers change the ZipCode to: 20817

Telephone Number is: 301-435-0715*Note: Applications submitted in response to an RFA usually will also require that copies be sent to a specific Program Officer named in the RFA. Be sure to read the mailing instructions in the RFA!

NIH Receipt, Review and Award Cycles

NIH Standard Deadlines: New Research & Research Career Grants,

All Program Project Grants & Center Grants: February 1, June 1, October 1

Competing Continuation and Supplemental Grants, Revised Research & Career Grants: March 1, July 1, November 1

All AIDS-Related Grants: May 1, September 1, January 2

Institutional NRSA Training All Grants: January 10, May 10, September 10

SBIR & STTR: April 1, August 1, December 1

See http://grants.nih.gov/grants/funding/submissionschedule.htm

PHS-398 Submission Requirements to NIH

Postmark Vs. Receipt Date

Unsolicited investigator-initiated new, revised, competing continuation applications may be postmarked before the deadline date or uploaded via Grants.gov by 5pm on the deadline date.

If the deadline falls on a weekend or holiday, the application may be postmarked by the first working day following the weekend or holiday.

Solicited (i.e., in response to an RFA, RFP or PA with a specific deadline date other than the standard NIH deadline dates) applications must be received by the deadline date!

If the deadline falls on a weekend or holiday, the application may be received on the first working day following the weekend or holiday.

PHS-398 APPLICATION KIT REMINDERS

Font: MUST BE Arial, Helvetica, Palatino Linotype or Georgia typeface and a font size of 11 points or larger

Watch page limitations on Research Plan (25 pages for Sections A-D). Submission via grants.gov requires separation of the Research Plan into individual files.

IRB or IACUC approval letters should be attached, if available. If not available, they will be submitted upon NIH request in a just-in-time fashion.

COMPLIANCE ISSUES

INSTITUTIONAL REVIEW BOARD proof of approval required by NIH in a “Just-in-Time” manner prior to issuance of award.

INSTITUTIONAL ANIMAL CARE & USE COMMITTEE proof of approval required by NIH in a “Just-in-Time” manner prior to issuance of award.

OFFICE OF BIOLOGICAL SAFETY, OFFICE OF CHEMICAL SAFETY, OFFICE OF RADIATION SAFETYAuthorized Organizational Official signature (RSP) on application certifies that the project will not be conducted without these approvals in place.

Note: RSP cannot set up an account for any project which involves human, animals, or other biohazards until RSP has been provided proof of approvals!

Current PHS-398 Forms (Rev. 09/04)

Four (4) page Biographical Sketch Biosketch the same for modular and

non-modular submission NO Other Support, until requested NO Personnel Report, until requested Checklist includes space to calculate

F&A for each project year Provisions for SBIR/STTR applications

Biosketch Reminder for the PHS-398

•Biosketch format is identical for modular Biosketch format is identical for modular and non-modular submissionsand non-modular submissions

•Four (4) page limitFour (4) page limit•NOTE: “Positions, Education and NOTE: “Positions, Education and Honors” and “Publications” sections Honors” and “Publications” sections each may not exceed two of the four each may not exceed two of the four page limitpage limit

•Include section on Research Support Include section on Research Support (Ongoing & Completed in the Last 3 (Ongoing & Completed in the Last 3 Years)Years)

NIH Budget Preparation for the “Traditional” Format: DIRECT COSTS

Personnel (Salary & Fringe) Consultant Costs Supplies Equipment*

> $5,000 = equipment < $5,000 = supplies

Travel Patient Care Costs Other Expenses

*Equipment is defined at UW-Madison as an article of tangible nonexpendable personal property that has a useful life of more than 1 year and an acquisition cost of $5,000 or more per unit.

NIH Budget Preparation:Fringe Benefit Rates*

Regular Faculty and Academic Staff  35% Regular Classified 50% Research Associates and Grad Interns 24% Research Assistants, Project Assistants, Teaching Assistants, Pre-Doc Fellows

and/or Trainees  27% Post-Doc Fellows and/or Trainees 12.5% Limited Term Employes (LTE's) 20% Ad Hoc Program Specialists, Undergraduate Assistants and Undergraduate Interns

6% Student Hourly Employee 2%

The rates for Research, Project, and Teaching  Assistants, and Pre and Post-doctoral Fellows and/or Trainees represent the University’s contribution to health insurance only.  All other rates include the University’s contribution to retirement, health and life insurance, social security, unemployment and worker's compensation insurance, and income continuation insurance as appropriate.

*These rates are effective July 1, 2006. For other fiscal periods, please see:

http://www.rsp.wisc.edu/rates.html

Mysteries of A-21: Cost Accounting Standards

Cost Accounting Standards (CAS) Policy EFFECTIVE SEPTEMBER 1, 1994

FOLLOWING COSTS UNALLOWABLE AS Direct Costs, except in justified extraordinary circumstances:

Clerical/Administrative Salaries Postage Office Supplies Local Telephone Service/Equipment Dues/Memberships General Purpose Equipment

UW-Madison largely relies upon the College/School Dean’s offices to review budgets for CAS Exceptions. However, if RSP notices such costs on a budget, it should be pointed out to the PI or C/S. They will need to have adequate justification for the CAS exception on file.

Budget Terminology:Facilities & Administration Costs

DefinitionCosts that are incurred by a grantee

organizationfor common or joint objectives which cannot be identified specifically with a particular project

or program. F&A Rates may be found on RSP’s website

at:http://www.rsp.wisc.edu/rates.html

Variations on a Theme…NIH Modular Grants

NIH modular grant process applies to:

•Research Project Grant: Unsolicited New, Revised,Competing Continuation, Competing Supplements (R01, R03, R15, R21, R41, & R43)

•For applications up to $250,000 direct cost annually or IF SPECIFIED in program announcement or request for applications

What is MODULAR about it?

•Costs requested in “Modules” of $25,000e.g., $125,000, $225,000

•Level funding for life of competitive period:“A typical modular grant application will request the same number of modules in each year.”NOTE: This is not a requirement, but any variation in modules must be justified.

•No detailed categorical budget informationNarrative information for Personnel, and (if applicable) consortium/contractual

Why the MODULAR GRANT?

•Simplify/Improve NIH granting process •Simplify/Improve NIH oversight process•Saves Administrative Effort

-Eliminate pre-award cost analysis-Focus on Science, not cost detail

•Eliminates post-award categorical budget oversight•Oversight based on total cost•Emphasize Program over administration

Preparing the “Modular” NIH Grant Proposal

•No submission of detailed budget•Direct cost totals for each year & grand total (includes any subcontractor direct cost totals)•Subcontractor indirect costs for each year & grand total•Total project direct costs for each year & grand total

•Provide only narrative NIH Modular Grant budget justification:

•Budget justification listing key personnel by position, role, and level of effort (no salaries)•Itemize subcontracts to nearest $1,000

More Variations on a Theme…“Just-in-Time” Instructions for the PHS-398

Just-in-Time concept applies to the R, P & K-series.

Just-in-Time instructions are still occasionally seen in a PA or RFA. Be aware that the special instructions found in the relevant PA or RFA take precedence over the standard instructions in the PHS-398 kit.

Just-in-Time now applies to IRB and IACUC approvals.

T-Form Review:Current RSP Practice

Deadline date (prioritize proposals for processing). Note mailing instructions and number of copies needed for sponsor. Agency name – remember to watch for pass thru sponsors. Dept. name should be typed out under UDDS code. PI eligibility, the following are acceptable:

Tenure Track Permanent PI status

Dean's initials as approval for "Other Appointment" (not required for continuations, supplements, revisions) PI signatures (3 total – which includes page 2 of the t-form). Chair signature (if applicable). Dean's signature. Financial Disclosure – 2nd page of T-form (for Federal applications only) All 3 questions must be answered. Question #1 must be "YES".

Reviewing & Processing NIH Applications on the PHS-398 Forms:

Current RSP Practices

Proposal Check Check Institutional information. Budget

Is F&A rate correct? Some centers have specific F&A rates (Primate Center, WCER)

Is waiver of indirect cost required? Is there cost sharing/matching/Institutional commitment? Modular budgets are allowed on grants less than $250,000

(Research Project Grant Series Only). Ensure that proper agency forms are included. Number of copies of proposal ? (see item 4 of T-Form) Flag each area where signature is required.

Reviewing & Processing NIHApplications on the PHS-398 Forms:

Current RSP Practices

Proposal Data Entry in PALS

Complete PALS Entry.

Record routing number, date and initials on t-form.

A proposal file label will be generated automatically for each new proposal # created.

If proposal is a “revision,” withdraw original application in ESIS (if not already done) and process the revised application in PALS. Clip all previous versions to the back of the revised application.

Reviewing & Processing NIHApplications on the PHS-398 Forms:

Current RSP Practices

Completing the Proposal

Prepare standard cover letter.

All copies of the application, plus one for the RSP file should be signed by RSP Supervisor.

Mail proposal or call contact for pick-up as provided by proposal directions.

Put completed RSP proposal in assigned basket to be matched up with file folder the following day.