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eRA Assembly of the SF424 _R_R_ Application _Forms Version 2 _ 2a_

VIEWS: 3 PAGES: 10

									                                                                                       NIH SF424(R&R) application guide
                                                 NIH SF424 (R&R)
                                  http://grants2.nih.gov/grants/funding/424/#inst
                                                    User Guide
                                   Applicable to R01, R03, and R21 Parent Applications

This user guide is intended to facilitate SF424 (R&R) applications to NIH submitted through Grants.gov. The SF424
(R&R) application has replaced the PHS 398 used for paper applications.
Presented in the table on page 2 are:
     the ―Grant Image‖, which corresponds to each component of the application;
     a cross-reference for the Grant Image to the relevant section in the SF424 (R&R) instructions;
     applicability of the component to the R01, R03, and/or R21;
     Additional information or considerations - key points you must or should attend to assure that the application is
        transmitted without errors to the NIH Commons as well as links to formats/additional information.
     A check box to indicate the need for PDF files and a space for file name; this may be particularly helpful in noting
        Senior/Key personnel who must also be listed in the budget.

In addition to being familiar with the SF424 (R&R), principal investigators are responsible for the reading specific Funding
Opportunity Announcements and complying with any deviations from the SF424 (R&R) instructions.

Suggestions to improve the usefulness of this tool are most welcomed, and should be directed to Trish Lowney at plow-
ney@syr.edu.
Terminology
New application – No change from 398
Resubmission – Formerly amended application
Renewal – formerly competing continuation

New Application Deadlines
http://grants.nih.gov/grants/guide/notice-files/not-od-07-001.html

Parent R03
Parent Funding Opportunity Announcement (FOA): http://grants.nih.gov/grants/guide/pa-files/PA-06-180.html
  Not accepted by All Centers/Institutes (C/Is). Check Parent FOA; some C/Is have their own FOA or use the R03 for
   specific purposes.
  Budget format: Modular grant
  Budget Limits: $100,000 direct costs over a two-year period, no more than $50,000 in direct costs in any single year.
  Not renewable
PURE EDGE DOCUMENT (SU Information entered): http://osp.syr.edu/files/Parent_R03_SU_OSP.xfd

Parent R21
Parent FOA: http://grants2.nih.gov/grants/guide/pa-files/PA-06-242.html
  Not accepted by All Centers/Institutes. Check Parent FOA; some C/Is have their own FOA
  Budget format: Modular grant
  Budget Limits: $275,000 direct costs over a two-year period, no more than $200,000 in direct costs in any single
   year.
  Not renewable
PURE EDGE DOCUMENT (SU Information entered): http://osp.syr.edu/files/Parent_R21_SU_OSP.xfd

Parent R01
Parent FOA: http://grants.nih.gov/grants/guide/pa-files/PA-07-070.html
  Budget format: Modular grant for budgets ≤ $250,000 direct costs, regular budget > $250,000 direct costs
  Budget Limits: C/I approval generally required for direct costs ≥ $500,000 in any year.
PURE EDGE DOCUMENT (SU Information entered): http://osp.syr.edu/files/Parent_R01_SU_OSP.xfd
                                                                                                               Revised: 2/2/07
                                                                                              NIH SF424(R&R) application guide




                         Applica-    Section
                          ble to:     in 424   Additional Information or considerations
Grant Image Order
                         R01, R21,     R&R        PDF attachment required or needed; check if included
                          or R03       app.
                                               Relevant data for items in Cover Component
                                               Item 5. Applicant Institution: Syracuse University
                                                        Person Contacted: your OSP Research Administrator
SF 424 R&R Face
                         R01, R21,             Item 6. Employer TIN: 1150532081A1
   Page (Page 1 and                   § 4.2
   Page 2)
                          & R03                Item 12: enter ―N/A‖
                                               Item 14. Congressional Districts: NY-025
                                               Item 15. SUFFIX. Do not use to record degrees
                                               Item 17. Check ―No, program not covered by EO 12372‖
                         Normally
Pre-Application                       § 4.2    Item 20. in the SF424 (R&R) Cover Component
                         not used.
Project Congressional    R01, R21,             Item 21. Add additional districts if necessary.
                                      § 4.2,
   District               & R03                    PDF File Name: _____________________________
                         R01, R21,
Table of Contents                     § 4.2    System-generated
                          & R03
Research & Related
                         R01, R21,
  Project/Performanc                  § 4.3    Self-explanatory
                          & R03
  e Site Locations(s)
                         R01, R21,             Required if more than 8 locations needed,
Additional Locations                  § 4.3
                          & R03                   PDF File Name: _____________________________
Research & Related
                         R01, R21,             Item 1a. Human Subject Assurance Number: 00007077
  Other Project In-                   § 4.4
                          & R03                Item 2a Animal Welfare Assurance Number: A3687-01
  formation
                                               Item 6: Limited to 30 lines of text following required font & margin specifica-
                                                   tions. Succinct and accurate description of the proposed work. State broad,
Project Sum-             R01, R21,                 long-term objectives and specific aims, making reference to health relatedness of
                                      § 4.4
   mary/Abstract          & R03                    the project. Concisely describe the research design and methods to achieve
                                                   goals. Use language for scientifically literate reader.
                                                  Mandatory PDF Attachment; File Name: :_____________________________
Public Health Relev-
                                               Item 7 using no more than 2 or 3 sentences, describe the relevance of the research
   ance Statement        R01, R21,
                                      § 4.4        to public health. Use general, lay language.
   (Narrative attach-     & R03
                                                   Mandatory PDF Attachment; File Name: :_____________________________
   ment)
                                               Item 8. Provide complete reference i.e., all authors in sequence appearing in publica-
Bibliography & Refer-    R01, R21,                 tion; article and journal title; book title; volume number; page numbers; and year
                                      § 4.4
   ences Cited            & R03                    of publication; URL or PMC submission identification numbers can be included.
                                                  Mandatory PDF Attachment: File Name: :_____________________________
                                               Item 9. Identify laboratory, animal, computer, office, clinical and other facilities availa-
                                                   ble and directly applicable to the proposed work. Indicate their capacities, perti-
                                                   nent capabilities, relative proximity and extent of availability to project. If there
Facilities & Other Re-   R01, R21,                 are multiple sites, then resources at each should be described. Discuss ways in
                                      § 4.4
   sources                & R03                    which proposed studies will benefit from unique features of scientific environ-
                                                   ment, subject populations etc. If involving select agents, describe biocontainment
                                                   resources.
                                                  Mandatory PDF Attachment: File Name: :_____________________________
                                               Item 10. List major items of equipment already available, and identify location and
                         R01, R21,
Equipment                             § 4.4         pertinent capability.
                          & R03
                                                   If applicable PDF Attachment: File Name: :_____________________________
                         R01, R21,             Item 11. Provide any other files required by solicitation.
Other Attachments                     § 4.4
                          & R03                    If applicable PDF Attachment: File Name: :_____________________________




                                                                                                                          Revised: 2/2/07
                            Applica-    Section
                             ble to:     in 424   Additional Information or considerations
Grant Image Order
                            R01, R21,     R&R        PDF attachment required or needed; check if included
                             or R03       app.
                                                  Senior/key personnel: all individuals who contribute in a substantive, measurable
                                                      way to the scientific development or execution of the project, whether or not sala-
                                                      ries are requested. Consultants should be included if they meet this definition.
Research & Related                                Other Significant Contributors (OSC): individuals who contribute in a substantive,
  Senior/Key Person                                   measurable way to the scientific development or execution of the project but are
  or                                                  not committing any specified effort.
Research & Related                                Credential, e.g. agency log in: Commons User name
  Senior/Key Person                               Project Role: Select from List.
  (Expanded)                                                If multiple PIs, ALL must use PI role.
                            R01, R21,                       NOTE: NIH does not recognize the co-PI role, even though it appears in the
                                         § 4.5
**If ―Expanded‖ not          & R03                              drop down list.
     used, limit is 8 and                          After PD/PI, add remaining Senior/Key Person Profiles in alphabetical order
     additional Key Per-                           Add OSCs after all Key Persons. NOTE: if more than 40 Senior/key person
     sons and their bi-                               profiles are proposed, enter the information in a separate file.
     osketches added                               Format for profiles: http://grants.nih.gov/grants/funding/424/index.htm
     as PDF attach-                                Page I-68 (version 2) When submitting > 8, attach additional senior/key person
     ments                                            forms to …Expanded, Additional Senior/Key person form attachment. Select the
                                                      ―Select to extract the R&R additional senior/key person form‖ button. Save the
                                                      file using a descriptive name and use the ―*.xfd‖ extension. Without *.xfd, you
                                                      can’t open file in Pure Edge later. Do not convert this form to PDF.
                                                  All individuals included as a Senior/Key Person must have an NIH biosketch.
                                                   Biosketch may not exceed 4 pages per individual.
                                                   Include eRA commons user name when available (mandatory for all PDs/PIs).
                                                        A. Positions should be in chronological order.
                                                        B. Selected peer-reviewed publications should be presented in chronological
Biographical Sketches
                            R01, R21,                        order.
   for each listed Se-                   § 4.5
                             & R03                      C. Research Support. List both selected ongoing and completed (last 3 yrs) re-
   nior/Key Person
                                                             search (fed and non-fed). Begin with project most relevant to research pro-
                                                             posed. Indicate the overall goals of the project, responsibilities of the key
                                                             person identified on biosketch. DO NOT include person months, or direct
                                                             costs. Used to highlight your accomplishments and those of colleagues as
                                                             scientists.
                                                  NIH format:
                                                  http://grants2.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc#Additional_
                                                  Bio_Instruct

                                                  Recommended file name: Lastname.first_intial

                                                     Mandatory PDF Attachment: File Name(s):_____________________________
Biographical Sketches
                            R01, R21,                Mandatory PDF Attachment: File Name(s):_____________________________
   for each listed Se-                   § 4.5
                             & R03                   Mandatory PDF Attachment: File Name(s):_____________________________
   nior/Key Person
                                                     Mandatory PDF Attachment: File Name(s):_____________________________
                                                     Mandatory PDF Attachment: File Name(s):_____________________________
                                                     Mandatory PDF Attachment: File Name(s):_____________________________
                                                     Mandatory PDF Attachment: File Name(s):_____________________________
                                                     Mandatory PDF Attachment: File Name(s):_____________________________

                                                  Add more file/names as need to separate page: ___________________________
Current and Pending
   Support (when ap-           n/a       § 4.5    Not applicable for NIH
   plicable)
Additional Senior/Key
                            R01, R21,                If applicable PDF Attachment: File Name: _____________________________
     Person Profiles                     § 4.5
                             & R03                Format: http://grants.nih.gov/grants/funding/424/index.htm
(If Expanded not used)
                                                      If applicable PDF Attachment: File Name: :_____________________________
Additional Biographical
                            R01, R21,
     Sketches                            § 4.5    NIH Biosketch format:
                             & R03
(If Expanded not used)                            http://grants2.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc#Additional_
                                                  Bio_Instruct
Additional Current and
                               n/a                Not applicable
   Pending Support

                                                             3                                                  12/26/2006
                         Applica-    Section
                          ble to:     in 424   Additional Information or considerations
Grant Image Order
                         R01, R21,     R&R        PDF attachment required or needed; check if included
                          or R03       app.
                                               Must include the names of all senior/key persons that meet definition of Senior/Key
                                               Persons at the applicant organization who are involved ion the project in a particular
                                               budget year regardless of whether a salary is requested.

                                               Confirmation of all Senior Personnel – See above list or attached ____________
                                                 Biosketch File Name(s):_____________________________
                                                 Biosketch File Name(s):_____________________________
                                                 Biosketch: File Name(s):_____________________________
                                                 Biosketch: File Name(s):_____________________________
                                                 Biosketch: File Name(s):_____________________________
                                                 Biosketch: File Name(s):_____________________________
                                                 Biosketch: File Name(s):_____________________________
Research & Related                               Biosketch: File Name(s):_____________________________
  Budget (for detailed     R01        § 4.7
  budgets)
                                                   Details of collaborators at other institutions will be provided in the Subaward
                                                    budget for each subaward consortium organization
                                                Effort: If calendar effort use, it is assumed effort will be the same in AY and
                                                    Summer
                                                Committed Effort for all activities (sponsored + institutional) can not exceed
                                                    100%
                                                Graduate student compensation. NIH caps Grad student compensation. While
                                                    NIH allows actual institutional-based compensation to be requested and justified,
                                                    OSP strongly recommends assuring compensation cap not exceeded. (Grad
                                                    Compensation can not exceed cap in Modular Grant Budgets)
                                                Budget Justification remark: Note that SU’s AY duration is 8.5 months, not 9 so
                                                    budget narratives must make this point.
                                               Section A Senior/Key Person. If funds for >8 Senior/key persons is requested, in-
                                                       clude all pertinent budget info and attach as PDF file.
                                      § 4.7    Section A, Line 9. Enter total funds requested for all additional senior/key persons
                                                   If applicable (> 8 Senior/Key Persons); File Name: :________________________
                                               B. Other Personnel.
                                     § 4.7.2    All postdoctoral associates and graduate students not named in Section A, must
                                                    be listed by name in the budget justification along with person months, salary
                                                    and fringe.
                                                Do not include consultants, they are included in Section F. Other Direct Costs
                                               Section C. Equipment. Items > $5,000
Additional Senior Key
                                                General purpose equipment, such as a personal computer, is not eligible for
   Persons Attach-
                                                    support unless primarily or exclusively used in the actual conduct of the scientific
   ment (specific to       R01
                                                    research. Rationale for need must be clearly presented in budget justification.
   each year that is
                                                List estimated cost of each item, including shipping and maintenance costs and
   being submitted)
                                                    agreements.
                                               Section D. Travel.
                                                Budget justification should specify: purpose, destination, dates of travel and
                                                    number of individuals for each trip. If dates of travel are not know, specify esti-
                                                    mated length of trip (e.g. 3 days)
                                                Foreign Travel. Any travel outside of North American and or US possessions.
                                                    Provide above information. Fly America Act applies.
                                               Section E. Participant/Trainee support costs.
                                                Leave blank unless guidelines specify otherwise.
                                                Tuition remission should be included in Section F. Other Direct Costs




                                                          4                                                   12/26/2006
                             Applica-    Section
                              ble to:     in 424   Additional Information or considerations
Grant Image Order
                             R01, R21,     R&R        PDF attachment required or needed; check if included
                              or R03       app.
                                                   Section F. Other Direct Costs
                                                    Materials & Supplies. In budget justification, indicate general categories such as
                                                       glassware, chemicals, animal costs, include an amount for each category. Cate-
                                                       gories less than $1,000 do not have to be itemized.
                                                    Publication costs. Justify costs of documenting, preparing, publishing or other-
                                                       wise making available to others the findings and products of the work conducted.
                                                    Consultant services In budget justification, identify each consultant and their
                                                       affiliation by name, the services s/he will provide, the total number of days of ser-
                                                       vice, travel costs, and the total estimated costs. Include persons confirmed to
                                                       serve on external monitoring boards or advisory committees to the project.
Additional Senior Key
                                                    Subawards/Contract. Contractual costs for support services (e.g. lab testing of
                                                       biological materials, data processing) are occasionally sufficient high to warrant a
   Persons Attach-
                                                       categorical breakdown of costs. When the case, provide detailed information as
   ment (specific to           R01
                                                       part of the budget justification
   each year that is
   being submitted)
                                         § 4.7.3    Equipment or facility rental/user fees. In budget justification, identify each rental
                                                       user fee and justify.
                                                   Section H. Indirect Costs
                                                    Indicate MTDC: Modified total direct cost, the rate, and the base.
                                                    Cognizant Federal Agency: Dept Health & Human Services; POC: Jeffrey War-
                                                       ren, POC phone number: 212-264-2069

                                                   Repeat for all years. (select ―Next Period‖ button at top of Section F – K budget
                                                   page.)

                                                   NOTE: Any field on form that is highlighted or marked with an ―*‖ (e.g. budget justifi-
                                                       cation) must be completed before the Next Period button will activate.
Additional Equipment                               Section C. Equipment. Items > $5,000
                               R01       § 4.7.2
   Attachment                                         If applicable (> 10 items); File Name: _____________________________
                                                   Section K. Budget Justification (Must attach a doc in Yr 1 to release next year for data
                                                         entry; this can be blank and replaced at a later point in time)
                                                    List names, role, associated months, salary and fringe benefits for all postdocs
                                                         and grad students included in Budget Section B. Other personnel
Budget Justification
                               R01       § 4.7.3    Include justification for any significant increases or decreases from the initial year
   Attachment                                            budget. Justify budget with more than a standard escalation for the initial to the
                                                         future years of support.
                                                   If a subaward budget is included, a separate budget justification must be submitted
                                                   with that budget. (see § 4.8)
                                                       Mandatory PDF Attachment: File Name(s): :_____________________________
Research & Related
  Budget – Cumula-             R01       § 4.7.4   Auto calculated by the forms
  tive Budget
Research & Related
  Consortium Budg-             R01        § 4.8    An R&R Component—titled ―R&R Subaward Budget
  ets
Attachment Form‖.                                     Select the Subaward Budget Attachment form (Optional Documents)
   Allows for up to 10                                Open and select ―Click here to extract R&R subaward budget attachment
   separate budget at-
   tachments for sepa-
                               R01        § 4.8       Save file using first 10 letters of institution’s name and leave *xfd as file exten-
   rate consortium                                     sion
   budgets in .xfd format.                            Email form to collaborating institution; they complete and mail to PI or OSP
SBIR/STTR Informa-
                               N/A        N/A      An R&R Component
   tion
Research & Develop-
  ment Outside the             N/A        N/A      A PDF Attachment in the SBIR/STTR Information Component (Item 4)
  U.S.
Commercialization
                               N/A        N/A      A PDF Attachment in the SBIR/STTR Information Component (Item 7)
  Plan
Prior SBIR Phase II
    Awards—
                               N/A        N/A      A PDF Attachment in the SBIR/STTR Information Component (Item 8)
    Commercialization
    History

                                                              5                                                    12/26/2006
                           Applica-    Section
                            ble to:     in 424    Additional Information or considerations
Grant Image Order
                           R01, R21,     R&R         PDF attachment required or needed; check if included
                            or R03       app.
                                                  A PHS398 Component
PHS 398 Specific
  Cover Page Sup-
                           R01, R03,
                                        § 5.3
                                                   For multi-PI applications, to qualify as a New Investigator application, all PI’s
                             R21                      must be new investigators; excludes funding from R03, R21, R15 or mentored
  plement
                                                      awards.
                                                  Budget Period
                                                          Enter start and end dates MM/DD/YYY
                                                  A. Direct Costs
                                                   DC less consortium F&A: Enter amount in Direct Costs in $25,000 increments
                                                   Consortium F&A – leave blank if there is no subcontractor/consortium
                           R03, R21,              B. Indirect costs
PHS 398 Specific              R01                          IDC type: Modified Total Direct Costs
                                        § 5.4
  Modular Budget           <$250,000                       Rate: Enter rate (47.5%, 29.3%, 26% - off campus requires OSP prior ap-
                              DC                           proval
                                                           Base: Modified total Direct Costs ($)
                                                   Cognizant Federal Agency: Dept Health & Human Services; POC: Jeffrey War-
                                                      ren, POC phone number: 212-264-2069
                                                   IDC Rate Agreement Date: 06/15/2006

                                                    List all personnel, including names, number of person months devoted to the
                           R01, R03,                 project (indicate AY, CAL and/or SUM) and roles on the project. Do NOT provide
                              R21                    salary information
Personnel Justification                § 5.4.2
                           <$250,000               NIH graduate student compensation cap can not be exceeded when estimating
                              DC                     the number of modules
                                                    Mandatory PDF Attachment: File Name(s): :_____________________________
                                                     Estimate total costs (Direct + F&A) for each year, rounded to the nearest $1,000.
                                                     List individual/organization with whom consortium arrangements have been
                           R01, R03,                  made, along with all personnel, including effort in person months and roles on
Consortium Justifica-         R21                     project. Indicate whether collaborating institution is foreign or domestic.
                                       § 5.4.2
  tion                     <$250,000               NOTE: OPS must have received a letter of intent to collaborate, statement of
                              DC                      work, authorized budget and all other necessary documents prior to proposal
                                                      submission.
                                                    If applicable PDF Attachment: File Name(s): :_____________________________
                           R01, R03,                   Justification for deviations in modules requested or any other unusual circums-
Additional Narrative          R21                       tances (e.g. requesting support for normally unallowable costs such as office
                                       § 5.4.2
   Justification           <$250,000                    supplies, alcohol etc).
                              DC                      If applicable PDF Attachment: File Name(s): :_____________________________
                                                  A PHS398 Component—titled PHS 398 Research Plan
                                                  NOTE: The page limits specified in the parent announcement or funding opportunity
                                                  announcement must be followed.
PHS 398 Specific Re-       R01, R03,              OSP recommends confirming page limits are met prior to converting to PDF.
                                        § 5.5
  search Plan                R21                  Page limits for items 2 - 5
                                                           R01: 25
                                                           R21: 15 pages
                                                           R03: 10 pgs including table, graphs, figures, diagrams and charts
                                                  Item 1 -Required Header: Introduction
                                                           Additional Pages allowed:
                           R01, R03,    § 5.5              R01 - 3 pages
Introduction to Applica-
                             R21       (Vers 2             R21 – 1 page
    tion
                                       – I-104)            R03 – 1 page
                                                     Mandatory PDF Attachment for Resubmission application:
                                                           File Name(s): :_____________________________
                                                  Item 2 – Required Header: Specific Aims
                           R01, R03,
                                        § 5.5      List the broad, long-term objectives and the goal of the specific research pro-
Specific Aims                          (Vers 2        posed
                             R21
                                       – I-104)        1 page recommended (R01)
                                                     Mandatory PDF Attachment: File Name(s):_____________________________




                                                              6                                                12/26/2006
                         Applica-    Section
                          ble to:     in 424    Additional Information or considerations
Grant Image Order
                         R01, R21,     R&R         PDF attachment required or needed; check if included
                          or R03       app.
                                                Item 3 - Required Header: Background & Significance
                                                 Provide context leading to application; critically evaluate existing know ledge
                                                 Identify gaps that the project is intended to fill
                                                 State concisely the importance and health relevance of the research by relating
                                      § 5.5          the specific aims to the board, long-term objectives.
Background and Signi-    R01, R03,
   ficance                 R21
                                     (Vers 2     State how scientific knowledge or clinical practice will be advance is aims of the
                                     – I-105)        project are achieved.
                                                 Describe effect of project on concepts, methods, technologies, treatments, ser-
                                                     vice or preventative interventions that drive the field.
                                                     2-3 pages recommended (R01)
                                                   Mandatory PDF Attachment: File Name(s):_____________________________
                                                Item 4 - Required Header: Preliminary Studies/Progress Report
                                                 Preliminary studies. Describe foundational studies pertinent to the application,
                                                     include preliminary experience with and outreach to the proposed racial ethnic
                                                     group members as application.
                                                               o Not required in R21 (ha) or R03, but may be included if available
                                                 Progress Report: for R01 renewal and revision applications. Provide beginning
                         R01, R21
                                                     and ending data for period covered since the project was last reviewed competi-
Preliminary Stu-                      § 5.5          tively
   dies/Progress Re-     Progress    (Vers 2
                                                 Summarize the previous applications specific aims and importance of findings.
   port                  Report –    – I-105)
                         R01 only                Provide a succinct account of the published and unpublished results, indicating
                                                     progress toward their achievement.
                                                 Discuss any changes in the specific aims as a result of budget reductions.
                                                 In item 7, list publications, manuscripts accepted for publications, patens and
                                                     other printed materials. Do not include in Item 4.
                                                     6 – 8 pages recommended (R01)
                                                   Mandatory PDF Attachment: File Name(s):_____________________________
                                                Item 5 Required Header: Research Design and Methods
                                                 Describe the research design’ conceptual or clinical framework, the procedures
                                                     and analyses to be used to accomplish the specific aims
                                                 Unless addressed separately in Item 17, include how data will be collected, ana-
                                                     lyzed, and interpreted as well as the data-sharing plan, as appropriate
                                                 Describe any new methodology and its advantage over existing methodologies
                                      § 5.5
Research Design and      R01, R03,   (Vers 2
                                                 Describe any novel concepts, approaches, tools or technologies for the proposed
                                                     studies
  Methods                  R21       – I-105
                                       – 6)      Discuss the potential difficulties and limitation of the proposed procedures and
                                                     alternative approaches to achieve the aims
                                                 Provide a tentative sequence or timetable for the project
                                                 Point out any procedures, situations, or materials that may be hazardous to per-
                                                     sonnel and the precautions to be exercises.
                                                      Remaining pages, but do not feel obligated to fill space (R01)
                                                    Mandatory PDF Attachment: File Name(s):_____________________________
                                                Item 6: Required Header: Inclusion Enrollment report
                                      § 5.5     If renewal or revision application if project involves clinical research
Inclusion Enrollment     R01, R03,
                                     (Vers 2              http://grants.nih.gov/grants/funding/424/SF424R-R_enrollmentreport.doc
    Report                 R21
                                     – I-106)       Mandatory for clinical renewal/revision applications only
                                                          PDF. Attachment: File Name(s):_____________________________
                                                Item 7‖ Required Header: Progress Report Publication List
                                                 List titles and complete reference 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
Progress Report Publi-
                                      § 5.5      URLs or PMC submission identification numbers many accompany the full refer-
                           R01       (Vers 2         ence.
   cations List
                                     – I-106)    NOTE: Copes of these publications are no longer accepted as appendix materi-
                                                     al
                                                 See Item 18 for what is allowed for inclusion in appendix.
                                                   For Renewal or revision applications
                                                         PDF Attachment: File Name(s):_____________________________



                                                           7                                                 12/26/2006
                        Applica-    Section
                         ble to:     in 424    Additional Information or considerations
Grant Image Order
                        R01, R21,     R&R         PDF attachment required or needed; check if included
                         or R03       app.
                                               Refer to Part II Instructions for complete instructions:
Protection of Human
                                               http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc#Huma
   Subjects (now in-
                                     § 5.5     n_Subjects_PartII
   cludes Data and      R01, R03,
                                    (Vers 2
   Safety Monitoring      R21
                                    – I-107)   Item 8 Required Header: Protection of Human Subjects
   Plan when applica-
                                                   Mandatory if Human Subjects on Cover Page Checked ―YES‖
   ble)
                                                         PDF Attachment: File Name(s):_____________________________
                                               Refer to Part II Instructions for complete instructions:
                                               http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc#Huma
                                     § 5.5     n_Subjects_PartII
Inclusion of Women      R01, R03,
                                    (Vers 2
    and Minorities        R21
                                    – I-107)   Item 9 Required Header: Inclusion of Women and Minorities
                                                   Mandatory if Human Subjects on Cover Page Checked ―YES‖
                                                         PDF Attachment: File Name(s):_____________________________
                                               Refer to Part II Instructions for complete instructions:
                                               http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc#Hum a
                                     § 5.5     n_Subjects_PartII
Targeted/Planned        R01, R03,
                                    (Vers 2
   Enrollment Table       R21
                                    – I-107)   Item 10 Required Header: Inclusion of Women and Minorities
                                                  Mandatory if Human Subjects on Cover Page Checked ―YES‖
                                                       PDF Attachment: File Name(s):_____________________________
                                               Refer to Part II Instructions for complete instructions:
                                               http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.doc#Huma
                                        §
                                               n_Subjects_PartII
                        R01, R03,   5.5(Vers
Inclusion of Children
                          R21           2
                                               Item 11 Required Header: Inclusion of Children
                                    – I-107)
                                                  Mandatory if Human Subjects on Cover Page Checked ―YES‖
                                                         PDF Attachment: File Name(s):_____________________________
                                               Item 12: Required Header: Vertebrate Animals
                                               1. Provide a detailed description of the proposed use of the animals in the work
                                                   outlined in the Research Design and Methods section.
                                                         a. Identify the species, strains, ages, sex, and numbers of animals to be
                                                              used in the proposed work.
                                               2. Justify the use of animals, the choice of species, and the numbers to be used.
                                     § 5.5
                        R01, R03,   (Vers 2              a. If animals are in short supply, costly, or to be used in large numbers,
Vertebrate Animals                                            provide an additional rationale for their selection and numbers.
                          R21       – I-107-
                                        8)     3. Provide information on the veterinary care of the animals involved.
                                               4. Describe the procedures for ensuring that discomfort, distress, pain, and injury
                                                   will be limited to that which is unavoidable in the conduct of scientifically sound
                                                   research.
                                                         a. Describe the use of analgesic, anesthetic, and tranquilizing drugs
                                                              and/or comfortable restraining devices, where appropriate, to minimize
                                                              discomfort, distress, pain, and injury.
                                               5.    Describe any method of euthanasia to be used and the reasons for its selection.
                                     § 5.5              a. State whether this method is consistent with the recommendations of
                        R01, R03,   (Vers 2                  the Panel on Euthanasia of the American Veterinary Medical Associa-
Vertebrate Animals
                          R21       – I-107-                 tion. If not, present a justification for not following the recommendations.
                                        8)          Mandatory if Vertebrate Animals on Cover Page Checked ―YES‖
                                                        PDF Attachment: File Name(s):_____________________________
                                               Item 13 Required Header Select Agent Research
                                     § 5.5
                        R01, R03,              NOTE: OSP must be notified by EHO that project approvals are in place. Select
Select Agent Research               (Vers 2
                          R21                  Agent research currently not supported at SU.
                                    – I-108)
                                                  Mandatory PDF Attachment: File Name(s):_____________________________




                                                            8                                                  12/26/2006
                         Applica-    Section
                          ble to:     in 424    Additional Information or considerations
Grant Image Order
                         R01, R21,     R&R         PDF attachment required or needed; check if included
                          or R03       app.
                                                Item 14 Required Header Multiple PI Leadership Plan
                                                 Describe rationale for choosing a multiple PD/PI approach
                                                 Describe the governance and organizational structure of the leadership team and
                                                     the research project, including communication plans, process for making deci-
                                                     sions on scientific direction, and the procedures for resolving conflicts.
                                      § 5.5
Multiple PI Leadership   R01, R03,
                                     (Vers 2
                                                 Delineate the roles and administrative, technical and scientific responsibilities for
   Plan                    R21                       the project or program for the PDs/PI and other collaborators.
                                     – I-109)
                                                 If budget allocation is planned, the distribution of resource to specific compo-
                                                     nents of the project or the individual PDs/PIs should be described. In the even to
                                                     fan award, the requested allocations may be reflected in a footnote on the NGA.
                                                   Mandatory for multiple PDs/PIs applications
                                                          PDF Attachment: File Name(s):_____________________________
                                                Item 15 Required Header Consortium/Contractual Arrangements
                                                 Explain the programmatic, fiscal, and administrative arrangement to be made
                                                    between the applicant organization and the consortium organizations(s).
Consor-                               § 5.5
                                                 OSP’s signature on the SF424 (R&R) signifies:
  tium/Contractual
                         R01, R03,
                                     (Vers 2
                                                 The appropriate programmatic and administrative personnel of each organization
                           R21                      involved in this grant application are award of the agency’s consortium agree-
  Arrangements                       – I-110)
                                                    ment policy and are prepared to establish the necessary inter-organization
                                                    agreements consistent with that policy. A separate statement is no longer re-
                                                    quired.
                                                   Mandatory PDF Attachment: File Name(s):_____________________________
                                                Item 16
                                      § 5.5
Letters of Support
                         R01, R03,
                                     (Vers 2
                                                 Attach letters from all consultants/collaborating individuals confirming their roles
                           R21                      in the project and the rate/charge for consulting services.
                                     – I-110)
                                                   Optional PDF Attachment: File Name(s):_____________________________
                                                Item 17 Required Header Resource Sharing Plan(s)
                                                 For those seeking > $500,000 or more in direct costs in any year – 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 require this regardless of $$
                                                    threshold.
                                      § 5.5      Applicants are encouraged to discuss their data-sharing plan with the program
Resource Sharing         R01, R03,   (Vers 2        contact at the time they negotiate an agreement with the Institute/Center staff to
  Plan(s)                  R21         – I-         accept assignment of their application (required if requesting >$500,000 DC)
                                     110/11)    Sharing Model Organisms – REQUIRED is model organisms will be developed.
                                                 Describe a specific plan for sharing and distributing unique model organism re-
                                                    search resources for state appropriate reasons why such sharing is restricted or
                                                    not possible.
                                                   Mandatory if >$500k DC or is specified in FOA or if model organisms are devel-
                                                oped
                                                         PDF Attachment: File Name(s):_____________________________
PHS 398 Specific         R01, R03,
                                                A PHS398 Component—titled PHS 398 Checklist
  Checklist                R21
Assurances/ Certifica-   R01, R03,
                                                A PDF Attachment in the PHS 398 Checklist Component, Section 5
   tion Explanation        R21
                                                Stored separately in the eRA Electronic Grant folder but not as a part of the main
                                                grant application. Is accessible only to appropriate NIH staff, but not peer reviewers.
                                                Letter should contain
                                                      Application title
                                                      Funding Opp (PA or RFA) title of the NIH initiative
                                                      Request of the assignment (referral) to a particular awarding component(s)
                                                          or Scientific review Group.
                         R01, R03,
Cover Letter—.
                           R21
                                      § 5.2           List of people who should not review your application and why (NOT ROU-
                                                          TINELY RECOMMENDED)
                                                      Disciplines involved if multidisciplinary
                                                      Statement that you have attached any required agency approval documen-
                                                          tation for the type of application submitted. E.g. applications > $500,00+,
                                                          approval for Conference grant or Cooperative Agreement (R13, U13) etc.
                                                If application late, additional information required in addition to above. Systems write
                                                over prior documents.

                                                           9                                                   12/26/2006
                      Applica-    Section
                       ble to:     in 424    Additional Information or considerations
Grant Image Order
                      R01, R21,     R&R         PDF attachment required or needed; check if included
                       or R03       app.
                                             Stored separately in the eRA Electronic Grant folder but not as part of the
                                             main grant application. Is accessible to appropriate NIH staff and peer re-
                                             viewers.
                                              ONLY one (1) copy is necessary
                                              Use file names descriptive of content
                                              Maximum of 10 attachments is allowed
                                                  R21 – Limit is 5 attachments
                                              If more than 10 needed, combine remaining into attachment #10.
                                              A summary sheet listing all items is encouraged.(as first attachment)
                                             What’s allowed and not allowed in appendix for new, resubmission, renewal and revi-
                                             sion applications
                                             NOT ALLOWED
                      R01, R03,
                                   § 5.5      Anything in press
Appendix—                         Ver2 2 –    Anything published except as indicated below:
                        R21
                                   I-111      Photographs or color images of gels, micrographs etc. These must be in the
                                                 research plan PDF. Images embedded in publications are allowed.
                                             ALLOWED
                                              Allowed, UP TO 3 (Three) of the following
                                                  Manuscripts or abstracts accepted for publication but not yet published.
                                                  Manuscripts or abstracts published but not available via a free, online publi-
                                                      cally available journal link
                                                  Surveys, questionnaires, data collection instruments, clinical protocols and
                                                      consent documents
                                             Unusual items
                                             For materials that cannot be submitted electronically or can not be converted to PDF
                                             (medical devices, prototypes, DVD, CD) applicants should contact the Scientific Re-
                                             view administrator for instructions following notification of assignment

Additional Senior/Key Personnel
   Biosketch File Name(s):_____________________________           Biosketch File Name(s):_____________________________
   Biosketch File Name(s):_____________________________           Biosketch File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch File Name(s):_____________________________           Biosketch File Name(s):_____________________________
   Biosketch File Name(s):_____________________________           Biosketch File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________
   Biosketch: File Name(s):_____________________________          Biosketch: File Name(s):_____________________________




                                                       10                                               12/26/2006

								
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