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PHS 398 (Rev 609)

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PHS 398 (Rev 609)

    Form Approved Through 6/30/2012 OMB No. 0925-0001

    Department of Health and Human Services LEAVE BLANKFOR PHS USE ONLY. Public Health Services Type Activity Number

    Review Group Formerly Grant Application

    Council/Board (Month, Year) Date Received Do not exceed character length restrictions indicated.

    1. TITLE OF PROJECT (Do not exceed 81 characters, including spaces and punctuation.)

2. RESPONSE TO SPECIFIC REQUEST FOR APPLICATIONS OR PROGRAM ANNOUNCEMENT OR SOLICITATION NO YES (If ―Yes,‖ state number and title)

    Number: Title:

    3. PROGRAM DIRECTOR/PRINCIPAL INVESTIGATOR

    3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. eRA Commons User Name

    3d. MAILING ADDRESS (Street, city, state, zip code) 3c. POSITION TITLE

3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT

3f. MAJOR SUBDIVISION

3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS:

     FAX: TEL:

    4. HUMAN SUBJECTS RESEARCH 4a. Research Exempt If “Yes,” Exemption No.

     No Yes No Yes

    4b. Federal-Wide Assurance No. 4c. Clinical Trial 4d. NIH-defined Phase III Clinical Trial

     No Yes No Yes

    5. VERTEBRATE ANIMALS No Yes 5a. Animal Welfare Assurance No. 6. DATES OF PROPOSED PERIOD OF 7. COSTS REQUESTED FOR INITIAL 8. COSTS REQUESTED FOR PROPOSED SUPPORT (month, day, yearMM/DD/YY) BUDGET PERIOD PERIOD OF SUPPORT From Through 7a. Direct Costs ($) 7b. Total Costs ($) 8a. Direct Costs ($) 8b. Total Costs ($)

    9. APPLICANT ORGANIZATION 10. TYPE OF ORGANIZATION Name Public: Federal State Local Address Private: Private Nonprofit

    For-profit: General Small Business

     Woman-owned Socially and Economically Disadvantaged

    11. ENTITY IDENTIFICATION NUMBER

    Cong. District DUNS NO.

    12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE 13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION Name Name

    Title Title

    Address Address

    Tel: FAX: FAX: Tel: E-Mail: E-Mail:

    14. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that the SIGNATURE OF OFFICIAL NAMED IN 13. DATE statements herein are true, complete and accurate to the best of my knowledge, and accept (In ink. ―Per‖ signature not acceptable.) the obligation to comply with Public Health Services terms and conditions if a grant is awarded as a result of this application. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties.

    PHS 398 (Rev. 6/09) Face Page Form Page 1

    Use only if preparing an application with Multiple PDs/PIs. See http://grants.nih.gov/grants/multi_pi/index.htm for details. Contact Program Director/Principal Investigator (Last, First, Middle):

     3. PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR

    3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. NIH Commons User Name

    3d. MAILING ADDRESS (Street, city, state, zip code) 3c. POSITION TITLE

3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT

3f. MAJOR SUBDIVISION

3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS:

    TEL: FAX:

     3. PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR

    3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. NIH Commons User Name

    3d. MAILING ADDRESS (Street, city, state, zip code) 3c. POSITION TITLE

3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT

3f. MAJOR SUBDIVISION

3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS:

    TEL: FAX:

     3. PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR

    3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. NIH Commons User Name

    3d. MAILING ADDRESS (Street, city, state, zip code) 3c. POSITION TITLE

3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT

3f. MAJOR SUBDIVISION

3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS:

    TEL: FAX:

     3. PROGRAM DIRECTOR / PRINCIPAL INVESTIGATOR

    3a. NAME (Last, first, middle) 3b. DEGREE(S) 3h. NIH Commons User Name

    3d. MAILING ADDRESS (Street, city, state, zip code) 3c. POSITION TITLE

3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT

3f. MAJOR SUBDIVISION

3g. TELEPHONE AND FAX (Area code, number and extension) E-MAIL ADDRESS:

    TEL: FAX:

    PHS 398 (Rev. 6/09) Face Page-continued Form Page 1-continued

     Program Director/Principal Investigator (Last, First, Middle):

     PROJECT SUMMARY (See instructions):

RELEVANCE (See instructions):

    PROJECT/PERFORMANCE SITE(S) (if additional space is needed, use Project/Performance Site Format Page) Project/Performance Site Primary Location

    Organizational Name:

     DUNS:

     Street 1: Street 2:

     City: County: State:

     Province: Country: Zip/Postal Code:

     Project/Performance Site Congressional Districts:

     Additional Project/Performance Site Location

    Organizational Name:

     DUNS:

     Street 1: Street 2:

     City: County: State:

     Province: Country: Zip/Postal Code:

     Project/Performance Site Congressional Districts:

    PHS 398 (Rev. 6/09) Page 2 Form Page 2

     Program Director/Principal Investigator (Last, First, Middle):

     SENIOR/KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Program Director(s)/Principal Investigator(s). List all other senior/key personnel in alphabetical order, last name first. Name eRA Commons User Name Organization Role on Project

    OTHER SIGNIFICANT CONTRIBUTORS Name Organization Role on Project

     No Yes Human Embryonic Stem Cells

    If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list:

    http://stemcells.nih.gov/research/registry/eligibilityCriteria.asp. Use continuation pages as needed. If a specific line cannot be referenced at this time, include a statement that one from the Registry will be used.

    Cell Line

PHS 398 (Rev. 6/09) Page 3 Form Page 2-continued Number the following pages consecutively throughout the application. Do not use suffixes such as 4a, 4b.

     Program Director/Principal Investigator (Last, First, Middle):

    The name of the program director/principal investigator must be provided at the top of each printed page and each continuation page.

    RESEARCH GRANT

    TABLE OF CONTENTS

     Page Numbers Face Page ............................................................................................................................................ 1 Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells ..................................................................................................... 2 Table of Contents ................................................................................................................................ Detailed Budget for Initial Budget Period........................................................................................... Budget for Entire Proposed Period of Support......................................................................................... Budgets Pertaining to Consortium/Contractual Arrangements ........................................................ Biographical Sketch Program Director/Principal Investigator (Not to exceed four pages each) ......... Other Biographical Sketches (Not to exceed four pages each See instructions) .............................. Resources............................................................................................................................................ Checklist ..............................................................................................................................................

     Research Plan .....................................................................................................................................

     1. Introduction to Resubmission Application, if applicable, or Introduction to Revision Application,

     if applicable * ................................................................................................................................. 2. Specific Aims * ............................................................................................................................... 3. Research Strategy * ....................................................................................................................... 4. Inclusion Enrollment Report (Renewal or Revision applications only) ............................................... 5. Bibliography and References Cited/Progress Report Publication List ............................................... 6. Protection of Human Subjects ......................................................................................................... 7. Inclusion of Women and Minorities .................................................................................................. 8. Targeted/Planned Enrollment Table ................................................................................................ 9. Inclusion of Children ........................................................................................................................ 10. Vertebrate Animals .......................................................................................................................... 11. Select Agent Research .................................................................................................................... 12. Multiple PD/PI Leadership Plan ....................................................................................................... 13. Consortium/Contractual Arrangements ............................................................................................ 14. Letters of Support (e.g., Consultants) .............................................................................................. 15. Resource Sharing Plan (s) ..............................................................................................................

     Check if Appendix (Five identical CDs.) Appendix is Included * Follow the page limits for these sections indicated in the application instructions, unless the Funding Opportunity Announcement specifies otherwise.

    PHS 398 (Rev. 6/09) Page Form Page 3

    Program Director/Principal Investigator (Last, First, Middle):

    FROM THROUGH DETAILED BUDGET FOR INITIAL BUDGET PERIOD

     DIRECT COSTS ONLY

     List PERSONNEL (Applicant organization only) Use Cal, Acad, or Summer to Enter Months Devoted to Project Enter Dollar Amounts Requested (omit cents) for Salary Requested and Fringe Benefits

    Cal. Acad. Summer INST.BASE SALARY FRINGE ROLE ON Mnths Mnths Mnths SALARYREQUESTED BENEFITS TOTAL NAME PROJECT

    PD/PI

    SUBTOTALS CONSULTANT COSTS

EQUIPMENT (Itemize)

SUPPLIES (Itemize by category)

TRAVEL

    INPATIENT CARE COSTS OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS (Itemize by category)

OTHER EXPENSES (Itemize by category)

    CONSORTIUM/CONTRACTUAL COSTS DIRECT COSTS SUBTOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD (Item 7a, Face Page) $

    FACILITIES AND ADMINISTRATIVE COSTS CONSORTIUM/CONTRACTUAL COSTS TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD $ PHS 398 (Rev. 6/09) Page Form Page 4

     Program Director/Principal Investigator (Last, First, Middle):

    BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD

    DIRECT COSTS ONLY

    INITIAL BUDGET 2nd ADDITIONAL 3rd ADDITIONAL 4th ADDITIONAL 5th ADDITIONAL BUDGET CATEGORY PERIOD YEAR OF SUPPORT YEAR OF SUPPORT YEAR OF SUPPORT YEAR OF SUPPORT TOTALS (from Form Page 4)REQUESTED REQUESTED REQUESTED REQUESTED

    PERSONNEL: Salary and fringe benefits. Applicant organization only. CONSULTANT COSTS EQUIPMENT SUPPLIES TRAVEL INPATIENT CARE COSTS OUTPATIENT CARE COSTS ALTERATIONS AND RENOVATIONS OTHER EXPENSES DIRECT CONSORTIUM/ CONTRACTUAL COSTS

    SUBTOTAL DIRECT COSTS

    (Sum = Item 8a, Face Page) F&A CONSORTIUM/ CONTRACTUAL COSTS

    TOTAL DIRECT COSTS TOTAL DIRECT COSTS FOR ENTIRE PROPOSED PROJECT PERIOD $ JUSTIFICATION. Follow the budget justification instructions exactly. Use continuation pages as needed.

    PHS 398 (Rev. 6/09) Page Form Page 5

     Program Director/Principal Investigator (Last, First, Middle):

     RESOURCES

    Follow the 398 application instructions in Part I, 2.7 Resources.

    MAJOR EQUIPMENT: List the most important equipment items already available for this project, noting the location and pertinent capabilities of each.

PHS 398 (Rev. 6/09) Page

     Resources Format Page

    Program Director/Principal Investigator (Last, First, Middle):

     CHECKLIST

    TYPE OF APPLICATION (Check all that apply.)

     NEW application. (This application is being submitted to the PHS for the first time.)

     RESUBMISSION of application number: (This application replaces a prior unfunded version of a new, renewal, or revision application.)

     RENEWAL of grant number: (This application is to extend a funded grant beyond its current project period.)

     REVISION to grant number: (This application is for additional funds to supplement a currently funded grant.)

     CHANGE of program director/principal investigator.

    Name of former program director/principal investigator:

     CHANGE of Grantee Institution. Name of former institution:

    List Country(ies) FOREIGN application Domestic Grant with foreign involvement Involved:

    INVENTIONS AND PATENTS (Renewal appl. only) No Yes

    If “Yes,” Previously reported Not previously reported 1. PROGRAM INCOME (See instructions.) All applications must indicate whether program income is anticipated during the period(s) for which grant support is request. If program income is anticipated, use the format below to reflect the amount and source(s).

    Budget Period Anticipated Amount Source(s)

    2. ASSURANCES/CERTIFICATIONS (See instructions.) In signing the application Face Page, the authorized organizational representative agrees to comply with the policies, assurances and/or certifications listed in the application instructions when applicable. Descriptions of individual assurances/certifications are provided in Part III and listed in Part I, 4.1 under Item 14. If unable to certify compliance, where applicable, provide an explanation and place it after this page. 3. FACILITIES AND ADMINSTRATIVE COSTS (F&A)/ INDIRECT COSTS. See specific instructions.

     DHHS Agreement dated: No Facilities And Administrative Costs Requested.

     DHHS Agreement being negotiated with Regional Office.

     No DHHS Agreement, but rate established with Date CALCULATION* (The entire grant application, including the Checklist, will be reproduced and provided to peer reviewers as confidential information.)

     a. Initial budget period: Amount of base $ x Rate applied % = F&A costs $

     b. 02 year Amount of base $ x Rate applied % = F&A costs $

     c. 03 year Amount of base $ x Rate applied % = F&A costs $

     d. 04 year Amount of base $ x Rate applied % = F&A costs $

     e. 05 year Amount of base $ x Rate applied % = F&A costs $

     TOTAL F&A Costs $ *Check appropriate box(es):

     Salary and wages base Modified total direct cost base Other base (Explain)

     Off-site, other special rate, or more than one rate involved (Explain)

    Explanation (Attach separate sheet, if necessary.):

4. DISCLOSURE PERMISSION STATEMENT: If this application does not result in an award, is the Government permitted to disclose the title of your proposed project, and the name, address, telephone number and e-mail address of the official signing for the applicant organization, to organizations

    that may be interested in contacting you for further information (e.g., possible collaborations, investment)? Yes No PHS 398 (Rev. 6/09) Page Checklist Form Page

     Program Director/Principal Investigator (Last, First, Middle):

    Targeted/Planned Enrollment Table

    This report format should NOT be used for data collection from study participants. Study Title:

    Total Planned Enrollment:

    TARGETED/PLANNED ENROLLMENT: Number of Subjects

    Ethnic Category Females Males Total Hispanic or Latino Not Hispanic or Latino Ethnic Category: Total of All Subjects *

    Racial Categories American Indian/Alaska Native Asian Native Hawaiian or Other Pacific Islander Black or African American White Racial Categories: Total of All Subjects * * The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.”

    PHS 398/2590 (Rev. 6/09) Page

     Targeted/Planned Enrollment Table Format Page

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