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Grant Application Package Opportunity Title: Offering Agency: CFDA Number: CFDA Description: Opportunity Number: Competition ID: Opportunity Open Date: Opportunity Close Date: Agency Contact: NIH Research Project Grant (Parent R01) National Institutes of Health PA-16-160 FORMS-D 04/17/2016 05/07/2019 era Service Desk Monday to Friday 7 am to 8 pm ET http://grants.nih.gov/support/ This opportunity is only open to organizations, applicants who are submitting grant applications on behalf of a company, state, local or tribal government, academia, or other type of organization. Application Filing Name: Select Forms to Complete Mandatory SF424 (R & R) PHS 398 Cover Page Supplement Research And Related Other Project Information Project/Performance Site Location(s) Research and Related Senior/Key Person Profile (Expanded) PHS 398 Research Plan Optional Research & Related Budget PHS 398 Modular Budget R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT PHS 398 Inclusion Enrollment Report PHS Assignment Request Form Instructions Show Instructions >> This electronic grants application is intended to be used to apply for the specific Federal funding opportunity referenced here. If the Federal funding opportunity listed is not the opportunity for which you want to apply, close this application package by clicking on the "Cancel" button at the top of this screen. You will then need to locate the correct Federal funding opportunity, download its application and then apply.

APPLICATION FOR FEDERAL ASSISTANCE SF 424 (R&R) 3. DATE RECEIVED BY STATE State Application Identifier OMB Number: 4040-0001 Expiration Date: 6/30/2016 1. TYPE OF SUBMISSION 4. a. Federal Identifier Pre-application Application Changed/Corrected Application b. Agency Routing Identifier 2. DATE SUBMITTED Applicant Identifier c. Previous Grants.gov Tracking ID 5. APPLICANT INFORMATION Organizational DUNS: Legal Name: Joan & Sanford I Weill Medical College of Cornell University Department: Office of Sponsored Research Division: Sponsored Research Admin. 0602175020000 Street1: 1300 York Avenue Box 89 City: New York County / Parish: State: NY: New York Country: USA: UNITED STATES ZIP / Postal Code: 10065-4805 Person to be contacted on matters involving this application Prefix: Ms. First Name: Aleta Middle Name: R. Last Name: Gunsul Suffix: MPA Position/Title: Director, Office of Sponsored Research Admin. Street1: 1300 York Avenue Box 89 City: New York State: Country: Phone Number: County / Parish: NY: New York USA: UNITED STATES ZIP / Postal Code: 10065-4805 646-962-8290 Fax Number: 646-962-0531 Email: grantsandcontracts@med.cornell.edu 6. EMPLOYER IDENTIFICATION (EIN) or (TIN): 7. TYPE OF APPLICANT: Other (Specify): 13-1623978 O: Private Institution of Higher Education Small Business Organization Type Women Owned Socially and Economically Disadvantaged 8. TYPE OF APPLICATION: New Resubmission Renewal Continuation Revision If Revision, mark appropriate box(es). A. Increase Award B. Decrease Award C. Increase Duration D. Decrease Duration E. Other (specify): Is this application being submitted to other agencies? What other Agencies? 9. NAME OF FEDERAL AGENCY: National Institutes of Health 10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: TITLE: 11. DESCRIPTIVE TITLE OF APPLICANT'S PROJECT: 12. PROPOSED PROJECT: Start Date Ending Date 13. CONGRESSIONAL DISTRICT OF APPLICANT NY-012

SF 424 (R&R) APPLICATION FOR FEDERAL ASSISTANCE Page 2 14. PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION Prefix: Last Name: Position/Title: 15. ESTIMATED PROJECT FUNDING a. Total Federal Funds Requested b. Total n-federal Funds First Name: c. Total Federal & n-federal Funds 17. By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein are true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with any resulting terms if I accept an award. I am aware that any false, fictitious. or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. (U.S. Code, Title 18, Section 1001) I agree *The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions. 18. SFLLL (Disclosure of Lobbying Activities) or other Explanatory Documentation 19. Authorized Representative Prefix: Ms. First Name: Aleta Middle Name: R. Last Name: Gunsul Suffix: MPA Position/Title: Organization: Director, Office of Sponsored Research Admin. Joan & Sanford I Weill Medical College of Cornell University Department: Office of Sponsored Research Division: Sponsored Research Admin. Street1: 1300 York Avenue Box 89 City: New York County / Parish: State: NY: New York Country: USA: UNITED STATES ZIP / Postal Code: 10065-4805 Phone Number: 646-962-8290 Fax Number: 646-962-0531 Email: grantsandcontracts@med.cornell.edu Signature of Authorized Representative Middle Name: Organization Name: Department: Joan & Sanford I Weill Medical College of Cornell University Division: Street1: City: 1300 York Avenue Box 89 New York County / Parish: State: NY: New York Country: Phone Number: USA: UNITED STATES Fax Number: ZIP / Postal Code: 10065-4805 Email: d. Estimated Program Income Suffix: 16. IS APPLICATION SUBJECT TO REVIEW BY STATE EXECUTIVE ORDER 12372 PROCESS? a. YES THIS PREAPPLICATION/APPLICATION WAS MADE AVAILABLE TO THE STATE EXECUTIVE ORDER 12372 PROCESS FOR REVIEW ON: DATE: b. NO PROGRAM IS NOT COVERED BY E.O. 12372; OR PROGRAM HAS NOT BEEN SELECTED BY STATE FOR REVIEW Date Signed Completed on submission to Grants.gov Completed on submission to Grants.gov 20. Pre-application 21. Cover Letter Attachment

PHS 398 Cover Page Supplement OMB Number: 0925-0001 Expiration Date: 10/31/2018 1. Human Subjects Section Clinical Trial? *Agency-Defined Phase III Clinical Trial? 2. Vertebrate Animals Section Are vertebrate animals euthanized? If "" to euthanasia Is method consistent with American Veterinary Medical Association (AVMA) guidelines? If "" to AVMA guidelines, describe method and provide scientific justification 3. *Program Income Section *Is program income anticipated during the periods for which the grant support is requested? If you checked "yes" above (indicating that program income is anticipated), then use the format below to reflect the amount and source(s). Otherwise, leave this section blank. *Budget Period *Anticipated Amount ($) *Source(s) 4. Human Embryonic Stem Cells Section *Does the proposed project involve 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/. Or, if a specific stem cell line cannot be referenced at this time, please check the box indicating that one from the registry will be used: Specific stem cell line cannot be referenced at this time. One from the registry will be used. Cell Line(s) (Example: 0004):

PHS 398 Cover Page Supplement 5. Inventions and Patents Section (RENEWAL) *Inventions and Patents: If "" then answer the following: *Previously Reported: 6. Change of Investigator / Change of Institution Section Change of Project Director / Principal Investigator Name of former Project Director/Principal Investigator: Prefix: *First Name: Middle Name: *Last Name: Suffix: Change of Grantee Institution *Name of former institution:

RESEARCH & RELATED Other Project Information OMB Number: 4040-0001 Expiration Date: 6/30/2016 1. Are Human Subjects Involved? 1.a. If YES to Human Subjects Is the Project Exempt from Federal regulations? If yes, check appropriate exemption number. If no, is the IRB review Pending? IRB Approval Date: 1 2 3 4 5 6 Human Subject Assurance Number: 2. Are Vertebrate Animals Used? 2.a. If YES to Vertebrate Animals Is the IACUC review Pending? IACUC Approval Date: Animal Welfare Assurance Number: If applicable, WCM's Human Subject FWA is: 00000093 If applicable, WCM's Animal Welfare Assurance number is: D16-00186 3. Is proprietary/privileged information included in the application? 4.a. Does this Project Have an Actual or Potential Impact - positive or negative - on the environment? 4.b. If yes, please explain: 4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an environmental assessment (EA) or environmental impact statement (EIS) been performed? 4.d. If yes, please explain: 5. Is the research performance site designated, or eligible to be designated, as a historic place? 5.a. If yes, please explain: 6. Does this project involve activities outside of the United States or partnerships with international collaborators? 6.a. If yes, identify countries: 6.b. Optional Explanation: 7. Project Summary/Abstract 8. Project Narrative 9. Bibliography & References Cited 10. Facilities & Other Resources 11. Equipment 12. Other Attachments s s s

Project/Performance Site Location(s) OMB Number: 4040-0010 Expiration Date: 9/30/2016 Project/Performance Site Primary Location I am submitting an application as an individual, and not on behalf of a company, state, local or tribal government, academia, or other type of organization. Organization Name: DUNS Number: Joan & Sanford I Weill Medical College of Cornell University 0602175020000 * Street1: * City: County: * State: * Country: USA: UNITED STATES * ZIP / Postal Code: * Project/ Performance Site Congressional District: NY-012 Project/Performance Site Location Organization Name: 1 I am submitting an application as an individual, and not on behalf of a company, state, local or tribal government, academia, or other type of organization. DUNS Number: * Street1: * City: County: * State: * Country: USA: UNITED STATES * ZIP / Postal Code: * Project/ Performance Site Congressional District: Additional Location(s)

RESEARCH & RELATED Senior/Key Person Profile (Expanded) OMB Number: 4040-0001 Expiration Date: 6/30/2016 PROFILE - Project Director/Principal Investigator Prefix: * First Name: Middle Name: * Last Name: Suffix: Position/Title: Department: Organization Name: Joan & Sanford I Weill Medical College of Cornell University Division: * Street1: * City: 1300 York Avenue Box 89 New York County/ Parish: * State: NY: New York * Country: USA: UNITED STATES * Zip / Postal Code: 10065-4805 * Phone Number: Fax Number: * E-Mail: Credential, e.g., agency login: * Project Role: PD/PI Other Project Role Category: Degree Type: Degree Year: *Attach Biographical Sketch Attach Current & Pending Support PROFILE - Senior/Key Person 1 Prefix: * First Name: Middle Name: * Last Name: Suffix: Position/Title: Department: Organization Name: Division: * Street1: * City: County/ Parish: * State: * Country: USA: UNITED STATES * Zip / Postal Code: * Phone Number: Fax Number: * E-Mail: Credential, e.g., agency login: * Project Role: Other Project Role Category: Degree Type: Degree Year: Attach Biographical Sketch Attach Current & Pending Support Delete Entry Next Person To ensure proper performance of this form; after adding 20 additional Senior/ Key Persons; please save your application, close the Adobe Reader, and reopen it.

PHS 398 Research Plan OMB Number: 0925-0001 Expiration Date: 10/31/2018 Introduction 1. Introduction to Application (Resubmission and Revision) Research Plan Section 2. Specific Aims 3. *Research Strategy 4. Progress Report Publication List Human Subjects Section 5. Protection of Human Subjects 6. Data Safety Monitoring Plan 7. Inclusion of Women and Minorities 8. Inclusion of Children Other Research Plan Section 9. Vertebrate Animals 10. Select Agent Research 11. Multiple PD/PI Leadership Plan 12. Consortium/Contractual Arrangements 13. Letters of Support 14. Resource Sharing Plan(s) 15. Authentication of Key Biological and/or Chemical Resources Appendix 16. Appendix s s s

RESEARCH & RELATED BUDGET - Budget Period 1 ORGANIZATIONAL DUNS: 0602175020000 Enter name of Organization: Joan & Sanford I Weill Medical College of Cornell University Budget Type: Project Subaward/Consortium Budget Period: 1 Start Date: End Date: A. Senior/Key Person Prefix First Middle Last Suffix Base Salary ($) Months Cal. Acad. Sum. Requested Salary ($) Fringe Benefits ($) Project Role: PD/PI Additional Senior Key Persons: Total Funds requested for all Senior Key Persons in the attached file Total Senior/Key Person B. Other Personnel Number of Personnel Project Role Post Doctoral Associates Cal. Months Acad. Sum. Requested Salary ($) Fringe Benefits ($) Graduate Students Undergraduate Students Secretarial/Clerical Total Number Other Personnel Total Other Personnel Total Salary, Wages and Fringe Benefits (A+B) OMB Number: 4040-0001 Expiration Date: 6/30/2016 Funds Requested ($) Funds Requested ($)

C. Equipment Description List items and dollar amount for each item exceeding $5,000 Equipment item Funds Requested ($) Additional Equipment: Total funds requested for all equipment listed in the attached file Total Equipment D. Travel Funds Requested ($) 1. Domestic Travel Costs ( Incl. Canada, Mexico and U.S. Possessions) 2. Foreign Travel Costs Total Travel Cost E. Participant/Trainee Support Costs Funds Requested ($) 1. Tuition/Fees/Health Insurance 2. Stipends 3. Travel 4. Subsistence 5. Other Number of Participants/Trainees Total Participant/Trainee Support Costs

F. Other Direct Costs Funds Requested ($) 1. Materials and Supplies 2. Publication Costs 3. Consultant Services 4. ADP/Computer Services 5. Subawards/Consortium/Contractual Costs 6. Equipment or Facility Rental/User Fees 7. Alterations and Renovations 8. 9. 10. Total Other Direct Costs G. Direct Costs Funds Requested ($) Total Direct Costs (A thru F) H. Indirect Costs Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($) MTDC 69.50 Total Indirect Costs Cognizant Federal Agency (Agency Name, POC Name, and POC Phone Number) Department of Health & Human Services, Louis Martillotti, 212-264-0918 I. Total Direct and Indirect Costs Funds Requested ($) Total Direct and Indirect Institutional Costs (G + H) J. Fee Funds Requested ($) K. Budget Justification (Only attach one file.)

RESEARCH & RELATED BUDGET - Cumulative Budget Totals ($) Section A, Senior/Key Person Section B, Other Personnel Total Number Other Personnel Total Salary, Wages and Fringe Benefits (A+B) Section C, Equipment Section D, Travel 1. Domestic 2. Foreign Section E, Participant/Trainee Support Costs 1. Tuition/Fees/Health Insurance 2. Stipends 3. Travel 4. Subsistence 5. Other 6. Number of Participants/Trainees Section F, Other Direct Costs 1. Materials and Supplies 2. Publication Costs 3. Consultant Services 4. ADP/Computer Services 5. Subawards/Consortium/Contractual Costs 6. Equipment or Facility Rental/User Fees 7. Alterations and Renovations 8. Other 1 9. Other 2 10. Other 3 Section G, Direct Costs (A thru F) Section H, Indirect Costs Section I, Total Direct and Indirect Costs (G + H) Section J, Fee

PHS 398 Modular Budget OMB Number: 0925-0001 Expiration Date: 10/31/2018 Budget Period: 1 Start Date: End Date: A. Direct Costs Direct Cost less Consortium Indirect (F&A) Consortium Indirect (F&A) Total Direct Costs Funds Requested ($) 0.00 0.00 B. Indirect (F&A) Costs Indirect (F&A) Type Indirect (F&A) Rate (%) Indirect (F&A) Base ($) Funds Requested ($) Cognizant Agency (Agency Name, POC Name and Phone Number) Department of Health & Human Services, Louis Martillotti, 212-264-0918 Indirect (F&A) Rate Agreement Date 11/19/2015 Total Indirect (F&A) Costs C. Total Direct and Indirect (F&A) Costs (A + B) Funds Requested ($) 0.00 Cumulative Budget Information 1. Total Costs, Entire Project Period Section A, Total Direct Cost less Consortium Indirect (F&A) for Entire Project Period $ 0.00 Section A, Total Consortium Indirect (F&A) for Entire Project Period $ Section A, Total Direct Costs for Entire Project Period $ 0.00 Section B, Total Indirect (F&A) Costs for Entire Project Period $ Section C, Total Direct and Indirect (F&A) Costs (A+B) for Entire Project Period $ 0.00 2. Budget Justifications Personnel Justification Consortium Justification Additional Narrative Justification