Form 3A Paper Application Form

Form Approved Through 6/30/2015 OMB No. 0925-0001

Department of Health and Human Services Public Health Services Grant Application Do not exceed character length restrictions indicated.

LEAVE BLANK—FOR PHS USE ONLY.

Type

Activity

Number

Review Group

Formerly

Council/Board (Month, Year)

Date Received

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

     

     

     

     

     

3c. POSITION TITLE      

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

3e. DEPARTMENT, SERVICE, LABORATORY, OR EQUIVALENT      

3f. MAJOR SUBDIVISION      

3g. TELEPHONE AND FAX (Area code, number and extension)

E-MAIL ADDRESS:

TEL:

     

FAX:

     

     

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 SUPPORT (month, day, year—MM/DD/YY)

7. COSTS REQUESTED FOR INITIAL BUDGET PERIOD

8. COSTS REQUESTED FOR PROPOSED 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      

DUNS NO.

     

Cong. District

     

12. ADMINISTRATIVE OFFICIAL TO BE NOTIFIED IF AWARD IS MADE

13. OFFICIAL SIGNING FOR APPLICANT ORGANIZATION

Name

     

Name

     

Title

     

Title

     

Address

     

Address

     

Tel:

     

FAX:

     

Tel:

     

FAX:

     

E-Mail:

     

E-Mail:

     

14. APPLICANT ORGANIZATION CERTIFICATION AND ACCEPTANCE: I certify that the statements herein are true, complete and accurate to the best of my knowledge, and accept 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.

SIGNATURE OF OFFICIAL NAMED IN 13. (In ink. “Per” signature not acceptable.)

DATE      

PHS 398 (Rev. 6/12) 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
     				     	     	     	     
3c. POSITION TITLE      				3d. MAILING ADDRESS (Street, city, state, zip code)      
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
     				     	     	     	     
3c. POSITION TITLE      				3d. MAILING ADDRESS (Street, city, state, zip code)      
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
     				     	     	     	     
3c. POSITION TITLE      				3d. MAILING ADDRESS (Street, city, state, zip code)      
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
     				     	     	     	     
3c. POSITION TITLE      				3d. MAILING ADDRESS (Street, city, state, zip code)      
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. 6/12) 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. 6/12) 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
     			     			     
     			     			     
     			     			     
     			     			     
     			     			     
     			     			     
     			     			     
     			     			     
     			     			     
     			     			     
Human Embryonic Stem Cells	No		Yes
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. 6/12) 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)				     
Appendix (Five identical CDs.)				Check if 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. 6/12) Page     Form Page 3

Program Director/Principal Investigator (Last, First, Middle):	     
DETAILED BUDGET FOR INITIAL BUDGET PERIOD DIRECT COSTS ONLY		FROM	THROUGH
		     	     

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

NAME	ROLE ON PROJECT	Cal. Mnths	Acad. Mnths	Summer Mnths		INST.BASE SALARY	SALARY REQUESTED	FRINGE BENEFITS		TOTAL
     	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)									$	     
CONSORTIUM/CONTRACTUAL COSTS					FACILITIES AND ADMINISTRATIVE COSTS				     
TOTAL DIRECT COSTS FOR INITIAL BUDGET PERIOD									$	     

PHS 398 (Rev. 6/12) Page     Form Page 4

Program Director/Principal Investigator (Last, First, Middle):			     
BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD DIRECT COSTS ONLY
BUDGET CATEGORY TOTALS	INITIAL BUDGET PERIOD (from Form Page 4)	2nd ADDITIONAL YEAR OF SUPPORT REQUESTED		3rd ADDITIONAL YEAR OF SUPPORT REQUESTED	4th ADDITIONAL YEAR OF SUPPORT REQUESTED		5th ADDITIONAL YEAR OF SUPPORT 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. 6/12) Page     Form Page 5

Program Director/Principal Investigator (Last, First, Middle):	     
RESOURCES
Follow the 398 application instructions in Part I, 4.7 Resources.
     

PHS 398 (Rev. 6/12) 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:

     

FOREIGN application

Domestic Grant with foreign involvement

List Country(ies) 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. 6/12) 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				     	     		     
More Than One Race				     	     		     
Racial Categories: Total of All Subjects *				     	     		     
* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories: Total of All Subjects.”

0925-0001/0002 (Rev. 06/12) Page     Targeted/Planned Enrollment Table Format Page

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

     

Inclusion Enrollment Report

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

Study Title:

     

Total Enrollment:

     

Protocol Number:

     

Grant Number:

     

PART A. TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date (Cumulative) by Ethnicity and Race

Ethnic Category

Females

Males

Sex/Gender Unknown or Not Reported

Total

Hispanic or Latino

     

     

     

     

**

Not Hispanic or Latino

     

     

     

     

Unknown (individuals not reporting ethnicity)

     

     

     

     

Ethnic Category: Total of All Subjects*

     

     

     

     

*

Racial Categories

American Indian/Alaska Native

     

     

     

     

Asian

     

     

     

     

Native Hawaiian or Other Pacific Islander

     

     

     

     

Black or African American

     

     

     

     

White

     

     

     

     

More Than One Race

     

     

     

     

Unknown or Not Reported

     

     

     

     

Racial Categories: Total of All Subjects*

     

     

     

     

*

PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative)

Racial Categories

Females

Males

Sex/Gender Unknown or Not Reported

Total

American Indian or Alaska Native

     

     

     

     

Asian

     

     

     

     

Native Hawaiian or Other Pacific Islander

     

     

     

     

Black or African American

     

     

     

     

White

     

     

     

     

More Than One Race

     

     

     

     

Unknown or Not Reported

     

     

     

     

Racial Categories: Total of Hispanics or Latinos**

     

     

     

     

**

* These totals must agree. ** These totals must agree.

0925-0001/0002 (Rev. 06/12) Page     Inclusion Enrollment Report Format Page

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

DO NOT SUBMIT UNLESS REQUESTED

Renewal Applications Only

ALL PERSONNEL REPORT

Always list the PD/PI(s). In addition, list all other personnel who participated in the project during the current budget period for at least one person month or more, regardless of the source of compensation (a person month equals approximately 160 hours or 8.3% of annualized effort). Use Cal, Acad, or Summer to Enter Months Devoted to Project.

Commons ID	Name	Degree(s)	SSN (last 4 digits)	Role on Project (e.g. PD/PI, Res. Assoc.)	DoB (MM /YY)	Cal	Acad	Summer
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    
     	     	     	    	     	     	    	    	    

PHS 398 (Rev. 6/12) Page     All Personnel Report Format Page

Mailing address for application

Use this label or a facsimile

All applications and other deliveries to the Center for Scientific Review must come either via courier delivery or via the United States Postal Service (USPS.) Applications delivered by individuals to the Center for Scientific Review will not be accepted.

Applications sent via the USPS EXPRESS or REGULAR MAIL should be sent to the following address:

CENTER FOR SCIENTIFIC REVIEW

NATIONAL INSTITUTES OF HEALTH

6701 ROCKLEDGE DRIVE

ROOM 1040 – MSC 7710

BETHESDA, MD 20892-7710

NOTE: All applications sent via a courier delivery service (non-USPS) should use this address, but CHANGE THE ZIP CODE TO 20817

The telephone number is 301-435-0715. C.O.D. applications will not be accepted.

A special label for responding to RFAs is not required.

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

     

Use only if additional space is needed to list additional project/performance sites.

Additional Project/Performance Site Location

Organizational Name:

     

DUNS:

     

Street 1:

     

Street 2:

     

City:

     

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State:

     

Province:

     

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Zip/Postal Code:

     

Project/Performance Site Congressional Districts:

     

Additional Project/Performance Site Location

Organizational Name:

     

DUNS:

     

Street 1:

     

Street 2:

     

City:

     

County:

     

State:

     

Province:

     

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Zip/Postal Code:

     

Project/Performance Site Congressional Districts:

     

Additional Project/Performance Site Location

Organizational Name:

     

DUNS:

     

Street 1:

     

Street 2:

     

City:

     

County:

     

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Province:

     

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Zip/Postal Code:

     

Project/Performance Site Congressional Districts:

     

Additional Project/Performance Site Location

Organizational Name:

     

DUNS:

     

Street 1:

     

Street 2:

     

City:

     

County:

     

State:

     

Province:

     

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Zip/Postal Code:

     

Project/Performance Site Congressional Districts:

     

Additional Project/Performance Site Location

Organizational Name:

     

DUNS:

     

Street 1:

     

Street 2:

     

City:

     

County:

     

State:

     

Province:

     

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Zip/Postal Code:

     

Project/Performance Site Congressional Districts:

     

0925-0001/0002 (Rev. 06/12) Page     Project/Performance Site Format Page

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

BIOGRAPHICAL SKETCH Provide the following information for the Senior/key personnel and other significant contributors in the order listed on Form Page 2. Follow this format for each person. DO NOT EXCEED FOUR PAGES.
NAME		POSITION TITLE
eRA COMMONS USER NAME (credential, e.g., agency login)
EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable.)
INSTITUTION AND LOCATION	DEGREE (if applicable)		MM/YY	FIELD OF STUDY

Please refer to the application instructions in order to complete sections A, B, C, and D of the Biographical Sketch.

0925-0001/0002 (Rev. 06/12) Page Biographical Sketch Format Page

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

0925-0001/0002 (Rev. 06/12) Page Continuation Format Page