oppRFA-DD-18-001-cfda93.073-cidRFA-DD-18-001.pdf

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Research & Related Budget 10YR

Information Analysis, Inc.

D:20061211100028- 05'00'

D:20061211100028- 05'00'

Budget Type:

Enter name of Organization:

Start Date:

End Date:

ORGANIZATIONAL DUNS:

Budget Type is required.

Budget Type is required.

OMB Number: 4040-0001

Expiration Date: 10/31/2019

A. Senior/Key Person

Prefix

First

Middle

Last

Suffix

Base Salary ($)

Months

Cal.

Acad.

Sum.

Requested

Salary ($)

Fringe

Benefits ($)

Funds

Requested ($)

Project Role:

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

Funds

Requested ($)

Fringe

Benefits ($)

Requested

Salary ($)

Sum.

Acad.

Cal.

Months

Post Doctoral Associates

Graduate Students

Undergraduate Students

Secretarial/Clerical

Total Number Other Personnel

Total Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

C. Equipment Description

List items and dollar amount for each item exceeding $5,000

Equipment item

Funds Requested ($)

Total funds requested for all equipment listed in the attached file

Total Equipment

Additional Equipment:

D. Travel

Domestic Travel Costs ( Incl. Canada, Mexico and U.S. Possessions)

1.

Foreign Travel Costs

2.

Total Travel Cost

Funds Requested ($)

E. Participant/Trainee Support Costs

Tuition/Fees/Health Insurance

1.

Stipends

2.

Travel

3.

Subsistence

4.

Other

5.

Funds Requested ($)

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 ($)

Total Indirect Costs

Cognizant Federal Agency

(Agency Name, POC Name, and POC Phone Number)

I. Total Direct and Indirect Costs

Funds Requested ($)

Total Direct and Indirect Institutional Costs (G + H)

J. Fee

Funds Requested ($)

K. Total Costs and Fee

Funds Requested ($)

Total Costs and Fee (I + J)

L. Budget Justification

(Only attach one file.)

Section A, Senior/Key Person

Section C, Equipment

RESEARCH & RELATED BUDGET - Cumulative Budget

Section D, Travel

Domestic

Section E, Participant/Trainee Support Costs

Foreign

Tuition/Fees/Health Insurance

Stipends

Travel

Subsistence

Other

Number of Participants/Trainees

1.

2.

3.

4.

5.

6.

1.

2.

Section F, Other Direct Costs

Materials and Supplies

1.

Publication Costs

2.

Consultant Services

3.

ADP/Computer Services

4.

Subawards/Consortium/Contractual Costs

5.

Equipment or Facility Rental/User Fees

6.

Alterations and Renovations

7.

8.

9.

10.

Totals ($)

Total Number Other Personnel

Total Salary, Wages and Fringe Benefits (A+B)

Other 1

Other 2

Other 3

Section B, Other Personnel

Section J, Fee

Section I, Total Direct and Indirect Costs (G + H)

Section H, Indirect Costs

Section G, Direct Costs (A thru F)

Budget Type is required.

Section K, Total Costs and Fee (I + J)

Mandatory:

T347:

cbSubaward:

ORGANIZATIONAL DUNS: This is the DUNS or DUNS+4 number of the applicant organization. For the project applicant, this field is prepopulated from the R&R SF424 Cover Page. For subaward applicants, this field is a required enterable field.:

Budget Type - Project, Subaward/Consortium: Check the appropriate block.

Project: The budget requested for the primary applicant organization.:

Budget Type - Project, Subaward/Consortium: Check the appropriate block.

Subaward/Consortium: The budget requested for subawardee/consortium organization(s). Note, separate budgets are required only for subawardee/consortium organizations that perform a substantive portion of the project.

If creating Subaward Budget, use the R&R Subaward Budget Attachment and attach as a separate file on the R&R Budget Attachment(s) form. :

PrintButton:

Organization: Pre-populated from the R&R SF424. Enter name of the organization.:

Budget Period End Date: Enter the requested/proposed end date of each budget period. This field is required.:

Budget Period Start Date: Enter the requested/proposed start date of each budget period. This field is required.:

recordno:

Delete Entry:

Check Form for Errors Button: Click here to check form for errors.:

Save Button: Click here to save the form.:

Delete Period: Click here to delete this budget year.:

Next Period: Click here to view the next year.:

Previous Period: Click here to view the previous year.:

Delete Entry:

Prefix: Enter the prefix (e.g., Mr., Mrs., Rev.) for the name of each Senior/Key Person.:

First Name: Enter the first name of the Senior/Key Person. :

Middle Name: Enter the middle name of the Senior/Key Person.:

Last Name: Enter the last (family) name of the Senior/Key Person. :

Suffix: Enter the suffix (e.g., Jr, Sr, PhD) for the name of the Senior/Key Person.:

Base Salary (Senior/Key Person): Enter the annual compensation paid by the employer for each senior/key personnel. This includes all activities such as research, teaching, patient care, or other. You may choose to leave this column blank. :

Calendar Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Academic Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Summer Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Requested Salary (Other Personnel): Regardless of the number of months being devoted to the project, indicate only the amount of salary/wages being requested for each project role.:

Fringe Benefits (Other Personnel):

Enter applicable fringe benefits, if any, for this project role category.:

Indirect Costs Funds Requested: Enter funds requested for each indirect cost type.:

DataEntered:

Additional Project Role Description:

List any additional project role(s) in the blank(s) provided, e.g., Engineer, IT Professionals, etc.:

Next:

Budget Justification: Use the budget justification to provide the additional information requested in each budget category identified above and any other information the applicant wishes to submit to support the budget request. The following budget categories must be justified, where applicable: equipment, travel, participant/trainee support and other direct cost categories. Only one file may be attached. This is a required field.:

Budget Justification - Add Attachment: Click this button to add an attachment. Use the budget justification to provide the additional information requested in each budget category identified above and any other information the applicant wishes to submit to support the budget request. The following budget categories must be justified, where applicable: equipment, travel, participant/trainee support and other direct cost categories. Only one file may be attached. This field is required.:

Budget Justification - Delete Attachment: Click here to delete this attachment.:

Budget Justification - View Attachment: Click here to view this attachment.:

Total Funds requested for all Senior Key Persons in the attached file: Enter the total funds requested for all additional senior/key persons. This is required information.:

Total Senior/Key Person: Total funds requested for all Senior Key Persons.:

FileName:

MimeType:

href:

hashAlgorithm:

HashValue_data:

Number of Personnel Post Doctoral Associates: For each project role category identify the number of personnel proposed. :

Calendar Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Academic Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Summer Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Requested Salary (Other Personnel): Regardless of the number of months being devoted to the project, indicate only the amount of salary/wages being requested for each project role.:

Fringe Benefits (Other Personnel):

Enter applicable fringe benefits, if any, for this project role category.:

Funds Requested (Other Personnel): Enter requested salary/wages & fringe benefits for each project role.:

b_1:

Calendar Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Academic Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Summer Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Requested Salary (Other Personnel): Regardless of the number of months being devoted to the project, indicate only the amount of salary/wages being requested for each project role.:

Fringe Benefits (Other Personnel):

Enter applicable fringe benefits, if any, for this project role category.:

Funds Requested (Other Personnel): Enter requested salary/wages & fringe benefits for each project role.:

Number of Personnel Graduate Students:

For each project role category identify the number of personnel proposed. :

b_2:

Calendar Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Academic Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Summer Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Requested Salary (Other Personnel): Regardless of the number of months being devoted to the project, indicate only the amount of salary/wages being requested for each project role.:

Fringe Benefits (Other Personnel):

Enter applicable fringe benefits, if any, for this project role category.:

Funds Requested (Other Personnel): Enter requested salary/wages & fringe benefits for each project role.:

Number of Personnel Undergraduate Students:

For each project role category identify the number of personnel proposed. :

b_3:

Calendar Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Academic Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Summer Months (Other Personnel): Identify the number of months devoted to the project in the applicable box for each project role category; i.e., calendar, academic, summer.:

Requested Salary (Other Personnel): Regardless of the number of months being devoted to the project, indicate only the amount of salary/wages being requested for each project role.:

Fringe Benefits (Other Personnel):

Enter applicable fringe benefits, if any, for this project role category.:

Funds Requested (Other Personnel): Enter requested salary/wages & fringe benefits for each project role.:

Number of Personnel Secretarial/Clerical: Enter the number of personnel proposed for this project role category. In most circumstances, the salaries of administrative or clerical staff at educational institutions and nonprofit organizations are included as part of indirect costs. Examples, however, of situations where direct charging of administrative or clerical staff salaries may be appropriate may be found at: http://www.whitehouse.gov/omb/circulars/a021/a21_2004.html#exc. The circumstances for requiring direct charging of these services must be clearly described in the budget justification.:

b_4:

Number of Personnel ADDITIONAL PROJECT ROLE(S):

For each project role category identify the number of personnel proposed. :

Total Number Other Personnel: This total will auto-calculate. Total Number of Personnel.:

Total Other Personnel: Total Funds requested for all Other Personnel.:

Total Salary, Wages, & Fringe Benefits (A & B): Total Funds requested for all Senior Key Persons and all Other Personnel.:

Equipment Item: Equipment is defined as an item of property that has an acquisition cost of $5,000 or more (unless the organization has established lower levels) and an expected service life of more than one year. List each item of equipment separately and justify each in the budget justification section. Allowable items ordinarily will be limited to research equipment and apparatus not already available for the conduct of the work. General-purpose equipment, such as a personal computer, is not eligible for support unless primarily or exclusively used in the actual conduct of scientific research.:

Total Equipment: Total Funds requested for all equipment.:

Total funds requested for all equipment listed in the attached file: Dollar amount for item should exceed $5000.:

Domestic Travel Costs: Identify the total funds requested for domestic travel. Domestic travel includes Canada, Mexico and US Possessions. In the budget justification section, include purpose, destination, dates of travel (if known) and number of individuals for each trip. If the dates of travel are not known, specify estimated length of trip (e.g., 3 days).:

Foreign Travel Costs: Identify the total funds requested for foreign travel. Foreign travel includes any travel outside of North America and/or US Possessions. In the budget justification section, include purpose, destination, dates of travel (if known) and number of individuals for each trip. If the dates of travel are not know, specify estimated length of trip (e.g., 3 days).:

Total Travel Cost: Total Funds requested for all travel.:

Participant/Trainee Tuition/Fees/Health Insurance: List total funds requested for Participant/Trainee Tuition/Fees/Health Insurance.:

Participant/Trainee Stipends: List total funds requested for Participant/Trainee Stipends.:

Participant/Trainee Travel: List total funds requested for Participant/Trainee Travel.:

Participant/Trainee Subsistence: List total funds requested for Participant/Trainee Subsistence.:

Other Participant/Trainee Costs (Specify): Describe any other participant trainee funds requested.:

Other Participant/Trainee Costs: List total funds requested for any other Participant/Trainee costs described.:

Number of Participants/Trainees: List total number of proposed participant/trainees, value cannot be greater than 9999.:

Total Participant/Trainee Costs:

Total funds requested for all trainee costs. This field is required if any data has been entered in section E.:

1. Materials and Supplies: List total funds requested for materials & supplies. In the budget justification, indicate general categories such as glassware, chemicals, animal costs, including an amount for each category. Categories less than $1,000 are not required to be itemized.:

2. Publication Costs: List the total publication funds requested. The proposal budget may request funds for the costs of documenting, preparing, publishing or otherwise making available to others the findings and products of the work conducted under the award. In the budget justification include supporting information.:

3. Consultant Services: List the total costs for all consultant services. In the budget justification, identify each consultant, the services he/she will perform, total number of days, travel costs, and total estimated costs. :

4. ADP/Computer Services: List total funds requested for ADP/Computer Services. The cost of computer services, including computer-based retrieval of scientific, technical and education information may be requested. In the budget justification, include the established computer service rates at the proposing organization if applicable. :

5. Subawards/Consortium/Contractual Costs: List total funds requested for 1) all subaward/consortium organization(s) proposed for the project and 2) any other contractual costs proposed for the project.:

6. Equipment or Facility Rental/User Fees: List total funds requested for Equipment or Facility Rental/User Fees. In the budget justification, identify each rental user fee and justify.:

7. Alterations and Renovations: List total funds requested for Alterations & Renovations. In the budget justification, itemize, by category and justify the costs of alterations and renovations including repairs, painting, removal or installation of partitions, shielding, or air conditioning. Where applicable, provide the square footage and costs. :

"Other" (Specify): Add text to describe any "other" Direct Costs not requested above. Use the budget justification to further itemize and justify.:

"Other" Funds Requested: List total funds requested for items 8-10 "Other.":

"Other" (Specify): Add text to describe any "other" Direct Costs not requested above. Use the budget justification to further itemize and justify.:

"Other" Funds Requested: List total funds requested for items 8-10 "Other.":

"Other" (Specify): Add text to describe any "other" Direct Costs not requested above. Use the budget justification to further itemize and justify.:

"Other" Funds Requested: List total funds requested for items 8-10 "Other.":

Total Other Direct Costs: Total Funds requested for all other direct costs.:

Total Direct Costs (A -F): Total Funds requested for all direct costs.:

Indirect Cost Type: Indicate the type of base; e.g., Salary & Wages, Modified Total Direct Costs, Other (explain). Also indicate if Off-site. If more than one rate/base is involved, use separate lines for each. If you do not have a current indirect rate(s) approved by a Federal agency, indicate "None--will negotiate" and include information for a proposed rate. Use the budget justification if additional space is needed.:

Indirect Cost Rate (%): Indicate the most recent Indirect Cost rate(s) (also known as Facilities & Administrative Costs [F&A]) established with the cognizant Federal office, or in the case of for-profit organizations, the rate(s) established with the appropriate agency. If you have a cognizant/ oversight agency and are selected for an award, you must submit your indirect rate proposal to that office for approval. If you do not have a cognizant/oversight agency, contact the awarding agency.:

Indirect Cost Base ($): Enter the amount of the base for each indirect cost type.:

Indirect Costs: Total Funds requested for indirect costs.:

Cognizant Agency (Agency Name, POC Name and Phone Number): Enter the name of the cognizant Federal Agency, name & phone number of the individual responsible for negotiating your rate. If no cognizant agency is known, enter "None".:

Total Direct and Indirect Costs (G & H): Total Funds requested for direct and indirect costs.:

Fee: Generally, a fee is not allowed on a grant or cooperative agreement. Do not include a fee in your budget, unless the program announcement specifically allows the inclusion of a "fee" (e.g., SBIR/STTR). If a fee is allowable, enter the requested fee.:

Total Costs and Fee (I + J): Total Funds requested for direct and indirect costs plus fee. :

Next Period: Click here to view the next year.:

Add Period: Click here to add another budget period.:

Section A, Senior/Key Person: Cumulative Total Funds requested for all Senior Key Persons.:

Section B, Other Personnel: Cumulative Total Funds requested for all Other Personnel.:

Total Number Other Personnel: The cumulative total number of other Personnel.:

Total Salary, Wages, & Fringe Benefits(A & B): Cumulative Total Funds requested for all Senior Key Persons and all Other Personnel.:

Section C, Equipment: Cumulative Total Funds requested for all equipment.:

Section D, Travel: Cumulative Total Funds requested for all travel.:

Domestic Travel Costs: The cumulative total funds requested for domestic travel.:

Foreign Travel Costs: The cumulative total funds requested for foreign travel.:

Section E, Participant/Trainee Support Costs: The cumulative total funds requested for all trainee costs.:

Participant/Trainee Tuition/Fees/Health Insurance: The cumulative total funds requested for Participant/Trainee Tuition/Fees/Health Insurance.:

Participant/Trainee Stipends: The cumulative total funds requested for Participant/Trainee Stipends.:

Participant/Trainee Travel: The cumulative total funds requested for Participant/Trainee Travel.:

Participant/Trainee Subsistence: The cumulative total funds requested for Participant/Trainee Subsistence.:

Other Participant/Trainee Costs: The cumulative total funds requested for any other Participant/Trainee costs described.:

Number of Participants/Trainees: The cumulative total number of proposed participant/trainees, value cannot be greater than 9999.:

Section F, Other Direct Costs: The cumulative total funds requested for all other direct costs.:

Materials and Supplies: The cumulative total funds requested for materials & supplies.:

Publication Costs: The cumulative total publication funds requested.:

Consultant Services: The cumulative total costs for all consultant services.:

ADP/Computer Services: The cumulative total funds requested for ADP/Computer Services.:

Subaward/Consortium/Contractual Costs: The cumulative total funds requested for 1) all subaward/consortium organization(s) proposed for the project and 2) any other contractual costs proposed for the project.:

Equipment or Facility Rental/User Fees: The cumulative total funds requested for Equipment or Facility Rental/Use Fees.:

Alterations and Renovations: The cumulative total funds requested for Alterations & Renovations.:

Other1: The cumulative total funds requested in line 8 or the first Other Direct Cost Category.:

Other2: The cumulative total funds requested in line 9 or the second Other Direct Cost Category.:

Other3: The cumulative total funds requested in line 10 or the third Other Direct Cost Category.:

Section G, Total Direct Costs (A -F): The cumulative total funds requested for all direct costs.:

Section H, Total Indirect Costs: Cumulative Total Funds requested for indirect costs.:

Section I, Total Direct and Indirect Institutional Costs (G - H): The cumulative total funds requested for direct and indirect costs.:

Section J, Fee: The cumulative total funds requested for fees.:

Section K, Total Costs and Fee (I + J): The cumulative total funds requested for direct and indirect costs plus fee.:

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Planned Enrollment Report

D:20060509122150- 04'00'

D:20060509122150- 04'00'

OMB Number: 0925-0001

Expiration Date: 03/31/2020

Study Record: PHS Human Subjects and Clinical Trials Information

* Always required field

Section 1 - Basic Information

1.1. * Study Title (each study title must be unique)

1.2. * Is this Study Exempt from Federal Regulations?

1.3. Exemption Number

1.4. * Clinical Trial Questionnaire

If the answers to all four questions below are yes, this study meets the definition of a Clinical Trial.

1.4.a. Does the study involve human participants?

1.4.b. Are the participants prospectively assigned to an intervention?

1.4.c. Is the study designed to evaluate the effect of the intervention on the participants?

1.4.d. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

1.5. Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable

Section 2 - Study Population Characteristics

2.1. Conditions or Focus of Study

2.2. Eligibility Criteria

2.3. Age Limits

Minimum Age

Maximum Age

2.4. Inclusion of Women, Minorities, and Children

2.5. Recruitment and Retention Plan

2.6. Recruitment Status

2.7. Study Timeline

2.8. Enrollment of First Subject

Inclusion Enrollment Report(s)

Inclusion Enrollment Report

1. * Using an Existing Dataset or Resource

2. * Enrollment Location Type

3. Enrollment Country(ies)

4. Enrollment Location(s)

5. Comments

Planned

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female

Male

Hispanic or Latino

Female

Male

Total

American Indian/

Alaska Native

Asian

Native Hawaiian or

Other Pacific Islander

Black or African

American

White

More than One Race

Total

Cumulative (Actual)

Racial Categories

Ethnic Categories

Not Hispanic or Latino

Female

Male

Unknown/

Not

Reported

Hispanic or Latino

Female

Male

Unknown/

Not

Reported

Unknown/Not Reported Ethnicity

Female

Male

Unknown/

Not

Reported

Total

American Indian/

Alaska Native

Asian

Native Hawaiian or

Other Pacific Islander

Black or African

American

White

More than One Race

Unknown or Not Reported

Total

Report of

Section 3 - Protection and Monitoring Plans

3.1. Protection of Human Subjects

3.2. Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

If yes, describe the single IRB plan

3.3. Data and Safety Monitoring Plan

3.4. Will a Data and Safety Monitoring Board be appointed for this study?

3.5. Overall Structure of the Study Team

Section 4 - Protocol Synopsis

4.1. Brief Summary

4.2. Study Design

4.2.a. Narrative Study Description

Narrative Study Description: Enter the narrative study description.

4.2.b. Primary Purpose

4.2.c. Interventions

Intervention Type

Name

Description

4.2.d. Study Phase

Is this an NIH-defined Phase III clinical trial?

4.2.e. Intervention Model

4.2.f. Masking

4.2.g. Allocation

4.3. Outcome Measures

Name

Type

Time Frame

Brief Description

4.4. Statistical Design and Power

4.5. Subject Participation Duration

4.6. Will the study use an FDA-regulated intervention?

4.6.a. If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status

4.7. Dissemination Plan

Section 5 - Other Clinical Trial-related Attachments

5.1. Other Clinical Trial-related Attachments

Form Attachments:

XDPFirstField:

Mandatory:

Check Form for Errors Button: Click here to check form for errors.:

Save Button: Click here to save the form.:

Study Title: Enter a unique title that describes the study that the participants are involved in. This is a required field.:

Is the Project Exempt from Federal regulations is required.:

Is the Study Exempt from Federal regulations? - Yes: Check to select.:

Is the Study Exempt from Federal regulations? - No: Check to select.:

T240:

Exemption Number 1: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 2: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 3: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 4: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 5: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 6: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 7: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

Exemption Number 8: Select the appropriate exemption number(s) for this particular study. Multiple selections are permitted. See agency-specific instructions for additional guidance. :

ExemptionNumber:

HumanSubjectsIndicator_Req:

Does the study involve human participants? - Yes: Check to select. See agency-specific instructions for additional guidance. :

Does the study involve human participants? - No: Check to select. See agency-specific instructions for additional guidance. :

InterventionAssigned_Req:

Are the participants prospectively assigned to an intervention? - Yes: Check to select.:

Are the participants prospectively assigned to an intervention? - No: Check to select.:

EvaluateIntervention_Req:

Is the study designed to evaluate the effect of the intervention on the participants? - Yes: Check to select. See agency-specific instructions for additional guidance. :

Is the study designed to evaluate the effect of the intervention on the participants? - No: Check to select. See agency-specific instructions for additional guidance.:

HealthRelatedOutcome_Req:

Is the effect that will be evaluated a health-related biomedical or behavioral outcome? - Yes: Check to select. See agency-specific instructions for additional guidance. :

Is the effect that will be evaluated a health-related biomedical or behavioral outcome? - No: Check to select. See agency-specific instructions for additional guidance. :

ClinicalTrials.gov Identifier: Provide the ClinicalTrials.gov Identifier (e.g., NCT87654321) for this trial, if applicable.:

DataEntered:

Delete: Click to delete this entry.:

Conditions or Focus of Study: Identify the name(s) of the condition(s) you are studying or the focus of the study. See funding opportunity announcement and agency-specific instructions for additional guidance. :

Add New Intervention: Click to add another Intervention entry.:

Eligibility Criteria: List the study's inclusion and exclusion criteria. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Maximum Age: Enter the maximum participant age.:

Maximum Age Type: Provide the relevant unit of time.:

Inclusion of Women, Minorities, and Children: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Inclusion of Women, Minorities, and Children - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Inclusion of Women, Minorities, and Children - View Attachment: Click to view this attachment.:

Inclusion of Women, Minorities, and Children - Delete Attachment: Click to delete this attachment.:

FileName:

MimeType:

href:

hashAlgorithm:

HashValue_data:

Recruitment and Retention Plan: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Recruitment and Retention Plan - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Recruitment and Retention Plan - View Attachment: Click to view this attachment.:

Recruitment and Retention Plan - Delete Attachment: Click to delete this attachment.:

Recruitment Status: Select one.:

Study Timeline: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Study Timeline - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Study Timeline - View Attachment: Click to view this attachment.:

Study Timeline - Delete Attachment: Click to delete this attachment.:

Add Inclusion Enrollment Report: Click to add the Inclusion Enrollment Report.:

Enrollment of First Subject: Enter the date in the format MM/DD/YYYY. :

Anticipated or Actual: Select one.:

Remove Inclusion Enrollment Report: Click to remove the Inclusion Enrollment Report.:

Using Existing Dataset or Resource is required.:

Using Existing Dataset or Resource - Yes: Check "Yes" if this study involves use of an existing dataset or resource. See agency-specific instructions for additional guidance.:

Using Existing Dataset or Resource - No: Check "No" if this study does not involve use of an existing dataset or resource. See agency-specific instructions for additional guidance.:

Enrollment Location Type is required.:

Enrollment Location - Foreign: Select "Foreign" if the participants described in the study are based at a non-U.S. site. Participants at U.S. and non-U.S. sites must be reported separately even if for the same study. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Enrollment Location - Domestic: Select "Domestic" if the participants described in the study are based at a U.S. site. Participants at U.S. and non-U.S. sites must be reported separately even if for the same study. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Enrollment Countries: Select the enrollment countries. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Enrollment Location(s): Enter the enrollment location(s) for participants (e.g., hospital, university, research center). See funding opportunity announcement and agency-specific instructions for additional guidance.:

Comments: Maximum 500 characters. See funding opportunity announcement and agency-specific instructions for additional guidance.:

American Indian Not Hispanic Female: Enter the number of females who are American Indian/Alaska Native and Not Hispanic or Latino.:

Asian Not Hispanic Female: Enter the number of females who are Asian and Not Hispanic or Latino.:

Hawaiian Not Hispanic Female: Enter the number of females who are Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino.:

Black Not Hispanic Female: Enter the number of females who are Black or African American and Not Hispanic or Latino.:

White Not Hispanic Female: Enter the number of females who are White and Not Hispanic or Latino.:

More than One Race Not Hispanic Female: Enter the number of females who identify with more than one racial category and are Not Hispanic or Latino.:

NotHispanicFemaleisValid:

Total Not Hispanic or Latino Female: This field is auto-calculated to total all racial categories for females who are Not Hispanic or Latino.:

American Indian Not Hispanic Male: Enter the number of males who are American Indian/Alaska Native and Not Hispanic or Latino.:

Asian Not Hispanic Male: Enter the number of males who are Asian and Not Hispanic or Latino. :

Hawaiian Not Hispanic Male: Enter the number of males who are Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino. :

Black Not Hispanic Male: Enter the number of males who are Black or African American and Not Hispanic or Latino.:

White Not Hispanic Male: Enter the number of males who are White and Not Hispanic or Latino.:

More than One Race Not Hispanic Male: Enter the number of males who identify with more than one racial category and are Not Hispanic or Latino.:

Total Not Hispanic or Latino Male: This field is auto-calculated to total all racial categories for males who are Not Hispanic or Latino.:

NotHispanicMaleisValid:

American Indian Hispanic Female: Enter the number of females who are American Indian/Alaska Native and Hispanic or Latino.:

Asian Hispanic Female: Enter the number of females who are Asian and Hispanic or Latino.:

Hawaiian Hispanic Female: Enter the number of females who are Native Hawaiian or Other Pacific Islander and Hispanic or Latino.:

Black Hispanic Female: Enter the number of females who are Black or African American and Hispanic or Latino.:

White Hispanic Female: Enter the number of females who are White and Hispanic or Latino.:

More than One Race Hispanic Female: Enter the number of females who identify with more than one racial category and are Hispanic or Latino.:

Total Hispanic or Latino Female: This field is auto-calculated to total all racial categories for females who are Hispanic or Latino.:

HispanicFemaleisValid:

American Indian Hispanic Male: Enter the number of males who are American Indian/Alaska Native and Hispanic or Latino.:

Asian Hispanic Male: Enter the number of males who are Asian and Hispanic or Latino.:

Hawaiian Hispanic Male: Enter the number of males who are Native Hawaiian or Other Pacific Islander and Hispanic or Latino.:

Black Hispanic Male: Enter the number of males who are Black or African American and Hispanic or Latino.:

White Hispanic Male: Enter the number of males who are White and Hispanic or Latino.:

More than One Race Hispanic Male: Enter the number of males who identify with more than one racial category and are Hispanic or Latino.:

Total Hispanic or Latino Male: This field is auto-calculated to total all racial categories for males who are Hispanic or Latino.:

HispanicMaleisValid:

Total American Indian/Alaska Native: This field is auto-calculated to total all American Indian/Alaska Natives. This is a required field. :

Total Asian: This field is auto-calculated to total all Asians.:

Total Hawaiian or Other Pacific Islander: This field is auto-calculated to total all Native Hawaiian or Other Pacific Islanders.:

Total Black or African American: This field is auto-calculated to total all Black or African Americans.:

Total White: This field is auto-calculated to total all Whites.:

Total More than One Race: This field is auto-calculated to total all individuals who identify with more than one racial category.:

Total: This field is auto-calculated to total all participants in all categories.:

Unknown Race Not Hispanic Female: Enter the number of females whose race is unknown/not reported and are Not Hispanic or Latino.:

Unknown Race Not Hispanic Male: Enter the number of males whose race is unknown/not reported and are Not Hispanic or Latino.:

American Indian Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are American Indian/Alaska Native and Not Hispanic or Latino.:

Asian Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Asian and Not Hispanic or Latino.:

Hawaiian Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Native Hawaiian or Other Pacific Islander and Not Hispanic or Latino.:

Black Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Black or African American and Not Hispanic or Latino.:

White Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are White and Not Hispanic or Latino.:

More than One Race Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who identify with more than one racial category and are Not Hispanic or Latino.:

Unknown Race Not Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender, unknown/not reported race, and are Not Hispanic or Latino.:

Total Not Hispanic or Latino Unknown Sex: This field is auto-calculated to total all racial categories for individuals of unknown/not reported sex/gender who are Not Hispanic or Latino.:

NotHispanicUnknownGenderisValid:

Unknown Race Hispanic Female: Enter the number of females whose race is unknown/not reported and are Hispanic or Latino.:

Unknown Race Hispanic Male: Enter the number of males whose race is unknown/not reported and are Hispanic or Latino.:

American Indian Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are American Indian/Alaska Native and Hispanic or Latino.:

Asian Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Asian and Hispanic or Latino.:

Hawaiian Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Native Hawaiian or Other Pacific Islander and Hispanic or Latino.:

Black Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Black or African American and Hispanic or Latino.:

White Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are White and Hispanic or Latino.:

More than One Race Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who identify with more than one racial category and are Hispanic or Latino.:

Unknown Race Hispanic Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender, unknown race, and Hispanic or Latino.:

Total Hispanic or Latino Unknown Sex: This field is auto-calculated to total all racial categories for individuals of unknown/not reported sex/gender who are Hispanic or Latino.:

HispanicUnknownGenderisValid:

American Indian Unknown Ethnicity Female: Enter the number of females who are American Indian/Alaska Native and of unknown/not reported ethnicity.:

Asian Unknown Ethnicity Female: Enter the number of females who are Asian and of unknown/not reported ethnicity.:

Hawaiian Unknown Ethnicity Female: Enter the number of females who are Native Hawaiian or Other Pacific Islander and of unknown/not reported ethnicity.:

Black Unknown Ethnicity Female: Enter the number of females who are Black or African American and of unknown/not reported ethnicity.:

White Unknown Ethnicity Female: Enter the number of females who are White and of unknown/not reported ethnicity.:

More than One Race Unknown Ethnicity Female: Enter the number of females who identify with more than one racial category and of unknown/not reported ethnicity.:

Unknown Race Unknown Ethnicity Female: Enter the number of females of unknown/not reported race and of unknown/not reported ethnicity.:

Total Unknown Ethnicity Female: This field is auto-calculated to total all racial categories for females of unknown/not reported ethnicity.:

UnknownEthnicityFemaleisValid:

American Indian Unknown Ethnicity Male: Enter the number of males who are American Indian/Alaska Native and of unknown/not reported ethnicity.:

Asian Unknown Ethnicity Male: Enter the number of males who are Asian and of unknown/not reported ethnicity.:

Hawaiian Unknown Ethnicity Male: Enter the number of males who are Native Hawaiian or Other Pacific Islander and of unknown/not reported ethnicity.:

Black Unknown Ethnicity Male: Enter the number of males who are Black or African American and of unknown/not reported ethnicity.:

White Unknown Ethnicity Male: Enter the number of males who are White and of unknown/not reported ethnicity.:

More than One Race Unknown Ethnicity Male: Enter the number of males who identify with more than one racial category and of unknown/not reported ethnicity.:

Unknown Race Unknown Ethnicity Male: Enter the number of males of unknown/not reported race and of unknown/not reported ethnicity.:

Total Unknown Ethnicity Male: This field is auto-calculated to total all racial categories for males of unknown/not reported ethnicity.:

UnknownEthnicityMaleisValid:

American Indian Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are American Indian/Alaska Native and of unknown/not reported ethnicity.:

Asian Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Asian and of unknown/not reported ethnicity.:

Hawaiian Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Native Hawaiian or Other Pacific Islander and of unknown/not reported ethnicity.:

Black Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are Black or African American and of unknown/not reported ethnicity.:

White Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who are White and of unknown/not reported ethnicity.:

More than One Race Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender who identify with more than one racial category and of unknown/not reported ethnicity.:

Unknown Race Unknown Ethnicity Unknown Sex: Enter the number of individuals of unknown/not reported sex/gender, unknown/not reported race, and unknown/not reported ethnicity.:

Total Unknown Ethnicity Unknown Sex: This field is auto-calculated to total all racial categories for individuals of unknown/not reported sex/gender and unknown/not reported ethnicity.:

UnknownEthnicityUnknownGenderisValid:

Total Unknown Race: This field is auto-calculated to total individuals of unknown/not reported race.:

Previous Report: Click to move to the previous report entry.:

CurrentPageNumber:

TotalPages_PHS_CIReport:

Next Report: Click to add or move to the next report entry.:

First Report: Click to move to the first report entry.:

Last Report: Click to move to the last report entry.:

Protection of Human Subjects - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance. :

Protection of Human Subjects - View Attachment: Click to view this attachment.:

Protection of Human Subjects - Delete Attachment: Click to delete this attachment.:

Protection of Human Subjects:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance. :

Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site - Yes: See agency-specific instructions for additional guidance.:

Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site - No: See agency-specific instructions for additional guidance.:

Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site - Not Applicable: See agency-specific instructions for additional guidance.:

Single IRB plan: Attach PDF formatted file. If yes, attach a PDF formatted file describing the single IRB plan. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Single IRB plan - Add Attachment:

Attach PDF formatted file. If yes, attach a PDF formatted file describing the single IRB plan. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Single IRB plan - Delete Attachment: Click to delete this attachment.:

Single IRB plan - View Attachment: Click to view this attachment.:

Data and Safety Monitoring Plan: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Data and Safety Monitoring Plan - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Data and Safety Monitoring Plan - View Attachment: Click to view this attachment.:

Data and Safety Monitoring Plan - Delete Attachment: Click to delete this attachment.:

Will a Data and Safety Monitoring Board be appointed for this study is required.:

Will a Data and Safety Monitoring Board be appointed for this study? - Yes: Select Yes if a Data and Safety Monitoring Board will be appointed for this study.:

Will a Data and Safety Monitoring Board be appointed for this study? - No: Select No if a Data and Safety Monitoring Board will not be appointed for this study.:

Overall Structure of the Study Team: Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Overall Structure of the Study Team - Add Attachment:

Attach PDF formatted file. See funding opportunity announcement and agency-specific instructions for additional guidance.:

Overall Structure of the Study Team - View Attachment: Click to view this attachment.:

Overall Structure of the Study Team - Delete Attachment: Click to delete this attachment.:

Brief Summary: Enter a brief description of objectives of the protocol, including the primary and secondary endpoints.:

Narrative Study Description: Enter the narrative study description of the protocol. See agency-specific instructions for additional guidance.:

Primary Purpose: Select one.:

tabNext:

tabPrev:

Other Primary Purpose: Enter description. This field is required if Primary Purpose is Other.:

Intervention Type: Select one.:

Name: Enter the name of the intervention.:

Description: Enter a description of the intervention.:

Study Phase: Select one.:

Other Study Phase: Enter description. This field is required if Study Phase is Other.:

Is this an NIH-defined Phase III clinical trial? - Yes: See agency-specific instructions for additional guidance.:

Is this an NIH-defined Phase III clinical trial? - No: See agency-specific instructions for additional guidance.:

Intervention Model: Select one.:

Other Intervention Model: Enter description. This field is required if Intervention Model is Other.:

Masking - Yes: See agency-specific instructions for additional guidance.:

Masking - No: See agency-specific instructions for additional guidance.:

Masking Type is required if Masking is Yes.:

Participant: Check to select.