Amendment made 01.23.08 to Section I. Funding Opportunity Description, 1. Research Objectives

 

All amendments are made in red.

 

Part I Overview Information

 

United States Department of Health and Human Services (HHS)

 

Issuing Organization

 

Centers for Disease Control and Prevention (NCIRD/CDC), at http://www.cdc.gov/vaccines/about/default.htm



 

Participating Organizations

 

Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov/

 

Components of Participating Organizations

 

National Center for Immunization and Respiratory Diseases (NCIRD/CDC), at http://www.cdc.gov/vaccines/about/default.htm

 

Title: School-based Adolescent Vaccination (UO1)


The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH).  If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information. 


Authority: This program is authorized under section 317 (k) (1) [42 U.S.C. 247b (k) (1)] of the Public Health Service Act, as amended.

 

Announcement Type: New

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Time on the application submission receipt date (see “Key Dates” below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-IP-08-006

Catalog of Federal Domestic Assistance Number(s): 93.185 Immunization Research, Demonstration, Public Information and Education-Training and Clinical Skills Improvement Projects.

 

Key Dates

 

Release/Posted Date: December 20, 2007
 Letter of Intent Receipt Date: Not Applicable
 Application Submission Receipt Date(s): March 19, 2008
Peer Review Date(s): April - May 2008
 Council Review Date(s): May-June 2008

Earliest Anticipated Start Date(s): August 1, 2008

Additional Information to Be Available Date: A conference call will be held with potential applicants on Tuesday, January 22, 2008 at 1:00 pm ET. Phone number 1-866-620-0420, pass code 8943360.

 

 

Due Date for E.O. 12372

 

Due no later than 60 days after the application receipt date.

 

Additional Overview Content


 Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents

 

Part I Overview Information

 Part II Full Text of Announcement

 Section I. Funding Opportunity Description
    1. Research Objectives

Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
        
    2.Cost Sharing or Matching
     3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
    1. Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
         A. Receipt and Review and Anticipated Start Dates
            1. Letter of Intent
        B. Submitting an Application to CDC
        C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
     6. Other Submission Requirements

Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
         A. Additional Review Criteria
        B. Additional Review Considerations
        C. Sharing Research Data
        D. Sharing Research Resources

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements  
         A. Cooperative Agreement

            1. Recipient Rights and Responsibilities
            2. HHS/CDC Responsibilities
            3. Collaborative Responsibilities

    3. Reporting

Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)

    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations


 Part II - Full Text of Announcement

 

Section I. Funding Opportunity Description

 

1. Research Objectives

 

The National Center for Immunization and Respiratory Disease (NCIRD) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area(s) of Immunization and Infectious Diseases and is in alignment with NCIRD performance goal(s) to reduce the number of vaccine-preventable diseases. For more information, www.healthypeople.gov. and http://intra-apps.cdc.gov/fmo/

 

The purpose of the FOA is to seek a cooperative agreement with a state or local public health entity to coordinate and evaluate a school-based adolescent immunization program done in partnership with entities who bill third party payers (for example community vaccinators or medical providers). The state or local public health entity must collaborate with an academic entity to carry out the evaluation.

 

Since 2005, three new vaccines have been licensed and recommended for the adolescent population, including tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap), meningococcal conjugate vaccine (MCV4), and human papillomavirus vaccine (HPV).  Prior to 2005 and currently, adolescents are recommended to receive the measles-mumps-rubella vaccine (MMR), hepatitis B vaccine (HBV), polio vaccine, and varicella vaccine (VZV) if they had not received these vaccines during childhood.

 

Traditionally, vaccination activities have been focused on the infant and older adult populations with little attention given to the adolescent population. The introduction of three new vaccines specifically targeting adolescents will present unique challenges to vaccinating this population. Because adolescents are the least frequent consumer of preventive health services (it is estimated that 30% of adolescents receive no health care in a 12 month period) it is essential to identify effective mechanisms to reach this population.

 

Schools have been proposed as a potential location for accessing and vaccinating large numbers of adolescents. Successful school based vaccination activities to extend protection against hepatitis B have been previously demonstrated.  Because hepatitis B vaccination of adolescents was recommended as a catch-up strategy, programs were by definition time-limited. Ultimately, school entry laws were largely responsible for the dramatic increase in hepatitis B coverage among adolescents in several states.

 

During the past two years, more than 30 U.S. school districts have conducted trial mass influenza vaccination clinics, spurred by the availability of free vaccine from one manufacturer.  However, because these trials were conducted with donated vaccine, they have not addressed aspects of implementation necessary for a sustainable school-based vaccination program, specifically, identification of mechanisms for vaccinators to be reimbursed for vaccine and for vaccine administration.

 

An estimated 40% of children nationally are covered under the Vaccines for Children (VFC) Program (Medicaid,uninsured, or under-insured, or American Indian/Alaska Native). For these children vaccine is provided by the CDC through the state and the vaccine administration fee is covered by Medicaid, by the parent, or waived. The remaining 60% of children are privately insured, and in the traditional medical home vaccine delivery model, their vaccination (vaccine and administration fee) is covered by third party payers. One potential means of creating sustainable school-based vaccination programs would involve a partnership between public health, school personnel, and an entity that would bill third party payers. The latter could administer vaccine, including VFC vaccine, and bill for both vaccine and for administration fees. 

 

Other aspects of implementation have also not been systematically evaluated, including attitudes of parents, school personnel, local physicians, barriers to activities, and amount of work involved in conducting such an activity.

 

With recently recommended and new vaccines for adolescents, developing an adolescent platform for vaccine delivery is becoming increasingly important.  This demonstration project will assist CDC evaluate the feasibility of conducting school based adolescent vaccination activities through the use of partners who engage in billing of third parties. 

 

RFA Objectives

 

NCIRD is soliciting research that will help expand and advance our understanding of evidence-based strategies for improving delivery of vaccinations to adolescents.  To assess the feasibility of conducting school based adolescent vaccination activities, the following research objectives are the focus of this solicitation. The applicants must address all of the following research objectives in the research plan of the application to be considered for funding:

 

 

1.         Evaluate the feasibility of providing adolescent vaccination services in the school setting.

2.         Evaluate the feasibility of billing health insurance plans for reimbursement of school-based vaccination services for insured students.

3.         Determine the cost of conducting school based adolescent vaccination activities.

4.         Evaluate the acceptability of school-based vaccination activities from the perspectives of parents.

5.         Determine vaccine uptake and understand barriers to participation

6.         Implement a school-based vaccination program in collaboration with a partner who bills third parties.

 

The applicant must provide a plan for conducting school based vaccination and an evaluation plan.

 

1.         The plan for conducting school-based vaccination must include:

 

a.         Description of schools that will participate in the demonstration project. 

b.         Method for notifying parents and students about the vaccination services,

c.          Method for obtaining parental consent

d.         Method for obtaining insurance information, and for assessing VFC eligibility status

e.         Method for distributing Vaccine Statements

f.          Method for assessing student’s vaccination history and medical conditions to determine which vaccines are indicated.

g.         Process for vaccine ordering and procedures for vaccine handling, including management by community vaccinator of VFC and of privately purchased vaccine.

h.         Logistics of the clinics, including anticipated months of service; use of a follow-up clinic for children absent from school on the day of the primary vaccination;

i.          Plan for vaccine risk management in case a vaccine adverse event occurs.

j.          Method for recording routinely required recordkeeping information and for sending information to the child’s medical provider or entering into an existing state or local electronic immunization information system (i.e. immunization registry)

k.         The process for billing insurance plans for reimbursement, including handling of denials of claim.

l.          In the case of uninsured students, description of how the vaccinator will be reimbursed for the cost of vaccine and/or the administration fee.

 

2.         The detailed evaluation plan areas of interest should include (but are not limited to):

 

a.         Vaccination process and outcome measures including

•          Number of students enrolled in the school

•          Number of parents contacted and number who provide consent

•          Number of students eligible for adolescent vaccines

•          Number vaccinated at primary and follow-up clinics;

 

b.         Third-party billing information, including:

•          Degree of success in obtaining accurate insurance information

•          Number of claims processed

•          Number of claims successfully reimbursed

•          Number of claims requiring single vs multiple submissions

•          Barriers to billing

•          Revenue generated from such claims

 

c.          Duties performed, hours spent, and costs sustained by public health and school nursing staff, and opportunity costs (specifically routine work activities delayed or not done, and routine educational activities not conducted at school because of the clinic), if any

 

d.         Parent attitudes towards school-based vaccination and reasons for non-vaccination

 

e.         Barriers related to conducting school based vaccination activities (e.g., obtaining parental consent);

 

 

The applicant, (specifically Public Health personnel at the state or local level, ) will work with a partner who bills third partners (may include community vaccinators or medical providers) to provide vaccination services in a minimum of eight middle schools targeting students 11-12 years of age.  Applicants may choose to target a specific grade that coincides with existing state laws requiring vaccines for school entry.  Applicants should provide justification if a specific grade will be targeted; at a minimum, the grade should include students 11-12 years of age.  Applicants may include additional grades/ages. 

 

All ACIP recommended vaccines for adolescents should be made available to the students.  Applicants will work closely with a minimum of eight middle schools to schedule vaccination days, select clinics, inform school personnel, students, and parents about the vaccination days/clinics, provide parents applicable Vaccine Information Statements, and obtain parental consent to administer vaccinations.  

 

When vaccinating insured students, the vaccinator will be expected to bill the student’s insurance plan for reimbursement.  Depending on the state’s vaccine financing policy (e.g. Universal, Universal-select, VFC & underinsured, VFC & underinsured-select, VFC only), claims may be submitted for the cost of the vaccine and/or the administration fee. 

 

The applicant must work with an academic researcher to complete the evaluation component of the project. 

 

The funding provided via this cooperative agreement is designed to pay for a project coordinator and for evaluation only.  These funds cannot be used to purchase vaccine or pay for its administration.

 

Applicants should describe their previous experience in mass school vaccination clinics for any vaccines.

 

 

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

 

1. Mechanism(s) of Support

 

This funding opportunity will use the U01 activity code.

The HHS/CDC U01 is a cooperative agreement assistance instrument. Under the U01 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The participating Centers, Institutes and Offices (CIO)(s) NCIRD intends to commit approximately up to $600,000 including both direct and indirect costs for the first 12-month budget period in FY2008 to fund 1-2 applications. The average award amount will be $300,000 including both direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to 2 years. An applicant may request up to $300,000 for the first 12-month budget period. The approximate total project period funded amount is $1,200,000 for both direct and indirect costs. The anticipated start date for new awards is August 1, 2008.

All estimated funding amounts are subject to availability of funds. Funding may vary by year.

 

The funding provided via this cooperative agreement is to pay for a project coordinator and for evaluation only. These funds must not be used to purchase vaccines or pay for their administration.

 

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

 


 Section III. Eligibility Information

 


 1. Eligible Applicants

1.A. Eligible Institutions

This study focuses on feasibility issues around school-based vaccination, a potential means of efficiently vaccinating large numbers of adolescents.  CDC funds all states, who in turn work with local health departments, to implement comprehensive immunization programs. These state and local public health immunization programs are responsible for leading the implementation of vaccinating adolescents. For this reason, we wish to limit eligibility for this FOA to state and local public health entities. Because this study seeks to understand the feasibility of future activities that will be conducted or coordinated by public health staff, it is critical that it be led by public health.

The state and local public health immunization programs generally do not conduct activities in isolation. Here we request the immunization program partner with a community vaccinator who would bill third party payers for reimbursement for vaccine and administration.  FOA funds will not be directed to the community vaccinators who will receive reimbursement for their efforts in the form of the administration fee from third party payers. The state and local public health immunization program would also collaborate with school nursing staff that will play a support role, but not a lead role. Because state or local public health often does not have the necessary expertise to conduct an evaluation, we are requiring that the applicant collaborate with an academic entity who will conduct the evaluation activities.

Since this study seeks to understand the feasibility of future activities, which will be conducted or coordinated by public health staff, assistance will be provided only to the public health department of:

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.


 2. Cost Sharing or Matching

 

Cost sharing, matching, and cost participation are not required.


 The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc


 3. Other-Special Eligibility Criteria


Application should include the letters of support from:

1.      Partnering entity to conduct school-based vaccination and bill 3rd party payers

2.      Academic institution to conduct evaluation of school-based vaccination

3.      School administration and school nursing to participate in school-based vaccination program

4.      Performing organization about the applicants effective and well-defined working relationship within the organization

 

Place all the letters of support in the appendix of your application.

 

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.


 Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

 

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to Grants.gov/Apply and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at the following:

·          Grants.gov Get Registered,http://www.grants.gov/applicants/get_registered.jsp

·          eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm

 

IMPORTANT: both the applicant organization, as well as, the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov Get Registered,  http://www.grants.gov/applicants/get_registered.jsp

2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply,  http://era.nih.gov/ElectronicReceipt/preparing.htm

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA); although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email:  PGOTIM@cdc.gov

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

 

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/Apply will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:

PHS398 Cover Letter File
Research & Related Sub award Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U01 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

 

3. Submission Dates and Times

See Section IV.3.A for details


 3. A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: Not Applicable

Application Submission Receipt Date(s):  March 19, 2008

Peer Review Date (s): April-May 2008

Council Review Date (s): May - June 2008

Earliest Anticipated Start Date: August 1, 2008

3.A.1. Letter of Intent

 

A letter of intent is not applicable to this funding opportunity announcement.

 

3.B. Submitting an Application to CDC

 

If the instructions in this announcement differ in any way from the SF424 R&R instructions, follow the instructions in this announcement.

 

To submit an application in response to this FOA, applicants should access this FOA via Grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application. 

 

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date.

 

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

 

3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

·          If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.

·          Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken.  Please remember that some warnings may not be applicable or may need to be addressed after application submission.

·          If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

·          If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.

·          Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness and responsiveness by the Coordinating Center for Infectious Diseases (CCID) and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications (see Section 3 for eligibility information).

 

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons. 

4. Intergovernmental Review

Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.

 

5. Funding Restrictions

 

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

 

Restrictions, which applicants must take into account while writing their budgets, are as follows:

 

·          Funds relating to the human subjects research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place. Awardees may not enroll human subjects until they receive a revised Notice of Award from the Procurement and Grants Office lifting the human subject’s restriction on the award.

·          Reimbursement of pre-award costs is not allowed.

·          Cooperative agreement funds will not be made available to purchase vaccines or pay for their administration.


6. Other Submission Requirements

 

Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.  "Award Administration Information”.

 

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement.  If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.  If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately. 

 

Applicants’ plan(s) should address activities they will conduct over the entire project period.

 

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.

 

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments.  Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

 

The following materials may be included in the Appendix:

Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

·          Publications in press:  Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.

·          Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

·          Manuscripts published but a publicly available online journal link is not available:  The entire article may be submitted electronically as a PDF attachment.

·          Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.

·          Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.

 

Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.”

Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

Plan for Sharing Research Data


The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.