Part I Overview Information

 

United States Department of Health and Human Services (HHS)

 

Issuing Organization

 

Centers for Disease Control and Prevention, Coordinating Office for Global Health (CDC/COGH) at http://www.cdc.gov/cogh/aboutus.htm   

 

Organizations

 

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


Components of Participating Organizations

 

Coordinating Office for Global Health (COGH) at http://www.cdc.gov/cogh/aboutus.htm

National Center for Immunization and Respiratory Diseases (NCIRD) at http://www.cdc.gov/ncird/overview.htm

National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP) at http://www.cdc.gov/nchhstp/

National Center for Zoonotic, Vector-Borne, and Enteric Diseases (NZVED) at http://www.cdc.gov/nczved/

National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID) at http://www.cdc.gov/ncpdcid/

    

Title: Strenthening Infectious-Disease Research Capacity for Public- Health Action in Guatemala and Central America (U01)  


The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement can differ from those used by the HHS National Institutes of Health (NIH).  If an HHS/CDC policy does not exist to cover an applicable topic, or is in the drafting process, HHS/CDC hereby adopts the HHS/NIH policy, which will be applicable to that particular topic.  In addition, if written guidance for completing this application is not available on the HHS/CDC website, then HHS/CDC/COGH will direct applicants elsewhere for that information. 

 
Authority: Section 307 of the Public Health Service Act [42 USC 242l], as amended

 

Announcement Type: New

Instructions for Submission of Electronic Research Applications:

NOTICE: Interested parties may submit electronic applications in response to this Funding Opportunity Announcement (FOA) for Federal assistance through Grants.gov (http://www.grants.gov) by using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

Applicants must read this FOA 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 should start the process at least four weeks prior to the deadline for submission of the grant. See Section IV.

Two steps are required for on time submission:

1) Grants.gov must successfully receive the application no later than 5:00 p.m. Eastern Standard 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 e-mail can be unreliable, it is the responsibility of applicants to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-GH-09-001

Catalog of Federal Domestic Assistance Number(s): 93.283 Centers for Disease Control and Prevention Investigations and Technical Assistance

 

Key Dates
 

Release/Posted Date:
Letter of Intent Receipt Date: Not applicable.
Application Submission Receipt Date(s): Feb. 4, 2009.  
Peer Review Date(s): March-April 2009.
Council Review Date(s): April-May 2009.

Earliest Anticipated Start Date(s):  August 1, 2009.

Additional Information to Be Available Date: Not applicable.

Expiration Date: February 5, 2009.

 

Due Date for E.O. 12372

 

Executive Order 12372 does not apply to this program.

 

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
        B. Eligible Individuals
    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 HHS/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 Coordinating Office for Global Health (COGH) of HHS/CDC 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 Food Safety; Health Communication; HIV; Immunization and Infectious Diseases; Maternal, Infant and Child Health; Public Health Infrastructure; Respiratory Diseases; and Sexually Transmitted Diseases, and is in alignment with HHS/CDC performance goal(s) to protect Americans from infectious diseases by providing global health promotion, health protection and health diplomacy. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

 

The HHS/CDC/COGH is seeking a cooperative agreement with the Center for Health Studies of the Institute for Research of the Universidad del Valle de Guatemala (UVG) to strengthen capacity in Guatemala and Central America to address the following goals:

 

1.  To conduct field and laboratory research on important human infectious diseases, with an emphasis on emerging and re-emerging infectious diseases as well as other identifiable public health problems.

2. To incorporate the results of research into operational disease prevention and control programs in Guatemala and Central America and ensure sharing of expertise and research findings with other nations. 

 

Projects may be developed as part of this Research Cooperative Agreement addressing the following public health issues:

 

1.         Improving local, national and regional capacity to detect newly emerging diseases, especially influenza, through the implementation of surveillance and the development and evaluation of sensitive and specific diagnostic tests;

2.         Identifying modifiable risk factors for priority infectious diseases in Guatemala and Central America, including influenza, other respiratory, vector-borne, diarrheal, and other water- and food-borne illnesses;

3.         Assessing and monitor antimicrobial resistance, including drug resistance to antivirals used to treat influenza, in emerging infectious pathogens in Guatemala and the region;

4.         Evaluating vaccines to prevent influenza, other respiratory, vector-borne, diarrheal, and other infectious diseases, including water- and food-borne illnesses;

5.         Strengthening the capacity of local, national and regional Governments in Guatemala and the Central American region to respond to infectious-disease threats;

6.         Determining the efficacy and effectiveness of disease prevention programs for key syndromes or pathogens in Central America.

 

Applicants may propose a variety of projects that address these issues.  Within each project, applicants must submit separate Research Plans and budgets for each project. Applicants must provide assurance of coordinated management and administrative support for the various projects.

 

Each project should focus on a single infectious disease or a group of diseases that are clinically or functionally related.

 

For each project proposed, the focus should be on infectious diseases of particular importance and impact in Guatemala and the Central America region.  Applicants may propose new projects, as well as those aimed at continuing and enhancing ongoing activities to address emerging diseases in Guatemala and Central America.  This includes disease surveillance, epidemiology, lab-based studies, and the evaluation of prevention or therapeutic strategies for the following:

•           Diarrheal or enteric illnesses like cholera, Shigella-associated dysentery, typhoid, rotavirus, and enterotoxigenic E. coli;

•           Pneumonia and other respiratory infections, with a particular focus on influenza, Streptococcus pneumoniae, Haemophilus influenzae, respiratory syncytial virus, parainfluenza, adenovirus, and metapneumovirus;

•           Vector-borne diseases, including visceral leishmaniasis, dengue, malaria, and filariasis; and

•           Encephalitis, Japanese encephalitis virus, West Nile virus, and others.

 

In a cooperative agreement, HHS/CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring.

 

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) of  HHS/CDC intend to commit approximately $4,400,000 for direct costs in Fiscal Year (FY) 2009 to fund one application.  Indirect costs are not allowed.  The average award amount will be approximately $4,400,000, which includes direct costs for the first 12-month budget period broken down as follows:

HHS/CDC/NCIRD - $1,700,000 to support activities related to influenza and other respiratory diseases

HHS/CDC/NCHHSTP – $1,500,000 to support activities related to HIV/AIDS

HHS/CDC/NCPDCID - $700,000 to support activities related to emerging infectious diseases

HHS/CDC/NCZVED - $500,000 to support activities related to malaria and Histoplasmosis

An applicant may request a project period of up to three years.  An applicant may request up to $4,400,000 for the first 12-month budget period. The approximate total project period funded amount is a maximum of $13,200,000, over a three-year period. The anticipated start date for new awards is August 1, 2009.

All estimated funding amounts are subject to availability of funds. The funding could vary from year to year.

 

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 if its proposal did not meet the submission requirements.



Section III. Eligibility Information


1. Eligible Applicants

 

1.A. Eligible Institutions

You may submit an application(s) if your organization has any of the following characteristics:

Eligibility for this program is limited to the Center for Health Studies of the Universidad del Valle de Guatemala in Guatemala City. This limited eligibility is based on the key objectives of the programs to develop and implement infectious-disease research projects, and allow the organization to carry out multiple, ongoing, public-health research activities in Guatemala and the Central America region.

1.      UVG is currently in its second year of a five-year non-research cooperative agreement, “Implementing Public Health Programs and Strengthening Public- Health Science in Guatemala and the Central American Region.” Some projects in the non-research agreement developed into related research activities. This interim FOA will allow UVG to move all research activities from the non-research to a research agreement, ensure these activities are properly peer-reviewed, and provide an opportunity for future research capacity.  The work of this new FOA is an extension of previous HHS/CDC projects in Guatemala, and will use previously generated databases currently under the administration of the UVG that would not be available to other potential applicants.

2.      UVG currently has the only biosafety level laboratory (BSL-2) in Guatemala, and is uniquely equipped to provide lab capacity and support to the Ministry of Health in Guatemala and other countries in the region.

3.      As part of a non-profit foundation that established the American School in Guatemala, UVG has the legal authority to hire third-country nationals with the technical skills to meet the requirements of the proposed research components through an expedited process, which provides UVG with unique capability to bolster research capacity in Guatemala and the region.

4.      UVG has an established history of collaboration with HHS/CDC beginning in 1978 under a tripartite agreement among HHS/CDC, the Guatemalan Ministry of Health and the UVG. In 1999, a revised Memorandum of Understanding expanded research, training and technical assistance in the area of infectious diseases.  Through this agreement, UVG has developed into the only public-health partner in Guatemala with the level of infrastructure and expertise necessary for supporting and strengthening the national regional lab capacity.

 

For the above reasons, UVG is uniquely equipped with the resources and infrastructure necessary for the scope of work required, which will eliminate start-up costs, and save significant U.S. taxpayer dollars.


1. B. Eligible Investigators

 

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Only investigators who  partner with UVG are eligible to apply.

 

 

2. Cost-Sharing or Matching
 

Cost-sharing is not required.


The most current HHS Grants Policy Statement is available at the following internet address: http://www.hhs.gov/grantsnet/gps/


3. Other-Special Eligibility Criteria


Applicants must include letters of support from all partners, including Ministries, non-governmental agencies and academic institutions with their 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 http://www.grants.gov/Apply/,and follow the directions provided on that Web site.

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

·         Grants.gov, http://www.grants.gov/GetStarted

·         eRA Commons, 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. Applicants obtain the Credentials Log-In, mentioned in Section IV. 2., Content and Form of Application Submission, through Step #3 in the required actions below.

Project Directors(PDs)/Principal Investigators (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 Started:

2) Organizational/Institutional Registration in the eRA Commons

3) HHS 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 not 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.  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: Applicants can only use the forms package directly attached to a specific FOA.  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 HHS/CDC: Telephone 1-770-488-2700, Email:  PGOTIM@cdc.gov

HHS/CDC Telecommunications for the hearing impaired: TTY 1-770-488-2783.

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.  HHS/CDC requires some fields within the SF424 (R&R) application components that, are not marked as mandatory, (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;

HHS/PHS398 Cover Page Supplement;
HHS/PHS398 Research Plan; and  
HHS/PHS398 Checklist.

Optional Components:

HHS/PHS398 Cover Letter File; and  
Research and Related Sub award Budget Attachment(s) Form.

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

 

Foreign Organizations

 

Several special provisions apply to applications submitted by foreign organizations:

 

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): February 4, 2009.

Peer Review Date (s): March-April 2009.

Council Review Date (s): April-May 2009.

Earliest Anticipated Start Date: August 1, 2009.

3.A.1. Letter of Intent
 

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

 

3. B. Submitting an Application to HHS/CDC

 

If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.

 

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply, and follow steps 1-4.  If applicants submit electronically through Grants.gov (http://www.grants.gov), Grants.gov will give the application an electronic time/date stamp.  Applicants will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application. 

 

The HHS/CDC Procurement and Grants Office must receive all requested information by 5:00 p.m., Eastern Standard Time on the deadline date.  If an applicant submits materials by the U.S. Postal Service or commercial delivery service, it must ensure the carrier will be able to guarantee delivery by the closing date and time.  If HHS/CDC receives your submission after closing because of (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time; or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as received by the deadline. 

 

This announcement is the definitive guide 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.

 

Otherwise, HHS/CDC will not notify you upon receipt of your paper submission.  If you have a question about the receipt of your application, first contact your courier.  If you still have a question, contact the HHS/CDC/PGO-TIMS staff at: 1-770-488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for HHS/CDC to process and log submissions.

 

If applicants submit a paper application, they must do so by using the 424 R&R instructions for preparing a research grant application.  Submit a signed, typewritten original of the application and all appendices, including the checklist, and three, signed photocopy(s) to the following address:

 

Technical Information Management Section – GH09-001

Procurements and Grants Office

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Phone:  1-770-488-2700 EST


3. C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time, on the deadline 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 applicant submits an application package successfully through Grants.gov, addressed any errors, 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 HHS/CDC, 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. The AOR/SO should use this option if he or she determines warnings need corrections. 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 the AOR/SO takes no action.  Please remember some warnings might not be applicable, or might need correction after submission.

·         If the two-day window falls after the submission deadline, the AOR/SO will have the option to “reject” the application if, because of 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 did not 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 problem.

·         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, the applicant can still submit a changed/corrected application but it will be subject to the HHS/CDC late policy guidelines, and HHS/CDC might not accept it.  The AOR/SO should explain the reason for this delay 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, HHS/CDC/COGH and the HHS/CDC Procurement and Grants Office (PGO) will evaluate applications for completeness and responsiveness. HHS/CDC will not review incomplete and non-responsive applications.

 

Grants.gov and the eRA Commons  will send an acknowledgement of having received applications.

 

4. Intergovernmental Review

 

Executive Order 12372 does not apply to this program.

 

5. Funding Restrictions

 

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

 

Additional guidance is available in the HHS/NIH Grants Policy Statement.

 

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

 


6. Other Submission Requirements

 

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

 

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

 

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 applicants need to upload each section of the Research Plan component separately as a PDF attachment, applicants should 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. Applicants must send all attachments to HHS/CDC in PDF format, must include filenames with no spaces or special characters, and must use 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 50 pages.  If your research plan exceeds the page limitation, HHS/CDC could consider your application unresponsive and ineligible for review. 

 

Applicants may include the following materials in the Appendix:

Up to ten 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 eligible for submission 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 HHS/NIH Pub Med Central (PMC) submission identification number; do not include the entire article.

·         Manuscripts accepted for publication, but not yet published: Applicants may submit the entire article electronically as a PDF attachment.

·         Manuscripts published, but a publicly available online journal link is not available:  Applicants may submit the entire article electronically as a PDF attachment.

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

·         Graphic images of gels, micrographs, etc, provided the image (may be reduced in size) is within the (stated) page limit of Items 2-5 of the Research Plan component. Applicants may not include any  images in the Appendix that do not also appear 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 HHS/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 use the Appendix to circumvent the page limitations of the Research Plan component.  HHS/CDC will not review an application that does not observe the relevant policies and procedures.  Applicants must 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 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 can also be appropriate in other sections of the application.

 

All applicants must include a plan for sharing research data in their application.  The HHS/CDC data sharing policy is available at the following internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm, under Additional Requirements 25, “Release and Sharing of Data.”  All investigators who respondto this funding opportunity should include a description of how they will share final research data, or explain why data-sharing is not possible.

The reviewers will assess reasonableness of the data-sharing plan, or the rationale for not sharing research data.  However, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit, or the priority score.

 

 

Sharing Research Resources HHS/PHS policy requires grant award recipients to make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the HHS/PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators who respond to this funding opportunity should include a plan for sharing research resources to address how they will share unique research resources or explain why sharing is not possible.

HHS/CDC staff will consider adequacy of the resources-sharing plan and any related data-sharing plans when making recommendations about funding applications.  The effectiveness of the resource-sharing will be part of the administrative review of each non-competing Grant Progress Report (PHS 2590,http://grants.nih.gov/grants/funding/2590/2590.htm).  See Section VI.3. Reporting.



 

Section V. Application Review Information

 

1. Criteria
 

HHS/CDC will consider only the review criteria described below in the review process:

·         Scientific merit of the proposed project, as determined by peer review;

·         Availability of funds;

·         Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services; and

·         Responsiveness to the announcement.

 

2. Review and Selection Process

An appropriate peer-review group convened by HHS/CDC/OCSO in accordance with the review criteria stated below, will review for scientific and technical merit applications that are complete and responsive to the FOA.

As part of the initial merit review, all applications will:

 

 

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness.  The written comments, will judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals.  The reviewers will address and consider each of these criteria in assigning the overall score, and will weigh them, as appropriate for each applications: 

 

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact, and thus deserve a high priority score. ,For example, an investigator may propose to carry out important work that, by its nature, is not innovative, but is essential to move a field forward.

Significance: Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions that drive this field?

 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative?  For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well-suited to carry out this work?  Is the work proposed appropriate to the experience level of the principal investigator and other researchers?  Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the applicant will do the work  contribute to the probability of success?  Do the proposed studies benefit from the unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements?  Is there evidence of institutional support?


2.A. Additional Review Criteria

In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:


Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8, on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet, at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

 

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) the proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) the proposed justification when representation is limited or absent; (3) a statement as to whether the design of the study is adequate to measure differences when warranted; and (4) a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9, Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R). 

 

Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 12, Vertebrate Animals of the Research Plan component of the SF424 (R&R).   Additional HHS/CDC Requirements under AR-3 “Animal Subjects Requirements” are available on the Internet, at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reviewers can assess the reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research.  Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?  The evaluation of the budget should not effect the priority score.

2.C. Sharing Research Data

 

Data Sharing Plan: HHS/CDC will assess the reasonableness of the data-sharing plan. However, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit, or the priority score.  The presence of a data sharing plan will be part of the terms and conditions of the award. HHS/CDC will be responsible for monitoring the data-sharing policy.  Program staff will be responsible for the administrative review of the plan for sharing research data.   


2.D. Sharing Research Resources

HHS/PHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication.  Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.  Investigators who respond to this funding opportunity should include a plan on sharing research resources.

 

Program staff will be responsible for the administrative review of the plan for sharing research resources.


HHS/CDC will consider the adequacy of the resources-sharing plan when making recommendations about funding applications. The effectiveness of the resource-sharing will be part of the administrative review of each non-competing Grant Progress Report (HHS/PHS 2590 http://grants.nih.gov/grants/funding/2590/2590.htm).  See Section VI.3., “Reporting.”

3. Anticipated Announcement and Award Dates

 

Anticipated award date is August 1, 2009.

 

Section VI. Award Administration Information

 

1. Award Notices

After the peer review of the application is complete, the applicant organization will receive a written critique, called a “Summary Statement.”  The applicant organization and the PD/PI will be able to see the Summary Statement via the eRA Commons.


HHS/CDC will contact those applicants under consideration for funding for additional information.

 

The applicant organization will receive a formal notification in the form of a Notice of Award (NoA).  The NoA, signed by the Grants Management Officer (GMO), is the authorizing document.  HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application. 

 

Selection of the application for award is not an authorization to begin performance.  Any cost incurred before receipt of the NoA is at the recipient’s risk.  HHS/CDC will reimburse these costs only to the extent they are considered allowable pre-award costs.  See also Section IV.5., “Funding Restrictions.”

 

Add Additional Information Here

2. Administrative and National Policy Requirements


The Code of Federal Regulations 45 CFR, Parts 74 and  92, have details about  requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration, at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.  Additional requirements are available Section VIII., “Other Information,” of this document, or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.  The NoA will incorporate these by reference.
 

The NoA will incorporate the following terms and conditions, which HHS/CDC will provide to the appropriate institutional official, and a courtesy copy to the PD/PI at the time of award.


2.A. Cooperative Agreement


The following terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS/PHS and HHS/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U01, an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities.  Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees, and HHS/CDC may share specific tasks and activities, as defined above.

2.A.1. Recipient Rights and Responsibilities


The Recipient will have the primary responsibility for the following:

 

·          The recipient will have the primary responsibility for the oversight of all management, administrative, and scientific aspects of the research, including all data, resources, and operations.

 

•          Providing the necessary personnel and supplies to implement the study, and to analyze the results.

 

•          Collaborating with local, national and regional senior researchers, HHS/CDC, HHS/FDA and HHS/NIH researchers and community-based organizations or other public and private partners for the duration of the project period on several activities such as the development of data-collection instruments, specimen-collection protocols, and data-management procedures.

 

•          Work with HHS/CDC scientists to refine protocols to improve the study, based on reviewers’ comments in the summary statement.

   

•          Identify, recruit, obtain informed consent from, and enroll an adequate number of study participants, as determined by the study protocols and the program requirements.

 

•          Follow study participants, as determined by the study protocols.

 

•          Establish procedures to maintain the rights and confidentiality of all study participants.

 

•          Agree to share data and specimens with HHS/CDC, HHS/FDA and HHS/NIH scientists, as well as appropriate international partners, such as the World Health Organization.

 

•          Utilize polymerase chain reaction (PCR) and viral culture for the laboratory confirmation of isolates during influenza studies.

 

•          In collaboration with HHS/CDC, present at national or international meetings, and publish research findings in peer-reviewed scientific journals.

 

•          Participate in conference calls with HHS/CDC project officer(s) and research team, and to attend one yearly in-person meeting with CDC co-investigators.

 

•          Collaborate with HHS/CDC, HHS/FDA and HHS/NIH scientists to meet the objectives of this agreement.

 

·                      Participate in training activities convened by HHS/FDA at the Regional Health-Care Training Center in Panama City.

 

 

The recipient organization will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access, consistent with current HHS, HHS/PHS, and applicable HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities


An HHS/CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

 

HHS/CDC Activities:

 

•          Collaborate with the recipient to establish priorities for the development and implementation of the recipient activities, both among and within each of the areas, through regular meetings and communication.

 

•          Provide technical assistance to the recipient by linking them with other national and international agencies that might provide additional technical or material assistance, including HHS/FDA.

 

•          Collaborate, as needed, with the recipient by providing technical assistance in support of activities implemented under this agreement.

 

•          Collaborate with the recipient in the development and setting of goals, objectives, effective and innovative strategies and methodologies.

 

•          Development of a research protocol for review by the Institutional Review Board (IRB) by all cooperating institutions that are participating in the research project, including the HHS/CDC IRB, if applicable.  The HHS/CDC IRB will review the protocol initially and annually until the research project is completed for those studies in which HHS/CDC is engaged in research that involves human subjects.

 

•          Monitor and evaluate scientific and operational accomplishments of this project through frequent telephone contact, review of technical reports, and interim data analyses.  Based on this, HHS/CDC will make recommendations aimed at solving problems and improving the quality and timeliness of the research activities.

 

•          Provide consultation and guidance as needed in support of activities implemented under this agreement

 

•          Participate in the analysis and dissemination of information, data and findings from the project, and facilitate dissemination of results.   


Additionally, an HHS/CDC agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award, named in the NoA.

 

2. A.3. Collaborative Responsibilities

 

Not applicable.

3. Reporting

 

Additional Information Here


The recipient organization must provide HHS/CDC with an original, plus two hard copies, of the following reports:

1.      Non-Competing Grant Progress Report, (use form HHS/PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm, and at http://grants.nih.gov/grants/funding/2590/2590.htm, not less than 120 days prior to the end of the current budget period.  The progress report will serve as the non-competing continuation application.

2.      Financial status report, not more than 90 days after the end of the budget period.

3.      Final financial and performance reports, not more than 90 days after the end of the project period.

 

The recipient organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this NoA.

 

Audit Report Requirement: Foreign recipients are subject to audit requirements specified in 45CFR 74.26(d). A non-Federal audit is required, if during the recipient’s fiscal year, the recipient expended a total of $500,000 or more under one or more HHS awards (as a direct recipient and/or as a subrecipient).  The recipient either may have (1) a financial related audit (as defined in the Government Auditing Standards, GPO stock#020-000-00-265-4) of a particular award in accordance with Government Auditing Standards, in those cases in which the recipient received awards under only one HHS program; or, if the organization has received awards under multiple HHS programs, a financial related audit of all HHS awards in accordance with Government Auditing Standards; or (2) audit that meets the requirements contained in OMB Circular A-133.

 

Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

 

Section VII. Agency Contacts

 

HHS/CDC encourages your inquiries concerning this FOA, and welcomes the opportunity to answer questions from potential applicants.  Inquiries can fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Angel Roca
Regional Office for Central America and Panama
Centers for Disease Control and Prevention

U.S. Department of Health and Human Services
Building 21, Room Number
1600 Clifton Road NE, MS D-69
Atlanta, GA 30329
Telephone: 1-404-553-8831
FAX: 1-404-639-7490
Email: aroca@gt.cdc.gov

2. Peer Review Contacts:

 

Juliana Cyril
 Centers for Disease Control and Prevention

U.S. Department of Health and Human Services
 Building 21, Room 8027
1600 Clifton Road NE, MS D-72
Atlanta, GA 30329
Telephone: 1-404-639-4639
FAX: 1-404-639-4903
 Email: jcyril@cdc.gov

3. Financial or Grants Management Contacts:

Randolph B. Williams   
Procurement and Grants Office
Center for Disease Control and Prevention

U.S. Department of Health and Human Services
Colgate Building, Room 2714
2920 Brandywine Road, MS-K75
Atlanta, GA 30341
Telephone: 1-770-488-8382
FAX: 1-770-488-2688
 Email: gur2@cdc.gov

 

4. General Questions Contacts:

Technical Information Management Section

CDC Procurement and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Telephone: 1-770-488-2700

Email: PGOTIM@cdc.gov

 

Section VIII. Other Information

 

Required Federal Citations

 

AR-1 Human Subjects Requirements

Human Subjects Protection
Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).   Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

AR-2  Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

It is the policy of the HHS/Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in HHS/CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15, and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander.  Applicants shall ensure women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

 

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of HHS/CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by HHS/CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all HHS/CDC-conducted or HHS/CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in HHS/CDC-conducted or HHS/CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

AR-3 Animal Subjects Requirements

 

Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.  Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found at http://www.cdc.gov/od/pgo/funding/ARs.htm. 

 

AR-4  HIV/AIDS Confidentiality Provisions

Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.

 

Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.

 

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.


AR-5  HIV Program Review Panel Requirements

Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.

 

To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.

 

If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.

Before funds are used to develop educational materials, determine whether suitable materials already exist in the HHS/CDC National Prevention Information Network (NPIN).  The website can be found at; http://www.nchstp.cdc.gov/od/infocenter/npin.htm.

 

AR-6  Patient Care

Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

 

AR-8  Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

1.           A description of the population to be served.

2.           A summary of the services to be provided.

3.           A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

 

AR-9  Paperwork Reduction Act Requirements

Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

 

AR-10  Smoke-Free Workplace Requirements

HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

 

AR-11  Healthy People 2010

The HHS/Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

 

AR-12  Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

 

In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

 

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

 

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

 

It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

 

Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent HHS/CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-HHS/CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

 

AR-13  Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities

The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."

 

Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.

 

In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.

 

AR-14  Accounting System Requirements

The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

 

Capability Assessment

It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.


AR-15  Proof of Non-profit Status

Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.



 

AR-22  Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the HHS regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

 

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the HHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).

 

For example:

Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide HHS/PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with HHS/ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

 

 

AR-24  Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

 

AR-25  Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. Developed in accordance with HHS/CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 

 

AR-27 Conference Disclaimer and Use of Logos

{Mandatory for all grants and cooperative agreements.}

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

 

“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) .  The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

 

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by 42 U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the HHS/Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003).  Neither the HHS nor the HHS/CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer.  It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.