Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Centers for Disease Control and Prevention (NCCDPHP/CDC), at http://www.cdc.gov/nccdphp/
Participating
Organizations
Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov/
Components of Participating Organizations
Coordinating Center for Health Promotion (CoCHP), at http://www.cdc.gov/about/organization/cchp.htm/, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), at http://www.cdc.gov/nccdphp/, Division of Diabetes Translation (DDT), at http://www.cdc.gov/diabetes/
Title: Vision Health: Developing an Integrative Approach for Promotion and Protection (U58)
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: Section 301(a) of the Public Health Service Act, 42 U.S.C. 241(a)
Announcement Type: New
Instructions for Submission of Electronic Research Applications:
NOTICE: Applications submitted in response to this FOA (FOA) for Federal assistance may 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 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 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-DP-08-001
Catalog of Federal Domestic Assistance Number(s): 93.068 Chronic Diseases: Research, Control, and Prevention
Key Dates
Release/Posted Date: November 8, 2007
Letter of Intent Receipt
Date: January 11, 2008
Application Submission Receipt Date: February 11, 2008
Peer Review Date:
March 2008
Council Review Date:
May 2008
Earliest Anticipated Start Date: September 30, 2008
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
· This FOA solicits applications to fund research that will develop an effective comprehensive public health approach to address eye health promotion and vision loss prevention by: 1) developing an intervention model to identify and reach high risk individuals for the control of eye diseases and conditions leading to vision loss; 2) developing methods to integrate and link vision public health initiatives to state, local, and community health programs; and 3) evaluating vision health data systems and developing strategies to expand and improve vision health information.
· The participating organization intends to commit approximately $1,000,000 to this RFA for payment of applications responsive to this announcement.
· Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
· The anticipated number of awards to be issued under this FOA: one award
· Budget Period, Project Period, and Award Amounts: The total project period for applications submitted in response to this FOA may not exceed three years. Total costs are limited to approximately $1,000,000 for the first 12-month budget period.
· Eligible Organizations: Public nonprofit organizations; private nonprofit organizations; for-profit organizations; small, minority, and women-owned businesses; universities; colleges; research institutions; hospitals; community-based organizations; faith-based organizations; federally recognized or state-recognized American Indian/Alaska Native tribal governments; American Indian/Alaska Native tribally designated organizations; Alaska Native health corporations; urban Indian health organizations; tribal epidemiology centers; state and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and political subdivisions of states (in consultation with states.) 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 required documentation 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.
· See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc (MS Word); http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.pdf (PDF)
· For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm; General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
· HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783.
Funding Opportunity Announcement Glossary:
http://pgo.cdc.gov/pgo/webcache/Templates/Glossary__7-7-06.doc
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 Chronic Disease Prevention and Health Promotion (NCCDPHP) 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 areas of 1) Vision and Hearing and 2) Disability and Secondary Conditions and is in alignment with the NCCDPHP performance goal to improve the lives of racial and ethnic populations who suffer disproportionately from the burdens of disease and disability, and develop tools and strategies that will enable the nation to eliminate these health disparities. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.
This funding opportunity announcement (FOA) specifically supports the Healthy Vision 2010 goal to reduce new cases of eye disease and its complications, disability, death, and economic costs. For additional information on the Division of Diabetes Translation’s Vision Health Initiative, see http://www.cdc.gov/diabetes/projects/vision.htm.
Nature of the Research Opportunity
Background
More than 3.4 million (3%) Americans 40 years and older are either blind or are visually impaired and millions more are at risk for developing vision impairment and blindness. The cost of major vision problems among adult populations in the U.S. is estimated at $51.4 billion dollars annually.
The results of a seven-state assessment for vision and eye health capacity were reported in Vision Problems in the United States: Recommendations for a State Public Health Response. This report indicated that while many states have vision advisory committees, councils or coalitions, their mandates differ. There was little evidence of systematic, coordinated planning across the range of vision and eye health services that include early detection, diagnosis, treatment, and rehabilitation.
In 2005, the optional vision module, Vision Impairment and Access to Eye Care, was introduced to the Behavioral Risk Factor Surveillance System (BRFSS) questionnaire. Since then a total of 14 states have identified vision data as critical to their state data needs. The 2005 data from five states reinforces the urgency of the vision public health problem in that more than half (60%) of survey respondents said that the main reason for not seeking eye care was because they had no reason to go or had not thought about it.
These facts are especially significant considering that in the prioritization of effective clinical services, vision screening for adults older than 65 years scored on par with high blood pressure screening, and vision screening for children less than five years scored on par with breast cancer screening for women (Improving the Nation's Health: A Coordinated Public Health Approach). Moreover, the lead Federal agency charged with improving the quality, safety, efficiency, and effectiveness of health care for all Americans, the Agency for Healthcare Research and Quality (AHRQ), in its 2006 National Healthcare Quality Report reflects that Americans are not accessing preventive services such as eye exams (http://www.ahrq.gov/qual/nhqr06/nhqr06report.pdf).
In March 2007 the results on analyzed data from the 2002 National Health Interview Survey revealed low levels of access to eye care in the United States, including substantial disparity based on gender, race or ethnicity, and socioeconomic levels. Of the estimated 61 million adults in the United States that were identified as being at high risk for serious vision loss (people with diabetes or with vision/eye problems or aged ≥65), where preventative or regular eye care services are recommended, not much more than half had visited an eye doctor in the past 12 months.
CDC through its Vision Health Initiative and diverse stakeholders, has developed a report entitled, Improving the Nation’s Vision Health: A Coordinated Public Health Approach, that documents the compelling and urgent challenge to health and outlines specific action steps and strategies that may, if implemented, facilitate improved vision health at the national, state, local, and community levels (http://www.cdc.gov/diabetes/pubs/pdf/vision.pdf).
Scientific Knowledge to be Achieved through this Funding Opportunity
The research supported by this FOA is expected to result in a vision integration approach that enhances eye health promotion and vision loss prevention by coordinating and integrating vision health activities across the public health infrastructure. This FOA will support research that will create/design evidence-based interventions and strategies for promoting and protecting vision health and that will enhance and expand eye health data collection and quality.
Research Objectives and Experimental Approach
The objective of this research program is to increase eye health promotion, prevent vision loss, and build vision health capacity at the state, local, and community level. It seeks to reduce the burden of eye disease among Americans, especially those from high-risk populations, by designing and testing approaches and strategies aimed at increasing the availability of vision health services and improving eye health data. To achieve a significant, sustainable, and measurable health impact, activities in support of this FOA should utilize partnerships and a multi-disciplinary approach for vision health care and promotion and capacity-building. Relevant partners include national, state, local, and community level agencies and organizations, health care provider groups, and academic and research institutions.
This FOA has three inter-related components:
Component 1: Develop and implement an intervention model to identify and reach high risk individuals for the control of eye diseases and conditions leading to vision loss that can be adapted for use at the state, local, and community level.
Effective vision screening can assist in the detection of asymptomatic diseases and conditions that, if left untreated, can lead to vision loss and disability. This component seeks the development and implementation of an intervention model for a comprehensive approach to effective and targeted vision screening, early diagnosis, timely treatment and ongoing surveillance that can be adapted for diverse settings and populations (e.g., community health centers, clinics, schools, workplace). The proposed intervention model is to be pilot-tested and evaluated, adapted, and implemented in three distinct settings.
Model design should target those most vulnerable to vision loss, be based on sufficiently rigorous scientific evaluation, and incorporate public health theories relevant to prevention (i.e., behavioral, cultural, temporal [screening/testing intervals], and geographic factors).
Component 2: Develop and implement methods and strategies to integrate and link vision and eye health activities into existing programs and messages within state, local, and community agencies or organizations.
This component seeks the development and testing of a systematic approach to integrate vision health activities, including the model developed in Component One, into existing health programs and other appropriate settings. The integration plan should augment essential public health elements to improve access to care, strengthen health delivery systems, and create innovative collaboration and partnerships among public health systems and organizations. Traditional and non-traditional settings should be examined. Partners can include those engaged with or who sponsor programs addressing cardiovascular disease, wellness, healthy aging, disabilities, injury, smoking, maternal and child health, nutrition and physical activity, school health, diabetes, genomics, and mental health.
Applicants should: 1) identify and assess a sample of existing programs representing diverse settings and populations; 2) analyze factors that will facilitate the integration of vision health activities within those programs; and 3) develop methods and strategies to accelerate the adoption and institutionalization of vision health activities into the existing programs. The integration plan should be applied in one or more of the selected programs and evaluated for factors affecting adoption and sustainability, including an economic evaluation (cost- effectiveness analysis) of the described plan.
Component 3: Evaluate existing vision health data systems and design strategies to increase availability and improve completeness and quality of vision and eye health information by building upon existing data sources and/or identifying new data sources.
Vision data assists in identifying high-risk populations, gaps in services, and quality of eye care and can be used to identify emerging trends and to compare differences between population groups or geographic areas. An enhanced and expanded vision eye health data collection system will provide a means of monitoring comprehensive vision related information and provide a more complete understanding of issues related to access to eye care and vision health disparities. Additionally, improved surveillance will aid in the development and evaluation of public health interventions, methods, and strategies for preventing vision loss and promoting eye health.
Existing data sources (e.g., BRFSS, Medicaid, managed care, schools) should be evaluated to determine their effectiveness in assessing the burden of vision loss and eye diseases and related causes, assessing the use of eye care services, and identifying possible public health interventions to prevent or delay vision loss. Plans to enhance and expand vision health data systems should: 1) identify effective data collection systems; 2) recommend enhancements/modifications to existing data sources; 3) recommend new data measures and data sources, including non-traditional sources (i.e., Department of Motor Vehicles); and 4) provide strategies to support sustainable data collection and use.
See
Section VIII, Other Information - Required Federal
Citations, for policies related to this announcement.
Section II. Award
Information
1. Mechanism of Support
This funding opportunity will use the U58 activity code. The HHS/CDC U58 is a cooperative agreement assistance instrument. Under the cooperative agreement 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) NCCDPHP intends to commit approximately $1,000,000 in total costs (direct and indirect) in FY2008 to fund one application. An applicant may request a project period of up to three years and request up to $1,000,000 in total costs (direct and indirect) for the first 12-month budget period. The approximate total for the entire project period is $3,000,000. The anticipated start date for new awards is September 30, 2008.
All estimated funding amounts are subject to availability of funds.
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
You may submit an application(s) if your organization has any of the following characteristics:
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 funds, or cost participation are not required under this program.
The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.
3. Other-Special Eligibility
Criteria
The following criteria will be used to determine the
applicant’s eligibility:
The institution/organization must assure that the research team will include an optometrist and ophthalmologist. Evidence must be provided in the Research & Related Senior/Key Person Section of the SF424 (R&R).
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 U58
(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:
January 11, 2008
Application Submission Receipt Date: February 11, 2008
Peer Review Date: March 2008
Council Review Date: May 2008
Earliest Anticipated Start Date:
September 30, 2008
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
· Descriptive title of proposed research
· Name, address, and telephone number of the Principal Investigator
· Names of other key personnel
· Participating institutions
· Number and title of this funding opportunity
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV. 3.A.
The letter of intent should be sent to:
Brenda
Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention
U.S.
Department of Health and Human Services
Koger
Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-8390
FAX: (770) 488-8046
Email: bjc4@cdc.gov
3.B. Submitting an Application to 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 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 Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that 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 having been received by the deadline.
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.
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 PGO-TIMS staff at:
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 submitting a paper application, it must be prepared 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 – DP08-001
CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Phone: 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 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 CoCHP and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.
There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.
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 Grants Policy Statement. Additional guidance can be found at HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
· Funds relating to the conduct of human subjects research will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place.
· Reimbursement of pre-award costs is not allowed.
6. Other Submission Requirements
The research plan of applications submitted in response to this FOA should address the activities that will be conducted over the entire project period.
Application Content:
1. A timeline of activities, for each component, to be conducted over the three year project period. The timeline should reflect the interrelationships of the three components in this FOA.
2. A staffing plan describing the team members’ roles in carrying out the objectives of the project, including the planned percent of effort for the team members. Information on the research team should include:
a. A description of the PD/PI’s previous collaborations and partnerships with national, state, and local agencies, community health programs, private organizations, and provider groups in the development and implementation of wide-scale public health research programs and surveillance. Evidence of previous collaborations should be provided in the form of publications, reports, and/or research in the last five years.
b. A description of the research teams experience collaborating with state-level health organizations on surveillance, health assessment, and health care delivery systems related to vision health. Evidence of collaborations should be provided in the form of publications, reports, or letters of support describing previous collaborations and/or publications/reports within the last five years on the incidence, prevalence, cost, morbidity, and mortality of eye disease and vision conditions that may lead to vision loss in the U.S.
3. Plans for involvement of stakeholders that include traditional and non-traditional partners.
4. Letters of support from potential partners describing the commitment of the organization to the project, any specified limits to collaboration, and if applicable, terms of access to data or populations.
5. The costs of attending an annual meeting with CDC must be included in the budget.
For Component 1, the research plan should address the following other submission requirements:
1. The evidence-base (i.e., guidelines, reports, research) for the proposed intervention model that includes vision health related clinical measurements and methods that are to be used among different age groups and high risk populations.
2. Proposed methodological tools and adaptations to the intervention model for implementation in different practice settings.
3. A description of the evaluation plan that will be used to address key factors of implementation of the proposed intervention model, i.e., generalizability, feasibility, reach, fidelity, and cost-effectiveness.
For Component 2, the research plan should address the following other submission requirements:
1. A description of the plan for identifying, evaluating, and selecting state, local, community programs for integrating vision health activities. The plan for evaluating programs should include: 1) a critical assessment of the commonality and standardization of shared roles and responsibilities; 2) an analysis of the feasibility and ease of incorporation; and 3) an assessment of factors that may impact the integration approach, including facilitators and impediments.
2. A description of activities to promote vision health integration among partners.
For Component 3, the research plan should address the following other submission requirements:
1. A description of the plan for evaluating the effectiveness of existing state, local, and community data sources to assess and monitor the burden of vision loss and eye diseases and the use of eye care services.
2. The criteria that will be used to identify and address the gaps in the existing data sources.
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’ research 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 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 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 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.
All
applicants must include a plan for sharing research data in
their application. The HHS/CDC data sharing policy is
available at
http://www.cdc.gov/od/pgo/funding/ARs.htm under
Additional Requirements 25 Release and Sharing of Data. All
investigators responding to this funding opportunity should
include a description of how final research data will be
shared, or explain why data sharing is not possible.
The
reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the
priority score.
Sharing Research Resources
HHS
policy requires that grant award recipients make unique
research resources readily available for research purposes
to qualified individuals within the scientific community
after publication (see the HHS Grants Policy Statement
http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.)
Investigators responding to this funding opportunity should
include a plan for sharing research resources addressing how
unique research resources will be shared or explain why
sharing is not possible.
The
adequacy of the resources
sharing plan and any related data sharing plans will be
considered by the HHS/CDC Program staff of the funding
organization when making recommendations about funding
applications. The effectiveness of the resource sharing will
be evaluated as 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
Only the review criteria described below will be considered 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
2. Review and
Selection Process
Applications that are complete and responsive to the FOA
will be evaluated for scientific and technical merit by an
appropriate peer review group convened by the Office of
Public Health Research in accordance with the review
criteria stated below.
As part
of the initial merit review, all applications will:
· Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score
· Receive a written critique; and
· Receive a second level of review by HHS/CDC CoCHP
Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions.
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. In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each applications.
· Significance
· Approach
· Innovation
· Investigators
· Environment
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?
Will findings from this project provide insight and methods or strategies for integrating vision health into the public health infrastructure?
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?
Is the approach consistent with current literature? Does the approach have the potential for wide-spread application?
Component 1: Has the applicant adequately documented the evidence for the proposed intervention model? Does the proposed intervention model include strategies for targeting those most vulnerable to vision loss (e.g., individuals with diabetes and other chronic diseases, the economically disenfranchised, children, the elderly and racial/ethnic minorities)? Do the three proposed implementation sites for the intervention model offer unique features?
Component 2: Was the applicant successful in identifying traditional and non-traditional programs for integration activities? Does the integration approach have the potential for wide-spread application especially in diverse settings (e.g., community health centers, clinics, schools, workplace)?
Component 3: Did the applicant provide a comprehensive review of the data sources and methods for analysis? Does the approach for enhancing and expanding vision and eye health data systems support the use of existing systems?
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?
Does the project draw from other disciplines and offer avenues for community feedback and comment?
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?
Does the PD/PI have experience leading teams in the implementation of large-scale public health research programs and activities? Does the research team have experience utilizing partnerships and a multi-disciplinary approach for vision health care with other national, state, local, and community level organizations, health care provider groups, and/or academic and research institutions? Does the research team have demonstrable experience in interpreting and analyzing data sources containing vision health information?
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 unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?
Has the applicant utilized partnerships and a multi-disciplinary approach for vision health care as demonstrated through collaborative efforts with other national, state, local, and community level organizations, health care provider groups, and academic and research institutions? Does the applicant have the capacity to implement vision health activities in programs within state, local, and community agencies or organizations?
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 reasonableness of the proposed
budget and the appropriateness of the requested period of
support in relation to the proposed research may be assessed
by the reviewers. 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 affect 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. The funding organization 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
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 responding to this funding opportunity should
include a plan on sharing research Program staff will be
responsible for the administrative review of the plan for
sharing research resources.
The
adequacy of the resources sharing plan will be considered by
Program staff of the funding organization when making
recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as
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
It is
anticipated that awards will be announced August 2008.
Section VI. Award Administration Information
1. Award
Notices
After
the peer review of the application is completed, the
applicant organization will receive a written critique
called a “Summary Statement.”
The applicant organization and the PD/PI will be able to
access the Summary Statement via the eRA Commons.
HHS/CDC will contact those
applicants under consideration for funding for additional
information.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. 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. See also Section IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
The
Code of Federal Regulations 45 CFR Part 74 and Part 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. These will be
incorporated into the NoA by reference.
The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous 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/CDC grant administration policies.
The administrative and
funding instrument used for this program will be the
cooperative agreement U58 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 the 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:
1. Developing the methodology and protocol for each component of the research study, coordinating and conducting on-going data collection and follow-up, quality control, data analysis, and interpretation, and preparing peer-reviewed publications for presentations of findings at state and national scientific conferences.
2. Monitoring progress of each component, including information on newly established tools, mechanisms and methods, reports, manuals or other deliverables, details of operations and evaluation and translation outcomes.
3. Preparing and coordinating the submission of the protocol(s) to the designated IRB(s) and ensuring that the protocol(s) is(are) conducted in compliance with the terms and conditions of IRB approval.
4. Maintaining an adequate management and staffing plan to support the project activities.
5. Fostering and maintaining regular communication with CDC Project Scientists.
6. Planning and maintaining the confidentiality of the study data.
7. Attending conferences convened to develop a formal public health vision model for the prevention and control of eye diseases and vision disorders that may lead to vision loss and disability.
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/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:
1. Participating in the development of the research study by providing scientific consultation and technical assistance in the design, development and implementation of the methodology, model, and protocol.
2. Supporting the grantee’s activities by collaborating and providing ongoing public health consultation in the development of activities related to the cooperative agreement.
3. Serving as liaison for scientific matters that may require access to CDC subject matter experts.
4. Verifying adherence to human subject’s requirements and approval of study protocol by the designated IRB(s).
5. Assisting in data analyses and interpretation.
6. Participating in reporting of the results of the study in technical reports, scientific publications and conferences commensurate with contributions.
7. Assisting with the development of an evaluation framework which includes measurement methods, surveillance instruments for future use, data standards and definitions, and a structure for evaluating the effectiveness of program services.
8. Providing the expertise, staff, and resources of CDC programs to assist and enhance the work of the funded organization.
Additionally, an HHS/CDC agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.
2.A.3. Collaborative Responsibilities
The Recipient and HHS/CDC Project Scientist will have joint responsibility for the following:
1. Collaborating in the areas of public health program standards, evaluation, surveillance, and service delivery.
2. Reporting the findings and recommendation from the research project through presentation, technical reports, and manuscripts for peer-reviewed publications commensurate with contributions.
3. Disseminating the findings and recommendations from this research to organizations engaged in public health prevention and promotion.
3. Reporting
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 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, no 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, no more than 90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days after the end of the project period.
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 FOA.
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:
Brenda
Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention
U.S.
Department of Health and Human Services
Koger
Center-Williams Building, MS K-92
2877
Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-8390
Email:
bjc4@cdc.gov
2. Peer Review Contacts:
Juliana Cyril, PhD, MPH
Scientific Review Service
Office
of Public Health Research
Centers
for Disease Control and Prevention
U.S.
Department of Health and Human Services
1600
Clifton Road NE, MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4639
Email:
jcyril@cdc.gov
3. Financial or Grants
Management Contacts:
Veronica Davis, Grants Management Specialist
Procurement and Grants Office
Center for Disease Control and Prevention
U.S.
Department of Health and Human Services
Koger Center-Colgate
Building, MS E-09
2920
Brandywine Road
Atlanta, GA 30341
Telephone: (770) 488-2743
Email: vdavis@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: (770) 488-2700
Email: PGOTIM@cdc.gov
Section VIII. Other Information
Required
Federal Citations
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.
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.
Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the 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 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 that 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 CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or 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 CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.
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.
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).
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.
The
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
www.healthypeople.gov
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 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-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.
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.
Proof of Nonprofit 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.
Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:
1. Place small, minority, women-owned business firms on bidders mailing lists.
2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.
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 Department of Health and Human Services (DHHS) 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 DHHS 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 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 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.
Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS. If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization’s name, select its board members on a religious basis, and include religious references in its organization’s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site: http://www.whitehouse.gov/government/fbci/.
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.
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:
a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with 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) http://www.cdc.gov/od/foia/index.htm.
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.
National Historic Preservation Act of 1966
(Public Law 89-665, 80 Stat. 915)
The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:
a. Section 106 of the National Historic Preservation Act (NHPA) states:
The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking, shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register. The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.
b. Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”
Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.
Conference Disclaimer and Use of Logos
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 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 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 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.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:
http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm