Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Centers for Disease Control and Prevention (NCIRD/CDC), at http://www.cdc.gov/vaccine/about/default.htm
Participating Organizations
Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov/
Components of Participating Organizations
National Center for Immunization and Respiratory Diseases (NCIRD/CDC), at http://www.cdc.gov/vaccine/default.htm
Title: Annual Estimates of Influenza Vaccine Effectiveness for Preventing Laboratory-confirmed Medically Attended Outcomes in the United States (U18)
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:
42 U.S.C. 247b(k)(1), as amended
Announcement Type: New
Instructions for Submission of Electronic Research Applications:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)
A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Time on the application submission receipt date (see “Key Dates” below.)
2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.
Funding Opportunity Announcement (FOA) Number: RFA-IP08-001
Catalog
of Federal Domestic Assistance Number(s):
93.185 Microbiology and
Infectious Disease Research
Key
Dates
Release/Posted
Date:
December 7, 2007
Earliest Anticipated Start Date(s): July 1, 2008
Additional Information to Be Available Date: Not Applicable
Expiration Date: February 5, 2008
Due Date for E.O. 12372
Due no later than 60 days after the application receipt date.
Additional Overview Content
Funding Opportunity Announcement Glossary: FOA Glossary Terminology
Table of Contents
Part I Overview
Information
Part II Full Text
of Announcement
Section I.
Funding Opportunity Description
1. Research
Objectives
Section II. Award
Information
1.
Mechanism(s) of Support
2. Funds
Available
Section III.
Eligibility Information
1. Eligible
Applicants
A.
Eligible Institutions
2.Cost
Sharing or Matching
3.Other -
Special Eligibility Criteria
Section IV.
Application and Submission Information
1. Request
Application Information
2. Content
and Form of Application Submission
3. Submission
Dates and Times
A.
Receipt and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Submitting an Application to CDC
C.
Application Processing
4.
Intergovernmental Review
5. Funding
Restrictions
6. Other
Submission Requirements
Section V.
Application Review Information
1. Criteria
2. Review and
Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Sharing Research Data
D.
Sharing Research Resources
3. Anticipated
Announcement and Award Dates
Section VI. Award
Administration Information
1. Award
Notices
2.
Administrative and National Policy Requirements
A.
Cooperative Agreement
1.
Recipient Rights and Responsibilities
2.
HHS/CDC Responsibilities
3.
Collaborative Responsibilities
3. Reporting
Section VII.
Agency Contact(s)
1.
Scientific/Research Contact(s)
2. Peer
Review Contact(s)
3. Financial/
Grants Management Contact(s)
4. General
Questions Contact(s)
Section VIII.
Other Information - Required Federal Citations
Part II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
The National Center for Immunization and Respiratory Diseases (NCIRD) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses “Healthy People 2010” priority area(s) of Immunization and Infectious Diseases and is in alignment with NCIRD’s performance goal(s) to protect Americans from infectious disease. For more information, www.healthypeople.gov. and http://intra-apps.cdc.gov/fmo/
Estimates of the effectiveness of influenza vaccines are needed to assess the protection against influenza infection and its associated complications provided by annual, nationwide vaccination programs. Vaccine effectiveness can vary by the age and underlying health status of vaccine recipients and by influenza season, because the match between circulating and vaccine influenza strain changes over time. Due to the changing nature of influenza viruses and vaccine composition, annual estimates of the effectiveness of the influenza vaccine are needed to assess the effects of the U.S. influenza vaccination program and to help guide influenza vaccination policy. In addition, results of annual vaccine effectiveness studies may provide valuable data for future influenza vaccine strain selection decisions and provide a methodological basis for conducting vaccine effectiveness evaluations during an influenza pandemic.
The purpose of this FOA is to enable several research institutions to conduct annual assessments of the effectiveness of licensed influenza vaccines against laboratory-confirmed medically attended influenza infections diagnosed by viral culture and RT-PCR. Results of these assessments must be available for public health use by the September following the conclusion of the influenza season. The populations to be studied should include those for whom CDC’s Advisory Committee on Immunization Practices (ACIP) recommends receipt of trivalent inactivated influenza vaccine or live attenuated influenza vaccine. Influenza-related complications are greatest among those aged 65 years and older. Each applicant must demonstrate the ability to enroll sufficient numbers of laboratory-confirmed cases of influenza among persons aged 65 years and older to estimate vaccine effectiveness, based on conservative estimates of annual attack rates, vaccine coverage, and medical care utilization.
Observational studies of the effectiveness of licensed vaccines (as compared with randomized clinical trials) can suffer from several types of bias, including selection bias and confounding bias. Confounding by propensity to seek health care (e.g., subjects who receive recommended annual vaccinations may be more likely to seek care for acute illnesses) is a concern in observational studies of vaccine effectiveness against medically attended outcomes. The funded sites and CDC will develop methods to address this source of bias. Severe outcomes of influenza infection are relatively rare, and many past single-site studies of influenza vaccine effectiveness have been underpowered to assess vaccine effectiveness against more severe outcomes, including influenza-related hospitalizations. Thus, CDC’s Influenza Division will work with each of the funded sites to develop common methods for measuring vaccine effectiveness against laboratory-confirmed influenza hospitalizations; it is expected that an anonymized dataset containing selected variables from the data collected at each of the funded sites will be made available for this aspect of the funded work. Because the predominant circulating influenza strains during a particular influenza season may vary by geographic location, preference will be given to funding study sites in different U.S. Census regions (Northeast, South, Midwest, and West). It is anticipated that influenza vaccines will be administered according to usual clinical practice; no funding will be made available to applicants for purchase of influenza vaccines.
RFA Objectives
Applicants must address all four of the required objectives described below in the research plan section of their application:
1. Assess the effectiveness of influenza vaccines against laboratory-confirmed influenza infections among children and adults who present for inpatient care in hospitals and in either outpatient or emergency department settings, or both. Make available to CDC sufficient data so that vaccine effectiveness against hospitalizations across all funded sites can be estimated by using methods developed by the funded sites and CDC.
a. Applicants must propose a case-control approach that uses as controls those who seek care for respiratory illness, but test negative for influenza virus infection.
b. Applicants may also propose a variety of observational study methods to assess vaccine effectiveness (e.g., cohort, case-cohort, or case-control methods), and must describe plans to minimize confounding and selection biases in each proposed analysis
2. Diagnose influenza cases by using both viral culture and RT-PCR methods (with probes, primers and reagents approved by CDC). The application must describe in detail the viral culture, RT-PCR, and other laboratory methods to be used and provide evidence of competency in the use of these methods, and a system to demonstrate the quality of the laboratory methods and results. Proposals will not be funded unless applicant’s state in their applications that influenza isolates obtained in this work will be submitted to CDC for antigenic characterization and for other WHO Influenza Collaborating Center surveillance purposes.
3. Describe methods to provide an interim estimate of vaccine effectiveness during the influenza season, to provide more detailed results by the September following the conclusion of the influenza season, and to summarize final results for publication.
4. Describe how vaccination data will be obtained and validated:
a. Describe the use of a real-time, electronic vaccine registry that captures vaccination data for enrolled persons to determine fact and date of receipt of influenza vaccinations.
b. If a real-time electronic vaccine registry is not available for tracking receipt of influenza vaccines, describe how the applicant will rapidly assess and verify influenza vaccine status during an influenza season among enrolled persons, and conduct a validation study of the method(s) used.
Optional Objective 5. Applicants may choose to address this optional objective in the research plan; only 1 or 2 applicants will be funded to perform this work.
Collect, process, store, and ship to a reference laboratory designated by CDC paired serum specimens so that the serologic responses to influenza vaccines can be studied among older adults. Describe a process to enroll patients for collection of serum specimens on or before the date of vaccination, and several weeks after receipt of vaccine. Paired sera will be tested by hemagglutination-inhibition assay methods by a single reference laboratory by using standard, validated procedures. For a subset of persons enrolled to provide pre- and post-vaccination blood specimens, additional blood will be collected for the isolation of peripheral blood mononuclear cells (PBMC). PBMC’s will be separated, processed and stored, and shipped once a year to a designated reference lab for testing. The numbers of paired serum and PBMC specimens to be collected each season would be approximately 300-450 and 100-150, respectively, among all awardees combined.
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 U18 activity code.
The HHS/CDC U18 is a cooperative agreement assistance instrument. Under the U18 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
NCIRD intends to commit approximately $3,000,000 in direct and indirect costs in FY2008 to fund 3 to 5 applications. The average award amount will range from $500,000 to $750,000, including both direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to 3 years. An applicant may request up to $1,000,000 for the first 12-month budget period, if the applicant addresses optional objective 5, which requires the collection, processing, storage and shipping of paired sera and PBMCs. Only 1 or 2 applications will be funded for work related to optional objective 5. All other applications will be limited to maximum request of $750,000 for each 12-month period. The approximate total project period funded amount is $11,000,000. The anticipated start date for new awards is July 1, 2008. Applicants should budget for travel to annual investigator meetings.
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.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the CIO (s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
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, or cost participation is not required.
3. Other-Special Eligibility Criteria
Each applicant may submit only one application.
Only studies proposed for conduct in the United States are eligible for consideration
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.
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.htmIMPORTANT: 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.
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
U18
(activity code) uses ONLY the detailed
Research & Related
Budget. (Do not use the PHS 398
Modular Budget.)
3.
Submission Dates and Times
See Section IV.3.A for details
3. A. Submission, Review and Anticipated Start Dates
Letter of Intent
Receipt Date:
Not applicable
Application Submission Receipt Date(s): February 4, 2008
Peer Review Date (s): March-April 2008
Council Review Date (s): April – May, 2008
Earliest
Anticipated Start Date:
July 1, 2008
3.A.1.
Letter of Intent
A letter of intent is not applicable to this funding opportunity announcement.
3.B. Submitting an Application to CDC
If the instructions in this announcement differ in any way from the SF424 R&R instructions, follow the instructions in this announcement.
To submit an application in response to this FOA, applicants should access this FOA via Grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov. The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application.
All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date.
This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.
3.C.
Application Processing
HHS/CDC must receive
applications on
or before 5:00 P.M. Eastern Time on the application
submission date(s) described above (Section IV.3.A.). If
HHS/CDC receives an application after that submission date
and time, the application may be delayed in the review
process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
· If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.
· Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
· If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.
· If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.
· Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.
Upon receipt, applications will be evaluated for completeness and responsiveness by the Coordinating Center for Infectious Diseases (CCID) and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.
There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.
4. Intergovernmental Review
Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.
5. Funding Restrictions
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
· Funds relating to the conduct of human subject’s research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place. · Reimbursement of pre-award costs is not allowed. · Awardees may not enroll human subjects until they receive a revised Notice of Award from the Procurement and Grants Office lifting the human subject’s restriction.
6. Other Submission Requirements
Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information”.
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.
Applicants’ 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 five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.
·
Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.·
Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.·
Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment.·
Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.·
Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.
Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.”
Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.
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.
Section V. Application Review Information
1.
Criteria
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·
Funding preferences 1. Applications that do not address all four required objectives listed in Part II, Section 1 Research Objectives will not be funded even if they rank higher than other applications that address all required objectives. 2. Because the circulation of influenza viruses may differ across the United States, funding decisions will attempt to achieve geographic diversity among the research sites selected. Applications will be stratified by the U.S. Census regions and an attempt will be made to fund the highest ranking award in each of the four U.S. Census regions (Northeast, South, Midwest, and West) prior to funding additional awards in the same Census region 3. The three highest ranked applications addressing all four required objectives will be funded prior to potentially skipping any higher-ranked applications in order to fund applications that include the optional objective 5. Applications including objective 5 must have a priority score between 100 and 200 to be eligible for funding. The criteria that will be used in funding decisions for the optional objective include prior experience with conducting studies that require the collection, processing, and storage of serum specimens obtained both pre- and post-vaccination; demonstration of sufficient research personnel and facilities to process and store specimens; and adequate documentation of a system to enroll and follow-up adults who receive influenza vaccines. 4. Proposals will not be funded unless applicant’s state in their applications that influenza isolates obtained in this work will be submitted to CDC for antigenic characterization and for other WHO Influenza Collaborating Center surveillance purposes. 5. Applicants must demonstrate the ability to enroll sufficient numbers of laboratory- confirmed cases of influenza in adults aged 65 years and older to estimate vaccine effectiveness, based on conservative estimates of annual attack rates, vaccine coverage, and medical care utilization or they will not be funded. 6. The investigative team must demonstrate in their biosketches prior experience in conducting large clinical or epidemiologic studies, and proficiency in conducting laboratory testing for influenza, or the application will not be funded.
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 CCID or its designee and will score
applications based on the review criteria listed 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 CCID
· 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?
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?
Does the applicant
provide evidence of the ability to enroll sufficient numbers
of laboratory- confirmed cases of influenza to estimate
vaccine effectiveness, based on conservative estimates of
annual attack rates, vaccine coverage, and medical care
utilization, in adults aged 65 years and older?
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
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. 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 resources.
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
Earliest anticipated award date is July 1, 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 t
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. These costs may be reimbursed only to the extent considered allowable pre-award costs. 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 U18 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:
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:
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 PIs for all awarded projects will establish, in conjunction with CDC, a Research Planning and Coordination Committee (RPCC) within 60 days of awards and on a regular schedule. Each PI will be a voting member of the RPCC and will participate in its activities and follow the policies and procedures developed by the RPCC. A CDC Project Scientific Officer will serve as a voting member of the RPCC and schedule its first meeting. Recent ACIP recommendations will be considered. The RPCC will function to:
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:
Dr. Shoukat Qari
Office of Extramural Research
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
1600 Clifton Road, MS E-05
Atlanta, GA 30333
Telephone: (404) 639-8942
FAX: (404) 639-2469
Email: SQari@cdc.gov
2. Peer
Review Contacts:
Dr. Juliana Cyril
Office of Public Health Research
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
1600 Clifton Road
Atlanta, GA 30333
Telephone: (404) 639-4639
Fax: 404-639-4903
Email:
JCyril@cdc.gov
3. Financial or Grants Management Contacts:
Peaches Brown, Grants Management Specialist
Procurement and Grants Office
Center for Disease Control and Prevention
U.S. Department of Health and Human Services
2920 Brandywine Road, MS K14
Atlanta, GA 30341
Telephone: (770) 488-2738
Fax: (770) 488-2670
Email:
prb0@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 on 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.
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The order sets up a system for State and local governmental review of proposed Federal assistance applications. Applicants should contact their State single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each State affected.
Click on the following link to get the current SPOC list
http://www.whitehouse.gov/omb/grants/spoc.html
Indian tribes must request tribal government review of their applications.
Specs or tribal governments that have recommendations about an application submitted to HHS/CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:
Peaches Brown, Grants Management Specialist
Procurement and Grants Office
Announcement Number IP08-001
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146
HHS/CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.
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.
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.
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.
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 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.
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.
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