Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Centers for Disease Control and Prevention, National Center for Environmental Health, (CDC/NCEH)) at http://www.cdc.gov/nceh/
Participating Organizations
Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/
Components of Participating
Organizations
National Center for Environmental Health (NCEH/CDC) at http://www.cdc.gov/nceh/
Title:
Program to Assess Health Effects Associated with Exposures to Volcanic Emissions and Environmental Air Pollutants (R01)
The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH). If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information.
Authority: This Program is Authorized under the Public Health Service Act, section 391(a), and 42 U.S.C. section 280b(a).
Announcement Type: This is a new announcement.
Instructions for Submission of Electronic Research Applications:
If you do not have access to the Internet, or if you have difficulty accessing the forms online, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGOTIMS) staff. For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: PGOTIM@cdc.gov.
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (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-EH-08-001
Catalog of Federal Domestic Assistance Number(s): Centers for Disease Control and Prevention-Investigations and Technical Assistance Centers for Disease Control and Prevention – Investigations and Technical Assistance, CFDA Number 93.283
Key Dates
Release/Posted Date: January 15, 2008
Letter of Intent Receipt Date:
Not Applicable
Application Submission Receipt
Date(s):
March 31,
2008
Peer Review Date(s):
May – June, 2008
Council Review Date(s):
July 30, 2008
Earliest Anticipated Start Date(s): September 1, 2008
Additional Information to Be Available Date: Not Applicable
Expiration Date: April 1, 2008
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
· The purpose of this FOA is to provide (R01) grant funds for a public health agency or university to conduct a research study on human health effects associated with exposures to volcanic emissions in Hawaii. Measurable outcomes of the program will be in alignment with the following performance goals for the National Center for Environmental Health (NCEH): Determine the human health effects associated with environmental exposures; and prevent or reduce illnesses, injury and death related to environmental risk factors.
· The participating organization intends to commit a total up to $ 95,000 to this RFA for payment of applications responsive to this announcement statement.
· Awards issued under this FOA are contingent upon the availability of funds and the submission of a meritorious application.
· There will be one award under this announcement.
· Budget Period, Project Period, and Award Amounts: Up to Approximately $95,000 (including both direct and indirect costs) is expected to be available in FY 2008 to fund one award. An applicant may request up to $95,000 (including both direct and indirect costs) for the first 12-month budget period. An applicant may request a project period of up to 5 years. The approximate total project period funded amount is expected to be up to $475,000 (including both direct and indirect costs) with a maximum of $95,000 funded per year.
· Eligible Organizations: Eligibility is limited to a public health agency or university with experience and expertise in collecting air monitoring data on volcanic emissions and established partnerships with impacted communities living in close proximity to the active volcanoes on the Hawaiian Island. These capabilities are necessary to estimate exposures to the volcanic emissions and to conduct a study to assess the human health effects experienced by Hawaiian residents who are exposed to these volcanic emissions.
· See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: Grants.gov Application Guide SF424 (R&R) - MS Word ; or Grants.gov Application Guide SF424 (R&R) - PDF
· For general information on SF424 (R&R) Application and Electronic Submission, see the following Web sites: SF424 (R&R) Application and Electronic Submission Information ;and General Information on Electronic Submission of Grant Applications.
· HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783.
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. 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 Environmental Health 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 the “Healthy People 2010” priority areas of Environmental Health and Respiratory Diseases to “Promote health for all through a healthy environment including health homes and healthy communities,” and is in alignment with the CDC Health Protection Goals for Healthy People in Every Stage of Life and for a Health Community. For more information, see www.healthypeople.gov and http://www.cdc.gov/about/goals.htm.
The purpose of this FOA is to provide (R01) grant funds for a public health agency or university to conduct a research study on human health effects associated with exposures to volcanic emissions in Hawaii. This program addresses the “Healthy People 2010” focus areas of Environmental Health and Respiratory Diseases. Measurable outcomes of the program will be in alignment with the following performance goals for the National Center for Environmental Health (NCEH): Determine the human health effects associated with environmental exposures; and prevent or reduce illnesses, injury and death related to environmental risk factors.
Research Objectives
The environment plays an important role in human development and health. Researchers have linked exposures to some environmental hazards with specific diseases. Residents living on the Hawaiian Island are potentially exposed to air pollution and gaseous and particulate materials that can result from continuous volcanic eruptions. The objectives of this research are to assess the relationship between exposures to air pollution and substances released from volcanic emissions and health effects, and to develop potential intervention strategies to reduce exposures and decrease or prevent related health effects.
· This research is intended to increase understanding of:
· Objectives of this research program are to:
1. Identify and monitor air pollution and potentially toxic substances present in volcanic emissions.
2. Identify potentially exposed residents and assess the risk of exposure to air pollution or specific substances present in volcanic emissions.
3. Evaluate health effects in residents exposed to volcanic emissions
4. Assess the relationship between health effects and exposure to air pollution and volcanic eruption.
5. Develop and implement intervention strategies to reduce exposures and to decrease, and/or prevent, health effects related to exposures to air pollution and substances from volcanic emissions.
6. Disseminate research findings publications and materials from the project to varied audiences, in particularly to communities of Hawaiian Island residents affected by volcanic emissions.
The anticipated research and methods to achieve these objectives include public health surveillance methods; exposure assessment; epidemiological studies; and environmental monitoring and transport of substances and materials from volcanic emissions and air pollution.
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 R01 activity code.
2. Funds Available
The participating Centers, Institutes, and Offices (CIOs) (NCEH) intend to commit up to approximately $95,000 (direct and indirect costs) in FY2008 to fund one application. The average award amount is expected to be $95,000. An applicant may request a project period of up to 5 years. An applicant may request up to $95,000 for the first budget period. The approximate total project period funded amount is expected to be up to $475,000. The anticipated start date for new awards is September 1, 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.
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
Eligibility is limited to a public health agency or university that has experience and expertise in collecting air monitoring data on volcanic emissions and that has also established partnerships with impacted communities living in close proximity to the active volcanoes on the Hawaiian Island . These capabilities are necessary to estimate exposures to the volcanic emissions and to conduct a study to assess the human health effects experienced by Hawaiian residents who are exposed to these volcanic emissions.
Previously, the National Center for Environmental Health of CDC established a working relationship with the Hawaii Department of Health (HDOH) regarding environmental health concerns for air pollution from volcanic emissions. The CDC funded the HDOH to collect air monitoring data on volcanic emissions and to estimate exposures among the Hawaiian Island residents. The HDOH developed the expertise for conducting air monitoring for volcanic emissions. In addition, the HDOH has obtained data on the pollutants emitted seasonally from this source and estimated the potential for exposures to the emissions among the residents. These data are critical for assessing the potential health effects associated with exposures to the volcanic emissions.
The HDOH established community relationships with leaders and residents of communities impacted by volcanic emissions and, in partnership with the University of Hawaii, conducted a pilot study to evaluate respiratory and cardiovascular effects related to their exposures to the volcanic emissions. The pilot study is important for guiding a more detailed study of heath effects from volcanic emissions. Such a study has been requested by congress as stated in the Conference Report (Report 110-424) from the 110th Congress, dated November 5, 2007, providing for FY 2008 appropriations for the Center for Disease Control and Prevention, in which it is stated that “within the amount provide for general environmental health activities, the conference agreement includes the following amounts: $99,000 for research into the health effects of volcanic emissions, instead of $100,000 as proposed by the Senate…” The House did not propose funding for this program;”.
The Conference Report 110-424 represents the will of the Congress, thus far, directing the CDC to fund a program to assess health effects related to exposures to volcanic emissions. In order to conduct such a study, experience and expertise in conducting air monitoring of volcanic emissions are necessary, along with established community relationships to facilitate participation by residents in communities near active volcanoes on the Hawaiian Island. Such an organization with the required experience and established relationships is uniquely qualified to conduct this study with the funding resources available.
2. Cost Sharing or Matching
Cost sharing, matching, or cost participation is not
required.
The most current HHS Grants
Policy Statement is available at:
http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc
3. Other-Special Eligibility
Criteria
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
· Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
· If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
· The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
· If Foreign Institutions are listed in Section III.1.A. Eligible Institutions include the following bullet: Applicants outside the US are required to include a NATO Commercial and Government Entity (NCAGE) number on their CCR registration. See section IV.2. Content and Form of Application Submission, for instructions.
·
Direct
questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email
support@grants.gov
2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm
· To find out if an organization is already eRA Commons-registered, see the "List of Grantee Organizations Registered in eRA Commons.”
·
Direct
questions regarding the eRA Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email
commons@od.nih.gov
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.
If you do not have access to the Internet, or if you have difficulty accessing the forms online, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGOTIMS) staff. For this, or 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 Subaward
Budget Attachment(s) Form
Note: While both budget
components are included in the SF424 (R&R) forms package,
the CDC R01 activity code uses ONLY the detailed
Research & Related
Budget. (Do not use the PHS 398
Modular Budget.)
3. Submission Dates and
Times
See Section IV.3.A for details
3.A. Submission, Review and
Anticipated Start Dates
Letter of Intent Receipt
Date:
Not Applicable
Application Submission Receipt Date(s): March 31, 2008
Peer Review Date:
May -
June, 2008
Secondary or Council Review
Date:
July 30, 2008
Earliest Anticipated Start Date: September 1, 2008
3.A.1. Letter of Intent
A letter of intent is not required.
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 http://www.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 –
RFA EH08-001
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 NCEH 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.
The HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
Executive Order 12372 does 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.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
6. Other Submission
Requirements
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 Organizational 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 5 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.
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 the specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.
Plan for Sharing Research Data
Note: HHS/CDC normally requires a plan for sharing research data. However, only proposals submitted to NCEH for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. Because the ceiling for this FOA is below $500,000, a data sharing plan is not required and the HHS/CDC steps outlined in this section do not apply.
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 RFA will be evaluated for
scientific and technical merit by an appropriate peer review
group convened by
NCEH in accordance with the review criteria stated
below.
As part of the initial merit
review, all applications will:
The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. 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 as appropriate for each application.
Note that an application does not need to be strong in all
categories to be judged likely to have major scientific
impact and thus deserve a high priority score. For example,
an investigator may propose to carry out important work that
by its nature is not innovative but is essential to move a
field forward.
Significance:
Does this study address an important problem? If the
applicant achieves the aims of the application, how will it
advance scientific knowledge or clinical practice? What will
be the effect of these studies on the concepts, methods,
technologies, treatments, or preventative interventions that
drive this field?
Approach:
Are the conceptual or clinical framework, design, methods,
and analyses adequately developed, well integrated, well
reasoned, and appropriate to the aims of the project? Does
the applicant acknowledge potential problem areas and
consider alternative tactics?
Innovation:
Is the project original and innovative? For example: Does
the project challenge existing paradigms or clinical
practice; address an innovative hypothesis or critical
barrier to progress in the field? Does the project develop
or employ novel concepts, approaches, methodologies, tools,
or technologies for this area?
Investigators:
Are the investigators appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to
the experience level of the principal investigator and other
researchers? Does the investigative team bring complementary
and integrated expertise to the project (if applicable)?
Environment:
Does the scientific environment in which the work will be
done 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?
2.A. Additional Review Criteria
In addition to the above
criteria, the following items will continue to be considered
in the determination of scientific merit and the priority
score:
Application Review