Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, (NCBDDD/CDC) at http://www.cdc.gov/ncbddd
Participating Organizations
Centers for Disease Control and Prevention (CDC), at http://www.cdc.gov
Components of Participating Organizations
National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC) at
http://www.cdc.gov/ncbdddTitle: Reducing Prenatal Exposure to Alcohol and other Co-Occurring Risk Behaviors in the Preconception Period (U84)
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 Sections 301, 311 and 317 (C) of the Public Health Service Act, (42 U.S.C., Sections 241, 243 and 247b-4), 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 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-DD-08-003
Catalog of Federal Domestic Assistance Number(s): 93.283 Centers for Disease Control and Prevention Investigations and Technical Assistance
Key Dates
Release/Posted Date: March 6, 2008
Letter of Intent
Receipt Date:
April 7, 2008
Application
Submission Receipt Date(s):
May 7,
2008
Peer Review
Date(s):
June/July 2008
Council Review
Date(s): August
2008
Earliest Anticipated Start Date(s): September 30, 2008
Additional Information to Be Available Date: N/A
Expiration Date: May 8, 2008
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
· This funding opportunity announcement (FOA) solicits Cooperative Agreements (U84) proposals to reduce both alcohol and smoking among women (18-44) at high risk for an alcohol and tobacco-exposed pregnancy.
· Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
· Anticipated number of awards: Up to three
· Budget Period, Project Period, and Award Amounts: The total project period will be four (4) years. It is expected that the average yearly award will be $375,000, ranging from $350,000 to $400,000 per year including direct and indirect costs.
· Eligible Organizations: Public nonprofit organizations; private nonprofit organizations; for profit organizations; small, minority, and women-owned businesses; universities; colleges; research institutions; hospitals; community-based organizations; faith-based organizations; federally recognized or state-recognized American Indian/Alaska Native tribal governments; American Indian/Alaska Native tribally designated organizations; Alaska Native health corporations; urban Indian health organizations; tribal epidemiology centers; state and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and political subdivisions of states (in consultation with states.) A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide required documentation from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.
· See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc (MS Word); http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.pdf (PDF)
· For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm; General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
· HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783.
Funding Opportunity Announcement Glossary: 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
Section I. Funding Opportunity Description
1. Research Objectives
The NCBDDD 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 Substance Abuse: Alcohol, Tobacco, and Other Drugs, and Maternal, Infant, and Child Health and is in alignment with NCBDDD performance goal(s) to prevent birth defects and developmental disabilities. For more information, www.healthypeople.gov. and
http://intra-apps.cdc.gov/fmo/
Prenatal alcohol exposure can lead to a spectrum of adverse consequences for the fetus defined as Fetal Alcohol Spectrum Disorders (FASD) with Fetal Alcohol Syndrome (FAS) representing the most commonly recognized condition. Children with FAS have facial abnormalities, pronounced neuro-developmental disorders and growth deficits. Prevalence estimates of FAS range from 0.3 to 2 per 1,000 live births. Prevalence estimates of children affected by conditions along the full spectrum (FASD) are as high as 1 in 10. Centers for Disease Control and Prevention (CDC) studies find that approximately 1 in 2 childbearing-aged women report past-month alcohol use, with 1 in 8 reporting binge drinking. Many of these women who are sexually active but not using contraception will become pregnant and are at risk for having an alcohol-exposed pregnancy (AEP). CDC estimates that 1-2% of childbearing aged women overall are at risk for an AEP. Identifying and intervening with these women before they become pregnant is an important strategy for reducing FASDs. In 2007, CDC published the results of an efficacious preconception intervention targeting this group of high risk women consisting of motivational counseling sessions and a family planning consultation and services visit (Project CHOICES). See http://www.cdc.gov/ncbdd/fas/default.htm for more information on project CHOICES. This study was supported by Public Law 105-392, Fetal Alcohol Syndrome and Fetal Alcohol Effect Services and Prevention, that charged CDC to “coordinate, support, and conduct prevention and intervention studies as well as epidemiologic research concerning Fetal Alcohol Syndrome and Fetal Alcohol Effects”. Based on the demonstrated efficacy of this intervention, CDC seeks to conduct translation studies of the Project CHOICES intervention model in additional community-based healthcare settings serving women at high-risk for an AEP. In addition to being at risk for AEP, more than 70% of women in the Project CHOICES efficacy study reported they were smokers. Given the risks of smoking to both the woman and her fetus, this translation study will also investigate the value of a facilitated referral to an evidence-based smoking cessation program such as a CDC-funded telephone quit line or a nicotine treatment program for assistance in achieving cessation for women who are current smokers. For more information on best practices for smoking cessation please see http://www.cdc.gov/tobacco.
The primary objectives of this project are to:
(1) Increase the number of preconception women (18-44 years) who reduce their use of alcohol and tobacco using the Project CHOICES intervention model.
(2) Demonstrate the feasibility and impact of integrating the CHOICES intervention and data collection components of the study into the existing electronic medical records (EMR) of the healthcare system.
(3) Estimate the cost of implementing the intervention.
(4) Determine the feasibility and impact of combining a smoking cessation referral and intervention with the Project CHOICES intervention.
Potential applicants will be required to identify a population of women in the preconception period who are at increased risk for an alcohol-exposed pregnancy and who receive ambulatory women’s healthcare within a designated publicly or privately managed healthcare system. The applicant must develop a protocol for the intervention and provide supporting evidence of their capacity to:
· Estimate the required sample size for the study, including power calculations.
· Randomly assign clinics within the health care system to intervention and control groups.
· Provide a plan for integrating the study into the EMR system including screening, intervention, and follow-up of study participants.
· Recruit and train qualified health professionals to provide the intervention which will include a referral for smoking cessation.
· Recruit and follow study participants to assess the impact of the intervention on pregnancy outcomes; a follow-up rate equal to or greater than 70% is desirable.
· Analyze study data to determine the efficacy of the intervention using appropriate statistical methods.
· Collect cost-analysis data as part of the study and perform appropriate analyses.
Applicants may consider adaptations to the CHOICES intervention based on population characteristics, clinical settings, and methods for implementing the facilitated smoking cessation referral. Such adaptations may include fewer than 4 counseling sessions and/or shorter sessions. Providers of the intervention must be designated by the applicant along with evidence that these individuals possess or will be adequately trained to possess the interviewing and counseling skills necessary for delivering the intervention.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
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 U84 activity code.
The HHS/CDC U84 is a cooperative agreement assistance instrument. Under the U84 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.
2. Funds Available
The participating Centers, Institutes and Offices (CIO)(s) NCBDDD intends to commit approximately $1,200,000 direct and indirect dollars in FY2008 to fund up to 3 applications. The average award amount will be $375,000 for a 12-month budget period. An applicant may request a project period of up to four years. An applicant may request up to $400,000 for the 12-month budget period. The anticipated start date for new awards is September 30, 2008.
All estimated funding amounts are subject to availability of funds.
If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.
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.
Cost sharing is not required under this announcement.
3. Other-Special Eligibility Criteria
To be eligible, applicants must:
All estimates must be substantiated using vital records, surveys (i.e. Behavioral Risk Factor Surveillance System (BRFSS), National Survey on Drug Use and Health (NSDUH), and other available clinical and epidemiological data.
A letter of commitment/support from the managed care organization indicating: (1) their ability to provide health care services to the target population, and (2) conformation that the health care organization providing these services has a fully functioning EMR system.
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.
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.htm
IMPORTANT: both the applicant organization, as well as, the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp
2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm
3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.
1. Request Application Information
Applicants must
download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through
Grants.gov/Apply.
Note: Only the
forms package directly attached to a specific FOA can be
used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA); although
some of the "Attachment" files may be useable for more than
one FOA.
For further
assistance, contact PGO TIMS: Telephone 770-488-2700,
Email: PGOTIM@cdc.gov
HHS/CDC
Telecommunications for the hearing impaired: TTY
770-488-2783.
2. Content and Form of Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the
SF424 (R&R) Application Guide (MS Word or PDF).The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/Apply will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424 (R&R)
(Cover component)
Research &
Related Project/Performance Site Locations
Research &
Related Other Project Information
Research &
Related Senior/Key Person
PHS398 Cover Page
Supplement
PHS398 Research
Plan
PHS398 Checklist
Optional Components:
3. Submission Dates and Times
See Section IV.3.A for details
Application Submission Receipt Date(s): May 7, 2008
Peer Review Date (s): June/July 2008
Council Review Date (s): August 2008
Earliest Anticipated Start Date: September 30, 2008
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
· Descriptive title of proposed research
· Name, address, and telephone number of the Principal Investigator
· Names of other key personnel
· Participating institutions
· Number and title of this funding opportunity
Although a letter of intent is not required
, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.The letter of intent is to be sent by April 7, 2008.
The letter of intent should be sent to:
JoAnn M. Thierry, Ph.D.
CDC/NCBDDD
1600 Clifton Road, MS-E88
Executive Park, Building 12
Atlanta, GA
30333
Telephone: (404) 498-3022
Fax:
(404) 498-3060
Email:
jthierry@cdc.gov
3.B. Submitting an Application to CDC
If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.
To submit an application in response to this FOA, applicants should access this FOA via Grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov. The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application.
All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.
This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.
Otherwise, HHS/CDC
will not notify you upon receipt of your paper submission.
If you have a question about the receipt of your
application, first contact your courier. If you still have
a question, contact the PGO-TIMS staff at: 770-488-2700.
Before calling, please wait two to three days after the
submission deadline. This will allow time for HHS/CDC to
process and log submissions.
If submitting a paper application, it must be prepared using the 424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:
Technical Information Management Section – RFA-DD-08-003
CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Phone: 770-488-2700 EST
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 NCBDDD 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 not apply to this program.
5. Funding Restrictions
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Additional guidance can be found at HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
· Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.
A description of the study population and risk behaviors such as alcohol use, binge drinking, smoking, sexual activity, and ineffective use of contraception, including no contraception, must be provided.
A thorough description of the managed health care system should be provided including but not limited to: the number of clinics serving childbearing aged women, types of services provided, and number of annual visits.
Applicants must also provide a thorough description of their EMR system platform including capacity for data entry, alert triggers, recommendations, and follow-up actions.
Applicants will be required to participate in monthly conference calls and an initial training session sponsored by CDC to review the CHOICES protocol. Meetings of the key investigators and appropriate staff will be convened annually. Applicants should include the cost for one annual trip to Atlanta in their budget.
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”.
Applicants’ research plan(s) should address activities they will conduct over the entire project period.
The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.
Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.
The following materials may be included in the Appendix:
Up to ten publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific 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
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
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
· Geographical diversity is desirable and may be considered in making final selection decisions
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 NCBDDD in
accordance with the review criteria stated below.
As part of the
initial merit review, all applications will:
· Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score
· Receive a written critique; and
· Receive a second level of review by HHS/CDC NCBDDD
· 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?
Approach:
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).
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.
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
The CDC
Procurement and Grants will notify successful applicants in
a pre-award conference call and provide a notice of award.
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.
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.
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
U84 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
(1)
Providing oversight of all management and administrative aspects of the project, including maintaining an adequate staffing plan to support project activities.(2) Developing and implementing all scientific aspects of the study protocol, including ongoing data collection and follow-up, quality control, data analyses and interpretation, and preparing peer–reviewed publications and presentations.
(3) Preparing and coordinating the submission of the study protocol to the designated IRB(s) and ensure that the protocol(s) is(are) conducted in compliance with the terms and conditions of the IRB approval.
(4) Maintaining the confidentiality of the study data.
(5) Participating in monthly coordinating committee meetings and provide input into the agenda.
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:
There
are two separate CDC scientific roles – Scientific
Collaborator and Scientific Program Administrator
In this cooperative agreement, a CDC Scientist (Scientific Collaborator) within the National Center on Birth Defects and Developmental Disabilities (NCBDDD) is an equal partner with scientific and programmatic involvement during the conduct of the project through technical assistance, advice and coordination
Scientific Collaborators will:
1. Use their experience in studies of this nature to advise the project on specific questions regarding the project-developed protocol, and collaborate on the development of new protocol;
2. Support grantee activities in data management, data analysis, intervention design, formats for presenting research findings, and in comparing project-developed evaluation formats with other research projects and activities known to CDC;
3. Provide scientific consultation and technical assistance on questions related to epidemiology, statistical and power calculations, and data storage and tracking formats used in other CDC sponsored research that could be advantageous to the project;
4. Assist in the analysis, interpretation, and reporting of findings in the literature that can serve a broad range of scientific interests;
5. Facilitate the monthly conference calls with the coordinating committee; and
6. Provide training in the use of the original Project CHOICES intervention.
CDC
Scientific Program Administrator (SPA)
The CDC NCBDDD Office of Extramural Research (OER) will appoint a SPA, apart from the NCBDDD Scientific Collaborator who will:
1. Serve as the Program Official for the funded research institutions.
2. Carry out continuous review of all activities to ensure objectives are being met.
3. Attend Coordinating Committee meetings for purposes of assessing overall progress and for program evaluation purposes.
4. Provide scientific consultation and technical assistance in the conduct of the project as requested.
5. Conduct site visits to recipient institutions to monitor performance against approved project objectives.
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.
The planning and implementation of the cooperative aspects of the study will be effected by a Coordinating Committee consisting of the Principal Investigator from organizations receiving awards under this announcement and the CDC Scientific Collaborator; and will address issues of common concern throughout the life of the project. Organizations serving as sub-contractors under awarded projects are not considered members of the Coordinating Committee.
At periodic Coordinating Committee meetings among recipients, the group will: (1) make recommendations on the study protocol and data collection approaches; (2) discuss common elements of protocols as they relate to intervention components; (3) discuss the target populations that have been or will be recruited; (4) identify and recommend solutions to unexpected study problems; and (5) discuss ways to efficiently coordinate study activities and best practices.
Each full member will have one vote. Awardee members of the Coordinating Committee (including a CDC member) should accept and implement policies approved by the Committee.
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:
JoAnn M. Thierry, Ph.D.
CDC/NCBDDD
1600 Clifton Road, MS-E88
Executive Park, Building 12
Atlanta, GA
30333
Telephone: (404) 498-3022
Fax:
(404) 498-3060
Email: jthierry@cdc.gov
Dr. Juliana Cyril
Office of Public Health Research (OPHR)
U.S. Department of Health
and Human Services
1600 Clifton Road, NE, Mailstop D-72
Atlanta, GA 30333
Telephone: (404) 639-4639
Fax: (404) 639-4063
Email:
zdq4@cdc.gov
Ms. Tracey Simms
Procurement
and Grants Office
Center
for Disease Control and Prevention
U.S. Department of Health
and Human Services
2920 Brandywine Road
Atlanta, GA
30341
Telephone: (770) 488-2722
Fax: (770) 488-2777
Email:
nea1@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.
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.
HIV/AIDS Confidentiality Provisions
Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.
Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.
Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.
Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.
To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.
If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.
Before funds are
used to develop educational materials, determine whether
suitable materials already exist in the CDC National
Prevention Information Network (NPIN).
The website can be found at;
http://www.nchstp.cdc.gov/od/infocenter/npin.htm.
Patient Care
Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.
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:
Ms. Tracey Simms, Grants Management Specialist
Procurement and
Grants Office
Announcement
Number DD08-003
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.
Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).
Smoke-Free Workplace Requirements
HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.
The Public Health
Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010,"
a PHS-led national activity for setting priority areas. This
FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People
2010" at
www.healthypeople.gov
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.
In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation
It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.
Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.
Proof of nonprofit status 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.
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.
Peer and Technical Reviews of Final Reports of Health Studies – HHS/ATSDR
Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by Superfund Amendments and Reauthorization Act of 1986 (SARA), Section 104 (I)(13), and [42 U.S.C. 9604 (I)] requires all studies and results of research (other than public health assessments) that ATSDR carries out or funds in whole or in part will be peer reviewed by ATSDR. The ATSDR peer review process for final reports requires that:
1. Studies must be reported or adopted only after appropriate peer review.
2. Studies shall be peer reviewed within a period of 60 days to the maximum extent practical.
3. Studies shall be reviewed by no fewer than three or more than seven reviewers who:
a. Are selected by the Assistant Administrator, ATSDR;
b. Are disinterested scientific experts;
c. Have a reputation for scientific objectivity; and
d. Who lack institutional ties with any person involved in the conduct of the study or research under review.
HHS/ATSDR encourages rapid reporting and interpretation of laboratory results and reference ranges back to individual participants. However, if summary tables or distribution of laboratory results are prepared using the study data, this is considered a preliminary finding and will require ATSDR technical and peer review prior to release.
When, in the opinion of the investigator(s), a public health concern exists requiring the release of summary study statistics prior to the completion of the study, the investigator must obtain concurrence from HHS/ATSDR prior to releasing the summary statistics. A request for HHS/ATSDR concurrence for the release of information must be documented in a letter to HHS/ATSDR and should outline the public health concern, the investigator's interpretation of the concern and recommended response, and the draft document proposed for release by the investigator. HHS/ATSDR will provide a technical review and peer review within ten working days to the maximum extent possible. At sites where HHS/ATSDR must coordinate with another Federal agency, this requires additional time. Summary statistics may be released only after peer review. The release of summary statistics does not preclude the requirement for a final report.
By statute, the reporting of preliminary studies and preliminary research results to the public is not acceptable without prior review by HHS/ATSDR. This includes manuscripts prepared for publication, presentations at scientific meetings and reporting of preliminary findings to the community or the media.
Final Report
1. The final report for every study should include a detailed description of the problem, hypothesis, methods, results, conclusions, and recommendations that constitute a complete performance record of the study. A copy of the suggested format for the final report will be supplied by HHS/ATSDR to the investigator.
2. HHS/ATSDR is responsible for the technical and peer review of the draft final reports of any study that it funds prior to the submission of the final report. This will allow the recipient to incorporate technical and peer review comments into the final report. Responses to all HHS/ATSDR required technical and peer review comments should be summarized in a letter to HHS/ATSDR. This letter should also include the investigator's response to each comment and a rationale for those responses. Based upon the comments of the technical and peer reviewers, modifications in the study report may result. The modified study report should accompany the letter to HHS/ATSDR.
3. Following the steps outlined above, a final report of all studies and results of research carried out or supported by HHS/ATSDR must be submitted to the Procurement and Grants Office with a copy furnished to HHS/ATSDR.
All requirements, including peer review, technical review, and cost recovery, are applicable to award recipients and any subcontractors employed by the award recipient. Failure to comply with these requirements could adversely affect future funding.
Third Party Agreements – HHS/ATSDR
Applicant must justify the need to use a contractor. If contractors are proposed, the following must be provided: (1) name of contractor, (2) method of selection, (3) period of performance, (4) detailed budget, (5) justification for use of contractor, and (6) assurance of non-conflict of interest.
Project activities which are approved for contracting pursuant to the prior approval provisions shall be formalized in a written agreement that clearly establishes the relationship between the recipient and the third party.
The written agreement shall, at a minimum:
1. State or incorporate by reference all applicable requirements imposed on the contractors under the terms of the grant and/or cooperative agreement, including requirements concerning technical review (ATSDR selected reviewers), ownership of data, and the arrangement for copyright when publications, data, or other copyrightable works are developed under or in the course of work under a PHS grant-supported project or activity.
2. State that any copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal government purposes.
3. State that whenever any work subject to this copyright policy may be developed in the course of a grant by a contractor under a grant, the written agreement (contract) must require the contractor to comply with these requirements and can in no way diminish the government's right in that work.
4. State the activities to be performed, the time schedule for those activities, the policies and procedures to be followed in carrying out the agreement, and the maximum amount of money for which the grantee may become liable to the third party under the agreement.
5. State non-conflict of interest concerning activities conducted for HHS/ATSDR and site-remediation activities for other parties.
The written agreement required shall not relieve the recipient of any part of its responsibility or accountability to PHS under the cooperative agreement. The agreement shall, therefore, retain sufficient rights and control to the recipient to enable it to fulfill this responsibility and accountability.
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:
1. Place small, minority, women-owned business firms on bidders mailing lists.
2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.
Research Integrity
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).
For example:
Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.
Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS. If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:
http://www.whitehouse.gov/government/fbci/
Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:
a. In a timely manner.
b. Completely, and as accurately as possible.
c. To facilitate the broader community.
d. Developed in accordance with CDC policy on Releasing and Sharing Data.
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.cdc.gov/od/foia/index.htm.
Applications must include a copy of the applicant's Data Release Plan. Applicants should provide HHS/CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
Conference Disclaimer and Use of Logos
{Mandatory for all grants and cooperative agreements.}
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:
“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”
Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by 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