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Amendments to this announcement have been made in red.
Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (NCIPC/CDC) at http://www.cdc.gov/ncipc/
Participating Organizations
Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/
Components of Participating
Organizations
National Center for Injury Prevention and Control (NCIPC/CDC) at http://www.cdc.gov/ncipc/
Title: Unintentional Poisoning from Prescription Drug Overdoses in Adults (R21)
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 Section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, and Section 391 (a)[42 U.S.C. 280 b(a)] of the Public Health Service Act, as amended.
Announcement Type: New
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 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 -CE-09-004
Catalog of Federal Domestic Assistance Number(s): 93.136, Injury Prevention and Control Research and State and Community Based Programs
Key Dates
Release/Posted Date:
Letter of Intent Receipt Date:
December 22, 2008
Application Submission Receipt
Date(s):
January 21, 2009
Peer Review Date(s):
March -
April, 2009
Council Review Date(s):
May - June, 2009
Earliest Anticipated Start Date(s): September, 2009
Additional Information to Be Available Date: December 10, 2008
Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on December 10, 2008 from 1:30 p.m. to 3:00 p.m. (Eastern Time). The conference can be accessed by calling: 1-877-921-3815, stating the leader name: Gail Wilson, and entering the passcode: 3776277.
Expiration Date: 91 days after publication date.
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
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 Injury Prevention and Control 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 FOA addresses “Healthy People 2010” priority area(s) of injury and violence prevention and is in alignment with NCIPC performance goal(s) to increase the capacity of injury prevention and control programs to address the prevention of injuries and violence. It also supports CDC’s performance goals of prevention research involving sustainable and transferable community-based interventions. For more information, see www.healthypeople.gov and http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm.
This funding opportunity announcement encourages research that will build the scientific base for the prevention of unintentional poisonings from drug overdoses in the adult population (ages 15 to 64 years). It solicits proposals from organizations to conduct exploratory/developmental research that involves the evaluation of novel approaches to drug overdose prevention and addresses the NCIPC’s research agenda priorities related to unintentional poisoning. It is meant to engage professionals from a wide spectrum of disciplines in epidemiology, community medicine, pharmacology, biostatistics, public policy, public health law, justice, and behavioral and social sciences.
Background
Unintentional poisoning is now the second leading cause of unintentional injury death for Americans.1 Its rates have increased dramatically since 1990 and surpassed the rate for fatal fall injuries in 2002.2 By 2005, there were 23,618 unintentional poisoning deaths, of which 22,448 (95%) were due to drug overdoses.3 More than half of these were associated with prescription drugs.4 In 2005, unintentional poisoning was the leading cause of unintentional injury death in the 35-54 years age group, surpassing motor vehicle traffic deaths for the first time. This age group is of particular concern because its unintentional poisoning death rate was higher than other age groups in 2005. Relatively few such deaths occur among persons over age 60 or under age 15.1
Injury deaths are only part of the problem. The Drug Abuse Warning Network (DAWN) estimated that there were 1.4 million emergency department (ED) visits associated with drug misuse and abuse in the U.S. in 2005.5 Approximately half of these ED visits involved pharmaceuticals. The numbers of new recreational users of prescriptions drugs in the United States in recent years have outnumbered the new users of marijuana. In 2006 for example, there were 2.2 new nonmedical users of prescription painkillers and 1.1 million new nonmedical users of sedatives, as compared with 2.1 million new uses of marijuana.6
Principal among prescription drugs associated with these deaths and ED visits are the prescription painkillers, also known as narcotic analgesics. Deaths and ED visits associated with these drugs have risen steadily since the mid-1990s, when such drugs began to be used much more liberally in medical practice. The most important “problem drugs” in this group are methadone, oxycodone, hydrocodone, morphine, and fentanyl.7 This health problem has received a great deal of publicity and prompted a variety of efforts to address it by both private and public sectors at federal, state, and local levels. To date there is no empiric evidence that any of these efforts have been successful in reducing drug overdose morbidity or mortality on a statewide or national level. In 2006, preliminary mortality data from NCHS indicates that drug poisoning death rates continued to rise nationwide.8 Preliminary, unweighted data from a national sample of hospitals in the DAWN Live system indicates that emergency department overdose counts have also risen through 2007.9
Research Objectives:
The proposed research must address at least one of the research objectives in this FOA.
The goal of this FOA is to support investigator-initiated exploratory research that will expand and advance our understanding of approaches to prevent unintentional drug overdoses in the adult population associated with prescription drugs. Applications are sought that will address one (or more) of the following research objectives proposed in the research plan and identified in the "Project Summary/Abstract”:
1. Research that evaluates risk management strategies (“RiskMAPs”) employed by pharmaceutical companies after a drug comes on the market. This might include evaluation of the surveillance measures put in place to detect misuse and abuse or overmedication of opioids. Studies that use objective measures of the completeness, accuracy, and timeliness of such surveillance are particularly desirable. Studies that compare RiskMAPs with alternative surveillance methods such as the emergency department component of the Drug Abuse Warning Network (DAWN) are also desirable.
2. Research that evaluates the response of pharmaceutical companies when surveillance indicates a potential problem with the abuse of one of their products. Such responses have often included educational messages to physicians. Studies could include determining whether such messages change either the volume or patient mix for the problematic drug.
3. Research to evaluate the effectiveness of actions taken by the Food and Drug Administration (short of removing the product from the market) to correct problems associated with overdoses from controlled substances, including opioids, once they reach the market. This might include evaluation of “black box” warnings placed on drugs, restriction of the indications or circumstances under which a drug can be used, physician education, or other control measures.
4. Research to evaluate the effectiveness of economic-based interventions that identify potential abusers and restrict their accessibility to drugs with overdose potential, through insurance mechanisms that require prescriptions from specified providers or pharmacies. This might include evaluation of the Patient Restriction and Review programs of state Medicaid agencies or similar programs instituted by private insurers.
5. Research to evaluate programs that provide naloxone as an antidote to high risk persons who have been prescribed opioids and have the potential of abuse, unintentional misuse, or overdose. This may include community trials of such programs that produce data on both the risks and benefits of making naloxone routinely available for such patients.
6. Opportunistic evaluations of imminent changes in policies or environments that could influence the rising rate of prescription drug overdoses among adults are needed. For example "natural experiments," legislative changes, state laws adopted, changes in physician prescribing practices, physician training and education initiatives, etc.
7. Research that can inform the ongoing policy debate on prescription drug overdose prevention, for example, small experimental studies, secondary data analyses in a state or county, cost-effectiveness analyses of promising interventions, modeling health systems change, health impact assessments, simulations of policy effects, or macro-level policy analyses.
8. Research on the impact of guidelines for the use of opioids in the management of chronic noncancer- related pain. Such guidelines have been promulgated by the Agency Medical Directors in Washington State, for example (Available at: http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf). Impact could be measured in terms of changes in the total number of prescriptions, total milligrams, milligrams per patient per day, emergency department visits for overdoses of scheduled drugs, and other measures.
9. Research on the impact of guidelines for the use of scheduled drugs in emergency departments. Individual hospitals and community programs have instituted such guidelines, e.g., the Sacred Heart Medical Center in Spokane, Washington (http://consistentcare.com). Empirical evidence of their impact on the volume of opioids used and types of injuries/illnesses for which they are used is needed. Their impact might also be measured in terms of the volume of use of emergency departments by patients enrolled in the program.
Special Considerations:
1. Applicants will be required to include evidence of prior experience in evaluation studies. This evidence may include publications or technical reports from pilot data or prior published research related to this topic (included in the appendix of the application).
2. Government, private sector, and academic applicants are encouraged to work in partnership with each other, where possible, to strengthen their overall approach.
3. Preference will be given to applicants from geographic areas with above-average rates of mortality from unintentional drug poisoning or those classified from undetermined intent. Applicants are expected to address the potential this research would have in reducing morbidity and mortality rates in similar areas of the country where rates are also high.
REFERENCES
1. Centers for Disease Control and Prevention. Web-based Injury Statistics Query and Reporting System (WISQARS) [Online]. (2003) National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (producer). Available at: www.cdc.gov/ncipc/wisqars. Accessed December 11, 2006
2. Paulozzi LJ, Ballesteros MF, Stevens JA. Recent trends in mortality from unintentional injury in the United States. J Safety Res 2006;37:277-83.
3. Centers for Disease Control and Prevention. WONDER [Online]. (2007) Centers for Disease Control and Prevention (producer). Available at: http://wonder.cdc.gov.
Accessed October 5, 2007
4. Paulozzi LJ, Budnitz DS, Xi Y. Increasing deaths from opioid analgesics in the United States. Pharmacoepidemiol Drug Safety 2006;15:618-27.
5. US Department of Health and Human Services (USDHHS), Substance Abuse and Mental Health Services Administration, Office of Applied Studies, Drug Abuse Warning Network. (2003) The DAWN Report -- trends in drug-related emergency department visits, 1994-2002 at a glance. Available at: dawninfo.samhsa.gov/old_dawn/pubs_94_02/shortreports/files/DAWN_EDvisits_glance.pdf. Accessed December 17, 2004.
6. US Department of Health and Human Services (USDHHS) Substance Abuse and Mental Health Services Administration Office of Applied Studies. Results from the 2006 National Survey on Drug Use and Health: national findings. Available at: www.drugabusestatistics.samhsa.gov/nsduhLatest.htm. Accessed December 17, 2007.
7. Paulozzi LJ. Opioid analgesic involvement in drug abuse deaths in American metropolitan areas. AJPH 2006;96:1755-7.
8. Heron M.P., Hoyert DL, Xu J, Scott C, Tejada-Vera B. Deaths: preliminary data for 2006. National vital statistics reports 2008;56:1-52.
9. Substance Abuse and Mental Health Services Administration. DAWNLive! Available at: https://restricted.dawninfo.net/login.asp. Accessed February 26, 2008.
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 is a research grant and will use the Exploratory/Developmental Research (R21) activity code.
2. Funds Available
The participating Centers, Institutes, and Offices (CIOs) (NCIPC) intend to commit approximately $350,000 (direct and indirect costs) dollars in FY2009 to fund two applications. The average award amount will be $175,000 (direct and indirect costs) per year. An applicant may request a project period of up to two years. An applicant may request up to $175,000 (direct and indirect) during the first 12 month budget period. The approximate total project period funded ceiling of award amount is $350,000. The anticipated start date for new award is September, 2009.
All estimated funding amounts are subject to availability of funds.
If an applicant requests a funding amount greater than the ceiling of the award, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.
Section III. Eligibility Information
1. Eligible Applicants
1.A.
Eligible Institutions
You may submit an application if your organization has any of the following characteristics:
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a .pdf file and attach as “Other Documents” and label as appropriate.
2. Cost Sharing or Matching
Cost sharing, matching, or cost participation is not
required.
The most
current HHS Grants Policy Statement is available at:
http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc
3. Other-Special Eligibility
Criteria
To be considered responsive to this announcement, the applicant institution must provide:
• To be considered responsive to this announcement, the applicant must propose at least one of the research objectives as described under the heading “Research Objective”. An application will only be accepted and reviewed if it addresses one of the research objectives and provides it in the "Project Summary/Abstract".
• Applicants will be required to include evidence of prior experience in evaluation studies. This evidence may include publications or technical reports from pilot data or prior published research related to this topic.
• Documentation of effective and well-defined working relationships with any organization and/or outside entities expected to participate in the proposed research that will ensure implementation of the proposed activities. This should be evidenced by letters of support detailing the nature and extent of the involvement from the performing organization and outside entities (include in the appendices).
• Preference will be given to applicants from geographic areas with above-average rates of mortality from unintentional drug poisoning or those classified from undetermined intent. Applicants are expected to address the potential this research would have in reducing morbidity and mortality rates in similar areas of the country where rates are also high.
• An applicant institution can submit more than one application in response to this FOA, but may not submit more than one application with the same principal investigator. Applicants may not submit a revised or amended application but must submit as a new application.
• Your research plan must not exceed 15 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review. The proposed research must address at least one of the research objectives in this FOA.
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process.
Note: Title 2 of the United
States Code Section 1611 states that an organization
described in Section 501(c)(4) of the Internal Revenue Code
that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant, or loan.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to Grants.gov/Apply and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at the following:
·
Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp·
eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htmIMPORTANT: both the applicant organization, as well as the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp
·
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.·
Direct questions regarding Grants.gov registration to: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: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)
Project Summary/Abstract
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
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:
December
22, 2008
Application Submission
Receipt Date(s):
January
21, 2009
Peer Review Date:
March -
April, 2008
Council Review Date:
May -
June, 2008
Earliest Anticipated Start Date: September, 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
·
Descriptive title of proposed research·
Name, address, and telephone number of the Principal Investigator·
Names of other key personnel·
Participating institutions·
Number and title of this funding opportunity
Although a letter of intent is not required
, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A
The letter of intent should be sent by mail, fax or email to:
J. Felix Rogers, Ph.D., MPH
Scientific Review Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control
Address for Express Mail or Delivery Service:
4770 Buford Hwy. NE, Bldg 106, Room 08013
Atlanta, GA 30341
Address for U.S. Postal Service Mail:
4770 Buford Hwy. NE, Mailstop F-62
Atlanta, GA 30341
FAX: (770) 488-1665
Email: frogers@cdc.gov
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.
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 NCIPC 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.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
6.
Other Submission Requirements
A detailed categorical budget for the “Initial budget Period” and the “Entire Proposed Period of Support” must be submitted with the application. 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. Guidance for completing a detailed justified budget can be found on the CDC Web site, at the following address: http://www.cdc.gov/od/pgo/funding/budgetguide.htm.
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 15 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 to10 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 specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.
It is especially important that the abstract (Project Summary/Abstract, SF424 form page 2) of your grant application reflect the project’s focus; the abstract will be used to help determine the responsiveness of the application. The following instructions supersede those provided in the SF424 instructions. If your application is funded, your abstract will become public information.
The Project Summary/Abstract should be a 1 page document and should contain the following sections:
• Identify the proposed objective(s)
• Importance (One or two sentences explaining the importance of the study question)
• Objectives (Include specific aims and hypotheses)
• Study Design
• Setting
• Participants (Include the number of participants and how they will be selected)
• Interventions (Explain the essential features of any interventions)
• Outcome Measures
The language of the abstract must be simple and easy to understand for a broad audience. For more information on how to write an abstract please see the “Structured Abstracts” section at: http://jama.ama-assn.org/ifora_current.dtl
Research Plan
You must include a research plan in your application. The research plan should address activities to be conducted over the entire project period. The research plan should include the following information:
• The project's focus, a justification for the research proposed, and a description of the scientific basis for the research. The focus should be based on recommendations in “Healthy People 2010" (http://www.healthypeople.gov) and the “CDC Injury Research Agenda,” (http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm) and should seek creative approaches that will contribute to a national program for injury control.
• Specific, measurable, and time-framed objectives.
• A detailed plan describing the methods by which the objectives will be achieved, including their sequence. A comprehensive evaluation plan is an essential component of the application.
• A description of the principal investigator's role and responsibilities.
• A description of those activities related to, but not supported by, the grant.
• A description of the involvement of other entities that will relate to the proposed project, if applicable. It should include commitments of support and a clear statement of their roles.
• An explanation of how the research findings will contribute to the national effort to reduce the morbidity, mortality and disability caused by injuries within three to five years from project start-up. See also http://www.hhs.gov/.
Plan for Sharing Research Data
All data sets produced by the grantees must be shared with
CDC at the completion of the project.
Sharing Research Resources
Not applicable
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
• Preference will be given to applicants from geographic areas with above-average rates of mortality from unintentional drug poisoning or those classified from undetermined intent. Applicants are expected to address the potential this research would have in reducing morbidity and mortality rates in similar areas of the country where rates are also high.
• Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services, for more information see, www.healthypeople.gov
and http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm
• Applications that do not address one of the objectives listed in Part II, Section 1 Research Objective, will not be funded even if they rank higher than other applications that address all required objectives.
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 NCIPC 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?
Does the proposed research plan and
objectives address one or more of the program priorities as
described under the heading “Research Objectives”?
Does the
application propose research to be conducted in geographic
area(s) with above-average rates of mortality from
unintentional drug poisoning or those classified from
undetermined intent? Does the application address the
potential this research would have in reducing morbidity and
mortality rates in similar areas of the country where rates
are also high?
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)?
Does the application demonstrate evidence of prior
experience in evaluation studies?
Does the application document effective and well-defined
working relationships with organizations and/or outside
entities expected to participate in the proposed research
that will ensure implementation of the proposed activities,
as evidenced by letters of support detailing the nature and
extent of the involvement?
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
· The comments and recommendations of the primary review including the application’s priority score as the primary factor in the selection process. · The relevance and balance of proposed research relative to the HHS/CDC/NCIPC programs priorities and the research objectives identified in this FOA.
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)] located at, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women and Minorities in Research:
Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R).
Care and Use of Vertebrate Animals in Research:
If applicants plan to use
vertebrate animals in the project, HHS/CDC will assess the
five items described under Section 2, item 12 Vertebrate
Animals of the Research Plan component of the SF424 (R&R).
Additional
HHS/CDC Requirements under AR-3 Animal Subjects Requirements
are available on the Internet at the following address:
http://www.cdc.gov/od/pgo/funding/ARs.htm.
Biohazards:
If applicants propose the applicant has proposed materials
or procedures that are potentially hazardous to research
personnel and/or the environment, HHS/CDC will determine if
the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget and Period of
Support: The
reasonableness of the proposed budget and the
appropriateness of the requested period of support in
relation to the proposed research may be assessed by the
reviewers. Is the number of person months listed for the
effort of the PD/PI appropriate for the work proposed? Is
each budget category realistic and justified in terms of the
aims and methods? The evaluation of the budget should not
affect the priority score.
2.C. Sharing Research Data
All data sets produced by the grantees must be shared with CDC/NCIPC at the completion of the project.
2.D. Sharing
Research Resources
Not applicable
3. Anticipated Announcement
and Award Dates
Grantees
will be notified in
September, 2009
by
HHS/CDC’s Procurement and Grants Office (PGO) if their
applications were selected for funding.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the
application is completed, the applicant organization will
receive a written critique called a “Summary Statement.”
The applicant organization and the PD/PI will be able to
access the Summary Statement via the eRA Commons.
HHS/CDC will contact t
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer (GMO) is the authorizing document. HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application.
Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about policy requirements. For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available in Section VIII. Other Information on this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
The following terms and
conditions will be incorporated into the NoA and will be
provided to the appropriate institutional official and a
courtesy copy to the PD/PI at the time of award.
3. Reporting
Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:
1.
Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.2.
The annual performance report is due 30 days after the end of the budget period.3.
Financial status report, no more than 90 days after the end of the budget period.4.
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:
Adele M. Childress, Ph. D, M.S.P.H
Scientific Program Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
4770 Buford Hwy, NE, Mailstop F-62
Atlanta, GA, 30341
Telephone: (770) 488-4233
FAX: (770) 488-4422
Email: achildress@cdc.gov
2. Peer Review Contacts:
Felix Rogers, Ph.D., MPH
Scientific Review Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
4770 Buford Hwy, NE, Mailstop F-62
Atlanta, GA 30341
Telephone: (770) 488-4334
FAX: (770) 488-4422
Email: frogers@cdc.gov
3. Financial or Grants
Management Contacts:
LaKasa Wyatt, Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2728
FAX: 770-488-2670
E-mail: lgw5@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
5. Special Guidelines for Technical Assistance:
NCIPC Website: For additional help in preparing your grant application please see the “frequently asked questions” section on the NCIPC webpage at: http://www.cdc.gov/ncipc/res-opps/2004pas.htm.
Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on
December 10, 2008 from 1:30 p.m. to 3:00 p.m. (Eastern Time). The conference call can be accessed by calling 1-877-921-3815, and stating the leader name: Gail Wilson, and entering the passcode: 3776277.Participation in this conference call is not mandatory.
At the time of the call, if you have problems accessing the conference call, please call 770-488-1563 for assistance.
Section VIII. Other Information
Required Federal Citations
Human Subjects Protection:
Federal
regulations (45 CFR Part 46)
require that applications
and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of
protection against these risks, the potential benefits of
the research to the subjects and others, and the importance
of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Additional HHS/CDC Requirements under AR-1 Human Subjects
Requirements can be found on the Internet at the following
address:
http://www.cdc.gov/od/pgo/funding/ARs.htm.
Use of Animals in Research:
Recipients of PHS support
for activated involving live, vertebrate animals must comply
with PHS Policy on Humane Care and Use of Laboratory Animals
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable. Additional HHS/CDC Requirements under AR-3
Animal Subjects Requirements can be found at
http://www.cdc.gov/od/pgo/funding/ARs.htm.
Requirements for Inclusion
of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.
INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must
be included in all human subjects research that is conducted
or supported by CDC, unless there are scientific and ethical
reasons not to include them. This policy applies to all
CDC-conducted or CDC-supported research involving human
subjects, including research that is otherwise exempt in
accordance with Sections 101(b) and 401(b) of
45 C.F.R. Part 46, HHS Policy for the Protection of Human
Subjects. Therefore, proposals for research
involving human subjects must include a description of plans
for including persons under the age of 21. If persons under
the age of 21 will be excluded from the research, the
application or proposal must present an acceptable
justification for the exclusion.
In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.
The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.
The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.
Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.
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
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 PA 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 CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation
It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Prohibition on Use of CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."
Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.
Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.
Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.
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:
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 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 CDC data sharing agreement will be released as follows:
When required (see note below) applications must include a copy of the applicant's Data Release Plan. Applicants should provide 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
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a subgrant 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