and Human Services (HHS)
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Department of Health and Human Services
Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov)
Components of Participating Organizations
National Center for Public Health Informatics (NCPHI)
Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.
Title: The BioSense Initiative to Improve Early Event Detection
Announcement Type
New
RFA Number: RFA-PH-05-126
Catalog of Federal Domestic Assistance Number(s)
93.061
Key Dates
Release Date: June 14, 2005
Application Receipt Dates(s): July 15, 2005
Objective Review Date(s): September 2005
Earliest Anticipated Start Date: October 1, 2005
Expiration Date: July 16, 2005
Due Dates for E.O. 12372
Not applicable
Executive Summary
The Centers for Disease Control and Prevention (CDC) invites applications for research in support of the BioSense Initiative to improve early detection of disease outbreaks of public health importance . This project will award approximately $1.8 million in total costs to fund 3 - 5 grants. The BioSense Initiative seeks to develop the science of early event detection and situational awareness through the secondary use of existing information in electronic, health-related databases. This field is still early in its development and this Program seeks to support research to make it as useful and efficient as possible for public health purposes. The Program focuses on three broad areas: (1) increasing the sensitivity and specificity of detection algorithms, (2) establishing the efficacy of different data sources, and (3) developing software methods and components compatible with the Public Health Information Network Preparedness Initiative functional and technical specifications (http://www.cdc.gov/phin). Responders should focus on one key question or problem . Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. CDC encourages individuals from all racial and ethnic groups as well as individuals with disabilities to apply for this program. Only one application per Principal Investigator will be funded under this announcement.
Table of ContentsPart 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
B. Eligible Individuals
2.Cost Sharing
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates
A. Receipt and Review and Anticipated Start Dates
B. Sending an Application to the 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
3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
3. Reporting
Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part II - Full Text of AnnouncementAuthority: 42 U.S.C. 247d-4
1. Research Objectives
Background
Traditional public health surveillance makes use of pre-specified definitions, manual data collection, human decision-making, and manual data entry. This approach is time-consuming, expensive, untimely, and has variable sensitivity and specificity. The BioSense Initiative seeks to implement an alternate method, electronic biosurveillance, for early event detection and situational awareness during outbreaks. This approach makes secondary use of information in computer database collected primarily for clinical care and other health-related purposes 1.
One approach to electronic biosurveillance is termed syndromic surveillance 2. Most commonly, ICD-9 CM diagnosis codes or free-text chief complaints are assigned to one or more disease syndromes (e.g., respiratory, gastrointestinal). Counts of records in the various syndrome groups are analyzed to determine when excess numbers are reported. Health department staff monitor analytic disease indicators continually (real-time) or at least daily (near real-time). Moving beyond this syndromic surveillance approach may improve sensitivity and specificity. Therefore, this Program is not restricted to the consideration of syndromic data or to the use of syndrome bins .
This Program focuses on three broad areas for the use of health data for monitoring disease outbreaks of public health importance. The first is related to increasing the sensitivity and specificity of algorithms for automated identification and monitoring. The second area includes work to establish the efficacy of different health-related data sources and work to characterize the attributes of these data sources in normal populations. And the third area relates to software methods and components, compatible with the Public Health Information Network Preparedness Initiative functional and technical specifications (http://www.cdc.gov/phin), which can facilitate the efficient use of secondary health data for public health surveillance purposes.
This Program addresses at least two focus areas of Healthy People 2010: VA 14: Immunization and Infectious Diseases; and FA23: Public Health Infrastructure (http://www.health.gov/healthypeople). It is also related to the CDC Draft Health Protection Goals: Preparedness, People in all communities will be protected from infectious, occupational, environmental, and terrorist threats; and Decrease the time needed to classify health events as terrorism or naturally occurring in partnership with other agencies. (http://www.cdccoalition.org/resources/CDCFuturesInitiative.pdf).
Research Objectives
The primary objective is to increase the utility of electronic biosurveillance for monitoring health-related data for early detection of disease outbreaks of public health importance. This should be accomplished through improved understanding of input data, enhanced analytic methods, and the development of sharable software methods and tools.
Types of Research and Experimental Approaches That Are Being Sought
Responders to this RFA should focus on one key question or problem. Specific approaches to the primary objective can include, but are not limited to, the following:
1. Loonsk JW. BioSense--A National Initiative for Early Detection and Quantification of Public Health Emergencies. Morbid Mortal Weekly Report. 2004: 53(Suppl);53-55.
2. Mandl KD, Overhage JM, Wagner MM, Lober WB, Sebastiani P, Mostashari F, Pavlin J, Gesteland PH, Treadwell T, Koski E, Hutwagner L, Buckeridge DL, Aller R, Grannis S. Syndromic surveillance: a guide informed by the early experience? J Am Med Inform Assoc. Mar-Apr 2004; 11(2): 141-150.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the CDC research program project grant (R01) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.
This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions. Specifically, a detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
2. Funds Available
CDC intends to commit approximately $1.8 million in total costs in FY 2005 to fund up to 5 new grants in response to this RFA. Awards will range from approximately $360,000 to $600,000 in total costs per year for no more than three years. An applicant may request up to three consecutive 12-month budget periods within a project period of up to 3 years. The anticipated start date is September 1, 2005. Although the financial plans of CDC provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued.
Section III. Eligibility Information1. Eligible Applicants
1.A. 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. Place this documentation behind the first page of your application form.
1.B. Principal Investigators
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. CDC encourages individuals from all racial and ethnic groups as well as individuals with disabilities to apply for this program. 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.
2. Cost Sharing
Cost sharing is not required
3. Other-Special Eligibility Criteria
Public Health Information Network Standards
Awardees will use the standards and specifications of the Public Health Information Network(PHIN) (http://www.cdc.gov/phin/) if appropriate for the project undertaken. The PHIN Initiative seeks to ensure information systems capabilities are in place to support public health systems across the broad range of public health functions. The PHIN functional areas defined to support these activities include detection and monitoring, data analysis and interpretation, information resources and knowledge management, alerting and communications, and response. PHIN strives to improve the electronic exchange of health data and information between clinical healthcare and all levels of public health (federal, state, local) through national standards based approaches to information technology and health data. PHIN also leverages, integrates and coordinates existing systems and initiatives to help achieve these goals.
Annual Grantee Meeting
Upon initiation of the program, the CDC will arrange annual meetings to encourage the exchange of information among investigators who participate in this program. In the preparation of the budget for the grant application, applicants should include travel funds for one meeting each year to be held in Atlanta, GA. Applicants should also include a statement in the applications indicating their willingness to participate in such meetings.
Section IV. Application and Submission Information1. Address to Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact:
Technical Information Management
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
GrantsInfo, Telephone (770) 488-2700
Email: pgotim@cdc.gov
2. Content and Form of Application Submission
Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 9/2004). Applications must have a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the website at http://www.dnb.com.The D&B number should be entered on line 11 of the face page of the PHS 398 form.
See Section VI.2. Administrative Requirements for additional information.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.
3. Submission Dates
3.A. Receipt, Review and Anticipated Start Dates
Application Receipt Dates(s): July 15, 2005
Objective Review Date(s): September 2005
Earliest Anticipated Start Date: October 1, 2005
3.B. Sending an Application to the CDC
Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. Submit a signed, typewritten original of the application, including the checklist and appendix material, and one signed photocopy in one package to:
Technical Information Management
RFA-PH-05-126
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:
Jerome I. Tokars, MD, MPH
BioSense Initiative
Centers for Disease Control and Prevention
Regular mail:
1600 Clifton Road , Mailstop E-06
Atlanta , GA 30333
Courier:
2400 Century Center, Room 4405
Atlanta , GA 30345
Voice: 404-498-6306
Fax: 404-498-6145
Email: JIT1@cdc.gov
For further assistance contact the CDC Procurement and Grants Office Technical Information Management Section, Telephone 770-488-2700, Email: pgotim@cdc.gov
3.C. Application Processing
Applications must be received on or before 4 PM on the application receipt date listed in the heading of this funding opportunity. If an application is received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be reviewed for completeness by PGO and responsiveness by CDC. Incomplete applications will not be reviewed.
The CDC will not accept any application in response to this funding opportunity 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.
Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks after objective review.
4. Intergovernmental Review
This initiative is not subject to intergovernmental review under Executive Order 12372.
Restrictions, which must be taken into account while writing your budget, are as follows:
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.
6. Other Submission Requirements
The following should be addressed in a clear and organized manner (see also peer review criteria section):
Timeline: a detailed timeline for the proposed study must be included in the application. Tasks should be identified for each specific aim, showing how the study will be managed over the project period.
If applicable, in a separate section labeled, Participant Notification of Study Results , the applicant should describe plans for notifying participants about their individual results and the overall results of the study.
Applicants should include in their budget support for themselves to attend an annual one day grantee meeting in Atlanta, GA. These meetings are to review and assess overall progress and provide the opportunity for investigators to exchange information and discuss research issues.
Section V. Application Review Information1. Criteria
Only the review criteria described below will be considered in the review process.
2. Review and Selection Process
If the application is not responsive to the RFA, CDC staff may contact the applicant to determine whether to return the application to the applicant.
Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate objective review group convened by CDC in accordance with the review criteria stated below.
As part of the initial merit review, all applications will:
Reviewers will evaluate the application using the criteria listed below. Each criterion will be addressed and considered by the reviewers in determining scientific merit and assigning the overall project score:
The 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 public health problem? If the aims of the application are achieved, how will scientific knowledge and public health practice be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Will the proposed research contribute to the overall aim of promoting health and/or preventing disease, injury, or disability and protecting people from health threats including infectious, environmental, and terrorist threats ?
Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is sufficient detail provided to explain clearly how the study will be conducted? Are statistical considerations appropriately addressed to ensure usefulness of the study results?
Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
Investigator: Is the investigator 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 (if any)?
Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Is there documentation of cooperation from business, industry, academic institutions, communities, or other participants in the project, where applicable?
2.A. Additional Review Criteria:
In addition to the above criteria, in accordance with DHHS policy, all applications will also be reviewed with respect to the following:
Additional information on these requirements can be found on the CDC web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
2.B. Additional Review Considerations
Budget: While the priority score will not be affected by evaluation of the budget, the objective review group will examine the reasonableness of the proposed budget and the requested period of support in relation to the proposed research.
3. Anticipated Announcement and Award Dates
Not applicable
1. Award Notices
A formal notification in the form of a Notice of Award will be provided to the applicant organization. The notice of award signed by the grants management officer is the authorizing document. This document will be mailed and/or emailed to the recipient fiscal officer identified in the application.
Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA (Notice of Award) are 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 Notice of Award will be transmitted by mail and/or e-mail to the business official.
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. The following additional requirements can be found in Section VIII. Other Information of 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 award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.
2.A. Cooperative Agreement Terms and Conditions of Award
Not applicable
Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually: http://grants.nih.gov/grants/funding/2590/2590.htm and financial statements as required in the PHS Grants Policy Statement.
You must provide CDC with an original, plus two hard copies of the following reports:
1. Interim progress report, (use form PHS 2590, OMB Number 0925-0001, rev. 5/2001 as posted on the CDC website) no less than 90 days before the end of the budget period The progress report will serve as your non-competing continuation application, and must contain the following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Measures of Effectiveness.
f. Additional Requested Information.
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.
These reports must be mailed to the Grants Management Specialist listed in the Agency Contacts section of this announcement.
Section VII. Agency ContactsWe encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues:
1. Scientific/Research Contact:
Jerome I. Tokars, MD, MPH
BioSense Initiative
Centers for Disease Control and Prevention
Mailstop E-06
Voice: 404-498-6306
Fax: 404-498-6145
Email: JIT1@cdc.gov
2. Financial or Grants Management Contact:
Technical Information Management Section (TIMS)
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, GA 30341
Phone: 770-488-2700
Email: pgotim@cdc.gov
Rick Jaeger
Grants Management Specialist
Acquisition and Assistance, Branch VI
Procurement and Grants Office
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, GA 30341
Phone: 770-488-2727
Email: Rjaeger@cdc.gov
Required Federal Citations
Human Subjects Requirements
If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services (DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) regarding the protection of human research subjects. All awardees of CDC grants and cooperative agreements and their performance sites engaged in human subjects research must file an assurance of compliance with the Regulations and have continuing reviews of the research protocol by appropriate institutional review boards.
In order to obtain a Federalwide Assurance (FWA) of Protection for Human Subjects, the applicant must complete an on-line application at the Office for Human Research Protections (OHRP) website or write to the OHRP for an application. OHRP will verify that the Signatory Official and the Human Subjects Protections Administrator have completed the OHRP Assurance Training/Education Module before approving the FWA. Existing Multiple Project Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single Project Assurances (SPAs) remain in full effect until they expire.
To obtain a FWA contact the OHRP at:
http://www.hhs.gov/ohrp/assurances/assurances_index.html
OR
If your organization is not Internet-active, please obtain an application by writing to:
Office for Human Research Protections (OHRP)
Department of Health and Human Services
6100 Executive Boulevard, Suite 3B01, MSC 7501
Rockville, Maryland 20892-7507
(Note: For Express or Hand Delivered Mail, Use Zip Code 20852)
Note: In addition to other applicable committees, Indian Health Service (IHS) institutional review committees must also review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve the applicable portion of that project.
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.
Animal Subjects Requirements
If the proposed project involves research on animal subjects, compliance with the "PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions" is required. An applicant (as well as each subcontractor or cooperating institution that has immediate responsibility for animal subjects) proposing to use vertebrate animals in CDC-supported activities must file (or have on file) the Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health. The applicant must provide in the application the assurance of compliance number and evidence of review and approval (including the date of the most recent approval) by the Institutional Care and Use Committee (IACUC). Web page: http://grants.nih.gov/grants/olaw.
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.
HIV Program Review Panel Requirements
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 AIDS Clearinghouse.
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.
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The order sets up a system for State and local governmental review of proposed Federal assistance applications. Applicants should contact their State single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each State affected.
Click on the following link to get the current SPOC list, http://www.whitehouse.gov/omb/grants/spoc.html.
Indian tribes must request tribal government review of their applications.
SPOCs or tribal governments that have recommendations about an application submitted to CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:
Grants Management Specialist
Procurement and Grants Office
Announcement Number [ ]
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146
CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.
Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:
A. A copy of the face page of the application (SF 424).
B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:
A description of the population to be served.
A summary of the services to be provided.
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.
Healthy People 2010
CDC is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a national activity to reduce morbidity and mortality and improve the quality of life. For the conference copy of "Healthy People 2010," visit the internet site: http://www.health.gov/healthypeople.
Lobbying Restrictions
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, 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 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 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 CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that 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, CDC interprets the language in the CDC's Appropriations Act to mean that CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.
Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.
Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.
Security Clearance Requirement
All individuals who will be performing work under a grant or cooperative agreement in a CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardee employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at CDC must undergo a security clearance process.
Peer and Technical Reviews of Final Reports of Health Studies ATSDR
Not applicable
Cost Recovery ATSDR
Not applicable
Third Party Agreements ATSDR
Not applicable
Conference Support
The purpose of conference support funding is to provide PARTIAL support for specific nonfederal conferences in the areas of health promotion and disease prevention information/education programs. Because conference support by CDC creates the appearance of CDC co-sponsorship, there will be active participation by CDC in the development and approval of those portions of the agenda supported by CDC funds. CDC funds will not be expended for non-approved portions of meetings. In addition, CDC will reserve the right to approve or reject the content of the full agenda, press events, promotional materials (including press releases), speaker selection, and site selection. Contingency awards will be made allowing usage of only 10% of the total amount to be awarded until a final full agenda is approved by CDC. This 10% portion will provide funds to support costs associated with preparation of the agenda. The remainder of funds will be released only upon approval of the final full agenda. CDC reserves the right to terminate co-sponsorship if it does not concur with the final agenda.
Any conference sponsored by CDC or ATSDR shall be held in facilities that are fully accessible to the public as required by the Americans with Disabilities Act Accessibility Guidelines (ADAAG). Accessibility as per ADAAG also addresses accommodations for persons with sensory impairments.
The conference organizer(s) may use CDC's name only in factual publicity for the conference, and they should understand that CDC involvement in the conference does not necessarily indicate support for the organizer's general policies, activities, products, or service.
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:
Place small, minority, women-owned business firms on bidders mailing lists.
Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
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 Program Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science."
The regulation places several requirements on institutions receiving or applying for funds under the
PHS Act that are monitored by the DHHS Office of Research Integrity's (ORI) Assurance Program.
For example:
Section 50.103(a) of the regulation states: "Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research must have an assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has established an administrative process, that meets the requirements of this subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS-sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant; and (2) Will comply with its own administrative process and the requirements of this Subpart."
Section 50.103(b) of the regulation states that: "an applicant or recipient institution shall make an annual submission to the [ORI] as follows: (1) The institution's assurance shall be submitted to the [ORI], on a form prescribed by the Secretary,...and updated annually thereafter...(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe."
An additional policy was added in the year 2000 that "requires research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds.
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. 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:
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.
(http://www.cdc.gov/od/foia/policies/sharing.htm,
http://www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA))
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. CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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