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/) with funding support from the Doris Duke Foundation.
Components of Participating Organizations
National Center for Injury Prevention and Control, Division of Violence Prevention, Prevention Development and Evaluation Branch (NCIPC/DVP/PDEB), (http://www.cdc.gov/ncipc/)
Title: Using Technology to Augment the Effectiveness of Parenting Programs in the Prevention of Child Maltreatment
The CDC policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.
Authority: This program is authorized under sections 317(k)(2) and 391(a) of the Public Health Service Act [42 U.S.C. Sections 247b(k)(2) and 280b(a), as amended.
Announcement Type:
New
Request For Applications (RFA) Number: RFA-CE-06-006
Catalog of Federal Domestic Assistance Number(s):
93.136
Key Dates:
Release Date: December 23, 2005
Letter of Intent Receipt Date: 02/19/2006
Application Receipt Date: 03/19/2006
Peer Review Date: May, 2006
Council Review Date: June, 2006
Earliest Anticipated Start Date: September, 2006
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: 03/20/2006
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
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
B. Eligible Individuals
2. Cost Sharing or Matching
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 and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application
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 Terms and Conditions of Award
1. Principal Investigator 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
1. Research Objectives
The CDC and NCIPC are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses Healthy People 2010 priority area(s) of injury and violence prevention and is in alignment with the NCIPC performance goal to conduct a targeted program of research to reduce injury-related death and disability. For more information, see: http://www.health.gov/healthypeople and http://www.whitehouse.gov/omb/mgmt-gpra.
The purpose of this program is to take a previously demonstrated efficacious or effective parenting program and examine the effects of information and communication technology (e.g. cell phones, internet, video conferencing, web cameras, etc.) on program outcomes, fidelity, enrollment, attrition rates, and cost-effectiveness in reducing child maltreatment.
Research Objectives
Early childhood home visiting programs and other parenting programs have been shown to positively affect parent-child interactions and parental disciplinary practices, and to reduce occurrences of child abuse and neglect (Gershater-Molko, Lutzker, & Wesch, 2003; Hahn et al, 2003). However, many of these programs struggle to enroll, adequately involve, and retain parents (Gomby, Culross, & Behrman, 1999) as well as implement services as intended by their original program models. Low levels of parental engagement and fidelity in programs can undermine program effectiveness. High staff turnover due to concerns with safety is another problem affecting fidelity in home visitation programs.
Over the past two decades, communication and information technology (e.g., cell phone, internet, video conferencing) have brought about major changes in the way people work, live, and communicate. Programs and some investigators have used these technologies to improve assessment and fidelity. For example, in a pilot study utilizing cell phones to gather detailed information about predictors of early child neglect among adolescent and adult mothers, Borkowski et al. (2004) found that respondents perceived cell phone interviews fun, interesting and non-intrusive; and cell phones assisted in collecting reliable and valid data on parenting behaviors, maintaining frequent contacts with participants, establishing a high level of comfort among participants with project staff, increasing the quality of service delivery, and increasing retention rates (98% across sites). Beyond these findings, using cell phones to interview or monitor participants may also increase the safety of the working environment and help reduce staff turnover rate.
In another example, Feil et al. (2005) developed a computerized parenting program based on the Incredible Years program and provided computers and internet access to a high risk group of parents. Their initial findings suggest that this medium combined with coaching has the potential to reach those at high risk and improve parenting practices.
In addition to cell phones, computers and the internet, there might be other technologies, such as video conferencing, web cameras, or a combination of technologies, which can be used to assist in improving the effectiveness of programs. Technological advancements alone are not expected to result in an impact on parenting. Instead, these enhancements are expected to remedy problems of parental participation and retention in programs as well as program fidelity. For this reason, this announcement is limited to programs that have demonstrated efficaciousness or effectiveness among some sector of the population but have encountered problems in participation, retention, or fidelity. Before such methodologies can be applied, researchers need to test their feasibility with samples of a target population by recognizing there is wide diversity in the theoretical assumptions, program components, and implementation practices among child maltreatment prevention programs. Even if the use of technology proves feasible and effective at improving the implementation and quality of program services, cost may mitigate widespread use in large intervention programs. Thus, cost-effectiveness of using technology will need to be demonstrated before it is widely adopted.
NCIPC is seeking applications to better understand the role of technology in improving the effectiveness of parenting programs to prevent child maltreatment. The primary research objective of this solicitation is to determine whether adding technology to existing skill and evidence-based parenting protocols increases enrollment, retention, or fidelity of implementation, improves parenting, or reduces child maltreatment efficiently (cost-effectively) when compared to standard implementation protocols.
Research funded under this announcement is expected to adhere to high scientific standards, and to incorporate the following elements:
Applicants are expected to justify their use of the research design chosen and should discuss the merits of the design with respect to attributing changes in fidelity, enrollment, attrition, and parents behavior to the particular strategies used. Applicants are expected to conduct measurements appropriate to the type of outcome variable(s) examined, the type of technological enhancement(s) utilized, and the nature of the intervention program. For example, procedures and measurement necessarily would include tracking of enrollment, participation, and attrition. Fidelity of implementation and compliance with the program’s regimens (e.g., mastery and use/generalization of new parenting skills assessed through controlled behavioral observation) should also be assessed periodically during the course of the program.
See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.
Section II. Award Information1. Mechanism(s) of Support
This funding opportunity will use the U49 (research cooperative agreement) award mechanism.
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 (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.
The CDC U49 (research cooperative agreement) is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
2. Funds Available
The participating CIO (NCIPC) intends to commit approximately $1.2 million in FY 2006 to fund 1-3 new competing cooperative agreements in response to this RFA. The average award amount will be $400,000. An applicant may request a project period of up to 4 years and a budget for total costs (including direct and indirect costs) up to $400,000 per year. An applicant may request up to $400,000 for the first 12-month period. The approximate total amount available for the four year project period is $1.6 million per project. The anticipated start date for new awards is August 31, 2006.
All estimated funding amounts are subject to availability of funds.
If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the CIO (s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.
Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.
Section III. Eligibility Information1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an) application(s) if your organization has any of the following characteristics:
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Place this documentation behind the first page of your application form.
1.B. Eligible Individuals
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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs.
In order for the application to be deemed responsive and entered into the review process, the following requirements for the principal investigator must be met:
2. Cost Sharing or Matching
Cost sharing, matching funds, or cost participation are not required.
The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/gps/
3. Other-Special Eligibility Criteria
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 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. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov .
If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to you.
Telecommunications for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
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 and Times
All requested information must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date. If you submit your application 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 CDC receives your submission after closing due to: (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 will be given the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline.
This announcement is the definitive guide on 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 will be discarded. You will be notified that you did not meet the submission requirements.
Otherwise, CDC will not notify you upon receipt of your 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 submissions to be processed and logged.
3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: 02/19/2006
Application Receipt Date(s): 03/19/2006
Peer Review Date: May 2006
Council Review Date: June 2006
Earliest Anticipated Start Date: September 2006
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
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 CIO 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 to:
NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control
Address for Express Mail or Delivery Service:
2945 Flowers Rd.
Yale Building, Room 2054
Atlanta, GA 30341
Address for U.S. Postal Service Mail:
4770 Buford Hwy., NE, Mailstop K-62
Atlanta, GA 30341
Telephone: (770) 488-4037
FAX: (770) 488-1662
Email: CIPERT@cdc.gov
3.B. Sending an Application
Applications follow the PHS 398 application instructions for content and formatting of your applications. If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.
Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and one signed photocopy in one package to:
Technical Information Management Section RFA-CE-06-006
CDC, Procurements and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
At the time of submission, four (4) additional copies of the application, including the appendix material, must be sent to:
NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control
Address for Express Mail or Delivery Service:
2945 Flowers Rd.
Yale Building, Room 2054
Atlanta, GA 30341
Address for U.S. Postal Service Mail:
4770 Buford Hwy., NE, Mailstop K-62
Atlanta, GA 30341
Fax: 770-488-1662
Email: CIPERT@cdc.gov
Note: Applications must be sent to CDC in Atlanta, GA not NIH in Bethesda, MD.
3.C. Application Processing
Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness and responsiveness by NCIPC and PGO. Incomplete and non-responsive applications will not be reviewed.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
5. Funding Restrictions
All CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement.
Additional guidance can be found in the NIH Grants Policy Statement.
Restrictions, which must be taken into account while writing your budget, are as follows:
6. Other Submission Requirements
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI. "Award Administration Information".
If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.
Your research plan should address activities to be conducted over the entire project period.
Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.
All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25, Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.
Sharing Research Resources
Not applicable
1. Criteria
The following will be considered in making funding decisions:
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 CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals.
Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, 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? Is the selection of a research design appropriate to answer the research question? Does the evaluation design reflect a rigorous examination of the effectiveness of the intervention? Are descriptions of sampling methods, sample size and power estimates, and data collection measures well described and justified? How complete are planned investigations of intervention fidelity and program exposure? Are the outcome measures concrete, specific, and directly relevant to the research objectives? Does the data analytic plan appropriately consider the level of intervention and data collection, and the longitudinal design of the study? Is there an appropriate work plan included?
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)? Is there a prior history of conducting violence-related research? Is there evidence of a working relationship between the principal investigator and the parenting program being studied?
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? Is there an appropriate degree of commitment and cooperation of other interested parties as evidenced by letters detailing the nature and extent of the involvement?
Application Review
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:
Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional CDC Requirements under AR-1, Human Subjects Requirements, can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women and Minorities in Research: Does the application adequately address the 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.
2.B. Additional Review Considerations
Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.
2.D. Sharing Research Resources
Program staff will be responsible for the administrative review of the plan for sharing research resources.
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590 http://www.cdc.gov/od/pgo/forminfo.htm). See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Applicants will be notified in August, 2006 by CDC’s Procurements and Grants Office (PGO) if their cooperative agreement was funded. It is anticipated that awards will be made in September, 2006.
Section VI. Award Administration Information1. Award Notices
After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.
Those applicants under consideration for funding will be contacted by CDC for additional information.
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. This document will be mailed and/or emailed 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 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 NoA by reference.
2.A. Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the CDC purpose is to support and stimulate the recipients' activities by involvement in, and otherwise working jointly with, the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the CDC as defined above.
2.A.1. Principal Investigator Rights and Responsibilities
The Principal Investigator will have the primary responsibility for:
a) Designing and conducting research to address the described goals of this cooperative agreement. Formative research or pilot work is strongly encouraged.
b) Collecting and reporting program costs (e.g. personnel, supplies, travel, space) and costs of injury due to child maltreatment (e.g. medical and non-medical costs) for both the control group and experimental group. These data will be critical in conducting a cost-effectiveness analysis of the intervention.
c) Collaborating with CDC in the development of the human subjects protocol for the CDC Institutional Review Board (IRB), implementation, and evaluation of project delivery.
d) Partnering effectively with the organization implementing the parenting program and other outside entities expected to participate in the proposed research. Such partnerships should be well-defined and documented by memorandums of understanding.
e) Obtaining approval of the study protocol by the recipient’s local IRB.
f) Analyzing data and publish findings in peer-reviewed journals.
g) Conducting one reverse site visit with CDC in Atlanta on an annual basis.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and CDC policies.
2.A.2. CDC Responsibilities
A CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
a) Providing scientific and technical assistance for the design and implementation of this research, including data required for subsequent cost-effectiveness analyses.
b) Collaborating with the grantee in the development of a research protocol for IRB review by all collaborating institutions. The CDC IRB will review the protocol initially and on an annual basis until the project is complete.
c) Collaborating with the grantee to ensure human subjects assurances are in place as needed.
d) Providing scientific leadership in identifying data elements for and conducting cost-effectiveness analyses.
e) Participating in the analysis and dissemination of study findings.
f) Monitoring and evaluating the scientific and operational accomplishments of the project through conference calls, site visits, and review of technical reports.
Additionally, an agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
2.A.3. Collaborative Responsibilities
Not applicable
3. Reporting
You must provide CDC with an original, plus two hard copies of the following reports:
1. Interim/Grant Progress Report, (use form PHS 2590, OMB Number 0925-0001, rev. 9/04 as posted on the CDC website) no less than 120 days prior to the end of the current budget period. The progress report will serve as your non-competing continuation application.
2. Yearly outcome report summarizing the results, including publications, and impact resulting from the research. An outcome report form will be sent by NCIPC to the grantees. The outcome report will be due at the same time as the Interim/Grant Progress Report.
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.
These reports must be forward by U.S. Postal Service or Express Delivery to the Grants Management Specialist listed in the Agency Contacts section of this announcement.
Although the financial plans of the CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, 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 ContactsWe encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:
1. Scientific/Research Contacts:
Jennifer Wyatt, Extramural Program Official
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
4770 Buford Highway, NE, Mailstop K-60
Atlanta, GA 30341
Telephone: 770-488-4058
E-mail: jwyatt@cdc.gov
2. Peer Review Contacts:
Gwendolyn Cattledge, Ph.D.
Scientific Review Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
4770 Buford Hwy, NE, Mailstop K-02
Atlanta, GA 30341
Telephone: (770) 488-4655
FAX: (770) 488-4422
Email: gxc8@cdc.gov
3. Financial or Grants Management Contacts:
Lisa R. Williams, Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Rd.
Atlanta, GA 30341
Telephone: (770) 488-2897
FAX: (770) 488-2670
Email: lrw3@cdc.gov
4. General Questions Contacts:
Technical Information Management Section
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2700
Email: PGOTIM@cdc.gov
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.
Section VIII. Other InformationRequired Federal Citations
Human Subjects Protection:
Federal regulations (45CFR46) 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 CDC Requirements under AR-1, Human Subjects Requirements, can be found on 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.
Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National AIDS Clearinghouse.
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
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 http://www.health.gov/healthypeople.
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 ActivitiesAnti-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.
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:
1. Place small, minority, and women-owned business firms on bidders mailing lists.
2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.
Research Integrity
The signature of the institution official on the face page of the application submitted under this 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 examples:
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 is 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
April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, http://www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.4.law.cornell.edu/uscode/5/5/552/html.
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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