Announcement Type: New.
Funding Opportunity Number: CI06-001.
Catalog of Federal Domestic Assistance Number: 93.283.
Letter of Intent Deadline: September 22, 2005.
Application Deadline: October 24, 2005.
I. Funding Opportunity Description
II. Award Information
Type of Award: Cooperative Agreement. CDC involvement in this program is listed in the Activities Section above.
Mechanism of Support: U01.
Fiscal Year Funds: $2,000,000.
Approximate Current Fiscal Year Funding: $2,000,000.
Approximate Total Project Period Funding: $10,000,000.
This amount is an estimate, and is subject to availability of funds. This amount includes Direct and Indirect costs.
Approximate Number of Awards: four—five.
Approximate Average Award: $350,000.
This includes Direct an Indirect costs for the first 12 month budget period.
Floor of Award Range: $300,000.
Ceiling of Award Range: $400,000 total cost for each of five years of the funding period, which includes direct and indirect costs. Proposals that exceed this amount for any years of the project will be considered ineligible and will not be reviewed.
Anticipated Award Date: February 2006.
Budget Period Length: 12 months.
Project Period Length: five years.
Throughout the project period, CDC's commitment to continuation of awards will be conditioned on 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.
III. Eligibility Information
III.1. Eligible Applicants
Applications may be submitted by public and private nonprofit organizations.
- Public nonprofit organizations
- Private nonprofit organizations
- Research institutions
- Community-based organizations
- Faith-based organizations
- Federally recognized Indian tribal governments
- Indian tribes
- Indian tribal organizations
- State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)
- Political subdivisions of States (in consultation with States)
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Place this documentation behind the first page of your application form.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not Start Printed Page 49285be entered into the review process. You will be notified that your application did not meet the submission requirements.
Special Requirements: If your application is incomplete or non-responsive to the requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements.
- Late applications will be considered non-responsive. See section “IV.3. Submission Dates and Times” for more information on deadlines.
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.
Individuals Eligible to Become 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. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs. Additional Principal Investigator qualifications are as follows:
- Knowledge of healthcare infection control practices.
- Knowledge of electronic data reporting systems used in healthcare.
- Experience in administering multi-center programs.
IV. Application and Submission Information
IV.1. Address To Request Application Package
To apply for this funding opportunity, use application form PHS 398 (OMB number 0925-0001 rev. 9/2004). Forms and instructions are available in an interactive format on the CDC Web site, at the following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
Forms and instructions are also available in an interactive format on the National Institutes of Health (NIH) Web site at the following Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
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.
IV.2. Content and Form of Application Submission
Letter of Intent (LOI). Your LOI must be written in the following format:
- Maximum number of pages: two
- Font size: 12-point unreduced
- Double spaced
- Paper size: 8.5 by 11 inches
- Page margin size: One inch
- Printed only on one side of page
- Written in plain language, avoid jargon
Your LOI must contain the following information:
- Descriptive title of the proposed research
- Name, address, E-mail address, telephone number, and FAX number of the Principal Investigator
- Names of other key personnel
- Participating institutions
- Number and title of this Announcement
Application: Follow the PHS 398 application instructions for content and formatting of your application. If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement. For further assistance with the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or contact GrantsInfo, Telephone (301) 435-0714, E-mail: GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over the entire project period. As part of the application preparation process, the applicants must develop a strategic plan and provide a timeline of planning and priority-setting processes. The purpose of the strategic plan is to identify unique approaches for measuring HAIs, AR and adverse events, developing successful interventions and prevention programs to reduce them, and assessing their cost implications. The plan must include both short- and long-term goals, and must include descriptions of objective milestones that will be used to measure progress. The following framework is suggested for developing the strategic plan:
- Strengths—Identify and describe the strengths of the application including a brief summary of the research expertise of participants, description of the current facilities including the extent to which there is shared common administrative and information technology infrastructure that will facilitate aggregation of electronic information and coordination of interventions and/or prevention programs across facilities, and other research resources available.
- Opportunities—Identify and evaluate the potential opportunities to establish a high quality research program using project funds. As part of the planning process, the applicant needs to include a description of how they will participate in the steering committee to: Determine which collaborations will be developed, identify opportunities that utilize the unique strengths within the healthcare system, and target opportunities that will address the goals of the project.
- Research Theme—The intent of the Epicenter Program is to support a substantial range of research activities that involve vibrant, multi-disciplinary approaches that transcend customary thinking and organizational structures to address critical questions related to monitoring and prevention of HAIs, AR and other adverse events. The theme and the range of activities pursued should be clearly defined as a result of the strategic planning process.
- Action Plan—Outline the major approaches to measuring HAIs, AR and other adverse events to be investigated using project funds and describe how these research efforts will yield measurable benefits when they are disseminated and deployed in a variety of other healthcare institutions in the United States. Develop a detailed research plan, with milestones, for the first year of funding and describe overall aims and milestones for subsequent years of funding. Elements of the action plan should include: Determining what research projects will be pursued, identifying possible pilot projects for support as developmental research projects, and defining milestones for specific products that the project proposes to pursue.
- Outcome Measurements—Determine and describe how progress on the action plan will be measured. Include qualitative and quantitative criteria for measuring how each participating healthcare facility provides “added value” and for assessing unique contributions that cannot be provided by other research awards. Define metrics (both process and outcome measures) for assessing long-term goals for the entire funding period, and specific, detailed milestones with timelines for the first year for each project and activity.
Each application must propose a Research Program that includes at least three research Projects or activities, which together will enable the Program to contribute significantly to the identification, reporting, and ultimate prevention or reduction in HAIs, AR and other adverse events in healthcare institutions. The range of research topics that may be proposed is outlined above. Each research project must Start Printed Page 49286include measurable milestones and process and outcome measures, with timelines, and criteria for assessing success/productivity at periodic intervals. Applicants are encouraged to consider the scope and range of research proposed and develop a Research Program that is coherent and consistent with available resources and personnel.
You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm.
This announcement requires summary budget information provided in the application package along with budget justification and support must be written in the form, format, and the level of detail as specified in the budget guidelines. You may access the latest version of the budget guidelines by accessing the following Web site: http://www.cdc.gov/od/pgo/funding/budgetguide2004.htm.
Additional requirements that may require you to submit additional documentation with your application are listed in section “VI.2. Administrative and National Policy Requirements.”
IV.3. Submission Dates and Times
LOI Deadline Date: September 22, 2005. CDC requests that you send a LOI if you intend to apply for this program. Although the LOI is not required, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, and to allow CDC to plan the application review.
Application Deadline Date: October 24, 2005.
Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 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 above, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements.
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-TIM 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.
IV.4. Intergovernmental Review of Applications
Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state's process. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html.
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing your budget, are as follows:
- Funds relating to the conduct of research will not be released until the appropriate assurances and IRB approvals are in place.
- Reimbursement of pre-award costs is not allowed.
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.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery service, fax, or E-mail to: Dr. Trudy Messmer, Scientific Review Administrator, CDC/NCID, 1600 Clifton Road, MS C-19, Atlanta, GA 30333. Phone: (404) 639-3770. Fax: (404) 639-2469. E-mail: TMessmer@cdc.gov.
Application Submission Address: Submit the original and one hard copy of your application and appendices by mail or express delivery service to: Technical Information Management—CI06-001, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
At the time of submission, four additional copies of the application with appendices must be sent to: Dr. Trudy Messmer—CI06-001, Scientific Review Administrator, CDC/NCID, 1600 Clifton Road, MS C-19, Atlanta, GA 30333. Phone: (404) 639-3770. E-mail: TMessmer@cdc.gov.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Review Criteria
Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the “Purpose” section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.
The goals of CDC-supported research are to advance the understanding of biological systems and health risks, improve the control and prevention of disease and injury, and enhance health. 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. The scientific review group will address and consider each of the following criteria equally in assigning the application's overall score, weighting them as appropriate for each application.
The review criteria are as follows:
Significance: Does this proposal address important problems? If the aims of the application are achieved, what new knowledge will be available about healthcare-associated infections; AR, other adverse events in healthcare; and processes to prevent HAIs, AR and adverse events? What will be the effect of these studies on the concepts or methods that drive this field? Start Printed Page 49287
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, problem-solving tactics?
Innovation: Does the project employ novel and promising 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 studies take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Is there evidence of previous collaboration among the facilities included in the application?
Additional Review Criteria: In addition to the above criteria, the following items will be considered in the determination of scientific merit and priority score:
- All major objectives are addressed.
- All three subject areas (HAIs, other adverse events and processes of care) are addressed.
- Presence of a detailed research plan, with measurable and achievable milestones and process and outcome measures, for the first year of funding that describes overall aims of the project.
- Metrics for assessing long-term goals for the entire funding period and approximate timelines for subsequent years.
- Demonstration of interdisciplinary coordination and collaboration.
- Demonstration of ability to involve multiple facilities of various types in validating interventions and reporting measures. Healthcare systems demonstrating the capacity and plans for involving a large number of facilities in the validation of both interventions and reporting measures will be given priority. Of particular importance will be demonstrating prior evidence of multi-facility collaboration within a healthcare system, or strong evidence for the administrative capacity to coordinate and standardize intervention and data collection strategies across a large number of facilities.
- Demonstration of an existing capacity for electronic healthcare recordkeeping and electronic clinical and laboratory data exchanges within the participating facilities in the healthcare system. Preference will be given to healthcare systems with shared common administrative and information technology infrastructure that will facilitate coordination of data collection and performance of prevention activities in a standardized fashion.
- Knowledge of healthcare infection control practices.
- Previous experience in multi-facility and/or multi-center research studies
Protection of Human Subjects from Research Risks: Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated and reference to the risk 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.
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.
Care and Use of Vertebrate Animals: If vertebrate animals are to be used in the project, the five items described under section f. of the PHS 398 research grant application instructions will be assessed.
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.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) and for responsiveness by NCID. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements.
Applications that are complete and responsive to the announcement will be evaluated for scientific and technical merit by an appropriate peer review group or charter study section convened by NCID in accordance with the review criteria listed above. As part of the initial merit review, all applications may:
- Undergo a process in which only those applications deemed to have the highest scientific merit by the review group, generally the top half of the applications under review, will be discussed and assigned a priority score.
- Receive a written critique.
- Receive a second programmatic level review by CDC senior staff.
Award Criteria: Criteria that will be used to make award decisions during the programmatic review include:
- Scientific merit (as determined by peer review)
- Availability of funds
- Programmatic priorities
V.3. Anticipated Award Date
VI. Award Administration Information
VI.1. Award Notices
After the peer review of the application is completed, all applications will receive a written critique called a summary statement.
Those applications under consideration for funding will receive a call or e-mail from the Grants Management Specialist (GMS) of the Procurements and Grants Office (PGO) 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. Costs incurred before receipt of the NoA are not allowed.
VI.2. Administrative and National Policy Requirements
45 CFR Part 74 and Part 92
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. Start Printed Page 49288
The following additional requirements apply to this project:
- AR-1 Human Subjects Requirements
- AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
- AR-3 Animal Subjects Requirements
- AR-6 Patient Care
- AR-7 Executive Order 12372
- AR-8 Public Health System Reporting Requirements
- AR-9 Paperwork Reduction Act Requirements
- AR-10 Smoke-Free Workplace Requirements
- AR-11 Healthy People 2010
- AR-12 Lobbying Restrictions
- AR-14 Accounting System Requirements
- AR-15 Proof of Non-Profit Status
- AR-16 Security Clearance Requirement
- AR-22 Research Integrity
- AR-23 States and Faith-Based Organizations
- AR-24 Health Insurance Portability and Accountability Act Requirements
- AR-25 Release and Sharing of Data
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.
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. 9/2004 as posted on the CDC Web site) due 90 days before the end of the budget period.
2. Financial status report, due 90 days after the end of the budget period.
3. Final financial and performance reports, due 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.
VII. Agency Contacts
We encourage inquiries concerning this announcement.
For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-2700.
For scientific/research issues, contact: Dr. Trudy Messmer, Scientific Review Administrator, CDC/NCID, 1600 Clifton Road, MS C-19, Atlanta, GA 30333. Telephone: (404) 639-3770. E-mail: TMessmer@cdc.gov.
For questions about peer review, contact: Ms. Barbara Stewart, Public Health Analyst, CDC/NCID, 1600 Clifton Road, MS C-19, Atlanta, GA 30333. Telephone: (404) 639-3770. E-mail: BStewart@cdc.gov.
For financial, grants management, or budget assistance, contact: Sharron P. Orum, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-488-2716. E-mail: firstname.lastname@example.org.
VIII. Other Information
This and other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”Start Signature
Dated: August 17, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control and Prevention.
[FR Doc. 05-16694 Filed 8-22-05; 8:45 am]
BILLING CODE 4163-18-P