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Research To Improve Smoke Alarm Maintenance and Function; Notice of Availability of Funds

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Start Preamble

Application Deadline: July 3, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 391 and 301(a) of the Public Health Service Act, (42 U.S.C. 280b and 241(a)). The Catalog of Federal Domestic Assistance number is 93.136.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 funds for a cooperative agreement for a randomized control study that will extend the current knowledge about what is the most effective approach to improve smoke alarm maintenance and function to reduce fire-related injuries. This study addresses the “Healthy People 2010” focus area, Injury and Violence Prevention.

The purpose of this funding is to determine the most effective approach to encourage behaviors that will improve smoke alarm maintenance and function over time. The applicant will develop a research model and implement a rigorous study to be conducted in a community setting that will:

1. Employ a variety of scientifically based strategies that are grounded in behavioral theory to improve household smoke alarm maintenance and function.

2. Evaluate the relative effectiveness of the proposed strategies over a minimum 18 months follow-up period when compared to control households. This study is intended to stimulate collaborative research by creating a community-based infrastructure in which State Health Departments will partner with university researchers and fire prevention organizations to develop, implement, and evaluate strategies to improve smoke alarm maintenance and long-term function.

Measurable outcomes of this research study will be in alignment with the following performance goal for the National Center for Injury Prevention and Control (NCIPC), described as a priority in the NCIPC Research Agenda: To conduct a targeted program of research to reduce injury-related death and disability. Start Printed Page 27089

C. Eligible Applicants

Applications may be submitted by: Public nonprofit organizations, private nonprofit organizations, universities, colleges, technical schools, research institutions, hospitals, managed care organizations, 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 Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau).

Other required eligibility criteria include the following:

(1) The applicant must provide evidence of effective and well-defined collaborative relationships needed to ensure the implementation of the proposed activities. (2) The collaboration must include at least a State Health Department (to provide leadership regarding local public health priorities), academic or research institution (to provide scientific and methodological expertise), and a fire prevention agency (to provide guidance in community implementation activities). (3) The applicant must include letters of support that describe the specific commitments and responsibilities that will be undertaken by the collaborating organizations.

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.

D. Funding

Availability of Funds

Approximately $500,000 is available in FY 2003 to fund one award. It is expected that the award will begin on or about September 1, 2003, and will be made for a 12-month budget period within a project period of up to four years. The funding estimate may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

Recipient Financial Participation

Matching funds are not required for this program.

E. Program Requirements

Overall Study Objectives

The objective of this study is to develop and implement an effective behavioral approach that will improve household smoke alarm maintenance and long-term function. Research shows that functioning smoke alarms are more likely to be present in a home if a fire safety program provides and installs them instead of simply providing vouchers or discounts to individuals to obtain alarms. CDC programs currently being conducted in 16 states include home installation of smoke alarms plus general fire safety education in households at high risk for fire, fire-related injury, and death. Programs of this type seem reasonable but have not been evaluated scientifically to assess their impact on smoke alarm maintenance and function. Such studies would target vulnerable populations (e.g., children under the age of five, adults age 65 and older, persons with low socioeconomic status) and incorporate training in smoke alarm testing behaviors, skill building, monitoring, educational boosters, reinforcement, modeling and/or practice behaviors, and self-efficacy to improve smoke alarm maintenance and to sustain alarm function over time.

In conducting activities to achieve the purpose of this study, the recipient will be responsible for the activities listed in 1. Recipient Activities, and CDC will be responsible for the activities listed in 2. CDC Activities.

1. Recipient Activities

a. Develop mutually beneficial collaborations among at least a State Health Department, academic or research institution, and a fire prevention agency. Identify agencies and organizations with the capacity to implement behavioral theory-based interventions.

b. Develop and implement a plan to obtain community input and develop partnerships to work together to reduce fire-related injuries by increasing smoke alarm maintenance and function among vulnerable populations in the community.

c. Develop a research model and implement a randomized study with at least two intervention groups plus a comparison group. All groups will receive home visits. One intervention will include smoke alarm installation and behavioral strategies (e.g., that employ training in smoke alarm testing behaviors, skill building, monitoring, educational boosters, reinforcement, modeling and/or practice behaviors, and self-efficacy) to improve smoke alarm maintenance and function. A second intervention will include smoke alarm installation with general fire safety education. This intervention will use a theory-based educational program incorporating behavioral guidance (e.g., fire escape planning, safe use of heaters, the need to maintain and test smoke alarms). The comparison households will receive home visits and a non-fire related, other public health educational program incorporating behavioral guidance (e.g., nutritional counseling and diet planning).

d. Develop an evaluation plan that includes both process and outcome measures. Assess effectiveness by comparing smoke alarm function among all three groups of households after a follow-up period of at least 18 months. Additional interim follow-up intervals could also be incorporated into the evaluation design.

e. Develop data collection instruments and methods, and a coordinated system for data management and data quality assurance.

f. Travel to Atlanta annually to present a briefing to NCIPC staff describing progress to date.

2. CDC Activities

a. Provide up-to-date scientific information and technical assistance to awardee to assist in their final study design, intervention strategies and implementation.

b. Assist in developing a research protocol for annual Institutional Review Board (IRB) review by all cooperating institutions participating in the research study. The CDC IRB will review and approve the protocol initially and on at least an annual basis until the research study is completed.

c. Assist in ensuring human subjects assurances are in place.

d. Assist in data analysis, preparation of manuscripts and dissemination of study results.

e. Monitor and evaluate the scientific and operational accomplishments of the project. This will be accomplished through periodic site visits, telephone calls, electronic communication, technical reports and interim data analyses.

F. Content

Letter of Intent (LOI)

A LOI is strongly encouraged for this program. The LOI will be used to determine level of interest in the announcement. The LOI should include the following information: Program Announcement Number 03100; name and address of institution; name and telephone number of contact person; Start Printed Page 27090specific objectives to be addressed by proposed study; and a brief description of project plans. The narrative should be no more than three pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point Times Roman font.

Applications

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed so it is important to address each, preferably in order, with sufficient detail. Applicants may submit only one proposal.

The narrative should be no more than 25 (eight and a half by eleven) double-spaced pages, printed on one side, with one inch margins on four sides, unreduced 12-point Times New Roman font, and a page number at the bottom of each page. Applications with more than 25 pages will be returned and not reviewed. Please provide only attachments or appendices that are directly relevant to this request for funding. Include sample forms and data collection instruments. The budget, budget justification and attachments/appendices, including letters of support, are not included in the count for the 25-page limit. All pages, including appendices, must be numbered sequentially.

Applications should follow the PHS-398 (Rev. 5/2001) application and Errata sheet.

To document eligibility, the narrative should contain the following sections in the order presented:

1. Abstract (one page recommended):

Provide a brief abstract of the project. The abstract must reflect the study's focus and the length of the project period (maximum of four years) for which assistance is being requested (see “Availability of Funds” for additional information).

2. Background (three to five pages recommended):

Describe the applicant's background and knowledge of the field as it relates to this study. Document their capacity to accomplish the proposed study as demonstrated by relevant past or current injury prevention studies and smoke alarm program activities. Justify the proposed study using existing scientific knowledge. Describe relevant behavioral theories and how these will be applied to improve smoke alarm maintenance and function.

3. Goals and Objectives (three to five pages recommended):

Describe the specific questions this research is intended to address, the hypotheses to be tested, the specific study goals, and measurable objectives for each goal. Include a plan that addresses activities to be conducted over the entire four-year project period as well as a detailed time-line for the first year of the study.

4. Study Design and Methods (10-15 pages recommended):

a. Describe the study design and the procedures that will be used to accomplish the specific aims of the study. Describe and justify where and how the study will be implemented in order to achieve the stated goals and test the proposed hypotheses.

b. Describe the target population. Provide evidence that the applicant has the ability to access this population.

c. Describe how intervention and control households will be selected; the process by which households will be randomized; and how households will be accessed, recruited and retained.

d. Describe one proposed intervention that will use behavioral strategies to improve smoke alarm maintenance and function over time (which will include training in testing behaviors, skill building, monitoring, educational boosters, reinforcement, modeling and/or practice behaviors, and self-efficacy) and one intervention that will use a theory-based educational program incorporating behavioral guidance to improve general fire safety behaviors.

e. Describe the proposed non-fire related, other public health educational program incorporating behavioral guidance that will be provided to the comparison households.

f. Describe the process measures that will be used to document the implementation of the intervention.

g. Describe the plans for data collection and data management including security of data, assurance of participant confidentially, data entry, editing, and quality assurance procedures.

g. For all study groups, describe the measurable outcomes that will be used to evaluate the proposed interventions. Describe the time frame for collecting these data.

h. Describe a statistical analysis plan appropriate for the study design, which will be used to evaluate the impact of the proposed behavioral and educational interventions.

i. Describe the nature and extent of collaboration with CDC and/or others during various phases of the project.

5. Personnel and Collaborations (three to five pages):

Describe the personnel and collaborative activities needed to accomplish the proposed study. Study personnel should represent, at a minimum, a State Health Department to provide leadership regarding local public health priorities and vulnerable populations, an academic or research institution to provide scientific and methodological expertise, and a fire prevention agency or similar community-based organization to provide guidance in community implementation activities. Provide evidence that the study personnel have the expertise and capacity to accomplish the proposed activities and to provide the appropriate scientific oversight necessary to fulfill the study goals and objectives. This will include design of a rigorous scientific study; development, implementation, evaluation of the proposed intervention strategies; data collection and management; experience in delivering educational and behavioral interventions; and preparation of scientific papers. Evidence of the experience and capacity for all key staff members should include an attachment containing CVs and position descriptions.

6. Community Capacity (three to five pages):

Provide evidence of effective working relationships between the applicant and community organizations. The applicant should describe their experience in developing community partnerships and the community's current and anticipated capacity to carry out the proposed activities. An advisory committee representing diverse organizations including (but not limited to) fire prevention organizations, professional organizations, and community service organizations is recommended. For such a committee, describe the qualifications and appropriateness of the proposed members.

7. Human Subject Involvement:

Describe procedures that will provide for the protection of human subjects. Address how these procedures adequately address the requirements of 45 CFR 46 for the protection of human subjects.

8. Inclusion of Women and Racial and Ethnic Populations:

Describe (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. Start Printed Page 27091

G. Submission and Deadline

Letter of Intent (LOI) Submission

On or before June 3, 2003, submit the LOI to appropriate recipient. The LOI should be on the applicant's letterhead and sent to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application Forms

Submit the signed original and two copies of PHS 398 (OMB Number 0925-0001). Adhere to the instructions on the Errata Instruction Sheet (as posted on the CDC website for PHS 398) to the CDC Procurement and Grants Office. Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

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) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. eastern time July 3, 2003. Submit the application to: Technical Information Management—PA 03100, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgment of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Letters of intent and applications shall be considered as meeting the deadline if they are received before 4 eastern time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received 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, natural or manmade disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above requirements will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Process and Criteria

Application

Applications which are complete and responsive may be subjected to a preliminary evaluation (streamline review) by a peer review committee, the Special Emphasis Panel (SEP), to determine if the application is of sufficient and scientific merit to warrant further review by the SEP. CDC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization. A dual review process will evaluate applications that are complete and responsive.

All awards will be determined by the Director of the NCIPC based on priority scores assigned to applications by the primary review committee SEP, recommendations by the secondary review committee of the Science and Program Review Subcommittee of the Advisory Committee for Injury Prevention and Control (ACIPC), consultation with NCIPC senior staff, and the availability of funds.

1. The primary review will be a peer review conducted by the SEP. A committee of reviewers with appropriate expertise will review all applications for scientific merit using current National Institutes of Health (NIH) criteria (a scoring system of 100-500 points) to evaluate the methods and scientific quality of the application. All categories are of equal importance, however, the application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Factors to be considered will include:

a. Significance. Does this study address an important problem? Does the applicant justify the present proposal using existing scientific knowledge? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

b. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant describe the specific questions this research is intended to address? Does the applicant describe how relevant behavioral theories will be applied to encourage the proposed activities? Does the applicant describe the hypotheses to be tested, the specific study goals, measurable objectives, and outcomes? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Does the project include plans to measure progress toward achieving the stated objectives? Is there an appropriate work plan included? Does the applicant provide a detailed time-line for the first year of the study as well as a projected time-line for the subsequent four years?

Has the applicant clearly described how intervention and comparison households will be selected; the process by which households will be randomized; and how households will be accessed, recruited and retained? Does the applicant describe a proposed intervention strategy that will use behavioral strategies to improve smoke alarm maintenance and function over time?

Is there a statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community or communities and recognition of mutual benefits. Is there evidence of effective working relationships between the applicant and community organizations? Does the applicant describe experience in developing community partnerships and the community's current and anticipated capacity to carry out the proposed activities?

Are there adequate plans for data collection and data management including security of data, assurance of participant confidentially, data entry, editing, and quality assurance procedures? Is there a statistical analysis plan appropriate for the study design?

c. Innovation. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge or advance existing paradigms, or develop new methodologies or technologies?

d. Investigator. Is the principal investigator appropriately trained and well suited to carry out this work? Is the proposed work appropriate to the experience level of the principal investigator and other significant investigator participants? Is there a prior history of conducting injury-related research? Does the applicant document capacity to accomplish the proposed study as demonstrated by relevant past or current injury prevention studies and smoke alarm program activities?

e. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed research Start Printed Page 27092take advantage of unique features of the scientific environment or employ useful collaborative arrangements?

Is there evidence of institutional support? Does the applicant describe the personnel and study collaborators needed to accomplish the proposed activities? Does the applicant provide evidence that the study personnel have the expertise and capacity to accomplish the proposed activities and to provide appropriate scientific oversight necessary to fulfill study goals and objectives?

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? Is there evidence of the experience and capacity for all key staff members including CVs and position descriptions?

f. Study Samples. Are the samples rigorously defined to permit complete independent replication at another site? Have the referral sources been described, including the definitions and criteria? What plans have been made to include women and minorities and their subgroups as appropriate for the scientific goals of the research? How will the applicant deal with recruitment and retention of subjects?

g. Ethical Issues. What provisions have been made for the protection of human subjects and the safety of the research environments? How does the applicant plan to handle issues of confidentiality and compliance with mandated reporting requirements, (e.g., suspected child abuse)?

Does the application adequately address the requirements of 45 CFR part 46 for the protection of human subjects? Not scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

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.

(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.

h. Dissemination. What plans have been articulated for disseminating findings?

i. Measures of Effectiveness. The Peer Review Panel shall assure that measures set forth in the application are in accordance with CDC's performance plans. How adequately has the applicant addressed these measures?

j. Budget. The SEP will also examine the appropriateness of the proposed project budget and duration in relation to the proposed research and the availability of data required for the project.

2. The secondary review will be conducted by the Science and Program Review Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and Control (ACIPC). ACIPC Federal agency experts will be invited to attend the secondary review and will receive modified briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and project officer's briefing materials). ACIPC Federal agency experts will be encouraged to participate in deliberations when applications address overlapping areas of research interest so that unwarranted duplication in federally funded research can be avoided and special subject area expertise can be shared. The NCIPC Division Associate Directors for Science (ADS) or their designees will attend the secondary review in a similar capacity as the ACIPC Federal agency experts to assure that research priorities of the announcement are understood and to provide background regarding current research activities. Only SPRS members will vote on funding recommendations, and their recommendations will be carried to the entire ACIPC for voting by the ACIPC members in closed session. If any further review is needed by the ACIPC, regarding the recommendations of the SPRS, the factors considered would be the same as those considered by the SPRS.

The Subcommittee's responsibility is to develop funding recommendations for the NCIPC Director based on the results of the primary review, the relevance and balance of proposed research relative to the NCIPC programs and priorities, and to assure that unwarranted duplication of federally funded research does not occur. The secondary review Subcommittee has the latitude to recommend to the NCIPC Director, to reach over better-ranked proposals in order to assure maximal impact and balance of proposed research. The factors to be considered will include:

a. The results of the primary review including the application's priority score as the primary factor in the selection process.

b. The relevance and balance of proposed research relative to the NCIPC programs and priorities.

c. The significance of the proposed activities in relation to the priorities and objectives stated in “Healthy People 2010”, the Institute of Medicine report, “Reducing the Burden of Injury”, and the NCIPC Injury “Research Agenda.”

d. Budgetary considerations including the extent to which the budget is reasonable, clearly justified, and consistent with the intended use of funds.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two copies of:

1. Interim progress reports, 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. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

2. Financial status reports, 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.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement, as posted on the CDC Web site.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

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-21 Small, Minority, and Women-Owned Business Start Printed Page 27093

AR-22 Research Integrity

Executive Order 12372 does not apply to this program.

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC Web site, Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements”.

For general questions about this announcement, contact: Technical Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146. Telephone: 770-488-2700.

For business management and budget assistance, contact: Wanda Allison, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2645, E-mail address: wba3@cdc.gov.

For business management and budget assistance in the territories, contact: Angelia Hill, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2785, E-mail address: aph8@cdc.gov.

For program technical assistance, contact: Judy Stevens, Ph.D., Technical Adviser, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS K-63, Atlanta, GA 30341-3724, Telephone: 770-488-4649, E-mail address: JAS2@cdc.gov.

Start Signature

Dated: May 1, 2003.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention.

End Signature End Preamble

[FR Doc. 03-12395 Filed 5-16-03; 8:45 am]

BILLING CODE 4163-18-P