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[Federal Register Volume 69, Number 215 (Monday, November 8, 2004)]
[Notices]
[Pages 64762-64769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24715]

[[Page 64762]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Dissemination Research on Fall Prevention: Development and 
Testing of an Exercise Program Package To Prevent Older Adult Falls

    Announcement Type: New.
    Funding Opportunity Number: CEO5-029.
    Catalogue of Federal Domestic Assistance Number: 93.136.
    Key Dates: Letter of Intent Deadline: December 8, 2004.
    Application Deadline: February 7, 2005.
    Executive Summary: This research study is a Cooperative Agreement 
that seeks to: (a) Translate an effective exercise fall intervention 
for older adults into a program package that can be delivered to 
community-based organizations for implementation with older adults, and 
(b) develop and implement dissemination research that is focused on 
reach and uptake (adoption), feasibility for the organizations offering 
the program and the individual participants, fidelity by the provider 
to the key elements that made the original intervention effective, and 
acceptability of the program to the organizations and to the older 
adult recipients.
    Development of the program package will involve developing multiple 
package components, including the materials needed to: (a) Recruit 
organizations and individuals, (b) train program providers, and (c) 
deliver and implement the program in a non-research setting.
    The Principal Investigator (PI) is expected to seek collaboration 
with and feedback from relevant experts such as representatives from 
the administrations of senior service organizations; technical experts 
in areas such as health care, physical therapy, and occupational 
therapy; health education specialists; and community-dwelling seniors. 
In addition, the PI may utilize video and other media experts.
    As a result of this translation and dissemination research, future 
dissemination activities will be informed about strategies that may 
enhance reach; increase organizational uptake in diverse, non-research, 
community-based settings; improve provider fidelity to key elements in 
program delivery; and increase organizations' and older adults' 
acceptance of the fall prevention exercise program.

I. Funding Opportunity Description

    Authority: This program is authorized under section 301(a) [42 
U.S.C. 241(a)] of the Public Health Service Act, and section 
391(a)[42 U.S.C. 280b(a)] of the Public Service Health Act, as 
amended.
    Background: The problem of fall-related injuries among persons aged 
65 and older is enormous--accounting for 11,623 deaths\1\ and over 1.6 
million non-fatal emergency department-treated injuries \1\ each year. 
With a rapidly increasing older adult population, it is essential to 
address the problem of older adult falls. While physical activity 
provides many health benefits, certain types of exercise specifically 
address known fall risk factors by improving balance and lower body 
strength. The 2003 CMS-sponsored Rand Report on this topic showed that 
exercise interventions can reduce the rate of falls by 19 percent 
(pooled risk ratio: 0.81, [95 percent CI 0.72, 0.92]) \2\. While a 
number of exercise interventions have demonstrated effectiveness in a 
research setting, no researcher has taken the next steps: Translating 
the intervention into a program that retains the key elements that made 
the original research effective, implementing the program in a 
community setting, and conducting research to test dissemination 
factors such as uptake and acceptability of the program in a community-
based setting.

    References:
    1. Centers for Disease Control and Prevention (CDC). Web-based 
Injury Statistics Query and Reporting System (WISQARS) [Online]. 
(2004). National Center for Injury Prevention and Control (NCIPC) 
and, CDC (producer). Available from: URL: www.cdc.gov/ncipc/wisqars. 
[Cited 26 July 2004].
    2. Healthy Aging Initiative Evidence Reports. Falls Prevention 
Interventions in the Medicare Population. Rand Corporation, Contract 
Number 500-98-0281. Available from: URL: www.cms.hhs.gov/healthyaging/fallspi.asp?

    Purpose: The purpose of the programs is to support research on 
translating an exercise intervention that rigorous research has shown 
is effective in reducing falls among older adults into a program; 
testing implementation of the program in a community setting; and 
conducting dissemination research focusing on reach, uptake (adoption), 
feasibility, fidelity of the implementation, and acceptability.
    This program addresses the ``Healthy People 2010'' focus area of 
Injury and Violence Prevention. Specifically, it addresses Objective 
15-27, to reduce deaths from falls, and Objective 15-28, to reduce hip 
fractures among people age 65 and older.
    Measurable outcomes of the program will be in alignment with one 
(or more) of the following performance goal(s) for (NCIPC):
    1. Increase the capacity of injury prevention and control programs 
to address the prevention of injuries and violence.
    2. Conduct a targeted program of research to reduce injury-related 
death and disability.
    Outcomes also should be in alignment with the NCIPC Research Agenda 
priority areas to disseminate effective interventions to reduce 
injuries at home and in the community and to reduce older adult falls 
and fall-related injuries. Specifically, ``Evaluate strategies for 
widespread dissemination and implementation of effective interventions 
to reduce injuries at home and in the community.'' (NCIPC Research 
Agenda, p19); ``Research has demonstrated that many interventions at 
home and in the community work. * * * Encouraging widespread adoption 
of these efficacious interventions calls for dissemination research. * 
* * Demonstration programs should be developed and evaluated to 
determine the effectiveness of various persuasive communications 
techniques, audience segmentation, tailored messaging, and 
collaboration models to speed diffusion and widen adoption.'' (NCIPC 
Research Agenda, p19)
    ``[Pertaining to older adult falls:] Research is needed to develop 
and evaluate approaches to implementing and disseminating effective 
fall prevention programs in the community. * * * This includes research 
to identify the best formats and channels for delivering interventions 
to ensure that older adults adopt them.'' (NCIPC Research Agenda, p22)
    Available from: URL: www.cdc.gov/ncipc/pub-res /research-- agenda/
agenda.htm.
    Outcome measures of interest will include:
    1. Reach and uptake (adoption) at organizational and individual 
levels;
    2. Fidelity to the key elements when the program is implemented;
    3. Feasibility at organizational and individual levels; and
    4. Acceptability at the organizational and individual levels.
    Research Objectives:
    Note: Applicants will be expected to identify an effective exercise 
intervention to reduce older adult falls. Examples of such 
interventions may be found in:

    Healthy Aging Initiative Evidence Reports. Falls Prevention 
Interventions in the

[[Page 64763]]

Medicare Population. Rand Corporation, Contract Number 500-98-0281. 
Available from: URL: www.cms.hhs.gov/healthyaging/fallspi.asp?
    Gillespie LD, Gillespie WJ, Robertson MC et al. Interventions 
for preventing falls in elderly people (Cochrane Review). In: The 
Cochrane Library, Issue 3, 2004. Chinchester, UK: John Wiley & Sons, 
Ltd.

    This Announcement does not include dissemination of exercise 
programs to nursing home residents or frail, home-bound older adults 
where medical screening and follow up, or medical monitoring, is 
required.
    Specific interventions that fit the requirements of this 
Announcement and have credible evidence of effectiveness based on 
rigorous research trials include:
    (a) Tai Chi tailored for community-dwelling older adults offered as 
group classes.
    (b) Tai Chi group classes plus related activities undertaken by 
individuals in their homes.
    (c) Community-based group exercise classes focusing on strength, 
balance, and endurance training.
    (d) Community-based group exercise classes focusing on strength, 
balance, and endurance training, including individualized programs.
    1. To translate an effective exercise fall intervention for older 
adults into a program that can be implemented in community settings.
    Additional objectives are to translate the intervention into a 
program; create a program package of materials; recruit organizations 
for testing; implement the program in a community setting; evaluate the 
results of the implementation with particular emphasis on dissemination 
research questions of reach, uptake (adoption), feasibility, and 
implementation fidelity and acceptability; refine the fall prevention 
program, recruit a second organization and implement the revised 
program; and produce a final package that can be broadly disseminated 
and used nationwide. (Note: broad dissemination and nationwide use is 
not a part of this Announcement).
    2. To identify the key elements that made the intervention 
effective. In the absence of a component analysis which is rare in 
behavioral studies, the original investigators will need to derive 
these key elements based on their publications, notes, recall, and 
judgment. They will likely need to consult with their former research 
project staff and others, consider the underlying theoretical models 
used in their intervention design, and examine the data that was 
obtained in their study. Applicants other than the original 
investigators will need to demonstrate the ability to carry out these 
processes.
    3. To conduct research on translating and disseminating effective 
exercise fall interventions into programs that can be implemented in 
community settings.
    Research questions to be addressed might include:
    (a) Reach--Who are you most interested in reaching and how many 
persons from this target audience will be reached?
    (b) Uptake (adoption)--Do organizations and individuals who learn 
of the program consider using it, actually use it, and use it fully? 
What barriers and facilitators to use can be identified?
    (c) Feasibility--How much time, money, staff, space and other 
resources are needed vs. what is available?
    (d) Fidelity--Are the key components that made the intervention 
effective maintained when the program is implemented?
    (e) Acceptability--How acceptable is the intervention to those it 
will impact; e.g., are cultural norms taken into account? Is the 
program acceptable at organizational and individual levels?
    (f) Adaptability--Can the intervention vary, as needed depending on 
the audience?
    Translational research has been utilized to develop programs in 
topic areas such as HIV/AIDS. Two examples of this type of research 
are:

    1. Kraft JM. Mezoff JS. Sogolow ED. Neumann MS. Thomas PA. A 
technology transfer model for effective HIV/AIDS interventions: 
science and practice. AIDS Education & Prevention. 12(5 Suppl):7-20, 
2000.
    2. Sogolow ED. Kay LS. Doll LS. Neumann MS. Mezoff JS. Eke AN. 
Semaan S. Anderson JR. Strengthening HIV prevention: application of 
a research-to-practice framework. AIDS Education & Prevention. 12(5 
Suppl):21-32, 2000.

    Additional examples of translation and dissemination research are 
ongoing at the National Cancer Institute, National Institute of Mental 
Health, and National Institute on Drug Abuse, among others. Examples 
may be found at URLs:

www.nci.nih.gov/search/results.aspxwww.nimh.nih.gov/dsir/dirp.cfmwww.nimh.nih.gov/scientificmeetings/chddimtg.cfmwww.drugabuse.gov/CTN/whatisblending.html
    Although not specific to fall prevention, effective evidence-based 
exercise interventions have been identified and these may help inform 
the research translation process. These interventions have been 
described in:

    1. Task Force on Community Preventive Services. Recommendations 
to increase physical activity in communities. American Journal of 
Preventive Medicine, 2002; 22: 67-72.
    2. Kahn, EB, Ramsey, LT, Brownson, RC, et al. The effectiveness 
of interventions to increase physical activity: a systematic review. 
American Journal of Preventive Medicine, 2002, 22:73-107.

    Rigorous evaluations are needed to determine the effectiveness of 
interventions, programs, and policies addressing the prevention of 
violence. Experimental designs are strongly encouraged. However, NCIPC 
will consider other evaluation designs, if justified, as required by 
the needs and constraints in a particular setting.
    For effective interventions, it is possible to do cost-
effectiveness studies. To be comparable to other cost effectiveness 
studies, they should follow the guidelines in the following references:

    Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-Effectiveness 
in Health and Medicine. New York: Oxford University Press, 1996.
    Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A 
Guide to Decision Analysis and Economic Evaluation. Second Edition. 
New York: Oxford University Press, 2003.

    Activities:
    Awardee activities for this program are as follows:
    For the selected effective exercise intervention, a series of 
activities will take place over the three years of the Cooperative 
Agreement:

Year One: Planning and Development

     Identify those key elements that made this intervention 
effective.
     Establish an ad hoc expert group to guide and support 
development of a draft fall prevention program package.
     Develop a curriculum (including a variety of educational 
materials such as audio, video, and print) that translates these key 
elements into a community-based exercise program.;
     Develop materials for recruitment of organizations and 
individuals.;
     Develop materials for training providers of the exercise 
program, including criteria-based performance standards.
     Create the draft program package of materials;
     Develop a research protocol and submit for Institutional 
Review Board (IRB) review by all cooperating institutions participating 
in the research study.;
     Develop and pilot test evaluation instruments to assess 
reach, uptake (adoption), feasibility, fidelity, and acceptability.

[[Page 64764]]

     Recruit (two to three) community-based organizations for 
implementation. This applies only where organizational settings are 
relevant such as where the program takes place in a senior center.
     Revise materials pertaining to recruitment of 
organizations.

Year Two: Implementation

     Recruit older adults into the program.;
     Train personnel.;
     Implement the program in one community setting. Provide 
the program to a small number of older adults (less than eight), for a 
predetermined period depending on the program design (e.g., two to 
three months).
     Make minor revisions to the provider materials as needed 
and repeat implementation in same setting two to three times.
     Revise all materials.
     Recruit older adults into the program in a new setting, 
train personnel, and implement the program following guidance above.
     In all instances, employ the evaluation tools to collect 
data required to address the research questions previously listed under 
``Research Objectives.''

Year Three: Evaluation

     Evaluate the dissemination using data collected during 
Year Two; analyze reach, uptake (adoption), feasibility, implementation 
fidelity, and acceptability;
     Use findings to revise and refine the program package.
     Incorporate dissemination research results to produce a 
final program package that will enable the program to be broadly 
disseminated in various community settings nationwide.
     Prepare a paper for publication in a peer review practice 
journal.
    In a cooperative agreement, CDC staff is substantially involved in 
program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
    1. Provide up-to-date scientific information, technical assistance, 
and guidance in the design and conduct of the research when and where 
needed or requested.
    2. Provide to awardees:
    (a) Scientific information and guidance in translation and 
dissemination research design, data collection methods, and data 
quality assurance when requested;
    (b) If necessary, technical assistance in developing data 
collection instruments and methods for data management;
    (c) If necessary, guidance in developing a research protocol for 
annual Institutional Review Board (IRB) review for use by all 
cooperating institutions participating in the research study; and
    (d) Technical assistance and guidance in analysis and dissemination 
of results including the preparation of manuscripts when required.
    3. The CDC IRB will review the protocol initially and on at least 
an annual basis until the research study, including analyses, is 
completed and will assist in ensuring human subjects assurances are in 
place as needed.
    4. Monitor and evaluate the scientific and operational 
accomplishments of the project. This may be accomplished through 
periodic site visits, telephone calls, electronic communication, and 
bi-annual report.
    5. Convene meetings of recipients for the exchange of information.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed under ``CDC Activities'' above.
    Mechanism of Support: U49.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $350,000 (This amount is an estimate, 
and is subject to availability of funds.)
    Approximate Number of Awards: One.
    Approximate Average Award: $350,000 (This amount is for the first 
12-month budget period and includes both direct and indirect costs. 
Approximately $1,050,000 total is available over the entire three years 
of the project period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $350,000 (This ceiling is for the first 12-
month budget period and includes both indirect and direct costs.) If 
the budget proposed exceeds this amount it will not be eligible for 
review and will be discarded.
    Anticipated Award Date: September 1, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Three years.
    Throughout the project period, CDC's commitment to continuing the 
awards will be dependent 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 and 
for profit organizations and by governments and their agencies, such 
as:
     Research institutions.
     Universities.
     Colleges.
     Public nonprofit organizations.
     Private nonprofit organizations.
     For profit organizations.
     Small, minority, women-owned businesses.
     Hospitals.
     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).
    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.

III.3. Other

    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.
    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.
     In order to plan the application review more effectively 
and efficiently, CDC requires that you submit a Letter of Intent (LOI) 
to apply for this program. See ``IV.3. Submission Dates and Times'' for 
more information on deadlines.

[[Page 64765]]

     Application must demonstrate credible evidence of the 
effectiveness in a research study of any proposed intervention or that 
no negative effects have been demonstrated because of the intervention.
     Application must include an exercise program that has been 
subject to rigorous research. Rigorous research does not include 
studies that focus exclusively or primarily on participant satisfaction 
rather than falls as the primary outcome.
     Participants must be independent, community dwelling older 
adults (for example, the applicant should not propose to disseminate 
via health care providers to older adults who reside in assisted living 
or nursing homes).
     The applicant must provide evidence such as publications 
from peer reviewed journals (in the appendix of the application) that 
demonstrate expertise in:
    (a) Designing and conducting original intervention research on 
exercise for fall prevention; and/or
    (b) Conducting translation/dissemination research.
     If the applicant is not strong in both areas, the 
applicant must demonstrate enhanced capacity to perform the translation 
and dissemination research by including documentation of potential 
consultants or collaborators who have the relevant other area of 
expertise.
     The applicant must provide documentation of collaborating 
experts (e.g., administrators of senior centers, technical experts, and 
community-based seniors) describing the areas of expertise and 
indicating willingness to collaborate and areas of potential 
collaboration.

     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.

    Individuals Eligible to Become Principal Investigators: Any 
individual with the skills, knowledge, and resources necessary to carry 
out the proposed injury research as outlined above 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.
    PIs must demonstrate that they have the authority to carry out this 
research. For example, if a PI is affiliated with a university, he or 
she must be a faculty member and not a visiting scientist.
    PIs are encouraged to submit only one proposal in response to this 
program announcement. With few exceptions (e.g., research issues 
needing immediate public health attention), only one application per 
principal investigator will be funded under this announcement.

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. 5/2001). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: 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: 25 pages.
     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
    [cir] Name, address, E-mail address, telephone number, and FAX 
number of the Principal Investigator.
    [cir] Names of other key personnel.
    [cir] Participating institutions.
    [cir] 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: 
[email protected].
    Your research plan should address activities to be conducted over 
the entire project period.
    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 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 uses the non-modular budgeting format.
    In addition to the instructions provided in the PHS 398 for writing 
the Description on page 2 of the PHS 398 form, structure the 
Description using the following components: (1) Statement of the 
problem, (2) Purpose of the proposed research, (3) Methods, including 
study population, data sources and any statistical analyses to be 
performed, and (4) Implications for prevention.
    The Description (abstract) should answer the following questions:
     Does the Description state the hypothesis?
     Does the Description describe the objectives and specific 
aims?
     Does the Description state the importance of the research 
and how it is innovative?
     Does the Description outline the methods that will use to 
accomplish the goals?
     Is the language of the Description simple and easy to 
understand for a broad audience?
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''
    Additional documentation that may be required for submission with 
your application is listed in section ``VI.2. Administrative and 
National Policy Requirements.''

IV.3. Submission Dates and Times

    Letter of Intent (LOI): December 8, 2004.
    CDC requires that you submit a LOI if you intend to apply for this 
program. Although the LOI will not be evaluated, and does not enter 
into review of your

[[Page 64766]]

subsequent application, failure to submit a timely LOI will preclude 
you from submitting an application.
    Application deadline date: February 7, 2005.
    Explanation of deadlines: LOIs and 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 LOI or 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 is not 
received in the CDC Procurement and Grants office by 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 LOI or 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 Institutional Review 
Board approvals are in place. Sufficient time and resources should be 
devoted to preparing an acceptable IRB Protocol package. Funds for 
human subjects recruitment and human subjects research will be withheld 
until appropriate IRB approval has been obtained.
     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:

Address for Express Mail or Delivery Service: NCIPC Extramural 
Resources Team, CDC, National Center for Injury Prevention and Control, 
2945 Flowers Road, Yale Building, Room 2054, Atlanta, Georgia 30341.
Address for U.S. Postal Service Mail: NCIPC Extramural Resources Team, 
CDC, National Center for Injury Prevention and Control, 4770 Buford 
Hwy, NE., Mailstop K-62, Atlanta, GA 30341.

    Telephone: 770-488-4037.
    Fax: 770-488-1662.
    Email: [email protected].

    Application Submission Address: Submit the original and one hard 
copy of your application by mail or express delivery service to: 
Technical Information Management CE05-029, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    At the time of submission, four additional copies of the 
application, and four copies of all appendices must be sent to:
    Address for Express Mail or Delivery Service: NCIPC Extramural 
Resources Team, CDC, National Center for Injury Prevention and Control, 
2945 Flowers Road, Yale Building, Room 2054, Atlanta, Georgia 30341.
    Address for U.S. Postal Service Mail: NCIPC Extramural Resources 
Team, CDC, National Center for Injury Prevention and Control, 4770 
Buford Hwy, NE., Mailstop K-62, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. 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, 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 
application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority 
score. For example, an investigator may propose to carry out important 
work that by its nature is not innovative but is essential to move a 
field forward.
    The review criteria are as follows:
    Significance: Does this study address an important problem? 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? Will study advance scientific knowledge 
of how to disseminate community-based interventions for preventing 
older adult fall-related injuries.
    Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics? To what extent do the 
applicant's work plan and timetable include development of program 
package materials, specification of relevant experts and agreements 
with them, recruitment of organizations, staffing including trainer, 
training for providers, program delivery; and dissemination research 
design and implementation.

[[Page 64767]]

    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)? Does the PI have the authority to conduct the project?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Does the proposed 
experiments or study take advantage of unique features of the 
scientific environment or employ useful collaborative arrangements? Is 
there evidence of institutional support?
    To what extent have the applicant and proposed collaborators 
documented:
    a. Their history and current capacity to provide a leadership 
function in conducting translation/dissemination research of an 
exercise program package to reduce falls among older adults.
    b. A willingness to partner with CDC so that the Applicant 
Activities and CDC Activities are undertaken in a collaborative fashion 
as intended for Cooperative Agreement recipients. This would include a 
willingness to attend and participate in technical assistance and 
planning meetings and related travel to Atlanta coordinated by the CDC 
for all Cooperative Agreement recipients.
    c. Their organizational capacity to realize the objectives of the 
Cooperative Agreement.
    d. Their management operation, structure and/or organization. An 
organizational chart of the applicant's organization should be included 
as an appendix. Additionally, the applicant should include within their 
management plan the specific role and mechanisms to be established to 
ensure effective coordination, communication and shared decision making 
among the involved agencies/organizations.
    e. A staffing plan for the project, noting existing staff as well 
as additional staffing needs. The responsibilities of individual staff 
members including the level of effort and allocation of time for each 
project activity by staff position should be included. If relevant, the 
specific staff positions within other involved state level agencies, 
both in-kind and funded, should be described.
    f. CVs for the PI and co-PIs (if any), and CVs, resumes, and/or 
biosketches for current, proposed, and in-kind staff, and position 
descriptions for all proposed positions to be funded under this 
cooperative agreement) should be included as an appendix. This should 
include the use of consultants, as appropriate.
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 CFR Part 46 
for the protection of human subjects? This will not be 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.
    Applicants should consider the possible need for IRB and/or OMB 
submissions early in the Cooperative Agreement and plan appropriately 
for their completion to avoid delays and restriction of funds.
    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.
    Inclusion of children as participants in research involving human 
subjects: The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998. NCIPC has adopted this policy for this announcement.
    All investigators proposing research involving human subjects 
should read the ``NIH Policy and Guidelines'' on the inclusion of 
children as participants in research involving human subjects that is 
available at: http://grants.nih.gov/grants/funding/children/children.htm.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO), and for responsiveness by the National Center 
for Injury Prevention and Control. 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 the National 
Center for Injury Prevention and Control 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.
     Applications deemed to have the highest scientific merit 
will receive a second programmatic level review by the Science and 
Program Review Subcommittee (SPRS) of the Advisory Committee for Injury 
Prevention and Control (ACIPC).
    Applications that are complete and responsive may be subjected to a 
preliminary evaluation (streamline review) by an external 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 be used to 
further 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 external 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.
    The primary review will be a peer review conducted by the SEP. A 
committee of reviewers with appropriate expertise will review all

[[Page 64768]]

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.
    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.
    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.
     Geographic diversity.
     Racial/ethnic diversity.
     Balance of intervention approaches and strategies.
     Consistency with research priorities in CDC's Injury 
Research Agenda.
     Availability of funds within categories of violence and 
injury funding streams.

V.3. Anticipated Announcement of Award Date

    September 1, 2005

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA) 
from the CDC Procurement and Grants Office. The NGA shall be the only 
binding, authorizing document between the recipient and CDC. The NGA 
will be signed by an authorized Grants Management Officer, and mailed 
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

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
    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-6 Patient Care.
     AR-7 Executive Order 12372.
     AR-9 Paperwork Reduction Act Requirements.
     AR-10 Smoke-Free Workplace Requirements.
     AR-12 Lobbying Restrictions.
     AR-13 Prohibition on Use of CDC Funds for Certain Gun 
Control Activities.
     AR-14 Accounting System Requirements.
     AR-22 Research Integrity.
     AR-23 States and Faith-Based Organizations.
     AR-24 Health Insurance Portability and Accountability Act 
Requirements (HIPAA).
    Additional information on AR-1 through AR-24 can be found on the 
CDC web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
     AR-25 Release and Sharing of Data
    Starting with the December 1, 2004 receipt date, all ``Requests for 
Applications (RFA)/Program Announcements (PA)'' soliciting proposals 
for individual research projects of $500,000 or more in total (direct 
and indirect) costs per year require the applicant to include a plan 
describing how the final research data will be shared/released or 
explain why data sharing is not possible. Details on data sharing and 
release, including information on the timeliness of the data and the 
name of the project data steward, should be included in a brief 
paragraph immediately following the Research Plan Section of the PHS 
398 form. References to data sharing and release may also be 
appropriate in other sections of the application (e.g. background and 
significance, or human subjects requirements). The content of the data 
sharing and release plan will vary, depending on the data being 
collected and how the investigator is planning to share the data. The 
data sharing and release plan will not count towards the application 
page limit and will not factor into the determining scientific merit or 
the priority scoring. Investigators should seek guidance from their 
institutions on issues related to institutional policies, and local IRB 
rules, as well as local, state and federal laws and regulations, 
including the Privacy Rule.
    Projects that involve the collection of information from 10 or more 
individuals and funded by cooperative agreement will be subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act.
    Further detail on the requirements for addressing data sharing in 
applications for NCIPC funding may be obtained by contacting NCIPC 
program staff or by visiting the NCIPC internet Web site at:

[[Page 64769]]

http://www.cdc.gov/ncipc/osp/sharing_policy.htm

VI.3. Reporting

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC website) no less than 90 days 
before the end of the budget period. The progress report will serve as 
your non-competing continuation application, and must contain the 
following elements:
    a. Current budget period activities objectives.
    b. Current budget period financial progress.
    c. New budget period program proposed activity objectives.
    d. Budget.
    e. Measures of effectiveness.
    f. Additional requested information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

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: Karin Mack, Ph.D., 
National Center for Injury Prevention and Control, Centers for Disease 
Control and Prevention (CDC), 4770 Buford Hwy NE., Mailstop K-63, 
Atlanta, GA 30341. Telephone: 770-488-4389. E-mail: [email protected].
    For questions about peer review, contact: Gwendolyn Cattledge, PhD, 
Scientific Review Administrator, Associate Director for Extramural 
Research,National Center for Injury Prevention and Control Centers for 
Disease Control and Prevention (CDC), 4770 Buford Highway, NE., 
Mailstop K-02. Telephone: 770-488-1430. E-mail: [email protected].
    For financial, grants management, or budget assistance, contact: 
James Masone, Grants Management Specialist, CDC Procurement and Grants 
Office,2920 Brandywine Road, Atlanta, GA 30341. E-mail: 
[email protected].

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC web site, Internet address: www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.''

William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-24715 Filed 11-5-04; 8:45 am]
BILLING CODE 4163-18-U
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