[Federal Register: November 8, 2004 (Volume 69, Number 215)]
[Notices]
[Page 64762-64769]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08no04-78]
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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: http://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: http://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: http://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: http://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:
http://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: 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: 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:
GrantsInfo@nih.gov.
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 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 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: cipert@cdc.gov.
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: KMack@cdc.gov.
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: gxc8@cdc.gov.
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:
JMasone@cdc.gov.
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.''
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