64762 Federal Register / Vol. 69, No. 215 / Monday, November 8, 2004 / Notices 

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 nonresearch 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 fallrelated injuries among persons aged 65 

and older is enormous—accounting for 

11,623 deaths1 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

Federal Register / Vol. 69, No. 215 / Monday, November 8, 2004 / Notices 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, homebound 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 communitydwelling 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.aspx

www.nimh.nih.gov/dsir/dirp.cfm

www.nimh.nih.gov/scientificmeetings/

chddimtg.cfm

www.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 communitybased 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.

64764 Federal Register / Vol. 69, No. 215 / Monday, November 8, 2004 / Notices 

• Recruit (two to three) communitybased 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 biannual 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.

Federal Register / Vol. 69, No. 215 / Monday, November 8, 2004 / Notices 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 

Æ Name, address, E-mail address, 

telephone number, and FAX number of 

the Principal Investigator. 

Æ Names of other key personnel. 

Æ Participating institutions. 

Æ 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 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 nonmodular 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

64766 Federal Register / Vol. 69, No. 215 / Monday, November 8, 2004 / Notices 

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.

Federal Register / Vol. 69, No. 215 / Monday, November 8, 2004 / Notices 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

64768 Federal Register / Vol. 69, No. 215 / Monday, November 8, 2004 / Notices 

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-tablesearch.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:

Federal Register / Vol. 69, No. 215 / Monday, November 8, 2004 / Notices 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: 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

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Public Health Injury Surveillance and 

Prevention Program 

Announcement Type: New. 

Funding Opportunity Number: CE05–

027. 

Catalog of Federal Domestic 

Assistance Number: 93.136. 

Key Dates: Letter of Intent Deadline: 

December 8, 2004. 

Application Deadline: February 7, 

2005. 

I. Funding Opportunity Description 

Authority: This program is authorized 

under sections 391(a) and 301(a) of the 

Public Health Service Act (PHS Act) and 

[42 U.S.C. 241(a) and 280b(a)], as 

amended. 

Purpose: The Centers for Disease 

Control and Prevention (CDC) 

announces the availability of fiscal year 

(FY) 2005 funds for a cooperative 

agreement program for the development, 

enhancement, and integration of injury 

prevention and control and surveillance 

programs. The purpose of this program 

is to enable State public health agencies 

to develop or strengthen their 

organizational focus related to the 

prevention and control of injuries and to 

develop or strengthen their injury 

surveillance programs, particularly 

those with a focus on traumatic brain 

injury (TBI). This program addresses the 

‘‘Healthy People 2010’’ focus area of 

Injury and Violence Prevention. 

This announcement incorporates 

funding guidance for the following four 

components: Part A—the Integrated 

Core Injury Prevention and Control 

(ICIPC) Program, Part B—the Traumatic 

Brain Injury Extended Surveillance 

(TBIES) Program, Part C—the Traumatic 

Brain Injury Emergency Department 

(TBIED) Surveillance Program and Part 

D—the Traumatic Brain Injury Service 

Linkage (TBISL) Program. All States/

territories must qualify and be 

recommended for funding for Part A 

(ICIPC) in order to be eligible for Part B 

(TBIES), Part C (TBIED) or Part D 

(TBISL). The ICIPC component supports 

the planning, implementation and 

integration of comprehensive injury 

prevention and control activities with 

basic injury surveillance activities. CDC 

defines injury program integration as a 

coordinated approach to reducing the 

incidence, morbidity and mortality of 

injury through surveillance and 

prevention efforts. The TBIES 

component supports efforts to provide 

expanded information on the incidence 

of traumatic brain injury. The TBIED 

component supports efforts to provide 

information on the incidence of mild 

traumatic brain injury treated in the 

emergency department. The TBISL 

component supports efforts to link 

individuals with traumatic brain injury 

to information about services. 

Measurable outcomes of the program 

will be in alignment with one (or more) 

of the following performance goal(s) for 

the National Center for Injury 

Prevention and Control: 

1. Increase the capacity of injury 

prevention and control programs to 

address the prevention of injuries and 

violence. 

2. Monitor and detect fatal and nonfatal injuries. 

This announcement is only for nonresearch activities supported by CDC/

ATSDR. If research is proposed, the 

application will not be reviewed. For 

the definition of research, please see the 

CDC Web site at the following Internet 

address: http://www.cdc.gov/od/ads/

opspoll1.htm

Activities 

Part A: The Integrated Core Injury 

Prevention and Control (ICIPC) Program 

In conducting activities to achieve the 

purpose of Part A of this program, the 

recipient will be responsible for 

incorporating the core components of a 

model State injury prevention program 

as outlined in the STIPDA: Safe States—

2003 Edition. For a downloadable 

version of this document, please see the 

STIPDA Web site at the following 

Internet address: http://www.stipda.org/

safestates.htm.Activities to be followed 

related to this requirement are described 

below. CDC has developed performance 

measures to evaluate recipients’

progress in meeting ICIPC requirements. 

These performance measures are listed 

following each associated recipient 

activity. Activities are as follows:

• Building a Solid Infrastructure for 

Injury Prevention and Control. 

Æ Enhance comprehensive injury 

prevention and control 

infrastructure by acquiring key staff 

and associated resources to