67738 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Community-Based Interventions for 

Alcohol-Impaired Driving 

Announcement Type: New. 

Funding Opportunity Number: CE05–

024. 

Catalog of Federal Domestic 

Assistance Number: 93.136. 

Dates:

Letter of Intent deadline: December 

20, 2004. 

Application deadline: February 7, 

2005. 

I. Funding Opportunity Description 

Authority: This program is authorized 

under section 301(a) [42 U.S.C. 2410(a)] 

of the Public Health Service Act, and 

section 391(a) [42 U.S.C. 280 b(a)] of the 

Public Service Health Act, as amended. 

Background: Prevention of alcoholimpaired driving is among the most 

important strategies to reduce motor 

vehicle-related injuries and deaths. 

‘‘Healthy People 2010: Health 

Objectives for the Nation’’ has set 

objectives of reducing alcohol-related 

motor vehicle fatalities to no more than 

4.0 per 100,000 persons and reducing 

alcohol-related motor vehicle injuries to 

no more than 65 per 100,000 persons, 

from 1998 baselines of 5.9 and 113, 

respectively. To meet these objectives, 

the nation must reduce alcoholimpaired driving, community by 

community. 

According to health promotion 

theory, a multifaceted approach to the 

prevention of alcohol-impaired driving 

is desirable due to the potential for 

different interventions to work 

synergistically. The implementation and 

evaluation of multifaceted communitybased interventions that target alcoholimpaired driving is necessary to 

measure the effectiveness of such efforts 

and provide data to inform future 

efforts. 

Purpose: This research study is a 

cooperative agreement that seeks to 

evaluate interventions to decrease 

alcohol-impaired driving in community 

settings and the resulting deaths and 

injuries. This announcement is 

appropriate for organizations that are 

currently conducting research of 

multifaceted, community-based 

intervention that targets alcohol- and/or 

motor vehicle-related injuries. 

Funds will be provided to: (1) 

Evaluate the supplementary benefits 

from adding one or more strategies to 

reduce alcohol-impaired driving to an 

existing multifaceted community-based 

program to prevent alcohol- and/or 

motor vehicle-related injuries; or (2) 

evaluate the results of an existing, 

effective multifaceted community-based 

intervention to reduce alcohol-impaired 

driving when applied to another 

community with different demographic 

characteristics. 

This project addresses the ‘‘Healthy 

People 2010’’ focus areas of Injury and 

Violence Prevention and Adverse 

Consequences of Substance Use and 

Abuse. 

Measurable outcomes of the project 

will be in alignment with the following 

performance goals for the National 

Center for Injury Prevention and Control 

(NCIPC): 

• Conduct a targeted program of 

research to reduce injury-related death 

and disability.

Outcomes should also be in alignment 

with the following research priorities in 

transportation safety from the National 

Center for Injury Prevention and Control 

(NCIPC) Research Agenda: 

• Evaluate strategies to implement 

and disseminate known, effective 

interventions to reduce alcoholimpaired driving and test the 

effectiveness of new, innovative 

strategies. 

• Develop methodologies for and 

evaluate the effectiveness of various 

means to translate transportation safety 

research findings into public policy. 

The grantees are expected to widely 

disseminate the outcomes through 

traditional mechanisms, such as 

professional and peer-reviewed journal 

publications. 

Research Objectives 

• Nature of the research problem—

Research is needed to measure the 

effectiveness of multifaceted 

community-based interventions in 

reducing alcohol-impaired driving. 

• Scientific knowledge to be achieved 

through research supported by this 

program—

This research will help develop a 

better understanding of the extent to 

which: (1) Specific components of 

multifaceted interventions contribute to 

their effectiveness in reducing alcoholimpaired driving, and (2) outcomes 

generalize across communities with 

different demographic characteristics. 

Objectives of This Research Program 

• To assess the effectiveness of either: 

(1) Adding one or more strategies to 

reduce alcohol-impaired driving to an 

existing multifaceted community-based 

intervention to reduce alcohol- and/or 

motor vehicle-related injuries; or (2) 

implementing an existing communitybased intervention targeting alcoholimpaired driving that has evidence of 

effectiveness in the current community 

to a separate community that has 

different demographic characteristics. 

• To obtain process-related 

information regarding barriers to 

implementation of such interventions 

and the means to overcome them. This 

process and outcome information will 

be used to inform future communitybased programs to reduce alcoholimpaired driving. 

The goals of the announcement can be 

accomplished in either of two ways. 

First, an existing community-based 

intervention can be supplemented by 

adding strategies targeting alcoholimpaired driving. For example, sobriety 

checkpoints could be integrated into a 

multifaceted intervention targeting highrisk alcohol consumption and related 

injuries. Alternatively, an existing 

community-based intervention targeting 

alcohol-impaired driving that has 

evidence of effectiveness in the current 

community could be implemented in a 

separate community that has different 

demographic characteristics. For 

example, an intervention that is 

underway in an urban community could 

be expanded to a rural community. 

Research and Experimental Approaches 

To Achieve the Objectives 

The preferred approaches to assessing 

the effectiveness of the interventions 

include quasi-experimental research 

designs using time series data, 

comparison communities, or both (as 

appropriate given pre-existing 

evaluation plans). Baseline measures of 

variables related to alcohol-impaired 

driving should be collected before 

implementation of the intervention or 

addition of the new intervention 

strategy(s). Direct assessment of driver 

blood alcohol content levels in roadside 

surveys is the preferred outcome 

variable. However, other acceptable 

outcome variables would be selfreported alcohol-impaired driving from 

appropriately designed telephone 

surveys or crashes likely to be alcoholrelated, such as single-vehicle nighttime 

crashes. 

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 

Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 67739

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: 

1. This study will require the 

existence of a core coalition (or 

coalitions) that would ideally include 

representatives from the following 

groups: 

• Community leaders, groups, and 

organizations (e.g., policy makers, safety 

advocates, schools, youth organizations, 

local media, health care providers, and 

social service agencies) 

• Public health departments 

• Transportation and traffic safety 

agencies 

• Governors’ highway safety 

representatives 

• Law enforcement 

• Academic evaluation experts 

2. Applicants will be expected to: (1) 

Incorporate one or more additional 

strategies related to alcohol-impaired 

driving into an existing communitybased intervention; or (2) expand an 

existing, effective multifaceted 

community-based intervention to 

prevent alcohol-impaired driving to a 

community with different demographic 

characteristics. 

Examples of effective or innovative 

strategies that the applicant is 

encouraged to consider include: 

• Sobriety checkpoints to reduce 

alcohol-impaired driving. Key 

components of the intervention: Officer 

training in appropriate practices; 

implement or increase the frequency of 

sobriety checkpoints (or roving patrols if 

checkpoints are not feasible); develop a 

strategy for publicizing checkpoints 

through earned media (e.g., news 

stories) and/or paid media. 

• Server intervention training. Key 

components of the intervention: Face-toface training regarding legal obligations 

and methods of preventing patron 

intoxication for servers and other staff; 

training and/or on-site consultation 

with managers on responsible practices. 

• Community-wide designated driver 

promotion. A key component of the 

intervention: A substantial majority of 

drinking establishments in the 

community offer and promote 

incentives for designated drivers.

Applicants who choose to incorporate 

additional strategies into an existing 

community-based intervention may 

select other promising or innovative 

interventions to prevent alcoholimpaired driving. Justification for the 

selected interventions should be 

provided in the application. Applicants 

who choose to expand an existing 

community-based intervention to an 

additional community must provide 

some evidence of the effectiveness of 

the existing intervention and issues 

related to generalizability in the new 

community. 

Applicants will also be expected to 

collect outcome data on the 

effectiveness of interventions in 

reducing alcohol-impaired driving, such 

as changes in alcohol-related crashes, 

injuries, or deaths, and perform process 

evaluations from community-based 

activities designed to reduce alcoholimpaired driving. 

CDC Activities for This Program Are 

as Follows:

1. Assist to provide up-to-date 

scientific information, technical 

assistance, and guidance in project 

matters, where and when requested. 

2. Provide technical assistance and 

guidance in analysis and dissemination 

of results, including assistance in the 

preparation of manuscripts, where and 

when requested. 

3. Assist in ensuring human subjects 

assurances and protections are in place 

as necessary. 

4. Monitor and evaluate the scientific 

and operational accomplishments of the 

project, as needed. This may be 

accomplished through periodic site 

visits, telephone calls, electronic 

communication, and bi-annual reports. 

5. Convene meetings with recipient 

for the exchange of information. 

6. Review and approve, if needed, IRB 

protocols initially, and assist in filing 

IRB continuation applications, at CDC, 

on at least an annual basis until the 

research study, including analysis, is 

completed. 

II. Award Information 

Type of Award: Cooperative 

Agreement. 

CDC involvement in this program is 

listed in the Activities Section above. 

Mechanism of Support: E11. 

FY 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 continuation of awards 

will be conditioned on the availability 

of funds, evidence of satisfactory 

progress by the recipient (as 

documented in required reports), and 

the determination that continued 

funding is in the best interest of the 

Federal Government. 

III. Eligibility Information 

III.1. Eligible Applicants 

Applications may be submitted by 

public and private nonprofit and for 

profit organizations and by governments 

and their agencies, such as: 

• Federally recognized Indian tribal 

organizations 

• State, local, and tribal public health 

departments 

• Transportation and traffic safety 

agencies 

• Research Institutions 

• Colleges and Universities 

• Private non-profit organizations 

• For-profit organizations 

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. 

Eligible applicants will be limited to 

those currently conducting a 

multifaceted community-based 

intervention trial targeting alcoholimpaired driving, other high-risk 

alcohol use, or motor vehicle-related 

injuries. Due to the time and expense 

involved in building community 

coalitions, implementing interventions, 

and planning evaluations, the available 

funds are not sufficient to adequately 

support a trial for which these steps 

have not already taken place. 

III.2. Cost Sharing or Matching 

Matching funds are not required for 

this program. 

67740 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 

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. 

• The applicant should provide 

evidence that the performing 

organization is conducting a 

multifaceted community-based 

intervention to prevent alcohol-and/or 

motor vehicle-related injuries that could 

feasibly be expanded according to the 

terms of this RFA. This expansion could 

be accomplished either by adding a new 

alcohol-impaired driving strategy to the 

intervention, or by implementing the 

intervention in an additional 

community. 

• The applicant should provide 

evidence of effective and well-defined 

collaborative relationships within the 

performing organization and among the 

coalition members that will ensure 

implementation of the proposed 

activities. Documentation, such as 

letters of collaboration, describing the 

specific commitments and 

responsibilities that will be undertaken 

by the coalition members and 

community organizations must be 

included in an appendix. 

• The applicant and its collaborative 

team should provide evidence of prior 

experience in implementing and 

evaluating community-based 

interventions. This experience must be 

documented by including publications 

such as those from peer-reviewed 

journal articles or technical reports in 

the appendix of the application. 

• The recipient should provide 

evidence of access to target populations 

and experience with accessing 

community leaders and communitylevel groups. 

• The applicant must provide a 

written evaluation plan for the existing 

community-based intervention that 

details how the added intervention 

strategies or site will be incorporated. 

This plan should include: (1) A list of 

outcome measures and the data source 

for each measure, and (2) baseline 

measurement results for each outcome 

variable. 

• 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. 

Applications that do not meet the 

above requirements will be considered 

non-responsive. 

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. 

Principal investigators 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: 2 pages 

• Font size: 12-point unreduced 

• Single-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: 

Æ 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 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 nonmodular budgeting format. 

In addition to the instructions 

provided in the PHS 398 for writing the 

research plan on page 2 of the PHS 398 

form, structure the research plan 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 

Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 67741

prevention. The narrative portion of the 

application must not exceed 25 doublespaced pages with unreduced 12-point 

font. 

The research plan (abstract) should 

answer the following questions: 

• Does the research plan state the 

hypothesis? 

• Does the research plan describe the 

objectives?

• Does the research plan state the 

importance of the research and how it 

is innovative? 

• Does the research plan outline the 

methods that will use to accomplish the 

goals? 

• Is the language of the research plan 

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.’’

IV.3. Submission Dates and Times 

Letter of Intent (LOI): December 20, 

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 

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 by 4 p.m. Eastern 

time on the deadline date. If you submit 

your LOI and 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 carriers 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 

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 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, E-mail: 

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–

024], 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 

67742 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 

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 implement and 

evaluate community-based 

interventions for preventing alcoholimpaired driving. 

Approach: Are the conceptual 

framework, design, methods, and 

analyses adequately developed, wellintegrated, 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: 

• The identification of representatives 

to be named as members of the 

coalition, including a description of the 

areas of expertise covered by each; the 

specific roles and responsibilities of 

each in implementing this project; 

methods for making decisions; etc. 

• Memorandum of agreement and 

understanding or letters of support from 

these collaborating organizations as an 

appendix, and the extent to which these 

letters indicate that the applicant and 

the other collaborating organizations 

have established a ‘‘working 

partnership’’ which specifies the active 

roles each will have in the study. 

• Plans for collecting or obtaining and 

analyzing baseline (pre-intervention) 

and follow-up data for the measures of 

effectiveness. 

• A description of the process used in 

selecting the intervention strategies to 

be implemented or sites to be added. 

• A description of proposed methods 

for implementing and evaluating the 

additional intervention strategies or 

sites. 

• Initial plans to rigorously evaluate 

the interventions, including appropriate 

measures of effectiveness. Measures 

should be objective and quantifiable and 

include measures of alcohol-impaired 

driving and/or alcohol-related crashes. 

• Availability of adequate facilities 

and appropriately trained staff to carry 

out this activity. 

• Acknowledgement of potential 

problem areas and plans to consider 

alternative tactics.

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? If new, 

innovative strategies to reduce alcoholimpaired driving are tried, what is the 

rationale for selecting them and the 

likelihood they will succeed? 

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 

principal investigator, co-investigator, 

or subcontractor have extensive 

experience in implementing 

community-based research and 

programs? Does the Principal 

Investigator have the authority to 

manage the project? 

Environment: Does the scientific 

environment in which the work will be 

done contribute to the probability of 

success? Does the proposed 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: 

• Their history and current capacity 

to provide a leadership function in 

convening and facilitating the work of 

the coalition. 

• Their history and current capacity 

to provide a leadership function in the 

implementation and evaluation of the 

selected alcohol-impaired driving 

prevention activity. 

• Their history and current capacity 

to present findings at national 

conferences and prepare peer-reviewed 

manuscripts. 

• Their organizational capacity to 

realize the objectives of the cooperative 

agreement. 

• 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. 

• 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. 

• Resumes, biosketches, and/or 

position descriptions (i.e. for current 

staff, in-kind, and proposed positions to 

be funded under this cooperative 

agreement) should be included as an 

appendix. This should include the use 

of consultants, as appropriate. 

• A continuation plan in the event 

that key staff leave the project, how new 

staff will be smoothly integrated into the 

project, and assurances that resources 

will be available when needed for this 

project. 

• Previous experience of project staff 

to submit required reports on time. 

Additional Review Criteria: In 

addition to the above criteria, the 

following items will be considered in 

the determination of scientific merit and 

priority score: 

• Has the investigator developed an 

adequate plan for disseminating the 

study results? 

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 need 

for IRB submissions early in the grant 

cycle to avoid delays and restrictions on 

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 

Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 67743

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 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 which 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 

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 

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: 

• The results of the primary review 

including the application’s priority 

score as the primary factor in the 

selection process. 

• The relevance and balance of 

proposed research relative to the NCIPC 

programs and priorities. 

• 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.’’

• 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 Dates 

September 1, 2005

VI. Award Administration Information 

VI.1. Award Notices 

Successful applicants will receive a 

Notice of Award (NOA) from the CDC 

Procurement and Grants Office. The 

NOA shall be the only binding, 

authorizing document between the 

recipient and CDC. The NOA 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. 

67744 Federal Register / Vol. 69, No. 223 / Friday, November 19, 2004 / Notices 

• AR–2 Requirements for Inclusion of 

Women and Racial and Ethnic 

Minorities in Research. 

• AR–7 Executive Order 12372. 

• AR–9 Paperwork Reduction Act 

Requirements. 

• AR–10 Smoke-Free Workplace 

Requirements. 

• AR–11 Healthy People 2010. 

• 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. 

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: 

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 Web 

site) 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. Dissemination activities. 

g. 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: 

L.J. David Wallace, MS, Injury 

Prevention Specialist, National Center 

for Injury Prevention and Control, 

Centers for Disease Control and 

Prevention (CDC), 4770 Buford 

Highway, NE., Mailstop K–02, Atlanta, 

GA 30341; Telephone: 770/488–4712, Email: Dwallace2@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; Atlanta, GA 30341; 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; Telephone: 770/488–2736, Email: ZFT2@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.’’

Dated: November 10, 2004. 

William P. Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–25672 Filed 11–18–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

[Document Identifier: CMS–10052 and CMS–

370, 377, 378, R–54] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request

AGENCY: Centers for Medicare and 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare and Medicaid 

Services (CMS) (formerly known as the 

Health Care Financing Administration 

(HCFA), Department of Health and 

Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of currently 

approved collection; Title of 

Information Collection: Recognition of 

Pass-Through Payment for Additional 

(new) Categories of Devices under the 

Outpatient Prospective Payment System 

and Supporting Regulations in 42 CFR 

part 419; Use: Information is necessary 

to determine eligibility of medical 

devices for establishment of additional 

device categories for payment under