Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 64293

4The units shipped total is based on combined 

actual or estimated industry figures across all of the 

product categories, except for fluorescent lamp 

ballasts, lamp products, and plumbing products. 

Staff has determined that, for those product 

categories, there are little or no costs associated 

with the labeling requirements. The fact sheet 

estimation is based on the previously noted 

assumption that five percent of HVAC 

manufacturers produce fact sheets on their own. 

Based on total HVAC units shipped (10,291,965), 

five percent amounts to 514,598 HVAC units. 

Because manufacturers generally list more than one 

unit on a fact sheet, staff has estimated that 

manufacturers independently preparing them will 

use one sheet for every four of these 514,598 units. 

Thus, staff estimates that HVAC manufacturers 

produce approximately 128,650 fact sheets.

products is entered into the catalog. 

This is a conservative assumption 

because the number of incremental 

additions to the catalog from year to 

year is likely to be much lower after 

initial start-up efforts have been 

completed. The total catalog disclosure 

burden for all industries covered by the 

Rule is 2,550 hours (150 sellers x 17 

hours annually). 

Estimated annual cost burden:

($8,353,641 in labor costs and 

$3,519,422 in capital or other non-labor 

costs). 

Labor Costs: Staff derived labor costs 

by applying appropriate estimated 

hourly cost figures to the burden hours 

described above. In calculating the cost 

figures, staff assumes that test 

procedures are conducted by skilled 

technical personnel at an hourly rate of 

$20.00, and that recordkeeping and 

reporting, and labeling, marking, and 

preparation of fact sheets, generally are 

performed by clerical personnel at an 

hourly rate of $10.75. 

Based on the above estimates and 

assumptions, the total annual labor 

costs for the five different categories of 

burden under the Rule, applied to all 

the products covered by it, is $8,353,641 

(rounded to the nearest thousand), 

derived as follows:

Activity Burden hours

per year 

Wage category

hourly rate 

Total annual

labor cost 

Testing .................................................................................................. 360,721 Skilled technical/$20 ..................... $7,214,420 

Reporting .............................................................................................. 1,324 Clerical/$10.75 .............................. 14,233 

Recordkeeping ...................................................................................... 767 Clerical/$10.75 .............................. 8,245 

Labeling, marking, and fact sheet preparation ..................................... 101,333 Clerical/$10.75 .............................. 1,089,330 

Catalog disclosures .............................................................................. 2,550 Clerical/$10.75 .............................. 27,413 

8,353,641 

Capital or Other Non-Labor Costs:

$3,519,000 (rounded), determined as 

follows: 

Staff has examined the five distinct 

burdens imposed by EPCA through the 

Rule—testing, reporting, recordkeeping, 

labeling, and retail catalog disclosures—

as they affect the 11 groups of products 

that the Rule covers. Staff has 

concluded that there are no current 

start-up costs associated with the Rule. 

Manufacturers have in place the capital 

equipment necessary—especially 

equipment to measure energy and/or 

water usage—to comply with the Rule. 

Under this analysis, testing, 

recordkeeping, and retail catalog 

disclosures are activities that incur no 

capital or other non-labor costs. As 

mentioned above, testing has been 

performed in these industries in the 

normal course of business for many 

years as has the associated 

recordkeeping. The same is true 

regarding compliance applicable to the 

requirements for paper catalogs. 

Manufacturers and retailers who make 

required disclosures in catalogs already 

are producing catalogs in the ordinary 

course of their businesses; accordingly, 

capital cost associated with such 

disclosure would be minimal or nil. 

Staff recognizes that there may be initial 

costs associated with posting online 

disclosure, and it invites further 

comment to reasonably quantify such 

costs. 

Manufacturers that submit required 

reports to the Commission directly 

(rather than through trade associations) 

incur some nominal costs for paper and 

postage. Staff estimates that these costs 

do not exceed $2,500. Manufacturers 

must also incur the cost of procuring 

labels and fact sheets used in 

compliance with the Rule. Based on 

estimates of 50,113,098 units shipped 

and 128,650 fact sheets prepared,4 at an 

average cost of seven cents for each 

label or fact sheet, the total (rounded) 

labeling cost is $3,516,922.

William E. Kovacic, 

General Counsel.

[FR Doc. 04–24655 Filed 11–3–04; 8:45 am] 

BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Grants for New Investigator Training 

Awards for Unintentional Injury, 

Violence Related Injury, Injury 

Biomechanics, and Acute Injury Care 

Research 

Announcement Type: New. 

Funding Opportunity Number: CE05–

021. 

Catalog of Federal Domestic 

Assistance Number: 93.136. 

Key Dates:

Letter of Intent (LOI) Deadline:

December 6, 2004. 

Application Deadline: February 2, 

2005. 

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.

Purpose: The Centers for Disease 

Control and Prevention (CDC) 

announces the availability of fiscal year 

(FY) 2005 funds for grants for new 

investigator training awards in four 

research areas: unintentional injury 

prevention, violence-related injury 

prevention, injury-related acute care/

mass trauma research, and injuryrelated biomechanics research. This 

program addresses the ‘‘Healthy People 

2010’’ focus areas of Injury and Violence 

Prevention. 

The purposes of this program are to: 

• Solicit research applications that 

address the priorities reflected under 

the heading, ‘‘Research Objectives’’. 

• Encourage professionals from a 

wide spectrum of disciplines to conduct 

research aimed at preventing and 

controlling injuries more effectively. 

• Support injury research by new 

investigators who are doctoral-level 

graduates and who have not previously 

received injury-related CDC R49 or their 

equivalent grants. 

• Build the scientific base for the 

prevention and control of unintentionaland violence-related injuries, 

disabilities, and deaths. 

64294 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 

• Encourage qualified applicants who 

are beginning to focus on injury-related 

research. 

The career development objectives of 

this program are to encourage scientists 

to develop independent research skills 

and to gain experience in advanced 

methods and experimental approaches 

in injury-related research. This program 

is also intended to jump start the careers 

of researchers in injury prevention and 

control by providing support for pilot 

studies, enhancements to existing 

studies, or other studies that will serve 

as a foundation for a career in injury 

prevention and control. Applicants are 

required to have a mentor with 

extensive injury research experience 

who will assist the applicant with 

scientific and career-related issues 

during the period of the award. 

This program addresses the ‘‘Healthy 

People 2010’’ focus area of Injury and 

Violence Prevention. 

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 (NCIPC): 

• Increase the capacity of injury 

prevention and control programs to 

address the prevention of injuries and 

violence.

• Monitor and detect fatal and nonfatal injuries. 

• Conduct a targeted program of 

research to reduce injury-related death 

and disability. 

Background and Significance 

Unintentional Injury Research 

For the purposes of this program 

announcement, unintentional injuries 

are defined as unintentional damage to 

the body resulting from acute exposure 

to thermal, mechanical, electrical, or 

chemical energy or from the absence of 

such essentials as heat or oxygen. 

Unintentional injuries continue to be 

a major public health problem. In 2000, 

97,900 people died in the United States 

as a result of unintentional injuries. 

Someone dies every six minutes in the 

U.S. from causes such as motor vehicle 

crashes, falls, poisoning, drowning, fires 

and burns, pedestrians struck by 

vehicles, bicycle crashes, or choking 

and suffocation. In addition to deaths, 

injuries also constitute a significant 

cause of both permanent and temporary 

disability. In 2000, unintentional 

injuries resulted in an estimated 29.1 

million emergency department visits 

and millions more seek treatment for 

injuries from health care professionals. 

In addition to the emotional costs of 

injuries, the financial costs of 

unintentional injuries are staggering: 

well over $200 billion a year in medical 

care, wage and productivity losses and 

employer costs alone. Unintentional 

injuries are not accidents, they are 

predictable and they are preventable. 

Violence Related Injury Research 

Deaths and injuries associated with 

interpersonal violence and suicidal 

behavior are also a major public health 

problem in the United States and 

around the world. In 2000, over 46,000 

people died from homicide and suicide 

in the United States. Among 15 to 24 

year olds, homicide and suicide ranked 

as the second and third leading causes 

of death. Violent deaths are the most 

visible consequence of violent behavior 

in our society. Morbidity associated 

with physical and emotional injuries 

and disabilities resulting from violence, 

however, also constitute an enormous 

public health problem. For every 

homicide that occurs each year there are 

over 100 nonfatal injuries resulting from 

interpersonal violence. For every 

completed suicide it is estimated that 

there are 20 to 25 suicide attempts. The 

mortality and morbidity resulting from 

violence are associated with a variety of 

types of violence including child 

maltreatment, youth violence, intimate 

partner violence, sexual violence, elder 

abuse, and self-directed violence or 

suicidal behavior. 

Biomechanics Research 

The field of biomechanics quantifies 

the response and tolerance of the human 

body to impact (e.g., motor vehicle 

collisions, playground falls, and child 

battering) and addresses the underlying 

mechanisms of injury, the forces 

deforming the body and the physiologic 

effects of injury to infants, children, 

adults and the aged population. Based 

on interdisciplinary research, the 

engineering factors are determined that 

deform the body and the medical 

consequences are quantified that affect 

vital functions. This knowledge is used 

to modify the design of protective 

systems to improve safety. Improved 

safety systems protect an individual 

from impact forces that can injure, and 

they can include protective equipment 

(cycling helmets) and environments 

(playground surfaces), occupant 

restraints (airbags and safety belts), and 

policies (rules to minimize spearing in 

football). Biomechanical knowledge can 

also be used to improve post-injury 

outcomes through physiologic models to 

address emergency medical treatments, 

pharmacologic interventions and 

rehabilitation to advance recovery.

NCIPC’s biomechanics program 

attempts to build on the basic 

knowledge of biomechanics and 

encourage interdisciplinary 

intervention-oriented injury control 

research as supported in the CDC Injury 

Research Agenda. 

Acute Injury Care Research 

Each year, Americans make between 

30 and 40 million emergency 

department (ED) visits for injuries. 

While most injured patients are treated 

and released, many are admitted to 

inpatient trauma units and later receive 

rehabilitative services. The most 

favorable outcomes are achieved when 

acute care and subsequent rehabilitation 

are offered as early as possible and focus 

on returning patients to baseline or to an 

optimal level of functioning. Trauma 

systems are designed to match trauma 

patients with the acute care and 

rehabilitative facilities they need, but in 

many parts of the U.S. trauma systems 

are not fully operational or are 

nonexistent. Where these systems are 

lacking, as many as 30 percent to 40 

percent of deaths among trauma patients 

are due to preventable problems in 

clinical care, including missed 

diagnoses and treatment delays. 

Injuries are a major cause of 

disabilities in the U.S. Central nervous 

system injuries (those to the brain and 

spinal cord) are most likely to result in 

serious long-term disability. Each year, 

an estimated 80,000 Americans sustain 

a traumatic brain injury (TBI) that 

results in disability; an estimated 5.3 

million Americans live with TBI-related 

disability. Although physical 

impairments from the injury may 

contribute to TBI disability, cognitive 

deficits are the hallmark, frequently 

resulting in secondary conditions such 

as depression and other adverse 

outcomes such as the inability to work. 

An estimated 177,000 to 200,000 people 

in the U.S. live with spinal cord injuries 

(SCI), and this number increases 

annually by as many as 20,000 

individuals. 

Research Objectives 

Applicants are encouraged to propose 

studies that can feasibly be completed 

within the available funds and funding 

period. Proposed research for this 

program announcement must address 

one of the following research priorities. 

Applications that fail to address one of 

these topics will be deemed 

nonresponsive. 

Unintentional Injury 

1. Develop a theory-based 

intervention for use of supervision of 

children to reduce unintentional injury 

outcomes. 

2. Evaluate existing and develop new 

methods to obtain exposure and injury 

Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 64295

incidence data for sports, exercise and 

recreation-related injuries. 

3. Identify risk and protective factors 

related to injury from childhood falls, 

crashes involving young drivers or 

related to motor vehicle and pedestrian 

travel of older adults. 

4. Evaluate the effectiveness of 

environmental, behavioral, legislative or 

regulatory interventions to prevent 

pedestrian injuries or injuries related to 

sports, exercise, and recreation 

(including drowning). 

5. Assess how tailoring, training, 

packaging, feasibility (and other 

dimensions of an effective intervention 

or policy) would promote greater 

adoption, usability and uptake, 

especially for interventions that impact 

older adult falls injury, transportation 

safety, and sports & recreation injury 

prevention (including drowning). 

6. Evaluate theory-based strategies to 

increase dissemination of effective 

interventions that reduce injuries 

related to transportation, at home, or 

during recreation. 

For more information on the 

unintentional injury research objectives, 

see Attachment 2 of this announcement. 

The attachment is posted along with 

this announcement on the CDC Web 

site: http://www.cdc.gov/ncipc/

ncipchm.htm. 

Violence Related Injury 

1. Conduct studies to build 

knowledge on methods, structures, and 

processes to implement evidence-based 

interventions, programs and policies to 

prevent intimate partner violence, child 

maltreatment and youth violence. This 

research is intended to bridge the gap 

between prevention research and 

everyday practice by building a 

knowledge base about how evidencebased violence prevention information 

and strategies are disseminated, 

translated and integrated for use by 

communities and policymakers.

2. Evaluate the efficacy, effectiveness, 

and cost effectiveness of primary 

prevention interventions, programs, and 

policies to prevent perpetration of 

intimate partner violence, sexual 

violence, child maltreatment (includes 

physical, sexual, emotional abuse and 

neglect), youth violence or suicidal 

behavior. There is particular interest in 

assessing the impact of interventions, 

programs, or policies that may affect 

multiple forms of violence 

simultaneously. 

3. Identify protective factors across at 

least two levels of influence (e.g., 

individual, family, peers, school/

workplace, neighborhood, community) 

that reduce risk for the perpetration of 

intimate partner violence, sexual 

violence, child maltreatment, youth 

violence or suicidal behavior among 

populations at elevated risk for engaging 

in such behaviors. 

Injury Biomechanics 

1. Use biomechanics research and the 

knowledge of injury tolerance and 

injury mechanisms to develop and/or 

evaluate interventions that address the 

following specific injury prevention and 

control problems. An intervention can 

be broadly defined as a specific action, 

policy, device or strategy designed to 

address injury prevention and control: 

a. Falls that occur among older, 

community dwelling adults (e.g., hip 

pads). 

b. Injuries in mass trauma events. 

c. Severe and disabling falls among 

children. 

d. Sports, recreation, and exerciserelated injuries (e.g., playground and 

other play environments, safety gear). 

e. Injuries associated with people 

initiating or increasing physical activity 

(e.g., training programs or protective 

devices). 

f. Injuries related to outdoor 

recreation (e.g., vehicle design). 

g. Motorcycling, bicycling and 

pedestrian injuries (e.g., improved 

helmets or environments). 

h. Injuries to child occupants of motor 

vehicles (e.g., universal fasteners and 

alternative restraint designs). 

i. Injuries to older drivers. 

j. Injuries associated with the effects 

of emerging vehicle technologies. 

2. Identify the biomechanics and 

specific injuries that would be highly 

predictive of diagnoses of intimate 

partner violence and child 

maltreatment, and improve case 

definitions. 

3. Advance the biomechanical 

understanding of traumatic injury (e.g.,

injuries to the brain, spinal cord, thorax/

abdomen, extremities and joints) in 

children and older adults (greater than 

65 years old) including: development of 

biofidelic models to elucidate injury 

physiology as well as pharmacologic, 

surgical, rehabilitation, and other 

interventions; improvement of injury 

assessment technology; impact injury 

mechanisms research; and 

quantification of injury-related 

biomechanical responses for critical 

areas of the human body (e.g., brain and 

vertebral injury with spinal cord 

involvement). 

4. Define the human tolerance limits 

for injury in children and older adults 

(greater than 65 years old), especially 

determining the differences in human 

tolerance by age, fitness level, and 

gender and the biomechanics and injury 

tolerances of tissue, bone, and other 

human structures as a prerequisite for 

developing interventions. 

5. Identify the modifiable risk factors 

for and mechanisms of nonfatal 

whiplash injuries of the neck and back. 

Acute Injury Care 

1. Develop and evaluate protocols that 

provide onsite interventions in acute 

care settings or linkages to off-site 

services for patients at risk of injury or 

psychosocial problems following injury. 

2. Identify methods and strategies to 

ensure that people with traumatic brain 

injuries (TBI) and spinal cord injuries 

(SCI) receive needed services. 

3. Identify the effects on acute injury 

care of inter-jurisdictional, legal, 

governmental, and interdisciplinary 

issues related to mass casualty events. 

4. Identify and evaluate the 

components of trauma systems which 

contribute to improvement in care of the 

injured. 

5. Develop and evaluate new methods 

for linking prehospital databases to 

trauma registries, and other hospital 

databases, including those related to 

subsequent levels of care (e.g.,

rehabilitation).

Approximately $500,000 of the total 

award amount will be reserved to fund 

up to five proposals that address acute 

injury care research. 

Rigorous evaluations are needed to 

determine the effectiveness of 

interventions, programs, and policies 

addressing the prevention of injury. 

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.

For randomized trials, applicants are 

encouraged to clearly state how study 

subjects, whether individuals or groups, 

were selected, randomized, and 

followed through the trial. One relevant 

useful guidance document is Moher D, 

Schulz KF, Altman D, The CONSORT 

Statement, JAMA 2001;285:1987–2001. 

64296 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 

II. Award Information 

Type of Award: Grant. 

Mechanism of Support: R49. 

Fiscal Year Funds: 2005. 

Approximate Total Funding:

$900,000. (This amount is an estimate, 

and is subject to availability of funds.) 

Approximate Number of Awards:

Nine (Up to five of these awards will be 

made in the area of acute care research). 

Approximate Average Award:

$100,000. (This amount includes both 

direct and indirect costs.) 

Floor of Award Range: None. 

Ceiling of Award Range: $100,000. 

(This amount includes both direct and 

indirect costs.) 

Anticipated Award Date: August 30, 

2005. 

Budget Period Length: 12 months. 

Project Period Length: One year. 

Allowable costs include partial salary 

and tuition support for the applicant; 

direct research project expenses, such as 

trainee stipends, interviewer costs, data 

processing, participant incentives, 

statistical consultation services, and 

supplies; and travel to one scientific 

meeting, if adequately justified. 

Applicants should also include travel 

costs for one, two-day trip to CDC in 

Atlanta to present research findings. 

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: 

• Public nonprofit organizations. 

• Private nonprofit organizations. 

• For profit organizations. 

• Small, minority, women-owned 

businesses. 

• Universities. 

• Colleges. 

• Research institutions. 

• 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). 

• Political subdivisions of States (in 

consultation with States). 

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. 

Eligible applicants may enter into 

contracts, including consortia 

agreements, as necessary to meet the 

requirements of the program and 

strengthen the overall application. 

It is especially important that the 

abstract of your grant application 

(Description, PHS 398 form page 2) 

reflects the project’s focus, because the 

abstract will be used to help determine 

the responsiveness of the application. 

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. 

• Grant applications must 

demonstrate an overall match between 

the applicant’s proposed theme and 

research objectives and the program 

priorities as described under the 

heading, ‘‘Research Objectives.’’

• Applications must demonstrate 

effective and well-defined working 

relationships within the performing 

organization and with outside entities, 

which will ensure implementation of 

the proposed activities. 

• 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 

• The principal investigator must 

have a research or a health-professional 

doctorate-level degree from an 

accredited program and have 

demonstrated the capacity or potential 

for highly productive research in the 

period after the doctorate, 

commensurate with level of experience. 

• Applicants who have been the 

principal investigator on an RO1 or 

RO1-equivalent health-related research 

grant or who have had equivalent 

injury-related research support from an 

existing Injury Control Research Center 

(ICRC) are not eligible. Recipients of 

dissertation research grants or NIH 

Small Grant Awards are eligible to 

apply. 

• A principal investigator who has 

specific authority and responsibility to 

carry out the proposed project. 

• The ability of the principal 

investigator to carry out injury control 

research projects as defined under 

Attachment 1 of this program 

announcement. The attachment is 

posted along with this announcement 

on the CDC Web site: http://

www.cdc.gov/ncipc/ncipchm.htm.

Applications, which do not meet the 

above requirements, will be considered 

non-responsive. 

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: 

Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 64297

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: Two. 

• Font Size: 12-point unreduced. 

• Paper Size: 8.5 by 11 inches. 

• Page Margin Size: One inch. 

• Printed only on one side of page.

• Single spaced.

• Written in plain language, avoid 

jargon. 

Your LOI must contain the following 

information: 

• Descriptive title of the proposed 

research. 

• Name, address, e-mail address, and 

telephone number of the Principal 

Investigator. 

• Names of other key personnel. 

• Participating institutions. 

• Number and title of this Program 

Announcement. 

• Brief description of the scope and 

intent of the proposed research work. 

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. 

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. Follow the 

PHS–398 instructions for non-modular 

budget research grant applications. 

An applicant organization has the 

option of having specific salary and 

fringe benefit amounts for individuals 

omitted from the copies of the 

application, which are made available to 

outside reviewing groups. To exercise 

this option: on the original and five 

copies of the application, the applicant 

must use asterisks to indicate those 

individuals for whom salaries and fringe 

benefits are not shown; however, the 

subtotals must still be shown. In 

addition, the applicant must submit an 

additional copy of page 4 of Form PHS–

398, completed in full, with the 

asterisks replaced by the salaries and 

fringe benefits. This budget page will be 

reserved for internal staff use only. 

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: 

• Statement of the problem. 

• Purpose of the proposed research. 

• Methods, including study 

population, data sources and any 

statistical analyses to be performed. 

• 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 be used to accomplish 

the goals? 

• Is the language of the Description 

simple and easy to understand for a 

broad audience? 

You must include a research plan in 

your application. The research plan 

should be no more than 25 pages, 

printed on one side, single spaced, with 

one half-inch margins, and unreduced 

12-point font. The research plan should 

address activities to be conducted over 

the entire project period. Use the 

information in the Research Objectives, 

Administrative and National Policy 

Requirements, and Application Review 

Information sections to develop the 

application content. The research plan 

should include the following 

information:

• The project’s focus, a justification 

for the research proposed, and a 

description of the scientific basis for the 

research. The focus should be based on 

recommendations in ‘‘Healthy People 

2010’’ (http://www.healthypeople.gov) 

and the ‘‘CDC Injury Research Agenda,’’

(http://www.cdc.gov/ncipc/pub-res/

research_agenda/agenda.htm) and 

should seek creative approaches that 

will contribute to a national program for 

injury control. 

• Specific, measurable, and timeframed objectives. 

• A detailed plan describing the 

methods, which will achieve the 

objectives, including their sequence. A 

comprehensive evaluation plan is an 

essential component of the application. 

• A description of the roles and 

responsibilities of the principal 

investigator and the mentor. 

• A description of those activities 

related to, but not supported by, the 

grant. 

• A description of the involvement of 

other entities that will relate to the 

proposed project, if applicable. It should 

include commitments of support and a 

clear statement of their roles. 

• An explanation of how the research 

findings will contribute to the national 

effort to reduce the morbidity, mortality 

and disability caused by injuries within 

three to five years from project start-up. 

Additional materials required: In 

addition to the completed PHS 398 

application form, the applicant must 

also submit the following materials, 

attached to the application as 

appendices: 

• An official transcript of the 

applicant’s graduate school record. 

• A statement describing the 

applicant’s prior research training and 

experience and short and long term 

career goals in injury research, 

including a paragraph describing why 

he or she qualifies as a new investigator. 

• A letter from a senior injury 

researcher acknowledging that he or she 

has read the application and agrees to 

serve as a mentor. The letter should also 

include: (1) An outline of the mentor’s 

specific roles and responsibilities and 

time commitment (percent time); (2) a 

proposed plan for providing scientific 

advice and consultation to the 

applicant; and (3) a two-page biography 

of the mentor. (Use the Biographical 

Sketch page in application form PHS 

398.) 

• A justification for any proposed 

tuition support. 

Additional requirements that may 

require you to submit additional 

documentation with your application 

are listed in section ‘‘VI.2. 

Administrative and National Policy 

Requirements.’’

For additional help in preparing your 

grant application please see the 

‘‘frequently asked questions’’ section on 

the NCIPC Web page at: http://

www.cdc.gov/ncipc/res-opps/

2004pas.htm. 

IV.3. Submission Dates and Times 

LOI Deadline Date: December 6, 2004. 

64298 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 

CDC requests that you send a LOI if 

you intend to apply for this program. 

Although the LOI is not required, not 

binding, and does not enter into the 

review of your subsequent application, 

the LOI will be used to gauge the level 

of interest in this program, and to allow 

CDC to plan the application review. 

Application Deadline Date: February 

2, 2005. 

Explanation of Deadlines:

Applications must be received in the 

CDC Procurement and Grants Office 

(PGO) (not NIH) by 4 p.m. eastern time 

on the deadline date. If you submit your 

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 grant application 

content, submission address, and 

deadline. It supersedes information 

provided in the application instructions. 

If your application does not meet 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 

Executive Order 12372 does not apply 

to this program. 

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 (IRB) approvals are in 

place. 

• Grant funds will not be made 

available to support the provision of 

direct care. 

• Eligible applicants may enter into 

contracts, including consortia 

agreements, as necessary to meet the 

requirements of the program and 

strengthen the overall application. 

• Allowable costs include partial 

salary and tuition support for the 

applicant; direct research project 

expenses, such as trainee stipends, 

interviewer costs, data processing, 

participant incentives, statistical 

consultation services, and supplies; and 

travel to one scientific meeting, if 

adequately justified. 

• Applicants should also include 

travel costs for one, two-day trip to CDC 

in Atlanta to present research findings. 

• Funds for tuition support are 

limited to no more than 20 percent of 

the overall award and their use must be 

generally related to the content and 

methods of the proposed research. 

• Indirect costs for this trainee-related 

grant are limited to eight percent. 

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: NCIPC Extramural 

Resources Team, Centers for Disease 

Control and Prevention, 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—CE05–021, 

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: NCIPC Extramural Resources 

Team, CDC, National Center for Injury 

Prevention and Control. 

Address for Express Mail or Delivery 

Service: 2945 Flowers Road, Yale 

Building, Room 2054, Atlanta, Georgia 

30341. 

Address for U.S. Postal Service Mail: 

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 

grant. 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 improve the control and 

prevention of disease and injury and to 

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? 

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? Does 

the project include plans to measure 

progress toward achieving the stated 

objectives? Is there an appropriate work 

plan included? 

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)? Is there a 

Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 64299

prior history of conducting injuryrelated research? 

Environment: Does the scientific 

environment in which the work will be 

done contribute to the probability of 

success? Do the proposed experiments 

take advantage of unique features of the 

scientific environment or employ useful 

collaborative arrangements? Is there 

evidence of institutional support? Is 

there an appropriate degree of 

commitment and cooperation of other 

interested parties as evidenced by letters 

detailing the nature and extent of the 

involvement? 

Additional Review Criteria: In 

addition to the above criteria, the 

following items will be considered in 

the determination of scientific merit and 

priority score: 

Dissemination: What plans have been 

articulated for disseminating findings? 

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. 

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 PGO and for 

responsiveness by NCIPC. 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 

panel convened by the NCIPC in 

accordance with the review criteria 

listed above. As part of the initial merit 

review, all applications will: 

• 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. 

The primary review will be a peer 

review conducted by NCIPC Initial 

Review Group (IRG). Applications may 

be subjected to a preliminary evaluation 

(streamline review) by the IRG to 

determine if the application is of 

sufficient technical and scientific merit 

to warrant further review. NCIPC 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. Those applications judged 

to be competitive will be further 

evaluated by the IRG. These 

applications will be reviewed for 

scientific merit using current NIH 

criteria (a scoring system of 100–500 

points) to evaluate the methods and 

scientific quality of the application. 

The secondary review will be 

conducted by the Science and Program 

Review Subcommittee (SPRS) of the 

Advisory Committee for Injury 

Prevention and Control (ACIPC). The 

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 will 

be the same as those considered by the 

SPRS. 

The ACIPC committee’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 federallyfunded research does not occur. The 

secondary review committee 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 ‘‘CDC Injury Research Agenda.’’ (See

Attachment 1, Resource Materials.) The 

attachment is posted along with this 

announcement on the CDC Web site: 

http://www.cdc.gov/ncipc/

ncipchm.htm). 

• Budgetary considerations. 

All awards will be determined by the 

Director of the NCIPC based on priority 

scores assigned to applications by the 

primary review committee IRG, 

recommendations by the secondary 

review committee of the Science and 

Program Review Subcommittee of the 

ACIPC, consultation with NCIPC senior 

staff, and the availability of funds. 

Award Criteria: Criteria that will be 

used to make award decisions during 

the programmatic review include: 

64300 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Notices 

• Scientific merit (as determined by 

peer review). 

• Availability of funds. 

• Programmatic priorities. 

V.3. Anticipated Announcement and 

Award Dates 

August 30, 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–3 Animal Subjects 

Requirements. 

• 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–21 Small, Minority, and 

Women-Owned Business. 

• AR–22 Research Integrity.

Additional information on AR–1 

through AR–22 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, 2003 

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 

toward 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: 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. Financial status report, no more 

than 90 days after the end of the budget 

period. 

2. The final performance report, no 

more than 90 days after the end of the 

project period. The final performance 

report will be a brief summary (2,500 to 

4,000 words in length) written in nonscientific [laymen’s] terms. The report 

should highlight the findings and their 

implications for injury prevention 

programs, policies, environmental 

changes, etc. The grant recipient will 

also include a description of the 

dissemination plan for research 

findings. This plan will include 

publications in peer-reviewed journals 

and ways in which research findings 

will be made available to stakeholders 

outside of academia (e.g., State injury 

prevention program staff, community 

groups, public health injury prevention 

practitioners, and others). CDC will 

place the summary report and each 

grant recipient’s final report with the 

National Technical Information Service 

(NTIS) to further the agency’s efforts to 

make the information more available 

and accessible to the public. 

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: 

Paul Smutz, Ph.D, Project Officer, 

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) 488–1508, 

E-mail: wsmutz1@cdc.gov. 

For questions about peer review, 

contact: Gwendolyn Cattledge, Ph.D, 

Scientific Review Administrator, 

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: Pamela 

Render, Grants Management Specialist, 

CDC Procurement and Grants Office, 

2920 Brandywine Road, Atlanta, GA 

30341, Telephone: (770) 488–2712, Email: PLR3@cdc.gov. 

VIII. Other Information 

This and other CDC funding 

opportunity announcements can be 

found on the CDC Web site, Internet 

address: http://www.cdc.gov. Click on 

‘‘Funding’’ then ‘‘Grants and 

Cooperative Agreements.’’

William P. Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–24616 Filed 11–3–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Grants for Traumatic Injury 

Biomechanics Research 

Announcement Type: New. 

Funding Opportunity Number: CE05–

023. 

Catalog of Federal Domestic 

Assistance Number: 93.136.