Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62701

• AR–13 Prohibition on Use of CDC 

Funds for Certain Gun Control 

Activities 

• AR–14 Accounting System 

Requirements 

• AR–15 Proof of Non-Profit Status 

• AR–21 Small, Minority, and 

Women-Owned Business 

• AR–22 Research Integrity 

• AR–23 States and Faith-Based 

Organizations 

• AR–24 Health Insurance Portability 

and Accountability Act Requirements

Additional information on AR–1 

through AR–24 can be found on the 

CDC Web site.

• 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. For this 

proposal, those applicants requesting 

≥$450,000 will be required to write a 

brief paragraph describing their data 

sharing/release plan or justification as to 

why they will not be sharing their data. 

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 Web site.

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. 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 after the end 

of the project period. 

4. At the completion of the project, 

the grant recipient will submit a brief 

(2500 to 5000 words) summary 

highlighting the findings and their 

implications for injury prevention 

programs, policies, etc., that includes a 

plan for dissemination of the research 

findings. The dissemination plan will 

include publications in peer-reviewed 

journals and other methodologies for 

sharing results with stakeholders 

outside of academic settings (e.g., state 

and community groups, public health 

injury prevention practitioners). 

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:

Jennifer Wyatt, Ph.D., Extramural 

Program Official, National Center for 

Injury Prevention and Control, Centers 

for Disease Control and Prevention 

(CDC), 4770 Buford Highway, NE., 

Mailstop K–60; Telephone: 770–488–

4058, E-mail: ANU1@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; 

Telephone: 770–488–1430, E-mail: 

gxc8@cdc.gov.

For financial, grants management, or 

budget assistance, contact: Nancy Pillar, 

Grants Management Specialist, CDC 

Procurement and Grants Office, 2920 

Brandywine Road, Atlanta, GA 30341, 

E-mail: Nfp6@cdc.gov.

VIII. Other Information 

This and other CDC funding 

opportunity announcements can be 

found on the CDC Web site. Click on 

‘‘Funding’’ then ‘‘Grants and 

Cooperative Agreements.’’

Dated: October 20, 2004. 

William P. Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–24026 Filed 10–26–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Research Grants To Prevent 

Unintentional Injuries 

Announcement Type: New. 

Funding Opportunity Number: CE05–

022. 

Catalog of Federal Domestic 

Assistance Number: 93.136. 

Key Dates:

Letter of Intent Deadline: November 

26, 2004. 

Application Deadline: January 25, 

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 purposes of the program 

are to: 

• Solicit research applications that 

address the priorities reflected under 

the heading, ‘‘Research Objectives’’. 

• Build the scientific base for the 

prevention and control of fatal and 

nonfatal injuries and related disabilities. 

• Encourage professionals from a 

wide spectrum of disciplines of 

epidemiology, behavioral and social 

sciences, medicine, biostatistics, public 

health, law, criminal justice, and 

engineering to perform research in order 

to prevent and control injuries more 

effectively. 

• Encourage investigators to propose 

research that: involves intervention 

development and testing as well as 

research on methods; enhances the 

adoption and maintenance of effective 

intervention strategies among 

individuals, organizations, or 

communities. 

62702 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

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. 

Research Objectives: NCIPC is 

soliciting investigator-initiated research 

that will help expand and advance our 

understanding of what works to prevent 

unintentional injuries. The following 

research themes are the focus of this 

solicitation: (Applications that fail to 

address one of these six research 

objectives will be considered nonresponsive.) 

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 

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 these 

research objectives, see Attachment 2 of 

this announcement. The attachment is 

posted along with this announcement 

on the CDC website: http://

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

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. 

II. Award Information 

Type of Award: Grant. 

Mechanism of Support: R49. 

Fiscal Year Funds: 2005. 

Approximate Total Funding: $600,000 

(This amount is an estimate, and is 

subject to availability of funds). 

Approximate Number of Awards:

Two. 

Approximate Average Award:

$300,000 (This amount is for the first 

12-month budget period and includes 

both direct and indirect costs. 

Approximately $900,000 is expected to 

be available over the three-year project 

period). 

Floor of Award Range: None. 

Ceiling of Award Range: $300,000 

(This amount is for the first 12-month 

budget period and includes both direct 

and indirect costs. Approximately 

$900,000 is expected to be available 

over the three-year project period). 

Anticipated Award Date: August 30, 

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. 

Consideration will also be given to 

current grantees that submit a 

competitive supplement application 

requesting one year of funding to 

enhance or expand existing projects, or 

to conduct one-year pilot studies. These 

awards will not exceed $150,000, 

including both direct and indirect costs. 

Supplemental awards will be made for 

the budget period to coincide with the 

actual budget period of the grant and are 

based on the availability of funds. 

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 Marianas 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. 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62703

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 nonresponsive 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:

• A principal investigator who has 

conducted injury prevention and 

control research, published the findings 

in a peer-reviewed journal, and 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 with this announcement on the 

CDC website: 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 website, 

at the following Internet address: 

www.cdc.gov/od/pgo/forminfo.htm.

Forms and instructions are also 

available in an interactive format on the 

National Institutes of Health (NIH) 

website 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: 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, email 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 www.dunandbradstreet.com or 

call 1–866–705–5711. For more 

information, see the CDC website 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? 

62704 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

• 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 margin, 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 principal 

investigator’s role and responsibilities. 

• 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 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 webpage at: http://

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

2004pas.htm.

IV.3. Submission Dates and Times 

LOI Deadline Date: November 26, 

2004. 

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: January 

25, 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. 

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—CE05–022, 

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. 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62705

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 

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 

62706 Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 

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. 

Competing supplemental grant 

awards may be made, when funds are 

available, to support research work or 

activities not previously approved by 

the IRG. Applications should be clearly 

labeled to denote their status as 

requesting supplemental funding 

support. These applications will be 

reviewed by the IRG and the secondary 

review group. 

Continued Funding 

Continuation awards made after FY 

2005, but within the project period, will 

be made on the basis of the availability 

of funds and the following criteria: 

• The accomplishments reflected in 

the progress report of the continuation 

application indicate that the applicant is 

meeting previously stated objectives or 

milestones contained in the project’s 

annual work plan and satisfactory 

progress is being demonstrated through 

presentations at work-in-progress 

monitoring workshops (travel expenses 

for this annual one-day meeting should 

be included in the applicant’s proposed 

budget). 

• The objectives for the new budget 

period are realistic, specific, and 

measurable.

• The methods described will clearly 

lead to achievement of these objectives. 

• The evaluation plan will allow 

management to monitor whether the 

methods are effective. 

• The budget request is clearly 

explained, adequately justified, 

reasonable and consistent with the 

intended use of grant 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. 

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 website 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. Interim progress report, (use form 

PHS 2590, OMB Number 0925–0001, 

rev. 5/2001 as posted on the CDC 

website) no less than 90 days before the 

end of the budget period. The progress 

report will serve as your non-competing 

continuation application, and must 

contain the following elements: 

a. Current Budget Period Activities 

Objectives. 

b. Current Budget Period Financial 

Progress. 

Federal Register / Vol. 69, No. 207 / Wednesday, October 27, 2004 / Notices 62707

c. New Budget Period Program 

Proposed Activity Objectives. 

d. Budget. 

e. Measures of Effectiveness. 

f. Additional Requested Information. 

2. Financial status report, no more 

than 90 days after the end of the budget 

period. 

3. Final financial and performance 

reports, no more than 90 days after the 

end of the project period. 

4. At the completion of the project, 

the grant recipient will submit a brief 

summary 2,500 to 4,000 words written 

in non-scientific [laymen’s] terms. The 

narrative 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, 

Telephone: 770–488–1508, E-mail: 

wsmutz@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, 

Telephone: 770–488–1430, E-mail: 

gxc8@cdc.gov.

For financial, grants management, or 

budget assistance, contact: Nancy Pillar, 

Grants Management Specialist, CDC 

Procurement and Grants Office, 2920 

Brandywine Road, Atlanta, GA 30341, 

Telephone: 770/488–2721, E-mail: 

NFP6@cdc.gov.

VIII. Other Information 

This and other CDC funding 

opportunity announcements can be 

found on the CDC website, Internet 

address: www.cdc.gov. Click on 

‘‘Funding’’ then ‘‘Grants and 

Cooperative Agreements.’’

Dated: October 21, 2004. 

William P. Nichols, 

Acting Director, Procurement and Grants 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–24025 Filed 10–26–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Infectious Disease 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following committee 

meeting.

Name: Board of Scientific Counselors, 

National Center for Infectious Diseases 

(NCID). 

Times and Dates: 9 a.m.—5:30 p.m., 

December 9, 2004. 8:30 a.m.–2 p.m., 

December 10, 2004. 

Place: CDC, Auditorium B, Building 1, 

1600 Clifton Road, Atlanta, Georgia 30333. 

Status: Open to the public, limited only by 

the space available. 

Purpose: The Board of Scientific 

Counselors, NCID, provides advice and 

guidance to the Director, CDC, and Director, 

NCID, in the following areas: program goals 

and objectives; strategies; program 

organization and resources for infectious 

disease prevention and control; and program 

priorities. 

Matters To Be Discussed: Agenda items 

will include: 

1. Opening Session: NCID Update 

2. Futures Initiative Update 

3. Environmental Microbiology 

4. IT Consolidations/Bioinformatics Center 

5. Veterinary-Human Public Health Interface 

6. Global Disease Detection Initiative 

7. Topic Updates 

a. Influenza 

b. Pneumococcal Disease 

c. Genetics Initiatives 

8. Board meets with Director, CDC

Other agenda items include 

announcements/introductions; followup on actions recommended by the 

Board May 2004; consideration of future 

directions, goals, and recommendations. 

Agenda items are subject to change as 

priorities dictate. 

Written comments are welcome and 

should be received by the contact 

person listed below prior to the opening 

of the meeting. 

For Further Information Contact:

Tony Johnson, Office of the Director, 

NCID, CDC, Mailstop E–51, 1600 Clifton 

Road, NEO, Atlanta, Georgia 30333,

e-mail tjohnson3@cdc.gov; telephone 

404/498–3249. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry.

Dated: October 20, 2004. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention.

[FR Doc. 04–24024 Filed 10–26–04; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy.

Name of Committee: National Cancer 

Institute Initial Review Group. Subcommittee 

A—Cancer Centers. 

Date: December 10, 2004. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Conference Centers, 5701 

Marinelli Road, North Bethesda, MD 20852. 

Contact Person: David E. Maslow, PhD., 

Scientific Review Administrator, Resources 

and Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Blvd., Room 8117, 

Bethesda, MD 20892–7405, (301) 496–2330.