[Federal Register Volume 68, Number 229 (Friday, November 28, 2003)]
[Notices]
[Pages 66834-66839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29634]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Community Trial to Test the Effectiveness of the Smoke Alarm 
Installation and Fire Safety Education (SAIFE) Program

    Announcement Type: New.
    Funding Opportunity Number: 04058.
    Catalog of Federal Domestic Assistance Number: 93.136.
    Key Dates:
    Letter of Intent Deadline: December 29, 2003.
    Application Deadline: February 17, 2004.

I. Funding Opportunity Description

    Authority: This program is authorized under section 317 and 391 
of the Public Health Service Act (42 U.S.C. 247b and 280b), as 
amended.

Purpose

    The purpose of this program is to evaluate strategies to reduce the 
number of residential fire-related injuries and fatalities in high-risk 
communities.
    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 goals for the National Center for 
Injury Prevention and Control (NCIPC):
    1. Increase the capacity of injury prevention and control programs 
to address the prevention of injuries and violence.
    2. Monitor and detect fatal and non-fatal injuries.
    3. Conduct a targeted program of research to reduce injury-related 
death and disability.

Research Objectives

    The objective of this cooperative agreement is to rigorously 
evaluate strategies to reduce the number of residential fire-related 
injuries and fatalities in high-risk communities. Smoke alarms have 
proven effective in reducing the fire death and injury toll. Research 
shows that functioning smoke alarms are more likely to be present in a 
home when a fire safety program provides and installs them, rather than 
simply providing vouchers and/or discounts to individuals to obtain 
alarms that require resident installation. There are CDC programs 
currently being funded by PA 01076 in 16 states that provide for home 
installation of smoke alarms plus general fire safety education in 
households at high risk for fire, fire-related injury, and death. 
Programs of this type seem reasonable, but have not been studied 
scientifically to assess their impact on fire-related injury outcomes. 
This study will assess, through a community trial, the effectiveness of 
the program operating prospectively in multiple communities in one 
state.

Activities

    Awardee activities for this program are as follows:
    (a) Develop and implement a community trial to test the 
effectiveness of the smoke alarm installation and fire safety education 
(SAIFE) Program Announcement 01076 (intervention). Each year a minimum 
of three different communities having the capacity and willingness to 
implement smoke alarm installation combined with fire safety education 
for one year (intervention communities) will participate; and three 
comparison communities will not receive the intervention (control 
communities). Control communities should not become intervention 
communities in subsequent years to

[[Page 66835]]

ensure research findings are not contaminated during follow-up. At 
least nine intervention and nine control communities must be enrolled 
over three years. Program activities at the intervention sites are 
funded by program announcement 01076, and should be used for these 
sites only. Additionally, in order to test for the effectiveness of the 
intervention accurately, intervention and control communities must not 
have previously received funding from CDC or United States Fire 
Administration (USFA) for residential fire-related injury prevention 
programs. Non-intensive, relatively small awards, such as funding for 
equipment or education only programs, will not disqualify a community.
    (b) Study sites must target vulnerable populations (e.g., children 
under five, adults age 65 and older, persons with low social economic 
status) and include each year at least one urban, one suburban, and one 
rural community. All communities should have a population of 
approximately 50,000. These may be counties, cities, or neighborhoods. 
All communities should demonstrate fire incidence rates above the 
national average.
    (c) Control communities should be matched on urban/suburban/rural 
status, type(s) of vulnerable populations, and approximate population 
size.
    (d) Intervention communities will receive the smoke alarm 
installation and fire safety education program funded by program 
announcement 01076. Therefore, the intervention should facilitate the 
acquisition, distribution and proper installation of long-lasting, 
lithium-powered smoke alarms and fire safety education for targeted 
communities through the collaborative efforts of fire safety personnel 
and/or community workers.
    (e) In partnership and collaboration with an academic or research 
institution, develop a community trial study design with intervention 
and control communities (as described above). Follow-up assessments for 
each intervention community should include assessment of the continued 
presence and functionality of intervention-installed smoke alarms. 
Outcomes to be measured in both intervention and control communities 
should include a comparison of pre- and post-intervention residents' 
knowledge, attitudes, beliefs, and behaviors; fire incidence, injuries, 
and deaths. Follow-up on injuries and deaths will require partnering 
with local hospitals. Depending upon when communities enter the study, 
some communities will have longer follow-up periods than others.
    (f) The research team, including a research project coordinator, 
should provide oversight for the research activities to each community 
selected. Year one will address design and preparation issues, 
including the development of materials for Institutional Review Board 
(IRB). Years two through four will emphasize implementation of 
intervention and control community activities including data 
collection. Year five will include final months of follow-up activities 
and data analysis.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
    (a) Partner in a substantial way in all activities, especially with 
regard to understanding best practices and evidence that can be applied 
to intervention design for fire prevention.
    (b) Provide technical consultation and advice through routine 
meetings and conference calls with the awardee and any local partners 
on all aspects of intervention design, methods, analysis planning, and 
other recipient activities.
    (c) Provide up-to-date scientific information about fire-related 
injuries on a national scope and with respect to specific regions and 
population groups.
    (d) Partner and collaborate with the awardee in development and 
refinement of the intervention.
    (e) Partner in developing a research protocol for annual IRB review 
by all cooperating institutions participating in the research study. 
The CDC IRB will review and approve the protocol initially and on at 
least an annual basis until the research study is completed.
    (f) Ensure human subjects assurances are in place and in effect.
    (g) Monitor and evaluate the scientific and operational 
accomplishments of the project. This will be accomplished through 
periodic site visits, telephone calls, electronic communication, 
technical and data reports and interim data analyses.
    (h) Facilitate collaborative efforts to compile and disseminate 
research results through presentations at scientific conferences and 
publications in peer-reviewed public health journals.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities Section 
above.
    Fiscal Year Funds: FY 2004.
    Approximate Total Funding: $250,000.
    Approximate Number of Awards: One.
    Approximate Average Award: $250,000.
    Floor of Award Range: $250,000.
    Ceiling of Award Range: $250,000.
    Anticipated Award Date: September 1, 2004.
    Budget Period Length: 12 months.
    Project Period Length: Five 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. With satisfactory progress on this 
community trial, funding for program activities (program announcement 
01076) is expected to continue so that this community trial can be 
completed.

III. Eligibility Information

1. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for profit organizations and by governments and their agencies, such 
as:
    [sbull] Public nonprofit organizations.
    [sbull] Private nonprofit organizations.
    [sbull] For profit organizations.
    [sbull] Small, minority, women-owned businesses.
    [sbull] Universities.
    [sbull] Colleges.
    [sbull] Research institutions.
    [sbull] Hospitals.
    [sbull] Community-based organizations (including faith-based 
organizations).
    [sbull] 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)
    [sbull] 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 as a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.

2. Cost Sharing or Matching

    Matching funds are not required for this program.

[[Page 66836]]

3. Other Eligibility Requirements

    If your application is incomplete or non-responsive to the 
requirements listed below, it will not be entered into the review 
process. You will be notified that your application did not meet the 
submission requirements.
    1. The applicant (or team) must provide evidence of prior 
experience in designing, implementing, and evaluating community-based 
programs, including evaluation of knowledge, attitudes, beliefs, and 
behaviors; evidence of prior experience with implementing rigorous 
experimental studies; and/or experience with accessing and linking 
appropriate community level data with clinical, medical, and fire data. 
The applicant must include documentation of this experience such as 
publications from peer-reviewed journals.
    2. The applicant must provide evidence of effective and well-
defined collaborative relationships needed to ensure the implementation 
of the proposed activities. The collaboration must include at least a 
State Health Department (to provide leadership regarding local public 
health priorities), academic or research institution (to provide 
scientific and methodological expertise), fire prevention agencies (to 
provide guidance in community implementation activities), and local 
hospitals for follow-up of medical outcomes. The applicant must include 
letters of support that describe the specific commitments and 
responsibilities that will be undertaken by the collaborating 
organizations.
    3. The applicant must be funded currently by CDC Program 
Announcement 01076 to perform community-based smoke alarm installation 
and fire safety education activities, and their project period does not 
need to extend through the period of this community trial.
    4. Requested funding amount should not be greater than the ceiling 
of the award range.
    5. Principal investigators (PI's) 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 PI will be funded under this announcement.

    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.

IV. Application and Submission Information

1. Address To Request Application Package

    To apply for this funding opportunity, use application form PHS 398 
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm. Forms and 
instructions are also available in an interactive format on the 
National Institutes of Health (NIH) Web site at the following Internet 
address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

2. Content and Form of Application Submission

Letter of Intent (LOI)
    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, your LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review. Your LOI must be written in the 
following format:
    [sbull] Maximum number of pages: 2.
    [sbull] Font size: 12-point unreduced.
    [sbull] Paper size: 8.5 by 11 inches.
    [sbull] Single spaced.
    [sbull] Page margin size: one inch.
    [sbull] Printed only on one side of page.
    [sbull] Written in English, avoid jargon.
    Your LOI must contain the following information:
    [sbull] Descriptive title of the proposed research.
    [sbull] Name, address, E-mail address, and telephone number of the 
Principal Investigator.
    [sbull] Names of other key personnel.
    [sbull] Participating institutions.
    [sbull] Number and title of this Program Announcement (PA).
Application
    Follow the PHS 398 application instructions for content and 
formatting of your application. For further assistance with the PHS 398 
application form, contact GrantsInfo, Telephone (301) 435-0714, e-mail: 
[email protected].
    Your research plan should address activities to be conducted over 
the entire project period.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government. Your DUNS number must be entered 
in item 11 of the face page of the PHS 398 application form. The DUNS 
number is a nine-digit identification number, which uniquely identifies 
business entities. Obtaining a DUNS number is easy and there is no 
charge. To obtain a DUNS number, access www.dunandbradstreet.com or 
call 1-866-705-5711. For more information, see the CDC Web site at 
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.

3. Submission Dates and Times

    LOI Deadline Date: December 29, 2003.
    Application Deadline Date: February 17, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. eastern time on the deadline 
date. If you send your application by the United States Postal Service 
or commercial delivery service, you must ensure that the carrier will 
be able to guarantee delivery of the application by the closing date 
and time. If CDC receives your application after closing due to: (1) 
Carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the application as having 
been received by the deadline.
    This announcement is the definitive guide on application 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 application. If you 
have a question about the receipt of your application, first contact 
your courier. If you still have a question, contact the PGO-TIM staff 
at: 770-488-2700. Before calling, please wait two to three days after 
the application deadline. This will allow time for applications to be 
processed and logged.

[[Page 66837]]

4. Intergovernmental Review

    Executive Order 12372 does not apply to this program.

5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows: None
    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 must be less than 12 
months of age.

6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
mail, delivery service, fax or e-mail to: Robin Forbes, Centers for 
Disease Control and Prevention, National Center for Injury Prevention 
and Control, 4770 Buford Hwy., NE., Mailstop K-62, Atlanta, GA 30341, 
Fax: 770-488-1662, Telephone: 770-488-4037, E-mail: [email protected].
    Application Submission Address: Submit the signed original and five 
copies of your application by mail or express delivery service to: 
Technical Information Management--PA 04058, Procurement and 
Grants Office, Centers for Disease Control and Prevention, 2920 
Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

1. Criteria

    You are required to provide measures of effectiveness that will 
demonstrate the accomplishment of the various identified objectives of 
the cooperative agreement. Measures of effectiveness must relate to the 
performance goals stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative, and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease, and 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 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 it's nature is not innovative, but is essential 
to move a field forward.
    The 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 describe the specific questions 
this research is intended to address? Does the applicant describe the 
hypotheses to be tested, the specific study goals, measurable 
objectives, and outcomes? 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? Does 
the applicant provide a detailed time-line for the first year of the 
study as well as a projected time-line for the subsequent four years?
    Has the applicant clearly described how intervention and comparison 
communities will be selected?
    Is there a statement as to whether the plans for recruitment and 
outreach for study participants include the process of establishing 
partnerships with communities and recognition of mutual benefits? Is 
there evidence of effective working relationships between the applicant 
and community organizations? Does the applicant describe experience in 
developing community partnerships and the community's current and 
anticipated capacity to carry out the proposed activities? Is there 
evidence that the applicant is successfully reaching communities and 
households under Program Announcement 01076?
    Are there adequate plans for data collection and data management 
including security of data, assurance of participant confidentially, 
data entry, editing, and quality assurance procedures? Is there a 
statistical analysis plan appropriate for the study design?
    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? 
Is there a prior history of implementing injury-related research? Does 
the applicant document capacity to accomplish the proposed study as 
demonstrated by relevant past or current injury prevention studies and 
smoke alarm program activities?
    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? Does the applicant 
describe the personnel and study collaborators needed to accomplish the 
proposed activities? Does the applicant provide evidence that the study 
personnel have the expertise and capacity to accomplish the proposed 
activities and to provide appropriate scientific oversight necessary to 
fulfill study goals and objectives?
    Is there an appropriate degree of commitment and cooperation of 
other interested parties as evidenced by letters detailing the nature 
and extent of their involvement? Is there evidence of the experience 
and capacity for all key staff members including Curriculum Vitaes and 
position descriptions?
    Is there a continuation plan in the event that key staff leave the 
project? How will new staff be integrated smoothly into the project, 
and what assurances are there that resources will be available when 
needed for this project?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    Study Samples: Are the samples rigorously defined to permit 
complete independent replication at another site? Have the referral 
sources been described, including the definitions and criteria? What 
plans have been made to include women and minorities and their 
subgroups as appropriate for the scientific goals of the research? How 
will the applicant deal with recruitment and retention of subjects?
    Dissemination: What plans have been articulated for sharing the 
research findings?
    Measures of Effectiveness: Applicants are required to provide 
measures of effectiveness that will demonstrate the accomplishment of 
the various identified objectives of the cooperative

[[Page 66838]]

agreement. Measures must be objective and quantitative and must measure 
the intended outcomes. These measures of effectiveness will be 
submitted with the application and will be an element of evaluation. 
The Special Emphasis Panel shall assure that measures set forth in the 
application are in accordance with CDC's performance plans. How 
adequately has the applicant addressed these measures?
    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 woman, 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.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) and for responsiveness by the NCIPC. Incomplete 
applications and applications that are non-responsive will not advance 
through the review process. You will be notified that you did not meet 
submission requirements.
    Applications that are complete and responsive to the Program 
Announcement will be evaluated for scientific and technical merit by an 
appropriate peer review group convened by the NCIPC in accordance with 
the review criteria listed above. As part of the initial merit review, 
all applications will:
    [sbull] Undergo a process in which only those applications deemed 
to have the highest scientific merit, generally the top half of the 
applications under review, will be discussed and assigned a priority 
score.
    [sbull] Receive a written critique.
    [sbull] Receive a second level review by the Science and Program 
Review Section (SPRS) of the Advisory Committee for Injury Prevention 
and Control (ACIPC).
    Applications which are complete and responsive may be subjected to 
a preliminary evaluation (streamline review) by a peer review 
committee, the NCIPC Initial Review Group (IRG), to determine if the 
application is of sufficient technical and scientific merit to warrant 
further review by the IRG. CDC will withdraw from further consideration 
applications judged to be noncompetitive and promptly notify the 
principal investigator/program director and the official signing for 
the applicant organization. Those applications judged to be competitive 
will be further evaluated by a dual review process.
    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 
SPRS of the ACIPC, consultation with NCIPC senior staff, and the 
availability of funds.
    The primary review will be a peer review conducted by the IRG. All 
applications will be reviewed for scientific merit using current 
National Institutes of Health (NIH) criteria (a scoring system of 100-
500 points) to evaluate the methods and scientific quality of the 
application.
    The secondary review will be conducted by the SPRS of the 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 over 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 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 federally-funded 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:
    a. The results of the primary review including the application's 
priority score as the primary factor in the selection process.
    b. The relevance and balance of proposed research relative to the 
NCIPC programs and priorities.
    c. The significance of the proposed activities in relation to the 
priorities and objectives stated in ``Healthy People 2010'' (http://www.healthypeople.gov/), the Institute of Medicine report, ``Reducing 
the Burden of Injury,'' and the ``CDC Injury Research Agenda'' (http://www.cdc.gov/ncipc/pub-res/research_agenda).
    d. Budgetary considerations.

VI. Award Administration Information

1. Award Notices

    Successful applicant 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 (GMO), and 
mailed to the recipient fiscal officer identified in the application.

2. Administrative and National Policy Requirements

45 CFR Part 74 and 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: http://

[[Page 66839]]

www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:

[sbull] AR-1 Human Subjects Requirements
[sbull] AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
[sbull] AR-8 Public Health System Reporting Requirements
[sbull] AR-9 Paperwork Reduction Act Requirements
[sbull] AR-10 Smoke-Free Workplace Requirements
[sbull] AR-11 Healthy People 2010
[sbull] AR-12 Lobbying Restrictions
[sbull] AR-14 Accounting System Requirements
[sbull] AR-15 Proof of Non-Profit Status
[sbull] AR-16 Security Clearance Requirement
[sbull] AR-21 Small, Minority, and Women-Owned Business
[sbull] AR-22 Research Integrity
[sbull] AR-23 States and Faith-Based Organizations
[sbull] AR-24 Health Insurance Portability and Accountability Act 
Requirements
[sbull] AR-25 Release and Sharing of Data

    Starting with the December 1, 2003, receipt date, all NCIPC funded 
investigators seeking more than $500,000 in total costs in a single 
year are expected 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/release, including the timeliness and 
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/release may also be appropriate in 
other sections of the application (e.g., background and significance, 
human subjects requirements, etc.) The content of the data sharing/
release plan will vary, depending on the data being collected and how 
the investigator is planning to share the data. The data sharing/
release plan will not count towards the application page limit and will 
not factor into the determination scientific merit or priority scores. 
Investigators should seek guidance from their institutions, on issues 
related to institutional policies, 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 visiting the NCIPC Internet Web site at http://www.cdc.gov/ncipc/osp/sharing_policy.htm.
    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

3. Reporting

    You must provide CDC with an original, plus two copies of the 
following reports:
    1. Interim progress report, (PHS 2590, OMB Number 0925-0001, rev. 
5/2001) 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. Detailed Line-Item Budget and Justification.
    e. 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.

VII. Agency Contacts

    For general questions about this announcement, contact: Technical 
Information Management Section--PA04058, Procurement and 
Grants Office, Centers for Disease Control and Prevention, 2920 
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
    For scientific/research program technical assistance, contact: Mick 
Ballesteros, PhD, Project Officer, Division of Unintentional Injury 
Prevention, National Center for Injury Prevention and Control, Centers 
for Disease Control and Prevention, 4770 Buford Highway, NE., Mailstop 
K-63, Atlanta, GA 30341, Telephone: 770-488-1308, E-mail address: 
[email protected].
    For questions about peer review, contact: Gwen Cattledge, 
Scientific Review Administrator, National Center for Injury Prevention 
and Control, Centers for Disease Control and Prevention, 4770 Buford 
Highway, NE., Mailstop K-02, Atlanta, GA 30341, Telephone: 770-488-
1430, E-mail address: gxc8@cdc.
    For financial, grants management, or budget assistance, contact: 
Nancy Pillar, Grants Management (or Contract) Specialist, Procurement 
and Grants Office, Centers for Disease Control and Prevention, 2920 
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2721, E-mail 
address: [email protected].

VIII. Other Information--None

    Dated: November 20, 2003.
Edward J. Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 03-29634 Filed 11-26-03; 8:45 am]
BILLING CODE 4163-18-P