[Federal Register: November 28, 2003 (Volume 68, Number 229)]
[Notices]
[Page 66834-66839]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no03-68]
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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: http://www.cdc.gov/od/pgo/forminfo.htm. Forms and
instructions are also available in an interactive format on the
National Institutes of Health (NIH) Web site at the following Internet
address: http://grants.nih.gov/grants/funding/phs398/phs398.html.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
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: GrantsInfo@nih.gov.
Your research plan should address activities to be conducted over
the entire project period.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. Your DUNS number must be entered
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 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.
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: cipert@cdc.gov.
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
[[Page 66839]]
http://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: mballesteros@cdc.gov.
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: nfp6@cdc.gov.
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