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/ 2002
/ May
/ Wednesday, May 08, 2002
[Federal Register: May 8, 2002 (Volume 67, Number 89)]
[Notices]
[Page 30932-30935]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08my02-119]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 02127]
Grants for Acute Care, Rehabilitation and Diability; Prevention
Research; Notice of Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2002 funds for a grant program for
Grants for Acute Care, Rehabilitation and Disability Prevention
Research. This program addresses the ``Healthy People 2010'' focus area
of Injury and Violence Prevention.
The purposes of the program are to:
1. Solicit research applications that address the priorities
reflected under the heading, ``Program Requirements.''
2. Build the scientific base for the prevention and control of
injury and disability.
3. Encourage professionals from a wide spectrum of disciplines such
as medicine, health care, public health, health care research,
behavioral and social sciences, and others, to undertake research to
prevent and control injuries.
4. Encourage investigators to propose research that involves
intervention development and testing as well as research on methods, to
encourage individuals, organizations, or communities to adopt and
maintain effective intervention strategies.
B. Eligible Applicants
Applications may be submitted by public and private non-profit and
for-profit organizations and by governments and their agencies; that
is, universities, colleges, research institutions, hospitals, other
public and private non-profit and for-profit organizations, faith-based
organizations, State and local governments or their bona fide agents,
including the District of Columbia, the Commonwealth of Puerto Rico,
the Virgin Islands, the Commonwealth of the Northern Mariana Islands,
American Samoa, Guam, the Federated States of Micronesia, the Republic
of the Marshall Islands, and the Republic of Palau, federally
recognized Indian tribal governments, Indian tribes, or Indian tribal
organizations, and small, minority, and women-owned businesses.
Note: Title 2 of the United States code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant or loan.
Applications that are incomplete or non-responsive to the below
requirements will be returned to the applicant without further
consideration. The following are applicant requirements:
1. A principal investigator who has conducted research, published
the findings in peer-reviewed journals, and has specific authority and
responsibility to carry out the proposed project.
2. Demonstrated experience on the applicant's project team in
conducting, evaluating, and publishing injury control research in peer-
reviewed journals.
3. Effective and well defined working relationships within the
performing organization and with outside entities which will ensure
implementation of the proposed activities.
4. The ability to carry out injury control research projects as
defined under Attachment 2 (1.a-c). The attachment is contained in the
application package.
5. The overall match between the applicant's proposed theme and
research objectives, and the program priorities as described under the
heading, ``Program Requirements.''
C. Availability of Funds
Approximately $500,000 is available in FY 2002 to fund
approximately two awards.
It is expected that the awards will begin on or about September 30,
2002, and will be made for a 12-month budget period within a project
period of up to three years. The maximum funding level will not exceed
$250,000 (including both direct and indirect costs) per year or
$750,000 for the three-year project period.
Consideration will also be given to current grantees who submit a
competitive supplement 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 end of fiscal year funds.
Applications that exceed the funding caps noted above will be
excluded from the competition and returned to the applicant. The
availability of Federal funding may vary and is subject to change.
Continuation awards within the project period will be made based on
satisfactory progress demonstrated by investigators at work-in-progress
monitoring workshops (travel expenses for this annual one day meeting
should be included in the applicant's proposed budget), and the
achievement of work plan milestones reflected in the continuation
application.
Note: Grant funds will not be made available to support the
provision of direct care. Eligible applicants may enter into
contracts, including consortia agreements (as set forth in the PHS
Grants Policy Statement, dated April 1, 1994), as necessary to meet
the requirements of the program and strengthen the overall
application.
D. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for either Research Activity 1 or
Research Activity 2:
1. Develop and evaluate protocols that provide onsite interventions
in acute care settings or linkages to off-site services for patients at
risk of injury or psychosocial problems following injury (See
Attachment 3 in the application kit).
2. Develop and apply methods for calculating population-based
estimates of the incidence, costs, and long-term
[[Page 30933]]
consequences of nonhospitalized traumatic brain injury (TBI) and spinal
cord injury (SCI) (See Attachment 3 in the application kit).
E. Content
Letter of Intent (LOI)
A LOI is optional for this program. The program announcement title
and number must appear in the LOI. The narrative should be no more than
two pages, double-spaced, printed on one side, with one inch margins,
and unreduced font. Your letter of intent will be used to enable CDC to
determine the level of interest in the announcement and should include
the following information: Name of the principal investigator and a
brief description of the scope and intent of the proposed research
work.
Application
The program announcement title and number must appear in the
application. Use the information in the Program Requirements, Other
Requirements, and Evaluation Criteria sections to develop the
application content. Your application will be evaluated on the criteria
listed, so it is important to follow them in laying out your program
plan.
The narrative should consist of, at a minimum, a plan, objectives,
methods, evaluation, and budget. Applications should follow the PHS-398
(Rev. 5/2001) application and Errata Sheet (see Attachment 4 in the
application kit), and should include the following information:
1. The project's focus that justifies the research needs and
describes the scientific basis for the research, the expected outcome,
and the relevance of the findings to reduce injury morbidity,
mortality, disability, and economic losses. This focus should be based
on recommendations in ``Healthy People 2010'' and should seek creative
approaches that will contribute to a national program for injury
control.
2. Specific, measurable, and time-framed objectives.
3. A detailed plan describing the methods by which the objectives
will be achieved, including their sequence. A comprehensive evaluation
plan is an essential component of the application.
4. A description of the principal investigator's role and
responsibilities.
5. A description of all the project staff, regardless of their
funding source. It should include their title, qualifications,
experience, percentage of time each will devote to the project, as well
as that portion of their salary to be paid by the grant.
6. A description of those activities related to, but not supported
by the grant.
7. 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.
8. A detailed first year's budget for the grant with future annual
projections, if relevant.
9. 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.
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.
F. Submission and Deadline
Letter of Intent (LOI)
On or before May 31, 2002, submit the LOI to the Grants Management
Specialist identified in the ``Where to Obtain Additional Information''
section of this announcement.
Application
Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for
PHS 398). Forms are available in the application kit and at the
following Internet address: www.cdc.gov/od/pgo/forminfo.htm.
Application forms must be submitted in the following order:
Cover Letter
Table of Contents
Application
Budget Information Form
Budget Justification
Checklist
Assurances
Certifications
Disclosure Form
HIV Assurance Form (if applicable)
Human Subjects Certification (if applicable)
Indirect Cost Rate Agreement (if applicable)
Narrative
On or before 5 PM Eastern Time, June 14, 2002, submit the
application to: Technical Information Management-PA02127, Procurement
and Grants Office, Centers for Disease Control and Prevention, 2920
Brandywine Rd, Room 3000, Atlanta, GA 30341-4146.
Deadline: letters of intent and applications shall be considered as
meeting the deadline if they are received before 5 PM Eastern Time on
the deadline date. Applicants sending applications by the United States
Postal Service or commercial delivery services must ensure that the
carrier will be able to guarantee delivery of the application by the
closing date and time. If an application is received 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, CDC will upon receipt of proper
documentation, consider the application as having been received by the
deadline.
Applications which do not meet the above criteria will not be
eligible for competition and will be discarded. Applicants will be
notified of their failure to meet the submission requirements.
G. Evaluation Criteria
Application
Upon receipt, applications will be reviewed by CDC staff for
completeness and responsiveness as outlined under the ``Eligible
Applicants'' Section (Items 1-5). Incomplete applications and
applications that are not responsive will be returned to the applicant
without further consideration. It is especially important that the
applicant's abstract reflects the project's focus, because the abstract
will be used to help determine the responsiveness of the application.
Applications which are complete and responsive may be subjected to
a preliminary evaluation (triage) by a peer review committee, the
Injury Research Grant Review Committee (IRGRC), to determine if the
application is of sufficient technical and scientific merit to warrant
further review by the IRGRC. 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.
If end of fiscal year funds are available to support research work
or activities not previously approved by the IRGRC, competitive
supplemental grant awards may be made. Competitive
[[Page 30934]]
supplement applications should be clearly labeled to denote their
status as requesting supplemental funding support. These applications
will be reviewed by the IRGRC and the secondary review group.
All awards will be determined by the Director of the NCIPC based on
priority scores assigned to applications by the primary review
committee IRGRC, recommendations by the secondary review committee
Advisory Committee for Injury Prevention and Control (ACIPC),
consultation with NCIPC senior staff, and the availability of funds.
1. The primary review will be a peer review conducted by the IRGRC.
All applications will be reviewed for scientific merit using current
National Institutes of Health (NIH) criteria to evaluate the methods
and scientific quality of the application. Factors to be considered
will include:
a. 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?
b. 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?
c. Innovation. Does the project employ novel concepts, approaches
or methods? Are the aims original and innovative? Does the project
challenge or advance existing paradigms, or develop new methodologies
or technologies?
d. Investigator. Is the principal investigator appropriately
trained and well-suited to carry out this work? Is the proposed work
appropriate to the experience level of the principal investigator and
other significant investigator participants? Is there a prior history
of conducting injury-related research?
e. Environment. Does the scientific environment in which the work
will be done contribute to the probability of success? Does the
proposed research 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?
f. Ethical Issues. What provisions have been made for the
protection of human subjects and the safety of the research
environments? How does the applicant plan to handle issues of
confidentiality and compliance with mandated reporting requirements,
e.g., suspected child abuse? Does the application adequately address
the requirements of 45 CFR part 46 for the protection of human
subjects? (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.) The degree to which the
applicant has met the CDC Policy requirements regarding the inclusion
of women, ethnic, and racial groups in the proposed research. This
includes:
i. The proposed plan for the inclusion of both sexes and racial and
ethnic minority populations for appropriate representation.
ii. The proposed justification when representation is limited or
absent.
iii. A statement as to whether the design of the study is adequate
to measure differences when warranted.
iv. 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.
g. 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?
h. Dissemination. What plans have been articulated for
disseminating findings?
The IRGRC will also examine the appropriateness of the proposed
project budget and duration in relation to the proposed research and
the availability of data required for the project.
2. The secondary review will be conducted by the Science and
Program Review Committee (SPRS) from the ACIPC. The ACIPC Federal ex
officio members 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). Federal ex officio members 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 Federal ex officio members 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 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 delineated in the National Research Agenda.
d. Budgetary considerations.
3. Continued Funding. Continuation awards made after FY 2002, but
within the project period, will be made on the basis of the
availability of funds and the following criteria:
a. 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 demonstrated through
presentations at work-in-progress monitoring workshops.
b. The objectives for the new budget period are realistic,
specific, and measurable.
c. The methods described will clearly lead to achievement of these
objectives.
[[Page 30935]]
d. The evaluation plan will allow management to monitor whether the
methods are effective.
e. The budget request is clearly explained, adequately justified,
reasonable and consistent with the intended use of grant funds.
H. Other Requirements
Technical Reporting Requirements
Provide CDC with an original plus two copies of:
1. Annual progress report,
2. A financial status report, no more than 90 days after the end of
the budget period,
3. Final financial report and performance report, 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 (2,500 to 4,000 words written in non-scientific
[laymen's] terms) summary highlighting 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 practioners, 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.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
The following additional requirements are applicable to this
program. For a complete description of each see Attachment 1 of the
application kit.
AR-1 Human Subjects Certification
AR-2 Requirements for inclusion of Women and Racial and Ethnic
Minorities in Research
AR-3 Animal Subjects Requirement
AR-9 Paperwork Reduction Requirements
AR-10 Smoke-Free Workplace Requirement
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
I. Authority and Catalog of Federal Domestic Assistance Number
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. 280(b)]
of the Public Service Health Act, as amended. The Catalog of Federal
Domestic Assistance number is 93.136.
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
associated forms can be found on the CDC home page Internet address--
http://www.cdc.gov. Click on ``Funding Opportunities'' then ``Grants
and Cooperative Agreements.''
For business management technical assistance, contact: Van A. King,
Grants Management Specialist, Procurement and Grants Office, Centers
for Disease Control and Prevention, 2920 Brandywine Road, Room 3000,
Atlanta, Georgia 30341-4146. Telephone number (770) 488-2751. e-mail
address: vbk5@cdc.gov.
For program technical assistance, contact: Sharon Martin, Deputy
Director, Office of Research Grants, National Center for Injury
Prevention and Control, Centers for Disease Control and Prevention
(CDC), 4770 Buford Highway, NE., Mailstop K-58, Atlanta, GA 30341-3724.
Telephone number: (770) 488-4265. e-mail address: sat5@cdc.gov.
Dated: May 2, 2002.
Sandra R. Manning,
CGFM, Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 02-11360 Filed 5-7-02; 8:45 am]
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