[Federal Register: June 2, 2003 (Volume 68, Number 105)]
[Notices]
[Page 32753-32756]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02jn03-86]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 03106]
Development and Validation of Measures To Assess Outcomes of Mild
Traumatic Brain Injury; Notice of Availability of Funds
Application Deadline: July 2, 2003.
A. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under sections 391, 317(k)(2), and
301(a) of the Public Health Service Act, (42 U.S.C. sections 280b,
247b(k)(2), and 241(a)). The Catalog of Federal Domestic Assistance
number is 93.136.
B. Purpose
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 2003 funds for a cooperative agreement
for the development and validation of measures to assess outcomes of
mild traumatic brain injury (MTBI). This program addresses the
``Healthy People 2010'' focus area, Injury and Violence Prevention.
The purpose of this program is to fund research to develop reliable
and valid measures for assessing longer-term outcomes of mild traumatic
injury. These measures should be applicable to future population-based
studies of outcomes of MTBI to estimate the prevalence of MTBI-related
disability (See Attachment 2 of the announcement as posted on the CDC
Web site).
Measurable outcomes of this research study will be in alignment
with the following performance goal for the National Center for Injury
Prevention and Control (NCIPC), described as a priority in the NCIPC
Research Agenda: To monitor and detect fatal and non-fatal injuries.
C. Eligible Applicants
Applications may be submitted by: Public nonprofit organizations,
private nonprofit organizations, universities, colleges, technical
schools, research institutions, hospitals, managed care organizations,
community-based organizations, faith-based organizations, federally
recognized Indian tribal governments, Indian tribes, Indian tribal
organizations, State and local governments or their bona fide agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of Northern Mariana Islands,
American Samoa, Guam, the Federated States of Micronesia, the Republic
of the Marshall Islands, and the Republic of Palau.)
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.
D. Funding
Availability of Funds
Approximately $500,000 is available in FY 2003 to fund one award.
It is expected that the award will begin on or about September 15, 2003
and will be made for a 12-month budget period within a project period
of up to four years. The funding estimate may change.
Continuation awards within an approved project period will be made
on the basis of satisfactory progress as evidenced by required reports
and the availability of funds.
Use of Funds
Funds awarded may not be used to supplant funds available from
other sources to the recipient to conduct similar activities. Funds are
not to be used for construction purposes, the rental of office space,
or for the purchase or rental of furniture. Eligible applicants may
enter into contracts including consortia agreements as necessary to
meet the requirements of the program and strengthen the overall
application.
Recipient Financial Participation
Matching funds are not required for this program.
E. Program Requirements
In conducting activities to achieve the purpose of this program,
the recipient will be responsible for the activities listed in 1.
Recipient Activities, and CDC will be responsible for the activities
listed in 2. CDC Activities.
1. Recipient Activities
a. With assistance from the CDC, prepare a detailed research
protocol for Institutional Review Board (IRB) approval by all
cooperating institutions participating in the study. The protocol shall
include but is not limited to the following: Detailed description of
methods for selecting the study sample, recruitment and enrollment
methods, the informed consent process and consent forms, study
instruments including questionnaires if applicable, methods for data
handling and storage including methods for ensuring participant
confidentiality, data analysis, and plans for data dissemination.
b. Develop a detailed operations manual and other manuals
documenting study methods.
c. Train study personnel.
d. Recruit and enroll study participants.
e. Collect and enter the data.
f. Analyze and interpret the data.
g. Report study findings, including in peer-reviewed
publication(s).
2. CDC Activities
a. Assist in effective study planning and management.
b. CDC will provide critical guidance related to the study design,
including the case definition for mild traumatic brain injury and
selection of the study population.
c. Assist in the development of a research protocol for
Institutional Review Board (IRB) review by all cooperating institutions
participating in the research. The CDC IRB will review and approve the
protocol initially and on at least an annual basis until the research
project is completed.
d. CDC will provide guidance about protocol format and content as
well as scientific and human subjects considerations.
e. CDC staff will collaborate in the analysis of data.
f. CDC will collaborate in the reporting of findings by
participating as co-authors in the preparation of peer-reviewed
publications.
g. CDC staff will convene routine conference calls with the
recipient and
[[Page 32754]]
conduct a site visit annually or as needed to review progress.
F. Content
Letter of Intent (LOI)
A LOI is optional for this program. The Program Announcement title
and number must appear in the LOI. The LOI should be no more than two
pages, double-spaced, printed on one side, with one-inch margins, and
unreduced 12-point Times Roman font. Your LOI will be used to determine
level of interest in the announcement. The LOI should include the
following information:
1. Program Announcement Number 03106.
2. Name and address of institution.
3. Name and telephone number of the principal investigator.
4. A summary of the key research hypotheses, study design and
proposed methods you intend to use if awarded funding.
5. A brief description of proposed collaborations with health
departments or other entities, if applicable.
Applications
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 be no more than 30 (8\1/2\'' x 11'') double-
spaced pages, printed on one side, with one inch margins on all four
sides, and unreduced 12-point Times Roman font, and a page number at
the bottom of each page. Applications with more than 30 pages will be
returned and not reviewed. Please provide only attachments or
appendices that are directly relevant to this request for funding.
Include sample forms and data collection instruments. The budget and
attachments/appendices, including letters of support, are not included
in the count for the 30-page limit. All pages, including appendices,
must be numbered sequentially.
Applications should follow the PHS-398 (Rev. 5/2001) application
and Errata sheet. The PHS 398 Errata sheet is posted on the CDC web
site. The narrative should contain the following information in the
order presented:
1. Abstract (1 page recommended).
a. Provide a brief abstract of the proposed study including key
research hypotheses, study design and proposed methods.
b. The abstract must reflect the study's focus and the length of
the project period (maximum of four years) for which assistance is
being requested (see ``Availability of Funds''). Amount of federal
assistance requested.
2. Proposal Narrative
a. Background, including literature review and justification of the
need for the research.
b. Goals, objectives, and timeline for completion.
c. Study design and methods, including hypotheses to be tested,
proposed study population and methods for selection of the study
sample, proposed time post-injury for assessing participants, case
definition for mild traumatic brain injury, existing measure(s) to be
validated or proposed methods for development of new measure(s),
methods for assessing the reliability and validity of measure(s), and
data analysis methods.
d. Study management and staffing, including institutional
resources, investigator and staff qualifications and experience.
e. Proposed methods to evaluate the attainment of objectives.
3. Budget Narrative
4. Human Subjects
5. Appendices--which may include letters of commitment from key
collaborators, resumes of key staff, brief summary reports of analyses
of TBI surveillance data.
G. Submission and Deadline
Letter of Intent (LOI) Submission
The LOI must be received by June 17, 2003. Submit the LOI, on the
applicant's letterhead, to the Grants Management Specialist identified
in the ``Where to Obtain Additional Information'' section of this
announcement.
Application Forms
Submit the signed 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 at the following Internet address:
http://www.cdc.gov/od/pgo/forminfo.htm.
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) at: 770-488-2700. Application forms can be mailed to you.
Submission Date, Time, and Address
The application must be received by 4 p.m. Eastern Time July 2,
2003. Submit the application to: Technical Information Management-PA
03106, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341-4146.
Applications may not be submitted electronically.
CDC Acknowledgment of Application Receipt
A postcard will be mailed by PGO-TIM, notifying you that CDC has
received your application.
Deadline
Letters of Intent and applications shall be considered as meeting
the deadline if they are received before 4:00 Eastern Time on the
deadline date. Any applicant who sends their application 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, natural or manmade disasters, CDC will upon receipt of
proper documentation, consider the application as having been received
by the deadline.
Any application that does not meet the above requirements will not
be eligible for competition, and will be discarded. The applicant will
be notified of their failure to meet the submission requirements.
H. Evaluation Criteria
Application
Applications which are complete and responsive may be subjected to
a preliminary evaluation (streamline review) by a peer review
committee, the Special Emphasis Panel (SEP), to determine if the
application is of sufficient and scientific merit to warrant further
review by the SEP. 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. A dual review process will evaluate
applications that are complete and responsive.
All awards will be determined by the Director of the NCIPC based on
priority scores assigned to applications by the primary review
committee SEP, recommendations by the secondary review committee of the
Science and Program Review Subcommittee of the Advisory Committee for
Injury Prevention and Control (ACIPC), consultation with NCIPC senior
staff, and the availability of funds.
[[Page 32755]]
1. The primary review will be a peer review conducted by the SEP. A
committee of reviewers with appropriate expertise will review all
applications 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. All categories
are of equal importance, however, the application does not need to be
strong in all categories to be judged likely to have a major scientific
impact.
Factors to be considered will include:
a. Significance--Does this study address an important problem? Does
the applicant justify the present proposal using existing scientific
knowledge? 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 describe the specific questions
this research is intended to address? Does the applicant describe how
relevant behavioral theories will be applied to encourage the proposed
activities? 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 years?
Does the applicant describe methods for selecting the study
population and study sample, timing of assessments post-injury, and
identifying participants (case definition for MTBI) measure(s) or
validating existing measure(s) of outcomes of MTBI, and for assessing
the reliability and validity of those measures?
Are there adequate plans for data collection and data management
including security of data, assurance of participant confidentiality,
data entry, editing, and quality assurance procedures? Is there a
statistical analysis plan appropriate for the study design?
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 TBI-related research? Does the applicant document
capacity to accomplish the proposed study as demonstrated by relevant
past or current experience conducting research on TBI outcomes and/or
developing and validating outcome measures?
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? 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 the involvement? Is there evidence of the experience and
capacity for all key staff members including CVs and position
descriptions?
f. 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?
g. 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? Not 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.
Does the application adequately address the CDC Policy requirements
regarding the inclusion of women, ethnic, and racial groups in the
proposed research? This includes:
(1) The proposed plan for the inclusion of both sexes and racial
and ethnic minority populations for appropriate representation.
(2) The proposed justification when representation is limited or
absent.
(3) A statement as to whether the design of the study is adequate
to measure differences when warranted.
(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.
h. Dissemination--What plans have been articulated for
disseminating findings?
i. Measures of Effectiveness--The Peer Review 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?
j. Budget--The SEP 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 Subcommittee (SPRS) of the ACIPC. ACIPC Federal agency
experts will be invited to attend the secondary review and will receive
modified briefing books (i.e., abstracts, strengths and weaknesses from
summary statements, and project officer's briefing materials). ACIPC
Federal agency experts will be encouraged to participate in
deliberations when applications address overlapping areas of research
interest so that unwarranted duplication in federally funded research
can be avoided and special subject area expertise can be shared. The
NCIPC Division Associate Directors for Science (ADS) or their designees
will attend the secondary review in a similar capacity as the ACIPC
Federal agency experts to assure that research priorities of the
announcement are understood and to provide background regarding current
research activities. Only SPRS members will vote on funding
recommendations, and their recommendations will be carried to the
entire ACIPC for voting by the ACIPC members in closed session. If any
further review is needed by the ACIPC, regarding the recommendations of
the SPRS, the factors considered
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would be the same as those considered by the SPRS.
The Subcommittee'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 Subcommittee 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,'' the
Institute of Medicine report, ``Reducing the Burden of Injury,'' and
the NCIPC ``Injury Research Agenda.''
d. Budgetary considerations including the extent to which the
budget is reasonable, clearly justified, and consistent with the
intended use of funds.
I. Other Requirements
Technical Reporting Requirements
Provide CDC with original plus two copies of:
1. Interim progress reports, 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 reports, 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.
Send all reports to the Grants Management Specialist identified in
the ``Where to Obtain Additional Information'' section of this
announcement.
Additional Requirements
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment I of the
program announcement, as posted on the CDC Web site.
AR-1 Human Subjects Requirements
AR-2 Requirements for Inclusion of Women and Racial and Ethnic
Minorities in Research
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-13 Prohibition on Use of CDC funds for Certain Gun Control
Activities
AR-14 Accounting System Requirements
AR-15 Proof of Non-Profit Status
AR-21 Small, Minority, and Women-Owned Business
AR-22 Research Integrity
Executive order 12372 does not apply to this program.
J. Where To Obtain Additional Information
This and other CDC announcements, the necessary applications, and
associated forms can be found on the CDC web site, Internet address:
http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative
Agreements''.
For general questions about this announcement, contact: Technical
Information Management, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
For business management and budget assistance, contact: Wanda
Allison, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-
488-2645, E-mail address: wallison@cdc.gov. For business management and budget assistance in the territories,
contact: Angelia Hill, Grants Management Specialist, CDC Procurement
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146,
Telephone: (770) 488-2785, E-mail address: aph8@cdc.gov. For program technical assistance, contact: Stacy Harper, National
Center for Injury Prevention and Control, Centers for Disease Control
and Prevention, 4770 Buford Highway NE, MS F-41, Atlanta, GA 30341-
3724, Telephone number (770) 488-4031, E-mail address:
slharper@cdc.gov.
Dated: May 23, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 03-13652 Filed 5-30-03; 8:45 am]
BILLING CODE 4163-18-P