[Federal Register Volume 68, Number 105 (Monday, June 2, 2003)]
[Notices]
[Pages 32753-32756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13652]


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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: [email protected].
    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: [email protected].
    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: 
[email protected].

    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