[Federal Register Volume 67, Number 89 (Wednesday, May 8, 2002)]
[Notices]
[Pages 30939-30942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11359]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02073]


Traumatic Brain Injury(TBI) Follow-Up Registry and Surveillance 
of TBI in the Emergency Department (ED); Notice of Availability of 
Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) and the Social 
Security Administration (SSA), announce the availability of fiscal year 
(FY) 2002 funds for a cooperative agreement for a TBI Follow-up 
Registry and Surveillance of TBI in the ED. This Program addresses the 
``Healthy People 2010'' focus area for Injury and Violence Prevention. 
For a copy of ``Healthy People 2010'', visit the Internet site: http://www.health.gov/healthypeople.
    The purpose of this program is to fund a follow-up registry that 
collects and analyzes information on outcomes of TBI and develop 
existing surveillance of TBI in the ED. The goal of both programs is to 
produce data of demonstrated quality that will be useful to State 
injury control programs and other State agencies, and document the 
longer term effects of TBI, including disability.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit 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, 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.

C. Availability of Funds

    Approximately $565,000 (including direct and indirect costs) is 
available in FY 2002 to fund one award. It is expected that the award 
will begin on or about September 1, 2002 and will be made for a 12 
month budget period, within a project period of up to three years. 
Funding estimates may change.
    A continuation award within the approved project period will be on 
the basis of satisfactory progress as evidenced by required reports, 
the achievement of work plan milestones, and the availability of 
Federal funds.

1. Use of Funds

    Funds awarded may not be used to supplant funds available from 
other sources to the recipient to conduct similar activities, not be 
used to provide patient care or management and, not to be used for 
construction purposes, rental of office space, or for the purchase or 
rental of furniture. 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 the activities under 1. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under 2. (CDC Activities).

1. Recipient Activities

    a. Develop and implement a system for collecting data on pre-injury 
characteristics, information about acute and other care received and 
post-injury outcomes for a sample of people, including prisoners, 
identified through an existing TBI Surveillance System, and assess 
these outcomes at annual intervals. This includes identifying the 
sample, locating prospective participants and tracking them over time, 
abstracting pertinent medical record data, developing or modifying an 
existing questionnaire, and conducting telephone interviews.
    b. Conduct hospital-based ED surveillance of TBI, consistent with 
standard definitions and methods for CNS surveillance, described in the 
current CDC ``Annual Data Submission Standards for Central Nervous 
System Injury Surveillance.'' (See Section J) This includes linking and 
unduplicating data obtained from emergency departments, including data 
elements that describe diagnosis, demographics, external cause, and 
survival status.
    c. Convene meeting(s) of experts and others to advise on study 
goals, objectives, methods, and analysis of the data.
    d. Compile follow-up data each year.
    e. Analyze and interpret the data and report findings.
    f. Evaluate the quality and completeness of the data.
    g. Conduct yearly evaluations of the surveillance system to assess 
the predictive value positive and sensitivity of case ascertainment as 
well as the completeness and validity of the data collected.
    h. Link surveillance activities and findings to State injury 
prevention and control activities.
    i. Document the study methods.
    j. Develop a research protocol with assistance from CDC for 
Institutional Review Board (IRB) reviews by all cooperating 
institutions participating in the research project.

2. CDC Activities

    Provide technical assistance in conjunction with SSA where 
applicable and as necessary for effective project planning and 
management. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project.
    a. The CDC IRB will review and approve the protocol initially and 
on at least an annual basis until the research project is completed.
    d. Collaborate in the analysis of data and reporting of findings.
    e. Provide technical assistance, as requested, to evaluate the 
surveillance system for completeness and validity.
    f. Convene monthly conference calls with the recipient and SSA 
representative(s) to review progress.
    g. Collaborate with the recipient and SSA representative(s) in the 
analysis of data on employment after TBI.
    h. Participate in discussions with the recipient and SSA 
representative(s) on the feasibility of (a) tracking people with TBI 
who receive SSA, and (b) adding new questions on employment to the 
follow-up registry telephone interview.

E. Content

    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 
evaluation criteria listed, so it is important to follow the criteria 
in laying out your program plan. The narrative (excluding budget 
narrative and any appendices) should be no more than 30 double spaced 
pages, printed on one side, with one inch margins, and no smaller than 
12 point unreduced fonts.

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Number each page consecutively and provide a complete table of 
contents.
    The narrative should include:
    1. Executive Summary (one page, may be single spaced). This section 
should briefly summarize:
    a. Amount of federal assistance requested;
    b. Existing capacity;
    c. Key objectives and activities proposed.
    2. Proposal Narrative.
    a. Introduction, statement of need, proposed goals and objectives, 
and program plan.
    b. Existing program and capacity.
    c. Proposed methods and activities.
    d. Project management and project staff.
    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.

F. Submission and Deadline

Application

    Submit the original and 2 copies of PHS 5161-1 (OMB Number 0920-
0428). Forms are 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 p.m. Eastern Time, June 15, 2002, submit the 
application to the Technical Information Section 2920 Brandywine Road, 
Suite 3000, Atlanta, Georgia 30341.

Deadline

    Applications shall be considered as meeting the deadline if they 
are received before 5 p.m. 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

    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC or 
Agency for Toxic Substance and Disease Registry ATSDR). Does the 
application adequately address the requirements of Title 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:
    A. The proposed plan for the inclusion of both sexes and racial and 
the ethnic minority populations for appropriate representation.
    B. The proposed justification when representation is limited or 
absent.
    C. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    D. 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.
    Applications judged to be noncompetitive will be withdrawn from 
further consideration and CDC will promptly notify the principal 
investigator/Program director and the official signing or the applicant 
organization.
    Awards will be determined by the Director of the National Center 
for Injury Prevention and Control (NCIPC) based on priority scores 
assigned to applications by the Disease, Disability, and Injury 
Prevention and Control Special Emphasis Panel (SEP), consultation with 
NCIPC senior staff, and the availability of funds. All proposals will 
be reviewed using the current National Institutes of Health (NIH) 
priority scoring system to determine the technical and scientific 
quality of the proposal. Factors to be considered will include:
    1. Need for data on TBI incidence and outcomes: The extent to which 
the applicant documents the need for the project to address a key 
public health issue and inform prevention and/or service activities.
    2. Goals and objectives: The extent to which the project goals and 
objectives are relevant, specific, achievable, measurable, time-linked 
and can be addressed through the proposed methods.
    3. Existing TBI Surveillance Program and Capacity: The extent to 
which the applicant describes an effective incidence surveillance 
system for TBI and provides the following:
    a. Case definition for TBI.
    b. Description of the source(s) of TBI case reporting.
    c. Documentation of the timeliness and completeness of case 
ascertainment and other qualitative attributes of the system.
    d. Summary of current surveillance data (i.e., 1999 or 2000).
    e. Description of the prior usefulness of the system.
    4. Capacity for conducting collaborative activities:
    a. The analysis of employment data.
    b. Adding employment questions.
    c. The potential for tracking people with TBI receiving SSA 
assistance.
    5. Methods and Activities:
    a. The extent to which the proposed methods and activities can 
achieve the proposed objectives, consistent with the purposes of this 
Program Announcement.
    b. The extent to which clear explanations of appropriate methods 
are described for the following: addressing case definition(s), case 
ascertainment, including identification and contacting of prisoners, 
TBI participant tracking, data elements, sources and availability of 
data, data collection, including methods for interviewing prisoners, 
protection of confidentiality, data processing and analysis, and a 
brief summary of methods for collaborative activities with the SSA.
    c. The extent to which the operational plan and timetable are 
realistic, given available resources.
    6. Management and Staffing:
    a. The extent to which the scientific resources for project 
planning and data management/analysis are demonstrated within the 
applicant's organization or through collaboration with universities or 
other agencies.

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    b. The extent to which proposed staffing, staff qualifications and 
experience, and project organization indicate ability to accomplish the 
objectives of the program.
    7. Evaluation:
    a. The degree to which the applicant includes plans to evaluate the 
attainment of proposed objectives and the quality of the data 
collected.
    b. The SEP shall assure that measures set forth in the application 
are in accordance with CDC's performance plans.
    8. Human Subjects:
    The extent to which the applicant adequately addresses the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects, including those in subpart C dealing with the protection of 
prisoners as research participants. 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:
    a. The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    C. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    D. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with community or communities and recognition of mutual benefits.
    9. Budget:
    a. The extent to which the budget is reasonable, clearly justified, 
and consistent with stated objectives and proposed activities described 
in this announcement.
    b. The extent to which the budget for collaborative activities with 
the SSA is clearly justified.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with:
    1. An original, plus two copies, and a diskette copy of semi-annual 
progress reports.
    2. Financial status reports, no more than 90 days after the end of 
each 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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement.

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-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 317(k)(2) of the Public 
Health Service Act, [42 U.S.C.247b(k)(2)], as amended. The Catalog of 
Federal Domestic Assistance number is 93.136.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    The current CDC Annual Data Submission Standards for Central 
Nervous System Injury Surveillance can be obtained from Jacqui Butler 
at (770) 488-1496.
    To obtain business management technical assistance contact: Nancy 
Pillar, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Road, Suite 3000, Atlanta, GA 30341-4146, 
Telephone: (770) 488-2721, Fax: (770) 488-2777, Email address: 
[email protected].
    For program technical assistance, contact: Joseph Russel, National 
Center for Injury Prevention and Control, Centers for Disease Control 
and Prevention, 4770 Buford Highway, NE, Mailstop F41, Atlanta, GA 
30341-3724, Telephone: (770) 488-1042, Fax: (770) 488-4338, Email 
address: [email protected].

    Dated: May 2, 2002.
Sandra R. Manning,
Director, Procurement and Grants Office, Center for Disease Control and 
Prevention.

Addendum

Background

    TBI, a preventable disabling condition, is an important public 
health problem in the United States that is estimated to result in 
the annual occurrence of approximately 1,000,000 ED visits, 250,000 
hospital admissions, 50,000 deaths, and the onset of long-term 
disability in more than 80,000 people.
    TBI surveillance provides essential information for primary 
prevention (avoiding the occurrence of TBI) and valuable information 
for secondary prevention (mitigating the severity and sequelae of 
TBI). TBI surveillance also can provide a foundation for population-
based TBI registries. Such registries enable the assessment of the 
burden of TBI related disability and provide essential information 
for planning programs to provide medical care and services for 
people with TBI sequelae. CDC has promoted TBI surveillance through 
funds provided to four States since 1995 (Program Announcement 526 
in 1995 and Program Announcement 98022 in 1998) and eleven more 
States since 1997 (Program Announcement 716).
    Although there are increasing data to describe the current 
incidence and etiology of TBI, little is known, on a population 
basis, about the outcomes and secondary conditions experienced by 
persons who survive traumatic brain injury. These outcomes include: 
their impairments, disabilities (also known as functional 
limitations or decreased activities), and participation 
restrictions, (including major roles such as work or school); the 
occurrence of secondary conditions (i.e., additional physical or 
mental health conditions that occurs as a result of having a primary 
disabling condition); and the need for and use of post-acute 
medical, rehabilitation, and other services. In fact, most of what 
is known about outcomes is based on studies that rely on case series 
methodology, small regional samples, and anecdotal reports. Greater 
understanding of these issues is important for several reasons: 
First, a better understanding of outcomes will add to our knowledge 
about the public health impact and societal costs associated with 
disabling injuries. Second, a better understanding of factors 
associated with increased risk of disability and decreased 
participation could lead to improved acute care and rehabilitation 
interventions aimed at reducing these adverse outcomes and secondary 
conditions. Third, little is known about the needs for services and 
barriers to receiving them following TBI.
    In 1995, under Announcement 526--Part II, CDC funded one State 
(Colorado) to develop a full-scale population-based registry and 
follow-up study of persons with TBI (aged 16 years or older) to 
assess a wide range of outcomes and the need for, and barriers to 
receiving services in the year following injury, and in subsequent 
years. In 1998, under Announcement 98022--Part II, funding to 
Colorado was continued and a second state, South Carolina was funded 
to develop a similar registry, in collaboration with the Colorado 
project. In 2000, the Colorado project was completed and the SC 
project was continued.

Key References

    U.S. Department of Health and Human Services. Healthy People 
2010. Tracking.

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Healthy People 2010. Conference Edition November 30, 1999.
    Institute of Medicine. Enabling America Assessing the Role of 
Rehabilitation Science and Engineering. Brandt EN, Pope AM, Editors. 
National Academy Press, Washington, DC 1997. Published 
epidemiological studies of TBI are also reviewed in the section 
entitled ``Epidemiology of Traumatic Brain Injury in the United 
States'' located at the Internet Website of the CDC National Center 
for Injury Prevention and Control http://www.cdc.gov/ncipc/dacrrdp/tbi.htm>.

Definitions:

    Traumatic brain injury (TBI) and essential data elements for TBI 
surveillance are fully defined in CDC's Guidelines for Surveillance 
of Central Nervous System Injury. (For ordering a copy of the 
Guidelines, see Section J.--Where to Obtain Additional Information.)
    Surveillance is the ongoing, systematic collection, analysis, 
and interpretation of health data necessary for designing, 
implementing, and evaluating public health programs.
    Impairment: Any loss or abnormality of physiological, or 
anatomical structure or function.
    Restriction in Activity (Disability): Any restriction or lack 
(resulting from an impairment) of ability to perform an activity in 
the manner or within the range considered normal for a human being.
    Restriction in participation (Handicaps): a disadvantage for a 
given individual, resulting from an impairment or a disability, that 
limits or prevents the fulfillment of a role that is normal 
(depending on age, sex, and social and cultural factors) for that 
individual.
    A population-based follow-up system is defined as a system of 
ongoing registration of, and collection of information about, all or 
a representative sample of all cases of a condition in a defined 
population, such that cases can be related to the population base.

Elements of Disability:

    Impairment: Any loss or abnormality of physiological, or 
anatomical structure or function.
    Restriction in Activity (Disability): Any restriction or lack 
(resulting from an impairment) of ability to perform an activity in 
the manner or within the range considered normal for a human being.
    Restriction in participation (Handicaps): a disadvantage for a 
given individual, resulting from an impairment or a disability, that 
limits or prevents the fulfillment of a role that is normal 
(depending on age, sex, and social and cultural factors) for that 
individual.

[FR Doc. 02-11359 Filed 5-7-02; 8:45 am]
BILLING CODE 4163-18-P